albuterol has been researched along with Airflow Obstruction, Chronic in 694 studies
Albuterol: A short-acting beta-2 adrenergic agonist that is primarily used as a bronchodilator agent to treat ASTHMA. Albuterol is prepared as a racemic mixture of R(-) and S(+) stereoisomers. The stereospecific preparation of R(-) isomer of albuterol is referred to as levalbuterol.
albuterol : A member of the class of phenylethanolamines that is 4-(2-amino-1-hydroxyethyl)-2-(hydroxymethyl)phenol having a tert-butyl group attached to the nirogen atom. It acts as a beta-adrenergic agonist used in the treatment of asthma and chronic obstructive pulmonary disease (COPD).
| Excerpt | Relevance | Reference |
|---|---|---|
| " The aim of this study was to evaluate the effect of albuterol spray on hypoxia and bronchospasm in patients with COPD under general anesthesia." | 9.69 | The Effect of Albuterol Spray on Hypoxia and Bronchospasm in Patients with Chronic Obstructive Pulmonary Disease (COPD) under General Anesthesia: A bouble-Blind Randomized Clinical Trial. ( Barzegari, A; Maddah, SA, 2023) |
| "Results of a prospective study comparing clinical outcomes and costs of levalbuterol versus albuterol therapy for exacerbations of asthma or chronic obstructive pulmonary disease (COPD) are presented." | 9.20 | Clinical outcomes and treatment cost comparison of levalbuterol versus albuterol in hospitalized adults with chronic obstructive pulmonary disease or asthma. ( Brunetti, L; Dhanaliwala, F; Kang, H; Poiani, G; Poppiti, K; Suh, DC, 2015) |
| "In subjects with either asthma or COPD, FEV(1) decline and bronchospasm can occur following inhaled loxapine, but more frequently in asthmatic subjects." | 9.19 | Safety and tolerability of inhaled loxapine in subjects with asthma and chronic obstructive pulmonary disease--two randomized controlled trials. ( Cassella, JV; Fishman, RS; Greos, LS; Gross, N; Meltzer, EO; Spangenthal, S; Spyker, DA, 2014) |
| "The National Heart, Lung, and Blood Institute guideline recommends that dosing racemic albuterol be administered every 1 to 4 hours for treating patients with asthma or chronic obstructive pulmonary disease (COPD) in the hospital." | 9.13 | Comparison of levalbuterol and racemic albuterol in hospitalized patients with acute asthma or COPD: a 2-week, multicenter, randomized, open-label study. ( Andrews, WT; Ciubotaru, RL; Claus, R; Donohue, JF; Hanania, NA; Noe, L; Pasta, DJ; Roach, J; Schaefer, K, 2008) |
| "To compare in a group of doctor-diagnosed patients with asthma or COPD, the effects of a lower dose of fluticasone in a combination product with salmeterol with conventional treatment (i." | 9.12 | Lower inhaled steroid requirement with a fluticasone/salmeterol combination in family practice patients with asthma or COPD. ( Albers, JM; Costongs, RJ; Schermer, TR; Verblackt, HW; Westers, P, 2007) |
| "This analysis was designed to provide a comparison between budesonide/formoterol and salmeterol/fluticasone for the relative incidence of pneumonia adverse events, pneumonia serious adverse events and pneumonia-related mortality in patients being treated for chronic obstructive pulmonary disease." | 8.87 | Budesonide/formoterol vs. salmeterol/fluticasone in COPD: a systematic review and adjusted indirect comparison of pneumonia in randomised controlled trials. ( Edwards, SJ; Gray, J; Halpin, DM; Morais, J; Singh, D, 2011) |
| "This study aimed to investigate whether airway obstruction could interfere with real FENO levels and if different FeNO changes after albuterol inhalation could assist in distinguishing asthma from chronic obstructive pulmonary disease (COPD)." | 7.85 | Albuterol inhalation increases FeNO level in steroid-naive asthmatics but not COPD patients with reversibility. ( Cai, S; Dong, H; Li, R; Lv, Y; Wu, Y; Xiao, G; Yao, L; Zhao, H, 2017) |
| "We report a case of paradoxical bronchospasm to both levalbuterol and albuterol." | 7.73 | Paradoxical bronchospasm: a potentially life threatening adverse effect of albuterol. ( Nagajothi, N; Raghunathan, K, 2006) |
| "To report a case of acute myocardial infarction (AMI) following the use of albuterol (salbutamol) in a patient without preexisting coronary artery disease and to review the related literature." | 7.72 | Acute myocardial infarction associated with albuterol. ( Davis, MW; Fisher, AA; McGill, DA, 2004) |
| "A subset of patients with chronic obstructive pulmonary disease (COPD) may respond more favorably to inhaled corticosteroids (ICS), but no simple method is currently utilized to predict the presence or absence of ICS responses in patients with COPD." | 6.73 | Exhaled nitric oxide, systemic inflammation, and the spirometric response to inhaled fluticasone propionate in severe chronic obstructive pulmonary disease: a prospective study. ( Janoff, EN; Kunisaki, KM; Niewoehner, DE; Rector, TS; Rice, KL, 2008) |
| " Whether inhaled corticosteroids by themselves or in combination with a long-acting beta2-adrenoceptor agonist repress systemic inflammation in chronic obstructive pulmonary disease is unknown." | 6.72 | Can inhaled fluticasone alone or in combination with salmeterol reduce systemic inflammation in chronic obstructive pulmonary disease? Study protocol for a randomized controlled trial [NCT00120978]. ( Cowie, RL; FitzGerald, M; Ford, G; Mainra, RR; Man, SF; Marciniuk, DD; Melenka, LS; Ramesh, W; Rousseau, R; Sin, DD; Wilde, E; Williams, D; Wong, E; York, E, 2006) |
| "Before and after each course of treatment, airway inflammation was assessed via exhaled nitric oxide breath testing." | 6.72 | Randomized placebo controlled assessment of airway inflammation due to racemic albuterol and levalbuterol via exhaled nitric oxide testing. ( Allan, PF; Arora, R; Freiler, JF; Hagan, L; Kelley, TC, 2006) |
| "For patients with chronic obstructive pulmonary disease, quick-relief and long-acting bronchodilators are primarily used in the maintenance and treatment of associated symptoms, including shortness of breath." | 6.42 | Levalbuterol in the treatment of patients with asthma and chronic obstructive lung disease. ( Dalonzo, GE, 2004) |
| " The aim of this study was to evaluate the effect of albuterol spray on hypoxia and bronchospasm in patients with COPD under general anesthesia." | 5.69 | The Effect of Albuterol Spray on Hypoxia and Bronchospasm in Patients with Chronic Obstructive Pulmonary Disease (COPD) under General Anesthesia: A bouble-Blind Randomized Clinical Trial. ( Barzegari, A; Maddah, SA, 2023) |
| "Levalbuterol-treated patients required significantly fewer treatments with beta-agonists (mean [+/- SD] number of treatments, 19." | 5.32 | Levalbuterol compared to racemic albuterol: efficacy and outcomes in patients hospitalized with COPD or asthma. ( Halpern, M; Truitt, T; Witko, J, 2003) |
| "The long-acting muscarinic antagonist, umeclidinium (UMEC), combined with the inhaled corticosteroid, fluticasone furoate (FF), improves lung function in symptomatic patients with asthma." | 5.24 | The effect of umeclidinium on lung function and symptoms in patients with fixed airflow obstruction and reversibility to salbutamol: A randomised, 3-phase study. ( Collison, K; Kerwin, E; Lee, L; Nelsen, L; Pascoe, S; Wu, W; Yang, S, 2017) |
| "Results of a prospective study comparing clinical outcomes and costs of levalbuterol versus albuterol therapy for exacerbations of asthma or chronic obstructive pulmonary disease (COPD) are presented." | 5.20 | Clinical outcomes and treatment cost comparison of levalbuterol versus albuterol in hospitalized adults with chronic obstructive pulmonary disease or asthma. ( Brunetti, L; Dhanaliwala, F; Kang, H; Poiani, G; Poppiti, K; Suh, DC, 2015) |
| "Results confirm the antioxidant dose- and time-dependent activity of erdosteine, and support the utility of including erdosteine it in the therapeutic strategy for the prevention and treatment of oxidative stress-induced inflammation, which frequently leads to AECOPD occurrence." | 5.20 | Efficacy of erdosteine 900 versus 600 mg/day in reducing oxidative stress in patients with COPD exacerbations: Results of a double blind, placebo-controlled trial. ( Dal Negro, RW; Turco, P; Visconti, M, 2015) |
| "In subjects with either asthma or COPD, FEV(1) decline and bronchospasm can occur following inhaled loxapine, but more frequently in asthmatic subjects." | 5.19 | Safety and tolerability of inhaled loxapine in subjects with asthma and chronic obstructive pulmonary disease--two randomized controlled trials. ( Cassella, JV; Fishman, RS; Greos, LS; Gross, N; Meltzer, EO; Spangenthal, S; Spyker, DA, 2014) |
| " Changes in pulmonary function, dyspnea, and rescue levalbuterol use were evaluated, as were safety outcomes." | 5.14 | Effects of arformoterol twice daily, tiotropium once daily, and their combination in patients with COPD. ( Andrews, WT; Donohue, JF; Goodwin, E; Hanrahan, JP; Huang, H; Mahler, DA; Schaefer, K; Tashkin, DP, 2009) |
| " In a post hoc analysis of the TOwards a Revolution in COPD Health (TORCH) study, we analysed and identified potential risk factors for adverse event reports of pneumonia in this randomised, double-blind trial comparing twice-daily inhaled salmeterol (SAL) 50 microg, fluticasone propionate (FP) 500 microg, and the combination (SFC) with placebo in 6,184 patients with moderate-to-severe COPD over 3 yrs." | 5.14 | Pneumonia risk in COPD patients receiving inhaled corticosteroids alone or in combination: TORCH study results. ( Anderson, JA; Calverley, PM; Celli, B; Crim, C; Ferguson, GT; Jenkins, C; Jones, PW; Vestbo, J; Willits, LR; Yates, JC, 2009) |
| " Overall, there was a higher incidence of pneumonia in the fluticasone propionate and SFC arms, compared with other treatments in all GOLD stages." | 5.14 | Efficacy of salmeterol/fluticasone propionate by GOLD stage of chronic obstructive pulmonary disease: analysis from the randomised, placebo-controlled TORCH study. ( Anderson, JA; Calverley, PM; Celli, B; Ferguson, GT; Jenkins, CR; Jones, PW; Vestbo, J; Willits, LR; Yates, JC, 2009) |
| " Here, we investigated the long-term effects of therapy with fluticasone propionate (FP) alone, salmeterol (SAL) alone, and a SAL/FP combination (SFC) on bone mineral density (BMD) and bone fractures in patients with moderate-to-severe COPD in the TOwards a Revolution in COPD Health (TORCH) study." | 5.14 | Prevalence and progression of osteoporosis in patients with COPD: results from the TOwards a Revolution in COPD Health study. ( Anderson, JA; Calverley, PMA; Celli, B; Ferguson, GT; Jenkins, CR; Jones, PW; Vestbo, J; Willits, LR; Yates, JC, 2009) |
| "The National Heart, Lung, and Blood Institute guideline recommends that dosing racemic albuterol be administered every 1 to 4 hours for treating patients with asthma or chronic obstructive pulmonary disease (COPD) in the hospital." | 5.13 | Comparison of levalbuterol and racemic albuterol in hospitalized patients with acute asthma or COPD: a 2-week, multicenter, randomized, open-label study. ( Andrews, WT; Ciubotaru, RL; Claus, R; Donohue, JF; Hanania, NA; Noe, L; Pasta, DJ; Roach, J; Schaefer, K, 2008) |
| "Under stable conditions most subjects with severe COPD and hypercapnia will have a fall in P(a)CO(2) and P(a)O(2) following 10 mg rac-albuterol, suggesting that they maintain capacity to respond to any increase in VCO(2) and prevent a rise in P(a)CO(2)." | 5.12 | Effects of rac-albuterol on arterial blood gases in patients with stable hypercapnic chronic obstructive pulmonary disease. ( Cooper, S; Harrison, TW; Mortimer, K; Oborne, J; Sovani, MP; Tattersfield, AE; Whale, CI, 2006) |
| " In an open-label study at 38 outpatient centres, patients > or =12 years old with asthma or chronic obstructive pulmonary disease (COPD) received two actuations of fluticasone propionate/salmeterol 125/25 microg (115/21 microg ex-actuator) hydrofluoroalkane (ADVAIR) HFA) via MDI with counter twice a day until all 120 actuations were completed." | 5.12 | Fluticasone propionate/salmeterol hydrofluoroalkane via metered-dose inhaler with integrated dose counter: Performance and patient satisfaction. ( Carranza-Rosenzweig, J; Crim, C; Lincourt, WR; Locantore, NW; Sheth, K; Wasserman, RL, 2006) |
| "To compare in a group of doctor-diagnosed patients with asthma or COPD, the effects of a lower dose of fluticasone in a combination product with salmeterol with conventional treatment (i." | 5.12 | Lower inhaled steroid requirement with a fluticasone/salmeterol combination in family practice patients with asthma or COPD. ( Albers, JM; Costongs, RJ; Schermer, TR; Verblackt, HW; Westers, P, 2007) |
| "We studied 21 COPD patients in stable clinical conditions to evaluate whether changes in lung function induced by cumulative doses of salbutamol alter diffusing capacity for carbon monoxide (DL(CO)), and whether this relates to the extent of emphysema as assessed by high resolution computed tomography (HRCT) quantitative analysis." | 5.12 | Effect of bronchodilatation on single breath pulmonary uptake of carbon monoxide in chronic obstructive pulmonary disease. ( Baldi, S; Brusasco, V; Bruschi, C; Dore, R; Fracchia, C; Maestri, R; Pellegrino, R, 2006) |
| "The effects of salmeterol and fluticasone propionate, alone or in combination, on PEF and breathlessness are seen within days and most of the obtainable effect on these parameters is reached within 2 weeks." | 5.11 | Early onset of effect of salmeterol and fluticasone propionate in chronic obstructive pulmonary disease. ( Anderson, JA; Calverley, P; Jones, P; Pauwels, R; Vestbo, J, 2005) |
| "Our results indicate that adding theophylline to standard treatment with inhaled bronchodilators provides additional benefits in stable COPD patients by reducing dynamic pulmonary hyperinflation, improving exercise tolerance, dyspnea and QoL." | 5.11 | [Clinical and functional benefits of adding theophylline to a standard treatment with short acting bronchodilators in patients with COPD]. ( Borzone, G; Díaz, O; Dreyse, J; Lisboa, C; Silva, F, 2005) |
| " In a crossover study against placebo, albuterol caused a significant increase in expiratory flow and reduced lung hyperinflation and dyspnea at rest, but this was not associated with differences in symptoms with exercise or any relevant parameter of physical performance." | 5.10 | Effects of exercise and beta 2-agonists on lung function in chronic obstructive pulmonary disease. ( Barisione, G; Beccaria, M; Brusasco, V; Cerveri, I; Corsico, A; Fulgoni, P; Pellegrino, R; Zoia, MC, 2002) |
| "This study assessed the effect of the leukotriene receptor antagonist montelukast on hypertonic saline-induced airway obstruction." | 5.10 | Montelukast attenuates the airway response to hypertonic saline in moderate-to-severe COPD. ( Böhme, S; Jörres, RA; Kanniess, F; Magnussen, H; Nielsen-Gode, D; Richter, K; Zühlke, IE, 2003) |
| "To compare albuterol with isoproterenol as a bronchodilator in pulmonary function test and their value in the diagnosis and differential diagnosis of asthma." | 5.09 | [A comparison between the effects of albuterol and isoproterenol in bronchodilation test]. ( He, T; Luo, Y; Wang, L; Yuan, Y; Zeng, J, 2001) |
| "This analysis was designed to provide a comparison between budesonide/formoterol and salmeterol/fluticasone for the relative incidence of pneumonia adverse events, pneumonia serious adverse events and pneumonia-related mortality in patients being treated for chronic obstructive pulmonary disease." | 4.87 | Budesonide/formoterol vs. salmeterol/fluticasone in COPD: a systematic review and adjusted indirect comparison of pneumonia in randomised controlled trials. ( Edwards, SJ; Gray, J; Halpin, DM; Morais, J; Singh, D, 2011) |
| "This study aimed to investigate whether airway obstruction could interfere with real FENO levels and if different FeNO changes after albuterol inhalation could assist in distinguishing asthma from chronic obstructive pulmonary disease (COPD)." | 3.85 | Albuterol inhalation increases FeNO level in steroid-naive asthmatics but not COPD patients with reversibility. ( Cai, S; Dong, H; Li, R; Lv, Y; Wu, Y; Xiao, G; Yao, L; Zhao, H, 2017) |
| "The primary aim of pharmachotherapy in COPD is improvement of exertional dyspnea and quality of life through its bronchodilator effects." | 3.85 | [Evidence of pharmacotherapy in COPD--key findings from recently-conducted randomized clinical studies]. ( Nishimura, M; Shimizu, K, 2011) |
| "Responsiveness to corticosteroids dexamethasone (Dex), budesonide (Bud) and fluticasone propionate (FP) was determined, as IC(50) values on TNF-α-induced interleukin 8 release, in U937 monocytic cell line treated with hydrogen peroxide (H(2) O(2) ) or peripheral blood mononuclear cells (PBMCs) from patients with COPD or severe asthma." | 3.78 | Corticosteroid insensitivity is reversed by formoterol via phosphoinositide-3-kinase inhibition. ( Barnes, PJ; Ito, K; Ito, M; Osoata, G; Rossios, C; To, Y, 2012) |
| "To assess the risk of pneumonia among COPD patients using salmeterol/fluticasone propionate combination inhalers (SFC), inhaled corticosteroids (ICS), or long-acting beta-agonists (LABA), alone or in combination, compared to those using only short-acting bronchodilators (SABD)." | 3.76 | Pneumonia among COPD patients using inhaled corticosteroids and long-acting bronchodilators. ( Brown, J; Davis, K; Mapel, D; Miller, D; Schum, M; Yood, M, 2010) |
| "Epithelial cells from bronchial brushings of normal (n = 8), asthma (n = 8) and COPD (n = 8) subjects were grown in air-liquid interface cultures, and treated with cigarette smoke extract (CSE) and/or Th2 cytokine IL-13, followed by Mp infection and treatment with beta2-agonists albuterol and formoterol for up to seven days." | 3.76 | beta2-agonists promote host defense against bacterial infection in primary human bronchial epithelial cells. ( Bowler, RP; Chu, HW; Green, RM; Gross, CA; Schnell, C; Weinberger, AR, 2010) |
| " Efficacy was measured using serial spirometry, transition dyspnea index (TDI), rescue albuterol use, and St." | 3.75 | Nebulized formoterol provides added benefits to tiotropium treatment in chronic obstructive pulmonary disease. ( Chaudry, I; Denis-Mize, K; Hanania, NA; McGinty, J; Tashkin, DP, 2009) |
| "We evaluated the response to albuterol inhalation in 10 healthy subjects, 9 subjects with asthma, and 15 subjects with chronic obstructive pulmonary disease (COPD) with mean (SD) age in years of 38 (SD, 11), 45 (SD, 11), and 64 (SD, 8), respectively." | 3.74 | The confounding effects of thoracic gas compression on measurement of acute bronchodilator response. ( Babb, TG; Boriek, AM; Hanania, NA; Officer, TM; Sharafkhaneh, A; Sharafkhaneh, H, 2007) |
| "There are theoretical benefits of delivering drug aerosols to patients with asthma and chronic obstructive pulmonary disease (COPD) using Heliox as a carrier gas." | 3.74 | The effects of Heliox on the output and particle-size distribution of salbutamol using jet and vibrating mesh nebulizers. ( Bland, H; Crosby, D; Dougill, B; Jackson, J; O'Callaghan, C; White, J, 2007) |
| "We report a case of paradoxical bronchospasm to both levalbuterol and albuterol." | 3.73 | Paradoxical bronchospasm: a potentially life threatening adverse effect of albuterol. ( Nagajothi, N; Raghunathan, K, 2006) |
| "To report a case of acute myocardial infarction (AMI) following the use of albuterol (salbutamol) in a patient without preexisting coronary artery disease and to review the related literature." | 3.72 | Acute myocardial infarction associated with albuterol. ( Davis, MW; Fisher, AA; McGill, DA, 2004) |
| " During the treatment, the remission time of typical respiratory manifestations was recorded, and the adverse reactions were observed." | 3.01 | Efficacy and safety of combined doxofylline and salbutamol in treatment of acute exacerbation of chronic obstructive pulmonary disease. ( Bao, H; Du, X; Zhao, D, 2021) |
| "Heart failure (HF) and chronic obstructive pulmonary disease (COPD) are closely related in clinical practice." | 3.01 | Potential Mechanisms Between HF and COPD: New Insights From Bioinformatics. ( Li, Z; Liu, Y; Ma, X; Sun, Z; Wang, A; Zhang, D, 2023) |
| "Sevoflurane kinetics were determined by collecting end-tidal samples from the first breaths at 1, 2, 3, 4, 5, 7, 10, and 15 min before the surgery (wash-in) and after closing the vaporizer (wash-out)." | 3.01 | Effects of salbutamol on the kinetics of sevoflurane and the occurrence of early postoperative pulmonary complications in patients with mild-to-moderate chronic obstructive pulmonary disease: A randomized controlled study. ( Jiang, H; Jiang, Z; Lian, S; Liu, S; Wu, X; Zhang, C, 2021) |
| " The observed differences may be caused by the difference in dosing between the two regimens." | 2.94 | Long-acting dual bronchodilator therapy (indacaterol/glycopyrronium) versus nebulized short-acting dual bronchodilator (salbutamol/ipratropium) in chronic obstructive pulmonary disease: A double-blind, randomized, placebo-controlled trial. ( Carpaij, OA; Kerstjens, HAM; Niemeijer, A; Seigers, D; van Geffen, WH; Vonk, JM; Westbroek, LF, 2020) |
| "COPD is an inflammatory airway disease characterised by progressive airflow limitation and air trapping, leading to lung hyperinflation and exercise limitation." | 2.87 | Inhaled nebulised unfractionated heparin improves lung function in moderate to very severe COPD: A pilot study. ( Calzetta, L; Cardaci, V; Cazzola, M; di Toro, S; Page, CP; Shute, JK, 2018) |
| "COPD is a chronic inflammatory disease characterized by partially reversible airflow limitation." | 2.87 | Effect of adding roflumilast or ciclesonide to glycopyrronium on lung volumes and exercise tolerance in patients with severe COPD: A pilot study. ( Calzetta, L; Cavalli, F; Cazzola, M; Matera, MG; Ora, J; Puxeddu, E; Rogliani, P, 2018) |
| " This trend did not extend to the 24-h levels, in which bioavailability with the large spacer plus pMDI (49." | 2.87 | Performance of Large Spacer Versus Nebulizer T-Piece in Single-Limb Noninvasive Ventilation. ( Abdelrahim, ME; Elberry, AA; Fathy, M; Harb, HS; Rabea, H, 2018) |
| "In exacerbations of chronic obstructive pulmonary disease, administration of high concentrations of oxygen may cause hypercapnia and increase mortality compared with oxygen titrated, if required, to achieve an oxygen saturation of 88-92%." | 2.87 | Oxygen versus air-driven nebulisers for exacerbations of chronic obstructive pulmonary disease: a randomised controlled trial. ( Bardsley, G; Beasley, R; Berry, J; Fingleton, J; McKinstry, S; Pilcher, J; Shirtcliffe, P; Weatherall, M, 2018) |
| "Patient receiving invasive mechanical ventilation (IMV) may benefit from medical aerosol, but guidance on dosing with different aerosol devices is limited to in-vitro studies." | 2.84 | Inhaled salbutamol dose delivered by jet nebulizer, vibrating mesh nebulizer and metered dose inhaler with spacer during invasive mechanical ventilation. ( Abdelrahim, ME; Abdelrahman, MM; Al-Kholy, MB; Boules, ME; El Essawy, AFM; ElHansy, MHE; Hussein, RRS; Said, ASA, 2017) |
| " Data mining technology based on artificial neural networks and genetic algorithms were used here to model in-vitro inhalation process and predict bioavailability from inhaled doses delivered by three different vibrating mesh nebulisers (VMNs) in NIV." | 2.84 | Modelling of in-vitro and in-vivo performance of aerosol emitted from different vibrating mesh nebulisers in non-invasive ventilation circuit. ( Abdelrahim, ME; Abdelrahman, MM; Ali, AM; Rabea, H; Said, AS; Salah Eldin, R, 2017) |
| " The incidence of on-treatment adverse events across all treatment groups was 37-41% in Study 1 and 36-38% in Study 2." | 2.82 | Efficacy and Safety of Umeclidinium Added to Fluticasone Propionate/Salmeterol in Patients with COPD: Results of Two Randomized, Double-Blind Studies. ( Brooks, J; Church, A; Kerwin, E; Siler, TM; Singletary, K, 2016) |
| "The albuterol MDPI was generally well tolerated." | 2.82 | Prospective, open-label evaluation of a new albuterol multidose dry powder inhaler with integrated dose counter. ( Given, J; Iverson, H; Taveras, H, 2016) |
| "Patients with stable moderate-to-severe COPD were randomized to tiotropium HandiHaler® (n = 550) or placebo (n = 371) and followed for 13 weeks." | 2.82 | Effect of tiotropium on night-time awakening and daily rescue medication use in patients with COPD. ( Calverley, PM; Clerisme-Beaty, E; Metzdorf, N; Rennard, SI; Zubek, VB; ZuWallack, R, 2016) |
| " The primary efficacy variable was the change in forced expiratory volume in one second from predose to 60 minutes after dosing on day 85." | 2.82 | Efficacy and safety of ipratropium bromide/salbutamol sulphate administered in a hydrofluoroalkane metered-dose inhaler for the treatment of COPD. ( Bhargava, S; Bhattacharya, A; Gogtay, J; Purandare, S; Rebello, J; Singh, V; Talwar, D; Whig, J, 2016) |
| "Categorization of patients with COPD as reversible or nonreversible to a bronchodilator may change over time." | 2.82 | Bronchodilator reversibility in patients with COPD revisited: short-term reproducibility. ( Pascoe, S; Singh, D; Wu, W; Zhu, CQ, 2016) |
| "Asthma and chronic obstructive pulmonary disease (COPD) are heterogeneous disorders encompassing different phenotypes of airflow obstruction, which might differ in their response to treatment." | 2.80 | Treatment responsiveness of phenotypes of symptomatic airways obstruction in adults. ( Beasley, R; Bowles, D; Charles, T; Fingleton, J; Shirtcliffe, P; Strik, R; Travers, J; Weatherall, M; Williams, M, 2015) |
| " The incidence of on-treatment adverse events (AEs) was 48% with FF/VI 200/25 mcg and 37-40% with other treatments." | 2.80 | Efficacy and safety of fluticasone furoate/vilanterol (50/25 mcg; 100/25 mcg; 200/25 mcg) in Asian patients with chronic obstructive pulmonary disease: a randomized placebo-controlled trial. ( Crim, C; de Guia, T; Newlands, AH; Wang, C; Wang-Jairaj, J; Zheng, J; Zhong, N, 2015) |
| "ICS discontinuation after 30 months in COPD can worsen lung function decline, AHR, and QOL during 5-year follow-up." | 2.80 | Relapse in FEV1 Decline After Steroid Withdrawal in COPD. ( Hiemstra, PS; Kerstjens, HAM; Klooster, K; Kunz, LIZ; Lapperre, TS; Postma, DS; Snoeck-Stroband, JB; Sont, JK; Sterk, PJ; Vonk, JM, 2015) |
| " The GLISTEN trial compared the efficacy of two long-acting anti-muscarinic antagonists (LAMA), when combined with an inhaled corticosteroid (ICS) and a long-acting β2 agonist (LABA)." | 2.80 | Glycopyrronium once-daily significantly improves lung function and health status when combined with salmeterol/fluticasone in patients with COPD: the GLISTEN study, a randomised controlled trial. ( Bremner, P; Chang, CL; Day, P; Frenzel, C; Frith, PA; Kurstjens, N; Ratnavadivel, R; Thompson, PJ, 2015) |
| "30 patients presenting to ED with AECOPD were included." | 2.80 | Intravenous magnesium sulphate as an adjuvant therapy in acute exacerbations of chronic obstructive pulmonary disease: a single centre, randomised, double-blinded, parallel group, placebo-controlled trial: a pilot study. ( Armstrong, P; Clayton-Smith, B; Hardy, M; Marchant, G; Marsh, E; Mukerji, S; Shahpuri, B; Smith, N, 2015) |
| "The additional use of an SABA by COPD patients improved their pulmonary function, which was accompanied by changes in regional lung air flow." | 2.79 | Effects of bronchodilators on regional lung sound distribution in patients with chronic obstructive pulmonary disease. ( Matsuoka, S; Mineshita, M; Miyazawa, T, 2014) |
| "A core feature of chronic obstructive pulmonary disease (COPD) is the accelerated decline in forced expiratory volume in one second (FEV1)." | 2.79 | Airway gene expression in COPD is dynamic with inhaled corticosteroid treatment and reflects biological pathways associated with disease activity. ( Alekseyev, YO; Heijink, IH; Hiemstra, PS; Lenburg, ME; Liu, G; Postma, DS; Spira, A; Steiling, K; Sterk, PJ; Timens, W; van den Berge, M, 2014) |
| " For the combined asthma and COPD subjects, the plasma AUC and Cmax for FP and salmeterol were higher for Rotahaler:Rotahaler/Diskus geometric mean ratios (90% confidence intervals) for FP AUC0-τ of 1." | 2.79 | Pharmacokinetics and pharmacodynamics of fluticasone propionate and salmeterol delivered as a combination dry powder from a capsule-based inhaler and a multidose inhaler in asthma and COPD patients. ( Chan, RH; Daley-Yates, PT; Despa, SX; Louey, MD; Mehta, R, 2014) |
| "Twenty-eight stable COPD patients had their ILPs and FEV1 measured both before and 2 h after the use of a single dose of 18 mcg bronchodilator tiotropium and 50 mcg salmeterol." | 2.79 | Effects of long-acting bronchodilators and prednisolone on inspiratory lung function parameters in stable COPD. ( Dekhuijzen, PN; Heijdra, YF; Hop, WC; Ramlal, SK; Visser, FJ, 2014) |
| " Six patients in the FF/VI (2%) and three in the FP/SAL (1%) arm experienced serious adverse events, none of which were considered to be drug related." | 2.79 | A comparison of the efficacy and safety of once-daily fluticasone furoate/vilanterol with twice-daily fluticasone propionate/salmeterol in moderate to very severe COPD. ( Agustí, A; Barnes, N; Bourbeau, J; Crim, C; De Backer, W; de Teresa, L; Locantore, N; Zvarich, MT, 2014) |
| "Dyspnea was assessed using a Borg CR-10 scale." | 2.79 | Comparing dynamic hyperinflation and associated dyspnea induced by metronome-paced tachypnea versus incremental exercise. ( Bateman, ED; Bateman, ME; Calligaro, GL; Cooper, CB; Raine, RI, 2014) |
| "An exacerbation of COPD was defined as the increase or new onset of more than one symptom of COPD (cough, sputum, wheezing, dyspnoea, or chest tightness), with at least one of the symptoms lasting for 3 days or more and needing treatment with antibiotics or systemic glucocorticoids (moderate exacerbations), or admission to hospital (severe exacerbations)." | 2.79 | Effect of ADRB2 polymorphisms on the efficacy of salmeterol and tiotropium in preventing COPD exacerbations: a prespecified substudy of the POET-COPD trial. ( Fabbri, LM; Glaab, T; Israel, E; Kögler, H; Rabe, KF; Riemann, K; Schmidt, H; Vogelmeier, CF, 2014) |
| "BDP/FF extrafine combination provides COPD patients with an equivalent improvement of dyspnoea and a faster bronchodilation in comparison to FP/S." | 2.79 | Extrafine beclomethasone/formoterol compared to fluticasone/salmeterol combination therapy in COPD. ( Bindi, E; Corradi, M; Guastalla, D; Kampschulte, J; Nicolini, G; Pierzchała, W; Sayiner, A; Singh, D; Szilasi, M; Terzano, C; Vestbo, J, 2014) |
| "Evaluation of novel compounds for COPD often relies on FEV1 for signal detection." | 2.79 | Partial versus maximal forced exhalations in COPD: enhanced signal detection for novel therapies. ( Chambellan, A; Guenard, H; Kays, C; Martinot, JB; Silkoff, PE, 2014) |
| "Chronic obstructive pulmonary disease (COPD) affects millions worldwide." | 2.79 | Comparison of conventional medicine, TCM treatment, and combination of both conventional medicine and TCM treatment for patients with chronic obstructive pulmonary disease: study protocol of a randomized comparative effectiveness research trial. ( Li, JS; Li, SY; Xie, Y; Yu, XQ, 2014) |
| " Pooled adverse events (FF/VI 27%; FP/SAL 28%) and serious adverse events (FF/VI 2%; FP/SAL 3%) were similar between treatments." | 2.79 | Efficacy and safety of once-daily fluticasone furoate/vilanterol (100/25 mcg) versus twice-daily fluticasone propionate/salmeterol (250/50 mcg) in COPD patients. ( Crim, C; Dransfield, MT; Feldman, G; Korenblat, P; LaForce, CF; Locantore, N; Martinez, FJ; Pistolesi, M; Watkins, ML, 2014) |
| "In patients with severe COPD receiving tiotropium plus salmeterol, the risk of moderate or severe exacerbations was similar among those who discontinued inhaled glucocorticoids and those who continued glucocorticoid therapy." | 2.79 | Withdrawal of inhaled glucocorticoids and exacerbations of COPD. ( Calverley, PM; Chanez, P; Dahl, R; Decramer, M; Disse, B; Finnigan, H; Kirsten, A; Magnussen, H; Rodriguez-Roisin, R; Tetzlaff, K; Towse, L; Watz, H; Wouters, EF, 2014) |
| "This study compared the rate of COPD exacerbations over the 26 weeks after an initial exacerbation in patients receiving the combination of fluticasone propionate and salmeterol (FP/SAL) or SAL alone." | 2.79 | Fluticasone propionate/salmeterol 250/50 μg versus salmeterol 50 μg after chronic obstructive pulmonary disease exacerbation. ( Crater, GD; Dransfield, MT; Emmett, A; Ferro, TJ; Morris, AN; Ohar, JA; Raphiou, I; Sriram, PS, 2014) |
| "One hundred and twenty cases of COPD were randomized into three groups, 40 cases in each one." | 2.79 | [Efficacy on chronic obstructive pulmonary disease at stable stage treated with cutting method and western medication]. ( Deng, YQ; Xu, B; Xu, JH, 2014) |
| "In mild-to-moderate COPD, FSC was associated with significant improvements in airway function at rest and during exercise." | 2.78 | Effect of fluticasone/salmeterol combination on dyspnea and respiratory mechanics in mild-to-moderate COPD. ( Guenette, JA; O'Donnell, DE; Webb, KA, 2013) |
| " No effects were observed on glucose, potassium, heart rate, blood pressure and no dose-response effect was seen on corrected QT elongation." | 2.78 | A new class of bronchodilator improves lung function in COPD: a trial with GSK961081. ( Baggen, S; Chan, R; Locantore, N; Ludwig-Sengpiel, A; Riley, JH; Wielders, PL, 2013) |
| " Assumed the importance of this topic and the lack of a clinical evaluation specifically designed to assess the impact of chronic administration of indacaterol on the response to salbutamol, we sought to compare the effect of 4-week treatment with indacaterol 150 μg once-daily versus formoterol 12 μg twice-daily on the dose-response curve to inhaled salbutamol (total cumulative dose of 800 μg) in a non-double-blinded, crossover, randomised, and controlled pilot trial that enrolled 20 outpatients with moderate to severe COPD." | 2.78 | Chronic treatment with indacaterol and airway response to salbutamol in stable COPD. ( Cazzola, M; Matera, MG; Picciolo, S; Proietto, A; Rogliani, P; Ruggeri, P; Segreti, A, 2013) |
| " Systemic pharmacodynamics (potassium, heart rate, glucose and QTc), adverse events and systemic pharmacokinetics were also assessed." | 2.78 | Bronchodilation and safety of supratherapeutic doses of salbutamol or ipratropium bromide added to single dose GSK961081 in patients with moderate to severe COPD. ( Ambery, C; Norris, V, 2013) |
| " No clinically relevant systemic pharmacodynamic effects were observed." | 2.78 | Pharmacodynamics of GSK961081, a bi-functional molecule, in patients with COPD. ( Ambery, C; Bateman, ED; Kornmann, O; Norris, V, 2013) |
| "Time to first COPD exacerbation was slightly longer in the CVT-R group compared to the other treatment groups, although it did not reach statistical significance (CVT-R versus CVT-MDI, P = 0." | 2.78 | COPD patient satisfaction with ipratropium bromide/albuterol delivered via Respimat: a randomized, controlled study. ( Dai, L; Dunn, LJ; Ferguson, GT; Ghafouri, M, 2013) |
| "Patients with COPD diagnosed by a physician and prescriptions of either budesonide/formoterol or fluticasone/salmeterol." | 2.78 | Pneumonia and pneumonia related mortality in patients with COPD treated with fixed combinations of inhaled corticosteroid and long acting β2 agonist: observational matched cohort study (PATHOS). ( Goike, H; Janson, C; Johansson, G; Jörgensen, L; Larsson, K; Lisspers, KH; Ställberg, B; Stratelis, G, 2013) |
| "Forty-one stable COPD patients participated in a crossover trial." | 2.78 | The effect of bronchodilators administered via aerochamber or a nebulizer on inspiratory lung function parameters. ( Dekhuijzen, PN; Heijdra, YF; Hop, WC; Ramlal, SK; Visser, FJ, 2013) |
| "Patients with asthma or chronic obstructive pulmonary disease (COPD) (n = 1016)." | 2.78 | Inhaler competence and patient satisfaction with Easyhaler®: results of two real-life multicentre studies in asthma and COPD. ( Gálffy, G; Mezei, G; Müller, V; Németh, G; Orosz, M; Selroos, O; Tamási, L, 2013) |
| "The Global initiative for chronic Obstructive Lung Disease (GOLD) Committee has proposed a chronic obstructive pulmonary disease (COPD) assessment framework focused on symptoms and on exacerbation risk." | 2.78 | A study to assess COPD Symptom-based Management and to Optimise treatment Strategy in Japan (COSMOS-J) based on GOLD 2011. ( Betsuyaku, T; Fujimoto, K; Hagan, G; Hitosugi, H; James, M; Jones, PW; Kato, M; Kobayashi, A, 2013) |
| " Overall incidence of adverse events (including COPD exacerbations) was 55·4% (143 of 258) for the QVA149 group and 60·2% (159 of 264) for the SFC group." | 2.78 | Efficacy and safety of once-daily QVA149 compared with twice-daily salmeterol-fluticasone in patients with chronic obstructive pulmonary disease (ILLUMINATE): a randomised, double-blind, parallel group study. ( Alagappan, VK; Banerji, D; Bateman, ED; Chen, H; D'Andrea, P; Pallante, J; Vogelmeier, CF, 2013) |
| "Patients with severe or very severe chronic obstructive pulmonary disease (COPD) frequently suffer repeated exacerbations generating high health care utilization costs." | 2.78 | Influence of salmeterol/fluticasone via single versus separate inhalers on exacerbations in severe/very severe COPD. ( Banik, N; Fielder, K; Hagedorn, C; Kässner, F; Ntampakas, P, 2013) |
| "George's Respiratory Questionnaire for COPD patients (SGRQ-C) was -6." | 2.77 | Comparison of tiotropium plus fluticasone propionate/salmeterol with tiotropium in COPD: a randomized controlled study. ( Jung, KS; Kim, SK; Kim, YK; Lee, KH; Lee, SD; Moon, HS; Park, HY; Park, SY; Shim, JJ; Yoo, JH, 2012) |
| "The addition of FSC to subjects with COPD treated with TIO significantly improves lung function without increasing the risk of adverse events." | 2.77 | Benefits of adding fluticasone propionate/salmeterol to tiotropium in moderate to severe COPD. ( Crater, GD; Emmett, AH; Hanania, NA; Morris, AN; Niewoehner, DE; O'Dell, DM, 2012) |
| "In both COPD and healthy subjects, rapid saline infusion with placebo or salmeterol premedication lead to a significant decrease in diffusion capacity for carbon monoxide (DLCO) and forced expiratory volume in 1 s (FEV1)." | 2.77 | Salmeterol improves fluid clearance from alveolar-capillary membrane in COPD patients: a pilot study. ( Blasi, F; Busatto, P; Centanni, S; Di Marco, F; Guazzi, M; Piffer, F; Santus, P; Sferrazza Papa, GF; Vicenzi, M, 2012) |
| "Exacerbations of COPD (ECOPD) are characterized by increased dyspnea due to dynamic pulmonary hyperinflation." | 2.77 | Randomized controlled trial of a breath-activated nebulizer in patients with exacerbation of COPD. ( Haynes, JM, 2012) |
| " Secondary endpoints included pulmonary function, plethysmography, pharmacokinetics of GSK233705 and salmeterol, adverse events (AEs), electrocardiograms (ECGs), vital signs, and laboratory parameters." | 2.77 | Safety and efficacy of dual therapy with GSK233705 and salmeterol versus monotherapy with salmeterol, tiotropium, or placebo in a crossover pilot study in partially reversible COPD patients. ( Baggen, S; Beier, J; Brooks, J; Cahn, A; Deans, A; Maden, C; Mehta, R; van Noord, J, 2012) |
| "Seventeen patients with COPD and 9 healthy subjects were examined by body plethysmography and LFU." | 2.77 | Detection of air trapping in chronic obstructive pulmonary disease by low frequency ultrasound. ( Biller, H; Glaab, T; Hohlfeld, JM; Leonhadt, S; Morenz, K; Rüter, D; Uhlig, S; Wolfram, F, 2012) |
| "Treatment-naïve patients with COPD (n = 36) were prospectively treated with two kinds of LABA--inhaled salmeterol and transdermal tulobuterol patch--for 12 weeks in crossover study, and changes in pulmonary function data and 6-minute walk distance (6 MWD) were compared between groups stratified by the CysGlyGln." | 2.77 | β2-adrenergic receptor haplotype may be associated with susceptibility to desensitization to long-acting β2-agonists in COPD patients. ( Kawate, E; Mochizuki, H; Nanjo, Y; Takahashi, H; Tsuda, Y; Yamazaki, M, 2012) |
| "The study examined COPD patients with moderate COPD exacerbations." | 2.77 | Observational study of the outcomes and costs of initiating maintenance therapies in patients with moderate exacerbations of COPD. ( Crater, GD; D'Souza, AO; Dalal, AA; Lunacsek, OE; Nagar, SP; Shah, MB, 2012) |
| "Exacerbations of COPD are associated with increased symptoms that persist for weeks and the course is very similar between a first and second exacerbation." | 2.77 | Prediction and course of symptoms and lung function around an exacerbation in chronic obstructive pulmonary disease. ( Creemers, JP; Hop, WC; Postma, DS; Schreurs, AJ; van den Berge, M; van der Molen, T; van Noord, JA; Wouters, EF, 2012) |
| "Patients with mild chronic obstructive pulmonary disease (COPD) present abnormal ventilatory mechanics during exercise and may require bronchodilator therapy." | 2.77 | Walking exercise response to bronchodilation in mild COPD: a randomized trial. ( Bourbeau, J; Gagnon, P; Maltais, F; Martel, S; Milot, J; Provencher, S; Saey, D; Tan, WC, 2012) |
| "Pneumonia is an important complication of COPD and is reported more often in patients receiving inhaled corticosteroids (ICSs)." | 2.76 | Reported pneumonia in patients with COPD: findings from the INSPIRE study. ( Calverley, PMA; Hagan, G; Riley, JH; Seemungal, TAR; Stockley, RA; Wedzicha, JA; Willits, LR, 2011) |
| "Indacaterol is a novel, inhaled, once-daily, ultra-long-acting β(2)-agonist bronchodilator recently approved in Europe for the treatment of chronic obstructive pulmonary disease (COPD)." | 2.76 | Once-daily indacaterol versus twice-daily salmeterol for COPD: a placebo-controlled comparison. ( Centanni, S; Dahl, R; Dogra, A; Kornmann, O; Kramer, B; Lassen, C; Owen, R, 2011) |
| "Thirty COPD patients were randomized to receive inhaled Tio (18 µg once daily) or inhaled SFC (50/250 µg twice daily) plus Tio for 12 weeks." | 2.76 | Effects of adding salmeterol/fluticasone propionate to tiotropium on airway dimensions in patients with chronic obstructive pulmonary disease. ( Hoshino, M; Ohtawa, J, 2011) |
| "A large proportion of COPD patients demonstrate significant acute BDR." | 2.76 | Acute bronchodilator responsiveness and health outcomes in COPD patients in the UPLIFT trial. ( Celli, B; Decramer, M; Hanania, NA; Kesten, S; Lystig, T; Sharafkhaneh, A; Tashkin, D, 2011) |
| "Indacaterol is a novel, inhaled once-daily ultra-long-acting β(2)-agonist for the treatment of COPD." | 2.76 | Indacaterol once-daily provides superior efficacy to salmeterol twice-daily in COPD: a 12-week study. ( Amos, C; Atis, S; Kerwin, E; Korn, S; Lassen, C; Owen, R, 2011) |
| "Indacaterol is a novel, inhaled, ultra-long-acting β(2)-agonist bronchodilator for maintenance use in patients with COPD." | 2.76 | Profiling the effects of indacaterol on dyspnoea and health status in patients with COPD. ( Gale, R; Jones, PW; Kramer, B; Mahler, DA; Owen, R, 2011) |
| "Twenty-five COPD patients were studied, including 20 males of mean (standard deviation) age 62 years (7 years) with baseline forced expiratory volume in 1 second of 41% (10%) predicted, and maximal workload of 101 Watt (36 Watt)." | 2.76 | Bronchodilation improves endurance but not muscular efficiency in chronic obstructive pulmonary disease. ( Grevink, R; Postma, DS; Roemer, W; ten Hacken, N; van der Vaart, H, 2011) |
| "COPD is associated with increased arterial stiffness which may in part explain the cardiovascular morbidity observed in the disease." | 2.76 | Effect of fluticasone propionate/salmeterol on arterial stiffness in patients with COPD. ( Cicale, MJ; Cockcroft, JR; Coxson, HO; Crater, GD; Dransfield, MT; Emmett, AH; Martinez, FJ; Rubin, DB; Sharma, SS; Townsend, RR, 2011) |
| "Patients with COPD represent a heterogeneous population in terms of their reporting of symptoms and response to treatment." | 2.76 | Application of latent growth and growth mixture modeling to identify and characterize differential responders to treatment for COPD. ( Capkun-Niggli, G; Gale, R; Houghton, K; Jones, P; Stull, DE; Wiklund, I, 2011) |
| "To compare the clinical diagnosis of chronic obstructive pulmonary disease (COPD) with results of post-bronchodilator spirometry in general practice, and examine practitioner, practice and patient characteristics associated with agreement between clinical and spirometric diagnoses." | 2.76 | Predictors of accuracy of diagnosis of chronic obstructive pulmonary disease in general practice. ( Comino, EJ; Hasan, I; Hermiz, O; Marks, GB; Middleton, S; Vagholkar, S; Wilson, SF; Zwar, NA, 2011) |
| "Ten patients with COPD underwent a dose-response curve to salbutamol (until 800 μg of cumulative dose) after a 1-week washout (baseline), 8 hours after the first administration of formoterol 12 μg (day 1), and after a 12-week and 24-week period of treatment with formoterol (12 μg twice daily by dry powder inhaler)." | 2.76 | Dose-response curve to salbutamol during acute and chronic treatment with formoterol in COPD. ( Bertella, E; Corda, L; La Piana, GE; Montemurro, LT; Pini, L; Tantucci, C, 2011) |
| "Chronic obstructive pulmonary disease (COPD) is a common disease characterized by airflow obstruction and lung hyperinflation leading to dyspnea and exercise capacity limitation." | 2.76 | Effects of beclomethasone/formoterol fixed combination on lung hyperinflation and dyspnea in COPD patients. ( Aiello, M; Chetta, A; Clini, EM; Crisafulli, E; Nicolini, G; Olivieri, D; Tzani, P, 2011) |
| "Patients with moderate to severe COPD were randomized to receive double-blind treatment with indacaterol 75 μg once daily (n = 163 and 159) or placebo (n = 160 and 159) for 12 weeks." | 2.76 | Efficacy and tolerability of indacaterol 75 μg once daily in patients aged ≥40 years with chronic obstructive pulmonary disease: results from 2 double-blind, placebo-controlled 12-week studies. ( Gotfried, MH; Kerwin, EM; Kramer, B; Lassen, C; Lawrence, D, 2011) |
| "The TOwards a Revolution in COPD Health (TORCH) study was a 3-yr multicentre trial of 6,112 patients randomised to salmeterol (Salm), fluticasone propionate (FP), a Salm/FP combination (SFC) or placebo (P)." | 2.75 | Is treatment with ICS and LABA cost-effective for COPD? Multinational economic analysis of the TORCH study. ( Briggs, AH; Calverley, PM; Glick, HA; Jones, PW; Lozano-Ortega, G; Spencer, M; Vestbo, J, 2010) |
| "Chronic obstructive pulmonary disease (COPD) still poses a formidable challenge to patients and clinicians alike." | 2.75 | Does low-dose seretide reverse chronic obstructive pulmonary disease and are the benefits sustained over time? An open-label Swedish crossover cohort study between 1999 and 2005. ( Rustscheff, S; Rydén, L, 2010) |
| "Patients with moderate to severe COPD were randomized to ipratropium bromide/albuterol (20/100mcg) Respimat inhaler, ipratropium bromide/albuterol MDI [36mcg/206mcg (Combivent Inhalation Aerosol MDI)], or ipratropium bromide (20mcg) Respimat inhaler." | 2.75 | Efficacy and safety of ipratropium bromide/albuterol delivered via Respimat inhaler versus MDI. ( Abrahams, R; Bateman, ED; De Salvo, MC; Fakih, F; Kaelin, T; Park, CS; Pudi, K; Sachs, P; Wood, CC; Zhao, Y; Zuwallack, R, 2010) |
| "The Towards a Revolution in COPD Health (TORCH) trial was an international clinical trial of chronic obstructive pulmonary disease (COPD) patients where cause of death was assigned by an independent committee." | 2.75 | Accuracy of death certificates in COPD: analysis from the TORCH trial. ( Drummond, MB; John, M; McGarvey, LP; Wise, RA; Zvarich, MT, 2010) |
| "A total of 85 subjects with stable COPD participated in a crossover, randomized, double-blind, placebo-controlled study." | 2.75 | Reversibility of inspiratory lung function parameters after short-term bronchodilators in COPD. ( Dekhuijzen, PN; Heijdra, YF; Hop, WC; Ramlal, SK; Visser, FJ, 2010) |
| "Previous studies have suggested that long-term use of beta agonists to treat chronic obstructive pulmonary disease (COPD) may increase the risk of cardiovascular adverse events." | 2.75 | Cardiovascular events in patients with COPD: TORCH study results. ( Anderson, JA; Calverley, PM; Celli, B; Crim, C; Ferguson, GT; Jenkins, C; Jones, PW; Vestbo, J; Willits, LR; Yates, JC, 2010) |
| "indacaterol is a novel, inhaled once-daily ultra-long-acting β(2)-agonist for the treatment of chronic obstructive pulmonary disease (COPD)." | 2.75 | Onset of action of indacaterol in patients with COPD: comparison with salbutamol and salmeterol-fluticasone. ( Amos, C; Balint, B; Higgins, M; Kramer, B; Owen, R; Watz, H, 2010) |
| " We examined the effect of inhaled salmeterol, alone and in combination with fluticasone propionate, on the management of patients with COPD." | 2.75 | The effect of inhaled salmeterol, alone and in combination with fluticasone propionate, on management of COPD patients. ( Boskabady, M; Boskabady, MH; Mansori, F; Nemat Khorasani, A, 2010) |
| "The overall rate of COPD exacerbations/patient/year was similar and not statistically significantly different among treatments (beclomethasone/formoterol 0." | 2.75 | Beclomethasone/formoterol in the management of COPD: a randomised controlled trial. ( Brusasco, V; Calverley, PM; Costantini, M; Kuna, P; Monsó, E; Papi, A; Petruzzelli, S; Sergio, F; Varoli, G, 2010) |
| "To measure DH in COPD patients during upper limbs exercise tests with previous use of bronchodilator or placebo, and to evaluate the respiratory pattern to justify the dynamics of hyperinflation." | 2.74 | Modulation of operational lung volumes with the use of salbutamol in COPD patients accomplishing upper limbs exercise tests. ( Cardoso, F; Castro, AA; Jardim, JR; Nascimento, O; Oliveira, RC; Porto, EF, 2009) |
| "Chronic obstructive pulmonary disease (COPD) is a growing public health problem that has increased in recent years." | 2.74 | Faster onset of action of formoterol versus salmeterol in patients with chronic obstructive pulmonary disease: a multicenter, randomized study. ( Cote, C; Pearle, JL; Sharafkhaneh, A; Spangenthal, S, 2009) |
| "The regression slope of breathlessness as a function of oxygen consumption (primary outcome), mean ratings of breathlessness throughout exercise and peak ratings of breathlessness were significantly higher with naloxone than normal saline." | 2.74 | Endogenous opioids modify dyspnoea during treadmill exercise in patients with COPD. ( Baird, JC; Kraemer, WJ; Mahler, DA; Murray, JA; Ward, J; Waterman, LA; Zhang, X, 2009) |
| "The primary endpoint is time to first COPD exacerbation." | 2.74 | Study design considerations in a large COPD trial comparing effects of tiotropium with salmeterol on exacerbations. ( Beeh, KM; Glaab, T; Hederer, B; Kesten, S; Müller, A; Rutten-van Moelken, M; Vogelmeier, C, 2009) |
| "Our data suggest that COPD patients benefit from the addition of Ismigen on top of the routine maintenance treatment with SFC." | 2.74 | Value of adding a polyvalent mechanical bacterial lysate to therapy of COPD patients under regular treatment with salmeterol/fluticasone. ( Cazzola, M; Di Perna, F; Noschese, P, 2009) |
| " Overall, 37% of formoterol plus tiotropium recipients experienced adverse events versus 51% of those receiving placebo plus tiotropium." | 2.74 | Efficacy and safety of nebulized formoterol as add-on therapy in COPD patients receiving maintenance tiotropium bromide: Results from a 6-week, randomized, placebo-controlled, clinical trial. ( Boota, A; Denis-Mize, K; Hanania, NA; Kerwin, E; Tomlinson, L, 2009) |
| "Patients with chronic obstructive pulmonary disease (COPD) have few options for treatment." | 2.74 | Roflumilast in moderate-to-severe chronic obstructive pulmonary disease treated with longacting bronchodilators: two randomised clinical trials. ( Brose, M; Bundschuh, DS; Calverley, PM; Fabbri, LM; Izquierdo-Alonso, JL; Martinez, FJ; Rabe, KF, 2009) |
| "Patients with chronic obstructive pulmonary disease (COPD) often experience symptoms and problems with activities early in the morning." | 2.74 | Effect on lung function and morning activities of budesonide/formoterol versus salmeterol/fluticasone in patients with COPD. ( Beckman, O; Partridge, MR; Persson, T; Polanowski, T; Schuermann, W, 2009) |
| "Prevention and treatment of COPD exacerbations are recognized as key goals in disease management." | 2.74 | Effect of fluticasone propionate/salmeterol (250/50) on COPD exacerbations and impact on patient outcomes. ( Anzueto, A; Chinsky, K; Crater, G; Emmett, A; Feldman, G; Ferguson, GT; Kalberg, C; Knobil, K; O'Dell, D; Seibert, A, 2009) |
| "Airway absorption and bioavailability of inhaled corticosteroids (ICSs) may be influenced by differences in pharmacokinetic properties such as lipophilicity and patient characteristics such as lung function." | 2.74 | The bioavailability and airway clearance of the steroid component of budesonide/formoterol and salmeterol/fluticasone after inhaled administration in patients with COPD and healthy subjects: a randomized controlled trial. ( Borgström, L; Dalby, C; Edsbäcker, S; Harrison, TW; Larsson, T; Polanowski, T, 2009) |
| "The TORCH (Towards a Revolution in COPD Health) trial has highlighted some important issues in the design and analysis of long term trials in chronic obstructive pulmonary disease." | 2.74 | Methods for therapeutic trials in COPD: lessons from the TORCH trial. ( Anderson, JA; Calverley, PM; Celli, B; Ferguson, GT; Jenkins, C; Jones, PW; Keene, ON; Vestbo, J, 2009) |
| "Chronic obstructive pulmonary disease (COPD) is characterized by an accelerated decline in lung function." | 2.73 | Effect of pharmacotherapy on rate of decline of lung function in chronic obstructive pulmonary disease: results from the TORCH study. ( Anderson, JA; Calverley, PM; Celli, BR; Ferguson, GT; Jenkins, CR; Jones, PW; Knobil, K; Thomas, NE; Vestbo, J; Yates, JC, 2008) |
| "In 782 patients with COPD (mean FEV(1)=0." | 2.73 | Effect of fluticasone propionate/salmeterol (250/50 microg) or salmeterol (50 microg) on COPD exacerbations. ( Anzueto, A; Emmett, A; Fei, R; Ferguson, GT; Kalberg, C; Knobil, K, 2008) |
| "In those with severe COPD, TS resulted in equal exacerbation rates and slightly lower costs compared with TP." | 2.73 | Cost effectiveness of therapy with combinations of long acting bronchodilators and inhaled steroids for treatment of COPD. ( Aaron, SD; Fitzgerald, JM; Jones, PW; Marra, CA; Najafzadeh, M; Sadatsafavi, M; Sullivan, SD; Vandemheen, KL, 2008) |
| " This is a non-inferiority study where safety and efficacy outcomes were serially assessed, including adverse events, Baseline (BDI)/Transition Dyspnea Index (TDI), St." | 2.73 | A double-blind crossover study comparing the safety and efficacy of three weeks of Flu/Sal 250/50 bid plus albuterol 180 ug prn q4 hours to Flu/Sal 250/50 bid plus albuterol/Ipratropium bromide 2 puffs prn q4 hours in patients with chronic obstructive pul ( Balkissoon, R; Make, B, 2008) |
| "In conclusion, in this large cohort of COPD patients with no or stable cardiac comorbidities, a high proportion ( approximately 40%) of patients were observed to have atrial tachycardia before treatment, which increased by 2%-5% with LABA treatment." | 2.73 | Arrhythmias in patients with chronic obstructive pulmonary disease (COPD): occurrence frequency and the effect of treatment with the inhaled long-acting beta2-agonists arformoterol and salmeterol. ( Baumgartner, RA; Cheng, H; Grogan, DR; Hanrahan, JP; Morganroth, J; Wilson, A; Zimetbaum, PJ, 2008) |
| "It is concluded that four puffs of salmeterol delivered with an MDI and a spacer device induces significant bronchodilation in mechanically ventilated patients with COPD exacerbation, the duration of which is highly variable, precluding definite conclusions in regard to optimum dosing schedules." | 2.73 | Duration of salmeterol-induced bronchodilation in mechanically ventilated chronic obstructive pulmonary disease patients: a prospective clinical study. ( Gavriilidis, G; Georgopoulos, D; Linardakis, M; Malliotakis, P, 2008) |
| " The frequency of adverse events, COPD exacerbations, and use of short-acting bronchodilator agents were assessed throughout the study period." | 2.73 | Arformoterol and salmeterol in the treatment of chronic obstructive pulmonary disease: a one year evaluation of safety and tolerance. ( Baumgartner, RA; Donohue, JF; Goodwin, E; Grogan, DR; Hanania, NA; Hanrahan, JP; Sciarappa, KA, 2008) |
| "A subset of patients with chronic obstructive pulmonary disease (COPD) may respond more favorably to inhaled corticosteroids (ICS), but no simple method is currently utilized to predict the presence or absence of ICS responses in patients with COPD." | 2.73 | Exhaled nitric oxide, systemic inflammation, and the spirometric response to inhaled fluticasone propionate in severe chronic obstructive pulmonary disease: a prospective study. ( Janoff, EN; Kunisaki, KM; Niewoehner, DE; Rector, TS; Rice, KL, 2008) |
| "Thirty COPD patients (GOLD class 1-2), current smoker (>or=10 pack/year), randomly received E 300 mg, N-acetylcysteine (NAC) 600 mg, or placebo, twice daily for ten days." | 2.73 | Erdosteine enhances airway response to salbutamol in patients with mild-to-moderate COPD. ( Bertacco, S; Dal Negro, R; Micheletto, C; Tognella, S; Trevisan, F; Visconti, M, 2008) |
| "Doxofylline was better tolerated than theophylline considering either the number of unwanted side-effects: (Doxofylline 8 and theophylline 25) or number of drop-out side-effects (doxofylline 5 and theophylline 10)." | 2.73 | Treatment of moderate chronic obstructive pulmonary disease (stable) with doxofylline compared with slow release theophylline--a multicentre trial. ( Santra, CK, 2008) |
| "Patients were withdrawn for COPD exacerbation." | 2.73 | A pilot study to assess the effects of combining fluticasone propionate/salmeterol and tiotropium on the airflow obstruction of patients with severe-to-very severe COPD. ( Andò, F; Cazzola, M; D'Amato, M; Di Marco, F; Ruggeri, P; Sanduzzi, A; Santus, P, 2007) |
| "In severe or very severe COPD patients with relatively fixed airway obstruction bronchodilators enhance exercise performance obtained with oxygen." | 2.73 | The effect of bronchodilators and oxygen alone and in combination on self-paced exercise performance in stable COPD. ( Calverley, PM; Cortopassi, F; Cukier, A; Ferreira, CA; Ribeiro, M; Stelmach, R, 2007) |
| "Exacerbations of chronic obstructive pulmonary disease (COPD) greatly contribute to declining health status and the progression of the disease, thereby incurring significant direct and indirect health care costs." | 2.73 | Impact of salmeterol/fluticasone propionate versus salmeterol on exacerbations in severe chronic obstructive pulmonary disease. ( Glaab, T; Kardos, P; Vogelmeier, C; Wencker, M, 2007) |
| " The 95% CI exceeded the pre-determined margin of 100ml by 2 ml, so that the statistical hypothesis of non-inferiority of once daily dosing was not confirmed." | 2.73 | Once versus twice daily formoterol via Novolizer for patients with moderate to severe COPD--a double-blind, randomised, controlled trial. ( Hartmann, U; Metzenauer, P; Welte, T, 2008) |
| "We examined 63 subjects with COPD (mean age: 71." | 2.73 | Correlation between bronchodilator responsiveness and quality of life in chronic obstructive pulmonary disease. ( Kida, K; Kudoh, S; Omata, M; Wakabayashi, R, 2007) |
| "Treatment of moderate or severe chronic obstructive pulmonary disease (COPD) with combinations of inhaled corticosteroids, long-acting beta-agonists, and long-acting anticholinergic bronchodilators is common but unstudied." | 2.73 | Tiotropium in combination with placebo, salmeterol, or fluticasone-salmeterol for treatment of chronic obstructive pulmonary disease: a randomized trial. ( Aaron, SD; Anthony, J; Balter, M; Bishop, G; Bleskie, D; Bourbeau, J; Chapman, K; Cowie, R; Cox, G; Doucette, S; Fergusson, D; Field, S; FitzGerald, M; Ford, G; Fox, G; Goldstein, R; Hernandez, P; Hirsch, A; Hodder, R; Hoffstein, V; Maltais, F; Marciniuk, D; Mayers, I; McCormack, D; McIvor, A; O'Donnell, D; Prins, HB; Rivington, R; Road, J; Sharma, S; Vandemheen, KL; Zamel, N, 2007) |
| "Patients with COPD were randomized to receive either 200 mug of salbutamol (n = 40) or placebo (n = 40) before bronchoscopy." | 2.73 | A randomized, placebo-controlled trial of bronchodilators for bronchoscopy in patients with COPD. ( Chhajed, PN; Gysin, C; Pflimlin, E; Pollak, V; Stolz, D; Tamm, M, 2007) |
| "Patients over 50 years old with COPD were randomized into 3 groups: nebulizer, inhaler, or concomitant treatment." | 2.73 | Comparing COPD treatment: nebulizer, metered dose inhaler, and concomitant therapy. ( Colman, SS; Klein, GL; Schonfeld, WH; Tashkin, DP; Zayed, H, 2007) |
| "Airway inflammation in chronic obstructive pulmonary disease (COPD) is characterised by infiltration of CD8+ T cells and CD68+ macrophages and an increased number of neutrophils, whereas few studies have described the presence of eosinophils." | 2.73 | Effect of salmeterol/fluticasone propionate on airway inflammation in COPD: a randomised controlled trial. ( Bourbeau, J; Christodoulopoulos, P; Hamid, Q; Maltais, F; Olivenstein, R; Yamauchi, Y, 2007) |
| "Secondary end points included COPD exacerbation rate, lung function and health status." | 2.73 | [Clinical study of the month: the TORCH study (TOwards a Revolution in COPD Health)]. ( Corhay, JL; Louis, R, 2007) |
| "Transdermal beta 2-agonist tulobuterol showed an improvement in FEV1, FVC and IC after dosing compared with those at baseline." | 2.73 | Comparison of bronchodilatory properties of transdermal and inhaled long-acting beta 2-agonists. ( Akamatsu, K; Hirano, T; Ichikawa, T; Ichinose, M; Matsunaga, K; Minakata, Y; Nakanishi, M; Sugiura, H; Ueshima, K; Yamagata, T; Yanagisawa, S, 2008) |
| "In this study, we let patients with COPD hyperventilate to evoke hyperinflation, and evaluated the effects of tiotropium alone or in combination with salmeterol on hyperventilation-evoked hyperinflation." | 2.73 | Effects of tiotropium or combined therapy with salmeterol on hyperinflation in COPD. ( Eguchi, Y; Fujimoto, S; Hirata, K; Kamoi, H; Kanazawa, H; Kudoh, S; Tateishi, Y; Umeda, N; Yoshikawa, T, 2007) |
| "Data on the onset of action of COPD medications are lacking." | 2.73 | Fast onset of effect of budesonide/formoterol versus salmeterol/fluticasone and salbutamol in patients with chronic obstructive pulmonary disease and reversible airway obstruction. ( Lindberg, A; Pullerits, T; Radeczky, E; Szalai, Z, 2007) |
| "The adjusted ratio of exacerbations of COPD for the SFC group relative to the placebo group was 0." | 2.73 | The efficacy and safety of combination salmeterol (50 microg)/fluticasone propionate (500 microg) inhalation twice daily via accuhaler in Chinese patients with COPD. ( Chen, P; Huang, SG; Huang, WJ; Shi, Y; Sun, TY; Wang, CZ; Wang, GF; Wen, ZG; Wu, YM; Xiong, SD; Yang, L; Zheng, JP; Zhong, NS, 2007) |
| "Patients with severe COPD (stages III-IV, classification of the Global Initiative for Chronic Obstructive Lung Disease) and incapacitating dyspnea (scores 3-5, Medical Research Council [MRC] scale) were randomized to a control or domiciliary rehabilitation group." | 2.73 | [Benefits of a home-based pulmonary rehabilitation program for patients with severe chronic obstructive pulmonary disease]. ( Casan Clarà, P; Gáldiz, JB; Gorostiza, A; Güell Rous, R; López de Santa María, E; Regiane Resqueti, V, 2007) |
| "41 patients with COPD participated in a randomised, double blind, double dummy, three way crossover study with 2 week washout periods between treatments." | 2.73 | Superiority of "triple" therapy with salmeterol/fluticasone propionate and tiotropium bromide versus individual components in moderate to severe COPD. ( Brooks, J; Cahn, A; Hagan, G; O'Connor, BJ; Singh, D, 2008) |
| "After a 1-week washout, 8 steroid-naïve COPD patients with AATD (ZZ genotype), within a double-blind randomized cross-over study, were assigned to one of the following 16-week treatments: (1) HFA-BDP 400 microg b." | 2.73 | Inhaled corticosteroids as additional treatment in alpha-1-antitrypsin-deficiency-related COPD. ( Bertella, E; Boni, E; Corda, L; La Piana, GE; Redolfi, S; Tantucci, C, 2008) |
| "Forty-four patients with COPD completed the study." | 2.73 | Association of beta2-adrenoreceptor genotypes with bronchodilatory effect of tiotropium in COPD. ( Fujimoto, S; Hirata, K; Kanazawa, H; Umeda, N; Yoshikawa, T, 2008) |
| " Treatment with high-dose formoterol and salbutamol was equally well tolerated, with no reports of serious adverse events." | 2.72 | Safety and tolerability of high-dose formoterol (via Aerolizer) and salbutamol in patients with chronic obstructive pulmonary disease. ( Ayre, G; Dobson, C; Fitoussi, S; Horowitz, A; Kruse, M; Rosenkranz, B; Rouzier, R, 2006) |
| " Whether inhaled corticosteroids by themselves or in combination with a long-acting beta2-adrenoceptor agonist repress systemic inflammation in chronic obstructive pulmonary disease is unknown." | 2.72 | Can inhaled fluticasone alone or in combination with salmeterol reduce systemic inflammation in chronic obstructive pulmonary disease? Study protocol for a randomized controlled trial [NCT00120978]. ( Cowie, RL; FitzGerald, M; Ford, G; Mainra, RR; Man, SF; Marciniuk, DD; Melenka, LS; Ramesh, W; Rousseau, R; Sin, DD; Wilde, E; Williams, D; Wong, E; York, E, 2006) |
| "In the ex-smokers with COPD, the albuterol responsiveness measurement was repeated after 4 weeks of treatment with fluticasone/salmeterol and after a drug washout period of 4 or 8 weeks." | 2.72 | Airway blood flow reactivity in healthy smokers and in ex-smokers with or without COPD. ( Campos, MA; Mendes, ES; Wanner, A, 2006) |
| "Chronic obstructive pulmonary disease (COPD) is recognized as a major healthcare problem in the United States and around the world." | 2.72 | Management of chronic obstructive pulmonary disease associated with chronic bronchitis with inhaled fluticasone propionate/salmeterol (ADVAIR DISKUS) 250/50: results of a patient experience trial. ( Brown, CP; Kerney, D; Samuels, S; Stoloff, S, 2006) |
| "Forty-six patients with severe COPD treated with inhaled long-acting beta(2) agonists and corticosteroids (LABA/CS) were enrolled." | 2.72 | Additive benefits of tiotropium in COPD patients treated with long-acting beta agonists and corticosteroids. ( Lee, YC; Perng, DW; Perng, RP; Su, KC; Tao, CW; Wu, CC, 2006) |
| " The overall rate of adverse events was PBO 56." | 2.72 | Evaluation of the efficacy and safety of levalbuterol in subjects with COPD. ( Andrews, C; Baumgartner, RA; Claus, R; D'Urzo, T; Donohue, JF; Parsey, MV; Schaefer, K; Sharma, S, 2006) |
| "Before and after each course of treatment, airway inflammation was assessed via exhaled nitric oxide breath testing." | 2.72 | Randomized placebo controlled assessment of airway inflammation due to racemic albuterol and levalbuterol via exhaled nitric oxide testing. ( Allan, PF; Arora, R; Freiler, JF; Hagan, L; Kelley, TC, 2006) |
| "Chronic obstructive pulmonary disease (COPD) is associated with a large economic and social burden." | 2.71 | Cost-effectiveness of salmeterol in patients with chronic obstructive pulmonary disease: an economic evaluation. ( Jones, PW; Sondhi, S; Wilson, K, 2003) |
| "It has been shown that patients with chronic obstructive pulmonary disease (COPD) develop dynamic hyperinflation (DH), which contributes to dyspnoea and exercise intolerance." | 2.71 | Effect of inhaled bronchodilators on inspiratory capacity and dyspnoea at rest in COPD. ( Boveri, B; Carlucci, P; Casanova, F; Cazzola, M; Centanni, S; Di Marco, F; Milic-Emili, J; Santus, P, 2003) |
| "1465 patients with COPD were recruited from outpatient departments in 25 countries." | 2.71 | Combined salmeterol and fluticasone in the treatment of chronic obstructive pulmonary disease: a randomised controlled trial. ( Anderson, J; Calverley, P; Gulsvik, A; Jones, P; Maden, C; Pauwels, R; Pride, N; Vestbo, J, 2003) |
| "Patients with COPD were enrolled in two 6-month randomised, placebo controlled, double blind, double dummy studies of tiotropium 18 micro g once daily via HandiHaler or salmeterol 50 micro g twice daily via a metered dose inhaler." | 2.71 | Health outcomes following treatment for six months with once daily tiotropium compared with twice daily salmeterol in patients with COPD. ( Brusasco, V; Hodder, R; Kesten, S; Korducki, L; Miravitlles, M; Towse, L, 2003) |
| "A total of 67 stable patients with COPD were recruited at the Kyoto University Hospital." | 2.71 | A comparison of the effects of salbutamol and ipratropium bromide on exercise endurance in patients with COPD. ( Hajiro, T; Mishima, M; Nishimura, K; Oga, T; Sato, S; Tsukino, M, 2003) |
| "Treatment with salmeterol, 50 micro g bid, showed no increased risk of cardiovascular adverse events (AEs) compared with placebo (relative risk, 1." | 2.71 | Cardiovascular safety of salmeterol in COPD. ( Darken, P; Ferguson, GT; Fischer, T; Funck-Brentano, C; Reisner, C, 2003) |
| "Chronic obstructive pulmonary disease (COPD) is characterised by limited bronchial reversibility and chronic neutrophilic inflammation." | 2.71 | Reversibility to a beta2-agonist in COPD: relationship to atopy and neutrophil activation. ( Lötvall, J; Malakauskas, K; Sakalauskas, R; Sitkauskiene, B, 2003) |
| "However, in the severe COPD group, 7-19% of the patients were not able to generate the optimum flows through the DPIs." | 2.71 | Inhalation profiles in asthmatics and COPD patients: reproducibility and effect of instruction. ( Broeders, ME; Folgering, HT; Hop, WC; Molema, J, 2003) |
| "Eighteen moderate COPD patients (53-77 yr, mean basal FEV(1)=49." | 2.71 | Salmeterol & fluticasone 50 microg/250 microg bid in combination provides a better long-term control than salmeterol 50 microg bid alone and placebo in COPD patients already treated with theophylline. ( Dal Negro, RW; Micheletto, C; Pomari, C; Tognella, S, 2003) |
| "The cumulative dose-response study compared the biological effects (pulmonary function, respiratory muscle function, systemic effects) of an equal dose of salbutamol delivered via four different devices in 23 patients with asthma and 21 patients with moderate or severe chronic obstructive pulmonary disease (COPD)." | 2.71 | Does the inhalation device affect the bronchodilatory dose response curve of salbutamol in asthma and chronic obstructive pulmonary disease patients? ( Broeders, ME; Folgering, HT; Hop, WC; Molema, J; Vermue, NA, 2003) |
| " The incidence of adverse effects (except for an increase in oral candidiasis with FSC and FP) were similar among the treatment groups." | 2.71 | The efficacy and safety of fluticasone propionate (250 microg)/salmeterol (50 microg) combined in the Diskus inhaler for the treatment of COPD. ( Darken, P; Davis, S; Hanania, NA; Horstman, D; Lee, B; Reisner, C; Shah, T, 2003) |
| "Thirty patients with stable COPD (FEV(1) between 45% and 70% of predicted) were studied." | 2.71 | An evaluation of nebulized levalbuterol in stable COPD. ( Datta, D; Lahiri, B; Vitale, A; ZuWallack, R, 2003) |
| " IC was recorded before dosing and at 5, 10, 15 and 30 min and 1, 2, 3 and 4 h post-dose." | 2.71 | Effects of formoterol and salmeterol on resting inspiratory capacity in COPD patients with poor FEV(1) reversibility. ( Bouros, D; Della Cioppa, G; Kottakis, J; Le Gros, V; Overend, T; Siafakas, N, 2004) |
| "Some patients with irreversible chronic obstructive pulmonary disease (COPD) experience subjective benefit from long acting bronchodilators without change in forced expiratory volume in 1 second (FEV(1))." | 2.71 | Effect of salmeterol on respiratory muscle activity during exercise in poorly reversible COPD. ( Donaldson, N; Hart, N; Kaul, S; Man, WD; Moxham, J; Mustfa, N; Nikoletou, D; Polkey, MI; Rafferty, GF, 2004) |
| "The "TOwards a Revolution in COPD Health" (TORCH) survival study is aiming to determine the impact of salmeterol/fluticasone propionate (SFC) combination and the individual components on the survival of COPD patients." | 2.71 | The TORCH (towards a revolution in COPD health) survival study protocol. ( Vestbo, J, 2004) |
| "The prevalence of chronic obstructive pulmonary disease (COPD) in women is increasing worldwide." | 2.71 | Gender does not influence the response to the combination of salmeterol and fluticasone propionate in COPD. ( Anderson, JA; Calverley, P; Jones, P; Pauwels, R; Soriano, JB; Vestbo, J, 2004) |
| " The mean maximum increases in FEV1 from pre-dosing value on each of the dosing days were 0." | 2.71 | The functional impact of adding salmeterol and tiotropium in patients with stable COPD. ( Cazzola, M; Centanni, S; di Marco, F; Matera, MG; Mondoni, M; Santus, P; Verga, M, 2004) |
| "Patients with chronic obstructive pulmonary disease (COPD) often report greater relief of breathlessness with nebulised bronchodilators than with the same medicine administered from a metered dose inhaler (MDI)." | 2.71 | Comparison of the effects of nebulised and inhaled salbutamol on breathlessness in severe COPD. ( Black, PN; Brodie, SM; Poole, PJ; Saini, R, 2005) |
| "The Global Initiative for Chronic Obstructive Lung Disease guidelines recommend bronchodilator reversibility testing to guide treatment decisions." | 2.71 | Total reversibility testing as indicator of the clinical efficacy of formoterol in COPD. ( Bourcereau, J; Bourdeix, I; Le Gros, V; Molimard, M, 2005) |
| "Withdrawal of FP in COPD patients using SFC resulted in acute and persistent deterioration in lung function and dyspnoea and in an increase in mild exacerbations and percentage of disturbed nights." | 2.71 | Withdrawal of fluticasone propionate from combined salmeterol/fluticasone treatment in patients with COPD causes immediate and sustained disease deterioration: a randomised controlled trial. ( Creutzberg, EC; Fokkens, B; Hensing, CA; Hop, WC; Kuipers, AF; Pasma, HR; Postma, DS; Prins, J; Wouters, EF, 2005) |
| "In both groups of COPD patients inhaled corticosteroids (ICS) therapy caused a significant decrease in F(ENO) without significant changes in FEV1." | 2.71 | The influence of inhaled corticosteroids on exhaled nitric oxide in stable chronic obstructive pulmonary disease. ( Bodzenta-Lukaszyk, A; Kucharewicz, I; Zietkowski, Z, 2005) |
| " Safety evaluations were based on clinical adverse events and COPD exacerbations." | 2.71 | The efficacy and safety of inhaled fluticasone propionate/salmeterol and ipratropium/albuterol for the treatment of chronic obstructive pulmonary disease: an eight-week, multicenter, randomized, double-blind, double-dummy, parallel-group study. ( Brown, CP; Emmett, A; Hanania, NA; Kalberg, C; Knobil, K; Make, B; ZuWallack, R, 2005) |
| " Dose-response curves were constructed based on FEV(1) and peak expiratory flow rate (PEFR) recorded after each incremental dose." | 2.71 | A randomized controlled trial to assess the optimal dose and effect of nebulized albuterol in acute exacerbations of COPD. ( Henry, MT; Nair, S; Pearson, SB; Thomas, E, 2005) |
| "The Global Initiative for Chronic Obstructive Lung Disease (GOLD) recommends long-acting bronchodilators as first-line maintenance treatment for patients with chronic obstructive pulmonary disease (COPD)." | 2.71 | Improved daytime spirometric efficacy of tiotropium compared with salmeterol in patients with COPD. ( Bhattycharya, S; Briggs, DD; Cassino, C; Covelli, H; Kesten, S; Lapidus, R, 2005) |
| "Eleven patients with COPD were studied (mean age: 63 years, average FEV1 0." | 2.71 | Effect of inhaled salbutamol on dynamic intrinsic positive end-expiratory pressure in spontaneously breathing patients with stable severe chronic obstructive pulmonary disease. ( Kleinert, MM; Nigro, CA; Prieto, JE; Rhodius, EE, 2005) |
| "Clinically stable COPD patients (age > or = 40 years, postbronchodilator FEV1/FVC <70%, and postbronchodilator FEV1 <80% predicted) were enrolled in a multicenter, open-label randomized study." | 2.71 | Clinical efficacy and safety of transdermal tulobuterol in the treatment of stable COPD: an open-label comparison with inhaled salmeterol. ( Aizawa, H; Fukuchi, Y; Hirata, K; Ichinose, M; Kubo, K; Nagai, A; Nishimura, M; Seyama, K, 2005) |
| "A total of 691 patients with COPD received the combination of F and S (FSC), S (50 mcg), F (500 mcg), or placebo twice daily via the Diskus device for 24 weeks." | 2.70 | Effectiveness of fluticasone propionate and salmeterol combination delivered via the Diskus device in the treatment of chronic obstructive pulmonary disease. ( Chang, CN; Fischer, T; Horstman, D; Mahler, DA; Shah, T; Wire, P; Yates, J, 2002) |
| " Unfortunately the most effective dosage of beta2-agonists may increase above that recommended during acute exacerbations." | 2.70 | Acute effects of higher than customary doses of salmeterol and salbutamol in patients with acute exacerbation of COPD. ( Califano, C; Cazzola, M; D'Amato, G; D'Amato, M; Di Perna, F; Marsico, SA; Matera, MG; Terzano, C, 2002) |
| " The primary end point was mean morning peak expiratory flow (PEF) measured 5 minutes after dosing and entered in a patient diary each day during the first 4 weeks of treatment." | 2.70 | Comparison of the efficacy of formoterol and salmeterol in patients with reversible obstructive airway disease: a multicenter, randomized, open-label trial. ( Condemi, JJ, 2001) |
| "Ten patients with COPD, mechanically ventilated on volume-controlled mode, received 6 puffs of salbutamol (S, 100 micrograms/puff)." | 2.70 | Duration of salbutamol-induced bronchodilation delivered by metered-dose inhaler in mechanically ventilated COPD patients. ( Georgopoulos, D; Kafetzakis, A; Kondili, E; Maliotakis, C; Mouloudi, E, 2001) |
| "Eighteen stable patients with chronic obstructive pulmonary disease (mean FEV1=38." | 2.70 | Salbutamol delivery during non-invasive mechanical ventilation in patients with chronic obstructive pulmonary disease: a randomized, controlled study. ( Braschi, A; Fanfulla, F; Karakurt, S; Nava, S; Rampulla, C, 2001) |
| "In both asthmatic and COPD patients, the overall effect of salmeterol and zafirlukast on the forced expiratory volume in 1 s (FEV1) was considered extremely significant (p < 0." | 2.70 | Comparison of the bronchodilating effect of salmeterol and zafirlukast in combination with that of their use as single treatments in asthma and chronic obstructive pulmonary disease. ( Allegra, L; Boveri, B; Cazzola, M; Centanni, S; Di Marco, F; Matera, MG; Santus, P, 2001) |
| "34 individuals with severe COPD." | 2.70 | Treatment of patients hospitalized for exacerbations of chronic obstructive pulmonary disease: comparison of an oral/metered-dose inhaler regimen and an intravenous/nebulizer regimen. ( Blum, J; Branscombe, JM; Harrow, EM; Oldenburg, FA; Rodgerson, L; Shortall, SP, 2002) |
| "Twenty-three patients with severe COPD were studied." | 2.70 | Use of a mucus clearance device enhances the bronchodilator response in patients with stable COPD. ( Baltzan, MA; Kamel, H; Rotaple, M; Wolkove, N, 2002) |
| "A dose-response curve to formoterol via Turbuhaler or salbutamol via pressurized metered-dose inhaler (pMDI) was constructed." | 2.70 | Formoterol as dry powder oral inhalation compared with salbutamol metered-dose inhaler in acute exacerbations of chronic obstructive pulmonary disease. ( Calderaro, E; Califano, C; Cazzola, M; D'Amato, G; D'Amato, M; Di Perna, F; Matera, MG, 2002) |
| "Acute exacerbations of chronic obstructive pulmonary disease (COPD)--characterized by shortness of breath, increased sputum production, increased purulence, or a combination of these signs--are costly and can have major impacts on the patient's health." | 2.53 | Treating and preventing acute exacerbations of COPD. ( Aboussouan, LS; Hatipoglu, US, 2016) |
| " This systematic review tested the hypothesis that the bronchodilator effect of the LABA/LAMA combination, umeclidinium (UMEC)/vilanterol (VIL), would translate into better outcomes without incurring increased adverse events (AEs)." | 2.52 | A Systematic Review of the Efficacy and Safety of a Fixed-Dose Combination of Umeclidinium and Vilanterol for the Treatment of COPD. ( Neffen, H; Rodrigo, GJ, 2015) |
| "Chronic obstructive pulmonary disease (COPD) is the third leading cause of death worldwide." | 2.52 | Early chronic obstructive pulmonary disease: definition, assessment, and prevention. ( Drummond, MB; Rennard, SI, 2015) |
| "Results of an NMA of COPD treatments suggest that SFC and indacaterol may reduce mortality." | 2.52 | Mortality and drug therapy in patients with chronic obstructive pulmonary disease: a network meta-analysis. ( Calverley, P; Celli, BR; Chambers, M; Clark, JF; Hawkins, N; Scott, DA; Thompson, JC; Woods, B, 2015) |
| "The addition of FSC to subjects with COPD treated with tiotropium significantly improves lung function, quality of life and COPD exacerbations without increasing the risk of adverse events." | 2.50 | Benefits of adding fluticasone propionate/salmeterol to tiotropium in COPD: a meta-analysis. ( Li, M; Liu, Y; Mi, L; Shi, H; Sun, X; Yang, K; Zhang, D; Zhang, Y, 2014) |
| "Indacaterol studies have shown significant improvements in lung function of COPD patients, and these improvements have also translated into clinically meaningful improvements in patient symptoms and HR-QOL." | 2.49 | Improving the quality of life in patients with chronic obstructive pulmonary disease: focus on indacaterol. ( Feldman, GJ, 2013) |
| "Treatment with tiotropium bromide has generally improved patients' health-related quality of life, reduced the number of patients suffering from acute exacerbations, decreased the number of hospitalizations, improved dyspnea, and reduced adverse events compared to placebo." | 2.49 | Ten years of tiotropium: clinical impact and patient perspectives. ( Connolly, MJ; Hanania, NA; Yohannes, AM, 2013) |
| "The adverse environmental effects of CFC-pMDIs stimulated the invention of novel delivery systems including the Respimat SMI." | 2.49 | Efficacy and safety of eco-friendly inhalers: focus on combination ipratropium bromide and albuterol in chronic obstructive pulmonary disease. ( Panos, RJ, 2013) |
| "Indacaterol is a once-daily, long-acting β(2)-agonist bronchodilator that improves dyspnoea and health status in patients with moderate-to-severe COPD." | 2.49 | Effects of long-acting bronchodilators in COPD patients according to COPD severity and ICS use. ( Dahl, R; Decramer, M; Korn, S; Kornmann, O; Lawrence, D; McBryan, D, 2013) |
| " We summarized data relating to exacerbations and adverse events, particularly events related to COPD." | 2.49 | The safety of long-acting β2-agonists in the treatment of stable chronic obstructive pulmonary disease. ( Decramer, ML; Hanania, NA; Lötvall, JO; Yawn, BP, 2013) |
| "Salmeterol significantly reduced COPD exacerbations with both study arms exposed or not exposed to inhaled corticosteroids (ICS)." | 2.48 | Effect of long-acting beta-agonists on the frequency of COPD exacerbations: a meta-analysis. ( Nie, B; Wang, J; Xiong, W; Xu, Y, 2012) |
| "In terms of breathlessness (transitional dyspnea index) at 12 weeks, the results are inconclusive given the limited data." | 2.48 | Efficacy of indacaterol 75 μg versus fixed-dose combinations of formoterol-budesonide or salmeterol-fluticasone for COPD: a network meta-analysis. ( Capkun-Niggli, G; Cope, S; Jansen, JP; Kraemer, M; Zhang, J, 2012) |
| "In people with COPD, the evidence is equivocal as to whether or not tiotropium offers greater benefit than LABAs in improving quality of life; however, this is complicated by differences in effect among the LABA types." | 2.48 | Tiotropium versus long-acting beta-agonists for stable chronic obstructive pulmonary disease. ( Chong, J; Karner, C; Poole, P, 2012) |
| "The objective of this work was to characterize the dose-response relationship between two inhaled long-acting beta agonists (PF-00610355 and salmeterol) and the forced expiratory volume in one second (FEV1) in order to inform dosing recommendations for future clinical trials in patients with chronic obstructive pulmonary disease (COPD)." | 2.48 | Longitudinal FEV1 dose-response model for inhaled PF-00610355 and salmeterol in patients with chronic obstructive pulmonary disease. ( Cleton, A; Hutmacher, MM; Martin, SW; Nielsen, JC; Ribbing, J, 2012) |
| "A previously published, validated COPD progression model was updated with new exacerbation data and adapted to the Dutch setting by including Dutch estimates of healthcare use for COPD maintenance treatment and Dutch unit costs." | 2.48 | Which long-acting bronchodilator is most cost-effective for the treatment of COPD? ( Hoogendoorn, M; Kappelhoff, BS; Overbeek, JA; Rutten-van Mölken, MP; Wouters, EF, 2012) |
| " Two LABAs (salmeterol and formoterol) are currently licensed for COPD both as monotherapy and in combination with ICS (fluticasone propionate (FP) and budesonide respectively)." | 2.47 | The use of long acting β₂-agonists, alone or in combination with inhaled corticosteroids, in chronic obstructive pulmonary disease (COPD): a risk-benefit analysis. ( Cave, AC; Hurst, MM, 2011) |
| "Asthma and chronic obstructive pulmonary disease (COPD) are inflammatory disorders that have an increasing prevalence and associated morbidity and mortality." | 2.47 | (R)-salbutamol in the treatment of asthma and chronic obstructive airways disease. ( Patel, M; Thomson, NC, 2011) |
| "Indacaterol is a new once-daily, long-acting inhaled bronchodilator for COPD." | 2.47 | Efficacy of indacaterol in the treatment of patients with COPD. ( Barnes, N; Jones, PW; Kramer, B; Lawrence, D; Vogelmeier, C, 2011) |
| "Indacaterol is an inhaled, once-daily long-acting β(2)-agonist bronchodilator for regular use in patients with chronic obstructive pulmonary disease (COPD)." | 2.47 | Bronchodilator efficacy and safety of indacaterol 150 μg once daily in patients with COPD: an analysis of pooled data. ( Bleecker, ER; Kramer, B; Owen, R; Siler, T, 2011) |
| "Chronic obstructive pulmonary disease (COPD) is a major cause of morbidity and mortality throughout the world." | 2.46 | Inhaled albuterol/salbutamol and ipratropium bromide and their combination in the treatment of chronic obstructive pulmonary disease. ( Gordon, J; Panos, RJ, 2010) |
| " The first step in outpatient management should be to increase the dosage of inhaled short-acting bronchodilators." | 2.46 | Management of COPD exacerbations. ( Evensen, AE, 2010) |
| "In patients with COPD, treatment with a combination of the inhaled corticosteroid fluticasone propionate (250 microg) and the long-acting beta(2)-agonist salmeterol (50 microg) in a single inhaler (250/50 microg) is an effective therapy option that has been shown to reduce the frequency of exacerbations, to improve lung function, dyspnea and health status, and to be relatively cost-effective as a COPD maintenance therapy." | 2.46 | The role of fluticasone propionate/salmeterol combination therapy in preventing exacerbations of COPD. ( Dalal, AA; Hurley, JS; Raphiou, I; Yawn, BP, 2010) |
| "Chronic obstructive pulmonary disease is one of the most common chronic diseases throughout the world affecting prevalently older people." | 2.46 | Do we need different treatments for very elderly COPD patients? ( Bernabei, R; Corbo, GM; Pasciuto, G; Valente, S, 2010) |
| " dosing schedule, formulation, etc." | 2.46 | Adherence to controller therapy for chronic obstructive pulmonary disease: a review. ( Blanchette, CM; Charles, MS; Dalal, AA; Lavallee, D; Mapel, D; Silver, H, 2010) |
| "Roflumilast is an anti-inflammatory drug belonging to the novel therapeutic class of phosphodiesterase-4 inhibitors and is the first drug to be developed for the treatment of a specific COPD phenotype (COPD associated with chronic bronchitis)." | 2.46 | [Clinical profile of roflumilast]. ( Izquierdo Alonso, JL, 2010) |
| "Chronic obstructive pulmonary disease (COPD) is one of the most important respiratory diseases, characterized by its multicomponent complexity, with chronic inflammation, increased airway resistance and exacerbations." | 2.46 | [Triple therapy in chronic obstructive pulmonary disease]. ( Baloira, A, 2010) |
| "For the acute COPD studies, one was double-blind and randomised, one was single-blind and randomised, and one was open-label." | 2.45 | Use of dry powder inhalers in acute exacerbations of asthma and COPD. ( Borgström, L; Ingelf, J; Selroos, O, 2009) |
| "Influencing the progression of COPD has long been an elusive goal of drug therapy." | 2.45 | Insights into interventions in managing COPD patients: lessons from the TORCH and UPLIFT studies. ( Anzueto, A; Miravitlles, M, 2009) |
| "For many years, chronic obstructive pulmonary disease (COPD) was considered a disease of fixed airflow obstruction for which there was no good treatment." | 2.45 | Management of chronic obstructive pulmonary disease: moving beyond the asthma algorithm. ( Gordon, E; Lazarus, SC, 2009) |
| "The costs of asthma and chronic obstructive pulmonary disease (COPD), the two most common chronic respiratory illnesses, are substantial and rising." | 2.44 | Seretide: a pharmacoeconomic analysis. ( Chapman, KR; Fritscher, L, 2008) |
| " Further studies are needed to elucidate the clinical benefit of combination inhalers versus the individual components in different inhalers, and to investigate the clinical benefit of flexible dosing of combination inhalers in patients with COPD." | 2.44 | Comparison and optimal use of fixed combinations in the management of COPD. ( Aalbers, R; Mensing, M, 2007) |
| " Traditional press-and-breathe Metered Dose Inhalers (pMDIs) have recently improved their ecological appeal, can be used in every clinical and environmental situation, their dosing is convenient and highly reproducible, but their efficient delivery remains highly technique dependent." | 2.44 | Inhalatory therapy training: a priority challenge for the physician. ( Melani, AS, 2007) |
| "Tiotropium bromide is an effective bronchodilator for patients with COPD." | 2.43 | Tiotropium: a bronchodilator for chronic obstructive pulmonary disease. ( Remington, TL; Somand, H, 2005) |
| "Although large surveys have documented the favourable safety profile of beta(2)-adrenoceptor agonists (beta(2)-agonists) and, above all, that of the long-acting agents, the presence in the literature of reports of adverse cardiovascular events in patients with obstructive airway disease must induce physicians to consider this eventuality." | 2.43 | Inhaled beta2-adrenoceptor agonists: cardiovascular safety in patients with obstructive lung disease. ( Cazzola, M; Donner, CF; Matera, MG, 2005) |
| "Chronic obstructive pulmonary disease (COPD) is considered one of the most common chronic diseases in the world." | 2.43 | [The beta2-adrenergic receptor agonists in the treatment of chronic obstructive pulmonary disease]. ( Chorostowska-Wynimko, J, 2005) |
| "The sensation of dyspnea is experienced differently among individuals with COPD and may be based on diverse factors, such as muscle fatigue, patient perception, or trapped volumes." | 2.43 | Improving dyspnea in chronic obstructive pulmonary disease: optimal treatment strategies. ( Rabe, KF, 2006) |
| "Smoking cessation has been shown to slow lung function decline and to reduce mortality--including deaths due to lung cancer, other respiratory disease (including COPD), and cardiovascular disease." | 2.43 | Clinical course of chronic obstructive pulmonary disease: review of therapeutic interventions. ( Anzueto, A, 2006) |
| " LABAs are well-tolerated in patients with COPD, with a low incidence of reported adverse events (AEs)." | 2.43 | Clinical safety of long-acting beta2-agonist and inhaled corticosteroid combination therapy in COPD. ( Decramer, M; Ferguson, G, 2006) |
| "In studies of FP or of Sal/FP in COPD, there was a reduction in all-cause mortality by 25% relative to placebo." | 2.43 | Salmeterol/fluticasone combination in the treatment of COPD. ( Chung, KF, 2006) |
| "In the treatment of COPD, long-acting beta(2)-adrenoceptor agonists (LABAs) given twice daily cause the same degree of bronchodilation as tiotropium bromide given once daily." | 2.42 | Long-acting beta 2-adrenoceptor agonists or tiotropium bromide for patients with COPD: is combination therapy justified? ( Barnes, PJ; Erin, EM; Hansel, TT; Tennant, RC, 2003) |
| "We searched the Cochrane Airways Group chronic obstructive pulmonary disease (COPD) trials register (March 2003), the Cochrane Central Register of Controlled Trials (The Cochrane Library Issue 1, 2003), LILACS (all years to March 2003) and reference lists of articles." | 2.42 | Combined corticosteroid and longacting beta-agonist in one inhaler for chronic obstructive pulmonary disease. ( Lasserson, TJ; Nannini, L; Poole, P, 2003) |
| "Despite concerns in the 1970s and 1980s about the safety of short-acting beta2-agonists, it is now generally accepted that these agents, used at appropriate doses, provide safe and effective treatment for asthma symptoms." | 2.42 | State of the art in beta2-agonist therapy: a safety review of long-acting agents. ( Rabe, KF, 2003) |
| "Chronic-obstructive pulmonary disease (COPD) is a global public health problem and its impact is increasing." | 2.42 | Fluticasone propionate/salmeterol for the treatment of chronic-obstructive pulmonary disease. ( Bailey, WC; Dransfield, MT, 2004) |
| "For patients with chronic obstructive pulmonary disease, quick-relief and long-acting bronchodilators are primarily used in the maintenance and treatment of associated symptoms, including shortness of breath." | 2.42 | Levalbuterol in the treatment of patients with asthma and chronic obstructive lung disease. ( Dalonzo, GE, 2004) |
| " In the US, twice-daily salmeterol/fluticasone propionate 50/250 microg is approved for use in adults with chronic obstructive pulmonary disease (COPD) associated with chronic bronchitis, and in the EU, the twice-daily 50/500 microg dosage is approved for use in patients with severe COPD, repeat exacerbations and significant symptoms despite bronchodilator therapy." | 2.42 | Inhaled salmeterol/fluticasone propionate: a review of its use in chronic obstructive pulmonary disease. ( Fenton, C; Keating, GM, 2004) |
| "Indeed, the Global Initiative for Chronic Obstructive Lung Disease (GOLD) strategy emphasises the role of bronchodilators in symptomatic management of all stages of COPD." | 2.41 | Tiotropium bromide: a novel once-daily anticholinergic bronchodilator for the treatment of COPD. ( Barnes, PJ; Hansel, TT, 2002) |
| "The prospect for better treatment of chronic obstructive pulmonary disease looks brighter than ever." | 2.41 | New therapeutic drugs in the management of chronic obstructive pulmonary disease. ( Rennard, SI, 2002) |
| "These drugs are particularly useful in bronchial asthma and meet the requirements of several treatment guidelines to combine long-acting bronchodilator therapy with inhaled corticosteroids in patients with persistent asthma." | 2.40 | [Long-acting beta(2)-adrenoceptor agonists for asthma and COPD]. ( Magnussen, H; Rabe, KF; Ukena, D, 1997) |
| "Patients admitted for asthma or COPD exacerbations, doctors, and nurses in a university-affiliated hospital were surveyed from 1 April 2021 to 30 September 2021 regarding their views on the effectiveness, ease of use, preparation and administration, side effects, and infection risk of the two administration methods." | 1.91 | Nebulizer versus metered dose inhaler with space chamber (MDI spacer) for acute asthma and chronic obstructive pulmonary disease exacerbation: attitudes of patients and healthcare providers in the COVID-19 era. ( Alsuwaigh, R; Binte Mohd Noor, N; Cao, Y; Chen, H; Li, XL; Liew, J; Mohamed Noor, SB; Puan, Y; Tay, TR; Ye, H; Yii, A, 2023) |
| "The recommended treatment of COPD exacerbations includes administration of short-acting bronchodilators that act to reverse bronchoconstriction, restore lung volumes, and relieve breathlessness." | 1.91 | Response to Bronchodilators Administered via Different Nebulizers in Patients With COPD Exacerbation. ( Alsaid, A; Costello, RW; Cushen, B; Greene, G, 2023) |
| "Fall-related causes in patients with COPD might be associated to functional balance impairments and greater disease severity." | 1.72 | Balance impairment and lower limbs strength in patients with COPD who fell in the previous year. ( Brandão, AD; Castro, AAM; De Lima, PB; Fagundes, JC; Fausto, DM; Kümpel, C; Porto, EF; Zozimo, B, 2022) |
| "Fifteen COPD patients were recruited to undergo spirometry and SPECT-CT lung scan following nebulization of radioactively labeled albuterol in saline solution with a jet nebulizer ("NEB") and with a combined Pulsehaler™/jet nebulizer ("PH + NEB") treatment." | 1.72 | Pressure pulsations enhance penetration index in COPD. ( Fink, G; Gavriely, N; Golan, H; Shpirer, I; Volkov, O, 2022) |
| "24 (12 females) intubated chronic obstructive pulmonary disease (COPD) subjects had undergone the study." | 1.62 | Aerosol delivery of inhalation devices with different add-on connections to invasively ventilated COPD subjects: An in-vivo study. ( Abdelrahim, MEA; Ma, E; Rabea, H; Saeed, H; Seif, SM, 2021) |
| "Chronic obstructive pulmonary disease (COPD) is widely established as a health challenge, with predictions that it will be the third leading cause of global mortality and reduced health status within the next 10 years." | 1.56 | Management of COPD exacerbations: pharmacotherapeutics of medications. ( Moore, D, 2020) |
| "Chronic obstructive pulmonary disease (COPD) is a heterogeneous disease characterised by airflow obstruction and other morbidities such as respiratory symptoms, reduced physical activity and frequent bronchodilator use." | 1.51 | Real-world use of rescue inhaler sensors, electronic symptom questionnaires and physical activity monitors in COPD. ( Allinder, M; Bowler, R; Jacobson, S; Locantore, N; Miller, A; Miller, B; Tal-Singer, R, 2019) |
| "Thirty-five participants with COPD used an electronic inhaler sensor for 12 weeks which recorded the date and time of each albuterol actuation." | 1.48 | Use of a Remote Inhaler Monitoring Device to Measure Change in Inhaler Use with Chronic Obstructive Pulmonary Disease Exacerbations. ( Fan, VS; Gylys-Colwell, I; Humblet, O; Locke, ER; Magzamen, S; Nguyen, HQ; Sumino, K; Thomas, RM, 2018) |
| "The results showed the patients with AECOPD with good and poor response to standard corticosteroid treatment have a distinct DNA methylation pattern." | 1.48 | Whole-genome methylation profiling of peripheral blood mononuclear cell for acute exacerbations of chronic obstructive pulmonary disease treated with corticosteroid. ( Chen, CH; Chuang, TY; Hsu, PW; Lee, SW; Liu, CW; Weng, JT; Wu, LS, 2018) |
| " Safety in terms of adverse events (AEs) was also examined." | 1.48 | Real-life effectiveness and safety of salbutamol Steri-Neb™ vs. Ventolin Nebules® for exacerbations in patients with COPD: Historical cohort study. ( Davis, E; Gefen, E; Gopalan, G; McDonald, R; Ming, SWY; Price, DB; Thomas, V, 2018) |
| "Sputum induction is successful and safe in COPD." | 1.46 | The success and safety profile of sputum induction in patients with chronic obstructive pulmonary disease: An Indian experience. ( Fernandes, L; Mesquita, AM, 2017) |
| "Six smoking controls and 13 of the COPD patients also performed double reversibility test by using salbutamol and its combination with ipratropium." | 1.43 | Acinar ventilation heterogeneity in COPD relates to diffusion capacity, resistance and reactance. ( Ankerst, J; Bjermer, L; Jarenbäck, L; Tufvesson, E, 2016) |
| "Airway obstruction was more severe in COPD patients as compared with controls (mean FEV1 and FEV1% predicted both P<0." | 1.43 | Characteristics of reversible and nonreversible COPD and asthma and COPD overlap syndrome patients: an analysis of salbutamol Easyhaler data. ( Gálffy, G; Kováts, Z; Müller, V; Odler, B; Orosz, M; Selroos, O; Tamási, L, 2016) |
| "We outline 5 cases of stress cardiomyopathy where the precipitant was an acute exacerbation of chronic obstructive pulmonary disease treated with high-dose bronchodilator therapy." | 1.42 | Bronchogenic stress cardiomyopathy: a case series. ( Adam, Z; Hall, JA; Rajwani, A, 2015) |
| "In non-exacerbation chronic obstructive pulmonary disease (COPD) with mild lung function impairment, single bronchodilator therapy might be as effective as combined inhaled corticosteroid/bronchodilator therapy, whereas the risk of pneumonia associated with the latter would be practically absent." | 1.42 | Efficacy of indacaterol as a single therapy versus salmeterol/fluticasone therapy in patients with milder chronic obstructive pulmonary disease. ( Antoniu, SA; Boisteanu, D; Mihaltan, F; Ruxandra, U, 2015) |
| "Physically inactive patients with chronic obstructive pulmonary disease (COPD) exhibit higher rates of exacerbations and symptoms of dyspnoea than active patients." | 1.42 | Physical activity in COPD patients decreases short-acting bronchodilator use and the number of exacerbations. ( Katajisto, M; Kilpeläinen, M; Koskela, J; Laitinen, T; Lindqvist, A, 2015) |
| "Asthma and chronic obstructive pulmonary disease (COPD) are common lung diseases characterized by chronic airway inflammation and airway obstruction." | 1.42 | [Asthma-COPD overlap syndrome]. ( Bavbek, S; Çelik, G; Demir, T; Gemicioğlu, B; Günen, H; Kıyan, E; Mungan, D; Oğuzülgen, K; Polatlı, M; Saryal, S; Sayıner, A; Şen, E; Türktaş, H; Yıldırım, N; Yıldız, F; Yorgancıoğlu, A, 2015) |
| "A total of 77,480 newly-diagnosed COPD patients with a mean age of 68." | 1.40 | The association between inhaled long-acting bronchodilators and less in-hospital care in newly-diagnosed COPD patients. ( Kim, J; Kim, K; Kim, Y; Kim, YS; Lee, CK; Lee, JH; Lee, SD; Lee, SW; Oh, YM; Park, YB; Yoo, KH; Yoon, HK, 2014) |
| "14 subjects with COPD were commenced on combination fluticasone propionate/salmeterol therapy for 3 months." | 1.40 | Changes in oscillatory impedance and nitrogen washout with combination fluticasone/salmeterol therapy in COPD. ( Diba, C; King, GG; Salome, CM; Schoeffel, RE; Thamrin, C; Timmins, SC, 2014) |
| "Acute exacerbation of chronic obstructive pulmonary disease (AECOPD) is a common condition, which affects not only the quality of life of patients but also their prognosis." | 1.40 | Heliox as a driving gas to atomize inhaled drugs on acute exacerbation of chronic obstructive pulmonary disease: a prospective clinical study. ( Han, B; Su, L; Xiao, Y; Xie, L; Zhang, X, 2014) |
| "Subjects with COPD chronic obstructive pulmonary disease underwent spirometry, plethysmography, diffusing capacity of carbon monoxide, St George's Respiratory Questionnaire, 6-minute walk test, and imaging." | 1.40 | Hyperpolarized (3)He ventilation defects used to predict pulmonary exacerbations in mild to moderate chronic obstructive pulmonary disease. ( Coxson, HO; Kirby, M; McCormack, DG; Parraga, G; Pike, D, 2014) |
| "The changes exhibited by the COPD subgroups were greater than in the healthy individuals (p < 0." | 1.40 | Respiratory impedance and response to salbutamol in healthy individuals and patients with COPD. ( da Costa, GM; Di Mango, AM; Faria, AC; Lopes de Melo, P; Lopes, AJ, 2014) |
| "Associations between SABA use, COPD exacerbations, and health care costs over 1 year were examined retrospectively using de-identified patient data from the Optum Research Database (ORD; N = 56,581) and the Impact National Benchmark Database (IMPACT™; N = 9423)." | 1.40 | A simple rule to identify patients with chronic obstructive pulmonary disease who may need treatment reevaluation. ( Altan, AE; Altman, PR; Colice, GL; Donohue, JF; Hanania, NA; Kurlander, JL; Rodriguez-Roisin, R; Sharafkhaneh, A, 2014) |
| " RESULTS were adjusted for initial prescriber, initial medication, dosing regimen and relevant comorbidities." | 1.40 | Impact of multiple-dose versus single-dose inhaler devices on COPD patients' persistence with long-acting β₂-agonists: a dispensing database analysis. ( Dekhuijzen, PN; Postma, MJ; van Boven, JF; van der Galiën, R; van der Molen, T; van Raaij, JJ; Vegter, S, 2014) |
| "Patients with physician-diagnosed COPD and a record of postdiagnosis treatment with a fixed combination of budesonide/formoterol or fluticasone/salmeterol were included." | 1.39 | Combination of budesonide/formoterol more effective than fluticasone/salmeterol in preventing exacerbations in chronic obstructive pulmonary disease: the PATHOS study. ( Janson, C; Johansson, G; Jørgensen, L; Larsson, K; Lisspers, K; Ställberg, B; Stratelis, G; Telg, G, 2013) |
| "Chronic Obstructive Pulmonary Disease (COPD) is a chronic, progressive disease that is not curable." | 1.39 | A UK-based cost-utility analysis of indacaterol, a once-daily maintenance bronchodilator for patients with COPD, using real world evidence on resource use. ( Ananthapavan, J; Asukai, Y; Keyzor, I; Malcolm, B; Price, D; Radwan, A, 2013) |
| "In moderate-to-very severe COPD patients, both static and/or dynamic pulmonary hyperinflation have been demonstrated at rest." | 1.39 | Inspiratory drive is related to dynamic pulmonary hyperinflation in COPD patients. ( Aliprandi, G; Fredi, M; Gatta, D; Pini, L; Tantucci, C, 2013) |
| "Lactic acidosis is commonly used as a clinical marker for sepsis and shock, but in the absence of tissue hypoperfusion and severe hypoxia, alternative aetiologies for elevated levels should be sought to avoid unnecessary and potentially harmful medical interventions." | 1.39 | Inhaled β-agonist therapy and respiratory muscle fatigue as under-recognised causes of lactic acidosis. ( Carino, G; Lau, E; Mazer, J, 2013) |
| "Inpatient admissions for chronic obstructive pulmonary disease (COPD) represent a significant economic burden, accounting for over half of direct medical costs." | 1.39 | Hospital readmissions following initiation of nebulized arformoterol tartrate or nebulized short-acting beta-agonists among inpatients treated for COPD. ( Bollu, V; Braman, SS; Ernst, FR; Karafilidis, J; Rajagopalan, K; Robinson, SB, 2013) |
| "Eleven patients with stable COPD (9 men; age 48-79; FEV1 42-80%; FRC above 120%) were studied before and after 400 μg salbutamol." | 1.39 | Acute bronchodilation increases ventilatory complexity during resting breathing in stable COPD: toward mathematical biomarkers of ventilatory function? ( Fiamma, MN; Similowski, T; Straus, C; Teulier, M, 2013) |
| " This pharmacological profile combined with clinical data is consistent with once a day dosing of vilanterol in the treatment of both asthma and chronic obstructive pulmonary disease (COPD)." | 1.39 | In vitro pharmacological characterization of vilanterol, a novel long-acting β2-adrenoceptor agonist with 24-hour duration of action. ( Barrett, VJ; Emmons, AJ; Ford, AJ; Knowles, RG; Morrison, VS; Slack, RJ; Sturton, RG, 2013) |
| "Patients with chronic obstructive pulmonary disease (COPD) show different spirometric response patterns to bronchodilator, such that some patients show improvement principally in expiratory flow (forced expiratory volume in 1 s; FEV(1)), whereas others respond by improvement of lung volume (forced vital capacity; FVC)." | 1.38 | Response patterns to bronchodilator and quantitative computed tomography in chronic obstructive pulmonary disease. ( Chae, EJ; Huh, JW; Kim, EK; Kim, TH; Kim, WJ; Lee, JH; Lee, JS; Lee, S; Lee, SD; Lee, SM; Lee, YK; Lim, SY; Oh, YM; Ra, SW; Seo, JB; Sheen, SS; Shin, TR; Yoon, HI, 2012) |
| "Chronic obstructive pulmonary disease (COPD) is frequently associated with comorbid depression and anxiety." | 1.38 | Clinical and economic outcomes for patients initiating fluticasone propionate/salmeterol combination therapy (250/50 mcg) versus anticholinergics in a comorbid COPD/depression population. ( Chaudhari, S; Crater, G; D'Souza, AO; Dalal, AA; Shah, M, 2012) |
| "The risks of COPD exacerbations and healthcare costs were compared between cohorts during 1 year of follow-up." | 1.38 | Observational study on the impact of initiating tiotropium alone versus tiotropium with fluticasone propionate/salmeterol combination therapy on outcomes and costs in chronic obstructive pulmonary disease. ( Bechtel, B; Chatterjee, A; Crater, G; D'Souza, AO; Dalal, AA; Shah, M, 2012) |
| "Chronic obstructive pulmonary disease (COPD) is an inflammatory disorder associated with considerable morbidity and mortality." | 1.38 | Levosalbutamol for chronic obstructive pulmonary disease: a treatment evaluation. ( Patel, M; Thomson, NC, 2012) |
| "The proportion of patients with COPD-related healthcare events, the mean event rates, and the mean costs in the subsequent 12 months were calculated." | 1.38 | Rehospitalization risks and outcomes in COPD patients receiving maintenance pharmacotherapy. ( Crater, GD; D'Souza, AO; Dalal, AA; Shah, M, 2012) |
| "The prevalence of Chronic Obstructive Pulmonary Disease (COPD) in Cyprus is largely unknown." | 1.38 | Prevalence of chronic obstructive pulmonary disease in Cyprus: a population-based study. ( Adamide, T; Anagnostopoulou, U; Georgiou, A; Gourgoulianis, KI; Zachariades, AG; Zachariadou, T, 2012) |
| "1831 patients with COPD, 285 smoking (SC) and 228 non-smoking (NSC) controls from the Evaluation of COPD Longitudinally to Identify Predictive Surrogate Endpoints (ECLIPSE) cohort." | 1.38 | Bronchodilator responsiveness as a phenotypic characteristic of established chronic obstructive pulmonary disease. ( Agusti, A; Albert, P; Bakke, P; Calverley, P; Celli, BR; Coxson, HO; Crim, C; Edwards, L; Lomas, DA; Macnee, W; Miller, B; Rennard, S; Silverman, EK; Tal-Singer, R; Vestbo, J; Wouters, E; Yates, J, 2012) |
| "The etiology of chronic obstructive pulmonary disease (COPD) is complex and involves an aberrant inflammatory response." | 1.38 | Attenuation of inhibitory prostaglandin E2 signaling in human lung fibroblasts is mediated by phosphodiesterase 4. ( Basma, H; Fahrid, M; Gunji, Y; Holz, O; Kanaji, N; Liu, X; Magnussen, H; Michalski, J; Muller, KC; Nakanishi, M; Nelson, A; Nogel, S; Rabe, KF; Rennard, SI; Sato, T; Toews, ML; Wang, X, 2012) |
| "Chronic obstructive pulmonary disease (COPD) management was investigated in two sub-studies of the BEACH (Bettering the Evaluation and Care of Health) program at 5711 general practitioner-patient encounters in February to March 2010 and April to May 2011." | 1.38 | Management of COPD in general practice. ( Harrison, C; Henderson, J; Miller, G, 2012) |
| "Chronic obstructive pulmonary disease (COPD) is one of the most important diseases because of high and constantly increasing prevalence, morbidity and mortality." | 1.38 | [Diagnostic and treatment of chronic obstructive pulmonary disease based on GOLD statement 2011]. ( Barczyk, A; Pierzchała, W, 2012) |
| "Treatment with rosiglitazone preserved salbutamol relaxant activity, mitigated carbachol hyperresponsiveness and partially restored β₂-adrenoceptor binding sites in tracheal tissues from homologously desensitized animals." | 1.37 | Rosiglitazone reverses salbutamol-induced β(2) -adrenoceptor tolerance in airway smooth muscle. ( Adinolfi, B; Bardelli, C; Betti, L; Breschi, MC; Brunelleschi, S; Fabbrini, L; Fogli, S; Giannaccini, G; Lucacchini, A; Mariotti, V; Melissari, E; Pellegrini, S; Stefanelli, F, 2011) |
| "Among those with confirmed COPD, dyspnoea was worse in those with more severe airflow limitation though exacerbation frequency was comparable across COPD stages." | 1.37 | Disease severity and symptoms among patients receiving monotherapy for COPD. ( Bailey, W; Crater, G; Dransfield, MT; Emmett, A; O'Dell, DM; Yawn, B, 2011) |
| " Adverse events (AEs) were analysed overall and according to Anti-Platelet Trialists' Collaboration (APTC) criteria and baseline cardiovascular risk factors." | 1.37 | Cardio- and cerebrovascular safety of indacaterol vs formoterol, salmeterol, tiotropium and placebo in COPD. ( Chung, KF; Felser, JM; Hu, H; Rueegg, P; Worth, H, 2011) |
| "In patients with COPD, albuterol significantly decreases expiratory resistance at the end of expiration." | 1.37 | Effect of albuterol on expiratory resistance in mechanically ventilated patients. ( Alexopoulou, C; Georgopoulos, D; Kondili, E; Prinianakis, G; Vaporidi, K; Xirouchaki, N, 2011) |
| "Chronic obstructive pulmonary disease (COPD) is a heterogeneous disease and responses to therapies are highly variable." | 1.37 | Predictors of pulmonary function response to treatment with salmeterol/fluticasone in patients with chronic obstructive pulmonary disease. ( Chae, EJ; Huh, JW; Kim, EK; Kim, TH; Kim, WJ; Lee, JH; Lee, JS; Lee, S; Lee, SD; Lee, SM; Lee, YK; Lim, SY; Oh, YM; Ra, SW; Seo, JB; Sheen, SS; Shin, TR; Yoon, HI, 2011) |
| "Chronic obstructive pulmonary disease (COPD) is an important risk factor for perioperative morbidity and mortality in patients undergoing cardiac surgery." | 1.37 | Fast-track pulmonary conditioning before urgent cardiac surgery in patients with insufficiently treated chronic obstructive pulmonary disease. ( Dreger, H; Gromann, T; Hetzer, R; Melzer, C; Schaumann, B, 2011) |
| "Time to COPD-related events and healthcare costs were compared during up to 1 year of follow-up between the 2 cohorts." | 1.37 | COPD-related healthcare utilization and costs after discharge from a hospitalization or emergency department visit on a regimen of fluticasone propionate-salmeterol combination versus other maintenance therapies. ( D'Souza, AO; Dalal, AA; Mapel, DW; Shah, M, 2011) |
| "Seventy-two patients with stable COPD treated with tiotropium (n = 41) or salmeterol (n = 31) were evaluated for pulmonary function, dynamic hyperinflation following metronome-paced incremental hyperventilation, six-minute walking distance, and St George's Respiratory Questionnaire (SGRQ) before and 2-3 months following treatment with tiotropium or salmeterol." | 1.37 | Comparison of efficacy of long-acting bronchodilators in emphysema dominant and emphysema nondominant chronic obstructive pulmonary disease. ( Fujimoto, K; Hanaoka, M; Kanda, S; Kitaguchi, Y; Kubo, K; Urushihata, K, 2011) |
| "Indacaterol is a novel inhaled once-daily long-acting beta(2)-agonist (LABA) for the maintenance treatment of COPD that has been compared to existing inhaled monotherapies on a number of symptomatic endpoints in clinical studies." | 1.37 | Cost-utility analysis of indacaterol in Germany: a once-daily maintenance bronchodilator for patients with COPD. ( Asukai, Y; Gale, R; Gantner, T; Gray, A; Lloyd, A; Mungapen, L; Neidhardt, K; Peters, L; Price, D, 2011) |
| "Fourteen ex-smokers with COPD provided written informed consent to a local ethics board-approved and Health Insurance and Portability Accountability Act-compliant protocol and underwent hyperpolarized ³He and hydrogen 1 MR imaging, spirometry, and plethysmography before and a mean of 25 minutes ± 2 (standard deviation) after administration of 400 μg salbutamol." | 1.37 | Chronic obstructive pulmonary disease: quantification of bronchodilator effects by using hyperpolarized ³He MR imaging. ( Etemad-Rezai, R; Heydarian, M; Kirby, M; Mathew, L; McCormack, DG; Parraga, G, 2011) |
| "The risk of COPD exacerbation (moderate, severe, and any), COPD-related health care utilization, and COPD-related costs (overall and by service setting) were assessed over 12 months after the initiation of treatment with FSC or TIO in commercially-insured patients > or =40 years old diagnosed with COPD." | 1.37 | Outcomes and costs associated with initial maintenance therapy with fluticasone propionate-salmeterol xinafoate 250 microg/50 microg combination versus tiotropium in commercially insured patients with COPD. ( Candrilli, SD; Dalal, AA; Davis, KL, 2011) |
| "A retrospective cohort study assessed COPD-related outcomes using administrative claims data among ICS/LABA-naïve patients." | 1.37 | Comparative effectiveness of budesonide/formoterol and fluticasone/salmeterol for COPD management. ( Blanchette, C; Mapel, D; Petersen, H; Ramachandran, S; Roberts, M, 2011) |
| "FSC or other ICS exposure was not associated with an increased odds of cataracts or glaucoma, nor was a dose-response relationship observed in this population-based nested case-control study of COPD patients in the United Kingdom." | 1.37 | Long-term use of fluticasone propionate/salmeterol fixed-dose combination and incidence of cataracts and glaucoma among chronic obstructive pulmonary disease patients in the UK General Practice Research Database. ( Davis, KJ; Miller, DP; Sampson, T; Watkins, SE, 2011) |
| "Chronic obstructive pulmonary disease (COPD) increasingly is a cause of morbidity and mortality in and economic burden on the US healthcare system, and COPD exacerbations continue to be among the top 10 causes of hospitalization in adults." | 1.37 | An evaluation of inhaled bronchodilator therapy in patients hospitalized for non-life-threatening COPD exacerbations. ( Finch, CK; Self, TH; Usery, JB; Woods, JA, 2011) |
| "In severe COPD, with minimal change in hyperinflation or pulmonary mechanics, salmeterol-fluticasone induced a significant decrease in activity of the chest wall parasternal inspiratory muscle." | 1.36 | Parasternal muscle activity decreases in severe COPD with salmeterol-fluticasone propionate. ( Doig, CJ; Easton, PA; Hawes, HG; Johnson, MW; Wilde, ER; Yokoba, M, 2010) |
| "A previously-published COPD cost-effectiveness model was adapted for the UK, then used to estimate the cost-effectiveness of tiotropium compared to salmeterol and ipratropium." | 1.36 | Economic analyses comparing tiotropium with ipratropium or salmeterol in UK patients with COPD. ( Gani, R; Griffin, J; Kelly, S; Rutten-van Mölken, M, 2010) |
| "These COPD patients treated with BUD/FM were less likely to have ED visits and hospitalizations for COPD and used fewer doses of anticholinergic medication than patients treated with FP/SM in the year after treatment initiation." | 1.36 | Relative effectiveness of budesonide/formoterol and fluticasone propionate/salmeterol in a 1-year, population-based, matched cohort study of patients with chronic obstructive pulmonary disease (COPD): Effect on COPD-related exacerbations, emergency depart ( Blais, L; Forget, A; Ramachandran, S, 2010) |
| "Total adjusted annual COPD related exacerbation and therapeutic costs were $4,842 (95% CI; $4,731-$4,952) in the FSC group and $5,066 (95% CI; $4,937-$5,195) in the salmeterol group." | 1.36 | Cost-effectiveness of combination fluticasone propionate-salmeterol 250/50 microg versus salmeterol in severe COPD patients. ( Blanchette, CM; Dalal, AA; Manavi-Zieverink, K; Petersen, HV; Roberts, MH; St Charles, M, 2010) |
| "Some treatments for chronic obstructive pulmonary disease (COPD) can reduce exacerbations, and thus could have a favourable impact on overall healthcare costs." | 1.36 | A new method for examining the cost savings of reducing COPD exacerbations. ( Lydick, E; Mapel, DW; Marton, JP; Schum, M, 2010) |
| "COPD was likely the predominant diagnosis but patients with asthma may have been included." | 1.36 | Lung hyperinflation and its reversibility in patients with airway obstruction of varying severity. ( Deesomchok, A; Forkert, L; Jensen, D; Lam, YM; O'Donnell, DE; Ofir, D; Webb, KA, 2010) |
| "Time-to-first COPD-related health care event beginning 30 days following therapy initiation with FSC (n = 16,684), ipratropium alone or in fixed dose combination with albuterol (n = 14,449), or tiotropium (n = 12,659) was estimated using Cox proportional hazard models that controlled for differences in patient demographic characteristics, health care utilization, and comorbidities at baseline." | 1.36 | Comparative cost-effectiveness of a fluticasone-propionate/salmeterol combination versus anticholinergics as initial maintenance therapy for chronic obstructive pulmonary disease. ( Blanchette, CM; Dalal, AA; Mapel, DW; Petersen, HV; Roberts, MH, 2010) |
| "Levalbuterol-only users were more likely to be older than albuterol-only users (mean age: 71." | 1.36 | Albuterol and levalbuterol use and spending in Medicare beneficiaries with chronic obstructive pulmonary disease. ( Bergquist, H; Doshi, JA; McElligott, S; Puig, A, 2010) |
| "Airway responsiveness to salbutamol in COPD patients (PC 20 = 14." | 1.36 | Pharmacologic bronchodilation response to salbutamol in COPD patients. ( Boskabady, M; Boskabady, MH; Mansouri, F; Shafei, MN, 2010) |
| "The Global Initiative for Chronic Obstructive Lung Disease (GOLD) recommends the use of forced expiratory volume in 1s (FEV(1)) to assess airways reversibility." | 1.35 | The forgotten message from gold: FVC is a primary clinical outcome measure of bronchodilator reversibility in COPD. ( Ben Saad, H; Hayot, M; Préfaut, C; Tabka, Z; Zbidi, A, 2008) |
| "Time to first COPD-related hospitalization or emergency department (ED) visit was estimated by using Cox proportional hazard models." | 1.35 | Economic assessment of initial maintenance therapy for chronic obstructive pulmonary disease. ( Akazawa, M; Blanchette, CM; Hayflinger, DC; Stanford, RH, 2008) |
| "In patients with acute exacerbations of COPD (AECOPD), we assessed the role of ADRB2 haplotypes in morning lung function and in the bronchodilator response to salbutamol." | 1.35 | Beta2-adrenergic receptor haplotype and bronchodilator response to salbutamol in patients with acute exacerbations of COPD. ( Habalova, V; Joppa, P; Kluchova, Z; Micietova, L; Mokry, M; Rozborilova, E; Salagovic, J; Slaba, E; Tkacova, R; Zidzik, J, 2008) |
| "Cost-effective treatments for chronic obstructive pulmonary disease (COPD) are needed to reduce the burden on the Medicare system." | 1.35 | Risk of hospitalizations/emergency department visits and treatment costs associated with initial maintenance therapy using fluticasone propionate 500 microg/salmeterol 50 microg compared with ipratropium for chronic obstructive pulmonary disease in older ( Akazawa, M; Blanchette, CM; Dalal, A; Simoni-Wastila, L, 2008) |
"Treatment of COPD with fluticasone propionate/salmeterol 500/50 microg appears to be cost-effective (| 1.35 | Cost-effectiveness of fluticasone propionate/salmeterol (500/50 microg) in the treatment of COPD. ( Chambers, MG; Dalal, AA; Earnshaw, SR; Jhingran, P; Mapel, DW; Stanford, R; Wilson, MR, 2009) | |
| " On 3 separate days, a dose-response curve to inhaled salbutamol (100 microg puff-1), ipratropium bromide (20 microg puff-1) or placebo was constructed 3h after inhalation of the last dose of tiotropium, using one puff, one puff, two puffs and two puffs, for a total cumulative dose of 600 microg salbutamol or 120 microg ipratropium bromide." | 1.35 | Acute effects of higher than standard doses of salbutamol and ipratropium on tiotropium-induced bronchodilation in patients with stable COPD. ( Cazzola, M; Centanni, S; D'Adda, A; Di Marco, F; Pizzolato, S; Santus, P, 2009) |
| "Airflow limitation in COPD patients is not fully reversible." | 1.35 | Genetic association analysis of COPD candidate genes with bronchodilator responsiveness. ( DeMeo, DL; Hersh, CP; Kim, WJ; Reilly, JJ; Silverman, EK, 2009) |
| "We tested this concept in 42 COPD patients (FEV(1) 42." | 1.35 | Effect of bronchodilation on expiratory flow limitation and resting lung mechanics in COPD. ( Calverley, PM; Dellacà, RL; Duffy, N; Pedotti, A; Pompilio, PP; Walker, PP, 2009) |
| "COPD is a disease with a multi-component pathophysiology in which inflammation plays a key role." | 1.35 | Reflections on TORCH: potential mechanisms for the survival benefit of salmeterol/fluticasone propionate in COPD patients. ( Agusti, AG; Barnes, NC; Johnson, M, 2008) |
| "We evaluated 70 patients with COPD, divided into two groups based on spirometry findings: bronchodilator (BD)-negative (n = 39); and BD-positive (n = 31)." | 1.35 | Bronchodilation in COPD: beyond FEV1-the effect of albuterol on resistive and reactive properties of the respiratory system. ( Costa, GM; Di Mango, AM; Faria, AC; Jansen, JM; Lopes, AJ; Melo, PL, 2009) |
| "COPD is a debilitating disease that is primarily caused by smoking and is therefore largely preventable." | 1.35 | An analysis of the utilisation and expenditure of medicines dispensed for the management of severe asthma. ( Barry, M; Bennett, K; McGowan, B; O'Connor, M; Owens, M, 2009) |
| "Chronic obstructive pulmonary disease (COPD) is a highly prevalent condition with high morbidity and mortality among older and disabled adults." | 1.35 | Hospital and emergency department utilization associated with treatment for chronic obstructive pulmonary disease in a managed-care Medicare population. ( Blanchette, CM; Dalal, AA; Qian, J; Simoni-Wastila, L; Yang, HW; Zhao, L, 2009) |
| " Studies have shown that a large volume spacer attached to a metered dose inhaler provides similar bronchodilator effects to nebulized dosing during the management of patients following an acute exacerbation." | 1.35 | Relative lung deposition of salbutamol following inhalation from a spacer and a Sidestream jet nebulizer following an acute exacerbation. ( Chrystyn, H; Ismail, NE; Mazhar, SH; Newton, DA, 2008) |
| "Our hypothesis that COPD patients on the mild side of the severity spectrum differ from patients on the severe side regarding the association between their bronchodilator flow and volume responses was confirmed." | 1.34 | Flow and volume responses after routine salbutamol reversibility testing in mild to very severe COPD. ( Boonman-de Winter, L; Dekhuijzen, R; Heijdra, Y; Schermer, T; Smeele, I; van den Bemt, L; Zadel, S, 2007) |
| "Chronic obstructive pulmonary disease (COPD) exacerbations are associated with increased airway and systemic inflammation, though relationships between exacerbation recovery, recurrent exacerbation and inflammation have not been previously reported." | 1.34 | Inflammatory changes, recovery and recurrence at COPD exacerbation. ( Donaldson, GC; Hurst, JR; Müllerova, H; Perera, WR; Sapsford, RJ; Wedzicha, JA; Wilkinson, TM, 2007) |
| "In patients with moderate-to-severe COPD, tiotropium did not reduce MPH-induced DH and reduction in IC, compared to baseline." | 1.34 | Tiotropium and simplified detection of dynamic hyperinflation. ( Chapman, KR; Gelb, AF; Gutierrez, CA; McClean, PA; Rodrigues, MT; Shinar, CM; Taylor, CF; Zamel, N, 2007) |
| "We examined patients with severe COPD when hospitalized for exacerbation (n = 9), and while in stable convalescence." | 1.34 | Gas exchange response to short-acting beta2-agonists in chronic obstructive pulmonary disease severe exacerbations. ( Barberà, JA; Gómez, FP; Manrique, H; Polverino, E; Roca, J; Rodríguez-Roisin, R; Soler, N, 2007) |
| "All patients who were diagnosed with COPD between September 1, 2000 and August 31, 2001 and who had at least 3 months treatment with either a combined fluticasone/salmeterol inhaler (FSI, N=866), any ICS used with a LABA (ICS/LABA, N=525), ICS alone (N=742), LABA alone (N=531), or a short-acting bronchodilator alone (SABD, N=1832), were included." | 1.34 | Survival among COPD patients using fluticasone/salmeterol in combination versus other inhaled steroids and bronchodilators alone. ( Davis, KJ; Lydick, E; Mapel, DW; Nelson, LS; Soriano, J; Yood, MU, 2007) |
| "The prevalence of chronic obstructive pulmonary disease (COPD) in women is increasing, as is hospitalization for COPD." | 1.34 | Gender and chronic obstructive pulmonary disease: why it matters. ( Buist, S; Curtis, JL; Giardino, ND; Han, MK; Mannino, DM; Martinez, FJ; Postma, D, 2007) |
| "A total of 246 patients with COPD who were participants in a longitudinal study of COPD (ie, the Hokkaido COPD cohort study) were studied." | 1.34 | Beta2-adrenergic receptor genetic polymorphisms and short-term bronchodilator responses in patients with COPD. ( Betsuyaku, T; Hasegawa, M; Hizawa, N; Itoh, Y; Makita, H; Nagai, K; Nasuhara, Y; Nishimura, M, 2007) |
| "Severe COPD was associated with reduced TLR4 expression compared to less severe disease, with good correlation between nasal and tracheal expression." | 1.34 | Epithelial expression of TLR4 is modulated in COPD and by steroids, salmeterol and cigarette smoke. ( Dorscheid, DR; Greene, CM; MacRedmond, RE; McElvaney, NG; O'Neill, SJ, 2007) |
| "To compare the risk of total mortality and certain respiratory and cardiac adverse events among users of the two types of recommended long-acting bronchodilators, we conducted a cohort study." | 1.34 | Comparative safety of long-acting inhaled bronchodilators: a cohort study using the UK THIN primary care database. ( Jara, M; Kesten, S; Lanes, SF; May, C; Wentworth, C, 2007) |
| "Published data on the Italian COPD population and efficacy data from international reference trials were fitted in a disease progression model based on a Markov chain representing severity stages and death." | 1.34 | Cost-effectiveness and healthcare budget impact in Italy of inhaled corticosteroids and bronchodilators for severe and very severe COPD patients. ( Dal, NR; Eandi, M; Iannazzo, S; Pradelli, L, 2007) |
| "Patients with COPD are frequently prescribed inhaled corticosteroids (ICS); however, it is unclear whether the treatment with ICS might modify responses to inhaled bronchodilators." | 1.34 | Outcomes in COPD patients receiving tiotropium or salmeterol plus treatment with inhaled corticosteroids. ( Hodder, R; Kesten, S; Menjoge, S; Viel, K, 2007) |
| "However, the role of CREB in chronic obstructive pulmonary disease (COPD) is less clear." | 1.34 | Cytoplasm-nuclear trafficking of CREB and CREB phosphorylation at Ser133 during therapy of chronic obstructive pulmonary disease. ( Braszko, JJ; Chyczewska, E; Donaldson, K; Drost, EM; Holownia, A; Macnee, W; Mroz, RM; Noparlik, J, 2007) |
| "Both asthma and chronic obstructive pulmonary disease (COPD) are often underdiagnosed and undertreated among the elderly." | 1.33 | Treatment of acute bronchospasm in elderly patients. ( Berger, WE, 2005) |
| "We studied 10 steady-state COPD patients, eight patients with community-acquired pneumonia and eight healthy subjects as controls." | 1.33 | Effects of salmeterol on cilia and mucus in COPD and pneumonia patients. ( Allegra, L; Ambrosetti, U; Piatti, G; Santus, P, 2005) |
| "Deaths of COPD generated from the cohort of 135,871 patients for whom at least one prescription for drugs used to treat COPD had been dispensed between 1997 and 1999 entered into the study as cases." | 1.33 | Short-acting inhaled beta-2-agonists increased the mortality from chronic obstructive pulmonary disease in observational designs. ( Bagnardi, V; Corrao, G; Faini, S; Leoni, O; Suissa, S; Zambon, A, 2005) |
| "Twenty-four patients with COPD had impulse oscillometry, plethysmography and spirometry measured twice 30 mins apart, to determine variability." | 1.33 | Measuring bronchodilation in COPD clinical trials. ( Borrill, ZL; Houghton, CM; Singh, D; Vestbo, J; Woodcock, AA, 2005) |
| "Six patients with bronchial asthma and 12 patients with mild COPD." | 1.33 | Acute electrophysiologic effects of inhaled salbutamol in humans. ( Kallergis, EM; Kanoupakis, EM; Klapsinos, NK; Manios, EG; Mavrakis, HE; Schiza, SE; Vardas, PE, 2005) |
| "Of 516 cases, 54." | 1.33 | High resolution CT and bronchial reversibility test for diagnosing COPD. ( Hoshi, T; Kanauchi, T; Kanazawa, M; Kurashima, K; Sato, N; Sugita, Y; Takayanagi, N; Tokunaga, D; Ubukata, M; Yanagisawa, T, 2005) |
| "Conclusively, in carefully preselected COPD patients, bronchodilation/PEEPe exhibits additive benefits." | 1.33 | The effects of nebulized salbutamol, external positive end-expiratory pressure, and their combination on respiratory mechanics, hemodynamics, and gas exchange in mechanically ventilated chronic obstructive pulmonary disease patients. ( Armaganidis, A; Mentzelopoulos, SD; Roussos, C; Tzoufi, M, 2005) |
| "The results show a drop in COPD exacerbations in comparison to Ipratropium, Salmeterol and standard care (without use of anticholinergics and beta-adrenergics)." | 1.33 | [Economic value of tiotropium in the treatment of chronic obstructive pulmonary disease]. ( Brandt, A; Haake, D; Schramm, W, 2005) |
| "Approximately 15% of COPD patients obtained drug samples from their physicians as a method to reduce OOP costs, and there was no difference among the 3 groups in the prevalence of this cost management strategy." | 1.33 | Cost reduction strategies used by elderly patients with chronic obstructive pulmonary disease to cope with a generic-only pharmacy benefit. ( Chan, J; Hui, R; Spence, MM, 2006) |
| "For each patient the degree of COPD severity using the pre- and postbronchodilator FEV1 was established." | 1.33 | [Bronchial obstruction reversibility test in the assessment of COPD severity--controversies]. ( Chazan, R; Maskey-Warzechowska, M; Pankowska, M, 2006) |
| "Levalbuterol-treated patients required significantly fewer treatments with beta-agonists (mean [+/- SD] number of treatments, 19." | 1.32 | Levalbuterol compared to racemic albuterol: efficacy and outcomes in patients hospitalized with COPD or asthma. ( Halpern, M; Truitt, T; Witko, J, 2003) |
| "In moderate to severe COPD bronchodilator responsiveness is a continuous variable." | 1.32 | Bronchodilator reversibility testing in chronic obstructive pulmonary disease. ( Anderson, JA; Burge, PS; Calverley, PM; Jones, PW; Spencer, S, 2003) |
| "Chronic obstructive pulmonary disease (COPD) is characterized by the lack or only slight reversibility of obstruction which can be assessed by spirometry after inhalation of short-acting beta 2-mimetic (e." | 1.32 | [Influence of orthopnoea position on spirometric and plethysmographic parameters in patients with chronic obstructive pulmonary disease ]. ( Krzyzowski, G; Pierzchała, W; Szulakowski, P; Trzaska, M, 2003) |
| "Patients with COPD and a similar age, FEV1 and PaO2 who required no hospital care during the study year (1998) were randomly selected as controls." | 1.32 | Risk factors of emergency care and admissions in COPD patients with high consumption of health resources. ( Martínez, MA; Perpiñá, M; Román, P; Sánchez, L; Soler, JJ, 2004) |
| "and objective: Patients with COPD exhibit increased inspiratory work and dyspnea due to dynamic hyperinflation caused by expiratory flow limitation." | 1.32 | Effect of heliox breathing on dynamic hyperinflation in COPD patients. ( D'Angelo, E; Foresi, A; Milic-Emili, J; Pecchiari, M; Pelucchi, A, 2004) |
| "Pulmonary function methods which are able to detect small pharmacological effects may be useful for assessing the full dose-response curve of bronchodilatators." | 1.32 | A comparison of lung function methods for assessing dose-response effects of salbutamol. ( Houghton, CM; Singh, D; Woodcock, AA, 2004) |
| " The once-a-day dosing and easy-to-use HandiHaler device should improve patient compliance." | 1.32 | Tiotropium: a new, long-acting agent for the management of COPD--a clinical review. ( Crutchfield, D, 2004) |
| "Tremor was measured using a laser pointer technique." | 1.32 | Tremor side effects of salbutamol, quantified by a laser pointer technique. ( Broeders, ME; Folgering, HT; Nizet, TA, 2004) |
| "Forty stable COPD patients were studied using a single dose of salbutamol (200 microg)." | 1.32 | [Spirometric reversibility to salbutamol in chronic obstructive pulmonary disease (COPD). Differential effects on FEV1 and on lung volumes]. ( Borzone, G; Díaz, O; Lisboa, C; Manríquez, J, 2004) |
| "Newly physician-diagnosed COPD patients identified in primary care during 1990-1999 aged > or = 50 yrs, of both sexes and with regular prescriptions of respiratory drugs were identified in the UK General Practice Research Database." | 1.31 | Survival in COPD patients after regular use of fluticasone propionate and salmeterol in general practice. ( Kiri, V; Maden, C; Maier, WC; Pride, NB; Soriano, JB; Vestbo, J, 2002) |
| "Albuterol delivery was estimated by measuring the amount of the albuterol collected on a filter placed at the inlet of the lung model." | 1.31 | In vitro evaluation of aerosol bronchodilator delivery during noninvasive positive pressure ventilation: effect of ventilator settings and nebulizer position. ( Chatmongkolchart, S; Dillman, C; Hess, DR; Kacmarek, RM; Schettino, GP, 2002) |
| "Albuterol treatment caused a small but significant increase in FEV(1) and FVC, a significant decrease of Vcw at FRC (VcwFRC), but no changes of Vcw at TLC (VcwTLC) and breathing pattern variables." | 1.31 | Inspiratory capacity and decrease in lung hyperinflation with albuterol in COPD. ( Bianchi, R; Brusasco, V; Duranti, R; Filippelli, M; Pellegrino, R; Romagnoli, I; Scano, G, 2002) |
| "Since in COPD the severely obstructed segments of the lung may not be reached by inhaled medication, we reasoned that drug efficiency may be enhanced by intravenous administration of the agent." | 1.31 | Responsiveness to intravenous administration of salbutamol in chronic obstructive pulmonary disease patients with acute respiratory failure. ( Alvisi, R; Alvisi, V; Ferri, E; Marangoni, E; Milic-Emili, J; Ragazzi, R; Righini, ER; Verri, M; Volta, CA, 2001) |
| "Patients with COPD with EFL may experience less breathlessness after a bronchodilator, at least during light exercise, than those without EFL." | 1.31 | Volume effect and exertional dyspnoea after bronchodilator in patients with COPD with and without expiratory flow limitation at rest. ( Boni, E; Chiroli, P; Corda, L; Damiani, GP; Franchini, D; Grassi, V; Pini, L; Tantucci, C, 2002) |
| Timeframe | Studies, this research(%) | All Research% |
|---|---|---|
| pre-1990 | 0 (0.00) | 18.7374 |
| 1990's | 1 (0.14) | 18.2507 |
| 2000's | 355 (51.15) | 29.6817 |
| 2010's | 318 (45.82) | 24.3611 |
| 2020's | 20 (2.88) | 2.80 |
| Authors | Studies |
|---|---|
| Jacobsen, JR | 1 |
| Choi, SK | 1 |
| Combs, J | 1 |
| Fournier, EJ | 1 |
| Klein, U | 1 |
| Pfeiffer, JW | 1 |
| Thomas, GR | 1 |
| Yu, C | 1 |
| Moran, EJ | 1 |
| Xing, G | 1 |
| Woo, AY | 1 |
| Pan, L | 1 |
| Lin, B | 1 |
| Cheng, MS | 1 |
| Seif, SM | 1 |
| Ma, E | 1 |
| Rabea, H | 5 |
| Saeed, H | 2 |
| Abdelrahim, MEA | 1 |
| Du, X | 1 |
| Bao, H | 1 |
| Zhao, D | 1 |
| Porto, EF | 2 |
| Castro, AAM | 1 |
| Fausto, DM | 1 |
| Kümpel, C | 1 |
| Brandão, AD | 1 |
| De Lima, PB | 1 |
| Fagundes, JC | 1 |
| Zozimo, B | 1 |
| Alsuwaigh, R | 1 |
| Cao, Y | 1 |
| Puan, Y | 1 |
| Yii, A | 1 |
| Mohamed Noor, SB | 1 |
| Ye, H | 1 |
| Chen, H | 2 |
| Li, XL | 1 |
| Binte Mohd Noor, N | 1 |
| Liew, J | 1 |
| Tay, TR | 1 |
| Yang, Y | 1 |
| Huang, L | 2 |
| Tian, C | 1 |
| Qian, B | 1 |
| Wang, A | 2 |
| Li, Z | 2 |
| Sun, Z | 2 |
| Liu, Y | 5 |
| Zhang, D | 3 |
| Ma, X | 2 |
| Mulpuru, S | 1 |
| Aaron, SD | 5 |
| Ouédraogo, AR | 1 |
| Boncoungou, K | 1 |
| Ouédraogo, JCRP | 1 |
| Ouédraogo, GA | 1 |
| Kiendrebeogo, JA | 1 |
| Sourabie, A | 1 |
| Maiga, S | 1 |
| Kafando, S | 1 |
| Ouédraogo, G | 1 |
| Badoum, G | 1 |
| Ouédraogo, M | 1 |
| Cushen, B | 1 |
| Alsaid, A | 1 |
| Greene, G | 1 |
| Costello, RW | 1 |
| Maddah, SA | 1 |
| Barzegari, A | 1 |
| Agnihotri, NT | 1 |
| Saltoun, C | 1 |
| Ashoor, TM | 1 |
| Hasseb, AM | 1 |
| Esmat, IM | 1 |
| Cockcroft, DW | 1 |
| Davis, BE | 1 |
| Tollefson, G | 1 |
| Yurach Pikaluk, M | 1 |
| Amirav, I | 1 |
| Newhouse, MT | 1 |
| Moore, D | 1 |
| Hodroge, SS | 1 |
| Glenn, M | 1 |
| Breyre, A | 1 |
| Lee, B | 2 |
| Aldridge, NR | 1 |
| Sporer, KA | 1 |
| Koenig, KL | 1 |
| Gausche-Hill, M | 1 |
| Salvucci, AA | 1 |
| Rudnick, EM | 1 |
| Brown, JF | 1 |
| Gilbert, GH | 1 |
| van Geffen, WH | 1 |
| Carpaij, OA | 1 |
| Westbroek, LF | 1 |
| Seigers, D | 1 |
| Niemeijer, A | 1 |
| Vonk, JM | 4 |
| Kerstjens, HAM | 2 |
| Maltais, F | 7 |
| Naya, IP | 1 |
| Vogelmeier, CF | 5 |
| Boucot, IH | 1 |
| Jones, PW | 19 |
| Bjermer, L | 3 |
| Tombs, L | 1 |
| Compton, C | 1 |
| Lipson, DA | 2 |
| Kerwin, EM | 2 |
| Jiang, H | 1 |
| Wu, X | 1 |
| Lian, S | 1 |
| Zhang, C | 1 |
| Liu, S | 2 |
| Jiang, Z | 1 |
| Gavriely, N | 1 |
| Volkov, O | 1 |
| Fink, G | 1 |
| Shpirer, I | 1 |
| Golan, H | 1 |
| Wang, J | 4 |
| Cui, Z | 1 |
| Gao, X | 1 |
| Gao, P | 1 |
| Shi, Y | 2 |
| Guo, S | 1 |
| Li, P | 1 |
| Sofianopoulou, E | 2 |
| Pless-Mulloli, T | 2 |
| Rushton, S | 1 |
| Diggle, PJ | 2 |
| Konno, S | 2 |
| Makita, H | 3 |
| Suzuki, M | 1 |
| Shimizu, K | 2 |
| Kimura, H | 2 |
| Nishimura, M | 5 |
| ElHansy, MHE | 1 |
| Boules, ME | 1 |
| El Essawy, AFM | 1 |
| Al-Kholy, MB | 1 |
| Abdelrahman, MM | 2 |
| Said, ASA | 1 |
| Hussein, RRS | 1 |
| Abdelrahim, ME | 5 |
| Fernandes, L | 1 |
| Mesquita, AM | 1 |
| Singh, D | 10 |
| Scuri, M | 1 |
| Collarini, S | 1 |
| Vezzoli, S | 1 |
| Mariotti, F | 1 |
| Muraro, A | 1 |
| Acerbi, D | 1 |
| Lee, L | 1 |
| Kerwin, E | 4 |
| Collison, K | 1 |
| Nelsen, L | 1 |
| Wu, W | 2 |
| Yang, S | 1 |
| Pascoe, S | 2 |
| Shute, JK | 1 |
| Calzetta, L | 3 |
| Cardaci, V | 1 |
| di Toro, S | 1 |
| Page, CP | 2 |
| Cazzola, M | 25 |
| O'Donnell, DE | 7 |
| Elbehairy, AF | 1 |
| Faisal, A | 1 |
| Neder, JA | 2 |
| Webb, KA | 6 |
| Sumino, K | 1 |
| Locke, ER | 1 |
| Magzamen, S | 1 |
| Gylys-Colwell, I | 1 |
| Humblet, O | 1 |
| Nguyen, HQ | 1 |
| Thomas, RM | 1 |
| Fan, VS | 1 |
| Kibirige, D | 1 |
| Kampiire, L | 1 |
| Atuhe, D | 1 |
| Mwebaze, R | 1 |
| Katagira, W | 1 |
| Muttamba, W | 1 |
| Nantanda, R | 1 |
| Worodria, W | 1 |
| Kirenga, B | 1 |
| Sohal, SS | 1 |
| Rogliani, P | 3 |
| Ora, J | 1 |
| Puxeddu, E | 1 |
| Cavalli, F | 1 |
| Matera, MG | 12 |
| Lee, SW | 2 |
| Weng, JT | 1 |
| Hsu, PW | 1 |
| Chuang, TY | 1 |
| Liu, CW | 1 |
| Chen, CH | 1 |
| Wu, LS | 1 |
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| Trial | Phase | Enrollment | Study Type | Start Date | Status | ||
|---|---|---|---|---|---|---|---|
| A 24-week Treatment, Multi-center, Randomized, Double-blind, Double-dummy, Parallel Group Study to Compare Umeclidinium/Vilanterol, Umeclidinium, and Salmeterol in Subjects With Chronic Obstructive Pulmonary Disease (COPD)[NCT03034915] | Phase 4 | 2,696 participants (Actual) | Interventional | 2017-06-16 | Completed | ||
| Randomized, Double-blind, Placebo-controlled, Cross-over Study to Investigate the Bronchodilator Efficacy and Safety After Single and Repeated Administrations of Different Doses of Glycopyrrolate Via pMDI in Moderate to Severe COPD Patients.[NCT01176903] | Phase 1/Phase 2 | 65 participants (Actual) | Interventional | 2010-08-31 | Completed | ||
| 200699: A Clinical Study to Evaluate Four Doses of Umeclidinium Bromide in Combination With Fluticasone Furoate in COPD Subjects With an Asthmatic Component[NCT02164539] | Phase 2 | 338 participants (Actual) | Interventional | 2014-07-01 | Completed | ||
| Location and Timing of Inhaler Use, Exacerbations and Physical Activity in Chronic Obstructive Pulmonary Disease[NCT02661321] | 35 participants (Actual) | Observational | 2011-12-31 | Completed | |||
| A Phase II, Randomised, Double Blind, Placebo Controlled, Six Way Crossover Study to Assess the Bronchodilator Effect of RPL554 Administered on Top of Salbutamol and Ipratropium in Patients With COPD.[NCT02542254] | Phase 2 | 36 participants (Actual) | Interventional | 2015-10-31 | Completed | ||
| [NCT03028142] | Phase 2 | 30 participants (Actual) | Interventional | 2017-01-31 | Completed | ||
| Controlled Randomized Double-blind Study Comparing Salbutamol and Placebo Via Aerosol in Chronic Obstructive Respiratory Insufficiency in Exacerbartion Treated With Noninvasive Ventilation[NCT01958814] | Phase 2 | 43 participants (Actual) | Interventional | 2012-02-29 | Completed | ||
| A 4-week Dose-Ranging, Dose-Interval, Efficacy, Safety and Tolerability Study of GSK961081 in Subjects With Chronic Obstructive Pulmonary Disease (COPD)[NCT01319019] | Phase 2 | 437 participants (Actual) | Interventional | 2010-12-31 | Completed | ||
| A Retrospective Epidemiological Study to Map Out Patients With Chronic Obstructive Pulmonary Disease (COPD) and Describe COPD Health Care in Real-Life Primary Care During the First Ten Years of the 21th Century[NCT01146392] | 27,394 participants (Actual) | Observational | 2010-06-30 | Completed | |||
| A Randomized, Double-blind, Crossover Study to Investigate the Bronchodilatation Post-inhalation of GSK961081 Alone and With the Addition of Cumulative Doses of Short Acting Bronchodilators (Salbutamol and Ipratropium Bromide) in Patients With COPD[NCT00674817] | Phase 2 | 45 participants (Actual) | Interventional | 2008-04-01 | Completed | ||
| A Study to Assess the Pharmacokinetics of Single Escalating Doses of Inhaled GSK961081 DPI (a Dual Pharmacophore) in Healthy Subjects (Part 1) and a Randomised, Double-blind, Double Dummy, Crossover (Incomplete Block) Study to Assess the Safety, Tolerabil[NCT00478738] | Phase 2 | 82 participants (Actual) | Interventional | 2007-06-30 | Completed | ||
| Patient Acceptability of Ipratropium Bromide/Albuteroll Delivered by the Respimat® Inhaler in Adults With Chronic Obstructive Pulmonary Disease[NCT01019694] | Phase 3 | 470 participants (Actual) | Interventional | 2009-11-30 | Completed | ||
| Efficacy of Inhaling Bronchodilator Medications in Patients With Chronic Obstructive Pulmonary Disease Who Have a Low Peak Inspiratory Flow Rate[NCT01391559] | 20 participants (Actual) | Interventional | 2011-07-31 | Completed | |||
| A Study of Fluticasone Propionate/Salmeterol DISKUS Combination Product 250/50 mcg Twice Daily Plus Tiotropium 18 mcg Daily Versus Placebo DISKUS Twice Daily Plus Tiotropium 18 mcg Daily on Exercise Time and Physiological Parameters in Subjects With Chron[NCT01124422] | Phase 4 | 255 participants (Actual) | Interventional | 2010-07-19 | Completed | ||
| A Comparative Bioavailability Study to Compare the Pharmacokinetic (PK) and Pharmacodynamic (PD) Effects of Fluticasone Propionate and Salmeterol Delivered by Fluticasone Propionate/ Salmeterol Combination in a Capsule-based Inhaler and a Multi-dose Dry P[NCT01494610] | Phase 1/Phase 2 | 60 participants (Actual) | Interventional | 2010-10-25 | Completed | ||
| A 12-week Study to Evaluate the 24 Hour Pulmonary Function of Fluticasone Furoate (FF)/Vilanterol Inhalation Powder (FF/VI Inhalation Powder) Once Daily Compared With Salmeterol/Fluticasone Propionate (FP) Inhalation Powder Twice Daily in Subjects With Ch[NCT01342913] | Phase 3 | 528 participants (Actual) | Interventional | 2011-02-01 | Completed | ||
| Evaluating the Control of COPD Symptoms in Patients Treated With Tiotropium Bromide 18mcg Once Daily Alone, ADOAIR 50/250mcg Twice Daily Alone or ADOAIR 50/250mcg Plus Tiotropium Bromide 18mcg[NCT01762800] | Phase 4 | 407 participants (Actual) | Interventional | 2013-02-28 | Completed | ||
| Effect of Inhalation of Tiotropium Once Daily 18 Mcg Versus Salmeterol Twice Daily 50 Mcg on Time to First Exacerbation in COPD Patients (a Randomised, Double-blind, Double-dummy, Parallel Group, One-year Study).[NCT00563381] | Phase 4 | 7,376 participants (Actual) | Interventional | 2008-01-31 | Completed | ||
| A 26-week Treatment, Multi-center, Randomized, Doubleblind, Double Dummy, Parallel-group Study to Assess the Efficacy, Safety and Tolerability of QVA149 Compared to Fluticasone/Salmeterol in Patients With Moderate to Severe Chronic Obstructive Pulmonary D[NCT01315249] | Phase 3 | 523 participants (Actual) | Interventional | 2011-03-31 | Completed | ||
| A 12-week, Multicentre, Multinational, Randomized, Double-blind, Double-dummy, 2-arm Parallel Group Study Comparing the Efficacy and Safety of Foster® 100/6 (Beclomethasone Dipropionate 100 µg Plus Formoterol 6 µg/Actuation), 2 Puffs b.i.d., Versus Sereti[NCT01245569] | Phase 3 | 373 participants (Actual) | Interventional | 2011-04-30 | Completed | ||
| Pulmonary Safety of Staccato® Loxapine for Inhalation in Subjects With Chronic Obstructive Pulmonary Disease[NCT00889837] | Phase 1 | 53 participants (Actual) | Interventional | 2009-06-30 | Completed | ||
| Pulmonary Safety of Staccato® Loxapine for Inhalation in Subjects With Asthma[NCT00890175] | Phase 1 | 52 participants (Actual) | Interventional | 2009-05-31 | Completed | ||
| Comparison of Conventional Medicine, TCM Treatment and Combination of Both Conventional Medicine and TCM Treatment for Patients With Chronic Obstructive Pulmonary Disease: A Randomized Comparative Effectiveness Research Trial[NCT01836016] | Phase 3 | 360 participants (Anticipated) | Interventional | 2013-05-31 | Not yet recruiting | ||
| Prevalence and Clinical Relevance of Ventilation Heterogeneity and Luminal Cellular Inflammation in Lung Cancer Patients Prior to Lung Resection[NCT04191174] | 115 participants (Anticipated) | Observational | 2020-01-06 | Enrolling by invitation | |||
| A 12-week Study to Evaluate the 24-hour Pulmonary Function Profile of Fluticasone Furoate/Vilanterol (FF/VI) Inhalation Powder 100/25 mcg Once Daily Compared With Fluticasone Propionate/Salmeterol Inhalation Powder 250/50 mcg Twice Daily in Subjects With [NCT01323634] | Phase 3 | 519 participants (Actual) | Interventional | 2011-03-18 | Completed | ||
| A 12-week Study to Evaluate the 24-hour Pulmonary Function Profile of Fluticasone Furoate/Vilanterol (FF/VI) Inhalation Powder 100/25 mcg Once Daily Compared With Fluticasone Propionate/Salmeterol Inhalation Powder 250/50 mcg Twice Daily in Subjects With [NCT01323621] | Phase 3 | 512 participants (Actual) | Interventional | 2011-03-18 | Completed | ||
| A 12-Week Study to Evaluate the 24-Hour Pulmonary Function Profile of Fluticasone Furoate/Vilanterol (FF/VI) Inhalation Powder 100/25 mcg Once Daily Compared With Fluticasone Propionate/Salmeterol Inhalation Powder 250/50 mcg Twice Daily in Subjects With [NCT01706328] | Phase 3 | 828 participants (Actual) | Interventional | 2012-10-15 | Completed | ||
| "Reduction of Corticosteroid Use in Outpatient Treatment of Exacerbated COPD - a Randomized, Double-blind, Non-inferiority Study (The RECUT-Trial)"[NCT02386735] | 470 participants (Anticipated) | Interventional | 2015-03-31 | Recruiting | |||
| A Randomised, Double-blind, Active-controlled Study to Evaluate the Impact of Stepwise Withdrawal of Inhaled Corticosteroid Treatment in Patients With Severe to Very Severe Chronic Obstructive Pulmonary Disease (COPD) on Optimized Bronchodilator Therapy[NCT00975195] | Phase 4 | 2,488 participants (Actual) | Interventional | 2009-02-28 | Completed | ||
| A 6-week, Multicenter, Randomized, Double-blind, Placebo and Active-controlled, Parallel Group, Dose-ranging Study to Evaluate the Efficacy and Safety of 4 Doses of CHF 5259 pMDI (HFA Glycopyrronium Bromide Via Pressurized Metered Dose Inhaler) in Subject[NCT03084796] | Phase 2 | 733 participants (Actual) | Interventional | 2017-07-28 | Completed | ||
| A 4-Week Randomized Cross-Over Study to Evaluate Daily Lung Function Following the Administration of Albuterol/Salbutamol and Ipratropium in Subjects With Chronic Obstructive Pulmonary Disease[NCT01691482] | Phase 4 | 56 participants (Actual) | Interventional | 2012-07-23 | Completed | ||
| A Randomized, Double-Blind, Parallel Group, Multicenter Study of the Effects of Fluticasone Propionate/Salmeterol Combination Product 250/50mcg BID (ADVAIR DISKUS™) in Comparison to Salmeterol 50mcg BID (SEREVENT DISKUS™) on the Rate of Exacerbations of C[NCT01110200] | Phase 4 | 639 participants (Actual) | Interventional | 2010-04-30 | Completed | ||
| A 12-Month Double-Blind, Double-Dummy, Randomized, Parallel Group, Multicenter Efficacy and Safety Study of Symbicort® pMDI 2 x 160/4.5 μg Bid and 2 x 80/4.5 μg Bid Compared to Formoterol Turbuhaler® 2 x 4.5 μg Bid and Placebo in Patients With COPD[NCT00206167] | Phase 3 | 1,600 participants | Interventional | 2005-04-30 | Completed | ||
| A 6-Month Double-Blind, Double-Dummy, Randomized, Parallel Group, Multicenter Efficacy & Safety Study of SYMBICORT® pMDI 2 x 160/4.5 µg & 80/4.5 µg Bid Compared to Formoterol TBH, Budesonide pMDI (& the Combination) & Placebo in COPD Patients[NCT00206154] | Phase 3 | 1,500 participants (Anticipated) | Interventional | 2005-04-30 | Completed | ||
| A Phase IIIB, 12-Month, Double-blind, Double-dummy,Randomised, Parallel-group, Multicentre Exacerbation Study of SYMBICORT® pMDI 160/4.5 μg x 2 Actuations Twice-daily and 80/4.5 μg x 2 Actuations Twice-daily Compared to Formoterol Turbuhaler® 4.5 μg x 2 I[NCT00419744] | Phase 3 | 1,200 participants (Actual) | Interventional | 2007-01-31 | Completed | ||
| A 24-week Study to Evaluate the Efficacy and Safety of Fluticasone Furoate/Vilanterol Inhalation Powder Delivered Once Daily Via a Dry Powder Inhaler Compared With Placebo in Subjects of Asian Ancestry With Chronic Obstructive Pulmonary Disease[NCT01376245] | Phase 3 | 646 participants (Actual) | Interventional | 2011-04-30 | Completed | ||
| Modification of Disease Outcome in COPD. Shortterm Versus Longterm Treatment With Inhaled Corticosteroids, Either or Not Combined With a Long-Acting Beta2-Agonist.[NCT00158847] | Phase 4 | 200 participants | Interventional | 2000-04-30 | Terminated | ||
| An 8-week, Multicenter, Randomized, Double-blind, Placebo and Active-controlled, Parallel Group, Dose-ranging Study to Evaluate the Efficacy and Safety of 3 Doses of CHF 718 pMDI (HFA Beclomethasone Dipropionate Via Pressured Metered Dose Inhaler) in Asth[NCT03084718] | Phase 2 | 610 participants (Actual) | Interventional | 2017-07-28 | Completed | ||
| A Randomized, Double-blind, Placebo and Active-controlled, Incomplete Block Cross-over, Dose Ranging Study to Evaluate the Efficacy and Safety of 4 Doses of CHF 1531 pMDI (Formoterol Fumarate) in Asthmatic Subjects[NCT03086460] | Phase 2 | 67 participants (Actual) | Interventional | 2017-09-08 | Completed | ||
| A Multicenter, Randomized, Blinded, Active-controlled, Parallel-group Study to Compare the Efficacy, Tolerability and Safety of NVA237 Compared to Tiotropium Added on to Fluticasone/Salmeterol in Patients With Chronic Obstructive Pulmonary Disease[NCT01513460] | Phase 3 | 773 participants (Actual) | Interventional | 2012-04-30 | Completed | ||
| Site and Mechanism(s) of Expiratory Airflow Limitation in COPD, Emphysema and Asthma-COPD Overlap[NCT03263130] | 60 participants (Anticipated) | Observational [Patient Registry] | 2017-01-01 | Recruiting | |||
| A Prospective, Open-Label Assessment of the Albuterol Spiromax® DPI Integrated Dose Counter[NCT01857323] | Phase 3 | 317 participants (Actual) | Interventional | 2013-05-31 | Completed | ||
| Realization of Spirometry Measurement Using Electrical Impedance Tomography (EIT)[NCT03746795] | 22 participants (Actual) | Interventional | 2017-10-27 | Completed | |||
| Study of the Predictive Value of Airway Obstruction Reversibility on the Effectiveness of Indacaterol (Onbrez® Breezhaler ®) 150 mcg Once Daily in Patients With Moderate to Severe COPD[NCT01272362] | Phase 4 | 625 participants (Actual) | Interventional | 2010-04-30 | Completed | ||
| Detecting Errors In Using Metered Dose Inhalers (MDI) Among Asthma And Chronic Obstructive Pulmonary Disease (COPD) Patients[NCT02447575] | 23 participants (Actual) | Interventional | 2015-02-28 | Completed | |||
| A Multicentre, Randomised, Double-blind, Parallel Group, Placebo-controlled Study to Investigate the Long-term Effects of Salmeterol/Fluticasone Propionate (Seretide tm) 50/500mcg BD, Salmeterol 50mcg BD and Fluticasone Propionate 500mcg BD, All Delivered[NCT00268216] | Phase 3 | 6,228 participants (Actual) | Interventional | 2000-09-30 | Completed | ||
| Multicentre, Randomised, Double-Blind, Double Dummy, Parallel Group, 104-week Study to Compare the Effect of the Salmeterol/Fluticasone Propionate Combination Product (SERETIDE*) 50/500mcg Delivered Twice Daily Via the DISKUS*/ACCUHALER* Inhaler With Tiot[NCT00361959] | Phase 4 | 1,270 participants (Actual) | Interventional | 2003-06-30 | Completed | ||
| A Randomized, Double-Blind, Parallel Group, 52-Week Study to Compare the Effect of Fluticasone Propionate/Salmeterol DISKUS® Inhaler Combination Product 250/50mcg Twice Daily With Salmeterol DISKUS® Inhaler 50mcg Twice Daily on the Annual Rate of Moderate[NCT00144911] | Phase 4 | 740 participants (Actual) | Interventional | 2004-10-31 | Completed | ||
| Preliminary Study for Comparison of Triple Therapy Nebulizer Versus Dry Powdered Inhaler for Care Transitions in COPD[NCT03219866] | Phase 4 | 40 participants (Actual) | Interventional | 2017-10-03 | Terminated (stopped due to Lower enrollment than Sponsor expected - Sponsor stopped study) | ||
| Reducing Diagnostic Error to Improve Patient Safety in COPD and Asthma (REDEFINE Study)[NCT03137303] | Phase 3 | 402 participants (Actual) | Interventional | 2017-07-01 | Completed | ||
| An Open-label, Randomised, Cross-over, Single Centre Study in Healthy Volunteers to Optimise the Rotacap Formulation andROTAHALER Device for Delivery of Fluticasone Propionate/Salmeterol.[NCT01540708] | Phase 1 | 36 participants (Actual) | Interventional | 2012-01-16 | Completed | ||
| The Effect of Proprioceptive Neuromuscular Facilitation Technique on Respiratory Functions, Functional Capacity, Muscle Force, Posture, Activity of Daily Living, Quality of Life for Children With Chronic Pulmonary Diseases.[NCT03420209] | 40 participants (Actual) | Interventional | 2016-12-01 | Completed | |||
| Individualized Dosing Schedule of Inhaled Bronchodilator for Endotracheally Intubated Chronic Obstructive Pulmonary Disease Patients[NCT01933984] | 51 participants (Actual) | Interventional | 2013-08-31 | Completed | |||
| Anti-inflammatory Effects of Tiotropium in Patients With Stable COPD- A Multicenter Randomized Controlled Double-blind Study[NCT04061161] | Phase 4 | 50 participants (Anticipated) | Interventional | 2019-08-19 | Recruiting | ||
| Responsivity and Reproducibility of Messenger and Micro RNA Airway Inflammatory Markers - a Pilot Study[NCT03924843] | 21 participants (Actual) | Observational | 2017-11-14 | Completed | |||
| Predictive Value of Within-breath Respiratory Input Impedance in the Early Diagnosis of Obliterative Bronchiolitis After Allogeneic Hematopoietic Stem Cell Transplantation[NCT01255449] | 26 participants (Actual) | Interventional | 2010-12-31 | Completed | |||
| Diagnostic Accuracy Of Forced Oscillation Technique To Detect Lung Function Anomalies[NCT04006964] | 579 participants (Actual) | Observational | 2018-10-18 | Completed | |||
| Monitoring COPD Patients at Home by a Forced Oscillation Technique Device[NCT01552031] | 80 participants (Anticipated) | Observational | 2011-11-30 | Recruiting | |||
| Within-Breath Total Respiratory Input Impedance in Healthy Adult Subjects[NCT04140825] | 231 participants (Actual) | Observational | 2018-10-18 | Completed | |||
| Clinical Trials for Elderly Patients With Multiple Disease[NCT01960907] | 312 participants (Actual) | Interventional | 2013-10-31 | Completed | |||
| A Two-Week, Randomized, Modified-Blind, Double-Dummy, Parallel-Group Efficacy and Safety Study of Arformoterol Tartrate Inhalation Solution Twice-Daily, Tiotropium Once-Daily, and Arformoterol Tartrate Inhalation Solution Twice-Daily and Tiotropium Once D[NCT00424528] | Phase 4 | 235 participants (Actual) | Interventional | 2006-12-31 | Completed | ||
| Role of Endorphins in the Perception of Dyspnea in Patients With Chronic Obstructive Pulmonary Disease[NCT00458419] | 17 participants (Actual) | Interventional | 2005-09-30 | Completed | |||
| [NCT00462540] | Phase 3 | 100 participants (Anticipated) | Interventional | 2007-05-31 | Completed | ||
| Changes of Pulmonary Function, Voice and Swallowing Symptoms After Total Parathyroidectomy for Secondary Hyperparathyroidism in the Presence of Intact Recurrent Laryngeal Nerve[NCT04267965] | 48 participants (Actual) | Observational [Patient Registry] | 2017-08-01 | Completed | |||
| A 6-Week Trial to Compare the Efficacy and Safety of Concomitant Treatment With Formoterol Fumarate Inhalation Solution 20 Mcg Twice Daily and Tiotropium 18 Mcg Once Daily to Tiotropium 18 Mcg Once Daily Alone in the Treatment of Patients With Chronic Obs[NCT00507234] | Phase 3 | 128 participants (Actual) | Interventional | 2007-03-31 | Completed | ||
| A Prospective Baseline Assessment of the Risk of Osteoporosis in Patients With Chronic Obstructive Lung Disease and Outcomes After 2 Years; a Pilot Study[NCT01161680] | 30 participants (Actual) | Observational | 2010-07-31 | Completed | |||
| Effect of Roflumilast in COPD Patients Treated With Tiotropium. A 24-week, Double-blind Study With 500 µg Roflumilast Once Daily Versus Placebo. The HELIOS Study[NCT00424268] | Phase 3 | 743 participants (Actual) | Interventional | 2007-01-31 | Completed | ||
| Impact of Roflumilast on Visceral Adiposity and MetaBolic Profile in Chronic Obstructive Lung Disease: a Randomized and Controlled Trial: the RAMBO Trial.[NCT01701934] | Phase 2 | 14 participants (Actual) | Interventional | 2013-02-28 | Terminated (stopped due to The recruitment of the study was prematurely stopped in July 2014 for the following reason; no more study medication.) | ||
| Effect of Roflumilast in COPD Patients Treated With Salmeterol. A 24-week, Double-blind Study With 500 μg Roflumilast Once Daily Versus Placebo. The EOS Study[NCT00313209] | Phase 3 | 933 participants (Actual) | Interventional | 2006-04-30 | Completed | ||
| RELVAR Effects on Parasternal Muscle Activity, Diaphragm, and Ventilation in Severe COPD[NCT02989935] | Phase 4 | 25 participants (Anticipated) | Interventional | 2016-04-30 | Active, not recruiting | ||
| Therapeutic Drug Monitoring of Corticosteroids/β2-agonists in Hair in Asthmatic Patients: an Open-label Feasibility Study[NCT03691961] | 24 participants (Actual) | Interventional | 2018-09-20 | Active, not recruiting | |||
| A Randomized, Double-blind, Two-way Cross-over Study Evaluating Systemic Bioavailability and Airway Clearance of SymbicortTurbuhaler 320/9mcg vs SeretideDiskus 50/500mcg After Single Inhalations in Patients With COPD and Healthy Volunteers[NCT00379028] | Phase 4 | 54 participants (Actual) | Interventional | 2006-09-30 | Completed | ||
| A Remotely Supervised Exercise Program for Lung Cancer Patients Undergoing Chemoradiation[NCT03500393] | 4 participants (Actual) | Interventional | 2018-06-22 | Terminated (stopped due to feasibility of study recruitment) | |||
| Safety and Efficacy of Combivent Respimat in Chronic Obstructive Pulmonary Disease (COPD)[NCT00400153] | Phase 3 | 1,480 participants (Actual) | Interventional | 2006-11-30 | Completed | ||
| Effect of Inspiratory Muscle Training in the Ventilatory Muscle Metaboreflex in Chronic Obstructive Pulmonary Disease Patients.[NCT01945398] | 13 participants (Actual) | Interventional | 2013-06-30 | Completed | |||
| An Evaluation of Lung Function and Symptoms in Patients With Chronic Obstructive Pulmonary Disease (COPD) on Long-Acting Bronchodilator Monotherapy[NCT00791518] | 1,084 participants (Actual) | Observational | 2008-12-31 | Completed | |||
| "A 48-week, Double Blind, Double Dummy, Randomised, Multinational, Multicentre, 3-arm Parallel Group Clinical Study of Fixed Combination Beclometasone Dipropionate Plus Formoterol Fumarate Administered Via pMDI With HFA-134a Propellant Versus Fixed Combin[NCT00476099] | Phase 3 | 828 participants (Actual) | Interventional | 2006-12-31 | Completed | ||
| Static Lung Hyperinflation and Sympathetic Nerve Activity-Associated Large Artery Stiffness in COPD Patients[NCT03611699] | Phase 4 | 15 participants (Actual) | Interventional | 2019-01-24 | Completed | ||
| A 26-week Treatment, Multicenter, Randomized, Double Blind, Double Dummy, Placebo-controlled, Adaptive, Seamless, Parallel-group Study to Assess the Efficacy, Safety and Tolerability of Two Doses of Indacaterol (Selected From 75, 150, 300 & 600 µg o.d.) i[NCT00463567] | Phase 2/Phase 3 | 2,059 participants (Actual) | Interventional | 2007-04-30 | Completed | ||
| A 26-week Treatment, Multi-center, Randomized, Double-blind, Double- Dummy, Placebo-controlled, Parallel-group Study to Assess the Efficacy, and Safety of Indacaterol (150 µg o.d.) in Patients With Chronic Obstructive Pulmonary Disease, Using Salmeterol ([NCT00567996] | Phase 3 | 1,002 participants (Actual) | Interventional | 2007-11-30 | Completed | ||
| A 52-week Treatment, Multicenter, Randomized, Double-blind, Double-dummy, Placebo-controlled, Parallel-group Study to Assess the Efficacy, Safety, and Tolerability of Indacaterol (300 and 600 µg Once Daily) in Patients With Chronic Obstructive Pulmonary D[NCT00393458] | Phase 3 | 1,732 participants (Actual) | Interventional | 2006-10-31 | Completed | ||
| Outcomes and Costs Associated With Initiating Maintenance Treatment With Fluticasone Propionate 250mcg/Salmeterol Xinafoate 50mcg Combination (FSC) Versus Anticholinergics Including Tiotropium (TIO) in Patients With Chronic Obstructive Pulmonary Disease ([NCT01331694] | 76,130 participants (Actual) | Observational | 2009-07-31 | Completed | |||
| A 12 Week Treatment, Multi-center, Randomized, Parallel Group, Double Blind, Double Dummy Study to Assess the Superiority of Indacaterol (150 µg o.d.) Via a SDDPI in Patients With Moderate to Severe COPD, Using Salmeterol (50 µg b.i.d.) as an Active Compa[NCT00821093] | Phase 3 | 1,123 participants (Actual) | Interventional | 2009-01-31 | Completed | ||
| Efficacy and Safety of Indacaterol vs tiotropiuM on walkEd Distance From Baseline to 24 Weeks, in Women With modeRAte-severe COPD Secondary to Biomass Exposure: Randomized, Non Inferior, Open Label, Parallel Groups Clinical Trial[NCT05506865] | Phase 4 | 97 participants (Actual) | Interventional | 2012-09-30 | Completed | ||
| Chronic Obstructive Pulmonary Disease (COPD)-Related Healthcare Utilization and Costs After Discharge From a Hospitalization or Emergency Department Visit on a Regimen of Fluticasone Propionate-Salmeterol Combination Versus Other Maintenance Therapies[NCT01332461] | 5,677 participants (Actual) | Observational | 2009-11-30 | Completed | |||
| A Randomized, Double-Blind, Parallel-Group, 16-Week Study to Evaluate the Effect of Fluticasone Propionate/Salmeterol DISKUS® 250/50mcg BID and Placebo on Arterial Stiffness in Subjects With Chronic Obstructive Pulmonary Disease (COPD)[NCT00857766] | Phase 4 | 249 participants (Actual) | Interventional | 2009-03-31 | Completed | ||
| A Phase III, 52-week, Multinational, Multicenter, Randomized, Double-blind, 2-arm Parallel Group Study Comparing Efficacy, Safety and Tolerability of the Fixed Dose Triple Combination of Beclomethasone Dipropionate Plus Formoterol Fumarate Plus Glycopyrro[NCT04320342] | Phase 3 | 2,934 participants (Anticipated) | Interventional | 2022-04-28 | Recruiting | ||
| A 12-week Treatment, Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Assess the Efficacy and Safety of Indacaterol (150 μg o.d.) in Patients With Chronic Obstructive Pulmonary Disease[NCT00624286] | Phase 3 | 416 participants (Actual) | Interventional | 2008-02-29 | Completed | ||
| A Randomized, Double-Blind, Parallel-Group, 24-Week Study to Evaluate the Efficacy and Safety of ADVAIR DISKUS (Fluticasone Propionate/Salmeterol Combination Product 250/50mcg Inhalation Powder) BID Plus Spiriva HandiHaler (Tiotropium Bromide Inhalation P[NCT00784550] | Phase 4 | 342 participants (Actual) | Interventional | 2008-12-31 | Completed | ||
| Prevalence of Chronic Airway Onstruction in a Subject Population With a History of Cigarette Smoking in a Primary Care Setting[NCT01013948] | 1,574 participants (Actual) | Observational | 2009-02-28 | Completed | |||
| A 12-week, Randomised, Double-blind, Placebo-controlled Study to Assess the Anti-inflammatory Activity, Efficacy and Safety of GW856553 in Subjects With Chronic Obstructive Pulmonary Disease (COPD)[NCT00642148] | Phase 2 | 306 participants (Actual) | Interventional | 2008-02-14 | Completed | ||
| A 12-week Treatment, Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Assess the Efficacy and Safety of Once Daily Indacaterol in Patients With Chronic Obstructive Pulmonary Disease[NCT01072448] | Phase 3 | 323 participants (Actual) | Interventional | 2010-01-31 | Completed | ||
| A 12-week Treatment, Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Assess the Efficacy and Safety of Once Daily Indacaterol in Patients With Chronic Obstructive Pulmonary Disease[NCT01068600] | Phase 3 | 318 participants (Actual) | Interventional | 2010-01-31 | Completed | ||
| A Randomised, Placebo-controlled, Double-blind (Double-dummy Technique),Crossover, Multi-centre Study, to Evaluate Onset of Effect in Patients With Chronic Obstructive Pulmonary Disease (COPD) Treated With Formoterol Turbuhaler® 9 μg, Compared With Sereve[NCT01048333] | Phase 2 | 109 participants (Actual) | Interventional | 2010-01-31 | Completed | ||
| A Multicentre, Randomised, Partially Blinded, Placebo-controlled, Three-way Crossover, Incomplete Block Design Study to Investigate the Safety, Tolerability, Pharmacodynamics/ Efficacy and Pharmacokinetics of Dual Bronchodilator Therapy With Salmeterol 50[NCT00422604] | Phase 2 | 60 participants (Actual) | Interventional | 2006-10-31 | Completed | ||
| [NCT01080924] | 50 participants (Anticipated) | Interventional | 2010-02-28 | Completed | |||
| A Multicentre 3 Year Longitudinal Prospective Study to Identify Novel Endpoints and Compare These With Forced Expiratory Volume in 1 Second (FEV1) for Their Ability to Measure and Predict COPD Severity and Its Progression Over Time[NCT00292552] | 2,747 participants (Actual) | Observational | 2005-12-31 | Completed | |||
| Effect of Inhalation of a Free Combination of Tiotropium Once Daily 18 Mcg and Salmeterol Twice Daily 50 Mcg Versus a Fixed Combination of Fluticasone and Salmeterol Twice Daily (500/50 Mcg) on Static Lung Volumes and Exercise Tolerance in COPD Patients ([NCT00530842] | Phase 4 | 344 participants (Actual) | Interventional | 2007-09-30 | Completed | ||
| A 12 Month Open-label Randomized Parallel Group Study to Investigate the Influence of Salmeterol Xinafoate/Fluticasone Propionate Either in Fixed Combination or Separately Via Diskus Inhalers on the Course of the Disease and Frequency of Exacerbations in [NCT00527826] | Phase 4 | 214 participants (Actual) | Interventional | 2007-11-30 | Completed | ||
| Effects of Bronchodilation on CT Parameters Reflecting Airways Remodelling, and Pulmonary Emphysema Extent: Comparisons Between CT Scans Obtained Before and After Bronchodilation and Relationships With Pulmonary Function Tests.[NCT01142531] | 20 participants (Actual) | Observational | 2010-03-31 | Completed | |||
| A Phase 4, Randomized, Double-blind, Multicenter, Placebo-Controlled Two Way Cross-Over Study to Evaluate Changes in Oxygen Consumption and Cardiac Function in COPD Patients With Resting Hyperinflation After Administration of Symbicort pMDI 160/4.5 μg.[NCT02533505] | Phase 4 | 51 participants (Actual) | Interventional | 2015-08-25 | Completed | ||
| Phase 4 Withdrawal of Inhaled Corticosteroids in Patients With Chronic Obstructive Pulmonary Disease in Primary Care: a Randomised Controlled Trial[NCT00440687] | Phase 4 | 256 participants | Interventional | 2001-01-31 | Completed | ||
| GR Activity in Induced Sputum Macrophages, and a Change in Inflammatory Biomarkers 2-hours After a Single Dose of Either Symbicort®/Budesonide/Formoterol or in Chronic Obstructive Pulmonary Disease (COPD)[NCT01787097] | Phase 4 | 31 participants (Actual) | Interventional | 2013-01-31 | Completed | ||
| A Pilot Study of the Mechanism of Synergism Between Fluticasone (FP) and Salmeterol in Preventing Chronic Obstructive Pulmonary Disease (COPD) Exacerbations[NCT00116402] | Phase 1 | 15 participants (Actual) | Interventional | 2005-01-31 | Completed | ||
| Comparing Treatment Efficacy With High and Medium Dose of Fluticasone in Combination With Salmeterol in COPD Patients[NCT01131806] | Phase 4 | 124 participants (Anticipated) | Interventional | 2009-12-31 | Recruiting | ||
| Effects of Heated Humidified High-Flow Nasal Cannula During Six-Minute Walk Test in Patient With COPD Undergoing Pulmonary Rehabilitation[NCT03863821] | 30 participants (Actual) | Interventional | 2019-03-18 | Completed | |||
| A 13-week, Double-blind, Parallel Group, Multi-centre Study to Compare the Bronchial Anti-inflammatory Activity of the Combination of Salmeterol/Fluticasone Propionate 50/500mcg Twice Daily Compared With Placebo Twice Daily in Patients With Chronic Obstru[NCT00268177] | Phase 3 | 130 participants | Interventional | 2002-10-31 | Completed | ||
| Efficacy and Safety of Fluticasone Furoate/Vilanterol vs. Umeclidinium/Vilanterol in Patients With COPD-asthma Phenotype vs. Emphysema Phenotype. A Controled Clinical Trial.[NCT05342558] | Phase 4 | 133 participants (Actual) | Interventional | 2017-09-19 | Completed | ||
| Non-Invasive Doppler Ultrasound For Assessing Patients With Chronic Obstructive Pulmonary Disease: A Prospective Observational Study[NCT02329522] | 200 participants (Anticipated) | Observational | 2014-02-28 | Active, not recruiting | |||
| The Value of Exhaled Nitric Oxide in Predicting Airway Eosinophilic Inflammation in Chronic Airway Inflammatory Disease[NCT04885738] | 2,052 participants (Anticipated) | Observational [Patient Registry] | 2021-05-25 | Not yet recruiting | |||
| The Filtering Facepiece Respirator Increases Inspiratory Time, But Does Not Change the Involvement of Breathing Compartments[NCT06053502] | 21 participants (Actual) | Observational | 2023-01-02 | Completed | |||
| Effect of an Inhaled Glucocorticosteroid (ICS) on Endothelial Dysfunction in Cigarette Smokers[NCT01216735] | 32 participants (Actual) | Interventional | 2008-09-30 | Completed | |||
| Advair - CRP Study[NCT00120978] | Phase 4 | 250 participants | Interventional | 2004-12-31 | Recruiting | ||
| Pulmonary Gas Exchange Response to Indacaterol in Stable Symptomatic Chronic Obstructive Pulmonary Disease Patients[NCT02547558] | Phase 4 | 20 participants (Anticipated) | Interventional | 2015-10-31 | Not yet recruiting | ||
| Comparative Effectiveness of COPD Assessment and Management Bundle Versus Usual Care in Patients Suspected of Having COPD[NCT01833026] | 56 participants (Actual) | Interventional | 2013-03-31 | Completed | |||
| Efficacy and Acute Effects on Walked Distance froM basEline and Post Dose of indacateRol vs Tiotropium in Women With modeRAte to Severe COPD Secondary to Biomass Exposure: Open Label Crossover Clinical Trial[NCT02473237] | Phase 4 | 40 participants (Anticipated) | Interventional | 2013-04-30 | Completed | ||
| Effectiveness of Tiotropium to Maintain Inspiratory Capacity Against Metronome Paced Hyperventilation Induced Dynamic Hyperinflation in COPD Patients With Lung CT Scored Emphysema[NCT00570544] | 29 participants (Actual) | Observational | 2004-08-31 | Completed | |||
| Simplified Detection of Dynamic Hyperinflation Using Metronome Paced Hyperventilation and the Effect of Tiotropium in Patients With COPD[NCT00569270] | Phase 4 | 30 participants (Actual) | Interventional | 2006-10-31 | Completed | ||
| A Randomised, Double-blind, Double Dummy, 3 Way Crossover Study Evaluating the Effects of a Combination of Seretide 50/500mcg Twice Daily Plus Tiotropium Bromide 18mcg Once Daily Compared With the Individual Agents (Tiotropium Bromide 18mcg Alone and Sere[NCT00325169] | Phase 2 | 41 participants (Actual) | Interventional | 2005-12-31 | Completed | ||
| A Six-Week, Randomized, Double-Blind, Quadruple-Dummy Parallel Group Multiple Dose Study Comparing the Efficacy and Safety of Tiotropium Inhalation Capsules Plus Formoterol Inhalation Capsules to Salmeterol Inhalation Aerosol Plus Fluticasone Inhalation A[NCT00239421] | Phase 4 | 605 participants | Interventional | 2003-11-30 | Completed | ||
| Effectiveness of Respiratory Therapy in Acute Exacerbations of Chronic Obstructive Pulmonary Disease[NCT02125747] | 35 participants (Actual) | Interventional | 2011-12-31 | Completed | |||
| [information is prepared from clinicaltrials.gov, extracted Sep-2024] | |||||||
The CAT is a participant-completed instrument designed to provide a simple and reliable measure of health status in COPD for the assessment and long-term follow-up of the individual participant. The CAT consists of eight items, each formatted on a differential scale. Participants rated their experience on a 6-point scale for each question, ranging from 0 (no impact) to 5 (high impact). A total CAT score was calculated by summing the non-missing scores on the eight items ranging from 0 to 40 with higher scores indicating greater disease impact. Baseline is defined as the last non-missing score recorded prior to dosing on Day 1. Change from Baseline was calculated by subtracting Baseline value from the value at Week 24. Analysis was performed using mixed model repeated measures (MMRM) with covariates of Baseline CAT score, geographical region, stratum (no. of bronchodilators per day during run-in), visit, treatment, visit by Baseline and visit by treatment interactions. (NCT03034915)
Timeframe: Baseline (Pre-dose on Day 1) and Week 24
| Intervention | Scores on a scale (Least Squares Mean) |
|---|---|
| UMEC/VI 62.5/25 mcg+ Placebo | -3.5 |
| UMEC 62.5 mcg + Placebo | -3.4 |
| Salmeterol 50 mcg+Placebo | -2.9 |
SGRQ is a disease-specific questionnaire designed to measure impact of respiratory disease and its treatment on HRQoL of participants with COPD. It contains 14 questions with a total of 40 items grouped into domains (Symptoms, Activity and Impacts). SGRQ total score was calculated as 100 multiplied by summed weights from all positive items divided by sum of weights for all items in questionnaire. It ranges from 0 to 100, higher score indicates poor HRQoL. Baseline is last non-missing score recorded prior to dosing on Day 1. Change from Baseline was calculated by subtracting Baseline value from the value at Week 24. Analysis was performed using mixed model repeated measures (MMRM) with covariates of Baseline SGRQ total score, geographical region, stratum (no. of bronchodilators per day during run-in), visit, treatment, visit by Baseline and visit by treatment interactions. (NCT03034915)
Timeframe: Baseline (Pre-dose on Day 1) and Week 24
| Intervention | Scores on a scale (Least Squares Mean) |
|---|---|
| UMEC/VI 62.5/25 mcg+ Placebo | -4.98 |
| UMEC 62.5 mcg + Placebo | -5.23 |
| Salmeterol 50 mcg+Placebo | -3.29 |
FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 at Week 24 is defined as the mean of the FEV1 values obtained 23 and 24 hours after dosing on the previous day. Baseline trough FEV1 is the mean of the values measured at 30 minutes and 5 minutes pre-dose on Day 1. Change from Baseline was calculated as the trough FEV1 value on Week 24 minus the Baseline value. Analysis was performed using a repeated measures model (MMRM) with covariates of Baseline FEV1, geographical region, stratum (number of bronchodilators per day during run-in), visit, treatment, visit by Baseline and visit by treatment interaction. ITT population comprised of all randomized participants (excluding those who were randomized in error) who received at least one dose of study medication. (NCT03034915)
Timeframe: Baseline (Pre-dose on Day 1) and Week 24
| Intervention | Liters (Least Squares Mean) |
|---|---|
| UMEC/VI 62.5/25 mcg+ Placebo | 0.122 |
| UMEC 62.5 mcg + Placebo | 0.056 |
| Salmeterol 50 mcg+Placebo | -0.019 |
The E-RS is intended to capture information related to respiratory symptoms. A daily symptom score for E-RS is derived by summing 11 item-scores. The domains include: respiratory symptoms (RS)-breathlessness (RS-BRL comprised of 5 items, score range [0-17]), RS-cough and sputum (RS-CSP comprised of 3 items, score range [0-11]), and RS-chest symptoms (RS-CSY comprised of 3 items, score range [0-12]). Total score ranged between 0-40 and higher values indicates severe respiratory symptoms. The instrument was completed each night prior to going to bed. Baseline E-RS score is the mean within-participant daily score over 7 days prior to randomization. Change from Baseline is the difference at Week 21-Week 24 value and Baseline value. Analysis was performed using MMRM with covariates of Baseline score, geographical region, stratum (no. of bronchodilators per day during run-in), 4-weekly period, treatment, 4-weekly period by Baseline and 4-weekly period by treatment interactions. (NCT03034915)
Timeframe: Baseline (Pre-dose on Day 1) and Week 21 to Week 24
| Intervention | Scores on a scale (Least Squares Mean) |
|---|---|
| UMEC/VI 62.5/25 mcg+ Placebo | -1.52 |
| UMEC 62.5 mcg + Placebo | -0.99 |
| Salmeterol 50 mcg+Placebo | -0.69 |
The E-RS is intended to capture information related to respiratory symptoms. A daily symptom score for E-RS is derived by summing 11 item-scores. The domains include: RS-BRL comprised of 5 items, score range (0-17); RS-CSP comprised of 3 items, score range (0-11); and RS-CSY comprised of 4 items, score range (0-12). Total score ranged between 0-40 and higher values indicates severe respiratory symptoms. The instrument was completed each night prior to going to bed. Response is defined as an E-RS total score of at least 2 or 3.35 below Baseline. Participants with a Baseline but all missing post-Baseline data are also considered a non-responder. Analysis was performed using a generalized linear mixed model with treatment as an explanatory variable and four-weekly period, Baseline score, stratum (no. of bronchodilators per day during run-in), geographical region, four-weekly period by baseline and four-weekly period by treatment interactions included as covariates. (NCT03034915)
Timeframe: Week 21 to Week 24
| Intervention | Percentage of responders (Number) |
|---|---|
| UMEC/VI 62.5/25 mcg+ Placebo | 36 |
| UMEC 62.5 mcg + Placebo | 27 |
| Salmeterol 50 mcg+Placebo | 27 |
The CAT is a participant-completed instrument designed to provide a simple and reliable measure of health status in COPD for the assessment and long-term follow-up of the individual participant. The CAT consists of eight items. Participants rated their experience on a 6-point scale for each question, ranging from 0 (no impact) to 5 (high impact). A total CAT score was calculated by summing the non-missing scores on the eight items ranging from 0 to 40 with higher scores indicate greater disease impact. Response was defined as an CAT score of >=2 below Baseline. Non response was defined as CAT score <2 units below Baseline or a missing CAT score with no subsequent on treatment scores. Analysis performed using a generalized linear mixed model with treatment as an explanatory variable and visit, baseline CAT score, stratum (no. of bronchodilators per day during run-in), geographical region, visit by baseline and visit by treatment interactions included as covariates. (NCT03034915)
Timeframe: Week 24
| Intervention | Percentage of responders (Number) |
|---|---|
| UMEC/VI 62.5/25 mcg+ Placebo | 55 |
| UMEC 62.5 mcg + Placebo | 48 |
| Salmeterol 50 mcg+Placebo | 50 |
SGRQ is a disease-specific questionnaire designed to measure impact of respiratory disease and its treatment on HRQoL of participants with COPD. It contains 14 questions with a total of 40 items grouped into domains (Symptoms, Activity and Impacts). SGRQ total score was calculated as 100 multiplied by summed weights from all positive items divided by sum of weights for all items in questionnaire. It ranges from 0 to 100, higher score indicates poor HRQoL. Analysis was performed using a generalized linear mixed model with treatment as an explanatory variable and visit, Baseline SGRQ score, stratum (no. of bronchodilators per day during run-in), geographical region, visit by Baseline and visit by treatment interactions included as covariates. Response was defined as an SGRQ total score of 4 or more units below Baseline. (NCT03034915)
Timeframe: Week 24
| Intervention | Percentage of responders (Number) |
|---|---|
| UMEC/VI 62.5/25 mcg+ Placebo | 45 |
| UMEC 62.5 mcg + Placebo | 41 |
| Salmeterol 50 mcg+Placebo | 36 |
TDI focal score comprises of 3 individual scales (Functional Impairment, Magnitude of Task, Magnitude of Effort). Each of these scales had a possible score ranging from -6 to +6, lower scores indicates impairment. TDI focal score was calculated as the sum of 3 individual scores (range is -18 to +18). Lower score indicates deterioration of dyspnea. If a score is missing for any of the three scales, then TDI focal score was set to missing. A participant was considered as a responder if the on-treatment TDI focal score was at least 1 unit at that visit. Non-response was SAC TDI focal score of less than 1 unit or a missing SAC TDI focal score with no subsequent non-missing on-treatment scores. Analysis was performed using a generalized linear mixed model with treatment as an explanatory variable and visit, SAC BDI focal score, stratum (no. of bronchodilators per day during run-in), geographical region, visit by SAC BDI and visit by treatment interactions included as covariates. (NCT03034915)
Timeframe: Week 24
| Intervention | Percentage of responders (Number) |
|---|---|
| UMEC/VI 62.5/25 mcg+ Placebo | 50 |
| UMEC 62.5 mcg + Placebo | 42 |
| Salmeterol 50 mcg+Placebo | 41 |
TDI focal score comprises of 3 individual scales (Functional Impairment, Magnitude of Task, Magnitude of Effort). Each of these scales had a possible score ranging from -6 to +6, lower scores indicates impairment. TDI focal score was calculated as the sum of 3 individual scores (range is -18 to +18). Lower score indicates deterioration of dyspnea. If a score is missing for any of the three scales, then the TDI focal score was set to missing. Analysis was performed using mixed model repeated measures (MMRM) with covariates of SAC BDI focal score, geographical region, stratum (no. of bronchodilators per day during run-in), visit, treatment, visit by SAC BDI and visit by treatment interactions. (NCT03034915)
Timeframe: Week 24
| Intervention | Scores on a scale (Least Squares Mean) |
|---|---|
| UMEC/VI 62.5/25 mcg+ Placebo | 1.68 |
| UMEC 62.5 mcg + Placebo | 1.30 |
| Salmeterol 50 mcg+Placebo | 1.22 |
The E-RS is intended to capture information related to respiratory symptoms. A daily symptom score for E-RS is derived by summing 11 item-scores. The domains include: respiratory symptoms (RS)-breathlessness (RS-BRL comprised of 5 items, score range [0-17]), RS-cough and sputum (RS-CSP comprised of 3 items, score range [0-11]), and RS-chest symptoms (RS-CSY comprised of 3 items, score range [0-12]). Total score ranged between 0-40 and higher values indicates severe respiratory symptoms. The instrument was completed each night prior to going to bed. Baseline E-RS score is the mean within-participant daily score over 7 days prior to randomization. Change from Baseline is the difference at Week 21-Week 24 value and Baseline value. Analysis was performed using MMRM with covariates of Baseline score, geographical region, stratum (no. of bronchodilators per day during run-in), 4-weekly period, treatment, 4-weekly period by Baseline and 4-weekly period by treatment interactions. (NCT03034915)
Timeframe: Baseline (Pre-dose on Day 1) and Week 21 to Week 24
| Intervention | Scores on a scale (Least Squares Mean) | ||
|---|---|---|---|
| RS-BRL | RS-CSP | RS-CSY | |
| Salmeterol 50 mcg+Placebo | -0.22 | -0.32 | -0.15 |
| UMEC 62.5 mcg + Placebo | -0.40 | -0.38 | -0.22 |
| UMEC/VI 62.5/25 mcg+ Placebo | -0.67 | -0.45 | -0.39 |
An AE is any untoward medical occurrence in a participant or clinical investigation participant , temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment or all events associated with liver injury and impaired liver function based on pre-defined criteria were categorized as SAE. (NCT03034915)
Timeframe: Up to Week 24
| Intervention | Participants (Number) | |
|---|---|---|
| Any AE | Any SAE | |
| Salmeterol 50 mcg+Placebo | 314 | 38 |
| UMEC 62.5 mcg + Placebo | 316 | 35 |
| UMEC/VI 62.5/25 mcg+ Placebo | 315 | 49 |
FEV1 is defined as forced expiratory volume in one second and measured in the morning at Visits 1 through 8 between 6:00 and 11:00 electronically by spirometry. Change from Baseline in trough FEV1 is defined as the difference in the value obtained at Visit 6 (24 hours post-dose on Visit 5) and the last acceptable/borderline acceptable value obtained prior to randomization (from Visit 2 pre-bronchodilator or Visit 3 pre-dose). Trough FEV1 is defined as the acceptable/borderline acceptable FEV1 value obtained at Visit 6, approximately 24 hours after morning dosing on Visit 5. ITT population is comprised of all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period. All comparisons for statistical purposes are with the FF 100 µg arm. (NCT02164539)
Timeframe: Baseline and Day 29
| Intervention | Liters (Mean) |
|---|---|
| FF 100 µg | 0.047 |
| FF/UMEC 100/15.6 µg | 0.146 |
| FF/UMEC 100/62.5 µg | 0.193 |
| FF/UMEC 100/125 µg | 0.175 |
| FF/UMEC 100/250 µg | 0.143 |
| FF/VI 100/25 µg | 0.121 |
Peak expiratory flow (PEF) stability limit was calculated from AM PEF measurements on the 7 days preceding Visit 3 as mean AM PEF from the available 7 days preceding Visit 3 x 80%. PEF stability limit serves as a benchmark of the participants run-in COPD status and used for comparison during the treatment phase to assess subject safety. Change from Baseline over the last 21 days of Treatment Phase A is the difference between the last 21 days of Treatment Phase A and the appropriate Baseline week. The last 21 days of Treatment Phase A include the AM assessments on the date of Visit 6. AM assessments include the date of Visit 6 and the 20 consecutive days preceding the date of Visit. Analysis performed using analysis of covariance with covariates of treatment, age, sex, Baseline AM PEF, pack years smoked per randomization stratification and age when first treated with an inhaler per randomization stratification. Baseline is the last 7 days of the run-in period prior to randomization (NCT02164539)
Timeframe: Baseline and from Day 8 through Day 29
| Intervention | Liters per minute (L/min) (Least Squares Mean) |
|---|---|
| FF 100 µg | -14.2 |
| FF/UMEC 100/15.6 µg | 3.9 |
| FF/UMEC 100/62.5 µg | 7.6 |
| FF/UMEC 100/125 µg | 5.5 |
| FF/UMEC 100/250 µg | 10.5 |
| FF/VI 100/25 µg | 4.3 |
FEV1 was measured in the morning by spirometry. At Visit 5, after trough FEV1 is measured, subject received investigational product. 3 hours post-dose, spirometry was repeated and subject then received 2 puffs of albuterol/salbutamol. After 30 minutes,spirometry was repeated.. Change from Baseline in clinic trough (pre-dose) FEV1 is the difference in the trough value at 3 hours post-dose peak FEV1 and the Baseline value. If the trough value or the Baseline was missing, then change from Baseline was considered as missing. Baseline value of clinic FEV1 is the last acceptable/borderline acceptable (pre-dose) FEV1 value obtained prior to randomization (from Visit 3 pre-dose or from Visit 2 pre-bronchodilator). Analysis done using analysis of covariance with covariates of treatment, age, sex, baseline clinic trough FEV1, pre-dose trough FEV1 at Visit 5, pack years smoked per randomization stratification and age when first treated with an inhaler per randomization stratification. (NCT02164539)
Timeframe: Baseline and Day 28
| Intervention | Liters (L) (Least Squares Mean) |
|---|---|
| FF 100 µg | 0.048 |
| FF/UMEC 100/15.6 µg | 0.093 |
| FF/UMEC 100/62.5 µg | 0.088 |
| FF/UMEC 100/125 µg | 0.072 |
| FF/UMEC 100/250 µg | 0.052 |
| FF/VI 100/25 µg | 0.124 |
FEV1 is defined as forced expiratory volume in one second and measured in the morning at Visits 1 through 8 between 6:00 and 11:00 electronically by spirometry. Reversibility was measured at Visit 1 and Visit 2 for study eligibility by change in clinic FEV1 within 20 to 60 minutes following 4 inhalations of albuterol/salbutamol and again measured 3 hours after dosing at Visit 5 by change in clinic FEV1 30 minutes following 2 inhalations of albuterol/salbutamol. Baseline value of clinic FEV1 is the last acceptable/borderline acceptable (pre-dose) FEV1 value obtained prior to randomization (either from Visit 3 pre-dose or from Visit 2 pre-bronchodilator). Analysis performed using analysis of covariance with covariates of treatment, age, sex, baseline clinic trough FEV1, pre-albuterol/salbutamol FEV1 at Visit 5, pack years smoked per randomization stratification and age when first treated with an inhaler per randomization stratification. (NCT02164539)
Timeframe: Baseline and Day 28
| Intervention | Liters (L) (Least Squares Mean) |
|---|---|
| FF 100 µg | 0.249 |
| FF/UMEC 100/15.6 µg | 0.161 |
| FF/UMEC 100/62.5 µg | 0.159 |
| FF/UMEC 100/125 µg | 0.160 |
| FF/UMEC 100/250 µg | 0.189 |
| FF/VI 100/25 µg | 0.087 |
A daily symptoms score for exacerbations of chronic pulmonary disease tool - Respiratory Symptoms (E-RS) is derived by summing the 11 item-level E-RS scores and has a theoretical range of 0-40, with higher values indicating more severe respiratory symptoms. The Baseline E-RS score is defined as the mean within-subject daily score over the 7 days prior to randomization, with data present for a minimum of 4 of the 7 days. Change from Baseline at the end of Treatment Phase is the difference between the end of Treatment Phase value and the appropriate Baseline week. Analysis performed using analysis of covariance with covariates of treatment, age, sex, baseline score, pack years smoked per randomization stratification and age when first treated with an inhaler per randomization stratification. Baseline is the last 7 days of the run-in period prior to randomization. All comparisons for statistical purposes are with the FF 100 µg arm. (NCT02164539)
Timeframe: Baseline and End of Treatment Phase A (The end of Treatment Phase A was defined as the last 7 days of Treatment Phase A, including the AM assessments on the date of Visit 6)
| Intervention | Score on scale (Least Squares Mean) |
|---|---|
| FF 100 µg | 0.5 |
| FF/UMEC 100/15.6 µg | -2.6 |
| FF/UMEC 100/62.5 µg | -2.5 |
| FF/UMEC 100/125 µg | -1.5 |
| FF/UMEC 100/250 µg | -1.5 |
| FF/VI 100/25 µg | -1.1 |
All participants received the albuterol/salbutamol via MDI as a rescue medication on an as-needed basis. Total daily rescue medication use for a given day is the sum of daytime albuterol/salbutamol use recorded in PM and nighttime albuterol/salbutamol use recorded in AM the next day. The number of puffs of albuterol (salbutamol) MDI used in the last 12 hours for relief of symptoms were recorded morning and evening in the eDiary by the participants. End of Treatment Phase A is the last 7 days of Treatment Phase A. Change from Baseline at the end of Treatment Phase is the difference between the end of Treatment Phase value and the appropriate baseline week. Analysis performed using analysis of covariance with covariates of treatment, age, sex, baseline rescue medication use, pack years smoked per randomization stratification and age when first treated with an inhaler per randomization stratification. Baseline is the last 7 days of the run-in period prior to randomization (NCT02164539)
Timeframe: Baseline and End of Treatment Phase A (The end of Treatment Phase A was defined as the last 7 days of Treatment Phase A, including the AM assessments on the date of Visit 6)
| Intervention | Puffs (Least Squares Mean) |
|---|---|
| FF 100 µg | 0.6 |
| FF/UMEC 100/15.6 µg | -0.4 |
| FF/UMEC 100/62.5 µg | -0.5 |
| FF/UMEC 100/125 µg | 0.0 |
| FF/UMEC 100/250 µg | -0.2 |
| FF/VI 100/25 µg | -0.1 |
Average FEV1 AUC over 12 hours on Day 1 (NCT03028142)
Timeframe: Day 1
| Intervention | Liters*hour (Mean) |
|---|---|
| Lower Dose Nebulised Treatment | 3.058 |
| Higher Dose Nebulised Treatment | 3.094 |
| Placebo | 2.510 |
Average FEV1 area under the curve (AUC) over 12 hours on the third day of dosing (NCT03028142)
Timeframe: Day 3
| Intervention | Liters*hour (Mean) |
|---|---|
| Lower Dose Nebulised Treatment | 3.804 |
| Higher Dose Nebulised Treatment | 3.967 |
| Placebo | 3.197 |
Peak FEV1 over 4 hours on Day 1 (NCT03028142)
Timeframe: Day 1
| Intervention | Liters (Mean) |
|---|---|
| Lower Dose Nebulised Treatment | 0.383 |
| Higher Dose Nebulised Treatment | 0.432 |
| Placebo | 0.337 |
Peak forced expired volume in 1 second (FEV1) over 4 hours on the third day of dosing (NCT03028142)
Timeframe: Day 3
| Intervention | Liters (Mean) |
|---|---|
| Lower Dose Nebulised Treatment | 0.477 |
| Higher Dose Nebulised Treatment | 0.500 |
| Placebo | 0.373 |
AUC(0-t) is the area under plasma concentration time curve of GSK961081 to the last quantifiable concentration. This parameter was determined using the linear trapezoidal rule for increasing concentrations and the logarithmic trapezoidal rule for decreasing concentrations. A large proportion of AUC(0-t) and Cmax values were reported as not countable (NC) at the GSK961081 400 micrograms (ug) dose level, therefore only limited summaries were calculated. Logarithmic transformed values are presented. AUC(0-t) imputed with 1/2 lowest observed AUC(0-t), where lowest AUC(0-t) was 56.46 hour picograms per milliliter (h*pg/mL). (NCT00674817)
Timeframe: Up to 82 days
| Intervention | h*pg/mL (Geometric Mean) |
|---|---|
| GSK961081 400 mg Plus SAL | NA |
| GSK961081 1200 mg Plus SAL | 233.93 |
| GSK961081 400 mg Plus IPR | NA |
| GSK961081 1200 mg Plus IPR | 216.22 |
| GSK961081 400 mg Plus Placebo | NA |
| GSK961081 1200 mg Plus Placebo | 229.51 |
Analysis of Q T (F) interval during ECG (taken in supine position) was performed using Fridericia's method. Change from baseline is the value at indicated time point minus the value at Baseline. Adjusted means are considered as LS mean values while presenting the data . (NCT00674817)
Timeframe: From dosing until 27 hours (0-27h)
| Intervention | msec (Mean) |
|---|---|
| GSK961081 400 mg Plus SAL | 19.70 |
| GSK961081 1200 mg Plus SAL | 19.53 |
| GSK961081 400 mg Plus IPR | 17.41 |
| GSK961081 1200 mg Plus IPR | 17.45 |
| GSK961081 400 mg Plus Placebo | 15.14 |
| GSK961081 1200 mg Plus Placebo | 18.60 |
Analysis of QT (F) interval during ECG (taken in supine position) was performed using Fridericia's method. Change from baseline is the value at indicated time point minus the value at Baseline. Adjusted means are considered as least square (LS) mean values while presenting the data. (NCT00674817)
Timeframe: From dosing until 4 hours (0-4h)
| Intervention | msec (Mean) |
|---|---|
| GSK961081 400 mg Plus SAL | 14.34 |
| GSK961081 1200 mg Plus SAL | 14.98 |
| GSK961081 400 mg Plus IPR | 12.31 |
| GSK961081 1200 mg Plus IPR | 11.99 |
| GSK961081 400 mg Plus Placebo | 10.60 |
| GSK961081 1200 mg Plus Placebo | 13.22 |
Cmax is the Maximum observed concentration of GSK961081 determined directly from the concentration-time data. A large proportion of Cmax values were reported as not countable (NC ) at the GSK961081 400 micrograms (ug) dose level, therefore only limited summaries were calculated. Logarithmic transformed values are presented. Cmax was imputed with 1/2 lowest limit of quantification (LLQ), where LLQ was 25 picograms per milliliter (pg/mL). (NCT00674817)
Timeframe: Up to 82 days
| Intervention | pg/mL (Geometric Mean) |
|---|---|
| GSK961081 400 mg Plus SAL | 66.93 |
| GSK961081 1200 mg Plus SAL | 169.05 |
| GSK961081 400 mg Plus IPR | 70.77 |
| GSK961081 1200 mg Plus IPR | 153.59 |
| GSK961081 400 mg Plus Placebo | 70.52 |
| GSK961081 1200 mg Plus Placebo | 176.92 |
Tlast is the time to last quantifiable plasma concentration of GSK961081 over period determined directly from the concentration-time data (NCT00674817)
Timeframe: Up to 82 days
| Intervention | hours (Median) |
|---|---|
| GSK961081 400 mg Plus SAL | 0.960 |
| GSK961081 1200 mg Plus SAL | 2.000 |
| GSK961081 400 mg Plus IPR | 1.930 |
| GSK961081 1200 mg Plus IPR | 3.920 |
| GSK961081 400 mg Plus Placebo | 1.920 |
| GSK961081 1200 mg Plus Placebo | 2.050 |
Tmax is the time to maximum plasma concentration of GSK961081 over period determined directly from the concentration-time data (NCT00674817)
Timeframe: Up to 82 days
| Intervention | Hours (Median) |
|---|---|
| GSK961081 400 mg Plus SAL | 0.920 |
| GSK961081 1200 mg Plus SAL | 0.930 |
| GSK961081 400 mg Plus IPR | 0.925 |
| GSK961081 1200 mg Plus IPR | 0.920 |
| GSK961081 400 mg Plus Placebo | 0.920 |
| GSK961081 1200 mg Plus Placebo | 0.920 |
Heart rate was recorded in supine position. Change from baseline is the value at indicated time point minus the value at Baseline. Weighted means are considered as LS mean values while presenting the data. (NCT00674817)
Timeframe: From dosing until 4 hours (0-4h)
| Intervention | Beats per minute (Least Squares Mean) |
|---|---|
| GSK961081 400 mg Plus SAL | 0.52 |
| GSK961081 1200 mg Plus SAL | 1.77 |
| GSK961081 400 mg Plus IPR | -2.93 |
| GSK961081 1200 mg Plus IPR | -1.27 |
| GSK961081 400 mg Plus Placebo | -3.57 |
| GSK961081 1200 mg Plus Placebo | -2.21 |
Analysis of QT (B) interval during ECG (taken in supine position) was performed using Bazett's method. Change from baseline is the value at indicated time point minus the value at Baseline. Weighted means are considered as LS mean values while presenting the data. (NCT00674817)
Timeframe: From dosing until 4 hours (0-4h)
| Intervention | msec (Least Squares Mean) |
|---|---|
| GSK961081 400 mg Plus SAL | 5.27 |
| GSK961081 1200 mg Plus SAL | 9.08 |
| GSK961081 400 mg Plus IPR | 0.08 |
| GSK961081 1200 mg Plus IPR | 4.44 |
| GSK961081 400 mg Plus Placebo | 0.07 |
| GSK961081 1200 mg Plus Placebo | 6.12 |
Analysis of QT(F) interval during ECG (taken in supine position) was performed using Fridericia's method. Change from baseline is the value at indicated time point minus the value at Baseline. Weighted means are considered as LS mean values while presenting the data. (NCT00674817)
Timeframe: From dosing until 4 hours (0-4h)
| Intervention | msec (Least Squares Mean) |
|---|---|
| GSK961081 400 mg Plus SAL | 5.42 |
| GSK961081 1200 mg Plus SAL | 7.53 |
| GSK961081 400 mg Plus IPR | 4.59 |
| GSK961081 1200 mg Plus IPR | 6.23 |
| GSK961081 400 mg Plus Placebo | 4.17 |
| GSK961081 1200 mg Plus Placebo | 8.18 |
Change from Baseline in systolic blood pressure (SBP) and diastolic blood pressure (DBP) was analyzed. Change from baseline is the difference in the blood pressure at the indicated time point minus the Baseline value. (NCT00674817)
Timeframe: Up to 27 hours post Day 1 dosing
| Intervention | Millimeters of mercury (mm of Hg) (Mean) | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| SBP, 1 hour(h) | SBP, 2h | SBP, 4h | SBP, 9h | SBP, 12h | SBP, 13h | SBP, 24h | SBP, 25h | SBP, 27h | DBP, 1h | DBP, 2h | DBP, 4h | DBP, 9h | DBP, 12h | DBP, 13h | DBP, 24h | DBP, 25h | DBP, 27h | |
| GSK961081 1200 mg Plus IPR | -1.73 | 2.33 | 2.68 | 2.71 | 0.32 | 2.27 | 2.56 | 2.44 | -0.32 | -2.66 | 0.48 | 0.12 | -0.34 | -0.90 | -0.39 | 2.32 | 1.49 | -1.12 |
| GSK961081 1200 mg Plus Placebo | -0.33 | 1.31 | 2.38 | 2.95 | -0.51 | 2.21 | 1.68 | 1.49 | -1.24 | -2.21 | -1.05 | 1.54 | -0.79 | -0.51 | -0.34 | -0.58 | 2.22 | -1.55 |
| GSK961081 1200 mg Plus SAL | 3.10 | 1.22 | 4.20 | 3.08 | 2.08 | 3.46 | 4.65 | 4.05 | 2.43 | -1.41 | -2.27 | 1.23 | 0.03 | -1.25 | -1.97 | 3.13 | 0.75 | -0.03 |
| GSK961081 400 mg Plus IPR | 0.61 | 3.49 | 3.27 | 1.07 | -0.46 | 1.05 | 1.41 | 2.32 | -3.24 | 1.25 | 0.07 | 1.24 | -1.73 | -2.68 | -0.56 | 0.37 | 1.24 | -2.51 |
| GSK961081 400 mg Plus Placebo | -0.13 | 1.03 | 0.63 | 0.00 | -1.95 | 3.45 | -1.50 | -0.10 | -3.25 | 0.55 | -1.48 | 1.38 | 0.28 | -3.05 | 0.85 | -0.23 | 0.78 | -3.35 |
| GSK961081 400 mg Plus SAL | -1.33 | -3.41 | -2.36 | -0.87 | -3.49 | -5.62 | -3.31 | -3.38 | -5.59 | -1.59 | -4.15 | -0.26 | -1.59 | -3.18 | -4.19 | -0.95 | -2.26 | -3.28 |
FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second as measured by spirometry. Adjusted mean has been presented as least square (LS) mean. (NCT00674817)
Timeframe: Baseline (pre-dose on Day 1), 1h, 12h, and 24h on Day 1
| Intervention | Liters (Least Squares Mean) | ||
|---|---|---|---|
| 1 hour | 12 hour | 24 hour | |
| GSK961081 1200 mg Plus IPR | 0.111 | 0.098 | 0.172 |
| GSK961081 1200 mg Plus Placebo | 0.094 | 0.043 | 0.049 |
| GSK961081 1200 mg Plus SAL | 0.113 | 0.134 | 0.175 |
| GSK961081 400 mg Plus IPR | 0.087 | 0.127 | 0.179 |
| GSK961081 400 mg Plus Placebo | 0.072 | 0.002 | 0.039 |
| GSK961081 400 mg Plus SAL | 0.111 | 0.141 | 0.161 |
FVC is defined as the amount of air that can be forcibly exhaled from the lungs after a maximum inspiration as measured by spirometry. Adjusted mean has been presented as least square (LS) mean. (NCT00674817)
Timeframe: Baseline (Pre-dose on Day 1), 1h, 12h, and 24h on Day 1
| Intervention | Liters (Least Squares Mean) | ||
|---|---|---|---|
| 1 hour | 12 hour | 24 hour | |
| GSK961081 1200 mg Plus IPR | 0.207 | 0.223 | 0.214 |
| GSK961081 1200 mg Plus Placebo | 0.229 | 0.088 | 0.113 |
| GSK961081 1200 mg Plus SAL | 0.281 | 0.182 | 0.205 |
| GSK961081 400 mg Plus IPR | 0.167 | 0.188 | 0.279 |
| GSK961081 400 mg Plus Placebo | 0.234 | 0.068 | 0.179 |
| GSK961081 400 mg Plus SAL | 0.169 | 0.160 | 0.247 |
Maximum change (MC) from Baseline (BL) and weighted mean change (WMC) from baseline in glucose (GLU) were analyzed. Change from Baseline is the value at indicated time point minus the value at Baseline. Weighted means are considered as LS mean values while presenting the data. (NCT00674817)
Timeframe: 0-4h and 0-27h for maximum change and 0-4 h for weighted mean change
| Intervention | Millimoles per Liter (Least Squares Mean) | ||
|---|---|---|---|
| MC from BL, Glu, 0-4h | MC from BL, Glu, 0-27h | WMC from BL, Glu, 0-4h | |
| GSK961081 1200 mg Plus IPR | 0.53 | 1.87 | -0.08 |
| GSK961081 1200 mg Plus Placebo | 0.22 | 1.30 | 0.19 |
| GSK961081 1200 mg Plus SAL | 0.53 | 2.13 | 0.02 |
| GSK961081 400 mg Plus IPR | 0.52 | 1.78 | -0.12 |
| GSK961081 400 mg Plus Placebo | 0.13 | 1.83 | -0.29 |
| GSK961081 400 mg Plus SAL | 0.66 | 2.71 | 0.02 |
Analysis of QT (B) interval during ECG (taken in supine position) was performed using Bazett's method. Change from baseline is the value at indicated time point minus the value at Baseline. Weighted means are considered as LS mean values while presenting the data . (NCT00674817)
Timeframe: From dosing until 4 hours (0-4h) and 27 hours (0-27h)
| Intervention | msec (Least Squares Mean) | |
|---|---|---|
| 0-4 hours | 0-27 hours | |
| GSK961081 1200 mg Plus IPR | 10.77 | 17.83 |
| GSK961081 1200 mg Plus Placebo | 11.65 | 19.91 |
| GSK961081 1200 mg Plus SAL | 19.51 | 25.88 |
| GSK961081 400 mg Plus IPR | 9.19 | 17.33 |
| GSK961081 400 mg Plus Placebo | 6.50 | 12.94 |
| GSK961081 400 mg Plus SAL | 16.70 | 24.17 |
Heart rate was measured in supine position. Change from baseline is the value at indicated time point minus the value at Baseline. Adjusted means are considered as LS mean values while presenting the data. (NCT00674817)
Timeframe: From dosing until 4 hours (0-4h) and until 27 hours (0-27 h)
| Intervention | Beats per minute (Least Squares Mean) | |
|---|---|---|
| 0-4 h | 0-27 h | |
| GSK961081 1200 mg Plus IPR | 3.17 | 10.28 |
| GSK961081 1200 mg Plus Placebo | 0.92 | 8.66 |
| GSK961081 1200 mg Plus SAL | 7.90 | 12.92 |
| GSK961081 400 mg Plus IPR | 2.18 | 9.49 |
| GSK961081 400 mg Plus Placebo | 0.92 | 9.21 |
| GSK961081 400 mg Plus SAL | 7.51 | 13.33 |
Systolic blood pressure (SBP) values were recorded in supine position. Change from baseline is the value at indicated time point minus the value at Baseline. Adjusted or maximum change/ (MC) and weighted mean change (WMC) are considered as LS mean change values while presenting the data. (NCT00674817)
Timeframe: 0-4h and 0-27h for maximum change and 0-4 h for weighted mean change
| Intervention | Millimeters of mercury (Least Squares Mean) | ||
|---|---|---|---|
| MC from BL,SBP,0-4h | MC from BL,SBP,0-27h | WMC from BL SBP,0-4h | |
| GSK961081 1200 mg Plus IPR | 5.55 | 12.87 | 0.10 |
| GSK961081 1200 mg Plus Placebo | 7.74 | 14.10 | 0.82 |
| GSK961081 1200 mg Plus SAL | 8.06 | 15.93 | 0.92 |
| GSK961081 400 mg Plus IPR | 8.05 | 14.08 | 2.24 |
| GSK961081 400 mg Plus Placebo | 7.45 | 14.16 | 1.06 |
| GSK961081 400 mg Plus SAL | 5.61 | 10.89 | -0.34 |
Heart rate was considered as a measure of vital sign. Change from baseline is the difference in the blood pressure at the indicated time point minus the Baseline value. (NCT00674817)
Timeframe: Up to 27 hours post Day 1 dosing
| Intervention | Beats per minute (Mean) | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1h | 1h 15 minutes | 1h 35 minutes | 1h 55 minutes | 4h | 9h | 12h | 12h 15 minutes | 12h 35 minutes | 12h 55 minutes | 24h | 24h 15 minutes | 24h 35 minutes | 24h 55 minutes | 27h | |
| GSK961081 1200 mg Plus IPR | -2.27 | -0.15 | -0.98 | -0.39 | -1.78 | 1.37 | 2.83 | 4.10 | 3.41 | 1.90 | -1.85 | -0.98 | -1.02 | -2.05 | 4.44 |
| GSK961081 1200 mg Plus Placebo | -3.10 | -1.74 | -2.36 | -2.21 | -3.97 | 0.28 | 1.87 | 2.05 | 1.29 | 1.37 | -4.55 | -4.03 | -4.63 | -4.21 | 2.68 |
| GSK961081 1200 mg Plus SAL | -1.37 | -0.46 | 1.51 | 4.54 | 1.13 | 2.97 | 3.65 | 5.35 | 6.90 | 6.50 | -1.08 | -1.60 | 0.53 | 0.83 | 6.38 |
| GSK961081 400 mg Plus IPR | -3.90 | -2.80 | -2.34 | -3.46 | -3.59 | -1.66 | 1.46 | 1.83 | 1.51 | 1.07 | -3.24 | -0.83 | -2.93 | -2.46 | 1.17 |
| GSK961081 400 mg Plus Placebo | -3.55 | -4.03 | -3.63 | -3.63 | -4.75 | -0.70 | 2.68 | 1.80 | 2.28 | 0.98 | -3.63 | -2.95 | -4.48 | -4.13 | 2.05 |
| GSK961081 400 mg Plus SAL | -2.56 | -0.95 | -0.03 | 3.21 | -0.71 | 1.92 | 1.95 | 3.95 | 4.97 | 5.79 | -2.36 | -1.49 | 0.23 | 1.05 | 6.74 |
Maximum change (MC) from Baseline (BL) and weighted mean change (WMC) from baseline in potassium (K) were analyzed. Change from Baseline is the value at indicated time point minus the value at Baseline. Weighted means are considered as LS mean values while presenting the data. (NCT00674817)
Timeframe: 0-4h and 0-27h for maximum change and 0-4 h for weighted mean change
| Intervention | Millimoles per Liter (Least Squares Mean) | ||
|---|---|---|---|
| MC from BL, K, 0-4h | MC from BL, K, 0-27h | WMC from BL, K, 0-4h | |
| GSK961081 1200 mg Plus IPR | -0.39 | -0.46 | -0.17 |
| GSK961081 1200 mg Plus Placebo | -0.36 | -0.45 | -0.14 |
| GSK961081 1200 mg Plus SAL | -0.44 | -0.62 | -0.22 |
| GSK961081 400 mg Plus IPR | -0.25 | -0.42 | -0.06 |
| GSK961081 400 mg Plus Placebo | -0.25 | -0.37 | -0.07 |
| GSK961081 400 mg Plus SAL | -0.42 | -0.53 | -0.18 |
Diastolic blood pressure (DBP) values were recorded in supine position. Change from baseline is the value at indicated time point minus the value at Baseline. Adjusted or maximum change/(MC) and weighted mean change (WMC) are considered as LS mean change values while presenting the data . (NCT00674817)
Timeframe: 0-4h and 0-27h for maximum change and 0-4 h for weighted mean change
| Intervention | Millimeters of mercury (Least Squares Mean) | ||
|---|---|---|---|
| MC from BL, DBP, 0-4h | MC from BL, DBP, 0-27h | WMC from BL, DBP, 0-4h | |
| GSK961081 1200 mg Plus IPR | -5.49 | -8.72 | -0.80 |
| GSK961081 1200 mg Plus Placebo | -4.42 | -9.18 | -0.44 |
| GSK961081 1200 mg Plus SAL | -5.76 | -9.20 | -1.25 |
| GSK961081 400 mg Plus IPR | -3.26 | -9.12 | 0.75 |
| GSK961081 400 mg Plus Placebo | -4.96 | -9.66 | -0.12 |
| GSK961081 400 mg Plus SAL | -5.53 | -10.04 | -1.30 |
An adverse event (AE) is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious AE (SAE) is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect. (NCT00674817)
Timeframe: Upto 82 days
| Intervention | Participants (Number) | |
|---|---|---|
| Participants with any AE | Participants with any SAE | |
| GSK961081 1200 mg Plus IPR | 9 | 0 |
| GSK961081 1200 mg Plus Placebo | 11 | 0 |
| GSK961081 1200 mg Plus SAL | 13 | 1 |
| GSK961081 400 mg Plus IPR | 15 | 1 |
| GSK961081 400 mg Plus Placebo | 6 | 0 |
| GSK961081 400 mg Plus SAL | 13 | 0 |
The normal ranges of laboratory parameters were hemoglobin: 130-167 grams per deciliter (g/dL), platelets: 173-383 Giga per liter (GI/L), lymphocytes: 20.1-44.5 %, glucose: 3.8857-6.106 millimoles per liter (mmol/L), creatinine: 44.2-132.6 micromoles per liter (uM/L) , aspartate transaminases (AST): 12-32 international units per liter (IU/L), total bilirubin (TB): 4.275-25.65 uM/L and potassium: 3.4-4.7 mmol/L, respectively. Laboratory values recorded outside the normal range were considered of potential clinical concern (PCC). (NCT00674817)
Timeframe: Up to 42 days
| Intervention | Participants (Number) | |||
|---|---|---|---|---|
| Hemoglobin high | Platelets high | Platelets low | Lymphocytes low | |
| GSK961081 1200 mg Plus IPR | 0 | 0 | 0 | 1 |
| GSK961081 1200 mg Plus Placebo | 0 | 0 | 0 | 0 |
| GSK961081 1200 mg Plus SAL | 1 | 1 | 0 | 0 |
| GSK961081 400 mg Plus IPR | 0 | 0 | 0 | 0 |
| GSK961081 400 mg Plus Placebo | 0 | 0 | 0 | 0 |
| GSK961081 400 mg Plus SAL | 0 | 0 | 1 | 0 |
Analysis QTc interval of ECG was performed by Bazett's formula (QTc B) and Fridericia's correction (QTc F). Number of participants with abnormal ECG findings were recorded. Any participant with QTc(B) or QTc(F) >500 milliseconds (msec) or uncorrected QT >600 msec (machine or manual over read) was withdrawn from the study. Participants that had right bundle branch block with QTc(B) or QTc(F) >530 msec were also withdrawn from the study. (NCT00674817)
Timeframe: From dosing until 24h post-dose.
| Intervention | Participants (Number) | |||||
|---|---|---|---|---|---|---|
| QTcB, <=30 msec | QTcB, >30 to <= 59 msec | QTcB, >=60 msec | QTcF, <=30 msec | QTcF, >30 to <= 59 msec | QTcF, >=60 msec | |
| GSK961081 1200 mg Plus IPR | 33 | 7 | 1 | 36 | 4 | 1 |
| GSK961081 1200 mg Plus Placebo | 31 | 6 | 2 | 35 | 2 | 2 |
| GSK961081 1200 mg Plus SAL | 31 | 9 | 1 | 31 | 9 | 1 |
| GSK961081 400 mg Plus IPR | 35 | 6 | 0 | 37 | 2 | 2 |
| GSK961081 400 mg Plus Placebo | 36 | 3 | 1 | 36 | 4 | 0 |
| GSK961081 400 mg Plus SAL | 26 | 12 | 1 | 34 | 5 | 0 |
Analysis of QT (B) or QTc (F) interval during ECG (taken in supine position) was performed using Bazett's method and Fridericia's method, respectively. Heart rate, BP, potassium, and glucose were measured in supine body position. Change from baseline is the value at indicated time point minus the value at Baseline. Weighted means are considered as LS mean values while presenting the data. (NCT00674817)
Timeframe: From dosing until 4 hours (0-4h)
| Intervention | hours (Median) | ||||||
|---|---|---|---|---|---|---|---|
| Heart rate | Systlic BP | Diastolic BP | QTcF | QTcB | Glucose | Potassium | |
| GSK961081 1200 mg Plus IPR | 1.517 | 2.100 | 0.933 | 2.100 | 2.100 | 0.967 | 1.950 |
| GSK961081 1200 mg Plus Placebo | 1.567 | 3.008 | 0.925 | 2.117 | 2.100 | 0.967 | 1.933 |
| GSK961081 1200 mg Plus SAL | 1.850 | 2.100 | 1.967 | 2.100 | 2.100 | 1.950 | 1.933 |
| GSK961081 400 mg Plus IPR | 1.517 | 2.100 | 2.100 | 2.167 | 2.100 | 0.967 | 1.933 |
| GSK961081 400 mg Plus Placebo | 1.567 | 2.008 | 1.983 | 2.133 | 2.100 | 1.150 | 1.942 |
| GSK961081 400 mg Plus SAL | 1.850 | 0.917 | 2.100 | 2.183 | 2.100 | 1.933 | 1.967 |
Change from test-day baseline in Forced Expiratory Volume in 1 second (FEV1) at 1 hour post dose on test day 1. (NCT01019694)
Timeframe: baseline, day 1
| Intervention | liters (Least Squares Mean) |
|---|---|
| Combivent Respimat | 0.22 |
| Combivent Inhalation Aerosol | 0.21 |
| Atrovent + Albuterol Aerosols | 0.21 |
Change from test-day baseline in Forced Expiratory Volume in 1 second (FEV1) at 1 hour post dose at Week 12 (NCT01019694)
Timeframe: baseline, 12 weeks
| Intervention | liters (Least Squares Mean) |
|---|---|
| Combivent Respimat | 0.23 |
| Combivent Inhalation Aerosol | 0.19 |
| Atrovent + Albuterol Aerosols | 0.20 |
Change from test-day baseline in Forced Expiratory Volume in 1 second (FEV1) at 1 hour post dose at Week 24 (NCT01019694)
Timeframe: baseline, 24 weeks
| Intervention | liters (Least Squares Mean) |
|---|---|
| Combivent Respimat | 0.20 |
| Combivent Inhalation Aerosol | 0.21 |
| Atrovent + Albuterol Aerosols | 0.21 |
Change from test-day baseline in Forced Expiratory Volume in 1 second (FEV1) at 1 hour post dose at Week 48 (NCT01019694)
Timeframe: baseline, 48 weeks
| Intervention | liters (Least Squares Mean) |
|---|---|
| Combivent Respimat | 0.22 |
| Combivent Inhalation Aerosol | 0.16 |
| Atrovent + Albuterol Aerosols | 0.23 |
Change from test-day baseline in Forced Vital Capacity (FVC) at 1 hour post dose on test day 1. (NCT01019694)
Timeframe: baseline, day 1
| Intervention | liters (Least Squares Mean) |
|---|---|
| Combivent Respimat | 0.37 |
| Combivent Inhalation Aerosol | 0.34 |
| Atrovent + Albuterol Aerosols | 0.36 |
Change from test-day baseline in Forced Vital Capacity (FVC) at 1 hour post dose at Week 12 (NCT01019694)
Timeframe: baseline, 12 weeks
| Intervention | liters (Least Squares Mean) |
|---|---|
| Combivent Respimat | 0.38 |
| Combivent Inhalation Aerosol | 0.31 |
| Atrovent + Albuterol Aerosols | 0.35 |
Change from test-day baseline in Forced Vital Capacity (FVC) at 1 hour post dose at Week 24 (NCT01019694)
Timeframe: baseline, 24 weeks
| Intervention | liters (Least Squares Mean) |
|---|---|
| Combivent Respimat | 0.33 |
| Combivent Inhalation Aerosol | 0.35 |
| Atrovent + Albuterol Aerosols | 0.35 |
Change from test-day baseline in Forced Vital Capacity (FVC) at 1 hour post dose at Week 48 (NCT01019694)
Timeframe: baseline, 48 weeks
| Intervention | liters (Least Squares Mean) |
|---|---|
| Combivent Respimat | 0.35 |
| Combivent Inhalation Aerosol | 0.30 |
| Atrovent + Albuterol Aerosols | 0.37 |
CCQ symptom domain score assessed patient feelings or limitations due to their COPD on a scale from 0 (not limited) to 6 (totally limited). (NCT01019694)
Timeframe: 0 weeks
| Intervention | units on a scale (Mean) |
|---|---|
| Combivent Respimat | 2.8 |
| Combivent Inhalation Aerosol | 2.7 |
| Atrovent + Albuterol Aerosols | 2.8 |
CCQ symptom domain score assessed patient feelings or limitations due to their COPD on a scale from 0 (not limited) to 6 (totally limited). (NCT01019694)
Timeframe: 12 weeks
| Intervention | unit on a scale (Least Squares Mean) |
|---|---|
| Combivent Respimat | 2.8 |
| Combivent Inhalation Aerosol | 2.9 |
| Atrovent + Albuterol Aerosols | 2.8 |
CCQ symptom domain score assessed patient feelings or limitations due to their COPD on a scale from 0 (not limited) to 6 (totally limited). (NCT01019694)
Timeframe: 24 weeks
| Intervention | unit on a scale (Least Squares Mean) |
|---|---|
| Combivent Respimat | 2.7 |
| Combivent Inhalation Aerosol | 2.8 |
| Atrovent + Albuterol Aerosols | 2.8 |
CCQ symptom domain score assessed patient feelings or limitations due to their COPD on a scale from 0 (not limited) to 6 (totally limited). (NCT01019694)
Timeframe: 3 weeks
| Intervention | unit on a scale (Least Squares Mean) |
|---|---|
| Combivent Respimat | 2.7 |
| Combivent Inhalation Aerosol | 2.7 |
| Atrovent + Albuterol Aerosols | 2.8 |
CCQ symptom domain score assessed patient feelings or limitations due to their COPD on a scale from 0 (not limited) to 6 (totally limited). (NCT01019694)
Timeframe: 36 weeks
| Intervention | unit on a scale (Least Squares Mean) |
|---|---|
| Combivent Respimat | 2.7 |
| Combivent Inhalation Aerosol | 2.8 |
| Atrovent + Albuterol Aerosols | 2.7 |
CCQ symptom domain score assessed patient feelings or limitations due to their COPD on a scale from 0 (not limited) to 6 (totally limited). (NCT01019694)
Timeframe: 48 weeks
| Intervention | unit on a scale (Least Squares Mean) |
|---|---|
| Combivent Respimat | 2.8 |
| Combivent Inhalation Aerosol | 2.7 |
| Atrovent + Albuterol Aerosols | 2.9 |
Mean number of puffs of daily rescue medication use (albuterol use per 24 hour period) in two weeks prior to week 0 (NCT01019694)
Timeframe: 0 weeks
| Intervention | number of puffs (Mean) |
|---|---|
| Combivent Respimat | 2.1 |
| Combivent Inhalation Aerosol | 1.5 |
| Atrovent + Albuterol Aerosols | 1.9 |
Mean number of puffs of daily rescue medication use (albuterol use per 24 hour period) in two weeks prior to week 12 (NCT01019694)
Timeframe: 12 weeks
| Intervention | number of puffs (Least Squares Mean) |
|---|---|
| Combivent Respimat | 1.9 |
| Combivent Inhalation Aerosol | 1.9 |
| Atrovent + Albuterol Aerosols | 1.7 |
Mean number of puffs of daily rescue medication use (albuterol use per 24 hour period) in two weeks prior to week 24 (NCT01019694)
Timeframe: 24 weeks
| Intervention | number of puffs (Least Squares Mean) |
|---|---|
| Combivent Respimat | 2.1 |
| Combivent Inhalation Aerosol | 2.0 |
| Atrovent + Albuterol Aerosols | 1.6 |
Mean number of puffs of daily rescue medication use (albuterol use per 24 hour period) in two weeks prior to week 3 (NCT01019694)
Timeframe: 3 weeks
| Intervention | number of puffs (Least Squares Mean) |
|---|---|
| Combivent Respimat | 1.7 |
| Combivent Inhalation Aerosol | 1.8 |
| Atrovent + Albuterol Aerosols | 1.7 |
Mean number of puffs of daily rescue medication use (albuterol use per 24 hour period) in two weeks prior to week 36 (NCT01019694)
Timeframe: 36 weeks
| Intervention | number of puffs (Least Squares Mean) |
|---|---|
| Combivent Respimat | 1.9 |
| Combivent Inhalation Aerosol | 2.1 |
| Atrovent + Albuterol Aerosols | 1.8 |
Mean number of puffs of daily rescue medication use (albuterol use per 24 hour period) in two weeks prior to week 48 (NCT01019694)
Timeframe: 48 weeks
| Intervention | number of puffs (Least Squares Mean) |
|---|---|
| Combivent Respimat | 2.0 |
| Combivent Inhalation Aerosol | 2.1 |
| Atrovent + Albuterol Aerosols | 1.8 |
"Patient satisfaction was assessed by asking: Overall, how satisfied are you with your inhaler?. Responses were made on a scale from 1 (very dissatisfied) to 7 (very satisfied)." (NCT01019694)
Timeframe: 0 weeks
| Intervention | units on a scale (Mean) |
|---|---|
| Combivent Respimat | 5.8 |
| Combivent Inhalation Aerosol | 5.9 |
| Atrovent + Albuterol Aerosols | 5.8 |
"Patient satisfaction was assessed by asking: Overall, how satisfied are you with your inhaler?. Responses were made on a scale from 1 (very dissatisfied) to 7 (very satisfied)." (NCT01019694)
Timeframe: 12 weeks
| Intervention | unit on a scale (Least Squares Mean) |
|---|---|
| Combivent Respimat | 6.2 |
| Combivent Inhalation Aerosol | 6.0 |
| Atrovent + Albuterol Aerosols | 5.8 |
"Patient satisfaction was assessed by asking: Overall, how satisfied are you with your inhaler?. Responses were made on a scale from 1 (very dissatisfied) to 7 (very satisfied)." (NCT01019694)
Timeframe: 24 weeks
| Intervention | unit on a scale (Least Squares Mean) |
|---|---|
| Combivent Respimat | 6.3 |
| Combivent Inhalation Aerosol | 6.0 |
| Atrovent + Albuterol Aerosols | 5.8 |
"Patient satisfaction was assessed by asking: Overall, how satisfied are you with your inhaler?. Responses were made on a scale from 1 (very dissatisfied) to 7 (very satisfied)." (NCT01019694)
Timeframe: 3 weeks
| Intervention | unit on a scale (Least Squares Mean) |
|---|---|
| Combivent Respimat | 6.2 |
| Combivent Inhalation Aerosol | 6.1 |
| Atrovent + Albuterol Aerosols | 5.9 |
"Patient satisfaction was assessed by asking: Overall, how satisfied are you with your inhaler?. Responses were made on a scale from 1 (very dissatisfied) to 7 (very satisfied)." (NCT01019694)
Timeframe: 36 weeks
| Intervention | unit on a scale (Least Squares Mean) |
|---|---|
| Combivent Respimat | 6.4 |
| Combivent Inhalation Aerosol | 6.0 |
| Atrovent + Albuterol Aerosols | 5.9 |
"Patient satisfaction was assessed by asking: Overall, how satisfied are you with your inhaler?. Responses were made on a scale from 1 (very dissatisfied) to 7 (very satisfied)." (NCT01019694)
Timeframe: 48 weeks
| Intervention | unit on a scale (Least Squares Mean) |
|---|---|
| Combivent Respimat | 6.3 |
| Combivent Inhalation Aerosol | 6.1 |
| Atrovent + Albuterol Aerosols | 6.0 |
Patient acceptability was assessed with the Performance Domain score from the PASAPQ. The score is a mean of 7 items on a scale from 0 (very dissatisfied) to 100 (very satisfied). (NCT01019694)
Timeframe: 12 weeks
| Intervention | unit on a scale (Least Squares Mean) |
|---|---|
| Combivent Respimat | 85.9 |
| Combivent Inhalation Aerosol | 78.0 |
| Atrovent + Albuterol Aerosols | 76.3 |
Patient acceptability was assessed with the Performance Domain score from the PASAPQ. The score is a mean of 7 items on a scale from 0 (very dissatisfied) to 100 (very satisfied). (NCT01019694)
Timeframe: 24 weeks
| Intervention | unit on a scale (Least Squares Mean) |
|---|---|
| Combivent Respimat | 86.6 |
| Combivent Inhalation Aerosol | 77.5 |
| Atrovent + Albuterol Aerosols | 78.9 |
Patient acceptability was assessed with the Performance Domain score from the PASAPQ. The score is a mean of 7 items on a scale from 0 (very dissatisfied) to 100 (very satisfied). (NCT01019694)
Timeframe: 3 weeks
| Intervention | unit on a scale (Least Squares Mean) |
|---|---|
| Combivent Respimat | 84.7 |
| Combivent Inhalation Aerosol | 79.4 |
| Atrovent + Albuterol Aerosols | 77.3 |
Patient acceptability was assessed with the Performance Domain score from the PASAPQ. The score is a mean of 7 items on a scale from 0 (very dissatisfied) to 100 (very satisfied). (NCT01019694)
Timeframe: 36 weeks
| Intervention | unit on a scale (Least Squares Mean) |
|---|---|
| Combivent Respimat | 88.2 |
| Combivent Inhalation Aerosol | 76.9 |
| Atrovent + Albuterol Aerosols | 80.5 |
Patient acceptability was assessed with the Performance Domain score from the PASAPQ. The score is a mean of 7 items on a scale from 0 (very dissatisfied) to 100 (very satisfied). (NCT01019694)
Timeframe: 48 weeks
| Intervention | unit on a scale (Least Squares Mean) |
|---|---|
| Combivent Respimat | 87.9 |
| Combivent Inhalation Aerosol | 78.3 |
| Atrovent + Albuterol Aerosols | 81.7 |
"Physicians evaluated the patient's overall clinical condition on a scale ranging from poor (score 1 or 2) to excellent (score 7 or 8)." (NCT01019694)
Timeframe: 0 weeks
| Intervention | units on a scale (Mean) |
|---|---|
| Combivent Respimat | 5.1 |
| Combivent Inhalation Aerosol | 4.9 |
| Atrovent + Albuterol Aerosols | 4.9 |
"Physicians evaluated the patient's overall clinical condition on a scale ranging from poor (score 1 or 2) to excellent (score 7 or 8)." (NCT01019694)
Timeframe: 12 weeks
| Intervention | unit on a scale (Least Squares Mean) |
|---|---|
| Combivent Respimat | 5.1 |
| Combivent Inhalation Aerosol | 5.2 |
| Atrovent + Albuterol Aerosols | 5.0 |
"Physicians evaluated the patient's overall clinical condition on a scale ranging from poor (score 1 or 2) to excellent (score 7 or 8)." (NCT01019694)
Timeframe: 24 weeks
| Intervention | unit on a scale (Least Squares Mean) |
|---|---|
| Combivent Respimat | 5.1 |
| Combivent Inhalation Aerosol | 5.2 |
| Atrovent + Albuterol Aerosols | 5.2 |
"Physicians evaluated the patient's overall clinical condition on a scale ranging from poor (score 1 or 2) to excellent (score 7 or 8)." (NCT01019694)
Timeframe: 3 weeks
| Intervention | unit on a scale (Least Squares Mean) |
|---|---|
| Combivent Respimat | 5.0 |
| Combivent Inhalation Aerosol | 5.1 |
| Atrovent + Albuterol Aerosols | 5.1 |
"Physicians evaluated the patient's overall clinical condition on a scale ranging from poor (score 1 or 2) to excellent (score 7 or 8)." (NCT01019694)
Timeframe: 36 weeks
| Intervention | unit on a scale (Least Squares Mean) |
|---|---|
| Combivent Respimat | 5.1 |
| Combivent Inhalation Aerosol | 5.2 |
| Atrovent + Albuterol Aerosols | 5.2 |
"Physicians evaluated the patient's overall clinical condition on a scale ranging from poor (score 1 or 2) to excellent (score 7 or 8)." (NCT01019694)
Timeframe: 48 weeks
| Intervention | unit on a scale (Least Squares Mean) |
|---|---|
| Combivent Respimat | 5.2 |
| Combivent Inhalation Aerosol | 5.3 |
| Atrovent + Albuterol Aerosols | 5.1 |
(NCT01019694)
Timeframe: 48 weeks
| Intervention | participants (Number) | |||||
|---|---|---|---|---|---|---|
| None | 1 exacerbation | 2 exacerbations | 3 exacerbations | 4 exacerbations | 5 or more exacerbations | |
| Atrovent + Albuterol Aerosols | 110 | 37 | 5 | 2 | 0 | 0 |
| Combivent Inhalation Aerosol | 113 | 32 | 9 | 0 | 0 | 0 |
| Combivent Respimat | 118 | 27 | 7 | 3 | 1 | 1 |
(NCT01019694)
Timeframe: 48 weeks
| Intervention | participants (Number) | |||
|---|---|---|---|---|
| None | 1 exacerbation | 2 exacerbations | 3 or more exacerbations | |
| Atrovent + Albuterol Aerosols | 146 | 8 | 0 | 0 |
| Combivent Inhalation Aerosol | 148 | 6 | 0 | 0 |
| Combivent Respimat | 147 | 9 | 0 | 1 |
FEV1 (NCT01391559)
Timeframe: 2 hours
| Intervention | mL (Mean) |
|---|---|
| Arformoterol | 84 |
| Salmeterol | 52 |
EDS at isotime (last common time point for an exercise assessment [i.e., last Borg score time point of the shortest exercise test for each participant]) was assessed using a 10-point modified Borg scale. Change from Baseline in EDS at isotime was calculated as the value at Week 8 minus the value at Baseline. (NCT01124422)
Timeframe: Baseline (Week 3) and Week 8
| Intervention | Scores on a scale (Mean) |
|---|---|
| TIO+Placebo | -0.3 |
| TIO+FSC | -0.5 |
The EIC was measured at 2 to 3.5 minutes during the exercise period. Change from Baseline in EIC was calculated as the value at Week 8 minus the value at Baseline. (NCT01124422)
Timeframe: Baseline (Week 3) and Week 8
| Intervention | mL (Mean) |
|---|---|
| TIO+Placebo | -148.3 |
| TIO+FSC | 200 |
EET is defined as the time taken by a participant to exert himself during an exercise. EET was calculated based on the Endurance Shuttle Walk test (ESWT). The ESWT is a standardized, externally controlled, constant-paced field test for the assessment of endurance capacity in participants with chronic lung disease. Change from Baseline in EET was calculated as the value at Week 8 minus the value at Baseline. (NCT01124422)
Timeframe: Baseline (Week 3) and Week 8
| Intervention | Seconds (sec) (Mean) |
|---|---|
| TIO+Placebo | 23.3 |
| TIO+FSC | 6.0 |
EIC is the volume of gas that can be taken into the lungs in a full inhalation during exercise. Participants were asked to undergo the IC test every 2 minutes during exercise and at the end of the exercise, to follow changes in operational lung volumes that occured in association with exercise. Change from Baseline in EIC was calculated as the value at the end of exercise at Week 8 minus the value at the end of exercise at Baseline. (NCT01124422)
Timeframe: Baseline (Week 3) and Week 8
| Intervention | mL (Mean) |
|---|---|
| TIO+Placebo | -7.4 |
| TIO+FSC | 46.6 |
The amount of CO2 in the hemoglobin of the participants was measured during the ESWT using the OMS. The system consisted of a carbon dioxide sensor and allowed breath-by-breath measurement of pulmonary gas exchange parameters. The V'CO2 per time slope was calculated for each participant by fitting a linear regression line to the V'CO2 recorded for each participant during the ESWT. V'CO2 per time slope results were compared between treatment groups as means of these regression lines. Change from Baseline in V'CO2 per time slope was calculated as the value at Week 8 minus the value at Baseline. (NCT01124422)
Timeframe: Baseline (Week 3) and Week 8
| Intervention | mL/min (Mean) |
|---|---|
| TIO+Placebo | -17.4 |
| TIO+FSC | -0.7 |
The V'O2 was measured during the ESWT using the Oxycon Mobile System (OMS), a portable telemetric monitoring system consisting of an oxygen sensor allowing for breath-by-breath measurement of gas exchange parameters in the lungs. The V'O2 was collected in units of mL and then regressed over the conduct of the exercise test measured in minutes. The V'O2 per time slope was calculated for each participant (par.) by fitting a linear regression line to the V'O2 recorded for each par. during the ESWT. V'O2 per time slope results were compared between treatment groups as means of these regression lin (NCT01124422)
Timeframe: Baseline (Week 3) and Week 8
| Intervention | mL/minute (min) (Mean) |
|---|---|
| TIO+Placebo | -13.3 |
| TIO+FSC | -6.1 |
HR is defined as the number of heartbeats per unit of time, typically expressed as beats per minute (bpm). It was measured during the ESWT using the OMS. The HR was collected in units of bpm and then regressed over the conduct of the exercise test measured in minutes. The HR per time slope was calculated for each participant by fitting a linear regression line to the HR recorded for each participant during the exercise test. HR per time slope results were compared between treatment groups as means of these regression lines. (NCT01124422)
Timeframe: Baseline (Week 3) and Week 8
| Intervention | bpm/min (Mean) |
|---|---|
| TIO+Placebo | -1.1 |
| TIO+FSC | 0.7 |
HR was measured during the course of the ESWT in the non-OMS subgroup using pulse oximetry. The HR per time slope was calculated for each participant by fitting a linear regression line to the HR recorded for each participant during the ESWT. HR per time slope results were compared between treatment groups as means of these regression lines. Change from Baseline in HR was calculated as the value at Week 8 minus the value at Baseline. (NCT01124422)
Timeframe: Baseline (Week 3) and Week 8
| Intervention | bpm/min (Mean) |
|---|---|
| TIO+Placebo | -0.8 |
| TIO+FSC | -0.6 |
The V'E was measured in the participants during the ESWT using the OMS. The system consisted of a volume transducer, oxygen sensor, and carbon dioxide sensor and allowed breath-by-breath measurement of pulmonary gas exchange parameters. The V'E was collected in liters and then regressed over the conduct of the exercise test measured in minutes. The V'E per time slope was calculated for each participant by fitting a linear regression line to the V'E recorded for each participant during the ESWT. V'E per time slope results were compared between treatment groups as means of the regression lines. (NCT01124422)
Timeframe: Baseline (Week 3) and Week 8
| Intervention | Liter (L)/min (Mean) |
|---|---|
| TIO+Placebo | -0.7 |
| TIO+FSC | -0.2 |
The RR and VT of the participants at isotime were measured during the ESWT using the OMS. The ratio of RR per VT (value of RR divided by value of VT) at isotime was calculated. Change from Baseline in RR/VT at isotime was calculated as the value at Week 8 minus the value at Baseline. (NCT01124422)
Timeframe: Baseline (Week 3) and Week 8
| Intervention | breaths/min/L (Mean) |
|---|---|
| TIO+Placebo | 2.7 |
| TIO+FSC | -2.5 |
The respiratory exchange ratio was calculated as the ratio of VCO2 and VO2. The ratio of the amount of carbon dioxide and oxygen in the hemoglobin of the participants was measured during the ESWT using the OMS. The system consisted of oxygen and carbon dioxide sensors and allowed breath-by-breath measurement of pulmonary gas exchange parameters. Change from Baseline in RER was calculated as the value at Week 8 minus the value at Baseline. (NCT01124422)
Timeframe: Baseline (Week 3) and Week 8
| Intervention | Ratio of VCO2 and VO2 (Mean) |
|---|---|
| TIO+Placebo | -0.01 |
| TIO+FSC | 0.01 |
RR is defined as the number of breaths taken within a set amount of time (typically within 60 secs). The RR of the participants at isotime was measured during the ESWT using the OMS. Change from Baseline in RR at isotime was calculated as the value at Week 8 minus the value at Baseline. (NCT01124422)
Timeframe: Baseline (Week 3) and Week 8
| Intervention | breaths/min (Mean) |
|---|---|
| TIO+Placebo | 0.8 |
| TIO+FSC | -0.5 |
RR is defined as the number of breaths taken within a set amount of time (typically within 60 secs). The RR of the participants was measured during the ESWT using the OMS. The system consisted of volume transducer oxygen and carbon dioxide sensors and allowed breath-by-breath measurement of pulmonary gas exchange parameters. The RR per time slope was calculated for each participant by fitting a linear regression line to the RR recorded for each participant during the ESWT. RR per time slope results were compared between treatment groups as means of these regression lines. (NCT01124422)
Timeframe: Baseline (Week 3) and Week 8
| Intervention | breaths/min/min (Mean) |
|---|---|
| TIO+Placebo | -0.1 |
| TIO+FSC | -0.5 |
EDS is used to measure the level of breathlessness due to exercise, assessed using a 10-point modified Borg scale at 2-minute intervals during the ESWT: 0=no difficulty in breathing at all, 10=maximal breathing difficulty (BD). The participant pointed to the level on the scale correlating with his BD, and the local study coordinator confirmed that level verbally to him. Change from Baseline was calculated as the value at Week 8 minus the value at Baseline. A dyspnea score/time slope was calculated by fitting a linear regression line to the dyspnea scores reported during the exercise tests. (NCT01124422)
Timeframe: Baseline (Week 3) and Week 8
| Intervention | Scores on a scale/minute (Mean) |
|---|---|
| TIO+Placebo | -0.1 |
| TIO+FSC | -0.06 |
VT is defined as the lung volume representing the normal volume of air displaced between normal inspiration and expiration when extra effort is not applied. The normal value is approximately 500 mL or 7 mL/kg body weight. The VT of the participants at isotime was measured during the ESWT using the OMS. Change from Baseline in VT at isotime was calculated as the value at Week 8 minus the value at Baseline. (NCT01124422)
Timeframe: Baseline (Week 3) and Week 8
| Intervention | L (Mean) |
|---|---|
| TIO+Placebo | -0.10 |
| TIO+FSC | 0.08 |
VT is the lung volume representing the normal volume of air displaced between normal inspiration and expiration when extra effort is not applied (normal value is approximately 500 mL or 7 mL/kg body weight). VT was measured during the ESWT using the OMS, consisting of volume transducer O2 and CO2 sensors and allowing breath-by-breath measurement of pulmonary gas exchange parameters. The participant's VT per time slope was calculated by fitting a linear regression line (RL) to their VT during the ESWT. VT per time slope results were compared between treatment groups as means of these RLs. (NCT01124422)
Timeframe: Baseline (Week 3) and Week 8
| Intervention | L/min (Mean) |
|---|---|
| TIO+Placebo | -0.02 |
| TIO+FSC | 0 |
The BDI-TDI is a multidimensional dyspnea measurement. The BDI, administered at Week 4, consisted of 3 items (functional impairment, magnitude of task in exertional capacity, and magnitude of effort) requiring recall over the previous 4 weeks. BDI scores ranged from 0 (very severe impairment) to 4 (no impairment); the summed total score = 0 to 12. The TDI, administered at Week 8 as a follow-up of the BDI, consisted of the same 3 items requiring recall over the previous 4 weeks. TDI scores ranged from -3 (major deterioration) to +3 (major improvement); the summed total score = -9 to 9. (NCT01124422)
Timeframe: BDI: Week 4; TDI: Week 8
| Intervention | Scores on a scale (Mean) | |
|---|---|---|
| BDI; n=130; 122 | TDI; n=121, 115 | |
| TIO+FSC | 6.9 | 1.4 |
| TIO+Placebo | 6.7 | 1.1 |
Resting IC is the volume of gas that can be taken into the lungs in a full inhalation at the resting position. The resting IC was measured before and after dosing. Change from Baseline in pre-dose resting IC was calculated as the pre-dose value at Week 8 minus the pre-dose value at Week 4. Change from Baseline in post-dose resting IC was calculated as the post-dose value at Week 8 minus the pre-dose value at Week 4. (NCT01124422)
Timeframe: Baseline (Week 4) and Week 8
| Intervention | Milliliters (mL) (Mean) | |
|---|---|---|
| Pre-dose | Post-dose | |
| TIO+FSC | 60 | 167 |
| TIO+Placebo | -29 | 73 |
The CRQ-SAS, a self-administered tool used to assess health-related quality-of-life (HRQOL), consists of 20 questions (q.) in 4 domains: Dyspnea (5 q.), Fatigue (4 q.), Emotional Function (7 q.), and Mastery (4 q.). Participants rated their experience on a 7-point scale in response to each q.: 1 (maximum impairment) to 7 (no impairment); higher scores indicate better HRQOL. Individual q. were equally weighted, and domain scores (range=1-7) were calculated as the mean across the non-missing items within each domain (domain scores were calculated although an individual item score was missing). (NCT01124422)
Timeframe: Week 4 and Week 8
| Intervention | Scores on a scale (Mean) | |||
|---|---|---|---|---|
| Mastery Score | Fatigue Score | Emotional Function Score | Dyspnea Score | |
| TIO+FSC | 0.09 | 0.26 | 0.13 | 0.32 |
| TIO+Placebo | 0.07 | 0.11 | 0.10 | 0.21 |
The electrocardiogram (ECG) of the participants was taken, and the maximum and weighted mean of QTc(B) and QTc(F) was measured. Weighted mean was calculated by using all values of QTc(B) and QTc(F) at the indicated timepoint contributing to the calculation of the mean but with different weightage. The ECG helps in the assessment of the condition of the heart. The QT interval gives the measure of the heart rate, and the cQT interval gives the corrected value. (NCT01494610)
Timeframe: At pre-morning dose; 15, 30, 60, 90 minutes post-dose (PD); and 2, 3 and 4 hours PD on Day 10 of each study period (P): Study Day (SD) 10 (reference day is SD 1 or Randomization day), 20, 30, and 40 (+/-1) for P 1, 2, 3, and 4, respectively
| Intervention | Milliseconds (msec) (Mean) | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Max, QTc(B) interval, Asthma + COPD; n=57, 57 | Max, QTc(B) interval, Asthma; n=33, 33 | Max, QTc(B) interval, COPD; n=24, 24 | Weighted mean QTc(B), Asthma + COPD; n=57, 57 | Weighted mean QTc(B), Asthma; n=33, 33 | Weighted mean QTc(B), COPD; n=24, 24 | Max QTc(F), Asthma + COPD; n=57, 57 | Max QTc(F), Asthma; n=33, 33 | Max QTc(F), COPD; n=24, 24 | Weighted mean QTc(F), Asthma + COPD; n=57, 57 | Weighted mean QTc(F), Asthma; n=33, 33 | Weighted mean QTc(F), COPD; n=24, 24 | |
| FP/Salmeterol From Capsule-based Inhaler | 434.4 | 424.7 | 447.6 | 416.8 | 406.3 | 431.3 | 422.6 | 413.7 | 434.9 | 410.1 | 401.3 | 422.3 |
| FP/Salmeterol From MDPI | 434.0 | 423.7 | 448.1 | 416.8 | 405.7 | 431.9 | 422.5 | 413.5 | 434.9 | 410.3 | 401.2 | 422.9 |
"The timing of the first and second administrations depended on the randomization schedule. If the treatment sequence received was ABBA, then Days 10 and 40, respectively, correspond to the first and second administrations for treatment A." (NCT01494610)
Timeframe: Day 10 of each study period (P): Study Day (SD) 10 (reference day is SD 1 or Randomization day), 20, 30, and 40 (+/-1) for P 1, 2, 3, and 4, respectively
| Intervention | g/L (Mean) | |||||||
|---|---|---|---|---|---|---|---|---|
| Albumin, 1st admin, Asthma; n=33, 33 | Albumin, 2nd admin, Asthma; n=31, 33 | Albumin, 1st admin, COPD; n=25, 25 | Albumin, 2nd admin, COPD; n=25, 25 | Total protein, 1st admin, Asthma; n=33, 33 | Total protein, 2nd admin, Asthma; n=31, 33 | Total protein, 1st admin, COPD; n=25, 25 | Total protein, 2nd admin, COPD; n=25, 25 | |
| FP/Salmeterol From Capsule-based Inhaler | 42.3 | 41.8 | 41.4 | 40.0 | 66.0 | 64.8 | 64.9 | 63.5 |
| FP/Salmeterol From MDPI | 43.0 | 42.0 | 40.9 | 40.8 | 66.8 | 65.4 | 64.7 | 64.6 |
"Blood samples of participants were collected for the evaluation of AP, ALT, AST, and GGT. All of these parameters are measured to help assess the condition of the liver. The timing of the first and second administrations depended on the randomization schedule. If the treatment sequence received was ABBA, then Days 10 and 40, respectively, correspond to the first and second administrations for treatment A." (NCT01494610)
Timeframe: Day 10 of each study period (P): Study Day (SD) 10 (reference day is SD 1 or Randomization day), 20, 30, and 40 (+/-1) for P 1, 2, 3, and 4, respectively
| Intervention | International units per liter (IU/L) (Mean) | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| AP, 1st admin, Asthma; n=33, 33 | AP, 2nd admin, Asthma; n=31, 33 | AP, 1st admin, COP ; n=25, 25 | AP, 2nd admin, COPD; n=25, 25 | ALT, 1st admin, Asthma; n=33, 33 | ALT, 2nd admin, Asthma; n=31, 33 | ALT, 1st admin, COPD; n=25, 25 | ALT, 2nd admin, COPD; n=25, 25 | AST, 1st admin, Asthma; n=33, 33 | AST, 2nd admin, Asthma; n=31, 33 | AST, 1st admin, COPD; n=25, 25 | AST, 2nd admin, COPD; n=25, 25 | GGT, 1st admin, Asthma; n=33, 33 | GGT, 2nd admin, Asthma; n=31, 33 | GGT, 1st admin, COPD; n=25, 25 | GGT, 2nd admin, COPD; n=25, 25 | |
| FP/Salmeterol From Capsule-based Inhaler | 63.4 | 63.9 | 69.9 | 68.4 | 20.4 | 19.1 | 23.4 | 21.2 | 21.6 | 20.1 | 24.7 | 21.1 | 21.0 | 21.0 | 44.0 | 29.6 |
| FP/Salmeterol From MDPI | 64.6 | 65.0 | 69.6 | 69.8 | 20.1 | 21.5 | 21.2 | 20.9 | 21.2 | 20.7 | 22.7 | 22.5 | 21.3 | 22.7 | 36.9 | 31.8 |
Blood samples of participants (par.) with asthma and chronic obstructive pulmonary disease (COPD) were collected and analyzed for AUC(0-tau), a measure of the amount of drug available at target tissue (in plasma) for a fixed dosing interval (12 hours). Asthma is a disorder that causes the airways of the lungs to swell and narrow, leading to difficulty in breathing. COPD is a chronic lung disease with structural changes in lungs, leading to difficulty in breathing. (NCT01494610)
Timeframe: At pre-morning dose; 5, 10, 30 minutes post-dose (PD); and 1, 2, 4, 8, 10, and 12 hours PD on Day 10 of each study period (P): Study Day (SD) 10 (reference day is SD 1 or Randomization day), 20, 30, and 40 (+/-1) for P 1, 2, 3, and 4, respectively
| Intervention | Picogram hours per milliliter (pg*h/mL) (Geometric Mean) | ||
|---|---|---|---|
| Asthma + COPD; n=57, 57 | Asthma; n=33, 33 | COPD; n=24, 24 | |
| FP/Salmeterol From Capsule-based Inhaler | 573.1 | 559.1 | 593.0 |
| FP/Salmeterol From MDPI | 376.9 | 350.5 | 416.4 |
Blood samples of participants with asthma and COPD were collected and analyzed for AUC(0-tlast). AUC(0-tlast) is a measure of the plasma drug concentration from pre-dose to the last measurable concentration. (NCT01494610)
Timeframe: At pre-morning dose; 5, 10, 30 minutes post-dose (PD); and 1, 2, 4, 8, 10, and 12 hours PD on Day 10 of each study period (P): Study Day (SD) 10 (reference day is SD 1 or Randomization day), 20, 30, and 40 (+/-1) for P 1, 2, 3, and 4, respectively
| Intervention | pg*h/mL (Geometric Mean) | ||
|---|---|---|---|
| Asthma + COPD; n=57, 57 | Asthma; n=33, 33 | COPD; n=24, 24 | |
| FP/Salmeterol From Capsule-based Inhaler | 580.9 | 558.4 | 613.2 |
| FP/Salmeterol From MDPI | 380.1 | 355.7 | 416.5 |
"Blood samples of participants were collected for the evaluation of basophils, eosinophils, lymphocytes, monocytes, total neutrophils, platelet count, and WBC count. Data are reported for the first (1st) and second (2nd) administration (admin) of FP/salmeterol via MDPI or capsule-based inhaler. The timing of the first and second administrations depended on the randomization schedule. If the treatment sequence received was ABBA, then Days 10 and 40, respectively, correspond to the first and second administrations for treatment A." (NCT01494610)
Timeframe: Day 10 of each study period (P): Study Day (SD) 10 (reference day is SD 1 or Randomization day), 20, 30, and 40 (+/-1) for P 1, 2, 3, and 4, respectively
| Intervention | Giga (10^9) cells/L (Mean) | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Basophils, 1st admin, Asthma; n=33, 33 | Basophils, 2nd admin, Asthma; n=31, 33 | Basophils, 1st admin, COPD; n=25, 25 | Basophils, 2nd admin, COPD; n=24, 25 | Eosinophils, 1st admin, Asthma; n=33, 33 | Eosinophils, 2nd admin, Asthma; n=31, 33 | Eosinophils, 1st admin, COPD; n=25, 25 | Eosinophils, 2nd admin, COPD; n=24, 25 | Lymphocytes, 1st admin, Asthma; n=33, 33 | Lymphocytes, 2nd admin, Asthma; n=31,33 | Lymphocytes, 1st admin, COPD; n=25, 25 | Lymphocytes, 2nd admin, COPD; n=24, 25 | Monocytes, 1st admin, Asthma; n=33, 33 | Monocytes, 2nd admin, Asthma; n=31, 33 | Monocytes, 1st admin, COPD; n=25, 25 | Monocytes, 2nd admin, COPD; n=24, 25 | TN, 1st admin, Asthma; n=33, 33 | TN, 2nd admin, Asthma; n=31, 33 | TN, 1st admin, COPD; n=25, 25 | TN, 2nd admin, COPD; n=24, 25 | Platelet count, 1st admin, Asthma; n=33, 33 | Platelet count, 2nd admin, Asthma; n=31, 33 | Platelet count, 1st admin, COPD; n=24, 24 | Platelet count, 2nd admin, COPD; n=23, 24 | WBC count, 1st admin, Asthma; n=33, 33 | WBC count, 2nd admin, Asthma; n=31, 33 | WBC count, 1st admin, COPD; n=25, 25 | WBC count, 2nd admin, COPD; n=24, 25 | |
| FP/Salmeterol From Capsule-based Inhaler | 0.06 | 0.04 | 0.04 | 0.04 | 0.33 | 0.31 | 0.23 | 0.26 | 1.92 | 1.86 | 1.72 | 1.68 | 0.55 | 0.52 | 0.60 | 0.63 | 3.37 | 3.28 | 3.48 | 3.75 | 223.9 | 230.8 | 226.6 | 240.1 | 6.182 | 5.976 | 6.036 | 6.312 |
| FP/Salmeterol From MDPI | 0.05 | 0.04 | 0.07 | 0.04 | 0.37 | 0.31 | 0.25 | 0.25 | 1.96 | 1.90 | 1.70 | 1.75 | 0.54 | 0.54 | 0.64 | 0.63 | 3.28 | 3.30 | 3.70 | 3.45 | 225.1 | 230.7 | 230.6 | 235.1 | 6.145 | 6.071 | 6.340 | 6.092 |
"Blood samples of participants were collected for the evaluation of calcium, chloride, glucose, potassium, sodium, carbon dioxide (CO2) content/bicarbonate, and urea/BUN. All of these parameters are measured to help assess the condition of the kidneys. The timing of the first and second administrations depended on the randomization schedule. If the treatment sequence received was ABBA, then Days 10 and 40, respectively, correspond to the first and second administrations for treatment A." (NCT01494610)
Timeframe: Day 10 of each study period (P): Study Day (SD) 10 (reference day is SD 1 or Randomization day), 20, 30, and 40 (+/-1) for P 1, 2, 3, and 4, respectively
| Intervention | µmol/L (Mean) | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Calcium, 1st admin, Asthma; n=33, 32 | Calcium, 2nd admin, Asthma; n=31, 33 | Calcium, 1st admin, COPD; n=25, 25 | Calcium, 2nd admin, COPD; n=25, 25 | Chloride, 1st admin, Asthma; n=33, 33 | Chloride, 2nd admin, Asthma; n=31, 33 | Chloride, 1st admin, COP; n=25, 25 | Chloride, 2nd admin, COPD n=25, 25 | Glucose, 1st admin, Asthma; n=33, 33 | Glucose, 2nd admin, Asthma; n=31, 33 | Glucose, 1st admin, COPD; n=25, 25 | Glucose, 2nd admin, COPD; n=25, 25 | Potassium, 1st admin, Asthma; n=32, 33 | Potassium, 2nd admin, Asthma; n=31, 33 | Potassium, 1st admin, COPD n=25, 25 | Potassium, 2nd admin, COPD; n=25, 25 | Sodium, 1st admin, Asthma; n=33, 33 | Sodium, 2nd admin, Asthma; n=31, 33 | Sodium, 1st admin, COPD n=25, 25 | Sodium, 2nd admin, COPD n=25, 25 | CO2 content/bicar, 1st admin, Asthma; n=33, 33 | CO2 content/bicar, 2nd admin, Asthma; n=31, 33 | CO2 content/bicar, 1st admin, COPD; n=25, 25 | CO2 content/bicar, 2nd admin, COPD; n=25, 25 | Urea/BUN, 1st admin, Asthma; n=33, 33 | Urea/BUN, 2nd admin, Asthma; n=31, 33 | Urea/BUN, 1st admin, COPD; n=25, 25 | Urea/BUN, 2nd admin, COPD; n=25, 25 | |
| FP/Salmeterol From Capsule-based Inhaler | 2.178 | 2.170 | 2.189 | 2.190 | 104.8 | 105.3 | 104.0 | 104.4 | 5.06 | 5.15 | 5.37 | 5.45 | 4.05 | 4.02 | 4.08 | 4.11 | 140.5 | 140.4 | 140.5 | 140.2 | 25.6 | 26.0 | 27.3 | 27.2 | 5.41 | 5.43 | 6.09 | 6.12 |
| FP/Salmeterol From MDPI | 2.191 | 2.190 | 2.205 | 2.206 | 104.7 | 104.5 | 104.4 | 104.1 | 5.06 | 5.06 | 5.36 | 5.63 | 4.15 | 4.06 | 4.16 | 4.10 | 140.5 | 140.1 | 140.5 | 140.1 | 26.1 | 26.2 | 27.2 | 27.3 | 5.34 | 5.31 | 5.98 | 5.90 |
"Blood samples of participants were collected for the evaluation of MCV. MCV is a measure of the average red blood cell size that is reported as part of a standard complete blood count. The timing of the first and second administrations depended on the randomization schedule. If the treatment sequence received was ABBA, then Days 10 and 40, respectively, correspond to the first and second administrations for treatment A." (NCT01494610)
Timeframe: Day 10 of each study period (P): Study Day (SD) 10 (reference day is SD 1 or Randomization day), 20, 30, and 40 (+/-1) for P 1, 2, 3, and 4, respectively
| Intervention | Femtoliters (fL; 10^-15 L)/cell (Mean) | |||
|---|---|---|---|---|
| 1st admin, Asthma; n=33, 33 | 2nd admin, Asthma; n=31, 33 | 1st admin, COPD; n=25, 25 | 2nd admin, COPD; n=24, 25 | |
| FP/Salmeterol From Capsule-based Inhaler | 89.41 | 89.77 | 90.37 | 90.64 |
| FP/Salmeterol From MDPI | 89.65 | 89.52 | 90.21 | 90.76 |
"Blood samples of participants were collected for the evaluation of MCH. MCH is the average mass or amount of hemoglobin per red blood cell in a sample of blood. The timing of the first and second administrations depended on the randomization schedule. If the treatment sequence received was ABBA, then Days 10 and 40, respectively, correspond to the first and second administrations for treatment A." (NCT01494610)
Timeframe: Day 10 of each study period (P): Study Day (SD) 10 (reference day is SD 1 or Randomization day), 20, 30, and 40 (+/-1) for P 1, 2, 3, and 4, respectively
| Intervention | picograms (pg)/cell (Mean) | |||
|---|---|---|---|---|
| 1st admin, Asthma; n=33, 33 | 2nd admin, Asthma; n=31, 33 | 1st admin, COPD; n=25, 25 | 2nd admin, COPD; n=24, 25 | |
| FP/Salmeterol From Capsule-based Inhaler | 29.86 | 29.92 | 29.72 | 29.83 |
| FP/Salmeterol From MDPI | 29.99 | 29.80 | 29.72 | 29.73 |
"Blood samples of participants were collected for the evaluation of DP, TB, creatinine, and uric acid. DB and TB are measures that help assess the condition of the liver, and creatinine and uric acid are measures that help assess the condition of the kidneys. The timing of the first and second administrations depended on the randomization schedule. If the treatment sequence received was ABBA, then Days 10 and 40, respectively, correspond to the first and second administrations for treatment A." (NCT01494610)
Timeframe: Day 10 of each study period (P): Study Day (SD) 10 (reference day is SD 1 or Randomization day), 20, 30, and 40 (+/-1) for P 1, 2, 3, and 4, respectively
| Intervention | Micromoles per liter (µmol/L) (Mean) | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| DB, 1st admin, Asthma; n=33, 33 | DB, 2nd admin, Asthma; n=31, 33 | DB, 1st admin, COPD; n=25, 25 | DB, 2nd admin, COPD; n=25, 25 | TB, 1st admin, Asthma; n=33, 33 | TB, 2nd admin, Asthma; n=31, 33 | TB, 1st admin, COPD; n=25, 25 | TB, 2nd admin, COPD; n=25, 25 | Creatinine, 1st admin, Asthma; n=33, 33 | Creatinine, 2nd admin, Asthma; n=31, 33 | Creatinine, 1st admin, COPD; n=25, 25 | Creatinine, 2nd admin, COPD; n=25, 25 | Uric acid, 1st admin, Asthma n=33, 33 | Uric acid, 2nd admin, Asthma; n=31, 33 | Uric acid, 1st admin, COPD; n=25, 25 | Uric acid, 2nd admin, COPD; n=25, 25 | |
| FP/Salmeterol From Capsule-based Inhaler | 2.7 | 2.6 | 2.8 | 2.9 | 9.9 | 8.6 | 9.4 | 8.4 | 75.8 | 75.2 | 77.7 | 79.4 | 331.5 | 325.6 | 348.3 | 352.0 |
| FP/Salmeterol From MDPI | 3.2 | 3.0 | 2.9 | 2.7 | 9.5 | 9.9 | 8.7 | 8.5 | 77.2 | 76.9 | 79.4 | 79.6 | 328.9 | 338.4 | 354.2 | 361.7 |
"Blood samples of participants were collected for the evaluation of hematocrit. The hematocrit is the percentage of the RBCs in the blood. The timing of the first and second administrations depended on the randomization schedule. If the treatment sequence received was ABBA, then Days 10 and 40, respectively, correspond to the first and second administrations for treatment A." (NCT01494610)
Timeframe: Day 10 of each study period (P): Study Day (SD) 10 (reference day is SD 1 or Randomization day), 20, 30, and 40 (+/-1) for P 1, 2, 3, and 4, respectively
| Intervention | percentage of RBCs (Mean) | |||
|---|---|---|---|---|
| 1st admin, Asthma; n=33, 33 | 2nd admin, Asthma; n=31, 33 | 1st admin, COPD; n=25, 25 | 2nd admin, COPD; n=24, 25 | |
| FP/Salmeterol From Capsule-based Inhaler | 0.405 | 0.396 | 0.405 | 0.391 |
| FP/Salmeterol From MDPI | 0.413 | 0.399 | 0.405 | 0.400 |
"Blood samples of participants were collected for the evaluation of mean hemoglobin (mean level of hemoglobin in the whole blood sample) and MCH concentration. The MCH concentration is the average concentration of hemoglobin in a red blood cell. Hemoglobin is the red pigment in the blood, and it is reponsible for carrying oxygen. The timing of the first and second administrations depended on the randomization schedule. If the treatment sequence received was ABBA, then Days 10 and 40, respectively, correspond to the first and second administrations for treatment A." (NCT01494610)
Timeframe: Day 10 of each study period (P): Study Day (SD) 10 (reference day is SD 1 or Randomization day), 20, 30, and 40 (+/-1) for P 1, 2, 3, and 4, respectively
| Intervention | Grams per liter (g/L) (Mean) | |||||||
|---|---|---|---|---|---|---|---|---|
| Hemoglobin, 1st admin, Asthma; n=33, 33 | Hemoglobin, 2nd admin, Asthma; n=31, 33 | Hemoglobin, 1st admin, COPD; n=25, 25 | Hemoglobin, 2nd admin, COPD; n=24, 25 | MCH concentration, 1st admin, Asthma; n=33, 33 | MCH concentration, 2nd admin, Asthma; n=31, 33 | MCH concentration, 1st admin, COPD; n=,25, 25 | MCH concentration, 1st admin, COPD; n=24, 25 | |
| FP/Salmeterol From Capsule-based Inhaler | 135.4 | 132.3 | 133.1 | 128.5 | 334.0 | 333.2 | 328.5 | 328.8 |
| FP/Salmeterol From MDPI | 138.2 | 133.0 | 133.3 | 130.6 | 334.7 | 333.0 | 329.0 | 327.4 |
Blood samples of participants with asthma and COPD were collected and analyzed for Cmax and Cmin of Salmeterol in the blood. Cmax and Cmin are used to estimate the time at which the activity of the drug will be at its maximum and minimum. (NCT01494610)
Timeframe: At pre-morning dose; 5, 10, 30 minutes post-dose (PD); and 1, 2, 4, 8, 10, and 12 hours PD on Day 10 of each study period (P): Study Day (SD) 10 (reference day is SD 1 or Randomization day), 20, 30, and 40 (+/-1) for P 1, 2, 3, and 4, respectively
| Intervention | pg/mL (Geometric Mean) | |||||
|---|---|---|---|---|---|---|
| Cmax, Asthma + COPD; n=57, 57 | Cmax, Asthma; n=33, 33 | Cmax, COPD; n=24, 24 | Cmin, Asthma + COPD; n=57, 57 | Cmin, Asthma; n=33, 33 | Cmin, COPD; n=24, 24 | |
| FP/Salmeterol From Capsule-based Inhaler | 92.27 | 110.21 | 72.27 | 14.354 | 14.634 | 13.978 |
| FP/Salmeterol From MDPI | 59.28 | 64.97 | 52.26 | 12.752 | 12.676 | 12.857 |
Blood samples of participants with asthma and COPD were collected and analyzed for Cmax and Cmin of FP in the blood. Cmax and Cmin are used to estimate the time at which the activity of the drug will be at its maximum and minimum, respectively. (NCT01494610)
Timeframe: At pre-morning dose; 5, 10, 30 minutes post-dose (PD); and 1, 2, 4, 8, 10, and 12 hours PD on Day 10 of each study period (P): Study Day (SD) 10 (reference day is SD 1 or Randomization day), 20, 30, and 40 (+/-1) for P 1, 2, 3, and 4, respectively
| Intervention | Picograms per milliliter (pg/mL) (Geometric Mean) | |||||
|---|---|---|---|---|---|---|
| Cmax, Asthma + COPD; n= 57, 57 | Cmax, Asthma; n=33, 33 | Cmax, COPD; n=24, 24 | Cmin, Asthma + COPD; n=57, 57 | Cmin, Asthma; n=33, 33 | Cmin, COPD; n=24, 24 | |
| FP/Salmeterol From Capsule-based Inhaler | 105.79 | 109.98 | 100.29 | 21.547 | 18.866 | 25.866 |
| FP/Salmeterol From MDPI | 54.64 | 53.66 | 56.02 | 15.904 | 13.635 | 19.654 |
The maximum observed value of heart rate was measured from the time of the morning dose on Day 10 to 4 hours post dose. (NCT01494610)
Timeframe: At pre-morning dose; 15, 30, 60, 90 minutes post-dose (PD); and 2, 4, 8, 10, and 12 hours PD on Day 10 of each study period (P): Study Day (SD) 10 (reference day is SD 1 or Randomization day), 20, 30, and 40 (+/-1) for P 1, 2, 3, and 4, respectively
| Intervention | bpm (Mean) | ||
|---|---|---|---|
| Asthma + COPD; n=57, 57 | Asthma; n=33, 33 | COPD; n=24, 24 | |
| FP/Salmeterol From Capsule-based Inhaler | 74.3 | 73.5 | 75.4 |
| FP/Salmeterol From MDPI | 73.0 | 72.3 | 74.0 |
Blood samples of participants with asthma and COPD were collected and analyzed for AUC(0-tau) and AUC(0-tlast). AUC(0-tau) is a measure of the amount of drug available at target tissue (in plasma) for a fixed dosing interval (12 hours). AUC(0-tlast) is a measure of the plasma drug concentration from pre-dose to the last measurable concentration. (NCT01494610)
Timeframe: At pre-morning dose; 5, 10, 30 minutes post-dose (PD); and 1, 2, 4, 8, 10, and 12 hours PD on Day 10 of each study period (P): Study Day (SD) 10 (reference day is SD 1 or Randomization day), 20, 30, and 40 (+/-1) for P 1, 2, 3, and 4, respectively
| Intervention | pg*h/mL (Geometric Mean) | |||||
|---|---|---|---|---|---|---|
| AUC(0-tau), asthma + COPD; n=57, 57 | AUC(0-tau), asthma; n=33, 33 | AUC(0-tau), COPD; n=24, 24 | AUC(0-t), asthma + COPD; n=57, 57 | AUC(0-t), asthma; n=33, 33 | AUC(0-t), COPD; n=24, 24 | |
| FP/Salmeterol From Capsule-based Inhaler | 345.1 | 356.4 | 330.1 | 345.0 | 356.4 | 330.0 |
| FP/Salmeterol From MDPI | 300.2 | 305.8 | 292.7 | 303.5 | 305.2 | 301.2 |
Blood samples of participants were collected for evaluating t1/2. The t1/2 is the time required for the plasma/blood concentration of the drug to decrease by 50% after the false equilibrium of distribution has been reached. (NCT01494610)
Timeframe: At pre-morning dose; 5, 10, 30 minutes post-dose (PD); and 1, 2, 4, 8, 10, and 12 hours PD on Day 10 of each study period (P): Study Day (SD) 10 (reference day is SD 1 or Randomization day), 20, 30, and 40 (+/-1) for P 1, 2, 3, and 4, respectively
| Intervention | hours (Geometric Mean) | ||
|---|---|---|---|
| Asthma + COPD; n=54, 55 | Asthma; n=30, 32 | COPD; n=24, 23 | |
| FP/Salmeterol From Capsule-based Inhaler | 5.844 | 5.238 | 6.806 |
| FP/Salmeterol From MDPI | 6.660 | 5.906 | 7.740 |
Blood samples of participants were collected for evaluating t1/2. t1/2 is the time required for the plasma/blood concentration of the drug to decrease by 50% after the false equilibrium of distribution has been reached. (NCT01494610)
Timeframe: At pre-morning dose; 5, 10, 30 minutes post-dose (PD); and 1, 2, 4, 8, 10, and 12 hours PD on Day 10 of each study period (P): Study Day (SD) 10 (reference day is SD 1 or Randomization day), 20, 30, and 40 (+/-1) for P 1, 2, 3, and 4, respectively
| Intervention | hours (Geometric Mean) | ||
|---|---|---|---|
| Asthma + COPD; n=56, 56 | Asthma; n=32, 32 | COPD; n=24, 24 | |
| FP/Salmeterol From Capsule-based Inhaler | 7.260 | 7.538 | 6.905 |
| FP/Salmeterol From MDPI | 6.576 | 6.429 | 6.776 |
Urine samples of participants were collected to evaluate urine cortisol excretion over 0-24 hours post treatment dose. A 24-hour urine cortisol sample was used to measure the total amount of cortisol excreted in urine in 24 hours. Any differences in systemic exposure as a result of the absorbed steroid component of the two differing inhaled devices should also result in differences in the amount of cortisol excreted in the urine. (NCT01494610)
Timeframe: 0-24 hours post dose on Day 10 of each study period (P): Study Day (SD) 10 (reference day is SD 1 or Randomization day), 20, 30, and 40 (+/-1) for P 1, 2, 3, and 4, respectively
| Intervention | nmol (Geometric Mean) | ||
|---|---|---|---|
| Asthma + COPD; n=57, 57 | Asthma; n=33, 33 | COPD; n=24, 24 | |
| FP/Salmeterol From Capsule-based Inhaler | 59.66 | 66.28 | 51.62 |
| FP/Salmeterol From MDPI | 63.53 | 72.86 | 52.62 |
The diastolic and systolic blood pressure of the participants was measured. The maximum and minimum observed values from the time of the morning dose on Day 10 to 4 hours post dose were measured for SBP and DBP. The weighted mean value from the time of the morning dose on Day 10 to 4 hours post dose was calculated. Weighted mean was calculated by using all values of DBP and SBP at the indicated timepoint contributing to the calculation of the mean but with different weightage. (NCT01494610)
Timeframe: At pre-morning dose; 15, 30, 60, 90 minutes post-dose (PD); and 2, 4, 8, 10, and 12 hours PD on Day 10 of each study period (P): Study Day (SD) 10 (reference day is SD 1 or Randomization day), 20, 30, and 40 (+/-1) for P 1, 2, 3, and 4, respectively
| Intervention | millimeters of mercury (mmHg) (Mean) | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| DBP, Asthma + COPD; n=57, 57 | DBP, Asthma; n=33, 33 | DBP, COPD; n=24, 24 | Weighted mean DBP, Asthma + COPD; n=57, 57 | Weighted mean DBP, Asthma; n=33, 33 | Weighted mean DBP, COPD; n=24, 24 | SBP, Asthma + COPD; n=57, 57 | SBP, Asthma; n=33, 33 | SBP, COPD; n=24, 24 | Weighted mean SBP, Asthma + COPD; n=57, 57 | Weighted mean SBP, Asthma; n=33, 33 | Weighted mean SBP, COPD; n=24, 24 | |
| FP/Salmeterol From Capsule-based Inhaler | 66.2 | 62.6 | 71.2 | 72.2 | 68.8 | 77.0 | 129.3 | 122.1 | 139.1 | 120.3 | 114.6 | 128.2 |
| FP/Salmeterol From MDPI | 64.7 | 61.6 | 69.1 | 71.1 | 68.0 | 75.4 | 128.0 | 119.9 | 139.1 | 118.8 | 112.9 | 126.9 |
An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. (NCT01494610)
Timeframe: Randomization (Day 1) up to Follow-up (Days 47-50)
| Intervention | participants (Number) | |||
|---|---|---|---|---|
| 1st admin, Asthma; n=33, 34 | 2nd admin, Asthma; n=31, 33 | 1st admin, COPD; n=26, 25 | 2nd admin, COPD; n=25, 25 | |
| FP/Salmeterol From Capsule-based Inhaler | 13 | 15 | 11 | 11 |
| FP/Salmeterol From MDPI | 13 | 12 | 14 | 9 |
"Blood samples of participants were collected for the evaluation of RBC and reticulocytes count. Reticulocytes are immature red blood cells. Normally, about 1% to 2% of the red blood cells in the blood are reticulocytes. The timing of the first and second administrations depended on the randomization schedule. If the treatment sequence received was ABBA, then Days 10 and 40, respectively, correspond to the first and second administrations for treatment A." (NCT01494610)
Timeframe: Day 10 of each study period (P): Study Day (SD) 10 (reference day is SD 1 or Randomization day), 20, 30, and 40 (+/-1) for P 1, 2, 3, and 4, respectively
| Intervention | Trillion (10^12) cells/L (Mean) | |||||||
|---|---|---|---|---|---|---|---|---|
| RBC, 1st admin, Asthma; n=33, 33 | RBC, 2nd admin, Asthma; n=31, 33 | RBC, 1st admin, Asthma, COPD; n=25, 25 | RBC, 2nd admin, COPD; n=24, 25 | Reticulocytes, 1st admin, Asthma ; n=33, 32 | Reticulocytes, 2nd admin, Asthma; n=31, 33 | Reticulocytes, 1st admin, COPD; n=25, 25 | Reticulocytes, 2nd admin, COPD; n=24, 25 | |
| FP/Salmeterol From Capsule-based Inhaler | 4.542 | 4.424 | 4.530 | 4.358 | 0.050 | 0.050 | 0.054 | 0.061 |
| FP/Salmeterol From MDPI | 4.608 | 4.460 | 4.523 | 4.438 | 0.049 | 0.051 | 0.054 | 0.059 |
Blood samples of participants were collected for the evaluation of minimum serum cortisol. Any differences in systemic exposure as a result of the absorbed steroid component of the two differing inhaled devices should also result in differences in serum cortisol concentrations. (NCT01494610)
Timeframe: Day 10 of each study period (Periods 1-4); Study Day 10 (+/-1) (reference day is Study Day 1 or Randomization day), Period 1; Study Day 20 (+/-1), Period 2; Study Day 30 (+/-1), Period 3; Study Day 40 (+/-1), Period 4
| Intervention | nmol/L (Geometric Mean) | ||
|---|---|---|---|
| Asthma + COPD; n=57, 57 | Asthma; n=33, 33 | COPD; n=24, 24 | |
| FP/Salmeterol From Capsule-based Inhaler | 79.6 | 70.0 | 94.9 |
| FP/Salmeterol From MDPI | 88.6 | 79.8 | 102.4 |
Blood samples of participants were collected for evaluating Tmax. Tmax is a measure of the time required to reach the maximum concentration of the drug. (NCT01494610)
Timeframe: At pre-morning dose; 5, 10, 30 minutes post-dose (PD); and 1, 2, 4, 8, 10, and 12 hours PD on Day 10 of each study period (P): Study Day (SD) 10 (reference day is SD 1 or Randomization day), 20, 30, and 40 (+/-1) for P 1, 2, 3, and 4, respectively
| Intervention | hours (Median) | ||
|---|---|---|---|
| Asthma + COPD; n=57, 57 | Asthma; n=33, 33 | COPD; n=24, 24 | |
| FP/Salmeterol From Capsule-based Inhaler | 0.530 | 0.335 | 0.673 |
| FP/Salmeterol From MDPI | 1.045 | 1.000 | 1.173 |
Blood samples of participants were collected for evaluating Tmax. Tmax is a measure of the time required to reach the maximum concentration of the drug. (NCT01494610)
Timeframe: At pre-morning dose; 5, 10, 30 minutes post-dose (PD); and 1, 2, 4, 8, 10, and 12 hours PD on Day 10 of each study period (P): Study Day (SD) 10 (reference day is SD 1 or Randomization day), 20, 30, and 40 (+/-1) for P 1, 2, 3, and 4, respectively
| Intervention | hours (Median) | ||
|---|---|---|---|
| Asthma + COPD; n=57, 57 | Asthma; n=33, 33 | COPD; n=24, 24 | |
| FP/Salmeterol From Capsule-based Inhaler | 0.080 | 0.080 | 0.080 |
| FP/Salmeterol From MDPI | 0.750 | 0.335 | 1.000 |
Blood samples of participants were collected for the evaluation of weighted mean over 0 to 4 hours post dose and the maximum plasma glucose level. Weighted mean was calculated by using all values of plasma glucose at the indicated timepoint contributing to the calculation of the mean but with different weightage. (NCT01494610)
Timeframe: At pre-morning dose; 30, 60 minutes post-dose (PD); and 2 and 4 hours PD on Day 10 of each study period (P): Study Day (SD) 10 (reference day is SD 1 or Randomization day), 20, 30, and 40 (+/-1) for P 1, 2, 3, and 4, respectively
| Intervention | mmol/L (Mean) | |||||
|---|---|---|---|---|---|---|
| Weighted mean, Asthma + COPD; n=57, 57 | Weighted mean, Asthma; n=33, 33 | Weighted mean, COPD; n=24, 24 | Max, Asthma + COPD; n=57, 57 | Max, Asthma; n=33, 33 | Max, COPD; n=24, 24 | |
| FP/Salmeterol From Capsule-based Inhaler | 5.95 | 5.80 | 6.16 | 7.19 | 6.96 | 7.50 |
| FP/Salmeterol From MDPI | 5.85 | 5.67 | 6.11 | 6.94 | 6.64 | 7.36 |
The heart rate (number of heartbeats per unit of time, typically expressed as beats per minute [bpm]) of the participants was monitored for evaluating the weighted mean over the course of 0 to 4 hours post dose. The Capsule-MDPI difference for heart rate was calculated for each participant, and the weighted mean value from the time of the morning dose on Day 10 to 4 hours post dose was calculated. The weighted mean was calculated by using all values at the indicated timepoint contributing to the calculation of the mean but with different weightage. (NCT01494610)
Timeframe: At pre-morning dose; 15, 30, 60, 90 minutes post-dose (PD); and 2, 4, 8, 10, and 12 hours PD on Day 10 of each study period (P): Study Day (SD) 10 (reference day is SD 1 or Randomization day), 20, 30, and 40 (+/-1) for P 1, 2, 3, and 4, respectively
| Intervention | bpm (Mean) | ||
|---|---|---|---|
| Asthma + COPD; n=57, 57 | Asthma; n=33, 33 | COPD; n=24, 24 | |
| FP/Salmeterol From Capsule-based Inhaler | 66.7 | 65.7 | 68.1 |
| FP/Salmeterol From MDPI | 66.2 | 64.8 | 68.2 |
Blood samples of participants were collected for the evaluation of weighted mean over 0 to 4 hours post dose and the minimum plasma potassium level. Weighted mean was calculated by using all values of plasma potassium at the indicated timepoint contributing to the calculation of the mean but with different weightage. (NCT01494610)
Timeframe: At pre-morning dose; 30, 60 minutes post-dose (PD); and 2 and 4 hours PD on Day 10 of each study period (P): Study Day (SD) 10 (reference day is SD 1 or Randomization day), 20, 30, and 40 (+/-1) for P 1, 2, 3, and 4, respectively
| Intervention | Millimoles per liter (mmol/L) (Mean) | |||||
|---|---|---|---|---|---|---|
| Weighted mean, Asthma + COPD; n=56, 57 | Weighted mean, Asthma; n=32, 33 | Weighted mean, COPD; n=24, 24 | Min, Asthma + COPD; n=57, 57 | Min, Asthma; n=33, 33 | Min, COPD; n=24, 24 | |
| FP/Salmeterol From Capsule-based Inhaler | 4.11 | 4.10 | 4.13 | 3.90 | 3.89 | 3.92 |
| FP/Salmeterol From MDPI | 4.11 | 4.11 | 4.11 | 3.91 | 3.92 | 3.89 |
Participants' blood samples were collected and analyzed for SC levels. Weighted mean SC levels are evaluted as a measure of the degree of cortisol suppression, allowing for the determination of whether differences in systemic exposure to the inhaled steroid component of two devices can be significant enough to result in the differences in the body's ability to release cortisol. Weighted means were derived by calculating the AUC over the 0-12 hour period, using the linear trapezoidal rule (statistical technique used for numerical analysis) and then dividing it by the actual time interval. (NCT01494610)
Timeframe: At pre-morning dose; 30 minutes post-dose (PD); and 1, 2, 4, 8, 10, and 12 hours PD on Day 10 of each study period (P): Study Day (SD) 10 (reference day is SD 1 or Randomization day), 20, 30, and 40 (+/-1) for P 1, 2, 3, and 4, respectively
| Intervention | Nanomoles per liter (nmol/L) (Geometric Mean) | ||
|---|---|---|---|
| Asthma + COPD;n=57, 57 | Asthma; n=33, 33 | COPD; n=24, 24 | |
| FP/Salmeterol From Capsule-based Inhaler | 178.3 | 166.6 | 195.6 |
| FP/Salmeterol From MDPI | 193.5 | 187.3 | 202.4 |
Pulmonary function was measured by forced expiratory volume in one second (FEV1). Trough FEV1 was defined as the 24-hour FEV1 assessment, which was obtained on Day 85. Baseline is defined as the mean of the two assessments made 30 minutes pre-dose and 5 minutes pre-dose on Treatment Day 1.Change from Baseline was calculated as the average of the Day 85 values minus the Baseline value. (NCT01342913)
Timeframe: Baseline and Day 85
| Intervention | Liters (Least Squares Mean) |
|---|---|
| Salmeterol/FP 50/500 µg BID | 0.088 |
| FF/VI 100/25 µg QD | 0.111 |
Pulmonary function was measured by forced expiratory volume in one second (FEV1). The weighted mean was calculated from the pre-dose FEV1 and post-dose FEV1 measurements at 5, 15, 30, and 60 minutes (min) and 2, 4, 6, 8, 12, 13, 14, 16, 20, and 24 hours on Treatment Day 84. Baseline trough FEV1 was the mean of the two assessments made 30 and 5 minutes pre-dose on Treatment Day 1. Change from Baseline was calculated as the average of the Day 84 values minus the Baseline value. (NCT01342913)
Timeframe: Baseline and Day 84
| Intervention | Liters (Least Squares Mean) |
|---|---|
| Salmeterol/FP 50/500 µg BID | 0.108 |
| FF/VI 100/25 µg QD | 0.130 |
Time to onset on Treatment Day 1 is defined as the time to an increase of 100 milliliters (mL) from Baseline in FEV1. Time of onset was calculated over 0 to 4 hours (5 min, 15 min, 30 min, 60 min, 120 min, and 240 min) post-dose. (NCT01342913)
Timeframe: Day 1
| Intervention | Minutes (Median) |
|---|---|
| Salmeterol/FP 50/500 µg BID | 28 |
| FF/VI 100/25 µg QD | 16 |
Percentage of participants managed by TRIPLE therapy was calculated as [(number of participants who switched to TRIPLE therapy) - (number of participants who stepped down)/ number of evaluable population]*100 (NCT01762800)
Timeframe: 24 weeks
| Intervention | Percentage of participants (Number) |
|---|---|
| TIO 18 µg QD | 36.82 |
| SAL/FLU 50/250 µg BID | 32.35 |
The percentage of participants who were withdrawn from the study. (NCT01762800)
Timeframe: 24 weeks
| Intervention | Percentage of participants (Number) |
|---|---|
| TIO 18 µg QD | 9 |
| SAL/FLU 50/250 µg BID | 10 |
The percentage of participants who required additional treatment to TRIPLE therapy is defined as number of participants who took additional medicine or therapy in TRIPLE therapy divided by number of participants who switch to TRIPLE therapy multiplied by 100. (NCT01762800)
Timeframe: 24 weeks
| Intervention | Percentage of participants (Number) |
|---|---|
| TIO 18 µg QD | 77.33 |
| SAL/FLU 50/250 µg BID | 72.06 |
The percentage of participants who stepped down from TRIPLE therapy to initial randomized treatment was calculated as number of participants who step-down from TRIPLE therapy divided by number of participants who switch to TRIPLE therapy and then multiplied by 100. (NCT01762800)
Timeframe: 24 weeks
| Intervention | Percentage of participants (Number) |
|---|---|
| TIO 18 µg QD | 1.33 |
| SAL/FLU 50/250 µg BID | 2.94 |
Switched to TRIPLE therapy is defined as: 1. Date of switch: when SAL/FLU or TIO was administered additionally to randomised treatment. 2. Date of randomisation was a start point and timing of switching (first switch if there are more than once) to TRIPLE was event. For participants without switching, last day of study or follow up period was regarded as censored. Percentage of participants who switched to TRIPLE therapy was calculated as: number of participants who switched to TRIPLE therapy divided by number of evaluable population and then multiplied by 100. (NCT01762800)
Timeframe: 24 weeks
| Intervention | Percentage of participants (Number) |
|---|---|
| TIO 18 µg QD | 37.31 |
| SAL/FLU 50/250 µg BID | 33.33 |
Each evening participants recorded the number of occasions in the last 24 hours when they used their salbutamol for symptomatic relief of COPD symptoms. The percentage of participants who used relief medication in the study are presented. (NCT01762800)
Timeframe: 24 weeks
| Intervention | Percentage of participants (Number) |
|---|---|
| SAL/FLU 50/250 µg BID-Single | 40.4 |
| SAL/FLU 50/250 µg BID-TRIPLE | 61.8 |
| TIO 18 µg QD-Single | 43.7 |
| TIO 18 µg QD-TRIPLE | 70.7 |
The randomized treatment could be switched to TRIPLE therapy in the case that chronic obstructive pulmonary disease (COPD) is not controlled by the randomized treatment. Participants on TRIPLE therapy received SAL/FLU 50/250 µg BID plus TIO 18 µg QD together. The percentage of participants who were able to remain on the randomized treatment was calculated by the following formula: 100 minus percentage of participants who switched over to TRIPLE therapy. (NCT01762800)
Timeframe: 24 weeks
| Intervention | Percentage of participants (Number) |
|---|---|
| TIO 18 µg QD | 62.69 |
| SAL/FLU 50/250 µg BID | 66.67 |
The EXAcerbations of Chronic pulmonary disease Tool (EXACT) is a 14-item patient-reported outcome (PRO) daily diary used to quantify and measure exacerbations of chronic obstructive pulmonary disease (COPD). Reported as units on a 0 [best health status] to 100 [worst possible status] scale). The day of detection of first exacerbation in any participant in each arm by EXACT. (NCT01762800)
Timeframe: 24 weeks
| Intervention | Days (Number) |
|---|---|
| SAL/FLU 50/250 µg BID-Single | 0 |
| SAL/FLU 50/250 µg BID-TRIPLE | 0 |
| TIO 18 µg QD-Single | 0 |
| TIO 18 µg QD-TRIPLE | 1 |
The day of detection of first exacerbation in any participant in each arm as diagnosed by physician. Exacerbation is defined primarily by physician's judgment. Date of randomisation will be start point and timing of exacerbation (first exacerbation if there are more than one) will be event. For subjects without exacerbation, last day of study or follow up period is regarded as censor. (NCT01762800)
Timeframe: 24 weeks
| Intervention | Days (Number) |
|---|---|
| SAL/FLU 50/250 µg BID-Single | 3 |
| SAL/FLU 50/250 µg BID-TRIPLE | 5 |
| TIO 18 µg QD-Single | 10 |
| TIO 18 µg QD-TRIPLE | 2 |
The day of first switch to TRIPLE therapy (SAL/FLU 50/250 µg BID+TIO 18 µg QD) for the first switching participant in each arm. (NCT01762800)
Timeframe: 24 weeks
| Intervention | Days (Number) |
|---|---|
| TIO 18 µg QD | 5 |
| SAL/FLU 50/250 µg BID | 5 |
Participants were assessed for COPD symptoms by means of CAT at each Visit. This assessment was performed prior to the spirometry testing. A CAT total score of less than 10 represents best health status and greater than 15 represents worst health status. Baseline was the value at Visit 2 (randomization). Change from Baseline was calculated as specific timepoint value minus Visit 2 value. Scores were assessed at Visit 2 (Baseline), Visit 3 (Week 4), Visit 4 (Week 8), Visit 5 (Week 8), Visit 6 (Week 12), Visit 7 (Week 16), and Visit 8 (Week 24). Scores range from 0 to 40, high value in score indicate worse outcome. (NCT01762800)
Timeframe: Baseline and up to 24 weeks
| Intervention | Scores on a scale (Mean) | |||||
|---|---|---|---|---|---|---|
| Visit 3, n=132, 68, 121, 75 | Visit 4, n=127, 68, 116, 74 | Visit 5, n=123, 68, 116, 73 | Visit 6, n=120, 66, 115, 74 | Visit 7, n=120, 66, 113, 71 | Visit 8, n=117, 66, 113, 70 | |
| SAL/FLU 50/250 µg BID-Single | -1.6 | -1.7 | -1.6 | -2.3 | -2.0 | -2.4 |
| SAL/FLU 50/250 µg BID-TRIPLE | 0.1 | -0.2 | -0.8 | 0.0 | -0.8 | -1.0 |
| TIO 18 µg QD-Single | 0.1 | -0.3 | -0.7 | -0.7 | -0.8 | -1.4 |
| TIO 18 µg QD-TRIPLE | 2.1 | 1.6 | 0.8 | 0.0 | -0.6 | -0.5 |
FEV1 is defined as the volume of air forcefully expelled from the lungs in one second. Baseline was a value at Visit 2 (randomization). Change from Baseline was calculated as specific timepoint value minus Visit 2 value. FEV1 was assessed at Visit 2 (Baseline), Visit 3 (Week 4), Visit 4 (Week 8), Visit 5 (Week 8), Visit 6 (Week 12), Visit 7 (Week 16), and Visit 8 (Week 24). (NCT01762800)
Timeframe: Baseline (Visit 2) and up to 24 weeks
| Intervention | Liters (Mean) | |||||
|---|---|---|---|---|---|---|
| Visit 3; n=131, 68, 119, 75 | Visit 4; n=127, 68, 116, 74 | Visit 5; n=122, 68, 116, 72 | Visit 6; n=120, 66, 114, 74 | Visit 7; n=119, 66, 113, 71 | Visit 8; n=117, 66, 113, 70 | |
| SAL/FLU 50/250 µg BID-Single | 0.024 | 0.008 | -0.010 | -0.007 | -0.012 | -0.019 |
| SAL/FLU 50/250 µg BID-TRIPLE | -0.043 | -0.030 | -0.001 | 0.027 | 0.018 | 0.049 |
| TIO 18 µg QD-Single | 0.007 | -0.011 | -0.006 | 0.002 | -0.010 | -0.017 |
| TIO 18 µg QD-TRIPLE | -0.077 | -0.032 | 0.005 | 0.037 | 0.050 | 0.027 |
Participants were assessed for COPD symptoms by means of CAT at each Visit. This assessment was performed prior to the spirometry testing. A CAT total score of less than 10 represents best health status and greater than 15 represents worst health status. Scores were assessed at Visit 1 (Screening), Visit 2 (Baseline), Visit 3 (Week 4), Visit 4 (Week 8), Visit 5 (Week 8), Visit 6 (Week 12), Visit 7 (Week 16), and Visit 8 (Week 24). Scores range from 0 to 40, high value in score indicate worse outcome. (NCT01762800)
Timeframe: 24 weeks
| Intervention | Scores on a scale (Mean) | |||||||
|---|---|---|---|---|---|---|---|---|
| Visit 1, n=136, 68, 126, 75 | Visit 2, n=136, 68, 126, 75 | Visit 3, n=132, 68, 121, 75 | Visit 4, n=127, 68, 116, 74 | Visit 5, n=123, 68, 116, 73 | Visit 6, n=120, 66, 115, 74 | Visit 7, n=120, 66, 113, 71 | Visit 8, n=117, 66, 113, 70 | |
| SAL/FLU 50/250 µg BID-Single | 11.3 | 9.9 | 8.4 | 8.3 | 8.3 | 7.4 | 7.7 | 7.2 |
| SAL/FLU 50/250 µg BID-TRIPLE | 13.3 | 13.4 | 13.5 | 13.2 | 12.6 | 13.3 | 12.4 | 12.3 |
| TIO 18 µg QD-Single | 11.2 | 9.6 | 9.2 | 8.8 | 8.4 | 8.5 | 8.3 | 7.8 |
| TIO 18 µg QD-TRIPLE | 13.4 | 12.1 | 14.3 | 13.6 | 12.8 | 12.0 | 11.4 | 11.6 |
The comparison of number of exacerbation between two detection methods EXACT and physician diagnosis: number of exacerbations detected by EXACT and number of exacerbations judged by physician. (NCT01762800)
Timeframe: 24 weeks
| Intervention | Number of exacerbations (Mean) | |
|---|---|---|
| EXACT | Physician's diagnosis | |
| SAL/FLU 50/250 µg BID | 0.7 | 0.1 |
| TIO 18 µg QD | 0.9 | 0.2 |
The randomized treatment could be switched to TRIPLE therapy in the case that chronic obstructive pulmonary disease (COPD) was not controlled by the randomized treatment. Participants on TRIPLE therapy received SAL/FLU 50/250 µg BID plus TIO 18 µg QD together. Continuation TRIPLE proportion is defined as [(number of subjects who switched to TRIPLE) - (number of subjects who stepped down)/ number of evaluable population]*100. Randomised treatment continuation proportion is calculated by a formula: (100 - switch proportion). (NCT01762800)
Timeframe: 24 weeks
| Intervention | Percentage of participants (Number) | |
|---|---|---|
| Randomised treatment | TRIPLE therapy | |
| SAL/FLU 50/250 µg BID | 66.67 | 32.35 |
| TIO 18 µg QD | 62.69 | 36.82 |
The E-RS total score is an 11-item patient questionnaire, which provides information specific to respiratory symptoms-severity of respiratory symptoms overall and severity of breathlessness, cough and sputum, and chest symptoms. The E-RS subscale scores for respiratory symptoms (RS)-breathlessness (RS-BRL), RS-cough and sputum (RS-CSP), and RS-chest symptoms (RS-CSY) are presented. Scores were assessed at Baseline, Week 1-4, Week 5-8, Week 9-12, Week 13-16, Week 17-20 and at Week 21-24. Daily EXACT total score is obtained as total score of 14 items from diary. Daily E-RS total score as 11 items and Daily E-RS subscale scores are subset of E-RS total score. Mean EXACT total score is mean value of daily EXACT total score within subject by every 4 weeks(Week1-4, Week5-8, Week9-12, Week13-16, Week17-20, Week21-24). Same calculation of mean values are applied to E-RS total and E-RS subscale scores. RS total scores range from 0 to 40, high value in score indicate worse outcome. (NCT01762800)
Timeframe: 24 weeks
| Intervention | Scores on a scale (Mean) | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| RS-BRL; Baseline; n=135, 68, 125, 73 | RS-BRL; Week 1-4; n=131, 68, 121, 75 | RS-BRL; Week 5-8; n=126, 68, 115, 73 | RS-BRL; Week 9-12; n=122, 68, 116, 74 | RS-BRL; Week 13-16; n=121, 66, 116, 74 | RS-BRL; Week 17-20; n=118, 66, 114, 72 | RS-BRL; Week 21-24; n=93, 51, 94, 51 | RS-CSP; Baseline; n=135, 68, 124, 73 | RS-CSP; Week 1-4; n=131, 68, 121, 75 | RS-CSP; Week 5-8; n=126, 68, 116, 73 | RS-CSP; Week 9-12; n=122, 68, 116, 74 | RS-CSP; Week 13-16; n=121, 66, 116, 74 | RS-CSP; Week 17-20; n=119, 66, 114, 72 | RS-CSP; Week 21-24; n=93, 51, 94, 51 | RS-CSY; Baseline; n=135, 67, 125, 73 | RS-CSY; Week 1-4; n=131, 68, 121, 75 | RS-CSY; Week 5-8; n=126, 68, 116, 73 | RS-CSY; Week 9-12; n=122, 68, 116, 74 | RS-CSY; Week 13-16; n=121, 66, 116, 74 | RS-CSY; Week 17-20; n=119, 66, 114, 72 | RS-CSY; Week 21-24; n=93, 51, 94, 51 | |
| SAL/FLU 50/250 µg BID-Single | 3.36 | 3.06 | 3.08 | 3.08 | 2.80 | 2.82 | 2.79 | 2.29 | 2.12 | 2.03 | 2.06 | 1.98 | 2.06 | 1.82 | 1.77 | 1.58 | 1.65 | 1.54 | 1.46 | 1.48 | 1.38 |
| SAL/FLU 50/250 µg BID-TRIPLE | 5.81 | 6.28 | 5.96 | 5.87 | 5.81 | 5.56 | 4.94 | 2.73 | 2.90 | 2.83 | 2.81 | 2.74 | 2.43 | 2.27 | 2.93 | 3.21 | 3.05 | 3.12 | 3.11 | 2.81 | 2.61 |
| TIO 18 µg QD-Single | 3.41 | 3.36 | 3.18 | 2.98 | 3.04 | 3.04 | 2.95 | 2.23 | 2.13 | 2.13 | 2.11 | 2.09 | 2.09 | 1.99 | 1.84 | 1.69 | 1.70 | 1.60 | 1.70 | 1.72 | 1.64 |
| TIO 18 µg QD-TRIPLE | 5.62 | 6.59 | 5.38 | 5.52 | 5.11 | 4.94 | 4.71 | 2.81 | 3.05 | 2.74 | 2.77 | 2.49 | 2.40 | 2.34 | 2.92 | 3.59 | 2.99 | 3.01 | 2.66 | 2.55 | 2.53 |
"The E-RS total score is an 11-item patient questionnaire, which provides information specific to respiratory symptoms-severity of respiratory symptoms overall and severity of breathlessness, cough and sputum, and chest symptoms. Scores were assessed at Baseline, Week 1-4, Week 5-8, Week 9-12, Week 13-16, Week 17-20 and at Week 21-24. Daily EXACT total score is obtained as total score of 14 items from diary. Daily E-RS total score as 11 items and Daily E-RS subscale scores are subset of E-RS total score.~Mean EXACT total score is mean value of daily EXACT total score within subject by every 4 weeks(Week1-4, Week5-8, Week9-12, Week13-16, Week17-20, Week21-24). Same calculation of mean values are applied to E-RS total and E-RS subscale scores. Scores range from 0-100, high value in score indicate worse outcome." (NCT01762800)
Timeframe: Baseline and up to 24 weeks
| Intervention | Scores on a scale (Mean) | ||||||
|---|---|---|---|---|---|---|---|
| Baseline; n=135, 67, 124, 73 | Week 1-4; n=131, 68, 121, 75 | Week 5-8; n=126, 68, 115, 73 | Week 9-12; n=122, 68, 116, 74 | Week 13-16; n=121, 66, 116, 74 | Week 17-20; n=118, 66, 114, 72 | Week 21-24; n=93, 51, 94, 51 | |
| SAL/FLU 50/250 µg BID-Single | 7.42 | 6.76 | 6.75 | 6.69 | 6.23 | 6.33 | 5.99 |
| SAL/FLU 50/250 µg BID-TRIPLE | 11.43 | 12.39 | 11.86 | 11.79 | 11.66 | 10.80 | 9.82 |
| TIO 18 µg QD-Single | 7.51 | 7.18 | 6.99 | 6.70 | 6.82 | 6.85 | 6.58 |
| TIO 18 µg QD-TRIPLE | 11.36 | 13.23 | 11.11 | 11.30 | 10.26 | 9.89 | 9.59 |
"EXACT is a 14-item patient questionnaire used as a measure of respiratory symptoms (reported as units on a 0 [best health status] to 100 [worst possible status] scale). Scores were assessed at Baseline, Week 1-4, Week 5-8, Week 9-12, Week 13-16, Week 17-20 and Week 21-24. Daily EXACT total score is obtained as total score of 14 items from diary. Daily E-RS total score as 11 items and Daily E-RS subscale scores are subset of E-RS total score.~Mean EXACT total score is mean value of daily EXACT total score within subject by every 4 weeks(Week1-4, Week5-8, Week9-12, Week13-16, Week17-20, Week21-24). Same calculation of mean values are applied to E-RS total and E-RS subscale scores." (NCT01762800)
Timeframe: Baseline and up to 24 weeks
| Intervention | Scores on a scale (Mean) | ||||||
|---|---|---|---|---|---|---|---|
| Baseline; n=125, 66, 111, 71 | Week 1-4; n=120, 67, 109, 73 | Week 5-8; n=117, 63, 102, 69 | Week 9-12; n=109, 67, 101, 72 | Week 13-16; n=105, 65, 100, 71 | Week 17-20; n=107, 65, 97, 66 | Week 21-24; n=79, 51, 77, 46 | |
| SAL/FLU 50/250 µg BID-Single | 28.99 | 27.83 | 27.35 | 27.63 | 27.33 | 26.98 | 26.50 |
| SAL/FLU 50/250 µg BID-TRIPLE | 36.00 | 36.92 | 37.58 | 36.16 | 35.92 | 34.92 | 32.72 |
| TIO 18 µg QD-Single | 29.77 | 28.88 | 28.80 | 28.40 | 28.93 | 28.66 | 28.80 |
| TIO 18 µg QD-TRIPLE | 35.78 | 38.26 | 35.87 | 35.57 | 33.79 | 34.03 | 33.67 |
FEV1 is defined as the volume of air forcefully expelled from the lungs in one second. At Screening (Visit 1) spirometric assessments were conducted before (Visit 1A) and 30 to 60 minutes after a bronchodilator challenge (400 µg of salbutamol) (Visit 1B). FEV1 during each visit are presented. FEV1 was assessed at Visit 1A (Screening), Visit 1B (Screening), Visit 2 (Baseline), Visit 3 (Week 4), Visit 4 (Week 8), Visit 5 (Week 8), Visit 6 (Week 12), Visit 7 (Week 16), and Visit 8 (Week 24). (NCT01762800)
Timeframe: Up to 24 weeks
| Intervention | Liters (Mean) | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Visit 1A; n=136, 68, 126, 75 | Visit 1B; n=136, 68, 126, 75 | Visit 2; n=136, 68, 126, 75 | Visit 3; n=131, 68, 119, 75 | Visit 4; n=127, 68, 116, 74 | Visit 5; n=122, 68, 116, 72 | Visit 6; n=120, 66, 114, 74 | Visit 7; n=119, 66, 113, 71 | Visit 8; n=117, 66, 113, 70 | |
| SAL/FLU 50/250 µg BID-Single | 1.687 | 1.764 | 1.695 | 1.731 | 1.713 | 1.718 | 1.716 | 1.710 | 1.694 |
| SAL/FLU 50/250 µg BID-TRIPLE | 1.401 | 1.471 | 1.385 | 1.342 | 1.355 | 1.384 | 1.413 | 1.404 | 1.435 |
| TIO 18 µg QD-Single | 1.675 | 1.754 | 1.681 | 1.710 | 1.703 | 1.708 | 1.712 | 1.694 | 1.688 |
| TIO 18 µg QD-TRIPLE | 1.349 | 1.429 | 1.362 | 1.285 | 1.336 | 1.376 | 1.405 | 1.423 | 1.390 |
Participants evaluated treatment efficacy by using the following grades: significantly improved (SII), moderately improved (MOI), mildly improved (MII), no change (NC), mildly worse (MIW), moderately worse (MOW), and significantly worse (SIW). Treatment efficacy was assessed at Visit 3 (Week 4), Visit 4 (Week 8), Visit 5 (Week 8), Visit 6 (Week 12), Visit 7 (Week 16), and Visit 8 (Week 24). (NCT01762800)
Timeframe: Up to 24 weeks
| Intervention | Participants (Number) | ||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Visit 3; SII | Visit 3; MOI | Visit 3; MII | Visit 3; NC | Visit 3; MIW | Visit 3; MOW | Visit 3; SIW | Visit 4; SII | Visit 4; MOI | Visit 4; MII | Visit 4; NC | Visit 4; MIW | Visit 4; MOW | Visit 5; SII | Visit 5; MOI | Visit 5; MII | Visit 5; NC | Visit 5; MIW | Visit 5; MOW | Visit 5; SIW | Visit 6; SII | Visit 6; MOI | Visit 6; MII | Visit 6; NC | Visit 6; MIW | Visit 6; MOW | Visit 6; SIW | Visit 7; SII | Visit 7; MOI | Visit 7; MII | Visit 7; NC | Visit 7; MIW | Visit 7; MOW | Visit 8; SII | Visit 8; MOI | Visit 8; MII | Visit 8; NC | Visit 8; MIW | Visit 8; MOW | |
| SAL/FLU 50/250 µg BID-Single | 5 | 9 | 35 | 74 | 7 | 1 | 1 | 3 | 15 | 31 | 67 | 10 | 1 | 2 | 13 | 31 | 66 | 10 | 0 | 1 | 2 | 13 | 35 | 66 | 4 | 0 | 0 | 1 | 13 | 27 | 75 | 4 | 0 | 5 | 9 | 39 | 58 | 5 | 1 |
| SAL/FLU 50/250 µg BID-TRIPLE | 0 | 2 | 10 | 32 | 19 | 5 | 0 | 1 | 6 | 12 | 39 | 8 | 2 | 1 | 7 | 17 | 34 | 7 | 2 | 0 | 1 | 4 | 16 | 33 | 11 | 0 | 1 | 2 | 4 | 17 | 37 | 5 | 1 | 1 | 4 | 19 | 37 | 5 | 0 |
| TIO 18 µg QD-Single | 1 | 3 | 20 | 85 | 9 | 3 | 0 | 2 | 5 | 25 | 79 | 5 | 0 | 2 | 3 | 31 | 78 | 2 | 0 | 0 | 2 | 4 | 30 | 72 | 7 | 0 | 0 | 2 | 5 | 28 | 71 | 7 | 0 | 2 | 8 | 30 | 69 | 3 | 1 |
| TIO 18 µg QD-TRIPLE | 1 | 3 | 7 | 32 | 22 | 9 | 1 | 1 | 6 | 21 | 28 | 13 | 5 | 4 | 6 | 20 | 31 | 9 | 3 | 0 | 4 | 13 | 14 | 34 | 7 | 2 | 0 | 4 | 11 | 20 | 26 | 9 | 1 | 4 | 9 | 19 | 34 | 4 | 0 |
Physician evaluated treatment efficacy by using the following grades: significantly improved (SII), moderately improved (MOI), mildly improved (MII), no change (NC), mildly worse (MIW), moderately worse (MOW), and significantly worse (SIW). Treatment efficacy was assessed at Visit 3 (Week 4), Visit 4 (Week 8), Visit 5 (Week 8), Visit 6 (Week 12), Visit 7 (Week 16), and Visit 8 (Week 24). (NCT01762800)
Timeframe: 24 weeks
| Intervention | Participants (Number) | |||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Visit 3; SII | Visit 3; MOI | Visit 3; MII | Visit 3; NC | Visit 3; MIW | Visit 3; MOW | Visit 3; SIW | Visit 4; SII | Visit 4; MOI | Visit 4; MII | Visit 4; NC | Visit 4; MIW | Visit 4; MOW | Visit 4; SIW | Visit 5; SII | Visit 5; MOI | Visit 5; MII | Visit 5; NC | Visit 5; MIW | Visit 5; MOW | Visit 5; SIW | Visit 6; SII | Visit 6; MOI | Visit 6; MII | Visit 6; NC | Visit 6; MIW | Visit 6; MOW | Visit 6; SIW | Visit 7; SII | Visit 7; MOI | Visit 7; MII | Visit 7; NC | Visit 7; MIW | Visit 7; MOW | Visit 8; SII | Visit 8; MOI | Visit 8; MII | Visit 8; NC | Visit 8; MIW | Visit 8; MOW | |
| SAL/FLU 50/250 µg BID-Single | 6 | 11 | 40 | 67 | 7 | 0 | 1 | 3 | 14 | 28 | 74 | 6 | 1 | 1 | 1 | 12 | 29 | 73 | 7 | 0 | 1 | 2 | 10 | 31 | 74 | 3 | 0 | 0 | 0 | 13 | 25 | 79 | 3 | 0 | 2 | 7 | 36 | 70 | 1 | 1 |
| SAL/FLU 50/250 µg BID-TRIPLE | 0 | 1 | 12 | 31 | 16 | 8 | 0 | 1 | 3 | 13 | 33 | 12 | 6 | 0 | 2 | 6 | 14 | 35 | 10 | 1 | 0 | 1 | 1 | 18 | 33 | 11 | 1 | 1 | 1 | 2 | 18 | 38 | 5 | 2 | 1 | 4 | 19 | 39 | 2 | 1 |
| TIO 18 µg QD-Single | 1 | 5 | 21 | 83 | 7 | 3 | 1 | 2 | 8 | 23 | 79 | 4 | 0 | 0 | 2 | 4 | 22 | 83 | 5 | 0 | 0 | 2 | 3 | 28 | 72 | 10 | 0 | 0 | 2 | 5 | 23 | 77 | 5 | 1 | 3 | 7 | 27 | 71 | 4 | 1 |
| TIO 18 µg QD-TRIPLE | 1 | 4 | 3 | 32 | 23 | 12 | 0 | 0 | 9 | 18 | 27 | 12 | 8 | 0 | 4 | 8 | 19 | 29 | 10 | 3 | 0 | 2 | 11 | 17 | 32 | 9 | 3 | 0 | 3 | 12 | 12 | 35 | 8 | 1 | 3 | 9 | 13 | 40 | 5 | 0 |
(NCT00563381)
Timeframe: 52 weeks
| Intervention | exacerbations per patient-year (Mean) |
|---|---|
| Tiotropium | 0.64 |
| Salmeterol | 0.72 |
An exacerbation was defined as an increase or new onset of more than 1 symptom (cough, sputum, wheezing, dyspnoea, chest tightness), with at least 1 symptom lasting at least 3 days and requiring treatment with systemic steroids and/or antibiotics (moderate exacerbation) or hospitalisation (severe exacerbation). (NCT00563381)
Timeframe: 52 weeks
| Intervention | Hospitalizations per patient-year (Mean) |
|---|---|
| Tiotropium | 0.09 |
| Salmeterol | 0.13 |
An exacerbation was defined as an increase or new onset of more than 1 symptom (cough, sputum, wheezing, dyspnoea, chest tightness), with at least 1 symptom lasting at least 3 days and requiring treatment with systemic steroids and/or antibiotics (moderate exacerbation) or hospitalisation (severe exacerbation). (NCT00563381)
Timeframe: 52 weeks
| Intervention | exacerbations per patient-year (Mean) |
|---|---|
| Tiotropium | 0.53 |
| Salmeterol | 0.59 |
An exacerbation was defined as an increase or new onset of more than 1 symptom (cough, sputum, wheezing, dyspnoea, chest tightness), with at least 1 symptom lasting at least 3 days and requiring treatment with systemic steroids and/or antibiotics (moderate exacerbation) or hospitalisation (severe exacerbation). (NCT00563381)
Timeframe: 52 weeks
| Intervention | exacerbations per patient-year (Mean) |
|---|---|
| Tiotropium | 0.23 |
| Salmeterol | 0.28 |
An exacerbation was defined as an increase or new onset of more than 1 symptom (cough, sputum, wheezing, dyspnoea, chest tightness), with at least 1 symptom lasting at least 3 days and requiring treatment with systemic steroids and/or antibiotics (moderate exacerbation) or hospitalisation (severe exacerbation). (NCT00563381)
Timeframe: 52 weeks
| Intervention | exacerbations per patient-year (Mean) |
|---|---|
| Tiotropium | 0.33 |
| Salmeterol | 0.41 |
First occurrence analysed by Cox regression as time to first exacerbation and reported as hazard ratio. An exacerbation was defined as an increase or new onset of more than 1 symptom (cough, sputum, wheezing, dyspnoea, chest tightness), with at least 1 symptom lasting at least 3 days and requiring treatment with systemic steroids and/or antibiotics (moderate exacerbation) or hospitalisation (severe exacerbation). (NCT00563381)
Timeframe: 52 weeks
| Intervention | number of first occurrences (Number) |
|---|---|
| Tiotropium | 1277 |
| Salmeterol | 1414 |
First occurrence analysed by Cox regression as time to first exacerbation leading to hospitalisation and reported as hazard ratio. An exacerbation was defined as an increase or new onset of more than 1 symptom (cough, sputum, wheezing, dyspnoea, chest tightness), with at least 1 symptom lasting at least 3 days and requiring treatment with systemic steroids and/or antibiotics (moderate exacerbation) or hospitalisation (severe exacerbation). (NCT00563381)
Timeframe: 52 weeks
| Intervention | number of first occurrences (Number) |
|---|---|
| Tiotropium | 262 |
| Salmeterol | 336 |
First occurrence analysed by Cox regression as time to first exacerbation or discontinuation of trial medication because of worsening of underlying disease, whichever comes first and reported as hazard ratio. An exacerbation was defined as an increase or new onset of more than 1 symptom (cough, sputum, wheezing, dyspnoea, chest tightness), with at least 1 symptom lasting at least 3 days and requiring treatment with systemic steroids and/or antibiotics (moderate exacerbation) or hospitalisation (severe exacerbation). (NCT00563381)
Timeframe: 52 weeks
| Intervention | number of first occurrences (Number) |
|---|---|
| Tiotropium | 1316 |
| Salmeterol | 1448 |
First occurrence analysed by Cox regression as time to first exacerbation treated with antibiotics and reported as hazard ratio. An exacerbation was defined as an increase or new onset of more than 1 symptom (cough, sputum, wheezing, dyspnoea, chest tightness), with at least 1 symptom lasting at least 3 days and requiring treatment with systemic steroids and/or antibiotics (moderate exacerbation) or hospitalisation (severe exacerbation). (NCT00563381)
Timeframe: 52 weeks
| Intervention | number of first occurrences (Number) |
|---|---|
| Tiotropium | 1154 |
| Salmeterol | 1259 |
First occurrence analysed by Cox regression as time to first exacerbation treated with systemic steroids and reported as hazard ratio. An exacerbation was defined as an increase or new onset of more than 1 symptom (cough, sputum, wheezing, dyspnoea, chest tightness), with at least 1 symptom lasting at least 3 days and requiring treatment with systemic steroids and/or antibiotics (moderate exacerbation) or hospitalisation (severe exacerbation). (NCT00563381)
Timeframe: 52 weeks
| Intervention | number of first occurrences (Number) |
|---|---|
| Tiotropium | 715 |
| Salmeterol | 852 |
First occurrence analysed by Cox regression as time to first exacerbation treated with systemic steroids and antibiotics and reported as hazard ratio. An exacerbation was defined as an increase or new onset of more than 1 symptom (cough, sputum, wheezing, dyspnoea, chest tightness), with at least 1 symptom lasting at least 3 days and requiring treatment with systemic steroids and/or antibiotics (moderate exacerbation) or hospitalisation (severe exacerbation). (NCT00563381)
Timeframe: 52 weeks
| Intervention | number of first occurrences (Number) |
|---|---|
| Tiotropium | 562 |
| Salmeterol | 671 |
Occurrence analysed by Cox regression as time to premature discontinuation of trial medication and reported as hazard ratio (NCT00563381)
Timeframe: 52 weeks
| Intervention | number of first occurrences (Number) |
|---|---|
| Tiotropium | 585 |
| Salmeterol | 648 |
PEFR means peak expiratory flow rate and is measured in liter per minute (NCT00563381)
Timeframe: 16 weeks
| Intervention | liter per minute (L/min) (Mean) |
|---|---|
| Tiotropium | 222.85 |
| Salmeterol | 224.45 |
PEFR means peak expiratory flow rate and is measured in liter per minute (NCT00563381)
Timeframe: 16 weeks
| Intervention | liter per minute (L/min) (Mean) |
|---|---|
| Tiotropium | 230.30 |
| Salmeterol | 231.27 |
PEFR means peak expiratory flow rate and is measured in liter per minute (NCT00563381)
Timeframe: 16 weeks
| Intervention | liter per minute (L/min) (Mean) |
|---|---|
| Tiotropium | 230.61 |
| Salmeterol | 231.91 |
PEFR means peak expiratory flow rate and is measured in liter per minute (NCT00563381)
Timeframe: 16 weeks
| Intervention | liter per minute (L/min) (Mean) |
|---|---|
| Tiotropium | 231.04 |
| Salmeterol | 232.04 |
PEFR means peak expiratory flow rate and is measured in liter per minute (NCT00563381)
Timeframe: 16 weeks
| Intervention | liter per minute (L/min) (Mean) |
|---|---|
| Tiotropium | 231.23 |
| Salmeterol | 231.89 |
PEFR means peak expiratory flow rate and is measured in liter per minute (NCT00563381)
Timeframe: 16 weeks
| Intervention | liter per minute (L/min) (Mean) |
|---|---|
| Tiotropium | 231.19 |
| Salmeterol | 232.42 |
PEFR means peak expiratory flow rate and is measured in liter per minute (NCT00563381)
Timeframe: 16 weeks
| Intervention | liter per minute (L/min) (Mean) |
|---|---|
| Tiotropium | 231.64 |
| Salmeterol | 232.75 |
PEFR means peak expiratory flow rate and is measured in liter per minute (NCT00563381)
Timeframe: 16 weeks
| Intervention | liter per minute (L/min) (Mean) |
|---|---|
| Tiotropium | 232.06 |
| Salmeterol | 232.65 |
PEFR means peak expiratory flow rate and is measured in liter per minute (NCT00563381)
Timeframe: 16 weeks
| Intervention | liter per minute (L/min) (Mean) |
|---|---|
| Tiotropium | 225.15 |
| Salmeterol | 227.21 |
PEFR means peak expiratory flow rate and is measured in liter per minute (NCT00563381)
Timeframe: 16 weeks
| Intervention | liter per minute (L/min) (Mean) |
|---|---|
| Tiotropium | 226.31 |
| Salmeterol | 228.38 |
PEFR means peak expiratory flow rate and is measured in liter per minute (NCT00563381)
Timeframe: 16 weeks
| Intervention | liter per minute (L/min) (Mean) |
|---|---|
| Tiotropium | 227.37 |
| Salmeterol | 229.25 |
PEFR means peak expiratory flow rate and is measured in liter per minute (NCT00563381)
Timeframe: 16 weeks
| Intervention | liter per minute (L/min) (Mean) |
|---|---|
| Tiotropium | 228.27 |
| Salmeterol | 229.37 |
PEFR means peak expiratory flow rate and is measured in liter per minute (NCT00563381)
Timeframe: 16 weeks
| Intervention | liter per minute (L/min) (Mean) |
|---|---|
| Tiotropium | 228.80 |
| Salmeterol | 229.81 |
PEFR means peak expiratory flow rate and is measured in liter per minute (NCT00563381)
Timeframe: 16 weeks
| Intervention | liter per minute (L/min) (Mean) |
|---|---|
| Tiotropium | 229.35 |
| Salmeterol | 230.13 |
PEFR means peak expiratory flow rate and is measured in liter per minute (NCT00563381)
Timeframe: 16 weeks
| Intervention | liter per minute (L/min) (Mean) |
|---|---|
| Tiotropium | 229.95 |
| Salmeterol | 230.43 |
PEFR means peak expiratory flow rate and is measured in liter per minute (NCT00563381)
Timeframe: 16 weeks
| Intervention | liter per minute (L/min) (Mean) |
|---|---|
| Tiotropium | 229.72 |
| Salmeterol | 230.57 |
An exacerbation was defined as an increase or new onset of more than 1 symptom (cough, sputum, wheezing, dyspnoea, chest tightness), with at least 1 symptom lasting at least 3 days and requiring treatment with systemic steroids and/or antibiotics (moderate exacerbation) or hospitalisation (severe exacerbation). (NCT00563381)
Timeframe: 52 weeks
| Intervention | Participants (Number) | |
|---|---|---|
| Participants with (at least one) event | Participants with no event | |
| Salmeterol | 1414 | 2255 |
| Tiotropium | 1277 | 2430 |
An exacerbation was defined as an increase or new onset of more than 1 symptom (cough, sputum, wheezing, dyspnoea, chest tightness), with at least 1 symptom lasting at least 3 days and requiring treatment with systemic steroids and/or antibiotics (moderate exacerbation) or hospitalisation (severe exacerbation). (NCT00563381)
Timeframe: 52 weeks
| Intervention | Participants (Number) | |
|---|---|---|
| Participants with (at least one) event | Participants with no event | |
| Salmeterol | 336 | 3333 |
| Tiotropium | 262 | 3445 |
(NCT00563381)
Timeframe: 52 weeks
| Intervention | Participants (Number) | |
|---|---|---|
| Participants with (at least one) event | Participants with no event | |
| Salmeterol | 648 | 3021 |
| Tiotropium | 585 | 3122 |
Forced Expiratory Volume in one second (FEV1) was calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. FEV1 was normalized by 12 hours (divided by time). This outcome measures absolute values at week 26. Results are obtained from linear mixed model. (NCT01315249)
Timeframe: Week 26
| Intervention | liters (Least Squares Mean) |
|---|---|
| QVA149 | 1.69 |
| Fluticasone/Salmeterol | 1.56 |
Standardized Forced Expiratory Volume in 1 Second (FEV1) was measured with spirometry conducted according to internationally accepted standards. Measurements were made between 0 and 12 hours after treatment. FEV1 was normalized by 12 hours (divided by time). This outcome measures absolute values at week 12. Results are obtained from linear mixed model. (NCT01315249)
Timeframe: Week 12
| Intervention | liters (Least Squares Mean) |
|---|---|
| QVA149 | 1.71 |
| Fluticasone/Salmeterol | 1.59 |
"Participants maintained an ediary to record daily symptom scores (AM and PM) over 12 weeks and 26 weeks of treatment. This analysis compares the mean symptom scores over 12 weeks and 26 weeks compared to baseline. The diary records morning and evening daily clinical symptoms including cough, wheezing, shortness of breath, sputum volume, sputum purulence, night time awakenings and rescue medication use.~Scale ranges: ranges are 0 to 3 with varying scale descriptions that pertain to the question being asked.~0 is the minimum score = none or No symptoms or never or No~= mild, a little~= moderate~= severe For the scale range provided, high values represent a worse outcome." (NCT01315249)
Timeframe: 12 weeks and 26 weeks
| Intervention | units on a scale (Least Squares Mean) | |
|---|---|---|
| Weeks 1-12 | Weeks 1-26 | |
| Fluticasone/Salmeterol | -1.17 | -1.24 |
| QVA149 | -1.08 | -1.28 |
Transition Dyspnea Index (TDI) captures changes from baseline. The TDI score is based on three domains with each domain scored from -3 (major deterioration) to +3 (major improvement), to give an overall score of -9 to +9, a negative score indicating a deterioration from baseline. A TDI focal score of 1 is considered to be a clinically significant improvement. (NCT01315249)
Timeframe: 12 weeks and 26 weeks
| Intervention | units on a scale (Least Squares Mean) | |
|---|---|---|
| 12 weeks (n=224 QVA149; 236 flut/salm) | 26 weeks (n=212 QVA149; 213 flut/salm) | |
| Fluticasone/Salmeterol | 1.45 | 1.60 |
| QVA149 | 2.03 | 2.36 |
"Forced Vital Capacity (FVC) is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. FVC was assessed via spirometry. A positive change from baseline in FVC indicates improvement in lung function.~This outcome measures absolute values at -45 min, -15 min predose; 5 min, 30 min, 1 hr, 2hr, 4 hr, 8 hr, 12 hr post-dose week 12. Results are obtained from linear mixed model." (NCT01315249)
Timeframe: -45 min, -15 min predose; 5 min, 30 min, 1 hr, 2hr, 4 hr, 8 hr, 12 hr post-dose on week 12
| Intervention | liters (Least Squares Mean) | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| -45 minutes (n=230 QVA149; 237 flut/salm) | -15 minutes (n=228 QVA149; 235 flut/salm) | 5 minutes (n=229 QVA149; 236 flut/salm) | 30 minutes (n=229 QVA149; 235 flut/salm) | 1 hour (n=228 QVA149; 236 flut/salm) | 2 hours (n=229 QVA149; 237 flut/salm) | 4 hours (n=228 QVA149; 237 flut/salm) | 8 hours (n=228 QVA149; 237 flut/salm) | 12 hours (n=228 QVA149; 236 flut/salm) | |
| Fluticasone/Salmeterol | 3.16 | 3.17 | 3.20 | 3.23 | 3.26 | 3.31 | 3.33 | 3.27 | 3.26 |
| QVA149 | 3.37 | 3.37 | 3.44 | 3.48 | 3.49 | 3.54 | 3.49 | 3.46 | 3.45 |
"Forced Vital Capacity (FVC) is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. FVC was assessed via spirometry. A positive change from baseline in FVC indicates improvement in lung function.~This outcome measures absolute values at -45 min, -15 min predose; 5 min, 30 min, 1 hr, 2hr, 4 hr, 8 hr, 12 hr post-dose on week 26. Results are obtained from linear mixed model." (NCT01315249)
Timeframe: -45 min, -15 min predose; 5 min, 30 min, 1 hr, 2hr, 4 hr, 8 hr, 12 hr post-dose on week 26
| Intervention | liters (Least Squares Mean) | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| -45 minutes (n=213 QVA149; 216 flut/salm) | -15 minutes (n=213 QVA149; 215 flut/salm) | 5 minutes (n=212 QVA149; 215 flut/salm) | 30 minutes (n=212 QVA149; 214 flut/salm) | 1 hour (n=212 QVA149; 216 flut/salm) | 2 hours (n=212 QVA149; 216 flut/salm) | 4 hours (n=212 QVA149; 215 flut/salm) | 8 hours (n=212 QVA149; 216 flut/salm) | 12 hours (n=211 QVA149; 213 flut/salm) | |
| Fluticasone/Salmeterol | 3.13 | 3.12 | 3.17 | 3.23 | 3.23 | 3.29 | 3.28 | 3.21 | 3.18 |
| QVA149 | 3.32 | 3.33 | 3.42 | 3.47 | 3.50 | 3.51 | 3.45 | 3.40 | 3.40 |
After 12 weeks of treatment, Inspiratory Capacity (IC) was measured via spirometry, conducted according to internationally accepted standards. The mean of 3 acceptable measurements was calculated and reported in liters. (NCT01315249)
Timeframe: 12 weeks
| Intervention | Liters (Least Squares Mean) | |||||
|---|---|---|---|---|---|---|
| -20 minutes (n=51 QVA149; 65 flut/salm) | 25 minutes (n=56 QVA149; 71 flut/salm) | 1 hour (n=59 QVA149; 68 flut/salm) | 3 hours (n=54 QVA149; 67 flut/salm) | 7 hours (n=58 QVA149; 67 flut/salm) | 11 hours (n=49 QVA149; 72 flut/salm) | |
| Fluticasone/Salmeterol | 2.31 | 2.42 | 2.43 | 2.45 | 2.41 | 2.34 |
| QVA149 | 2.39 | 2.55 | 2.54 | 2.52 | 2.42 | 2.40 |
After 26 weeks of treatment, Inspiratory Capacity (IC) was measured via spirometry, conducted according to internationally accepted standards. The mean of 3 acceptable measurements was calculated and reported in liters. (NCT01315249)
Timeframe: 26 weeks
| Intervention | Liters (Least Squares Mean) | |||||
|---|---|---|---|---|---|---|
| -20 minutes (n=53 QVA149; 63 flut/salm) | 25 minutes (n=58 QVA149; 63 flut/salm) | 1 hour (n=53 QVA149; 63 flut/salm) | 3 hours (n=52 QVA149; 60 flut/salm) | 7 hours (n=56 QVA149; 61 flut/salm) | 11 hours (n=57 QVA149; 66 flut/salm) | |
| Fluticasone/Salmeterol | 2.22 | 2.34 | 2.35 | 2.32 | 2.30 | 2.27 |
| QVA149 | 2.25 | 2.41 | 2.38 | 2.33 | 2.40 | 2.37 |
Participants maintained a diary to record the daily number of puffs of rescue medication used to treat COPD symptoms. (NCT01315249)
Timeframe: Baseline, 12 weeks and 26 weeks
| Intervention | puffs (Least Squares Mean) | |
|---|---|---|
| Weeks 1 to12 | Weeks 1 to 26 | |
| Fluticasone/Salmeterol | -1.90 | -1.93 |
| QVA149 | -2.18 | -2.32 |
The assessment of safety was based on Adverse Events. A summary of adverse events is presented with this outcome, additional details are provided in Adverse Events Section. (NCT01315249)
Timeframe: 26 weeks
| Intervention | participants (Number) | |||||
|---|---|---|---|---|---|---|
| Any Adverse Event | Death | Serious Adverse Events | Discontinued due to Adverse Events | Discontinued due to Serious Adverse Events | Discontinued due to non-Serious Adverse Events | |
| Fluticasone/Salmeterol | 159 | 1 | 14 | 27 | 9 | 18 |
| QVA149 | 143 | 0 | 13 | 22 | 5 | 17 |
The total score of the St. George's Respiratory Questionnaire (SGRQ-C) is a health related quality of life questionnaire consisting of 51 items in three components: symptoms, activity, and impacts. The lowest possible value is zero and the highest 100. Higher values correspond to greater impairment in quality of life. (NCT01315249)
Timeframe: 12 weeks and 26 weeks
| Intervention | units on a scale (Least Squares Mean) | |
|---|---|---|
| 12 weeks (n=230 QVA149; 238 flut/salm) | 26 weeks (n=211 QVA149; 216 flut/salm) | |
| Fluticasone/Salmeterol | 36.03 | 36.68 |
| QVA149 | 36.74 | 35.45 |
Pulmonary function was measured by forced expiratory volume in one second (FEV1). The weighted mean was calculated from the pre-dose FEV1 and the post-dose FEV1 measurements at 5, 15, 30, and 60 minutes (min) and 2, 4, 6, 8, 12, 13, 14, 16, 20, and 24 hours on Treatment Day 84. Baseline trough FEV1 was the mean of the two assessments made 30 and 5 minutes pre-dose on Treatment Day 1. Change from Baseline was calculated as the average of the Day 84 values minus the Baseline value. (NCT01323634)
Timeframe: Baseline (Day 1) and Day 84
| Intervention | Liters (Least Squares Mean) |
|---|---|
| FSC 250/50 µg BID | 0.094 |
| FF/VI 100/25 µg QD | 0.174 |
Time to onset on Treatment Day 1 is defined as the time to an increase of 100 milliliters (mL) from Baseline in FEV1. Time of onset was calculated over 0 to 4 hours (5 min, 30 min, 60 min, 120 min, and 240 min) post-dose. (NCT01323634)
Timeframe: Day 1
| Intervention | Minutes (Median) |
|---|---|
| FSC 250/50 µg BID | 30 |
| FF/VI 100/25 µg QD | 15 |
Pulmonary function was measured by forced expiratory volume in one second (FEV1), defined as the maximal amount of air that can be forcefully exhaled in one second. The weighted mean was calculated from the pre-dose FEV1 and the post-dose FEV1 measurements at 5, 15, 30, and 60 minutes (min) and 2, 4, 6, 8, 12, 13, 14, 16, 20, and 24 hours post-dose on Treatment Day 84. Baseline trough FEV1 was calculated as the mean of the two assessments made 30 and 5 minutes pre-dose on Treatment Day 1. Change from Baseline was calculated as the average of the Day 84 values minus the Baseline value. Analysis of covariance (ANCOVA) was conducted with covariates for country, smoking status, reversibility, and Baseline FEV1. (NCT01323621)
Timeframe: Baseline (Day 1) and Day 84
| Intervention | Liters (Least Squares Mean) |
|---|---|
| FSC 250/50 µg BID | 0.114 |
| FF/VI 100/25 µg QD | 0.142 |
Time to onset on Treatment Day 1 is defined as the time to an increase of 100 milliliters (mL) from Baseline in FEV1. Time to onset was calculated over 0 to 4 hours (5 min, 15 min, 30 min, 60 min, 120 min, and 240 min) post-dose. (NCT01323621)
Timeframe: Baseline and Day 1
| Intervention | Minutes (Median) |
|---|---|
| FSC 250/50 µg BID | 30 |
| FF/VI 100/25 µg QD | 16 |
FEV1 is a measure of lung function and is defined as the volume of air that can be forcefully exhaled in one second. Trough FEV1 is defined as the 24-hour FEV1 assessment, which was obtained on Day 85. Baseline trough was calculated as the mean of the two assessments made 30 minutes pre-dose and 5 minutes pre-dose on Treatment Day 1. Change from Baseline was calculated as the average of the Day 85 values minus the Baseline value. The analysis used an analysis of covariance (ANCOVA) model with covariates of Baseline FEV1, reversibility stratum, smoking status (at Screening), country, and treatment. (NCT01706328)
Timeframe: Baseline and Day 85
| Intervention | Liters (Least Squares Mean) |
|---|---|
| FF/VI 100/25 µg QD | 0.151 |
| FP/Salmeterol 250/50 µg BID | 0.121 |
FEV1 is a measure of lung function and is defined as the volume of air that can be forcefully exhaled in one second. The weighted mean was calculated from the pre-dose FEV1 and the post-dose FEV1 measurements taken at 5, 15, 30, and 60 minutes and 2, 4, 6, 8, 12, 13, 14, 16, 20, and 24 hours on Treatment Day 84. Baseline trough FEV1 was calculated as the mean of the two assessments made 30 minutes pre-dose and 5 minutes pre-dose on Treatment Day 1. The weighted mean was derived by calculating the area under curve, and then dividing by the relevant time interval. The weighted mean change from Baseline was calculated as the weighted mean of the 24-hour serial FEV1 measurements on Day 84 minus the Baseline trough FEV1 value. The analysis used an analysis of covariance (ANCOVA) model with covariates of Baseline FEV1, reversibility stratum, smoking status (at Screening), country, and treatment. (NCT01706328)
Timeframe: Baseline and Day 84
| Intervention | Liters (Least Squares Mean) |
|---|---|
| FF/VI 100/25 µg QD | 0.168 |
| FP/Salmeterol 250/50 µg BID | 0.142 |
Time to onset on Treatment Day 1 is defined as the time to an increase of 100 milliliters (mL) from Baseline in FEV1 during the 0- to 4-hour serial measurements (5, 15, 30, 60, 120, and 240 minutes post-dose). Participants who never met or exceeded a 100 mL increase over the Baseline value during the 4-hour serial measurements were censored at the actual time of their last FEV1 measurement. (NCT01706328)
Timeframe: Baseline and Day 1
| Intervention | Minutes (Median) |
|---|---|
| FF/VI 100/25 µg QD | 15 |
| FP/Salmeterol 250/50 µg BID | 15 |
"Number of moderate or severe on-treatment COPD exacerbations, based on a 7-day gap rule: exacerbations where the onset date of the second exacerbation event was ≤7 days after the end date of the first exacerbation event were combined and counted as moderate or severe if ≥1 of the contributing exacerbation events was moderate or severe. Exacerbations were considered severe if the patient was held and treated for an acute respiratory condition in an urgent care department or an observation unit for >6 hours, the patient was treated at home by a mobile urgent care team or the patient was admitted to hospital. Exacerbations were considered moderate if they required prescription of antibiotics and/or systemic steroids.~Measured values show adjusted mean event rate." (NCT00975195)
Timeframe: During randomised treatment, up to 488 days
| Intervention | exacerbations per patient-year (Mean) |
|---|---|
| Fluticasone Maintenance | 0.91 |
| Fluticasone Withdrawal | 0.95 |
"Number of on-treatment COPD exacerbations of any severity, based on a 7-day gap rule: exacerbations where the onset date of the second exacerbation event was ≤7 days after the end date of the first exacerbation event were combined.~Measured values show adjusted event rate." (NCT00975195)
Timeframe: During randomised treatment, up to 488 days
| Intervention | exacerbations per patient-year (Mean) |
|---|---|
| Fluticasone Maintenance | 1.03 |
| Fluticasone Withdrawal | 1.08 |
"Number of severe on-treatment COPD exacerbations based on a 7-day gap rule: exacerbations where the onset date of the second exacerbation event was ≤7 days after the end date of the first exacerbation event were combined and counted as severe if ≥1 of the contributing exacerbation events was severe. Exacerbations were considered severe if the patient was held and treated for an acute respiratory condition in an urgent care department or an observation unit for >6 hours, the patient was treated at home by a mobile urgent care team or the patient was admitted to hospital.~Measured values show adjusted event rate." (NCT00975195)
Timeframe: During randomised treatment, up to 488 days
| Intervention | exacerbations per patient-year (Mean) |
|---|---|
| Fluticasone Maintenance | 0.20 |
| Fluticasone Withdrawal | 0.23 |
Presence (yes vs no) of at least one moderate or severe on-treatment COPD exacerbation, displayed as a percentage. Exacerbations were considered severe if the patient was held and treated for an acute respiratory condition in an urgent care department or an observation unit for >6 hours, the patient was treated at home by a mobile urgent care team or the patient was admitted to hospital. Exacerbations were considered moderate if they required prescription of antibiotics and/or systemic steroids. (NCT00975195)
Timeframe: During randomised treatment, up to 488 days
| Intervention | percentage of participants (Number) |
|---|---|
| Fluticasone Maintenance | 44.2 |
| Fluticasone Withdrawal | 46.7 |
Presence (yes vs no) of at least one on-treatment COPD exacerbation of any severity, displayed as a percentage. (NCT00975195)
Timeframe: During randomised treatment, up to 488 days
| Intervention | percentage of participants (Number) |
|---|---|
| Fluticasone Maintenance | 46.9 |
| Fluticasone Withdrawal | 49.0 |
Presence (yes vs no) of at least one severe on-treatment COPD exacerbation, displayed as a percentage. Exacerbations were considered severe if the patient was held and treated for an acute respiratory condition in an urgent care department or an observation unit for >6 hours, the patient was treated at home by a mobile urgent care team or the patient was admitted to hospital. (NCT00975195)
Timeframe: During randomised treatment, up to 488 days
| Intervention | percentage of participants (Number) |
|---|---|
| Fluticasone Maintenance | 13.4 |
| Fluticasone Withdrawal | 15.2 |
"A Chronic Obstructive Pulmonary Disease (COPD) exacerbation was defined as an increase or new onset of ≥2 lower respiratory symptoms related to COPD, with ≥1 symptom lasting ≥3 days, requiring a change in treatment. Lower respiratory symptoms included shortness of breath, sputum production (volume), sputum purulence, cough, wheezing and chest tightness. A change in treatment included: hospitalisation/treatment in an urgent care unit, prescription of antibiotics and/or systemic steroids or a significant change of prescribed respiratory medication such as theophyllines, long-acting beta-agonists or inhaled corticosteroids. Exacerbations were considered severe if the patient was held and treated for an acute respiratory condition in an urgent care department or an observation unit for >6 hours, the patient was treated at home by a mobile urgent care team or the patient was admitted to hospital.The measure type displays the 25th percentile and its 95% confidence interval." (NCT00975195)
Timeframe: During randomised treatment, up to 488 days
| Intervention | days (Number) |
|---|---|
| Fluticasone Maintenance | 107.0 |
| Fluticasone Withdrawal | 110.0 |
"Time to first on-treatment COPD exacerbation of any severity. The measure type displays the 25th percentile and its 95% confidence interval." (NCT00975195)
Timeframe: During randomised treatment, up to 488 days
| Intervention | days (Number) |
|---|---|
| Fluticasone Maintenance | 365.0 |
| Fluticasone Withdrawal | 346.0 |
"Time to first severe on-treatment COPD exacerbation. Exacerbations were considered severe if the patient was held and treated for an acute respiratory condition in an urgent care department or an observation unit for >6 hours, the patient was treated at home by a mobile urgent care team or the patient was admitted to hospital.~The measure type displays the 25th percentile and its 95% confidence interval." (NCT00975195)
Timeframe: During randomised treatment, up to 488 days
| Intervention | days (Number) |
|---|---|
| Fluticasone Maintenance | NA |
| Fluticasone Withdrawal | 419.0 |
Change from baseline in on-treatment BODE index (Body mass index, airflow Obstruction, Dyspnea and Exercise capacity index), a composite score ranging from 0 (best) to 10 (worst); change was calculated as week score minus baseline score. Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest. (NCT00975195)
Timeframe: Baseline and week 18 and 52 visits
| Intervention | units on a scale (Least Squares Mean) | |
|---|---|---|
| Week 18 visit (N=1038, 1024) | Week 52 visit (N=931, 907) | |
| Fluticasone Maintenance | -0.06 | -0.03 |
| Fluticasone Withdrawal | 0.06 | 0.14 |
"Change from baseline in on-treatment cough and expectoration as measured by the cough and sputum assessment questionnaire (CASA-Q) (selected sites only): Cough impact domain. Change was calculated as week score minus baseline score. Response options for the items in this domain range from not at all/never to extremely/always on a five-point scale. Domain items were reverse scored, summed and transformed to a domain score ranging from 0 to 100 where a higher score is associated with less impact due to cough.~Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest." (NCT00975195)
Timeframe: Baseline and week 12, 18 and 52 visits
| Intervention | units on a scale (Least Squares Mean) | ||
|---|---|---|---|
| Week 12 visit (N=307, 319) | Week 18 visit (N=302, 312) | Week 52 visit (N=268, 269) | |
| Fluticasone Maintenance | -1.65 | -2.87 | -4.51 |
| Fluticasone Withdrawal | -1.24 | -3.71 | -5.54 |
"Change from baseline in on-treatment cough and expectoration as measured by the cough and sputum assessment questionnaire (CASA-Q) (selected sites only): Cough symptoms domain. Change was calculated as week score minus baseline score. Response options for the items in this domain range from not at all/never to a lot/always on a five-point scale. Domain items were reverse scored, summed and transformed to a domain score ranging from 0 to 100 where a higher score is associated with less symptoms due to cough.~Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest." (NCT00975195)
Timeframe: Baseline and week 12, 18 and 52 visits
| Intervention | units on a scale (Least Squares Mean) | ||
|---|---|---|---|
| Week 12 visit (N=309, 318) | Week 18 visit (N=305, 312) | Week 52 visit (N=270, 268) | |
| Fluticasone Maintenance | -0.32 | -1.47 | -1.69 |
| Fluticasone Withdrawal | -0.85 | -3.34 | -3.26 |
"Change from baseline in on-treatment cough and expectoration as measured by the cough and sputum assessment questionnaire (CASA-Q) (selected sites only): Sputum impact domain. Change was calculated as week score minus baseline score. Response options for the items in this domain range from not at all/never to a lot/always on a five-point scale. Domain items were reverse scored, summed and transformed to a domain score ranging from 0 to 100 where a higher score is associated with less impact due to sputum.~Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest." (NCT00975195)
Timeframe: Baseline and week 12, 18 and 52 visits
| Intervention | units on a scale (Least Squares Mean) | ||
|---|---|---|---|
| Week 12 visit (N=308, 317) | Week 18 visit (N=303, 310) | Week 52 visit (N=267, 267) | |
| Fluticasone Maintenance | -2.26 | -2.38 | -4.29 |
| Fluticasone Withdrawal | -1.63 | -3.31 | -4.15 |
"Change from baseline in on-treatment cough and expectoration as measured by the cough and sputum assessment questionnaire (CASA-Q) (selected sites only): Sputum symptoms domain. Change was calculated as week score minus baseline score. Response options for the items in this domain range from not at all/never to extremely/always on a five-point scale. Domain items were reverse scored, summed and transformed to a domain score ranging from 0 to 100 where a higher score is associated with less symptoms due to sputum.~Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest." (NCT00975195)
Timeframe: Baseline and week 12, 18 and 52 visits
| Intervention | units on a scale (Least Squares Mean) | ||
|---|---|---|---|
| Week 12 visit (N=308, 317) | Week 18 visit (N=302, 311) | Week 52 visit (N=269, 268) | |
| Fluticasone Maintenance | -1.36 | -2.71 | -5.10 |
| Fluticasone Withdrawal | -1.24 | -1.93 | -2.45 |
Change from baseline in on-treatment exercise capacity measured by six-minute walk test (6-MWT); change was calculated as week score minus baseline score. Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest. (NCT00975195)
Timeframe: Baseline and week 18 and 52 visits
| Intervention | meters (Least Squares Mean) | |
|---|---|---|
| Week 18 visit (N=1111, 1110) | Week 52 visit (N=1013, 987) | |
| Fluticasone Maintenance | 3.89 | 3.94 |
| Fluticasone Withdrawal | 1.94 | 0.42 |
Change from baseline in on-treatment Forced Expiratory Volume in One Second (FEV1) as measured by home based spirometry. Change was calculated as week score minus baseline score. The weekly mean was defined as the mean of the measurements taken during the last 7 days prior to the visit date, and was calculated if ≥4 of the 7 days had non-missing measurements. Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest. (NCT00975195)
Timeframe: Baseline and week 6, 12, 18, 27, 36, 45 and 52 visits
| Intervention | Litres (Least Squares Mean) | ||||||
|---|---|---|---|---|---|---|---|
| Week 6 visit (N=893, 939) | Week 12 visit (N=910, 930) | Week 18 visit (N=913, 901) | Week 27 visit (N=863, 843) | Week 36 visit (N=854, 845) | Week 45 visit (N=830, 815) | Week 52 visit (N=785, 788) | |
| Fluticasone Maintenance | -0.049 | -0.050 | -0.051 | -0.056 | -0.059 | -0.061 | -0.067 |
| Fluticasone Withdrawal | -0.053 | -0.056 | -0.093 | -0.092 | -0.099 | -0.103 | -0.115 |
Change from baseline in on-treatment forced vital capacity (FVC) as measured by home based spirometry. Change was calculated as week score minus baseline score. The weekly mean was defined as the mean of the measurements taken during the last 7 days prior to the visit date, and was calculated if ≥4 of the 7 days had non-missing measurements. Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest. (NCT00975195)
Timeframe: Baseline and week 6, 12, 18, 27, 36, 45 and 52 visits
| Intervention | Litres (Least Squares Mean) | ||||||
|---|---|---|---|---|---|---|---|
| Week 6 visit (N=893, 939) | Week 12 visit (N=910, 930) | Week 18 visit (N=913, 901) | Week 27 visit (N=863, 843) | Week 36 visit (N=854, 845) | Week 45 visit (N=830, 815) | Week 52 visit (N=785, 788) | |
| Fluticasone Maintenance | -0.116 | -0.113 | -0.122 | -0.123 | -0.135 | -0.141 | -0.157 |
| Fluticasone Withdrawal | -0.089 | -0.105 | -0.124 | -0.147 | -0.158 | -0.168 | -0.201 |
Change from baseline in on-treatment lung function as measured by trough forced expiratory volume in one second (FEV1); change was calculated as week score minus baseline score. Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest. (NCT00975195)
Timeframe: Baseline and week 6, 12, 18 and 52 visits
| Intervention | Litres (Least Squares Mean) | |||
|---|---|---|---|---|
| Week 6 visit (N=1135, 1135) | Week 12 visit (N=1114, 1092) | Week 18 visit (N=1077, 1058) | Week 52 visit (N=970, 935) | |
| Fluticasone Maintenance | -0.009 | -0.011 | -0.011 | -0.016 |
| Fluticasone Withdrawal | -0.011 | -0.018 | -0.050 | -0.059 |
Change from baseline in on-treatment peak expiratory flow rate (PEFR) as measured by home based spirometry; change was calculated as week score minus baseline score. Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest. (NCT00975195)
Timeframe: Baseline and week 6, 12, 18, 27, 36, 45 and 52 visits
| Intervention | Litres/sec (Least Squares Mean) | ||||||
|---|---|---|---|---|---|---|---|
| Week 6 visit (N=893, 939) | Week 12 visit (N=910, 930) | Week 18 visit (N=913, 901) | Week 27 visit (N=863, 843) | Week 36 visit (N=854, 845) | Week 45 visit (N=830, 815) | Week 52 visit (N=785, 788) | |
| Fluticasone Maintenance | -0.228 | -0.266 | -0.295 | -0.319 | -0.352 | -0.368 | -0.377 |
| Fluticasone Withdrawal | -0.230 | -0.290 | -0.435 | -0.430 | -0.473 | -0.490 | -0.538 |
Change from baseline in on-treatment physical health status as determined by body mass index (BMI); change was calculated as week score minus baseline score. Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest. (NCT00975195)
Timeframe: Baseline and week 18 and 52 visits
| Intervention | kg/m2 (Least Squares Mean) | |
|---|---|---|
| Week 18 visit (N=1143, 1146) | Week 52 visit (N=1047, 1021) | |
| Fluticasone Maintenance | 0.030 | 0.004 |
| Fluticasone Withdrawal | 0.040 | -0.009 |
"Change from baseline in on-treatment physician global evaluation. The evaluation reflected the physician's opinion of the patient's overall condition and was based on the need for concomitant medication, the number and severity of exacerbations, the severity of cough, the ability to exercise, the amount of wheezing and any other relevant clinical observations. Patients were graded on a scale of 1 (poor) to 8 (excellent). Change was calculated as week score minus baseline score.~Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest." (NCT00975195)
Timeframe: Baseline and week 27 and 52 visits
| Intervention | units on a scale (Least Squares Mean) | |
|---|---|---|
| Week 27 visit (N=1113, 1093) | Week 52 visit (N=1041, 1014) | |
| Fluticasone Maintenance | 0.10 | 0.19 |
| Fluticasone Withdrawal | 0.04 | 0.08 |
"Change from baseline in on-treatment St Georges Respiratory Questionnaire (SGRQ) scores: Activity domain. Scores range from 0 to 100, with higher scores indicating more limitations. Change was calculated as week score minus baseline score.~Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest." (NCT00975195)
Timeframe: Baseline and week 27 and 52 visits
| Intervention | units on a scale (Least Squares Mean) | |
|---|---|---|
| Week 27 visit (N=1002, 988) | Week 52 visit (N=942, 916) | |
| Fluticasone Maintenance | 0.09 | -0.19 |
| Fluticasone Withdrawal | 0.85 | 0.78 |
"Change from baseline in on-treatment St Georges Respiratory Questionnaire (SGRQ) scores: Impact Domain. Scores range from 0 to 100, with higher scores indicating more limitations. Change was calculated as week score minus baseline score.~Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest." (NCT00975195)
Timeframe: Baseline and week 27 and 52 visits
| Intervention | units on a scale (Least Squares Mean) | |
|---|---|---|
| Week 27 visit (N=1004, 998) | Week 52 visit (N=946, 921) | |
| Fluticasone Maintenance | -0.78 | -0.08 |
| Fluticasone Withdrawal | 0.35 | 1.27 |
"Change from baseline in on-treatment St Georges Respiratory Questionnaire (SGRQ) scores: Symptoms domain. Scores range from 0 to 100, with higher scores indicating more limitations. Change was calculated as week score minus baseline score.~Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest." (NCT00975195)
Timeframe: Baseline and week 27 and 52 visits
| Intervention | units on a scale (Least Squares Mean) | |
|---|---|---|
| Week 27 visit (N=1010, 998) | Week 52 visit (N=955, 921) | |
| Fluticasone Maintenance | 0.12 | 0.51 |
| Fluticasone Withdrawal | 0.62 | 1.11 |
"Change from baseline in on-treatment St Georges Respiratory Questionnaire (SGRQ) scores: Total score. Scores range from 0 to 100, with higher scores indicating more limitations. Change was calculated as week score minus baseline score.~Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest." (NCT00975195)
Timeframe: Baseline and week 27 and 52 visits
| Intervention | units on a scale (Least Squares Mean) | |
|---|---|---|
| Week 27 visit (N=996, 986) | Week 52 visit (N=939, 913) | |
| Fluticasone Maintenance | -0.42 | -0.07 |
| Fluticasone Withdrawal | 0.55 | 1.15 |
"Change from baseline in on-treatment dyspnoea as measured by the Modified Medical Research Council (MMRC) dyspnoea scale; change was calculated as week score minus baseline score. Negative changes from baseline indicate an improvement in health.~Scale from 0 to 4:~0 = not troubled by breathlessness, except during strenuous exercise~1 = short of breath when hurrying or walking up a slight hill~2 = walks slower than contemporaries on the same level because of breathlessness, or has to stop for breath when walking at own pace~3 = stops for breath after approximately 100 yards, or after a few minutes on the level~4 = too breathless to leave the house, or breathless when dressing or undressing~No breathlessness was given a score of -1~Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest." (NCT00975195)
Timeframe: Baseline and week 18 and 52 visits
| Intervention | units on a scale (Least Squares Mean) | |
|---|---|---|
| Week 18 visit (N=1140, 1143) | Week 52 visit (N=1043, 1019) | |
| Fluticasone Maintenance | -0.030 | -0.028 |
| Fluticasone Withdrawal | -0.001 | 0.035 |
Severity of on-treatment COPD exacerbations: for each patient, the worst applicable category was taken (i.e. none, mild, moderate or severe) (NCT00975195)
Timeframe: During randomised treatment, up to 488 days
| Intervention | percentage of participants (Number) | ||||
|---|---|---|---|---|---|
| None and patient completed randomised treatment | None and patient discontinued randomised treatment | Mild | Moderate | Severe | |
| Fluticasone Maintenance | 42.9 | 10.2 | 2.7 | 30.8 | 13.4 |
| Fluticasone Withdrawal | 41.2 | 9.8 | 2.3 | 31.5 | 15.2 |
"Change from baseline in FEV1 AUC(0-12h), normalized by time, at the end of treatment (Week 6).~Spirometry, used to measure FEV1, was performed according to internationally accepted standards. The AUC for FEV1 at Week 6 of treatment was calculated by using the linear trapezoidal rule, based on the changes in FEV1 from the baseline values, and divided by the observation time (12 hours).~Definitions:~AUC=Area under the curve; Baseline=Baseline value was the average of the pre-dose measurements (at 45 mins and 15 mins pre-dose), at Visit 2 (Week 0); FEV1=Forced expiratory volume in the 1st second; FEV1 AUC(0-12h)=Mean FEV1 after inhalation, measured at prespecified times for up to 12-h observation period (0-12 h), normalized by time;" (NCT03084796)
Timeframe: Baseline, Week 6
| Intervention | Litres (Least Squares Mean) |
|---|---|
| Treatment A | 0.070 |
| Treatment B | 0.118 |
| Treatment C | 0.153 |
| Treatment D | 0.147 |
| Treatment E | 0.002 |
| Treatment F | 0.213 |
"Change from baseline in FEV1 AUC(0-12h), normalized by time, on Day 1.~Spirometry, used to measure FEV1, was performed according to internationally accepted standards. The AUC for FEV1 on Day 1 of treatment was calculated by using the linear trapezoidal rule, based on the changes in FEV1 from the baseline values, and divided by the observation time (12 hours).~Definitions:~AUC=Area under the curve; Baseline=Baseline value was the average of the pre-dose measurements (at 45 mins and 15 mins pre-dose), at Visit 2 (Week 0); Day 1=Day of the first dose of randomized study drug at Visit 2 (Week 0); FEV1=Forced expiratory volume in the 1st second; FEV1 AUC(0-12h)=Mean FEV1 after inhalation, measured at prespecified times for up to 12-h observation period (0-12 h), normalized by time;" (NCT03084796)
Timeframe: Baseline, Day 1
| Intervention | Litres (Least Squares Mean) |
|---|---|
| Treatment A | 0.067 |
| Treatment B | 0.086 |
| Treatment C | 0.135 |
| Treatment D | 0.149 |
| Treatment E | 0.009 |
| Treatment F | 0.192 |
Number of patients achieving onset of action was defined as a change from baseline in post-dose FEV1 ≥100 mL on Day 1. These are the patients who contributed to the results, reported as median and 95% CI for 'time to onset of action' presented in Outcome Measure 8, above. (NCT03084796)
Timeframe: Day 1
| Intervention | Participants (Count of Participants) |
|---|---|
| Treatment A | 90 |
| Treatment B | 103 |
| Treatment C | 103 |
| Treatment D | 110 |
| Treatment E | 74 |
| Treatment F | 113 |
Time to onset of action is defined as the time (in minutes) from receiving the study drug on Day 1, until the FEV1 change from baseline is ≥100 mL. (NCT03084796)
Timeframe: Day 1
| Intervention | minutes (Mean) |
|---|---|
| Treatment A | 45.1 |
| Treatment B | 32.6 |
| Treatment C | 29.5 |
| Treatment D | 27.3 |
| Treatment E | 240.1 |
| Treatment F | 28.1 |
"Change from baseline in 24-Hour Holter electrocardiogram (ECG) parameters - Fridericia-corrected QT interval (QTcF).~Subjects had a 24-h Holter recording before and 24 h after the 1st dose of study drug (Visit 2) and for 24 h before the last dose of study drug (Visit 4). The time-matched values recorded during the 24 h before the 1st dose of study drug on Visit 2 and served as the baseline for the Holter-extracted ECG parameters. The time-averaged baseline score is the average of the Day -1 scores at +5 min, +55 min, and at +2.5 h." (NCT03084796)
Timeframe: Baseline, Day 1, Week 6
| Intervention | msec (Mean) | |||||
|---|---|---|---|---|---|---|
| QTcF, Day 1, 5 min post dose | QTcF, Day 1, 55 min post dose | QTcF, Day 1, 2.5 h post dose | QTcF, Day before Week 6, 5 min post dose | QTcF, Day before Week 6, 55 min post dose | QTcF, Day before Week 6, 2.5 h post dose | |
| Treatment A | 3.62 | 8.37 | 7.15 | 1.61 | 2.38 | 4.13 |
| Treatment B | 5.37 | 5.41 | 8.65 | 1.14 | 0.09 | 0.85 |
| Treatment C | 6.81 | 6.72 | 7.20 | -0.60 | 1.41 | -0.97 |
| Treatment D | 6.25 | 9.90 | 5.45 | 1.67 | 4.15 | 1.73 |
| Treatment E | 3.59 | 6.04 | 4.81 | -3.56 | 1.02 | 0.14 |
| Treatment F | 5.56 | 5.43 | 6.77 | 1.41 | 3.19 | 2.50 |
"Change from baseline in 24-Hour Holter electrocardiogram (ECG) parameters - Heart rate (HR)~Subjects had a 24-h Holter recording before and 24 h after the 1st dose of study drug (Visit 2) and for 24 h before the last dose of study drug (Visit 4). The time-matched values recorded during the 24 h before the 1st dose of study drug on Visit 2 and served as the baseline for the Holter-extracted ECG parameters. The time-averaged baseline score is the average of the Day -1 scores at +5m, +55m, and at +2.5 h." (NCT03084796)
Timeframe: Baseline, Day 1, Week 6
| Intervention | bpm (Mean) | |||||
|---|---|---|---|---|---|---|
| HR, Day 1, 5 min post dose | HR, Day 1, 55 min post dose | HR, Day 1, 2.5 h post dose | HR, Day before Week 6, 5 min post dose | HR, Day before Week 6, 55 min post dose | HR, Day before Week 6, 2.5 h post dose | |
| Treatment A | -8.85 | -7.19 | -7.57 | -1.72 | -1.52 | -2.30 |
| Treatment B | -6.62 | -8.29 | -6.75 | -1.06 | 0.41 | -0.01 |
| Treatment C | -7.78 | -8.28 | -9.20 | -1.61 | -1.10 | -1.13 |
| Treatment D | -7.64 | -9.59 | -7.46 | -1.85 | -1.40 | -0.73 |
| Treatment E | -4.84 | -7.44 | -6.12 | 3.92 | 1.12 | 2.49 |
| Treatment F | -5.54 | -7.19 | -8.96 | 1.70 | 1.22 | -1.47 |
"Change from baseline in 24-Hour Holter electrocardiogram (ECG) parameters - PR Interval~Subjects had a 24-h Holter recording before and 24 h after the 1st dose of study drug (Visit 2) and for 24 h before the last dose of study drug (Visit 4). The time-matched values were recorded during the 24 h before the 1st dose of study drug on Visit 2 and served as the baseline for the Holter-extracted ECG parameters. The time-averaged baseline score is the average of the Day -1 scores at +5 min, +55 min, and at +2.5 h." (NCT03084796)
Timeframe: Baseline, Day 1, Week 6
| Intervention | msec (Mean) | |||||
|---|---|---|---|---|---|---|
| PR Interval, Day 1, 5 min post dose | PR Interval, Day 1, 55 min post dose | PR Interval, Day 1, 2.5 h post dose | PR Interval, Day before Week 6, 5 min post dose | PR Interval, Day before Week 6, 55 min post dose | PR Interval, Day before Week 6, 2.5 h post dose | |
| Treatment A | 7.24 | 7.20 | 8.48 | 0.44 | 0.88 | 2.50 |
| Treatment B | 6.53 | 6.89 | 9.38 | 1.36 | 2.37 | 3.01 |
| Treatment C | 6.08 | 8.21 | 7.58 | -0.11 | 1.91 | 0.16 |
| Treatment D | 6.71 | 6.77 | 6.16 | 3.88 | 0.82 | 0.84 |
| Treatment E | 3.06 | 4.38 | 5.84 | -1.36 | -1.13 | -1.22 |
| Treatment F | 4.90 | 4.77 | 4.25 | 0.82 | -1.66 | -1.94 |
"Change from baseline in 24-Hour Holter electrocardiogram (ECG) parameters - QRS Interval~Subjects had a 24-h Holter recording before and 24 h after the 1st dose of study drug (Visit 2) and for 24 h before the last dose of study drug (Visit 4). The time-matched values were recorded during the 24 h before the 1st dose of study drug on Visit 2 and served as the baseline for the Holter-extracted ECG parameters. The time-averaged baseline score is the average of the Day -1 scores at +5 min, +55 min, and at +2.5 h." (NCT03084796)
Timeframe: Baseline, Day 1, Week 6
| Intervention | msec (Mean) | |||||
|---|---|---|---|---|---|---|
| QRS Interval, Day 1, 5 min post dose | QRS Interval, Day 1, 55 min post dose | QRS Interval, Day 1, 2.5 h post dose | QRS Interval, Day before Week 6, 5 min post dose | QRS Interval, Day before Week 6, 55 min post dose | QRS Interval, Day before Week 6, 2.5 h post dose | |
| Treatment A | 1.18 | 0.97 | 1.38 | 0.61 | 1.12 | 1.49 |
| Treatment B | 0.05 | 1.19 | 2.40 | -1.76 | -0.09 | 0.74 |
| Treatment C | 1.50 | 1.21 | 1.80 | 0.43 | 0.85 | 0.30 |
| Treatment D | 1.99 | 1.56 | 1.50 | 2.00 | 2.38 | 2.18 |
| Treatment E | 0.45 | 0.14 | 0.64 | 0.45 | 0.77 | 1.14 |
| Treatment F | 1.50 | 1.70 | 0.86 | 0.69 | 0.42 | 1.35 |
"Change from baseline in average EXACT-Respiratory Symptom (E-RS) total score during inter-visit periods and the entire treatment period~E-RS in COPD uses 11 respiratory symptom items from the 14-item EXAcerbations of COPD tool (EXACT). E-RS total score quantifies respiratory symptom severity on a scale ranging from 0 to 40. Higher E-RS total scores indicate more severe symptoms and a declining total score indicates health improvement. E-RS questionnaire was completed by the patient each evening (e-diary).~Definitions:~For details on baseline, inter-visit periods, and the entire treatment period, please refer to outcome measure #15." (NCT03084796)
Timeframe: Baseline, Inter-visit period 1, Inter-visit period 2, Entire treatment period
| Intervention | score on a scale (Least Squares Mean) | ||
|---|---|---|---|
| Inter-visit period 1 | Inter-visit period 2 | Entire treatment period | |
| Treatment A | -1.681 | -2.030 | -1.855 |
| Treatment B | -1.539 | -1.840 | -1.689 |
| Treatment C | -1.941 | -2.147 | -2.044 |
| Treatment D | -1.663 | -2.077 | -1.870 |
| Treatment E | -0.714 | -0.681 | -0.698 |
| Treatment F | -1.280 | -1.505 | -1.393 |
"Evaluate the change from baseline in average use of rescue medication (number of puffs/day) during the inter-visit periods and the entire treatment period.~Results are shown as number of puffs/day; a decrease (implies improvement) from baseline in average use of rescue medication.~Definitions:~Baseline=Data recorded during the run-in period (a 2-week period prior to randomization to study treatment and study drug intake); Inter-visit period 1=Starts at randomization to treatment (Visit 2, Week 0) and runs to the day before the subject returns to the clinic (Visit 3 (Week 3); Inter-visit period 2=Starts when the subject returns to the clinic (Visit 3, Week 3) and runs to the end of the randomized treatment period (Visit 4, Week 6); Entire Treatment period=From day of randomization to drug intake to the end of the randomized treatment period (Visit 4, Week 6); Randomization=Randomization to study drug treatment (Visit 2, Week 0);" (NCT03084796)
Timeframe: Baseline, Inter-visit period 1, Inter-visit period 2, Entire treatment period
| Intervention | Number of puffs/day (Least Squares Mean) | ||
|---|---|---|---|
| Inter-visit period 1 | Inter-visit period 2 | Entire treatment period | |
| Treatment A | -0.72 | -0.59 | -0.66 |
| Treatment B | -0.58 | -0.50 | -0.54 |
| Treatment C | -0.53 | -0.51 | -0.52 |
| Treatment D | -0.71 | -0.69 | -0.70 |
| Treatment E | -0.30 | -0.17 | -0.23 |
| Treatment F | -0.52 | -0.40 | -0.46 |
"Change from baseline in FEV1 AUC(0-4h), normalized by time on Day 1 of treatment (Week 0).~Spirometry, used to measure FEV1, was performed according to internationally accepted standards. The AUC for FEV1 on Day 1 and at Week 6 of treatment was calculated by using the linear trapezoidal rule, based on the changes in FEV1 from the baseline values, and divided by the observation time (4 hours).~Definitions:~AUC=Area under the curve; Baseline=Baseline value was the average of the pre-dose measurements (at 45 mins and 15 mins pre-dose), at Visit 2 (Week 0); Day 1=Day of the first dose of randomized study drug at Visit 2 (Week 0); FEV1=Forced expiratory volume in the 1st second; FEV1 AUC(0-4h)=Mean FEV1 after inhalation, measured at prespecified times for up to 4-h observation period (0-4h), normalized by time;" (NCT03084796)
Timeframe: Baseline, Day 1, Week 6
| Intervention | Litres (Least Squares Mean) | |
|---|---|---|
| Day 1 | Week 6 | |
| Treatment A | 0.101 | 0.116 |
| Treatment B | 0.115 | 0.157 |
| Treatment C | 0.173 | 0.198 |
| Treatment D | 0.190 | 0.204 |
| Treatment E | 0.030 | 0.024 |
| Treatment F | 0.194 | 0.253 |
"Change from baseline in FEV1 peak(0-4h) (L) on Day 1 and at Week 6.~Peak FEV1 is defined as the maximum FEV1 observed in the first 4 hours after dose of study medication.~Definitions:~Baseline=Baseline value was the average of the pre-dose measurements (at 45 mins and 15 mins pre-dose), at Visit 2 (Week 0); Day 1=Day of the first dose of randomized study drug at Visit 2 (Week 0); FEV1=Forced expiratory volume in the 1st second; Peak(0-4h)=Maximum FEV1 between 0 and 4 h." (NCT03084796)
Timeframe: Baseline, Day 1, Week 6
| Intervention | Litres (Least Squares Mean) | |
|---|---|---|
| Day 1 | Week 6 | |
| Treatment A | 0.197 | 0.212 |
| Treatment B | 0.211 | 0.255 |
| Treatment C | 0.260 | 0.305 |
| Treatment D | 0.288 | 0.301 |
| Treatment E | 0.136 | 0.143 |
| Treatment F | 0.299 | 0.356 |
"Change from baseline in FVC AUC(0-12h), normalized by time, on Day 1 and at the end of treatment (Week 6).~Spirometry, used to measure FVC, was performed according to internationally accepted standards. The AUC for FVC was calculated by using the linear trapezoidal rule, based on the changes in FVC from the baseline values, and divided by the observation time (4 hours).~Definitions:~AUC=Area under the curve; Baseline=Baseline value was the average of the pre-dose measurements (at 45 mins and 15 mins pre-dose), at Visit 2 (Week 0); Day 1=Day of the first dose of randomized study drug at Visit 2 (Week 0); FVC=Forced Vital Capacity; FVC AUC(0-12h)=Mean FVC after inhalation, measured at prespecified times for up to 12-h observation period (0-12 h), normalized by time;" (NCT03084796)
Timeframe: Baseline, Day 1, Week 6
| Intervention | Litres (Least Squares Mean) | |
|---|---|---|
| Day 1 | Week 6 | |
| Treatment A | 0.086 | 0.084 |
| Treatment B | 0.133 | 0.145 |
| Treatment C | 0.195 | 0.190 |
| Treatment D | 0.220 | 0.184 |
| Treatment E | 0.011 | -0.029 |
| Treatment F | 0.305 | 0.298 |
"Change from baseline in FVC AUC(0-4h), normalized by time, on Day 1 and at the end of treatment (Week 6).~Spirometry, used to measure FVC, was performed according to internationally accepted standards. The AUC for FVC was calculated by using the linear trapezoidal rule, based on the changes in FVC from the baseline values, and divided by the observation time (4 hours).~Definitions:~AUC=Area under the curve; Baseline=Baseline value was the average of the pre-dose measurements (at 45 mins and 15 mins pre-dose), at Visit 2 (Week 0); Day 1=Day of the first dose of randomized study drug at Visit 2 (Week 0); FVC=Forced Vital Capacity; FVC AUC(0-4)=Mean FVC after inhalation, measured at prespecified times for up to 4-h observation period (0-4 h), normalized by time;" (NCT03084796)
Timeframe: Baseline, Day 1, Week 6
| Intervention | Litres (Least Squares Mean) | |
|---|---|---|
| Day 1 | Week 6 | |
| Treatment A | 0.133 | 0.149 |
| Treatment B | 0.192 | 0.203 |
| Treatment C | 0.244 | 0.248 |
| Treatment D | 0.273 | 0.253 |
| Treatment E | 0.036 | 0.000 |
| Treatment F | 0.311 | 0.353 |
"Change from baseline in FVC peak(0-4h) (L) on Day 1 and at the end of treatment at Week 6. Peak FEV1 is defined as the maximum FEV1 observed in the first 4 hours after dose of study medication.~Definitions:~Baseline=Baseline value was the average of the pre-dose measurements (at 45 mins and 15 mins pre-dose), at Visit 2 (Week 0); Day 1=Day of the first dose of randomized study drug at Visit 2 (Week 0); FVC=Forced Vital Capacity; Peak(0-4h)=Maximum FEV1 between 0 and 4 h." (NCT03084796)
Timeframe: Baseline, Day 1, Week 6
| Intervention | Litres (Least Squares Mean) | |
|---|---|---|
| Day 1 | Week 6 | |
| Treatment A | 0.293 | 0.322 |
| Treatment B | 0.372 | 0.379 |
| Treatment C | 0.414 | 0.431 |
| Treatment D | 0.455 | 0.427 |
| Treatment E | 0.213 | 0.182 |
| Treatment F | 0.491 | 0.530 |
"Evaluate the number of rescue medication-free days compared with baseline. Results are shown as percentage (%) of rescue medication-free days; an increased value indicates improvement from baseline.~Definitions:~Baseline=Data recorded during the run-in period (a 2-week period prior to randomization to study treatment and study drug intake); Inter-visit period 1=Starts at randomization to treatment (Visit 2, Week 0) and runs to the day before the subject returns to the clinic (Visit 3, Week 3); Inter-visit period 2=Starts when the subject returns to the clinic (Visit 3, Week 3) and runs to the end of the randomized treatment period (Visit 4, Week 6); Entire Treatment period=From day of randomization to drug intake to the end of the randomized treatment period (Visit 4, Week 6); Randomization=Randomization to study drug treatment (Visit 2, Week 0)." (NCT03084796)
Timeframe: Baseline, Inter-visit period 1, Inter-visit period 2, Entire treatment period
| Intervention | % of of rescue medication-free days (Least Squares Mean) | ||
|---|---|---|---|
| Inter-visit period 1 | Inter-visit period 2 | Entire treatment period | |
| Treatment A | 16.78 | 13.83 | 15.30 |
| Treatment B | 15.67 | 15.51 | 15.59 |
| Treatment C | 15.55 | 14.03 | 14.79 |
| Treatment D | 18.19 | 18.15 | 18.17 |
| Treatment E | 8.90 | 7.07 | 7.98 |
| Treatment F | 13.51 | 11.27 | 12.39 |
"Change from baseline in FEV1 at treatment visit 3 (Week 3) and treatment visit 4 (Week 6) of treatment. Spirometry, used to measure FEV1, was performed according to internationally accepted standards.~Definitions:~Baseline=Baseline value was the average of the pre-dose measurements (at 45 mins and 15 mins pre-dose), at Visit 2 (Week 0); FEV1=Forced expiratory volume in the 1st second;" (NCT03084796)
Timeframe: Baseline, Week 3, Week 6
| Intervention | Litres (Least Squares Mean) | |
|---|---|---|
| Week 3 | Week 6 | |
| Treatment A | 0.059 | 0.020 |
| Treatment B | 0.080 | 0.088 |
| Treatment C | 0.122 | 0.107 |
| Treatment D | 0.111 | 0.130 |
| Treatment E | 0.000 | -0.012 |
| Treatment F | 0.122 | 0.112 |
"Change from baseline in IC at treatment Visit 3 (Week 3) and treatment Visit 4 (Week 6). Spirometry was used to measure IC and was performed according to internationally accepted standards.~Definitions:~Baseline: value of the measurement recorded at 45 mins pre-dose at Visit 2 (Week 0); IC=Inspiratory capacity;" (NCT03084796)
Timeframe: Baseline, Week 3, Week 6
| Intervention | Litres (Least Squares Mean) | |
|---|---|---|
| Week 3 | Week 6 | |
| Treatment A | 0.156 | 0.045 |
| Treatment B | 0.137 | 0.090 |
| Treatment C | 0.106 | 0.136 |
| Treatment D | 0.140 | 0.105 |
| Treatment E | 0.047 | 0.025 |
| Treatment F | 0.090 | 0.099 |
"Transitional Dyspnea Index (TDI) focal score at treatment visit 3 (Week 3) and treatment visit 4 (Week 6).~TDI is a validated, interviewer-administered questionnaire that measures changes in dyspnea severity from the baseline established by the BDI questionnaire. TDI consists of the same 24 items and 3 domains as the BDI, with the same 2-week recall period. Each category is rated by 7 grades ranging from -3 (major deterioration) to +3 (major improvement), with a total score ranging from -9 to +9, with higher scores indicating better outcomes. The minimal clinically important differences (MCID) is considered a change of ≥1 unit. The same investigator or designee interviewed the subject for the BDI and TDI during the study period. A TDI focal score of ≥1 is considered as clinically important.~Definitions:~Baseline=The BDI focal score value at Visit 2 (Week 0); BDI=Baseline Dyspnea Index; MCID=Minimal Clinically Important Differences; TDI=Transition Dyspnea Index;" (NCT03084796)
Timeframe: Baseline, Week 3, Week 6
| Intervention | score on a scale (Least Squares Mean) | |
|---|---|---|
| Week 3 | Week 6 | |
| Treatment A | 1.29 | 1.65 |
| Treatment B | 1.55 | 2.02 |
| Treatment C | 1.54 | 2.05 |
| Treatment D | 1.94 | 2.55 |
| Treatment E | 1.14 | 1.03 |
| Treatment F | 1.66 | 2.11 |
"Number of subjects achieving TDI focal score ≥1, at treatment visit 3 (Week 3) and at treatment visit 4 (Week 6).~TDI is a validated, interviewer-administered questionnaire that measures changes in dyspnea severity from the baseline established by the BDI questionnaire. TDI consists of the same 24 items and 3 domains as the BDI, with the same 2-week recall period. Each category is rated by 7 grades ranging from -3 (major deterioration) to +3 (major improvement); total score ranging from -9 to +9, with higher scores indicating better outcomes. The minimal clinically important differences (MCID) is considered a change of ≥1 unit. The same investigator or designee interviewed the subject for the BDI and TDI during the study period. A TDI focal score of ≥1 is considered as clinically important.~Definitions:~Baseline=The BDI focal score value at Visit 2 (Week 0); BDI=Baseline Dyspnea Index; MCID=Minimal Clinically Important Differences; TDI=Transition Dyspnea Index;" (NCT03084796)
Timeframe: Baseline, Week 3, Week 6
| Intervention | Participants (Count of Participants) | |
|---|---|---|
| Week 3 Focal Score ≥ 1 | Week 6 Focal Score ≥ 1 | |
| Treatment A | 70 | 74 |
| Treatment B | 78 | 83 |
| Treatment C | 75 | 82 |
| Treatment D | 84 | 91 |
| Treatment E | 67 | 55 |
| Treatment F | 74 | 80 |
"Vital signs -- Systolic blood pressure (SBP), Diastolic blood pressure (DBP) were measured at prespecified times, using a 12-Lead single ECGs were recorded at all study visits (pre-dose at V1 (Week -2) and V3 (Week 3), as well as at pre-dose and 1.5 hours post-dose at Visit 2 (Week 0) and Visit 4 (Week 6).~Results are shown by treatment group, as change from baseline (in mmHg) for representative timepoints.~Definitions:~Baseline=Values recorded pre-dose (Visit 2, Week 0); Day 1=Day of the first dose of randomized study drug (Visit 2, Week 0);" (NCT03084796)
Timeframe: Baseline, Day 1, Week 6
| Intervention | mmHg (Mean) | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| SBP, Day 1, 30 min post dose | DBP, Day 1, 30 min post dose | SBP, Day 1, 1,5 h post dose | DBP, Day 1, 1,5 h post dose | SBP, Day 1, 11 h post dose | DBP, Day 1, 11 h post dose | SBP, Week 6, pre-dose | DBP, Week 6, pre-dose | SBP, Week 6, 30 min post dose | DBP, Week 6, 30 min post dose | SBP, Week 6, 1,5 h post dose | DBP, Week 6, 1,5 h post dose | SBP, Week 6, 11 h post dose | DBP, Week 6, 11 h post dose | |
| Treatment A | -1.4 | -0.7 | 0.3 | -0.7 | 1.1 | -0.9 | 0.4 | 0.4 | -1.6 | -0.7 | -1.3 | -1.0 | 0.2 | -0.9 |
| Treatment B | -0.4 | -0.6 | -1.1 | -1.8 | 2.0 | 0.3 | 0.8 | 0.5 | -0.9 | -0.9 | -0.6 | -2.7 | 1.5 | -2.0 |
| Treatment C | -2.0 | -2.1 | -0.6 | -1.7 | -0.0 | -1.6 | 0.4 | -0.3 | -0.5 | -1.5 | -0.5 | -2.0 | 0.5 | -2.3 |
| Treatment D | -1.9 | -1.4 | -1.8 | -1.6 | 1.7 | -1.4 | -1.0 | -1.0 | -2.5 | -2.0 | -2.3 | -2.3 | 2.2 | -1.4 |
| Treatment E | -0.9 | -0.8 | 0.2 | -1.7 | 1.9 | -1.0 | 1.6 | 0.0 | 0.5 | -0.8 | 0.1 | -1.1 | 3.2 | -1.0 |
| Treatment F | -1.2 | 0.1 | -1.5 | -1.5 | 0.9 | -1.2 | 1.3 | -0.2 | 0.1 | -1.2 | 0.5 | -0.6 | 2.0 | -0.7 |
"24-hour Holter ECG - Prolonged QTcF - Change from baseline.~Subjects had a 24-h Holter recording before and 24 h after the 1st dose of study drug (Visit 2) and for 24 h before the last dose of study drug (Visit 4). The time-matched values recorded during the 24 h before the 1st dose of study drug on Visit 2 and served as the baseline for the Holter-extracted ECG parameters. The time-averaged baseline score is the average of the Day -1 scores at +5 min, +55 min, and at +2.5 h.~Results are presented as the number of subjects who had a change from baseline in QTcF of: > 30 msec, > 60 msec, and no prolongation (by > 30 msec or > 60 msec)." (NCT03084796)
Timeframe: Baseline, Day 1, Week 6
| Intervention | Participants (Count of Participants) | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| QTcF, Any post dose time point72488794 | QTcF, Any post dose time point72488795 | QTcF, Any post dose time point72488796 | QTcF, Any post dose time point72488797 | QTcF, Any post dose time point72488798 | QTcF, Any post dose time point72488793 | QTcF, Day 1, 5 min post dose72488793 | QTcF, Day 1, 5 min post dose72488795 | QTcF, Day 1, 5 min post dose72488796 | QTcF, Day 1, 5 min post dose72488797 | QTcF, Day 1, 5 min post dose72488798 | QTcF, Day 1, 5 min post dose72488794 | QTcF, Day 1, 55 min post dose72488793 | QTcF, Day 1, 55 min post dose72488794 | QTcF, Day 1, 55 min post dose72488796 | QTcF, Day 1, 55 min post dose72488797 | QTcF, Day 1, 55 min post dose72488798 | QTcF, Day 1, 55 min post dose72488795 | QTcF, Day 1, 2.5 h post dose72488793 | QTcF, Day 1, 2.5 h post dose72488795 | QTcF, Day 1, 2.5 h post dose72488796 | QTcF, Day 1, 2.5 h post dose72488797 | QTcF, Day 1, 2.5 h post dose72488798 | QTcF, Day 1, 2.5 h post dose72488794 | QTcF, Day before Week 6, 5 min post dose72488793 | QTcF, Day before Week 6, 5 min post dose72488794 | QTcF, Day before Week 6, 5 min post dose72488795 | QTcF, Day before Week 6, 5 min post dose72488796 | QTcF, Day before Week 6, 5 min post dose72488797 | QTcF, Day before Week 6, 5 min post dose72488798 | QTcF, Day before Week 6, 55 min post dose72488793 | QTcF, Day before Week 6, 55 min post dose72488794 | QTcF, Day before Week 6, 55 min post dose72488796 | QTcF, Day before Week 6, 55 min post dose72488797 | QTcF, Day before Week 6, 55 min post dose72488798 | QTcF, Day before Week 6, 55 min post dose72488795 | QTcF, Day before Week 6, 2.5 h post dose72488794 | QTcF, Day before Week 6, 2.5 h post dose72488796 | QTcF, Day before Week 6, 2.5 h post dose72488797 | QTcF, Day before Week 6, 2.5 h post dose72488798 | QTcF, Day before Week 6, 2.5 h post dose72488793 | QTcF, Day before Week 6, 2.5 h post dose72488795 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Change from baseline: > 60 msec | No change from baseline (> 30 msec or > 60 msec) | Change from baseline: > 30 msec | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Treatment A | 19 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Treatment B | 20 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Treatment C | 21 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Treatment D | 20 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Treatment E | 16 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Treatment F | 18 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Treatment A | 0 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Treatment B | 1 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Treatment C | 0 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Treatment D | 2 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Treatment E | 2 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Treatment F | 1 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Treatment A | 102 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Treatment B | 102 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Treatment C | 100 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Treatment D | 101 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Treatment E | 103 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Treatment F | 104 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Treatment A | 2 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Treatment B | 4 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Treatment C | 9 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Treatment E | 3 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Treatment F | 4 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Treatment D | 0 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Treatment E | 0 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Treatment A | 119 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Treatment B | 119 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Treatment C | 112 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Treatment D | 121 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Treatment E | 118 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Treatment F | 119 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Treatment A | 8 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Treatment C | 5 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Treatment D | 6 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Treatment E | 4 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Treatment F | 5 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Treatment A | 113 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Treatment C | 116 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Treatment D | 116 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Treatment E | 116 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Treatment F | 118 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Treatment A | 5 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Treatment B | 12 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Treatment C | 6 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Treatment D | 5 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Treatment E | 6 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Treatment F | 8 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Treatment B | 0 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Treatment D | 1 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Treatment E | 1 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Treatment F | 0 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Treatment A | 116 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Treatment B | 111 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Treatment C | 115 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Treatment D | 117 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Treatment E | 114 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Treatment F | 115 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Treatment B | 3 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Treatment D | 3 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Treatment F | 3 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Treatment C | 121 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Treatment D | 120 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Treatment E | 121 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Treatment F | 120 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Treatment C | 7 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Treatment D | 7 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Treatment B | 123 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Treatment C | 114 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Treatment A | 6 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Treatment B | 6 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Treatment C | 3 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Treatment F | 7 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Treatment A | 115 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Treatment B | 117 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Treatment C | 118 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Treatment F | 116 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
"24-hour Holter ECG - Prolonged QTcF - Female subjects.~Subjects had a 24-h Holter recording before and 24 h after the 1st dose of study drug (Visit 2) and for 24 h before the last dose of study drug (Visit 4). The time-matched values recorded during the 24 h before the 1st dose of study drug on Visit 2 and served as the baseline for the Holter-extracted ECG parameters. The time-averaged baseline score is the average of the Day -1 scores at +5 min, +55 min, and at +2.5 h." (NCT03084796)
Timeframe: Baseline, Day 1, Week 6
| Intervention | Participants (Count of Participants) | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| QTcF, Day -1, 5 min72488795 | QTcF, Day -1, 5 min72488798 | QTcF, Day -1, 5 min72488793 | QTcF, Day -1, 5 min72488794 | QTcF, Day -1, 5 min72488796 | QTcF, Day -1, 5 min72488797 | QTcF, Day -1, 55 min72488795 | QTcF, Day -1, 55 min72488797 | QTcF, Day -1, 55 min72488798 | QTcF, Day -1, 55 min72488793 | QTcF, Day -1, 55 min72488794 | QTcF, Day -1, 55 min72488796 | QTcF, Day -1, 2.5 h72488794 | QTcF, Day -1, 2.5 h72488797 | QTcF, Day -1, 2.5 h72488795 | QTcF, Day -1, 2.5 h72488793 | QTcF, Day -1, 2.5 h72488796 | QTcF, Day -1, 2.5 h72488798 | QTcF, Any post dose time point72488794 | QTcF, Any post dose time point72488795 | QTcF, Any post dose time point72488797 | QTcF, Any post dose time point72488798 | QTcF, Any post dose time point72488793 | QTcF, Any post dose time point72488796 | QTcF, Day 1, 5 min post dose72488798 | QTcF, Day 1, 5 min post dose72488795 | QTcF, Day 1, 5 min post dose72488793 | QTcF, Day 1, 5 min post dose72488794 | QTcF, Day 1, 5 min post dose72488796 | QTcF, Day 1, 5 min post dose72488797 | QTcF, Day 1, 55 min post dose72488793 | QTcF, Day 1, 55 min post dose72488798 | QTcF, Day 1, 55 min post dose72488797 | QTcF, Day 1, 55 min post dose72488794 | QTcF, Day 1, 55 min post dose72488795 | QTcF, Day 1, 55 min post dose72488796 | QTcF, Day 1, 2.5 h post dose72488795 | QTcF, Day 1, 2.5 h post dose72488793 | QTcF, Day 1, 2.5 h post dose72488794 | QTcF, Day 1, 2.5 h post dose72488796 | QTcF, Day 1, 2.5 h post dose72488797 | QTcF, Day 1, 2.5 h post dose72488798 | QTcF, Day before Week 6, 5 min post dose72488798 | QTcF, Day before Week 6, 5 min post dose72488793 | QTcF, Day before Week 6, 5 min post dose72488794 | QTcF, Day before Week 6, 5 min post dose72488795 | QTcF, Day before Week 6, 5 min post dose72488796 | QTcF, Day before Week 6, 5 min post dose72488797 | QTcF, Day before Week 6, 55 min post dose72488798 | QTcF, Day before Week 6, 55 min post dose72488793 | QTcF, Day before Week 6, 55 min post dose72488794 | QTcF, Day before Week 6, 55 min post dose72488795 | QTcF, Day before Week 6, 55 min post dose72488796 | QTcF, Day before Week 6, 55 min post dose72488797 | QTcF, Day before Week 6, 2.5 h post dose72488798 | QTcF, Day before Week 6, 2.5 h post dose72488793 | QTcF, Day before Week 6, 2.5 h post dose72488794 | QTcF, Day before Week 6, 2.5 h post dose72488795 | QTcF, Day before Week 6, 2.5 h post dose72488796 | QTcF, Day before Week 6, 2.5 h post dose72488797 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Actual value > 470 msec | Actual value > 500 msec | No prolongation (> 470 msec or > 500 msec) | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Treatment B | 64 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Treatment C | 67 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Treatment E | 0 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Treatment A | 3 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Treatment F | 1 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Treatment A | 55 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Treatment F | 0 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Treatment F | 57 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Treatment A | 2 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Treatment B | 3 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Treatment A | 56 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Treatment B | 65 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Treatment C | 0 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Treatment F | 56 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Treatment A | 1 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Treatment A | 57 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Treatment B | 2 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Treatment A | 0 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Treatment B | 0 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Treatment D | 0 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Treatment A | 58 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Treatment B | 66 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Treatment D | 65 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Treatment E | 52 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Treatment B | 1 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Treatment D | 1 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Treatment B | 67 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Treatment D | 64 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
"24-hour Holter ECG - Prolonged QTcF - Male subjects.~Subjects had a 24-h Holter recording before and 24 h after the 1st dose of study drug (Visit 2) and for 24 h before the last dose of study drug (Visit 4). The time-matched values recorded during the 24 h before the 1st dose of study drug on Visit 2 and served as the baseline for the Holter-extracted ECG parameters. The time-averaged baseline score is the average of the Day -1 scores at +5 min, +55 min, and at +2.5 h." (NCT03084796)
Timeframe: Baseline, Day 1, Week 6
| Intervention | Participants (Count of Participants) | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| QTcF, Day -1, 5 min72488794 | QTcF, Day -1, 5 min72488798 | QTcF, Day -1, 5 min72488797 | QTcF, Day -1, 5 min72488793 | QTcF, Day -1, 5 min72488795 | QTcF, Day -1, 5 min72488796 | QTcF, Day -1, 55 min72488793 | QTcF, Day -1, 55 min72488794 | QTcF, Day -1, 55 min72488795 | QTcF, Day -1, 55 min72488798 | QTcF, Day -1, 55 min72488797 | QTcF, Day -1, 55 min72488796 | QTcF, Day -1, 2.5 h72488794 | QTcF, Day -1, 2.5 h72488797 | QTcF, Day -1, 2.5 h72488798 | QTcF, Day -1, 2.5 h72488793 | QTcF, Day -1, 2.5 h72488795 | QTcF, Day -1, 2.5 h72488796 | QTcF, Any post dose time point72488793 | QTcF, Any post dose time point72488794 | QTcF, Any post dose time point72488797 | QTcF, Any post dose time point72488798 | QTcF, Any post dose time point72488795 | QTcF, Any post dose time point72488796 | QTcF, Day 1, 5 min post dose72488794 | QTcF, Day 1, 5 min post dose72488797 | QTcF, Day 1, 5 min post dose72488798 | QTcF, Day 1, 5 min post dose72488793 | QTcF, Day 1, 5 min post dose72488795 | QTcF, Day 1, 5 min post dose72488796 | QTcF, Day 1, 55 min post dose72488795 | QTcF, Day 1, 55 min post dose72488797 | QTcF, Day 1, 55 min post dose72488798 | QTcF, Day 1, 55 min post dose72488793 | QTcF, Day 1, 55 min post dose72488794 | QTcF, Day 1, 55 min post dose72488796 | QTcF, Day 1, 2.5 h post dose72488794 | QTcF, Day 1, 2.5 h post dose72488798 | QTcF, Day 1, 2.5 h post dose72488797 | QTcF, Day 1, 2.5 h post dose72488793 | QTcF, Day 1, 2.5 h post dose72488795 | QTcF, Day 1, 2.5 h post dose72488796 | QTcF, Day before Week 6, 5 min post dose72488794 | QTcF, Day before Week 6, 5 min post dose72488797 | QTcF, Day before Week 6, 5 min post dose72488798 | QTcF, Day before Week 6, 5 min post dose72488793 | QTcF, Day before Week 6, 5 min post dose72488795 | QTcF, Day before Week 6, 5 min post dose72488796 | QTcF, Day before Week 6, 55 min post dose72488793 | QTcF, Day before Week 6, 55 min post dose72488798 | QTcF, Day before Week 6, 55 min post dose72488794 | QTcF, Day before Week 6, 55 min post dose72488795 | QTcF, Day before Week 6, 55 min post dose72488796 | QTcF, Day before Week 6, 55 min post dose72488797 | QTcF, Day before Week 6, 2.5 h post dose72488793 | QTcF, Day before Week 6, 2.5 h post dose72488794 | QTcF, Day before Week 6, 2.5 h post dose72488797 | QTcF, Day before Week 6, 2.5 h post dose72488798 | QTcF, Day before Week 6, 2.5 h post dose72488795 | QTcF, Day before Week 6, 2.5 h post dose72488796 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Actual value > 450 msec | Actual value > 480 msec | Actual value > 500 msec | No prolongation (> 450 msec or > 480 msec or > 500 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Treatment F | 1 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Treatment B | 55 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Treatment C | 54 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Treatment F | 65 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Treatment C | 1 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Treatment A | 62 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Treatment C | 53 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Treatment E | 68 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Treatment F | 63 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Treatment B | 1 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Treatment E | 1 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Treatment B | 54 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Treatment E | 66 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Treatment F | 66 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Treatment B | 4 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Treatment C | 6 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Treatment D | 4 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Treatment E | 2 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Treatment F | 5 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Treatment E | 0 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Treatment F | 3 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Treatment B | 0 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Treatment F | 0 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Treatment B | 51 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Treatment C | 47 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Treatment D | 54 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Treatment E | 67 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Treatment F | 58 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Treatment B | 2 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Treatment C | 0 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Treatment C | 51 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Treatment F | 61 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Treatment C | 3 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Treatment A | 1 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Treatment B | 53 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Treatment C | 50 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Treatment A | 3 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Treatment B | 3 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Treatment F | 4 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Treatment A | 59 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Treatment B | 52 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Treatment F | 62 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Treatment D | 3 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Treatment F | 2 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Treatment A | 0 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Treatment A | 60 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Treatment D | 55 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Treatment A | 2 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Treatment C | 2 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Treatment D | 2 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Treatment D | 0 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Treatment A | 61 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Treatment C | 52 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Treatment D | 56 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Treatment E | 69 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Treatment D | 1 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Treatment D | 57 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
FEV1 is the maximal amount of air that can be forcefully exhaled in one second. During each study period, pre- and post-bronchodilator spirometry for evaluation of FEV1 was performed at study visits as follows: approximately 1 hour after administration of the first bronchodilator (1 hour), and approximately 1 hour after administration of the second short-acting bronchodilator (2 hours). (NCT01691482)
Timeframe: up to 35 days
| Intervention | percentage of days (Mean) | |||
|---|---|---|---|---|
| Albuterol/Salbutamol (A/S) alone, 1 hour | A/S followed by ipratropium, 2 hours | Ipratropium alone, 1 hour | Ipratropium followed by A/S, 2 hours | |
| Albuterol/Salbutamol Followed by Ipratropium | 58.4 | 71.7 | NA | NA |
| Ipratropium Follwed by Albuterol/Salbutamol | NA | NA | 55.4 | 69.1 |
FEV1 is the maximal amount of air that can be forcefully exhaled in one second. During each study period, pre- and post-bronchodilator spirometry for evaluation of FEV1 was performed at study visits as follows: approximately 1 hour after administration of the first bronchodilator (1 hour), and approximately 1 hour after administration of the second short-acting bronchodilator (2 hours). (NCT01691482)
Timeframe: up to 35 days
| Intervention | percentage of days (Mean) | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| A/S alone, 1 hour, 100 mL | A/S followed by ipratropium, 2 hours, 100 mL | Ipratropium alone, 1 hour, 100 mL | Ipratropium followed by A/S, 2 hours, 100 mL | A/S alone, 1 hour, 200 mL | A/S followed by ipratropium, 2 hours, 200 mL | Ipratropium alone, 1 hour, 200 mL | Ipratropium followed by A/S, 2 hours, 200 mL | A/S alone, 1 hour, 250 mL | A/S followed by ipratropium, 2 hours, 250 mL | Ipratropium alone, 1 hour, 250 mL | Ipratropium followed by A/S, 2 hours, 250 mL | |
| Albuterol/Salbutamol Followed by Ipratropium | 81.6 | 85.2 | NA | NA | 59.2 | 72.7 | NA | NA | 45.9 | 64.0 | NA | NA |
| Ipratropium Follwed by Albuterol/Salbutamol | NA | NA | 72.9 | 81.2 | NA | NA | 56.0 | 70.5 | NA | NA | 45.8 | 59.6 |
The maximal bronchodilator response for the first administered agent is defined as the FEV1 (the maximal amount of air that can be forcefully exhaled in one second) 1 hour post-dose of the first bronchodilator minus the pre-dose. The maximal bronchodilator response for the second agent is defined as the FEV1 1 hour post-dose of the second bronchodilator minus the FEV1 at 1 hour post-dose of the first bronchodilator. The maximal bronchodilator response for the combination is defined as the FEV1 (the maximal amount of air that can be forcefully exhaled in one second) at 1 hour post-administration of the second bronchodilator minus the corresponding pre-dose FEV1. Derived FEV1 response is FEV1 change from 0 hours (0H) for the first agent assessment (at 1 hour [1H]); change from 1H for the second agent assessment (at 2 hours [2H]); and change from 0H for the combination assessment (at 2H). Data were adjusted for FEV1, smoking status, and center. (NCT01691482)
Timeframe: up to 10 days
| Intervention | Liters (Least Squares Mean) | |||||
|---|---|---|---|---|---|---|
| First agent, albuterol/salbutamol (A/S) | First agent, ipratropium | Second agent, A/S | Second agent, ipratropium | A/S followed by ipratropium | Ipratropium followed by A/S | |
| All Randomized Participants | 0.269 | 0.243 | 0.094 | 0.094 | 0.363 | 0.337 |
FEV1 is the maximal amount of air that can be forcefully exhaled in one second. During each study period, pre- and post-bronchodilator spirometry for evaluation of FEV1 was performed at study visits as follows: prior to administration of the first short-acting bronchodilator, approximately 1 hour after administration of the first bronchodilator (1 hour), and approximately 1 hour after administration of the second short-acting bronchodilator (2 hours). Variability in daily FEV1 was measured as the fluctuation around the mean FEV1 data collected from Day 1 to Day 10. Variability was measured by the coefficient of variation (CV) and the half range. The CV is the dispersion of the data around the mean, whereas the half range method is the difference between the maximum and minimum FEV1 values. (NCT01691482)
Timeframe: up to 10 days
| Intervention | Liters (Mean) | ||||
|---|---|---|---|---|---|
| Pre-dose/non-bronchodilator | Albuterol/Salbutamol (A/S) alone, 1 hour | A/S followed by ipratropium, 2 hours | Ipratropium alone, 1 hour | Ipratropium followed by A/S, 2 hours | |
| Albuterol/Salbutamol Followed by Ipratropium | 0.081 | 0.059 | 0.054 | NA | NA |
| Ipratropium Followed by Albuterol/Salbutamol | 0.079 | NA | NA | 0.072 | 0.063 |
FEV1 is the maximal amount of air that can be forcefully exhaled in one second. During each study period, pre- and post-bronchodilator spirometry for evaluation of FEV1 was performed at study visits as follows: prior to administration of the first short-acting bronchodilator, approximately 1 hour after administration of the first bronchodilator (1 hour), and approximately 1 hour after administration of the second short-acting bronchodilator (2 hours). Variability in daily FEV1 was measured as the fluctuation around the mean FEV1 data collected from Day 1 to Day 10. Variability was measured by the coefficient of variation (CV) and the half range. The CV is the dispersion of the data around the mean, whereas the half range method is half the difference between the maximum and minimum FEV1 values. (NCT01691482)
Timeframe: up to 10 days
| Intervention | Liters (Mean) | ||||
|---|---|---|---|---|---|
| Pre-dose/non-bronchodilator | Albuterol/Salbutamol (A/S) alone, 1 hour | A/S followed by ipratropium, 2 hours | Ipratropium alone, 1 hour | Ipratropium followed by A/S, 2 hours | |
| Albuterol/Salbutamol Followed by Ipratropium | 0.136 | 0.125 | 0.122 | NA | NA |
| Ipratropium Followed by Albuterol/Salbutamol | 0.135 | NA | NA | 0.145 | 0.137 |
IC is the the total amount of air that can be drawn into the lungs after normal expiration. During each study period, pre- and post-bronchodilator spirometry for evaluation of IC was performed at study visits as follows: prior to administration of the first short-acting bronchodilator, approximately 1 hour after administration of the first bronchodilator (1 hour), and approximately 1 hour after administration of the second short-acting bronchodilator (2 hours). Variability in daily IC was measured as the fluctuation around the mean IC data collected from Day 1 to Day 10. Variability was measured by the coefficent of variation (CV) and the half range. The CV is the dispersion of the data around the mean, whereas the half range method is half the difference between the maximum and minimum IC values. (NCT01691482)
Timeframe: up to 10 days
| Intervention | Liters (Mean) | ||||
|---|---|---|---|---|---|
| Pre-dose/non-bronchodilator | Albuterol/Salbutamol (A/S) alone, 1 hour | A/S followed by ipratropium, 2 hours | Ipratropium alone, 1 hour | Ipratropium followed by A/S, 2 hours | |
| Albuterol/Salbutamol Followed by Ipratropium | 0.225 | 0.229 | 0.233 | NA | NA |
| Ipratropium Followed by Albuterol/Salbutamol | 0.236 | NA | NA | 0.235 | 0.221 |
IC is the the total amount of air that can be drawn into the lungs after normal expiration. During each study period, pre- and post-bronchodilator spirometry for evaluation of IC was performed at study visits as follows: prior to administration of the first short-acting bronchodilator, approximately 1 hour after administration of the first bronchodilator (1 hour), and approximately 1 hour after administration of the second short-acting bronchodilator (2 hours). Variability in daily IC was measured as the fluctuation around the mean IC data collected from Day 1 to Day 10. Variability was measured by the coefficent of variation (CV) and the half range. The CV is the dispersion of the data around the mean, whereas the half range method is the difference between the maximum and minimum IC values. (NCT01691482)
Timeframe: up to 10 days
| Intervention | Liters (Mean) | ||||
|---|---|---|---|---|---|
| Pre-dose/non-bronchodilator | Albuterol/Salbutamol (A/S) alone, 1 hour | A/S followed by ipratropium (A+I), 2 hours | Ipratropium alone, 1 hour | Ipratropium followed by A/S (I+A), 2 hours | |
| Albuterol/Salbutamol Followed by Ipratropium | 0.078 | 0.069 | 0.070 | NA | NA |
| Ipratropium Followed by Albuterol/Salbutamol | 0.083 | NA | NA | 0.072 | 0.066 |
A COPD EX was defined as the worsening of >=2 major symptoms (dyspnoea, sputum volume, sputum purulence [containing/discharging pus]) or the worsening of any 1 major symptom together with any 1 minor symptom (sore throat, cold [nasal discharge and/or nasal conjestion], fever without other cause, increased cough or wheeze) for at least 2 consecutive days. COPD EXs were identified by symptom review, and/or were based on investigator judgment (via phone contact or at a clinic visit). Hospitalization had to occur more than 21 days post-discharge or physician's office visit for a prior COPD EX. (NCT01110200)
Timeframe: From 21 days post-discharge (hospital or emergency room) or physician's office visit, up to 29 weeks
| Intervention | Exacerbations (Number) |
|---|---|
| FSC 250/50 | 50 |
| SAL 50 | 51 |
A COPD exacerbation (EX) was defined as the worsening of >=2 major symptoms (dyspnoea, sputum volume, sputum purulence [containing/discharging pus]) or the worsening of any 1 major symptom together with any 1 minor symptom (sore throat, cold [nasal discharge and/or nasal conjestion], fever without other cause, increased cough or wheeze) for at least 2 consecutive days. COPD EXs were identified by symptom review, and/or were based on investigator judgment (via phone contact or at a clinic visit). Hospitalization had to occur >21 days post-discharge/physician's office visit for a prior COPD EX. (NCT01110200)
Timeframe: From 21 days post-discharge (hospital or emergency room) or physician's office visit, up to 29 weeks
| Intervention | participants (Number) |
|---|---|
| FSC 250/50 | 43 |
| SAL 50 | 39 |
A COPD EX was defined as the worsening of >=2 major symptoms (dyspnoea, sputum volume, sputum purulence [containing/discharging pus]) or the worsening of any 1 major symptom together with any 1 minor symptom (sore throat, cold [nasal discharge and/or nasal conjestion], fever without other cause, increased cough or wheeze) for at least 2 consecutive days. COPD EXs were identified by symptom review, and/or were based on investigator judgment (via phone contact or at a clinic visit). (NCT01110200)
Timeframe: From Baseline up to Week 29, approximately
| Intervention | participants (Number) |
|---|---|
| FSC 250/50 | 102 |
| SAL 50 | 115 |
A COPD EX was defined as the worsening of >=2 major symptoms (dyspnoea, sputum volume, sputum purulence [containing/discharging pus]) or the worsening of any 1 major symptom together with any 1 minor symptom (sore throat, cold [nasal discharge and/or nasal conjestion], fever without other cause, increased cough or wheeze) for at least 2 consecutive days. COPD EXs were identified by symptom review, and/or were based on investigator judgment (via phone contact or at a clinic visit). (NCT01110200)
Timeframe: From Baseline up to Week 29, approximately
| Intervention | exacerbations (Number) | |||
|---|---|---|---|---|
| Number of EXs, n=314,325 | Number of EXs requiring hospitalization, n=156,182 | Number of EXs treated with OCSs, n=156, 182 | Number of EXs treated with ABs, n=156, 182 | |
| FSC 250/50 | 156 | 50 | 140 | 121 |
| SAL 50 | 182 | 51 | 167 | 144 |
A COPD EX was defined as the worsening of >=2 major symptoms (dyspnoea, sputum volume, sputum purulence [containing/discharging pus]) or the worsening of any 1 major symptom together with any 1 minor symptom (sore throat, cold [nasal discharge and/or nasal conjestion], fever without other cause, increased cough or wheeze) for at least 2 consecutive days. COPD EXs were identified by symptom review, and/or were based on investigator judgment (via phone contact or at a clinic visit). Hospitalization had to occur more than 21 days post-discharge or physician's office visit for a prior COPD EX. (NCT01110200)
Timeframe: From 21 days post-discharge (hospital or emergency room) or physician's office visit, up to 29 weeks
| Intervention | participants (Number) | ||||
|---|---|---|---|---|---|
| 0 | 1 | 2 | 3 | 4 | |
| FSC 250/50 | 271 | 36 | 7 | 0 | 0 |
| SAL 50 | 286 | 31 | 5 | 2 | 1 |
Change from baseline of Dyspnea symptoms evaluated using the breathlessness diary, a 5-point Likert-type scale, ranging from 0 to 4 with higher scores indicating a more severe manifestation of the Dyspnea symptom. Change from baseline was calculated by averaging treatment period Dyspnea scores and subtracting the baseline Dyspnea scores. (NCT00419744)
Timeframe: 12 months
| Intervention | Scores on a scale (Mean) |
|---|---|
| SYM 160/4.5 X 2 BID | -0.30 |
| SYM 80/4.5 X 2 BID | -0.29 |
| FOR 4.5 X 2 BID | -0.24 |
Change in evening PEF from baseline to the average of the randomized treatment period, as calculated by averaging treatment period PEF values and subtracting the baseline evening PEF value. (NCT00419744)
Timeframe: 12 months
| Intervention | L/min (Mean) |
|---|---|
| SYM 160/4.5 X 2 BID | 17.62 |
| SYM 80/4.5 X 2 BID | 17.77 |
| FOR 4.5 X 2 BID | 14.08 |
Change in morning PEF from baseline to the average of the randomized treatment period, as calculated by averaging treatment period PEF values and subtracting the baseline morning PEF value. (NCT00419744)
Timeframe: 12 months
| Intervention | L/min (Mean) |
|---|---|
| SYM 160/4.5 X 2 BID | 19.82 |
| SYM 80/4.5 X 2 BID | 19.61 |
| FOR 4.5 X 2 BID | 15.81 |
Change in pre-dose FEV1 from baseline to the average of the randomized treatment period, as calculated by averaging treatment period FEV1 values and subtracting the pre-dose value. (NCT00419744)
Timeframe: 12 months
| Intervention | Liters (L) (Mean) |
|---|---|
| SYM 160/4.5 X 2 BID | 0.07 |
| SYM 80/4.5 X 2 BID | 0.07 |
| FOR 4.5 X 2 BID | 0.04 |
Rate of exacerbations per subject-year (NCT00419744)
Timeframe: 12 months
| Intervention | Rate (Number) |
|---|---|
| SYM 160/4.5 X 2 BID | 0.639 |
| SYM 80/4.5 X 2 BID | 0.745 |
| FOR 4.5 X 2 BID | 1.029 |
Change from baseline in the SGRQ overall score, as calculated by averaging treatment period SGRQ scores and subtracting the baseline SGRQ scores. The SGRQ contains 3 domains: Symptoms (distress due to respiratory symptoms, 8 questions), Activity (disturbance of physical activity, 16 questions), and Impacts (overall impact on daily life and well-being, 26 questions). Lower scores are associated with less severe symptoms. (NCT00419744)
Timeframe: 12 months
| Intervention | Scores on a scale (Mean) |
|---|---|
| SYM 160/4.5 X 2 BID | -6.23 |
| SYM 80/4.5 X 2 BID | -5.00 |
| FOR 4.5 X 2 BID | -5.71 |
Number of COPD-related exacerbations per patient-treatment year. COPD-related exacerbation was defined as worsening COPD that required a course of oral steriods for treatment and/or hospitalization. (NCT00419744)
Timeframe: 12 months
| Intervention | Exacerbations (Number) |
|---|---|
| SYM 160/4.5 X 2 BID | 0.75 |
| SYM 80/4.5 X 2 BID | 0.84 |
| FOR 4.5 X 2 BID | 1.14 |
Change from baseline in the use of beta-2 agonists, as calculated by averaging treatment period inhalations per day and subtracting the baseline number of inhalations per day. (NCT00419744)
Timeframe: 12 months
| Intervention | Number of inhalations (Mean) |
|---|---|
| SYM 160/4.5 X 2 BID | -1.21 |
| SYM 80/4.5 X 2 BID | -1.03 |
| FOR 4.5 X 2 BID | -0.28 |
CRQ-SAS measures 4 domains (fatigue, emotional function, mastery and dyspnea) of functioning of participants (par.) with COPD: mastery (amount of control the par. feels he/she has over COPD symptoms); fatigue (how tired the par. feels); emotional function (how anxious/depressed the par. feels); and dyspnea (how short of breath the par. feels during physical activities). Each domain is calculated separately and measured on a scale of 1-7 (1=maximum impairment; 7=no impairment). Dyspnea domain score is the mean of all non-missing responses for that domain. Only the dyspnea domain was measured as a secondary outcome. BL scores are the derived scores for each domain and total at Day 1 pre-dose. Change from BL was calculated as the average of the Day 168 values minus the BL value. Analysis performed used a repeated measures model with covariates of treatment, smoking status at screening (stratum), BL (derived scores at Day 1 pre-dose), day, day by BL, and day by treatment interactions. (NCT01376245)
Timeframe: Baseline (BL) and Day 168
| Intervention | Scores on a scale (Least Squares Mean) |
|---|---|
| Placebo | 0.09 |
| FF/VI 50/25 µg OD | 0.30 |
| FF/VI 100/25 µg OD | 0.43 |
| FF/VI 200/25 µg OD | 0.37 |
Pulmonary function was measured by forced expiratory volume in one second (FEV1), defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 was defined as the pre-dose and pre-bronchodilator FEV1, which was obtained at each clinic visit. Baseline is defined as the mean of the two assessments made 30 minutes pre-dose and 5 minutes pre-dose on Treatment Day 1.Trough FEV1 is defined as the mean of the FEV1 values obtained 23 and 24 hours after dosing at each clinic visit. Change from Baseline was calculated as the average at each clinic visit minus the Baseline value. Analysis was performed using a repeated measures model with covariates of treatment, smoking status at screening (stratum), baseline - mean of the two assessments made 30 minutes pre-dose and immediately pre-dose on Day 1, day, day by baseline and day by treatment interactions. (NCT01376245)
Timeframe: Baseline to Day 169
| Intervention | Liters (Least Squares Mean) |
|---|---|
| Placebo | -0.027 |
| FF/VI 50/25 µg OD | 0.113 |
| FF/VI 100/25 µg OD | 0.152 |
| FF/VI 200/25 µg OD | 0.167 |
"12-lead electrocardiogram (12-lead ECG) parameter - heart rate (HR) was measured at baseline (Day 1) and Week 8.~Change from baseline.~Definitions:~Baseline=Baseline values were defined at visit 2 (Week 0) pre-dose;~bpm=Beats per minute;" (NCT03084718)
Timeframe: Baseline, Week 8
| Intervention | bpm (Mean) |
|---|---|
| Treatment A (CHF 718 pMDI 100 µg TDD) | 0.6 |
| Treatment B (CHF 718 pMDI 400 µg TDD) | 0.2 |
| Treatment C (CHF 718 pMDI 800 µg TDD) | 0.4 |
| Treatment D (Placebo) | 1.2 |
| Treatment E (QVAR^®, 320 µg TDD) | -0.4 |
"24-hr Creatinine - Change From Baseline.~For the evaluation of the 24-hr creatinine excretion, 24-hour urine sample were collected. Creatinine was measured using liquid chromatography-tandem mass spectrometry (LC-MS/MS).~Definitions:~Baseline=Baseline values were defined at visit 2 (Week 0) pre-dose;" (NCT03084718)
Timeframe: Baseline, Week 8
| Intervention | umol/mol (Median) |
|---|---|
| Treatment A (CHF 718 pMDI 100 µg TDD) | 0.00 |
| Treatment B (CHF 718 pMDI 400 µg TDD) | 0.00 |
| Treatment C (CHF 718 pMDI 800 µg TDD) | 0.00 |
| Treatment D (Placebo) | 0.00 |
| Treatment E (QVAR^®, 320 µg TDD) | 0.00 |
"24-hr Urinary Free Cortisol - Change From Baseline.~For the evaluation of the 24-hr Urine-Free cortisol excretion, 24-hour urine samples were collected. Urine-free cortisol was measured using liquid chromatography-tandem mass spectrometry (LC-MS/MS).~Definitions:~Baseline=Baseline values were defined at visit 2 (Week 0) pre-dose;" (NCT03084718)
Timeframe: Baseline, Week 8
| Intervention | nmol/day (Median) |
|---|---|
| Treatment A (CHF 718 pMDI 100 µg TDD) | -3.60 |
| Treatment B (CHF 718 pMDI 400 µg TDD) | -5.35 |
| Treatment C (CHF 718 pMDI 800 µg TDD) | -4.10 |
| Treatment D (Placebo) | 1.40 |
| Treatment E (QVAR^®, 320 µg TDD) | -3.50 |
"Change from baseline in pre-dose morning FEV1 at Week 4.~Spirometry, used to measure FEV1, was performed according to internationally accepted standards.~Definitions:~Baseline=Baseline values for pre-dose FEV1 were the average of measurements taken at V2 (Week 0) at 45 minutes and 15 minutes pre-dose; FEV1=Forced expiratory volume in the 1st second;" (NCT03084718)
Timeframe: Baseline, Week 4
| Intervention | Litres (Least Squares Mean) |
|---|---|
| Treatment A (CHF 718 pMDI 100 µg TDD) | 0.021 |
| Treatment B (CHF 718 pMDI 400 µg TDD) | 0.120 |
| Treatment C (CHF 718 pMDI 800 µg TDD) | 0.073 |
| Treatment D (Placebo) | 0.003 |
| Treatment E (QVAR^®, 320 µg TDD) | 0.077 |
"Change from baseline in pre-dose morning FEV1 (average of pre-dose FEV1 measurements) at Week 8.~Spirometry, used to measure FEV1, was performed according to internationally accepted standards.~Definitions:~Baseline=Baseline values for pre-dose FEV1 were the average of measurements taken at V2 (Week 0) at 45 minutes and 15 minutes pre-dose; FEV1=Forced expiratory volume in the 1st second;" (NCT03084718)
Timeframe: Baseline, Week 8
| Intervention | Litres (Least Squares Mean) |
|---|---|
| Treatment A (CHF 718 pMDI 100 µg TDD) | 0.021 |
| Treatment B (CHF 718 pMDI 400 µg TDD) | 0.090 |
| Treatment C (CHF 718 pMDI 800 µg TDD) | 0.070 |
| Treatment D (Placebo) | -0.023 |
| Treatment E (QVAR^®, 320 µg TDD) | 0.078 |
"12-lead electrocardiogram (12-lead ECG) parameters - PR, QRS, QTcF intervals - were measured at baseline (Day 1) and Week 8.~Changes from baseline.~Definitions:~Baseline=Baseline values were defined at visit 2 (Week 0); QTcF=Fridericia-corrected QT interval; msec=Millisecond;" (NCT03084718)
Timeframe: Baseline, Week 8
| Intervention | msec (Mean) | ||
|---|---|---|---|
| PR | QRS | QTcF | |
| Treatment A (CHF 718 pMDI 100 µg TDD) | -2.6 | 0.1 | 1.6 |
| Treatment B (CHF 718 pMDI 400 µg TDD) | 1.5 | -1.3 | 0.7 |
| Treatment C (CHF 718 pMDI 800 µg TDD) | -1.9 | 0.9 | 0.7 |
| Treatment D (Placebo) | -1.3 | -0.5 | 4.6 |
| Treatment E (QVAR^®, 320 µg TDD) | 1.0 | -0.3 | 1.2 |
"Number of participants with prolonged QTcF. Change from baseline.~Baseline=Baseline values were defined at visit 2 (Week 0) pre-dose; QTcF=Fridericia-corrected QT interval;" (NCT03084718)
Timeframe: Baseline, Week 8
| Intervention | Participants (Count of Participants) | |
|---|---|---|
| QTcF > 30 msec | QTcF > 60 msec | |
| Treatment A (CHF 718 pMDI 100 µg TDD) | 6 | 1 |
| Treatment B (CHF 718 pMDI 400 µg TDD) | 4 | 1 |
| Treatment C (CHF 718 pMDI 800 µg TDD) | 4 | 0 |
| Treatment D (Placebo) | 9 | 2 |
| Treatment E (QVAR^®, 320 µg TDD) | 3 | 1 |
"The ACQ consists of 7 items: 6 simple self-administered questions referring to asthma control and rescue treatment usage with 1 week recall, and a 7th item consisting of the percent (%) predicted FEV1 completed by clinic staff. Scoring uses a 7-point scale: 0 = totally controlled and 6 = severely uncontrolled. The ACQ score was calculated as the average of all 7 items.~Definitions:~ACQ-7 score=Asthma Control Questionnaire-7©; Information regarding the American Thoracic Society ACQ questionnaire is also available at: https://member.thoracic.org/members/assemblies/assemblies/srn/questionaires/acq.php; Baseline ACQ-7 score = ACQ score recorded at V2 (Week 0) Day 1, before randomization; FEV1=Forced expiratory volume in the 1st second;" (NCT03084718)
Timeframe: Baseline, Week 4, Week 8
| Intervention | score on a scale (Least Squares Mean) | |
|---|---|---|
| Week 4 | Week 8 | |
| Treatment A (CHF 718 pMDI 100 µg TDD) | -0.43 | -0.53 |
| Treatment B (CHF 718 pMDI 400 µg TDD) | -0.53 | -0.58 |
| Treatment C (CHF 718 pMDI 800 µg TDD) | -0.49 | -0.66 |
| Treatment D (Placebo) | -0.27 | -0.43 |
| Treatment E (QVAR^®, 320 µg TDD) | -0.47 | -0.64 |
"Change from baseline in average use of rescue medication, during Inter-visit period 1, Inter-visit period 2, Entire treatment period.~Definitions:~Baseline=For the efficacy variable -- average use of rescue medication -- derived from the electronic diary (eDiary), baseline values were the averages recorded during the run-in period;~Inter-visit period 1=Starts from the pm assessment of the Start of the Randomized Treatment Period to the am assessment at Visit 3 (Week 4);~Inter-visit Period 2=Starts from the pm assessment of the day the subject returns to the clinic (Visit 3) to the am assessment of the date of Visit 4 (Week 8);~Entire treatment period=Average of 8 weeks;~am=morning pm=evening" (NCT03084718)
Timeframe: Baseline (average of the 2-week run-in period); Inter-visit period 1 (average of the first 4 weeks); Inter-visit period 2 (average of the last 4 weeks); Entire treatment period (average of 8 weeks)
| Intervention | puffs/day (Least Squares Mean) | ||
|---|---|---|---|
| Inter-visit period 1 | Inter-visit period 2 | Entire treatment period | |
| Treatment A (CHF 718 pMDI 100 µg TDD) | -0.11 | -0.12 | -0.11 |
| Treatment B (CHF 718 pMDI 400 µg TDD) | -0.27 | -0.35 | -0.31 |
| Treatment C (CHF 718 pMDI 800 µg TDD) | -0.14 | -0.25 | -0.20 |
| Treatment D (Placebo) | 0.07 | 0.01 | 0.04 |
| Treatment E (QVAR^®, 320 µg TDD) | -0.13 | -0.18 | -0.15 |
"Overall daily asthma symptoms scores - Change From Baseline (am and pm).~Subjects had to record asthma symptom score (overall symptoms, cough, wheeze, chest tightness and breathlessness) in the am (night-time asthma symptom score) and in the pm (daytime asthma symptom score). These data were collected in the subject's diary. Daily asthma symptoms score were performed separately for am score and pm score and also as a total, where the total equals the sum of the am and pm scores. Degree of asthma symptoms by score: 0=None, 1=Mild, 2=Moderate, and 3=Severe.~Baseline=Averages values during the run-in period;~Inter-visit period 1=Starts from the pm assessment of the Start of the Randomized Treatment Period to the am assessment at Visit 3 (Week 4);~Inter-visit Period 2=Starts from the pm assessment of the day the subject returns to the clinic (Visit 3) to the am assessment of the date of Visit 4 (Week 8);~Entire treatment period=Average of 8 weeks;~am=morning pm=evening" (NCT03084718)
Timeframe: Baseline (average of the 2-week run-in period); Inter-visit period 1 (average of the first 4 weeks); Inter-visit period 2 (average of the last 4 weeks); Entire treatment period (average of 8 weeks)
| Intervention | score on a scale (Least Squares Mean) | ||
|---|---|---|---|
| Inter-visit period 1 | Inter-visit period 2 | Entire treatment period | |
| Treatment A (CHF 718 pMDI 100 µg TDD) | -0.1 | -0.1 | -0.1 |
| Treatment B (CHF 718 pMDI 400 µg TDD) | -0.1 | -0.1 | -0.1 |
| Treatment C (CHF 718 pMDI 800 µg TDD) | -0.1 | -0.1 | -0.1 |
| Treatment D (Placebo) | 0.0 | -0.0 | 0.0 |
| Treatment E (QVAR^®, 320 µg TDD) | -0.1 | -0.1 | -0.1 |
"Change from baseline in percentage (%) of asthma control days, during Inter-visit period 1, Inter-visit period 2, Entire treatment period.~This outcome measure was calculated according to the following definition: Days with a total daily morning + evening asthma score = 0 AND No rescue medication use.~Definitions:~Baseline=For the efficacy variable -- asthma control days -- derived from the eDiary, baseline values were the averages/percentages recorded during the run-in period;~Inter-visit period 1=Starts from the pm assessment of the Start of the Randomized Treatment Period to the am assessment at Visit 3 (Week 4);~Inter-visit Period 2=Starts from the pm assessment of the day the subject returns to the clinic (Visit 3) to the am assessment of the date of Visit 4 (Week 8);~Entire treatment period=Average of 8 weeks;~am=morning pm=evening" (NCT03084718)
Timeframe: Baseline (average of the 2-week run-in period); Inter-visit period 1 (average of the first 4 weeks); Inter-visit period 2 (average of the last 4 weeks); Entire treatment period (average of 8 weeks)
| Intervention | % of asthma control days (Least Squares Mean) | ||
|---|---|---|---|
| Inter-visit period 1 | Inter-visit period 2 | Entire treatment period | |
| Treatment A (CHF 718 pMDI 100 µg TDD) | 7.3 | 14.3 | 10.8 |
| Treatment B (CHF 718 pMDI 400 µg TDD) | 10.6 | 16.3 | 13.4 |
| Treatment C (CHF 718 pMDI 800 µg TDD) | 10.4 | 17.5 | 13.9 |
| Treatment D (Placebo) | 5.0 | 10.5 | 7.7 |
| Treatment E (QVAR^®, 320 µg TDD) | 12.8 | 20.63 | 16.7 |
"Change from baseline in Percentage (%) of asthma symptoms-free days.~Asthma symptoms-free days is the number of days with a total asthma score=0 (daily morning plus evening asthma score).~Subjects recorded asthma symptom score as described in the Outcome measure #7.~Definitions:~Baseline=For the efficacy variables -- daytime and night-time asthma symptom scores -- derived from the eDiary, baseline values were the averages/percentages recorded during the run-in period;~Inter-visit period 1=Starts from the pm assessment of the Start of the Randomized Treatment Period to the am assessment at Visit 3 (Week 4);~Inter-visit Period 2=Starts from the pm assessment of the day the subject returns to the clinic (Visit 3) to the am assessment of the date of Visit 4 (Week 8);~Entire treatment period=Average of 8 weeks;~am=morning pm=evening" (NCT03084718)
Timeframe: Baseline (average of the 2-week run-in period); Inter-visit period 1 (average of the first 4 weeks); Inter-visit period 2 (average of the last 4 weeks); Entire treatment period (average of 8 weeks)
| Intervention | % of of asthma symptom-free days (Least Squares Mean) | ||
|---|---|---|---|
| Inter-visit period 1 | Inter-visit period 2 | Entire treatment period | |
| Treatment A (CHF 718 pMDI 100 µg TDD) | 8.6 | 16.4 | 12.5 |
| Treatment B (CHF 718 pMDI 400 µg TDD) | 10.5 | 17.0 | 13.8 |
| Treatment C (CHF 718 pMDI 800 µg TDD) | 10.1 | 17.2 | 13.6 |
| Treatment D (Placebo) | 5.7 | 11.7 | 8.7 |
| Treatment E (QVAR^®, 320 µg TDD) | 12.8 | 21.2 | 17.0 |
"Change from baseline in percentage (%) of rescue medication-free days. An increased value indicates improvement from baseline.~Definitions:~Baseline=For the efficacy variable -- percentage (%) of rescue medication-free days -- derived from the electronic diary (eDiary), baseline values were the averages/percentages recorded during the run-in period.~Inter-visit period 1=Starts from the pm assessment of the Start of the Randomized Treatment Period to the am assessment at Visit 3 (Week 4);~Inter-visit Period 2=Starts from the pm assessment of the day the subject returns to the clinic (Visit 3) to the am assessment of the date of Visit 4 (Week 8);~Entire treatment period=Average of 8 weeks;~am=morning pm=evening" (NCT03084718)
Timeframe: Baseline (average of the 2-week run-in period); Inter-visit period 1 (average of the first 4 weeks); Inter-visit period 2 (average of the last 4 weeks); Entire treatment period (average of 8 weeks)
| Intervention | % of rescue medication-free days (Least Squares Mean) | ||
|---|---|---|---|
| Inter-visit period 1 | Inter-visit period 2 | Entire treatment period | |
| Treatment A (CHF 718 pMDI 100 µg TDD) | 5.9 | 8.9 | 7.4 |
| Treatment B (CHF 718 pMDI 400 µg TDD) | 9.0 | 13.1 | 11.1 |
| Treatment C (CHF 718 pMDI 800 µg TDD) | 6.1 | 10.0 | 8.1 |
| Treatment D (Placebo) | 1.5 | 4.1 | 2.8 |
| Treatment E (QVAR^®, 320 µg TDD) | 7.7 | 11.2 | 9.5 |
"Change from baseline in pre-dose morning FVC at Week 4 and 8.~Spirometry, used to measure FVC, was performed according to internationally accepted standards.~Definitions:~Baseline=Baseline values for pre-dose FVC were the average of measurements taken at V2 (Week 0) at 45 minutes and 15 minutes pre-dose; FVC=Forced vital capacity;" (NCT03084718)
Timeframe: Baseline, Week 4, Week 8
| Intervention | Litres (Least Squares Mean) | |
|---|---|---|
| Week 4 | Week 8 | |
| Treatment A (CHF 718 pMDI 100 µg TDD) | 0.036 | 0.014 |
| Treatment B (CHF 718 pMDI 400 µg TDD) | 0.099 | 0.089 |
| Treatment C (CHF 718 pMDI 800 µg TDD) | 0.066 | 0.036 |
| Treatment D (Placebo) | 0.023 | -0.016 |
| Treatment E (QVAR^®, 320 µg TDD) | 0.056 | 0.063 |
"Change from baseline in pre-dose Peak Expiratory Flow (PEF) (Liters/min), morning and evening measurements.~Definitions:~Baseline=For the efficacy variable -- morning and evening PEF -- derived from the eDiary, the baseline values were the averages/percentages recorded during the run-in period; PEF=evening peak expiratory flow;~Inter-visit period 1=Starts from the pm assessment of the Start of the Randomized Treatment Period to the am assessment at Visit 3 (Week 4);~Inter-visit Period 2=Starts from the pm assessment of the day the subject returns to the clinic (Visit 3) to the am assessment of the date of Visit 4 (Week 8);~Entire treatment period=Average of 8 weeks;~am=morning pm=evening" (NCT03084718)
Timeframe: Baseline (average of the 2-week run-in period); Inter-visit period 1 (average of the first 4 weeks); Inter-visit period 2 (average of the last 4 weeks); Entire treatment period (average of 8 weeks)
| Intervention | Liters/min (Least Squares Mean) | ||
|---|---|---|---|
| Inter-visit period 1 | Inter-visit period 2 | Entire treatment period | |
| Treatment A (CHF 718 pMDI 100 µg TDD) | -2 | -4 | -3 |
| Treatment B (CHF 718 pMDI 400 µg TDD) | -3 | 3 | 0.3 |
| Treatment C (CHF 718 pMDI 800 µg TDD) | -4 | -5 | -4 |
| Treatment D (Placebo) | -6 | -4 | -4.9 |
| Treatment E (QVAR^®, 320 µg TDD) | 0 | 2 | 1 |
"Vital signs (systolic and diastolic blood pressure) at baseline, week 4, and week 8.~Change from baseline.~Definitions:~Baseline=Baseline values were defined at visit 2 (Week 0) pre-dose; DBP=Diastolic blood pressure; SBP=Systolic blood pressure;" (NCT03084718)
Timeframe: Baseline, Week 4, Week 8
| Intervention | mmHg (Mean) | |||
|---|---|---|---|---|
| SBP, Week 4 | SBP, Week 8 | DBP, Week 4 | DBP, Week 8 | |
| Treatment A (CHF 718 pMDI 100 µg TDD) | -0.4 | 1.0 | -0.1 | 0.8 |
| Treatment B (CHF 718 pMDI 400 µg TDD) | 1.0 | 2.5 | 0.2 | 1.0 |
| Treatment C (CHF 718 pMDI 800 µg TDD) | 0.5 | 0.8 | -0.8 | 0.3 |
| Treatment D (Placebo) | 0.6 | 0.2 | 0.1 | -0.5 |
| Treatment E (QVAR^®, 320 µg TDD) | 0.0 | -0.9 | 0.8 | 1.2 |
"Spirometry used to measure FEV1, was performed according to internationally accepted standards. Results show the change from baseline in FEV1 AUC(0-12h), normalized by time on Day 14; it was calculated by using the linear trapezoidal rule, based on the changes in FEV1 from the baseline values.~Patients receiving the same treatment during two periods are considered twice in the ANCOVA model (once for each period attended).~Definitions:~AUC=Area under the curve; AUC(0-12h)=AUC between 0 and 12 h; Baseline=Baseline value was the average of the pre-dose measurements (at 45 mins and 15 mins pre-dose) on Day 1 of the treatment period; FEV1=Forced expiratory volume in the 1st second;" (NCT03086460)
Timeframe: Baseline, Day 14 post-dose
| Intervention | Litres (Least Squares Mean) |
|---|---|
| Treatment A | 0.174 |
| Treatment B | 0.221 |
| Treatment C | 0.197 |
| Treatment D | 0.231 |
| Treatment E | 0.064 |
| Treatment F | 0.208 |
"Spirometry used to measure FEV1, was performed according to internationally accepted standards.~Patients receiving the same treatment during two periods are considered twice in the ANCOVA model (once for each period attended).~Baseline=Baseline value was the average of the pre-dose measurements (at 45 mins and 15 mins pre-dose) on Day 1 of the treatment period;" (NCT03086460)
Timeframe: Baseline, Day 1 post-dose
| Intervention | Litres (Least Squares Mean) |
|---|---|
| Treatment A | 0.181 |
| Treatment B | 0.221 |
| Treatment C | 0.260 |
| Treatment D | 0.282 |
| Treatment E | 0.067 |
| Treatment F | 0.239 |
"Patients achieving onset of action, defined as a change from baseline in post-dose FEV1 ≥12% and ≥200 mL, on Day 1. These are the subjects who contributed to the results, reported as median and 95% CI for 'Time to onset of action' presented in the Outcome Measure 13, above.~For patients receiving the same treatment twice, the analysis includes only data from the first instance of each treatment.~Definitions:~Onset of action=Change from baseline in post-dose FEV1 ≥12% and ≥200 mL; Baseline=Baseline value was the average of the pre-dose measurements (at 45 mins and 15 mins pre-dose);" (NCT03086460)
Timeframe: Baseline, Day 1 post-dose
| Intervention | Participants (Count of Participants) |
|---|---|
| Treatment A | 23 |
| Treatment B | 22 |
| Treatment C | 30 |
| Treatment D | 29 |
| Treatment E | 11 |
| Treatment F | 31 |
"Spirometry, used to measure FEV1, was performed according to internationally accepted standards.~Patients receiving the same treatment during two periods are considered twice in the ANCOVA model (once for each period attended).~Baseline=Baseline value was the average of the pre-dose measurements (at 45 mins and 15 mins pre-dose) on Day 1 of the treatment period;" (NCT03086460)
Timeframe: Baseline, Day 14 post-dose
| Intervention | Litres (Least Squares Mean) |
|---|---|
| Treatment A | 0.071 |
| Treatment B | 0.102 |
| Treatment C | 0.073 |
| Treatment D | 0.149 |
| Treatment E | 0.037 |
| Treatment F | 0.126 |
"Spirometry, used to measure FVC, was performed according to internationally accepted standards.~Patients receiving the same treatment during two periods are considered twice in the ANCOVA model (once for each period attended).~Baseline=Baseline value was the average of the pre-dose measurements (at 45 mins and 15 mins pre-dose) on Day 1 of the treatment period;" (NCT03086460)
Timeframe: Baseline, Day 14 post-dose
| Intervention | Litres (Least Squares Mean) |
|---|---|
| Treatment A | 0.048 |
| Treatment B | 0.044 |
| Treatment C | 0.048 |
| Treatment D | 0.114 |
| Treatment E | 0.053 |
| Treatment F | 0.114 |
"The primary analysis was repeated, considering patients as randomized and including only the first instance of each treatment.~Patients receiving the same treatment in more than one period were included in the analysis with only data from the first instance of each treatment." (NCT03086460)
Timeframe: Baseline, Day 14 post-dose
| Intervention | Litres (Least Squares Mean) |
|---|---|
| Treatment A | 0.169 |
| Treatment B | 0.224 |
| Treatment C | 0.196 |
| Treatment D | 0.232 |
| Treatment E | 0.058 |
| Treatment F | 0.206 |
"The primary analysis was repeated, considering only patients and treatment periods for which treatment was assigned on or after the randomization error occurred.~The number of patients shown represents those with at least one post-baseline assessment available." (NCT03086460)
Timeframe: Baseline, Day 14 post-dose
| Intervention | Litres (Least Squares Mean) |
|---|---|
| Treatment A | 0.129 |
| Treatment B | 0.180 |
| Treatment C | 0.159 |
| Treatment D | 0.179 |
| Treatment E | -0.006 |
| Treatment F | 0.170 |
"Patients receiving the same treatment during two treatment periods are considered twice in the ANCOVA model (once for each period attended).~Patients considered in this analysis are those with at least one available post-baseline assessment." (NCT03086460)
Timeframe: Baseline, Day 14 post-dose
| Intervention | Litres (Least Squares Mean) |
|---|---|
| Treatment A | 0.144 |
| Treatment B | 0.194 |
| Treatment C | 0.170 |
| Treatment D | 0.198 |
| Treatment E | 0.037 |
| Treatment F | 0.184 |
"Spirometry, used to measure FEV1, was performed according to internationally accepted standards.~For patients receiving the same treatment twice, the analysis includes only data from the first instance of each treatment.~Definitions:~Time to onset of action=The time (in minutes) from receiving the study drug on Day 1, until the FEV1 change from baseline is ≥200 mL; Baseline=Baseline value was the average of the pre-dose measurements (at 45 mins and 15 mins pre-dose) on Day 1 of the treatment period;" (NCT03086460)
Timeframe: Baseline, Day 1 post-dose
| Intervention | minutes (Median) |
|---|---|
| Treatment A | 358.8 |
| Treatment B | 60.3 |
| Treatment C | 33.6 |
| Treatment D | 44.3 |
| Treatment E | NA |
| Treatment F | 45.5 |
"Results are shown by treatment group, as change from baseline (in bpm).~For patients receiving the same treatment in 2 periods, the average of the 2 available data points was considered in the calculation.~For safety variables, the baseline for each period was defined as pre-dose measurements on Day 1 of each treatment period." (NCT03086460)
Timeframe: Baseline, Day 1, Day 14 post-dose
| Intervention | bpm (Mean) | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Day 1, 30 min post-dose | Day 1, 1h post-dose | Day 1, 4h post-dose | Day 1, 8h post-dose | Day 1, 12h post-dose | Day 14, pre-dose | Day 14, 30 min post-dose | Day 14, 1h post-dose | Day 14, 4h post-dose | Day 14, 8h post-dose | Day 14, 12h post-dose | |
| Treatment A | 0.3 | -1.3 | 2.1 | 5.0 | 5.1 | 2.5 | 2.9 | 1.9 | 2.8 | 5.5 | 7.4 |
| Treatment B | 1.2 | 0.3 | 1.5 | 2.4 | 5.5 | 0.1 | -0.8 | -1.2 | 2.3 | 3.5 | 7.5 |
| Treatment C | 1.7 | 2.7 | 3.3 | 5.0 | 5.5 | 3.1 | 1.6 | 1.6 | 6.7 | 4.9 | 6.7 |
| Treatment D | 2.5 | 1.5 | 5.3 | 3.9 | 7.6 | 2.0 | 4.3 | 3.2 | 3.4 | 3.8 | 5.4 |
| Treatment E | -2.4 | -1.8 | 0.2 | 0.5 | 2.4 | 0.7 | -1.5 | -1.2 | 1.8 | 1.6 | 0.5 |
| Treatment F | -0.3 | -1.2 | 3.2 | 2.1 | 5.2 | 0.4 | 1.3 | 0.4 | 2.3 | 2.6 | 5.1 |
"12-lead electrocardiogram (ECG) parameters were monitored during the study. Results are shown by treatment group, as change from baseline (in msec).~For patients receiving the same treatment in 2 periods, the average of the 2 available data points was considered in the calculation.~For safety variables, the baseline for each period was defined as pre-dose measurements on Day 1 of each treatment period." (NCT03086460)
Timeframe: Baseline, Day 1, Day 14 post-dose
| Intervention | msec (Mean) | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Day 1, 30 min post-dose | Day 1, 1h post-dose | Day 1, 4h post-dose | Day 1, 8h post-dose | Day 1, 12h post-dose | Day 14, pre-dose | Day 14, 30 min post-dose | Day 14, 1h post-dose | Day 14, 4h post-dose | Day 14, 8h post-dose | Day 14, 12h post-dose | |
| Treatment A | -0.1 | 1.1 | -1.2 | -1.9 | -3.4 | 1.3 | -0.2 | 1.0 | -1.5 | -2.6 | -5.0 |
| Treatment B | 1.6 | 2.2 | 1.6 | -0.5 | -2.3 | 3.7 | 4.5 | 5.7 | 2.5 | 1.5 | 1.7 |
| Treatment C | -1.3 | -1.1 | -1.5 | -3.0 | -3.8 | -1.7 | -1.5 | 0.1 | -2.5 | -3.2 | -4.8 |
| Treatment D | -3.6 | -0.7 | -4.0 | -2.6 | -3.0 | -2.9 | -3.1 | -1.6 | -3.2 | -5.4 | -1.4 |
| Treatment E | 1.0 | 0.4 | -1.6 | -2.4 | -2.6 | 0.1 | 3.4 | 5.2 | 0.8 | -1.1 | 0.1 |
| Treatment F | 3.2 | 2.0 | 1.9 | -0.0 | -1.7 | 2.2 | 5.1 | 6.1 | 1.3 | 0.8 | -0.3 |
"12-lead electrocardiogram (ECG) parameters were monitored during the study. Results are shown by treatment group, as change from baseline (in msec).~For patients receiving the same treatment in 2 periods, the average of the 2 available data points was considered in the calculation.~For safety variables, the baseline for each period was defined as pre-dose measurements on Day 1 of each treatment period." (NCT03086460)
Timeframe: Baseline, Day 1, Day 14 post-dose
| Intervention | msec (Mean) | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Day 1, 30 min post-dose | Day 1, 1h post-dose | Day 1, 4h post-dose | Day 1, 8h post-dose | Day 1, 12h post-dose | Day 14, pre-dose | Day 14, 30 min post-dose | Day 14, 1h post-dose | Day 14, 4h post-dose | Day 14, 8h post-dose | Day 14, 12h post-dose | |
| Treatment A | 1.2 | 1.3 | 1.2 | 0.6 | 0.5 | 0.5 | 1.4 | 1.3 | 2.0 | 0.7 | 0.8 |
| Treatment B | 1.2 | 1.0 | 2.1 | 0.9 | 1.0 | 1.0 | 1.6 | 0.9 | 1.8 | 1.2 | 0.4 |
| Treatment C | 1.7 | 1.2 | 2.2 | 1.3 | 1.0 | -0.5 | 0.5 | 0.4 | 0.6 | 0.1 | 0.3 |
| Treatment D | 1.1 | 1.6 | 2.1 | 0.5 | 0.9 | 1.7 | 2.4 | 2.3 | 2.8 | 1.4 | 1.4 |
| Treatment E | 0.8 | 1.0 | 1.0 | -0.2 | 0.4 | -0.9 | -0.3 | 0.0 | -0.2 | -0.8 | -1.0 |
| Treatment F | 1.3 | 1.4 | 1.1 | 0.5 | 0.8 | 0.8 | 1.7 | 1.0 | 1.1 | 0.9 | 0.5 |
"12-lead electrocardiogram (ECG) parameters were monitored during the study. Results are shown by treatment group, as change from baseline (in msec).~For patients receiving the same treatment in 2 periods, the average of the 2 available data points was considered in the calculation.~For safety variables, the baseline for each period was defined as pre-dose measurements on Day 1 of each treatment period." (NCT03086460)
Timeframe: Baseline, Day 1, Day 14 post-dose
| Intervention | msec (Mean) | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Day 1, 30 min post-dose | Day 1, 1h post-dose | Day 1, 4h post-dose | Day 1, 8h post-dose | Day 1, 12h post-dose | Day 14, pre-dose | Day 14, 30 min post-dose | Day 14, 1h post-dose | Day 14, 4h post-dose | Day 14, 8h post-dose | Day 14, 12h post-dose | |
| Treatment A | 3.9 | 2.1 | 2.5 | 2.4 | 2.0 | 1.5 | 4.4 | 4.0 | 3.8 | 3.4 | 3.7 |
| Treatment B | 3.8 | 1.4 | 1.5 | 1.1 | 0.9 | -0.4 | 1.0 | 1.0 | 0.9 | 1.7 | 1.7 |
| Treatment C | 2.7 | 3.9 | 0.8 | 0.6 | -0.3 | 1.6 | 3.5 | 1.9 | 1.1 | 1.7 | -0.9 |
| Treatment D | 4.9 | 4.2 | 2.4 | 0.8 | 1.1 | 5.8 | 10.4 | 7.7 | 5.0 | 2.2 | 3.7 |
| Treatment E | -0.2 | 0.4 | -2.4 | -0.2 | -1.5 | -2.3 | 1.9 | 0.9 | -1.1 | 1.5 | -0.6 |
| Treatment F | 1.4 | -0.9 | -1.3 | -2.4 | -2.2 | 1.2 | 1.7 | 0.6 | -1.1 | 0.4 | -1.6 |
"Spirometry used to measure FEV1, was performed according to internationally accepted standards.~Patients receiving the same treatment during two periods are considered twice in the ANCOVA model (once for each period attended).~Baseline=Baseline value was the average of the pre-dose measurements (at 45 mins and 15 mins pre-dose) on Day 1 of the treatment period;" (NCT03086460)
Timeframe: Baseline, Day 1, Day 14 post-dose
| Intervention | Litres (Least Squares Mean) | |
|---|---|---|
| Day 1 | Day 14 | |
| Treatment A | 0.220 | 0.214 |
| Treatment B | 0.250 | 0.251 |
| Treatment C | 0.270 | 0.231 |
| Treatment D | 0.317 | 0.278 |
| Treatment E | 0.047 | 0.061 |
| Treatment F | 0.288 | 0.259 |
"Spirometry, used to measure FEV1, was performed according to internationally accepted standards.~Patients receiving the same treatment during two periods are considered twice in the ANCOVA model (once for each period attended).~Baseline=Baseline value was the average of the pre-dose measurements (at 45 mins and 15 mins pre-dose) on Day 1 of the treatment period;" (NCT03086460)
Timeframe: Baseline, Day 1, Day 14 post-dose
| Intervention | Litres (Least Squares Mean) | |
|---|---|---|
| Day 1 | Day 14 | |
| Treatment A | 0.359 | 0.346 |
| Treatment B | 0.370 | 0.373 |
| Treatment C | 0.393 | 0.349 |
| Treatment D | 0.430 | 0.389 |
| Treatment E | 0.178 | 0.183 |
| Treatment F | 0.416 | 0.367 |
"Spirometry, used to measure FVC, was performed according to internationally accepted standards.~Patients receiving the same treatment during two periods are considered twice in the ANCOVA model (once for each period attended).~Baseline=Baseline value was the average of the pre-dose measurements (at 45 mins and 15 mins pre-dose) on Day 1 of the treatment period;" (NCT03086460)
Timeframe: Baseline, Day 1, Day 14 post-dose
| Intervention | Litres (Least Squares Mean) | |
|---|---|---|
| Day 1 | Day 14 | |
| Treatment A | 0.111 | 0.103 |
| Treatment B | 0.156 | 0.134 |
| Treatment C | 0.160 | 0.120 |
| Treatment D | 0.182 | 0.142 |
| Treatment E | 0.059 | 0.060 |
| Treatment F | 0.172 | 0.134 |
"Spirometry, used to measure FVC, was performed according to internationally accepted standards.~Patients receiving the same treatment during two periods are considered twice in the ANCOVA model (once for each period attended).~Baseline=Baseline value was the average of the pre-dose measurements (at 45 mins and 15 mins pre-dose) on Day 1 of the treatment period;" (NCT03086460)
Timeframe: Baseline, Day 1, Day 14 post-dose
| Intervention | Litres (Least Squares Mean) | |
|---|---|---|
| Day 1 | Day 14 | |
| Treatment A | 0.158 | 0.135 |
| Treatment B | 0.186 | 0.146 |
| Treatment C | 0.159 | 0.136 |
| Treatment D | 0.215 | 0.194 |
| Treatment E | 0.036 | 0.050 |
| Treatment F | 0.213 | 0.177 |
"Spirometry, used to measure FVC, was performed according to internationally accepted standards.~Patients receiving the same treatment during two periods are considered twice in the ANCOVA model (once for each period attended).~Baseline=Baseline value was the average of the pre-dose measurements (at 45 mins and 15 mins pre-dose) on Day 1 of the treatment period;" (NCT03086460)
Timeframe: Baseline, Day 1, Day 14 post-dose
| Intervention | Litres (Least Squares Mean) | |
|---|---|---|
| Day 1 | Day 14 | |
| Treatment A | 0.331 | 0.310 |
| Treatment B | 0.347 | 0.331 |
| Treatment C | 0.354 | 0.304 |
| Treatment D | 0.367 | 0.350 |
| Treatment E | 0.216 | 0.198 |
| Treatment F | 0.385 | 0.340 |
"Heart rate (HR) AUC(0-4h) and HR peak(0-4h), normalized by time (in bpm).~Results are shown as change from pre-dose on Day 14 (in bpm).~For patients receiving the same treatment in 2 periods, the average of the 2 available data points was considered in the calculation.~Definitions:~HR=Heart rate; HR AUC(0-4h)=Area under the curve between 0 and 4 h for heart rate; HR peak(0-4h)=The maximum observed value over 4 h after dosing;" (NCT03086460)
Timeframe: Baseline, Day 14 post-dose
| Intervention | bpm (Mean) | |
|---|---|---|
| HR AUC(0-4h) | HR peak(0-4h) | |
| Treatment A | -0.4 | 3.5 |
| Treatment B | 0.5 | 5.1 |
| Treatment C | 0.4 | 5.1 |
| Treatment D | 1.3 | 5.3 |
| Treatment E | -0.2 | 4.3 |
| Treatment F | 0.9 | 4.8 |
"Heart rate HR AUC(0-4h) normalized by time. Results are shown by treatment group, as change from baseline (in bpm).~The HR AUC(0-4h) normalized by time is calculated based on the actual times, using the linear trapezoidal rule.~For patients receiving the same treatment in 2 periods, the average of the 2 available data points was considered in the calculation.~For safety variables, the baseline for each period was defined as pre-dose measurements on Day 1 of each treatment period." (NCT03086460)
Timeframe: Baseline, Day 1, Day 14 post-dose
| Intervention | bpm (Mean) | |
|---|---|---|
| Day 1 | Day 14 | |
| Treatment A | 0.2 | 2.3 |
| Treatment B | 0.8 | 0.2 |
| Treatment C | 2.7 | 3.5 |
| Treatment D | 3.0 | 3.3 |
| Treatment E | -1.0 | -0.1 |
| Treatment F | 0.3 | 1.2 |
"Heart rate (HR) peak(0-4h) normalized by time.~Results are shown by treatment group, as change from baseline (in bpm).~For patients receiving the same treatment in 2 periods, the average of the 2 available data points was considered in the calculation.~For safety variables, the baseline for each period was defined as pre-dose measurements on Day 1 of each treatment period.~Definitions:~HR=Heart rate; HR peak(0-4h)=The maximum observed value over 4 hours following dosing;" (NCT03086460)
Timeframe: Baseline, Day 1, Day 14 post-dose
| Intervention | bpm (Mean) | |
|---|---|---|
| Day 1 | Day 14 | |
| Treatment A | 4.7 | 6.1 |
| Treatment B | 4.4 | 4.8 |
| Treatment C | 6.5 | 8.3 |
| Treatment D | 7.5 | 7.3 |
| Treatment E | 2.9 | 4.4 |
| Treatment F | 5.1 | 5.2 |
"Serum glucose level was monitored during the study. Results are shown by treatment group, as change from baseline (in mmol/L).~For patients receiving the same treatment in 2 periods, the average of the 2 available data points was considered in the calculation.~For safety variables, the baseline for each period was defined as pre-dose measurements on Day 1 of each treatment period." (NCT03086460)
Timeframe: Baseline, Day 1, Day 14 post-dose
| Intervention | mmol/L (Mean) | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Day 1; 1.5h post-dose | Day 1; 3h post-dose | Day 1; 5h post-dose | Day 1; 7h post-dose | Day 1; 11h post-dose | Day 14; pre-dose | Day 14; 1.5h post-dose | Day 14; 3h post-dose | Day 14; 5h post-dose | Day 14; 7h post-dose | Day 14; 11h post-dose | |
| Treatment A | 0.49 | 0.45 | 0.83 | 0.81 | 0.98 | -0.34 | 0.09 | 0.09 | 0.04 | -0.04 | 0.39 |
| Treatment B | 0.34 | 0.54 | 1.12 | 0.42 | 1.08 | 0.00 | 0.26 | 0.77 | 0.90 | 0.60 | 1.30 |
| Treatment C | 0.57 | 1.10 | 1.11 | 1.24 | 1.89 | 0.49 | 0.97 | 1.31 | 1.12 | 0.73 | 1.50 |
| Treatment D | 1.19 | 1.79 | 1.58 | 1.37 | 1.42 | 0.49 | 1.21 | 1.51 | 1.16 | 1.09 | 1.47 |
| Treatment E | 0.47 | 0.26 | 0.51 | 0.84 | 1.40 | 0.37 | 0.35 | 0.25 | 0.32 | 0.25 | 1.03 |
| Treatment F | -0.06 | 0.39 | 0.44 | 0.61 | 0.90 | -0.03 | -0.03 | 0.16 | 0.53 | 0.18 | 0.68 |
"Serum potassium level was monitored during the study. Results are shown by treatment group, as change from baseline (in mmol/L).~For patients receiving the same treatment in 2 periods, the average of the 2 available data points was considered in the calculation.~For safety variables, the baseline for each period was defined as pre-dose measurements on Day 1 of each treatment period." (NCT03086460)
Timeframe: Baseline, Day 1, Day 14 post-dose
| Intervention | mmol/L (Mean) | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Day 1; 1.5h post-dose | Day 1; 3h post-dose | Day 1; 5h post-dose | Day 1; 7h post-dose | Day 1; 11h post-dose | Day 14; pre-dose | Day 14; 1.5h post-dose | Day 14; 3h post-dose | Day 14; 5h post-dose | Day 14; 7h post-dose | Day 14; 11h post-dose | |
| Treatment A | -0.01 | -0.06 | -0.14 | -0.02 | 0.07 | 0.06 | -0.02 | -0.04 | -0.02 | 0.05 | 0.11 |
| Treatment B | -0.05 | -0.08 | -0.03 | -0.00 | 0.02 | -0.02 | -0.03 | -0.09 | -0.05 | 0.06 | 0.05 |
| Treatment C | -0.08 | -0.23 | -0.12 | -0.05 | -0.08 | 0.08 | -0.10 | -0.13 | -0.01 | 0.09 | 0.03 |
| Treatment D | -0.17 | -0.28 | -0.19 | -0.16 | -0.10 | -0.14 | -0.23 | -0.24 | -0.26 | -0.19 | -0.06 |
| Treatment E | -0.06 | 0.03 | -0.04 | 0.04 | 0.01 | 0.05 | -0.03 | -0.00 | 0.00 | 0.02 | 0.01 |
| Treatment F | -0.18 | -0.21 | -0.20 | -0.14 | -0.13 | -0.13 | -0.15 | -0.15 | -0.15 | -0.09 | -0.02 |
"Vital signs -- Systolic blood pressure (SBP) and Diastolic blood pressure (DBP) were measured at pre-specified times (at baseline - pre dose and on Day 14 of each treatment period or on the day of early study termination).~Results are shown by treatment group, as change from baseline (in mmHg).~For patients receiving the same treatment in 2 periods, the average of the 2 available data points was considered in the calculation.~Definitions:~For safety variables, the baseline for each treatment period was defined as pre-dose measurements on Day 1 of each treatment period; Day 14=The day of the last dosing of a treatment period. Day 14 of the second, third, and fourth treatment periods (day of last dosing); treatments were separated by a 2-week wash-out interval;" (NCT03086460)
Timeframe: Baseline, Day 1 and Day 14 post-dose
| Intervention | mmHg (Mean) | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| SBP, Day 1, 30 min post-dose | SBP, Day 1, 1 h post-dose | SBP, Day 1, 4 h post-dose | SBP, Day 1, 8 h post-dose | SBP, Day 1, 12 h post-dose | SBP, Day 14, pre-dose | SBP, Day 14, 30 min post-dose | SBP, Day 14, 1 h post-dose | SBP, Day 14, 4 h post-dose | SBP, Day 14, 8 h post-dose | SBP, Day 14, 12 h post-dose | DBP, Day 1, 30 min post-dose | DBP, Day 1, 1 h post-dose | DBP, Day 1, 4 h post-dose | DBP, Day 1, 8 h post-dose | DBP, Day 1, 12 h post-dose | DBP, Day 14, pre-dose | DBP, Day 14, 30 min post-dose | DBP, Day 14, 1 h post-dose | DBP, Day 14, 4 h post-dose | DBP, Day 14, 8 h post-dose | DBP, Day 14, 12 h post-dose | |
| Treatment A | -1.2 | -0.1 | 1.7 | 0.8 | 1.8 | 1.0 | 0.3 | 0.1 | 0.9 | 0.7 | 1.2 | -2.1 | 0.0 | -0.6 | -1.5 | -0.5 | -1.2 | -0.2 | -0.3 | -1.0 | -1.1 | 0.0 |
| Treatment B | 0.2 | 0.5 | 0.4 | 0.2 | 2.1 | -1.8 | -3.1 | -1.8 | 0.1 | 1.3 | 1.0 | -1.5 | -1.9 | -1.4 | -0.9 | -0.1 | 0.1 | -2.1 | -2.4 | -1.5 | -1.0 | -0.7 |
| Treatment C | -0.8 | -0.6 | -0.9 | 1.1 | 3.0 | 0.0 | -0.7 | -1.8 | -1.4 | 1.1 | 1.5 | -1.2 | -0.4 | -0.4 | -0.4 | 0.4 | 1.1 | -0.8 | -0.5 | -1.7 | 0.3 | 0.7 |
| Treatment D | -1.2 | -0.6 | 0.9 | 0.7 | 1.4 | -0.4 | -0.7 | -1.9 | 1.0 | 0.6 | 4.4 | -2.0 | -1.6 | -1.0 | -1.9 | -1.0 | -0.1 | -2.9 | -2.4 | -2.5 | -2.6 | -0.6 |
| Treatment E | -0.5 | -0.8 | 0.2 | 0.5 | -0.1 | -2.5 | -3.6 | -1.7 | -0.5 | -3.3 | -0.3 | -0.3 | -2.5 | -1.6 | -1.7 | -0.3 | -0.6 | -1.5 | -1.8 | 0.4 | -1.7 | 1.4 |
| Treatment F | -0.8 | -0.8 | 0.5 | 2.5 | 3.4 | -0.3 | -2.5 | -1.1 | -0.8 | 0.6 | 2.5 | -1.2 | -1.7 | -1.0 | 0.4 | 0.0 | -0.7 | -2.0 | -1.6 | -2.3 | -1.3 | -0.1 |
Spirometry was conducted according to internationally accepted standards. Trough FEV1 referred to the mean of FEV1 at 23:15 hours and 23:45 hours after the morning dose of study drug. The baseline was defined as the average of FEV1 values taken in the clinic 45 min and 15 min prior to the first dose of randomized treatment at Visit 3. A mixed model was used and contained treatment as a fixed effect with the baseline measurement of trough FEV1, FEV1 prior to inhalation of short acting bronchodilators, and FEV1 post-inhalation of bronchodilators and stratification factors as covariates. A positive change from baseline indicates improvement. (NCT01513460)
Timeframe: baseline, 12 weeks
| Intervention | liters (Mean) |
|---|---|
| NVA237 + Fluticasone/Salmeterol (Flu/Sal) | 0.095 |
| Tiotropium + Flu/Sal | 0.102 |
The total number of puffs of rescue medication used over the last 12 h recorded in the morning (nighttime use) and in the evening (daytime use) over the full 12 weeks was divided by the total number of days with non-missing rescue data to derive the mean daytime and nighttime number of puffs of rescue medication. Change from baseline in the mean daytime and nighttime number of puffs of rescue medication was analyzed as for the change from baseline in the mean daily number of puffs of rescue medication. (NCT01513460)
Timeframe: baseline, 12 weeks
| Intervention | puffs of rescue medication (Mean) |
|---|---|
| NVA237 + Fluticasone/Salmeterol (Flu/Sal) | 2.191 |
| Tiotropium + Flu/Sal | 2.093 |
| Flu/Sal | 2.908 |
SGRQ-C is a health related quality of life questionnaire consisting of 40 items divided into two components: 1) symptoms, 2) activity& impacts. The lowest possible value is zero and the highest is 100. Higher values corresponded to greater impairment in quality of life. An analysis model included terms for treatment, baseline total SGRQ score, FEV1 and baseline smoking status. The model also contained as fixed effects the baseline total SGRQ score, FEV1 prior to inhalation of short acting bronchodilator, FEV1 post inhalation of short acting bronchodilator and stratification factors as covariates. A negative change from baseline indicates improvement. (NCT01513460)
Timeframe: 12 weeks
| Intervention | units on a scale (Mean) |
|---|---|
| NVA237 + Fluticasone/Salmeterol (Flu/Sal) | -2.806 |
| Tiotropium + Flu/Sal | -3.902 |
| Flu/Sal | -0.652 |
A 'day able to perform usual daily activities' was defined from diary data as any day where the patient was not prevented from performing their usual daily activities due to respiratory symptoms. The percentage of 'days able to perform usual daily activities' was derived and analyzed using a similar mixed model as specified for primary analysis as for the percentage of nights with 'no nighttime awakenings'. (NCT01513460)
Timeframe: 12 weeks
| Intervention | Percentage of days (Mean) |
|---|---|
| NVA237 + Fluticasone/Salmeterol (Flu/Sal) | 0.934 |
| Tiotropium + Flu/Sal | 0.946 |
| Flu/Sal | 0.903 |
A night with 'no nighttime awakenings' is defined from diary data as any night where patient did not wake up due to symptoms. Total number of nights with 'no nighttime awakenings' over treatment period was divided by total number of nights where diary recordings have been made in order to derive percentage of 'no nighttime awakenings' which will be summarized by treatment and analyzed using a similar mixed model as specified for primary analysis. Diary data recorded during the 7 day run-in period was used to calculate baseline percentage of nights 'no nighttime awakenings'. (NCT01513460)
Timeframe: 12 weeks
| Intervention | Percentage of nights (Mean) |
|---|---|
| NVA237 + Fluticasone/Salmeterol (Flu/Sal) | 0.834 |
| Tiotropium + Flu/Sal | 0.816 |
| Flu/Sal | 0.823 |
Spirometry was conducted according to internationally accepted standards. Trough FEV1 referred to the mean of FEV1 at 23:15h and 23:45h after the morning dose of study drug. The baseline was defined as the average of FEV1 values taken in the clinic 45min and 15min prior to the first dose of randomized treatment at Visit 3. A mixed model was used and contained treatment as a fixed effect with the baseline measurement of trough FEV1, FEV1 prior to inhalation of short acting bronchodilators, and FEV1 post-inhalation of bronchodilators and stratification factors as covariates. A positive change from baseline indicates improvement. (NCT01513460)
Timeframe: baseline, 4 weeks, 8 weeks, 12 weeks
| Intervention | Liters (Mean) | ||
|---|---|---|---|
| Week 4 | Week 8 | Week 12 | |
| Flu/Sal | -0.010 | -0.002 | -0.012 |
| NVA237 + Fluticasone/Salmeterol (Flu/Sal) | 0.077 | 0.084 | 0.089 |
| Tiotropium + Flu/Sal | 0.077 | 0.092 | 0.087 |
Spirometry was conducted according to internationally accepted standards. Trough FEV1 referred to the mean of FEV1 at 23:15h and 23:45h after the morning dose of study drug. The baseline was defined as the average of FEV1 values taken in the clinic 45min and 15min prior to the first dose of randomized treatment at Visit 3. A mixed model was used and contained treatment as a fixed effect with the baseline measurement of trough FEV1, FEV1 prior to inhalation of short acting bronchodilators, and FEV1 post-inhalation of bronchodilators and stratification factors as covariates. A positive change from baseline indicates improvement. (NCT01513460)
Timeframe: baseline, 4 weeks, 8 weeks, 12 weeks
| Intervention | Liters (Mean) | ||
|---|---|---|---|
| Week 4 | Week 8 | Week 12 | |
| Flu/Sal | -0.010 | -0.002 | -0.012 |
| NVA237/Tiotropium+Flu/Sal | 0.077 | 0.088 | 0.088 |
"The purpose of the study is to determine if the dose counter on Albuterol Spiromax is counting accurately; accuracy is determined by concordance/agreement between patient-reported Albuterol Spiromax counter readings and patient-reported dose cycles recorded in patient diaries. This outcome is calculated for each inhaler as beginning counter reading minus end counter reading minus patient-recorded number of dose cycles. The total inhaler discrepancy size is an important measure because it provides the most relevant means of ensuring that the inhaler does not exhaust its supply of albuterol before the counter has recorded the labeled 200 doses." (NCT01857323)
Timeframe: Day 1 - Day 50
| Intervention | discrepancies/inhaler (Mean) |
|---|---|
| Albuterol Spiromax® | 2.0 |
"The purpose of the study is to determine if the dose counter on Albuterol Spiromax is counting accurately; accuracy is determined by concordance/agreement between patient-reported Albuterol Spiromax counter readings and patient-reported dose cycles recorded in patient diaries. This outcome measures when the inhaler counter advances (decreases, e.g., 50 to 48) between dosing sessions but the participant has not knowingly executed the dose cycle (i.e., the counter number at the beginning of the dosing session is less than the counter number at the end of the previous dosing session). The discrepancy rate was calculated as number of discrepancies/total number of dose cycles *200." (NCT01857323)
Timeframe: Day 1 - Day 50
| Intervention | discrepancies/200 dose cycles (Number) |
|---|---|
| Albuterol Spiromax® | 0.43 |
"The purpose of the study is to determine if the dose counter on Albuterol Spiromax is counting accurately; accuracy is determined by concordance/agreement between patient-reported Albuterol Spiromax counter readings and patient-reported dose cycles recorded in patient diaries. This outcome measures when the inhaler counter counts upwards (number increases, e.g. 50 to 52) rather than downward between dosing sessions but the participant has not knowingly executed the dose cycle (i.e., the counter number at the beginning of the dosing session is greater than the counter number at the end of the previous dosing session). The discrepancy rate was calculated as number of discrepancies/total number of dose cycles *200." (NCT01857323)
Timeframe: Day 1 - Day 50
| Intervention | discrepancies/200 dose cycles (Number) |
|---|---|
| Albuterol Spiromax® | 0.17 |
"The purpose of the study is to determine if the dose counter on Albuterol Spiromax is counting accurately; accuracy is determined by concordance/agreement between patient-reported Albuterol Spiromax counter readings and patient-reported dose cycles recorded in patient diaries. This outcome measures when the inhaler counter reading increases, instead of decreases, after the participant has executed the dose cycle (i.e., the ending counter reading is greater than the beginning counter reading within a dosing session). The discrepancy rate was calculated as number of discrepancies/total number of dose cycles *200." (NCT01857323)
Timeframe: Day 1 - Day 50
| Intervention | discrepancies/200 dose cycles (Number) |
|---|---|
| Albuterol Spiromax® | 2.46 |
"The purpose of the study is to determine if the dose counter on Albuterol Spiromax is counting accurately; accuracy is determined by concordance/agreement between patient-reported Albuterol Spiromax counter readings and patient-reported dose cycles recorded in patient diaries. This outcome measures how often the dose cycle was not counted: the participant completes a full dose cycle (opens the mouthpiece cap, inhales the medication, and closes the mouthpiece cap) but the counter display does not advance (i.e., does not count down) within a dosing session. The discrepancy rate was calculated as number of discrepancies/total number of dose cycles *200." (NCT01857323)
Timeframe: Day 1 - Day 50
| Intervention | discrepancies/200 dose cycles (Number) |
|---|---|
| Albuterol Spiromax® | 2.05 |
Adverse events (AEs) summarized in this table are those that began or worsened after treatment with study drug (treatment-emergent AEs). An adverse event was defined in the protocol as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator on a scale of mild, moderate and severe, with severe= an AE which prevents normal daily activities. Relation of AE to treatment was determined by the investigator. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical intervention to prevent the previously listed serious outcomes. (NCT01857323)
Timeframe: Day 1 to Day 50
| Intervention | participants (Number) | |||||
|---|---|---|---|---|---|---|
| Any adverse event | Severe adverse event | Treatment-related adverse event | Deaths | Other serious adverse events | Withdrawn from study due to adverse event | |
| Albuterol Spiromax® | 85 | 2 | 7 | 0 | 2 | 1 |
"This is an observational study, the aim is to record a variety of MDI usage techniques performed by patients. The technique is scored out of 7 for the following 7 steps:~Shaking (0 = not shaken, 1 = shaken)~Coordination (0 = MDI actuated before inhalation start, 1 = MDI actuated after inhalation start)~Flow rate (0 = mean inspiratory flow rate <30L/min or greater than 60L/min, 1 = mean inspiratory flow rate between 30-60L/min)~Duration of inhalation (0 = duration of inhalation <3 sec, 1 = duration of inhalation >=3sec)~Orientation of inhaler (0 = inhaler not upright = > 30° from the vertical position, 1 = inhaler upright = within 30° from the vertical position)~Number of exhalation (0 = exhalation during inhaler use, 1 = no exhalations)~Single Actuation (0 = less than 0 or more than 1 inhaler actuation, 1 = exactly 1 inhaler actuation)~The total score is a minimum of 0 correct steps if all the steps are incorrect to a maximum of 7 correct steps." (NCT02447575)
Timeframe: Single event- Outcome measured per inhaler puff, during the single clinic visit.
| Intervention | correct steps (Mean) |
|---|---|
| MDI Use Evaluation | 3.52 |
Pulmonary inspiratory force (PIF) from hospital baseline between the two arms for the duration of the 90 day study. (NCT03219866)
Timeframe: Baseline and 90 days
| Intervention | cmH2O (Mean) |
|---|---|
| Nebulizers | 73.9 |
| Dry Powder Inhaler | 74.2 |
Pulmonary inspiratory force (PIF) from hospital baseline between the two arms for the duration of the 90 day study. (NCT03219866)
Timeframe: Baseline and 90 days
| Intervention | cmH2O (Mean) |
|---|---|
| Nebulizers | 43.7 |
| Dry Powder Inhaler | 46.5 |
Compare the number of hospital readmissions between the two arms after 30 days of using each device. (NCT03219866)
Timeframe: 30 Days
| Intervention | number of readmissions (Number) |
|---|---|
| Nebulizers | 1 |
| Dry Powder Inhaler | 3 |
Compare the number of hospital readmissions between the two arms after 90 days of using each device. (NCT03219866)
Timeframe: 90 Days
| Intervention | number of readmissions (Number) |
|---|---|
| Nebulizers | 2 |
| Dry Powder Inhaler | 4 |
(NCT03219866)
Timeframe: 90 days
| Intervention | Participants (Count of Participants) |
|---|---|
| Nebulizers | 1 |
| Dry Powder Inhaler | 1 |
Scores range from 0 to 100, with higher scores indicating more limitations - Symptoms component (frequency & severity) with a 1, 3 or 12-month recall (best performance with 3- and 12-month recall); Part 2: Activities that cause or are limited by breathlessness; Impact components (social functioning, psychological disturbances resulting from airways disease) refer to current state as the recall (NCT03219866)
Timeframe: 90 Days
| Intervention | score on a scale (Mean) |
|---|---|
| Nebulizers | 49.3 |
| Dry Powder Inhaler | 43.7 |
The COPD Assessment Test (CAT) is a patient-completed instrument that can quantify the impact of COPD on the patient's health. The CAT is a validated, short (8-item) and simple patient completed questionnaire. The CAT has a scoring range of 0-40 and a difference or change of 2 or more units over 2 to 3 months in a patient suggests a clinically significant difference or change in health status. A score of >30 indicates that COPD has a very high impact on daily life, a score of >20 indicates a high impact, 10-20 is medium impact, <10 is low impact, and 5 is the upper limit for healthy non-smokers. A higher score would represent a poor outcome for this test. (NCT03219866)
Timeframe: 90 Days
| Intervention | score on a scale (Mean) |
|---|---|
| Nebulizers | 19.2 |
| Dry Powder Inhaler | 16.5 |
The Modified Medical Research Council Dyspnea Scale, or MMRC, uses a simple grading system to assess a patient's level of dyspnea -- shortness of breath. The scale goes from 0-4 with a 0 = I only get breathless with strenuous exercise, 1 = I get short of breath when hurrying on level ground or walking up a slight hill, 2 = On level ground, I walk slower than people of the same age because of breathlessness or have to stop for breath when walking at my own pace, 3 = I stop for breath after walking about 100 yards or after a few minutes on level ground, and 4 = I am too breathless to leave the house or I am breathless when dressing. 4 would represent the worst outcome. (NCT03219866)
Timeframe: 90 Days
| Intervention | score on a scale (Mean) |
|---|---|
| Nebulizers | 2.1 |
| Dry Powder Inhaler | 1.6 |
Compare the number of unscheduled clinic or ER visits between the two arms after 90 days of using each device (NCT03219866)
Timeframe: 90 Days
| Intervention | number of visits (Number) |
|---|---|
| Nebulizers | 4 |
| Dry Powder Inhaler | 4 |
Determine differences in healthcare visits which include all-cause and respiratory related, acute care outpatient visits, emergency department visits, and hospitalizations between groups (NCT03137303)
Timeframe: 1 year
| Intervention | Participants (Count of Participants) | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Emergency room visit72551318 | Emergency room visit72551317 | Hospitalization72551317 | Hospitalization72551318 | Acute outpatient visit72551318 | Acute outpatient visit72551317 | Routine primary care visits72551317 | Routine primary care visits72551318 | New diagnostic tests72551318 | New diagnostic tests72551317 | |||||||||||||||||||||
| No | Missing | Yes | ||||||||||||||||||||||||||||
| Patient Subject Usual Care | 111 | |||||||||||||||||||||||||||||
| Patient-Subject Intervention | 76 | |||||||||||||||||||||||||||||
| Patient Subject Usual Care | 119 | |||||||||||||||||||||||||||||
| Patient-Subject Intervention | 93 | |||||||||||||||||||||||||||||
| Patient Subject Usual Care | 1 | |||||||||||||||||||||||||||||
| Patient Subject Usual Care | 48 | |||||||||||||||||||||||||||||
| Patient-Subject Intervention | 17 | |||||||||||||||||||||||||||||
| Patient Subject Usual Care | 182 | |||||||||||||||||||||||||||||
| Patient-Subject Intervention | 152 | |||||||||||||||||||||||||||||
| Patient Subject Usual Care | 61 | |||||||||||||||||||||||||||||
| Patient-Subject Intervention | 35 | |||||||||||||||||||||||||||||
| Patient Subject Usual Care | 169 | |||||||||||||||||||||||||||||
| Patient-Subject Intervention | 134 | |||||||||||||||||||||||||||||
| Patient Subject Usual Care | 198 | |||||||||||||||||||||||||||||
| Patient-Subject Intervention | 138 | |||||||||||||||||||||||||||||
| Patient Subject Usual Care | 32 | |||||||||||||||||||||||||||||
| Patient-Subject Intervention | 31 | |||||||||||||||||||||||||||||
| Patient-Subject Intervention | 2 | |||||||||||||||||||||||||||||
| Patient Subject Usual Care | 126 | |||||||||||||||||||||||||||||
| Patient-Subject Intervention | 72 | |||||||||||||||||||||||||||||
| Patient Subject Usual Care | 104 | |||||||||||||||||||||||||||||
| Patient-Subject Intervention | 97 | |||||||||||||||||||||||||||||
The value can be expressed as relative deviation from target =(measured Raw - target Raw)/target Raw X100 (NCT01933984)
Timeframe: Airway resistance will be recorded everyday. If a patient's ventilator was liberated less than 28 days, the day of liberation was the reported time frame. If the day of ventilator liberation was over 28 days, the 28th day was the reported time frame.
| Intervention | percentage of relative Raw deviation (Mean) |
|---|---|
| Individualized Dosing | 9 |
| Fixed Dosing | 44 |
The percentage of participants died at day 180. (NCT01933984)
Timeframe: the 180th day after enrollment
| Intervention | percentage of participants (Number) |
|---|---|
| Individualized Dosing | 35 |
| Fixed Dosing | 40 |
The number of episodes of nosocomial pneumonia happened by day 28. And nosocomial pneumonia is a lower respiratory infection that was not incubating at the time of hospital admission and that presents clinically 2 or more days after hospitalization. (NCT01933984)
Timeframe: the 28th day after enrollment
| Intervention | episodes of nosocomial pneumonia (Median) |
|---|---|
| Individualized Dosing | 0 |
| Fixed Dosing | 0 |
The number of total puff of rescue short-acting bronchodilator. (NCT01933984)
Timeframe: the 28th day after enrollment
| Intervention | puffs (Number) |
|---|---|
| Individualized Dosing | 0 |
| Fixed Dosing | 0 |
The numbers of episode of drug-related adverse effect. Naranjo score should be over 4 to be considered drug-related adverse effect. Naranjo score range form 0 to 9, and the higher scores means a higher relationship with drug-related adverse effect. (NCT01933984)
Timeframe: From day 1 to day 28 after enrollment
| Intervention | episodes (Median) |
|---|---|
| Individualized Dosing | 0 |
| Fixed Dosing | 0 |
The deviation of ∆Raw from the personal target, which was calculated as (measured Raw-target Raw)/target Raw multiplied by 100. (NCT01933984)
Timeframe: Airway resistance will be recorded everyday. If a patient's ventilator was liberated less than 28 days, the day of liberation was the reported time frame. If the day of ventilator liberation was over 28 days, the 28th day was the reported time frame.
| Intervention | percentage of relative Raw deviation (Mean) |
|---|---|
| Individualized Dosing | -3 |
| Fixed Dosing | 0.4 |
The number of participants who breath without ventilator by day 28 (NCT01933984)
Timeframe: the 28th day after enrollment
| Intervention | the number of participants (Number) |
|---|---|
| Individualized Dosing | 19 |
| Fixed Dosing | 22 |
Ventilator-free days from day 1 to 28 after enrollment (NCT01933984)
Timeframe: From day 1 to day 28 after enrollment
| Intervention | day (Number) |
|---|---|
| Individualized Dosing | 19 |
| Fixed Dosing | 22 |
We studied 26 subjects, 2 weeks before and 2 months after HSCT. Within-breath respiratory system conductance (Grs) at 5, 11 and 19 Hz was measured by forced oscillation technique (FOT) at functional residual capacity (FRC) and total lung capacity (TLC) (NCT01255449)
Timeframe: 2 weeks before and 2 months after HSCT
| Intervention | 1/cmH2O*s (Mean) |
|---|---|
| Airway Distensibility With Lung Inflation After HSCT | 0.07 |
Changes in lung tissue density were measured by quantitative computed tomography(CT) scan 2 weeks before and 2 months after HSCT (NCT01255449)
Timeframe: Before and 2 months after HSCT
| Intervention | g/mL (Mean) |
|---|---|
| Post-HSCT Changes in Lung Tissue Density | 0.03 |
Difference between the hospitalization rate during the study and the previous year. For each patient, hospitalization rate was defined as the number of hospital admissions during a period divided by the length (in days) of the period. Number of hospitalizations was collected by the hospital clinical records. (NCT01960907)
Timeframe: Baseline and 9 months
| Intervention | hospitalizations/year/patient (Median) |
|---|---|
| Monitored, Previously Hopitalized for COPD Exacerbation | -1 |
| Observational, Previously Hopitalized for COPD Exacerb. | -1 |
The quality of life of patients as quantified by the final utility index of the EQ-5D questionnaire. The utility index ranges from -0.074 to 1 with 1 being the highest possible quality of life. (NCT01960907)
Timeframe: 9 months
| Intervention | units on a scale (Mean) |
|---|---|
| Observational | 0.640 |
| Interventional | 0.637 |
It represents the number of days, since the enrolment into the study, to the first hospitalization (NCT01960907)
Timeframe: From enrolment up to 9 months
| Intervention | days (Mean) |
|---|---|
| Observational | 255 |
| Interventional | 224 |
Trough FEV1 is defined as the measurement collected approximately 24 hours after the first in-clinic double-blind dose at Week 0. Change is calculated as Week 2 24 hour post first dose FEV1 - Week 0 pre-first dose FEV1. (NCT00424528)
Timeframe: Following 2 weeks of dosing
| Intervention | Liters (Mean) |
|---|---|
| Arformoterol 15 Mcg Twice Daily | 0.086 |
| Tiotropium 18 Mcg Once Daily | 0.080 |
| Arformoterol /Tiotropium | 0.154 |
Trough Inspiratory Capacity is defined as the measurement collected approximately 24 hours after the first in clinic double-blind treatment dose at week 0. Change is calculated as Week 2 24 hr post dose IC - Week 0 pre first dose IC. (NCT00424528)
Timeframe: 2 weeks
| Intervention | Liters (Mean) |
|---|---|
| Arformoterol 15 Mcg Twice Daily | 0.074 |
| Tiotropium 18 Mcg Once Daily | 0.023 |
| Arformoterol /Tiotropium | 0.150 |
A Greater than or Equal to 1 unit of Improvement in the TDI Focal Score is considered to be clinically important. (NCT00424528)
Timeframe: 2 weeks
| Intervention | Participants (Number) |
|---|---|
| Arformoterol 15 Mcg Twice Daily | 50 |
| Tiotropium 18 Mcg Once Daily | 44 |
| Arformoterol /Tiotropium | 60 |
A Greater than or Equal to 1 unit of Improvement in the TDI Focal Score is considered to be clinically important. (NCT00424528)
Timeframe: 2 weeks
| Intervention | Percentage of participants (Number) |
|---|---|
| Arformoterol 15 Mcg Twice Daily | 66.67 |
| Tiotropium 18 Mcg Once Daily | 57.14 |
| Arformoterol /Tiotropium | 77.92 |
(NCT00424528)
Timeframe: Following 2 weeks of dosing
| Intervention | Liters (Mean) |
|---|---|
| Arformoterol 15 Mcg Twice Daily | 0.094 |
| Tiotropium 18 Mcg Once Daily | 0.054 |
| Arformoterol /Tiotropium | 0.217 |
Analyzed from end of dosing to 12 hours. (NCT00424528)
Timeframe: 2 weeks
| Intervention | Hours (Median) |
|---|---|
| Arformoterol 15 Mcg Twice Daily | 0.39 |
| Tiotropium 18 Mcg Once Daily | 0.72 |
| Arformoterol /Tiotropium | 0.17 |
Analyzed from end of dosing to 12 hours. (NCT00424528)
Timeframe: 2 weeks
| Intervention | Hours (Median) |
|---|---|
| Arformoterol 15 Mcg Twice Daily | 0.76 |
| Tiotropium 18 Mcg Once Daily | 1.29 |
| Arformoterol /Tiotropium | 0.39 |
(NCT00424528)
Timeframe: 0-12 hours following two weeks of dosing
| Intervention | Liters (Mean) |
|---|---|
| Arformoterol 15 Mcg Twice Daily | 0.118 |
| Tiotropium 18 Mcg Once Daily | 0.130 |
| Arformoterol /Tiotropium | 0.242 |
(NCT00424528)
Timeframe: 24 hours following two weeks of dosing.
| Intervention | Liters (Mean) |
|---|---|
| Arformoterol 15 Mcg Twice Daily | 0.104 |
| Tiotropium 18 Mcg Once Daily | 0.080 |
| Arformoterol /Tiotropium | 0.221 |
TDI Focal score (range -9 to 9) is defined as the sum of function impairment, magnitude of task, and magnitude of effort (each on a -3 to 3 scale). A score of -9 is maximum worsening and 9 is maximum improvement. (NCT00424528)
Timeframe: 2 weeks
| Intervention | Units on a scale (Mean) |
|---|---|
| Arformoterol 15 Mcg Twice Daily | 2.28 |
| Tiotropium 18 Mcg Once Daily | 1.79 |
| Arformoterol /Tiotropium | 3.13 |
Baseline is FEV1 measurement collected prior to the first double-blind dose at week 0. Change defined as Week 0 FEV1 - Week 2 pre first dose FEV1. (NCT00424528)
Timeframe: 2 weeks
| Intervention | Liters (Mean) | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Week 0: immediately post first dose; N=76, 78, 78 | Week 0: 30 minutes post first dose; N=75, 78, 76 | Week 0: 1 hour post first dose; N=75, 78, 77 | Week 0: 2 hours post first dose; N=76, 78, 77 | Week 0: 4 hours post first dose; N=75, 77, 77 | Week 0: 6 hours post first dose; N=72, 74, 77 | Week 0: 8 hours post first dose; N=70, 73, 77 | Week 0: 10 hours post first dose; N=69, 71, 76 | Week 0: 12 hours post first dose; N=69, 71, 75 | Week 2: immediately post first dose; N=71, 75, 74 | Week 2: 30 minutes post first dose; N=70, 74, 74 | Week 2: 1 hour post first dose; N=71, 75, 73 | Week 2: 2 hours post first dose; N=71, 73, 74 | Week 2: 4 hours post first dose; N=69, 72, 74 | Week 2: 6 hours post first dose; N=69, 72, 73 | Week 2: 8 hours post first dose; N=69, 70, 74 | Week 2: 10 hours post first dose; N=69, 71, 71 | Week 2: 12 hours post first dose; N=63, 67, 71 | Week 2: immediately post second dose; N=65, 67, 72 | Week 2: 12.5 hours post first dose; N=65, 66, 72 | Week 2: 13 hours post first dose; N=63, 68, 72 | Week 2: 14 hours post first dose; N=65, 71, 72 | Week 2: 16 hours post first dose; N=63, 70, 71 | Week 2: 23 hours post first dose; N=70, 74, 74 | Week 2: 24 hours post first dose; N=69, 73, 74 | |
| Arformoterol /Tiotropium | 0.139 | 0.183 | 0.189 | 0.239 | 0.223 | 0.214 | 0.194 | 0.190 | 0.199 | 0.240 | 0.280 | 0.308 | 0.330 | 0.279 | 0.266 | 0.220 | 0.205 | 0.189 | 0.235 | 0.270 | 0.272 | 0.292 | 0.240 | 0.145 | 0.154 |
| Arformoterol 15 Mcg Twice Daily | 0.132 | 0.163 | 0.182 | 0.193 | 0.155 | 0.128 | 0.102 | 0.101 | 0.044 | 0.154 | 0.188 | 0.185 | 0.213 | 0.154 | 0.123 | 0.067 | 0.054 | 0.035 | 0.115 | 0.143 | 0.159 | 0.182 | 0.114 | 0.040 | 0.086 |
| Tiotropium 18 Mcg Once Daily | -0.20 | 0.056 | 0.106 | 0.140 | 0.120 | 0.125 | 0.109 | 0.111 | 0.094 | 0.066 | 0.126 | 0.163 | 0.195 | 0.164 | 0.143 | 0.138 | 0.109 | 0.101 | 0.040 | 0.063 | 0.061 | 0.068 | 0.048 | -0.006 | 0.080 |
Baseline is FEV1 collected prior to first double-blind dose at week 0. Change is defined as Week 0 FEV1 percent predicted - Week 2 pre first dose FEV1 percent predicted. (NCT00424528)
Timeframe: 2 weeks
| Intervention | Percent of predicted FEV1 (Mean) | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Week 0: Immediately post first dose; N=76, 78, 78 | Week 0: 30 minutes post first dose; N=75, 78, 76 | Week 0: 1 hour post first dose; N-75, 78, 77 | Week 0: 2 hours post first dose; N=76, 78, 77 | Week 0: 4 hours post first dose; N=75, 77, 77 | Week 0: 6 hours post first dose; N=72, 74, 77 | Week 0: 8 hours post first dose; N=70, 73, 77 | Week 0: 10 hours post first dose; N=69, 71, 76 | Week 0: 12 hours post first dose; N=69, 71, 75 | Week 2: Immediately post first dose; N=71, 75, 74 | Week 2: 30 minutes post first dose; N=70, 74, 74 | Week 2: 1 hour post first dose; N=71, 75, 73 | Week 2: 2 hours post first dose; N=71, 73, 74 | Week 2: 4 hours post first dose; N=69, 72, 74 | Week 2: 6 hours post first dose; N=69, 72, 73 | Week 2: 8 hours post first dose; N=69, 70, 74 | Week 2: 10 hours post first dose; N=69, 71, 71 | Week 2: 12 hours post first dose; N=63, 67, 71 | Week 2: Immediately post second dose; N=65, 67, 72 | Week 2: 12.5 hours post first dose; N=65, 66, 72 | Week 2: 13 hours post first dose; N=63, 68, 72 | Week 2: 14 hours post first dose; N=65, 71, 72 | Week 2: 16 hours post first dose; N=63, 70, 71 | Week 2: 23 hours post first dose; N=70, 74, 74 | Week 2: 24 hours post first dose; N=69, 73, 74 | |
| Arformoterol /Tiotropium | 4.7 | 6.1 | 6.3 | 8.1 | 7.5 | 7.3 | 6.6 | 6.5 | 6.7 | 8.0 | 9.3 | 10.2 | 11.0 | 9.2 | 8.8 | 7.4 | 6.8 | 6.3 | 7.8 | 9.0 | 9.1 | 9.8 | 8.0 | 4.8 | 5.2 |
| Arformoterol 15 Mcg Twice Daily | 4.3 | 5.5 | 6.1 | 6.6 | 5.3 | 4.4 | 3.5 | 3.3 | 1.6 | 5.1 | 6.2 | 6.2 | 7.1 | 5.1 | 4.0 | 2.0 | 1.8 | 1.3 | 3.8 | 4.9 | 5.4 | 6.0 | 3.9 | 1.3 | 2.8 |
| Tiotropium 18 Mcg Once Daily | -0.6 | 2.0 | 3.5 | 4.7 | 4.0 | 4.1 | 3.5 | 3.7 | 2.9 | 1.9 | 4.0 | 5.2 | 6.3 | 5.1 | 4.7 | 4.4 | 3.5 | 3.4 | 1.1 | 2.0 | 1.8 | 2.0 | 1.4 | -0.2 | 2.6 |
(NCT00424528)
Timeframe: 2 Weeks
| Intervention | Liters (Mean) | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Week 0: Immediately post first dose; N=76, 78, 78 | Week 0: 30 minutes post first dose; N=75, 78, 76 | Week 0: 1 hour post first dose; N=75, 78, 77 | Week 0: 2 hours post first dose; N=76, 78, 77 | Week 0: 4 hours post first dose; N=75, 77, 77 | Week 0: 6 hours post first dose; N=72, 74, 77 | Week 0: 8 hours post first dose; N=70, 73, 77 | Week 0: 10 hours post first dose; N=69, 71, 76 | Week 0: 12 hours post first dose; N=69, 71, 75 | Week 2: Immediately post first dose; N=71, 75, 74 | Week 2: 30 minutes post first dose; N=70, 74, 74 | Week 2: 1 hour post first dose; N=71, 75, 73 | Week 2: 2 hours post first dose; N=71, 73, 74 | Week 2: 4 hours post first dose; N=69, 72, 74 | Week 2: 6 hours post first dose; N=69, 72, 73 | Week 2: 8 hours post first dose; N=69, 70, 74 | Week 2: 10 hours post first dose; N=69, 71, 71 | Week 2: 12 hours post first dose; N=63, 67, 71 | Week 2: Immediately post second dose; N=65, 67, 72 | Week 2: 12.5 hours post first dose; N=65, 66, 72 | Week 2: 13 hours post first dose; N=63, 68, 72 | Week 2: 14 hours post first dose; N=65, 71, 72 | Week 2: 16 hours post first dose; N=63, 70, 71 | Week 2: 23 hours post first dose; N=70, 74, 74 | Week 2: 24 hours post first dose; N=69, 73, 74 | |
| Arformoterol /Tiotropium | 0.259 | 0.323 | 0.351 | 0.429 | 0.392 | 0.371 | 0.338 | 0.346 | 0.344 | 0.389 | 0.461 | 0.487 | 0.526 | 0.461 | 0.413 | 0.349 | 0.323 | 0.301 | 0.360 | 0.399 | 0.424 | 0.459 | 0.374 | 0.226 | 0.250 |
| Arformoterol 15 Mcg Twice Daily | 0.276 | 0.312 | 0.344 | 0.376 | 0.291 | 0.242 | 0.207 | 0.209 | 0.131 | 0.293 | 0.343 | 0.350 | 0.380 | 0.265 | 0.202 | 0.136 | 0.098 | 0.087 | 0.210 | 0.262 | 0.307 | 0.343 | 0.215 | 0.082 | 0.138 |
| Tiotropium 18 Mcg Once Daily | -0.031 | 0.122 | 0.197 | 0.248 | 0.206 | 0.195 | 0.159 | 0.175 | 0.146 | 0.055 | 0.203 | 0.224 | 0.290 | 0.221 | 0.209 | 0.214 | 0.158 | 0.124 | 0.034 | 0.087 | 0.082 | 0.110 | 0.098 | -0.011 | 0.115 |
Overall: Average of the levalbuterol usage in days per week over the 2 week period. Mean number of days/week=number of days levalbuterol used during time period, divided by number of days in the period, multiplied by 7. An actuation is one puff of levalbuterol. (NCT00424528)
Timeframe: 2 weeks
| Intervention | Days per week (Mean) | |
|---|---|---|
| Baseline: Number of days used per week | Overall: Number of days used per week | |
| Arformoterol /Tiotropium | 4.57 | 1.38 |
| Arformoterol 15 Mcg Twice Daily | 4.44 | 2.16 |
| Tiotropium 18 Mcg Once Daily | 4.27 | 1.94 |
Overall: Average of the usage in number of actuations per day over the 2 week period. An actuation is one puff of levalbuterol. Mean number of actuations/day=number actuations used during time period, divided by number of days in time period. (NCT00424528)
Timeframe: 2 weeks
| Intervention | Actuations per day (Mean) | |
|---|---|---|
| Baseline: Number of actuations per day | Overall: Number of actuations per day | |
| Arformoterol /Tiotropium | 3.08 | 0.68 |
| Arformoterol 15 Mcg Twice Daily | 3.24 | 1.18 |
| Tiotropium 18 Mcg Once Daily | 2.77 | 1.00 |
12 hour peak change in FEV1 is defined as maximum of the post dose changes through the nominal 12 hour assessment. (NCT00424528)
Timeframe: 2 weeks
| Intervention | Liters (Mean) | |
|---|---|---|
| Week 0; N=76, 79, 78 | Week 2; N=71, 75, 74 | |
| Arformoterol /Tiotropium | 0.311 | 0.379 |
| Arformoterol 15 Mcg Twice Daily | 0.264 | 0.273 |
| Tiotropium 18 Mcg Once Daily | 0.218 | 0.265 |
Mean rate of COPD exacerbations requiring oral or parenteral glucocorticosteroids (=moderate COPD exacerbations), or requiring hospitalization, or leading to death (=severe COPD exacerbations), per patient per year. A COPD exacerbation is an event in the natural course of the disease characterized by a change in the patient's baseline dyspnea, cough and/or sputum beyond day-to-day variability sufficient to warrant a change in management [American Thoracic Society (ATS) / European Respiratory Society (ERS) 2005]. (NCT00424268)
Timeframe: 24 weeks treatment period
| Intervention | exacerbations per patient per year (Mean) |
|---|---|
| Roflumilast | 0.262 |
| Placebo | 0.342 |
Mean change from baseline during the treatment period in post-bronchodilator FEV1 [L] (NCT00424268)
Timeframe: Change from baseline over 24 weeks of treatment
| Intervention | mL (Least Squares Mean) |
|---|---|
| Roflumilast | 74 |
| Placebo | -7 |
Mean change from baseline during the treatment period in pre-bronchodilator FEV1 [L] (NCT00424268)
Timeframe: Change from baseline over 24 weeks of treatment
| Intervention | mL (Least Squares Mean) |
|---|---|
| Roflumilast | 65 |
| Placebo | -16 |
"Mean change from baseline during the treatment period in SOBQ. This is a 24-item measure that assesses self-reported shortness of breath while performing a variety of activities of daily living. The questions were administered at visits V0, V2, V3, V4, V5, V6 and Vend to assess the perceived shortness of breath of the patient. For each activity listed in the questionnaire the patient should rate his/her breathlessness on a scale between zero and five, where zero is not at all breathless and five is maximally breathless or too breathless to do the activity." (NCT00424268)
Timeframe: Change from baseline over 24 weeks of treatment
| Intervention | scores on a scale (Least Squares Mean) |
|---|---|
| Roflumilast | -3.4 |
| Placebo | -0.7 |
The TDI is a recognized questionnaire to measure dyspnea in an out patient COPD population. At baseline, 3 components of dyspnea, each graded with 4 questions, were asked: - Functional Impairment - Magnitude of Task - Magnitude of Effort At each of the post-randomization visits questions from the TDI were asked related to 3 components: Change in - Functional Impairment - Magnitude of Task - Magnitude of Effort Each question in the TDI is graded from -3 (major deterioration) to +3 (major improvement). This results in a TDI Focal Score ranging from -9 to +9. (NCT00424268)
Timeframe: Change from baseline over 24 weeks of treatment
| Intervention | scores on a scale (Least Squares Mean) |
|---|---|
| Roflumilast | 1.4 |
| Placebo | 0.9 |
Mean rate of COPD exacerbations requiring rescue medication of 3 or more puffs/day on at least 2 consecutive days (=mild COPD exacerbations), or requiring oral or parenteral glucocorticosteroids (=moderate COPD exacerbations), or requiring hospitalization, or leading to death (=severe COPD exacerbations), per patient per year. A COPD exacerbation is an event in the natural course of the disease characterized by a change in the patient's baseline dyspnea, cough and/or sputum beyond day-to-day variability sufficient to warrant a change in management [ATS / ERS 2005]. (NCT00313209)
Timeframe: 24 weeks treatment period
| Intervention | exacerbations per patient per year (Mean) |
|---|---|
| Roflumilast | 1.9 |
| Placebo | 2.4 |
Mean change from baseline during the treatment period in post-bronchodilator FEV1 [L] (NCT00313209)
Timeframe: Change from baseline over 24 weeks of treatment
| Intervention | mL (Least Squares Mean) |
|---|---|
| Roflumilast | 68 |
| Placebo | 8 |
Mean change from baseline during the treatment period in pre-bronchodilator FEV1 [L] (NCT00313209)
Timeframe: Change from baseline over 24 weeks of treatment
| Intervention | mL (Least Squares Mean) |
|---|---|
| Roflumilast | 39 |
| Placebo | -10 |
"Mean change from baseline during the treatment period in SOBQ. This is a 24-item measure that assesses self-reported shortness of breath while performing a variety of activities of daily living. The questions were administered at visits V0, V2, V3, V4, V5, V6 and Vend to assess the perceived shortness of breath of the patient. For each activity listed in the questionnaire the patient should rate his/her breathlessness on a scale between zero and five, where zero is not at all breathless and five is maximally breathless or too breathless to do the activity." (NCT00313209)
Timeframe: Change from baseline over 24 weeks of treatment
| Intervention | scores on a scale (Least Squares Mean) |
|---|---|
| Roflumilast | -0.6 |
| Placebo | -1.1 |
The TDI is a recognized questionnaire to measure dyspnea in an out patient COPD population. At baseline, 3 components of dyspnea, each graded with 4 questions, were asked: - Functional Impairment - Magnitude of Task - Magnitude of Effort At each of the post-randomization visits questions from the TDI were asked related to 3 components: Change in - Functional Impairment - Magnitude of Task - Magnitude of Effort Each question in the TDI is graded from -3 (major deterioration) to +3 (major improvement). This results in a TDI Focal Score ranging from -9 to +9. (NCT00313209)
Timeframe: Change from baseline over 24 weeks of treatment
| Intervention | scores on a scale (Least Squares Mean) |
|---|---|
| Roflumilast | 1.2 |
| Placebo | 1.1 |
COPD exacerbation is defined as an increase or new onset of more than one of the following respiratory symptoms (cough, sputum, sputum purulence, wheezing, dyspnea, and chest tightness) having a duration of three or more days requiring treatment with an antibiotic and/or systemic steroids with or without hospital admission. (NCT00400153)
Timeframe: During the 12-week on-treatment period
| Intervention | Percentage of patients (Number) |
|---|---|
| COMBIVENT Respimat 20/100 mcg | 3.27 |
| COMBIVENT CFC-MDI 36/206 mcg | 2.93 |
| Ipratropium Respimat 20 mcg | 2.13 |
Proportion of patients experiencing a COPD exacerbation per patient year. COPD exacerbation is defined as an increase or new onset of more than one of the following respiratory symptoms (cough, sputum, sputum purulence, wheezing, dyspnea, and chest tightness) having a duration of three or more days requiring treatment with an antibiotic and/or systemic steroids with or without hospital admission. (NCT00400153)
Timeframe: During the 12-week on-treatment period
| Intervention | Proportion of patients (Number) |
|---|---|
| COMBIVENT Respimat 20/100 mcg | 0.76 |
| COMBIVENT CFC-MDI 36/206 mcg | 0.69 |
| Ipratropium Respimat 20 mcg | 0.53 |
Cumulative amounts of Albuterol [μg] excreted in urine - Planned time intervals 0-2,ss. (NCT00400153)
Timeframe: Before drug administration to 2 hours after drug administration on Day 29
| Intervention | μg (Geometric Mean) |
|---|---|
| COMBIVENT Respimat 20/100 mcg | 14.7 |
| COMBIVENT CFC-MDI 36/206 mcg | 20.3 |
Cumulative amounts of Albuterol [μg] excreted in urine - Planned time intervals 0-6, ss (NCT00400153)
Timeframe: Before drug administration to 6 hours after drug administration on Day 29
| Intervention | μg (Geometric Mean) |
|---|---|
| COMBIVENT Respimat 20/100 mcg | 33.7 |
| COMBIVENT CFC-MDI 36/206 mcg | 39.4 |
Cumulative amounts of Ipratropium [μg] excreted in urine - Planned time intervals 0-2, ss (NCT00400153)
Timeframe: Before drug administration to 2 hours after drug administration on Day 29
| Intervention | μg (Geometric Mean) |
|---|---|
| COMBIVENT Respimat 20/100 mcg | 0.747 |
| COMBIVENT CFC-MDI 36/206 mcg | 0.692 |
| Ipratropium Respimat 20 Mcg | 0.723 |
Cumulative amounts of Ipratropium [μg] excreted in urine - Planned time intervals 0-6,ss (NCT00400153)
Timeframe: Before drug administration to 6 hours after drug administration on Day 26
| Intervention | μg (Geometric Mean) |
|---|---|
| COMBIVENT Respimat 20/100 mcg | 1.66 |
| COMBIVENT CFC-MDI 36/206 mcg | 1.41 |
| Ipratropium Respimat 20 mcg | 1.51 |
The mean number of puffs of rescue medication used during the daytime per week during the entire study (including baseline and on-treatment period) (NCT00400153)
Timeframe: During the 2-week baseline washout period and the 12-week treatment period
| Intervention | puffs (Least Squares Mean) |
|---|---|
| COMBIVENT Respimat 20/100 mcg | 2.3 |
| COMBIVENT CFC-MDI 36/206 mcg | 2.191 |
| Ipratropium Respimat 20 mcg | 2.456 |
"The weekly mean daytime symptom score per week during the entire study (including baseline and on-treatment period).~Daytime COPD symptoms: 0=none 1=occasional 2=frequent, no interference with activities 3=most of day, interference with activities 4=prevent working and activities" (NCT00400153)
Timeframe: During the 2-week baseline washout period and the 12-week treatment period
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| COMBIVENT Respimat 20/100 mcg | 1.015 |
| COMBIVENT CFC-MDI 36/206 mcg | 1.002 |
| Ipratropium Respimat 20 mcg | 0.999 |
The time interval between the onset and the the termination of a therapeutic FEV1 response (at least 1.15 times the corresponding test-day baseline value) during the 6-hour observation period at Day 1 (NCT00400153)
Timeframe: During the 6-hour observation period after drug administration at Day 1
| Intervention | Minutes (Median) |
|---|---|
| COMBIVENT Respimat 20/100 mcg | 189 |
| COMBIVENT CFC-MDI 36/206 mcg | 219 |
| Ipratropium Respimat 20 mcg | 104 |
The time interval between the onset and the the termination of a therapeutic FEV1 response (at least 1.15 times the corresponding test-day baseline value) during the 6-hour observation period at Day 29 (NCT00400153)
Timeframe: During the 6-hour observation period after drug administration at Day 29
| Intervention | Minutes (Median) |
|---|---|
| COMBIVENT Respimat 20/100 mcg | 170 |
| COMBIVENT CFC-MDI 36/206 mcg | 178 |
| Ipratropium Respimat 20 mcg | 122 |
The time interval between the onset and the the termination of a therapeutic FEV1 response (at least 1.15 times the corresponding test-day baseline value) during the 6-hour observation period at Day 57 (NCT00400153)
Timeframe: During the 6-hour observation period after drug administration at Day 57
| Intervention | Minutes (Median) |
|---|---|
| COMBIVENT Respimat 20/100 mcg | 165 |
| COMBIVENT CFC-MDI 36/206 mcg | 194 |
| Ipratropium Respimat 20 mcg | 84 |
The time interval between the onset and the the termination of a therapeutic FEV1 response (at least 1.15 times the corresponding test-day baseline value) during the 6-hour observation period at Day 85 (NCT00400153)
Timeframe: During the 6-hour observation period after drug administration at Day 85
| Intervention | Minutes (Median) |
|---|---|
| COMBIVENT Respimat 20/100 mcg | 168 |
| COMBIVENT CFC-MDI 36/206 mcg | 172 |
| Ipratropium Respimat 20 mcg | 70 |
Area between the test-day baseline FEV1 and the FEV1 change from the test-day baseline curve from 0 to 4 hours divided by 4 at Day 1 (NCT00400153)
Timeframe: Before drug administration to 4 hours after drug administration on Day 1
| Intervention | liters (Least Squares Mean) |
|---|---|
| COMBIVENT Respimat 20/100 mcg | 0.211 |
| COMBIVENT CFC-MDI 36/206 mcg | 0.227 |
| Ipratropium Respimat 20 mcg | 0.149 |
Area between the test-day baseline FEV1 and the FEV1 change from the test-day baseline curve from 0 to 4 hours divided by 4 at Day 29 (NCT00400153)
Timeframe: Before drug administration to 4 hours after drug administration on Day 29
| Intervention | liters (Least Squares Mean) |
|---|---|
| COMBIVENT Respimat 20/100 mcg | 0.197 |
| COMBIVENT CFC-MDI 36/206 mcg | 0.198 |
| Ipratropium Respimat 20 mcg | 0.153 |
Area between the test-day baseline FEV1 and the FEV1 change from the test-day baseline curve from 0 to 4 hours divided by 4 at Day 57 (NCT00400153)
Timeframe: Before drug administration to 4 hours after drug administration on Day 57
| Intervention | liters (Least Squares Mean) |
|---|---|
| COMBIVENT Respimat 20/100 mcg | 0.188 |
| COMBIVENT CFC-MDI 36/206 mcg | 0.200 |
| Ipratropium Respimat 20 mcg | 0.141 |
Area between the test-day baseline FEV1 and the FEV1 change from the test-day baseline curve from 0 to 4 hours divided by 4 at Day 85 (NCT00400153)
Timeframe: Before drug administration to 4 hours after drug administration on Day 85
| Intervention | liters (Least Squares Mean) |
|---|---|
| COMBIVENT Respimat 20/100 mcg | 0.189 |
| COMBIVENT CFC-MDI 36/206 mcg | 0.190 |
| Ipratropium Respimat 20 mcg | 0.142 |
Area between the test-day baseline FEV1 and the FEV1 change from the test-day baseline curve from 0 to 6 hours divided by 6 at Day 1 (NCT00400153)
Timeframe: Before drug administration to 6 hours after drug administration on Day 1
| Intervention | liters (Least Squares Mean) |
|---|---|
| COMBIVENT Respimat 20/100 mcg | 0.173 |
| COMBIVENT CFC-MDI 36/206 mcg | 0.189 |
| Ipratropium Respimat 20 mcg | 0.124 |
Area between the test-day baseline FEV1 and the FEV1 change from the test-day baseline curve from 0 to 6 hours divided by 6 at Day 29 (NCT00400153)
Timeframe: Before drug administration to 6 hours after drug administration on Day 29
| Intervention | liters (Least Squares Mean) |
|---|---|
| COMBIVENT Respimat 20/100 mcg | 0.154 |
| COMBIVENT CFC-MDI 36/206 mcg | 0.161 |
| Ipratropium Respimat 20 mcg | 0.127 |
Area between the test-day baseline FEV1 and the FEV1 change from the test-day baseline curve from 0 to 6 hours divided by 6 at Day 57 (NCT00400153)
Timeframe: Before drug administration to 6 hours after drug administration on Day 57
| Intervention | liters (Least Squares Mean) |
|---|---|
| COMBIVENT Respimat 20/100 mcg | 0.146 |
| COMBIVENT CFC-MDI 36/206 mcg | 0.16 |
| Ipratropium Respimat 20 mcg | 0.118 |
Area between the test-day baseline FEV1 and the FEV1 change from the test-day baseline curve from 0 to 6 hours divided by 6 at Day 85 (NCT00400153)
Timeframe: Before drug administration to 6 hours after drug administration on Day 85
| Intervention | liters (Least Squares Mean) |
|---|---|
| COMBIVENT Respimat 20/100 mcg | 0.145 |
| COMBIVENT CFC-MDI 36/206 mcg | 0.149 |
| Ipratropium Respimat 20 mcg | 0.119 |
Area between the test-day baseline FEV1 and the FEV1 change from the test-day baseline curve from 4 to 6 hours divided by 2 at Day 1 (NCT00400153)
Timeframe: Between 4 hours and 6 hours after drug administration on Day 1
| Intervention | liters (Least Squares Mean) |
|---|---|
| COMBIVENT Respimat 20/100 mcg | 0.1 |
| COMBIVENT CFC-MDI 36/206 mcg | 0.115 |
| Ipratropium Respimat 20 mcg | 0.074 |
Area between the test-day baseline FEV1 and the FEV1 change from the test-day baseline curve from 4 to 6 hours divided by 2 at Day 29 (NCT00400153)
Timeframe: Between 4 hours and 6 hours after drug administration on Day 29
| Intervention | liters (Least Squares Mean) |
|---|---|
| COMBIVENT Respimat 20/100 mcg | 0.068 |
| COMBIVENT CFC-MDI 36/206 mcg | 0.087 |
| Ipratropium Respimat 20 mcg | 0.078 |
Area between the test-day baseline FEV1 and the FEV1 change from the test-day baseline curve from 4 to 6 hours divided by 2 at Day 57 (NCT00400153)
Timeframe: Between 4 hours and 6 hours after drug administration on Day 57
| Intervention | liters (Least Squares Mean) |
|---|---|
| COMBIVENT Respimat 20/100 mcg | 0.063 |
| COMBIVENT CFC-MDI 36/206 mcg | 0.084 |
| Ipratropium Respimat 20 mcg | 0.073 |
Area between the test-day baseline FEV1 and the FEV1 change from the test-day baseline curve from 4 to 6 hours divided by 2 at Day 85 (NCT00400153)
Timeframe: Between 4 hours and 6 hours after drug administration on Day 85
| Intervention | liters (Least Squares Mean) |
|---|---|
| COMBIVENT Respimat 20/100 mcg | 0.056 |
| COMBIVENT CFC-MDI 36/206 mcg | 0.066 |
| Ipratropium Respimat 20 mcg | 0.073 |
Area between the test-day baseline FVC and the FVC change from the test-day baseline curve from 0 to 4 hours divided by 4 at Day 1 (NCT00400153)
Timeframe: Before drug administration to 4 hours after drug administration on Day 1
| Intervention | liters (Least Squares Mean) |
|---|---|
| COMBIVENT Respimat 20/100 mcg | 0.408 |
| COMBIVENT CFC-MDI 36/206 mcg | 0.422 |
| Ipratropium Respimat 20 mcg | 0.297 |
Area between the test-day baseline FVC and the FVC change from the test-day baseline curve from 0 to 4 hours divided by 4 at Day 29 (NCT00400153)
Timeframe: Before drug administration to 4 hours after drug administration on Day 29
| Intervention | liters (Least Squares Mean) |
|---|---|
| COMBIVENT Respimat 20/100 mcg | 0.381 |
| COMBIVENT CFC-MDI 36/206 mcg | 0.388 |
| Ipratropium Respimat 20 mcg | 0.291 |
Area between the test-day baseline FVC and the FVC change from the test-day baseline curve from 0 to 4 hours divided by 4 at Day 57 (NCT00400153)
Timeframe: Before drug administration to 4 hours after drug administration on Day 57
| Intervention | liters (Least Squares Mean) |
|---|---|
| COMBIVENT Respimat 20/100 mcg | 0.361 |
| COMBIVENT CFC-MDI 36/206 mcg | 0.380 |
| Ipratropium Respimat 20 mcg | 0.264 |
Area between the test-day baseline FVC and the FVC change from the test-day baseline curve from 0 to 4 hours divided by 4 at Day 85 (NCT00400153)
Timeframe: Before drug administration to 4 hours after drug administration on Day 85
| Intervention | liters (Least Squares Mean) |
|---|---|
| COMBIVENT Respimat 20/100 mcg | 0.359 |
| COMBIVENT CFC-MDI 36/206 mcg | 0.359 |
| Ipratropium Respimat 20 mcg | 0.265 |
Area between the test-day baseline FVC and the FVC change from the test-day baseline curve from 0 to 6 hours divided by 6 at Day 1 (NCT00400153)
Timeframe: Before drug administration to 6 hours after drug administration at Day 1
| Intervention | liters (Least Squares Mean) |
|---|---|
| COMBIVENT Respimat 20/100 mcg | 0.337 |
| COMBIVENT CFC-MDI 36/206 mcg | 0.354 |
| Ipratropium Respimat 20 mcg | 0.25 |
Area between the test-day baseline FVC and the FVC change from the test-day baseline curve from 0 to 6 hours divided by 6 at Day 29 (NCT00400153)
Timeframe: Before drug administration to 6 hours after drug administration at Day 29
| Intervention | liters (Least Squares Mean) |
|---|---|
| COMBIVENT Respimat 20/100 mcg | 0.3 |
| COMBIVENT CFC-MDI 36/206 mcg | 0.319 |
| Ipratropium Respimat 20 mcg | 0.246 |
Area between the test-day baseline FVC and the FVC change from the test-day baseline curve from 0 to 6 hours divided by 6 at Day 57 (NCT00400153)
Timeframe: Before drug administration to 6 hours after drug administration on Day 57
| Intervention | liters (Least Squares Mean) |
|---|---|
| COMBIVENT Respimat 20/100 mcg | 0.284 |
| COMBIVENT CFC-MDI 36/206 mcg | 0.303 |
| Ipratropium Respimat 20 mcg | 0.22 |
Area between the test-day baseline FVC and the FVC change from the test-day baseline curve from 0 to 6 hours divided by 6 at Day 85 (NCT00400153)
Timeframe: Before drug administration to 6 hours after drug administration on Day 85
| Intervention | liters (Least Squares Mean) |
|---|---|
| COMBIVENT Respimat 20/100 mcg | 0.279 |
| COMBIVENT CFC-MDI 36/206 mcg | 0.283 |
| Ipratropium Respimat 20 mcg | 0.219 |
Area between the test-day baseline FVC and the FVC change from the test-day baseline curve from 4 to 6 hours divided by 2 at Day 1 (NCT00400153)
Timeframe: Between 4 hours and 6 hours after drug administration on Day 1
| Intervention | liters (Least Squares Mean) |
|---|---|
| COMBIVENT Respimat 20/100 mcg | 0.2 |
| COMBIVENT CFC-MDI 36/206 mcg | 0.221 |
| Ipratropium Respimat 20 mcg | 0.156 |
Area between the test-day baseline FVC and the FVC change from the test-day baseline curve from 4 to 6 hours divided by 2 at Day 29 (NCT00400153)
Timeframe: Between 4 hours and 6 hours after drug administration on Day 29
| Intervention | liters (Least Squares Mean) |
|---|---|
| COMBIVENT Respimat 20/100 mcg | 0.137 |
| COMBIVENT CFC-MDI 36/206 mcg | 0.180 |
| Ipratropium Respimat 20 mcg | 0.156 |
Area between the test-day baseline FVC and the FVC change from the test-day baseline curve from 4 to 6 hours divided by 2 at Day 57 (NCT00400153)
Timeframe: Between 4 hours and 6 hours after drug administration on Day 57
| Intervention | liters (Least Squares Mean) |
|---|---|
| COMBIVENT Respimat 20/100 mcg | 0.128 |
| COMBIVENT CFC-MDI 36/206 mcg | 0.147 |
| Ipratropium Respimat 20 mcg | 0.13 |
Area between the test-day baseline FVC and the FVC change from the test-day baseline curve from 4 to 6 hours divided by 2 at Day 85 (NCT00400153)
Timeframe: Between 4 hours and 6 hours after drug administration on Day 85
| Intervention | liters (Least Squares Mean) |
|---|---|
| COMBIVENT Respimat 20/100 mcg | 0.117 |
| COMBIVENT CFC-MDI 36/206 mcg | 0.130 |
| Ipratropium Respimat 20 mcg | 0.124 |
"Patients rated their response on a seven point Likert scale:~1 = very dissatisfied, 2 = dissatisfied, 3 = somewhat dissatisfied, 4 = neither satisfied nor dissatisfied, 5 = somewhat satisfied, 6 = satisfied, 7 = very satisfied." (NCT00400153)
Timeframe: 12 weeks
| Intervention | units on a scale (Mean) |
|---|---|
| MDI Device | 5.729 |
| RESPIMAT Device | 6.150 |
"Patients rated their response on a seven point Likert scale:~1 = very dissatisfied, 2 = dissatisfied, 3 = somewhat dissatisfied, 4 = neither satisfied nor dissatisfied, 5 = somewhat satisfied, 6 = satisfied, 7 = very satisfied." (NCT00400153)
Timeframe: 12 weeks
| Intervention | units on a scale (Mean) |
|---|---|
| MDI Device | 5.326 |
| RESPIMAT Device | 5.808 |
"Patients rated their response on a seven point Likert scale:~1 = very dissatisfied, 2 = dissatisfied, 3 = somewhat dissatisfied, 4 = neither satisfied nor dissatisfied, 5 = somewhat satisfied, 6 = satisfied, 7 = very satisfied." (NCT00400153)
Timeframe: 12 weeks
| Intervention | units on a scale (Mean) |
|---|---|
| MDI Device | 6.048 |
| RESPIMAT Device | 6.275 |
"Patients rated their response on a seven point Likert scale:~1 = very dissatisfied, 2 = dissatisfied, 3 = somewhat dissatisfied, 4 = neither satisfied nor dissatisfied, 5 = somewhat satisfied, 6 = satisfied, 7 = very satisfied." (NCT00400153)
Timeframe: 12 weeks
| Intervention | units on a scale (Mean) |
|---|---|
| MDI Device | 5.411 |
| RESPIMAT Device | 5.810 |
"Patients rated their response on a seven point Likert scale:~1 = very dissatisfied, 2 = dissatisfied, 3 = somewhat dissatisfied, 4 = neither satisfied nor dissatisfied, 5 = somewhat satisfied, 6 = satisfied, 7 = very satisfied." (NCT00400153)
Timeframe: 12 weeks
| Intervention | units on a scale (Mean) |
|---|---|
| MDI Device | 5.639 |
| RESPIMAT Device | 6.103 |
"Patients rated their response on a seven point Likert scale:~1 = very dissatisfied, 2 = dissatisfied, 3 = somewhat dissatisfied, 4 = neither satisfied nor dissatisfied, 5 = somewhat satisfied, 6 = satisfied, 7 = very satisfied." (NCT00400153)
Timeframe: 12 weeks
| Intervention | units on a scale (Mean) |
|---|---|
| MDI Device | 5.715 |
| RESPIMAT Device | 6.117 |
"Patients rated their response on a seven point Likert scale:~1 = very dissatisfied, 2 = dissatisfied, 3 = somewhat dissatisfied, 4 = neither satisfied nor dissatisfied, 5 = somewhat satisfied, 6 = satisfied, 7 = very satisfied." (NCT00400153)
Timeframe: 12 weeks
| Intervention | units on a scale (Mean) |
|---|---|
| MDI Device | 4.573 |
| RESPIMAT Device | 6.184 |
"Patients rated their response on a seven point Likert scale:~1 = very dissatisfied, 2 = dissatisfied, 3 = somewhat dissatisfied, 4 = neither satisfied nor dissatisfied, 5 = somewhat satisfied, 6 = satisfied, 7 = very satisfied." (NCT00400153)
Timeframe: 12 weeks
| Intervention | units on a scale (Mean) |
|---|---|
| MDI Device | 6.014 |
| RESPIMAT Device | 6.279 |
"Patients rated their response on a seven point Likert scale:~1 = very dissatisfied, 2 = dissatisfied, 3 = somewhat dissatisfied, 4 = neither satisfied nor dissatisfied, 5 = somewhat satisfied, 6 = satisfied, 7 = very satisfied." (NCT00400153)
Timeframe: 12 weeks
| Intervention | units on a scale (Mean) |
|---|---|
| MDI Device | 5.682 |
| RESPIMAT Device | 6.190 |
"Patients rated their response on a seven point Likert scale:~1 = very dissatisfied, 2 = dissatisfied, 3 = somewhat dissatisfied, 4 = neither satisfied nor dissatisfied, 5 = somewhat satisfied, 6 = satisfied, 7 = very satisfied." (NCT00400153)
Timeframe: 12 weeks
| Intervention | units on a scale (Mean) |
|---|---|
| MDI Device | 5.749 |
| RESPIMAT Device | 6.127 |
The mean number of puffs of rescue medication used during the night-time per week during the entire study (including baseline and on-treatment period) (NCT00400153)
Timeframe: During the 2-week baseline washout period and the 12-week treatment period
| Intervention | puffs (Least Squares Mean) |
|---|---|
| COMBIVENT Respimat 20/100 mcg | 0.977 |
| COMBIVENT CFC-MDI 36/206 mcg | 0.977 |
| Ipratropium Respimat 20 mcg | 0.997 |
"The weekly mean night-time symptom score per week during the entire study (including baseline and on-treatment period).~Night-time COPD symptoms: 0=none 1=some - slept well 2=woke once 3=woke several times 4=woke most of night" (NCT00400153)
Timeframe: During the 2-week baseline washout period and the 12-week treatment period
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| COMBIVENT Respimat 20/100 mcg | 0.922 |
| COMBIVENT CFC-MDI 36/206 mcg | 0.914 |
| Ipratropium Respimat 20 mcg | 0.857 |
Geometric mean area under the plasma drug concentration time curve over one dosing interval (AUCτ). Each patient had eight plasma samples (trough pre-dose, 5, 15, 30, and 60 minutes post-dose, as well as 2, 4, and 6 hours post-dose). (NCT00400153)
Timeframe: Before drug administration to 6 hours after drug administration on Day 29
| Intervention | ng*h/mL (Geometric Mean) |
|---|---|
| COMBIVENT Respimat 20/100 mcg | 4.09 |
| COMBIVENT CFC-MDI 36/206 mcg | 5.52 |
Geometric mean area under the plasma drug concentration time curve over one dosing interval (AUCτ). Each patient had eight plasma samples (trough pre-dose, 5, 15, 30, and 60 minutes post-dose, as well as 2, 4, and 6 hours post-dose). (NCT00400153)
Timeframe: Before drug administration to 6 hours after drug administration on Day 29
| Intervention | pg*h/mL (Geometric Mean) |
|---|---|
| COMBIVENT Respimat 20/100 mcg | 128 |
| COMBIVENT CFC-MDI 36/206 mcg | 123 |
| Ipratropium Respimat 20 mcg | 115 |
Maximum change in recorded FEV1 value from the corresponding test-day baseline within the first 2 hours after drug administration on Day 1 (NCT00400153)
Timeframe: Within the first 2-hour post-treatment interval on Day 1
| Intervention | liters (Least Squares Mean) |
|---|---|
| COMBIVENT Respimat 20/100 mcg | 0.302 |
| COMBIVENT CFC-MDI 36/206 mcg | 0.323 |
| Ipratropium Respimat 20 mcg | 0.237 |
Maximum change in recorded FEV1 value from the corresponding test-day baseline within the first 2 hours after drug administration on Day 29 (NCT00400153)
Timeframe: Within the first 2-hour post-treatment interval on Day 29
| Intervention | liters (Least Squares Mean) |
|---|---|
| COMBIVENT Respimat 20/100 mcg | 0.302 |
| Ipratropium Respimat 20 mcg | 0.237 |
| COMBIVENT CFC-MDI 36/206 mcg | 0.296 |
Maximum change in recorded FEV1 value from the corresponding test-day baseline within the first 2 hours after drug administration on Day 57 (NCT00400153)
Timeframe: Within the first 2-hour post-treatment interval on Day 57
| Intervention | liters (Least Squares Mean) |
|---|---|
| COMBIVENT Respimat 20/100 mcg | 0.284 |
| COMBIVENT CFC-MDI 36/206 mcg | 0.296 |
| Ipratropium Respimat 20 mcg | 0.223 |
Maximum change in recorded FEV1 value from the corresponding test-day baseline within the first 2 hours after drug administration on Day 85 (NCT00400153)
Timeframe: Within the first 2-hour post-treatment interval on Day 85
| Intervention | liters (Least Squares Mean) |
|---|---|
| COMBIVENT Respimat 20/100 mcg | 0.293 |
| COMBIVENT CFC-MDI 36/206 mcg | 0.290 |
| Ipratropium Respimat 20 mcg | 0.225 |
Maximum change in recorded FVC value from the corresponding test-day baseline within the first 2 hours after drug administration on Day 1 (NCT00400153)
Timeframe: Within the first 2-hour post-treatment interval at Day 1
| Intervention | liters (Least Squares Mean) |
|---|---|
| COMBIVENT Respimat 20/100 mcg | 0.6 |
| COMBIVENT CFC-MDI 36/206 mcg | 0.612 |
| Ipratropium Respimat 20 mcg | 0.479 |
Maximum change in recorded FVC value from the corresponding test-day baseline within the first 2 hours after drug administration on Day 29 (NCT00400153)
Timeframe: Within the first 2-hour post-treatment interval at Day 29
| Intervention | liters (Least Squares Mean) |
|---|---|
| COMBIVENT CFC-MDI 36/206 mcg | 0.591 |
| Ipratropium Respimat 20 mcg | 0.465 |
| COMBIVENT Respimat 20/100 mcg | 0.594 |
Maximum change in recorded FVC value from the corresponding test-day baseline within the first 2 hours after drug administration on Day 57 (NCT00400153)
Timeframe: Within the first 2-hour post-treatment interval at Day 57
| Intervention | liters (Least Squares Mean) |
|---|---|
| COMBIVENT Respimat 20/100 mcg | 0.562 |
| COMBIVENT CFC-MDI 36/206 mcg | 0.577 |
| Ipratropium Respimat 20 mcg | 0.445 |
Maximum change in recorded FVC value from the corresponding test-day baseline within the first 2 hours after drug administration on Day 85 (NCT00400153)
Timeframe: Within the first 2-hour post-treatment interval at Day 85
| Intervention | liters (Least Squares Mean) |
|---|---|
| COMBIVENT Respimat 20/100 mcg | 0.575 |
| COMBIVENT CFC-MDI 36/206 mcg | 0.562 |
| Ipratropium Respimat 20 mcg | 0.449 |
COPD exacerbation is defined as an increase or new onset of more than one of the following respiratory symptoms (cough, sputum, sputum purulence, wheezing, dyspnea, and chest tightness) having a duration of three or more days requiring treatment with an antibiotic and/or systemic steroids with or without hospital admission. (NCT00400153)
Timeframe: During the 12-week on-treatment period
| Intervention | Percentage of patients (Number) |
|---|---|
| COMBIVENT Respimat 20/100 mcg | 14.81 |
| COMBIVENT CFC-MDI 36/206 mcg | 13.03 |
| Ipratropium Respimat 20 mcg | 10.35 |
"Physician's Global Evaluation score is based on the need for concomitant medication, number and severity of exacerbations since the last visit, severity of cough, ability to exercise, amount of wheezing, etc.~Score: 1,2 = poor; 3,4 = fair; 5,6 =good; 7,8 = excellent." (NCT00400153)
Timeframe: Prior to pulmonary function test on Day 29
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| COMBIVENT Respimat 20/100 mcg | 4.936 |
| COMBIVENT CFC-MDI 36/206 mcg | 4.859 |
| Ipratropium Respimat 20 mcg | 4.99 |
"Physician's Global Evaluation score is based on the need for concomitant medication, number and severity of exacerbations since the last visit, severity of cough, ability to exercise, amount of wheezing, etc.~Score: 1,2 = poor; 3,4 = fair; 5,6 =good; 7,8 = excellent." (NCT00400153)
Timeframe: Prior to pulmonary function test on Day 57
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| COMBIVENT Respimat 20/100 mcg | 4.971 |
| COMBIVENT CFC-MDI 36/206 mcg | 4.965 |
| Ipratropium Respimat 20 mcg | 5.04 |
"Physician's Global Evaluation score is based on the need for concomitant medication, number and severity of exacerbations since the last visit, severity of cough, ability to exercise, amount of wheezing, etc.~Score: 1,2 = poor; 3,4 = fair; 5,6 =good; 7,8 = excellent." (NCT00400153)
Timeframe: Prior to pulmonary function test on Day 85
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| COMBIVENT Respimat 20/100 mcg | 5.115 |
| COMBIVENT CFC-MDI 36/206 mcg | 5.018 |
| Ipratropium Respimat 20 mcg | 5.097 |
Number of patients used rescue medication during the 6-hour pulmonary function testing after drug administration on Day 1 (NCT00400153)
Timeframe: During the 6-hour pulmonary function testing after drug administration on Day 1
| Intervention | patients (Number) |
|---|---|
| COMBIVENT Respimat 20/100 mcg | 8 |
| COMBIVENT CFC-MDI 36/206 mcg | 9 |
| Ipratropium Respimat 20 mcg | 7 |
Number of patients used rescue medication during the 6-hour pulmonary function testing after drug administration on Day 29 (NCT00400153)
Timeframe: During the 6-hour pulmonary function testing after drug administration on Day 29
| Intervention | patients (Number) |
|---|---|
| COMBIVENT Respimat 20/100 mcg | 10 |
| COMBIVENT CFC-MDI 36/206 mcg | 7 |
| Ipratropium Respimat 20 mcg | 7 |
Number of patients used rescue medication during the 6-hour pulmonary function testing after drug administration on Day 57 (NCT00400153)
Timeframe: During the 6-hour pulmonary function testing after drug administration on Day 57
| Intervention | patients (Number) |
|---|---|
| COMBIVENT Respimat 20/100 mcg | 7 |
| COMBIVENT CFC-MDI 36/206 mcg | 7 |
| Ipratropium Respimat 20 mcg | 6 |
Number of patients used rescue medication during the 6-hour pulmonary function testing after drug administration on Day 85 (NCT00400153)
Timeframe: During the 6-hour pulmonary function testing after drug administration on Day 85
| Intervention | patients (Number) |
|---|---|
| COMBIVENT Respimat 20/100 mcg | 5 |
| COMBIVENT CFC-MDI 36/206 mcg | 7 |
| Ipratropium Respimat 20 mcg | 10 |
Achievement of recorded FEV1 measurement of at least 1.15 times of the corresponding test-day baseline value at any time during the first 2 hours of observation after drug administration at Day 1 (NCT00400153)
Timeframe: Within the first 2-hour post-treatment interval at Day 1
| Intervention | Minutes (Median) |
|---|---|
| COMBIVENT Respimat 20/100 mcg | 13 |
| COMBIVENT CFC-MDI 36/206 mcg | 12 |
| Ipratropium Respimat 20 mcg | 28 |
Achievement of recorded FEV1 measurement of at least 1.15 times of the corresponding test-day baseline value at any time during the first 2 hours of observation after drug administration at Day 29 (NCT00400153)
Timeframe: Within the first 2-hour post-treatment interval at Day 29
| Intervention | Minutes (Median) |
|---|---|
| COMBIVENT Respimat 20/100 mcg | 12 |
| COMBIVENT CFC-MDI 36/206 mcg | 13 |
| Ipratropium Respimat 20 mcg | 27 |
Achievement of recorded FEV1 measurement of at least 1.15 times of the corresponding test-day baseline value at any time during the first 2 hours of observation after drug administration at Day 57 (NCT00400153)
Timeframe: Within the first 2-hour post-treatment interval at Day 57
| Intervention | Minutes (Median) |
|---|---|
| COMBIVENT Respimat 20/100 mcg | 13 |
| COMBIVENT CFC-MDI 36/206 mcg | 12 |
| Ipratropium Respimat 20 mcg | 29 |
Achievement of recorded FEV1 measurement of at least 1.15 times of the corresponding test-day baseline value at any time during the first 2 hours of observation after drug administration at Day 85 (NCT00400153)
Timeframe: Within the first 2-hour post-treatment interval at Day 85
| Intervention | Minutes (Median) |
|---|---|
| COMBIVENT Respimat 20/100 mcg | 12 |
| COMBIVENT CFC-MDI 36/206 mcg | 13 |
| Ipratropium Respimat 20 mcg | 27 |
The first time point at which the maximum change in recorded FEV1 data from the corresponding test-day baseline occurred during the 6-hours observation period after drug administration at Day 1 (NCT00400153)
Timeframe: Within the 6-hour post-treatment observation period at Day 1
| Intervention | Minutes (Median) |
|---|---|
| COMBIVENT Respimat 20/100 mcg | 60 |
| COMBIVENT CFC-MDI 36/206 mcg | 60 |
| Ipratropium Respimat 20 mcg | 120 |
The first time point at which the maximum change in recorded FEV1 data from the corresponding test-day baseline occurred during the 6-hours observation period after drug administration at Day 29 (NCT00400153)
Timeframe: Within the 6-hour post-treatment observation period at Day 29
| Intervention | Minutes (Median) |
|---|---|
| COMBIVENT Respimat 20/100 mcg | 60 |
| COMBIVENT CFC-MDI 36/206 mcg | 60 |
| Ipratropium Respimat 20 mcg | 120 |
The first time point at which the maximum change in recorded FEV1 data from the corresponding test-day baseline occurred during the 6-hours observation period after drug administration at Day 57 (NCT00400153)
Timeframe: Within the 6-hour post-treatment observation period at Day 57
| Intervention | Minutes (Median) |
|---|---|
| COMBIVENT Respimat 20/100 mcg | 60 |
| COMBIVENT CFC-MDI 36/206 mcg | 60 |
| Ipratropium Respimat 20 mcg | 60 |
The first time point at which the maximum change in recorded FEV1 data from the corresponding test-day baseline occurred during the 6-hours observation period after drug administration at Day 85 (NCT00400153)
Timeframe: Within the 6-hour post-treatment observation period at Day 85
| Intervention | Minutes (Median) |
|---|---|
| COMBIVENT Respimat 20/100 mcg | 60 |
| COMBIVENT CFC-MDI 36/206 mcg | 60 |
| Ipratropium Respimat 20 mcg | 60 |
The weekly mean trough PEFR during the entire study (including baseline and on-treatment period) (NCT00400153)
Timeframe: During the 2-week baseline washout period and the 12-week treatment period and PEFR taken before administration of study medication
| Intervention | liters/min (Least Squares Mean) |
|---|---|
| COMBIVENT Respimat 20/100 mcg | 191.95 |
| COMBIVENT CFC-MDI 36/206 mcg | 190.290 |
| Ipratropium Respimat 20 mcg | 189.51 |
Frequency of patients due to device preference (NCT00400153)
Timeframe: 12 weeks
| Intervention | participants (Number) | ||
|---|---|---|---|
| Prefer Respimat | Prefer MDI | No preference | |
| Number of Patients | 584 | 146 | 105 |
(NCT00400153)
Timeframe: 12 weeks
| Intervention | participants (Number) | ||||||
|---|---|---|---|---|---|---|---|
| Very dissatisfied | Dissatisfied | Somewhat dissatisfied | Satisfied/dissatisfied | Somewhat satisfied | Satisfied | Very satisfied | |
| MDI Device | 16 | 27 | 37 | 54 | 109 | 351 | 240 |
| RESPIMAT Device | 13 | 20 | 17 | 27 | 46 | 305 | 407 |
Frequency of patients due to rating of action of turning clear base of Respimat (NCT00400153)
Timeframe: 12 weeks
| Intervention | participants (Number) | ||||
|---|---|---|---|---|---|
| Very easy | Easy | Neither easy nor difficult | Difficult | Very difficult | |
| Number of Patients | 587 | 204 | 40 | 4 | 0 |
The 5-point mMRC Dyspnea Scale measures the level of dyspnea (trouble breathing) experienced by participants. Scores range from 0 (none) to 4 (very severe). (NCT00791518)
Timeframe: Day 1 of a 1-day study
| Intervention | points on a scale (Mean) |
|---|---|
| Participants With Diagnosed COPD and Post-albuterol FEV1 <50% | 1.9 |
| Participants With Diagnosed COPD and Post-albuterol FEV1 >=50% | 1.6 |
The 5-point mMRC Dyspnea Scale measures the level of dyspnea (trouble breathing) experienced by participants. Scores range from 0 (none) to 4 (very severe). (NCT00791518)
Timeframe: Day 1 of a 1-day study
| Intervention | points on a scale (Mean) |
|---|---|
| Participants With Diagnosed COPD and Post-albuterol FEV1 <80% | 1.7 |
| Participants With Diagnosed COPD and Post-albuterol FEV1 >=80% | 1.6 |
The average number of puffs from all short-acting bronchodilators used in the past 2 weeks was calculated. (NCT00791518)
Timeframe: Day 1 of a 1-day study
| Intervention | puffs (Mean) |
|---|---|
| Participants With Diagnosed COPD and Post-albuterol FEV1 <50% | 5.2 |
| Participants With Diagnosed COPD and Post-albuterol FEV1 >=50% | 2.8 |
The average number of puffs from all short-acting bronchodilators used in the past 2 weeks was calculated. (NCT00791518)
Timeframe: Day 1 of a 1-day study
| Intervention | puffs (Mean) |
|---|---|
| Participants With Diagnosed COPD and Post-albuterol FEV1 <80% | 3.8 |
| Participants With Diagnosed COPD and Post-albuterol FEV1 >=80% | 2.3 |
The number of participants who had a COPD exacerbation (defined as worsening of COPD symptoms) requiring hospitalization was calculated. (NCT00791518)
Timeframe: Day 1 of 1-day study
| Intervention | participants (Number) |
|---|---|
| Participants With Diagnosed COPD and Post-albuterol FEV1 <50% | 16 |
| Participants With Diagnosed COPD and Post-albuterol FEV1 >=50% | 32 |
The number of participants who had a COPD exacerbation (defined as worsening of COPD symptoms) requiring hospitalization was calculated. (NCT00791518)
Timeframe: Day 1 of a 1-day study
| Intervention | participants (Number) |
|---|---|
| Participants With Diagnosed COPD and Post-albuterol FEV1 <80% | 41 |
| Participants With Diagnosed COPD and Post-albuterol FEV1 >=80% | 7 |
The number of participants with a COPD exacerbation (worsening of COPD symptoms) requiring treatment with oral corticosteroids and/or antibiotics was calculated. (NCT00791518)
Timeframe: Day 1 of 1-day study
| Intervention | participants (Number) |
|---|---|
| Participants With Diagnosed COPD and Post-albuterol FEV1 <50% | 79 |
| Participants With Diagnosed COPD and Post-albuterol FEV1 >=50% | 284 |
The number of participants with a COPD exacerbation (worsening of COPD symptoms) requiring treatment with oral corticosteroids and/or antibiotics was calculated. (NCT00791518)
Timeframe: Day 1 of 1-day study
| Intervention | participants (Number) |
|---|---|
| Participants With Diagnosed COPD and Post-albuterol FEV1 <80% | 246 |
| Participants With Diagnosed COPD and Post-albuterol FEV1 >=80% | 117 |
The number of participants with the indicated affected medical conditions were counted. (NCT00791518)
Timeframe: Day 1 of a 1-day study
| Intervention | participants (Number) | |||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Hypertension | Coronary artery disease | Edema | Atherosclerosis | Arrhythmia | Heart failure | Stable angina | Peripheral vascular disease | Valvular heart disease | Pulmonary edema | Ischemic heart disease without cardiomyopathy | Cardiomyopathy | Ischemic heart disease with cardiomyopathy | Cardiomegaly | Left ventricular dysfunction | Diastolic dysfunction | Cerebrovascular disease | Left ventricular hypertrophy | Stroke | Cardiac arrest | Myocardial infarction | Transient ischemic attack | Unstable angina | Generalized anxiety disorder | Major depressive disorder, recurrent episode | Social anxiety disorder (social phobia) | Panic disorder | Major depressive disorder, single episode | Post-traumatic stress disorder | Attention deficit/hyperactivity disorder | Osteoporosis | Osteopenia | |
| Participants With Diagnosed COPD and Post-albuterol FEV1 <50% | 123 | 26 | 23 | 20 | 16 | 10 | 13 | 6 | 6 | 6 | 5 | 4 | 5 | 3 | 1 | 1 | 2 | 2 | 0 | 0 | 1 | 0 | 0 | 37 | 30 | 7 | 7 | 4 | 4 | 4 | 29 | 11 |
| Participants With Diagnosed COPD and Post-albuterol FEV1 <80% | 389 | 87 | 69 | 50 | 40 | 26 | 25 | 22 | 18 | 11 | 10 | 8 | 11 | 8 | 5 | 5 | 5 | 4 | 1 | 2 | 1 | 0 | 2 | 113 | 107 | 24 | 24 | 17 | 14 | 9 | 92 | 32 |
| Participants With Diagnosed COPD and Post-albuterol FEV1 >=50% | 400 | 85 | 55 | 41 | 40 | 23 | 19 | 25 | 19 | 9 | 7 | 7 | 6 | 6 | 7 | 6 | 3 | 3 | 4 | 3 | 1 | 2 | 2 | 114 | 122 | 34 | 29 | 19 | 18 | 9 | 89 | 31 |
| Participants With Diagnosed COPD and Post-albuterol FEV1 >=80% | 134 | 24 | 9 | 11 | 16 | 7 | 7 | 9 | 7 | 4 | 2 | 3 | 0 | 1 | 3 | 2 | 0 | 1 | 3 | 1 | 1 | 2 | 0 | 38 | 45 | 17 | 12 | 6 | 8 | 4 | 26 | 10 |
The ratio is calculated as the amount of air expelled from the lungs in one second after a full inspiration (FEV1) divided by the volume of air that can forcibly be blown out after a full inspiration (FVC). (NCT00791518)
Timeframe: Day 1 of a 1-day study
| Intervention | participants (Number) | |
|---|---|---|
| <=0.70 | >0.70 | |
| Participants With Diagnosed COPD | 689 | 383 |
The percentage of participants on long-acting bronchodilator (LABD) monotherapy who met spirometric criteria for chronic obstructive pulmonary disease (COPD) and who had a post-albuterol FEV1 (the amount of air expelled from the lungs in one second after a full inspiration) <50% predicted normal was calculated. Predicted normal values for FEV1 were calculated using the reference values from the third National Health and Nutrition Examination Survey (NHANES III). Values are based on the participants' age, height, sex, and race; thus, normal values vary based on participants' demographics. (NCT00791518)
Timeframe: Day 1 of a 1-day study; 15-30 min post-albuterol (self-administered)
| Intervention | percentage of participants (Number) | |
|---|---|---|
| <50% predicted normal | >=50% predicted normal | |
| Participants With Diagnosed COPD | 23 | 77 |
The percentage of participants on long-acting bronchodilator (LABD) monotherapy who had a post-albuterol FEV1) <80% predicted normal was calculated. FEV1 is the amount of air that can be expelled from the lungs in one second after a full inspiration. Predicted normal values for FEV1 were calculated using the reference values from the third National Health and Nutrition Examination Survey (NHANES III). Values are based on the participants' age, height, sex, and race; thus, normal values vary based on participants' demographics. (NCT00791518)
Timeframe: Day 1 of a 1-day study; 15-30 min post-albuterol (self-administered)
| Intervention | percentage of participants (Number) | |
|---|---|---|
| <80% predicted normal | >=80% predicted normal | |
| Participants With Diagnosed COPD | 70 | 30 |
"A Chronic Obstructive Pulmonary Disease (COPD) day of poor control was defined as any day in the participant's diary with a score ≥2 (moderate or severe) for at least 2 of 5 symptoms (cough, wheeze, production of sputum, color of sputum, breathlessness). Score for each symptom ranges from 0-3; a higher number indicates a more severe symptom. The model contained baseline percentage of days of poor control as well as FEV1 reversibility components as covariates." (NCT00463567)
Timeframe: up to 26 weeks
| Intervention | Percentage of days (Least Squares Mean) |
|---|---|
| Indacaterol 150 µg (Continued Into Stage 2) | 31.5 |
| Indacaterol 300 µg (Continued Into Stage 2) | 30.8 |
| Tiotropium (Continued Into Stage 2) | 31.0 |
| Placebo (Continued Into Stage 2) | 34.0 |
"Interim Analysis: Stage 1.~Spirometry was conducted according to internationally accepted standards. Standardized with respect to time (AUC 1h-4h) for FEV1 measurements taken from 1 hour to 4 hour post morning dose on Day 14. Standardized FEV1 AUC was calculated by the trapezoidal rule. Mixed model used baseline FEV1, FEV1 prior to and 30 minutes post inhalation of salbutamol/albuterol, and FEV1 prior to and 1 hour post inhalation of ipratropium as covariates." (NCT00463567)
Timeframe: Day 14, After 2 Weeks of treatment in Stage 1
| Intervention | Liters (Least Squares Mean) |
|---|---|
| Indacaterol 150 µg | 1.53 |
| Indacaterol 300 µg | 1.58 |
| Tiotropium 18 µg | 1.49 |
| Placebo | 1.30 |
| Indacaterol 75 µg | 1.50 |
| Indacaterol 600 µg | 1.53 |
| Formoterol 12 µg | 1.52 |
FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of the 23 h 10 min and the 23 h 45 min post dose values. Mixed model used baseline FEV1, FEV1 prior to and 30 minutes post inhalation of salbutamol/albuterol, and FEV1 prior to and 1 hour post inhalation of ipratropium as covariates. (NCT00463567)
Timeframe: after 12 weeks of treatment
| Intervention | Liters (Least Squares Mean) |
|---|---|
| Indacaterol 150 µg (Continued Into Stage 2) | 1.46 |
| Indacaterol 300 µg (Continued Into Stage 2) | 1.46 |
| Tiotropium 18 µg (Continued Into Stage 2) | 1.42 |
| Placebo (Continued Into Stage 2) | 1.28 |
"Interim Analysis: Stage 1.~Spirometry was conducted according to internationally accepted standards. Trough FEV1 was defined as the average of the 23 h 10 min and the 23 h 45 min post dose values. Mixed model used baseline FEV1, FEV1 prior to and 30 minutes post inhalation of salbutamol/albuterol, and FEV1 prior to and 1 hour post inhalation of ipratropium as covariates." (NCT00463567)
Timeframe: Day 15, After 2 Weeks of treatment in Stage 1
| Intervention | Liters (Least Squares Mean) |
|---|---|
| Indacaterol 150 µg | 1.49 |
| Indacaterol 300 µg | 1.52 |
| Tiotropium 18 µg | 1.45 |
| Placebo | 1.31 |
| Indacaterol 75 µg | 1.46 |
| Indacaterol 600 µg | 1.51 |
| Formoterol 12 µg | 1.42 |
"Participants rated their symptoms on a scale of 0=none to 3=severe. A Chronic Obstructive Pulmonary Disease (COPD) day of poor control was defined as any day in the participants diary with a score >=2 (moderate or severe) for at least 2 of 5 symptoms (cough, wheeze, production of sputum, color of sputum, breathlessness). The mixed model used baseline percentage of days of poor control, FEV1 prior to and 30 minutes post inhalation of salbutamol/albuterol, and FEV1 prior to and one hour post inhalation of ipratropium as covariates." (NCT00567996)
Timeframe: Up to 26 weeks
| Intervention | Percentage of days (Least Squares Mean) |
|---|---|
| Indacaterol 150 μg | 34.1 |
| Salmeterol 50 μg | 34.1 |
| Placebo | 38.1 |
SGRQ is a health related quality of life questionnaire consisting of 76 items in three sections: symptoms, activity and impacts. The total score is 0 to 100 with a higher score indicating poorer health status. The mixed model used baseline SGRQ total score, FEV1 prior to and 30 minutes post inhalation of salbutamol/albuterol, and FEV1 prior to and one hour post inhalation of ipratropium as covariates. (NCT00567996)
Timeframe: Week 12
| Intervention | Score on a scale (Least Squares Mean) |
|---|---|
| Indacaterol 150 μg | 36.4 |
| Salmeterol 50 μg | 38.5 |
| Placebo | 42.6 |
Spirometry was conducted according to internationally accepted standards. Trough FEV1 was defined as the average of the 23 hour 10 minute and 23 hour 45 minute post-dose FEV1 readings. Mixed model used baseline FEV1, FEV1 prior to and 10-15 minutes post inhalation of salbutamol/albuterol, and FEV1 prior to and 1 hour post inhalation of ipratropium as covariates. (NCT00567996)
Timeframe: Week 12
| Intervention | Liters (Least Squares Mean) |
|---|---|
| Indacaterol 150 μg | 1.45 |
| Salmeterol 50 μg | 1.39 |
| Placebo | 1.28 |
Percentage of days of poor control was defined as the number of days in the patient diary with a score ≥ 2 (scale of 0-3, a higher number means more severe symptoms) for at least 2 of 5 symptoms (cough, wheeze, production of sputum, color of sputum, breathlessness) over 52 weeks divided by the number of evaluable days (days with ≥ 2 symptoms with scores). The analysis included baseline percentage of days of poor control, FEV1 pre-dose and 30 minutes post-dose of salbutamol/albuterol during screening, and FEV1 pre-dose and 1 hour post-dose of ipratropium during screening as covariates. (NCT00393458)
Timeframe: Baseline to end of study (Week 52)
| Intervention | Percentage of days (Least Squares Mean) |
|---|---|
| Indacaterol 300 μg Plus Placebo to Formoterol | 33.6 |
| Indacaterol 600 μg Plus Placebo to Formoterol | 30.0 |
| Formoterol 12 μg Plus Placebo to Indacaterol | 33.5 |
| Placebo to Indacaterol Plus Placebo to Formoterol | 38.3 |
FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 10 minutes and 23 hours 45 minutes post-dose at the end of treatment. The analysis included baseline FEV1, FEV1 pre-dose and 30 minutes post-dose of salbutamol/albuterol during screening, and FEV1 pre-dose and 1 hour post-dose of ipratropium during screening as covariates. (NCT00393458)
Timeframe: Week 12 + 1 day, Day 85
| Intervention | Liters (Least Squares Mean) |
|---|---|
| Indacaterol 300 μg Plus Placebo to Formoterol | 1.48 |
| Indacaterol 600 μg Plus Placebo to Formoterol | 1.48 |
| Formoterol 12 μg Plus Placebo to Indacaterol | 1.38 |
| Placebo to Indacaterol Plus Placebo to Formoterol | 1.31 |
Medical costs are associated with COPD-related medical care (claims submitted with a primary International Classification of Diseases, 9th Revision, Clinical Modification diagnosis of COPD) and pharmaceutical care (treatment arm medications, oral corticosteroids, oral antibiotics, short-acting beta-agonists, long-acting beta-agonists [LABA], inhaled corticosteroids [ICS], ICS/LABA combinations, etc.. Means are adjusted for age, sex, geographic region, pre-initial treatment comorbidities, and COPD-related utilization. Total costs are the sum of medical care and pharmacy costs. (NCT01331694)
Timeframe: Incurred over the 12 month period after initial treatment arm prescription
| Intervention | United States dollars (Mean) | ||
|---|---|---|---|
| Medical | Pharmacy | Total | |
| Cost Population: FSC | 1076 | 972 | 2068 |
| Cost Population: IP | 2481 | 614 | 2841 |
| Cost Population: TIO | 1419 | 985 | 2408 |
The first COPD event occurring after 30 days from initial treatment arm prescription was measured. Four categories of COPD events were analyzed; either a hospitalization or emergency department visit; an emergency department visit; an outpatient visit followed by an oral corticosteroid prescription claim within 10 days; an outpatient visit followed by an oral antibiotic prescription claim within 10 days. (NCT01331694)
Timeframe: Anytime from 30 days to 12 months after initial treatment arm prescription
| Intervention | days (Mean) | |||
|---|---|---|---|---|
| Hospitalization or emergency department visit | Emergency department visit | Outpatient visit with oral steroid fill | Outpatient visit with antibiotic fill | |
| Risk Population TIO | 321.59 | 328.48 | 331.23 | 326.70 |
| Risk Population: FSC | 325.17 | 330.24 | 332.74 | 329.96 |
| Risk Population: IP | 315.89 | 324.47 | 328.23 | 326.73 |
FEV1 was measured with spirometry conducted according to internationally accepted standards. Measurements were made at 5 and 30 minutes; 1, 2, 3, 4, and 8 hours; 11 hours 10 minutes and 11 hours 45 minutes post-dose at the end of the study (Week 12, Day 84). Standardized FEV1 AUC was calculated by the trapezoidal rule. The analysis included baseline FEV1 and FEV1 pre-dose and 10-15 minutes post-dose of salbutamol/albuterol during screening as covariates. (NCT00821093)
Timeframe: From 5 minutes to 11 hours 45 minutes post-dose at the end of the study (Week 12, Day 84)
| Intervention | Liters (Least Squares Mean) |
|---|---|
| Indacaterol 150 μg | 1.47 |
| Salmeterol 50 μg | 1.41 |
FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 10 minutes and 23 hours 45 minutes post-dose at the end of treatment. The analysis included baseline FEV1 and FEV1 pre-dose and 10-15 minutes post-dose of salbutamol/albuterol during screening as covariates. (NCT00821093)
Timeframe: 24 hours post-dose at the end of the study (Week 12 + 1 day, Day 85)
| Intervention | Liters (Least Squares Mean) |
|---|---|
| Indacaterol 150 μg | 1.41 |
| Salmeterol 50 μg | 1.35 |
The number of participants (par.) with a COPD-related hospitalization/ ER visit was computed during follow-up (FU) and was standardized by dividing by the total days of FU in each cohort since par. had different lengths of FU. The number of par. per 100 person-years was computed as: numerator = total number of par. with a COPD-related hospitalization/ER visit; denominator = sum of the time of FU in years across all par./100. The index date is defined as the date of discharge from a hospitalization/ER visit for COPD that had a maintenance medication dispensed within 60 days post-discharge. (NCT01332461)
Timeframe: Maximum of 1 year after index date (Jan 1, 2004 through May 30, 2008)
| Intervention | participants per 100 person-years (Number) |
|---|---|
| Fluticasone/Salmeterol Combination (FSC) Cohort | 8.6 |
| Other Maintenance Therapies Cohort | 16.3 |
Cost categories included medical, pharmacy, and total calculated as the sum of medical and pharmacy. Costs were computed during a variable follow-up period and were standardized on a per-month basis. COPD-related medical costs were computed using claims with a primary diagnosis of COPD, and COPD-related pharmacy costs were computed using the paid amounts of pharmacy claims for prescription medication used for COPD. (NCT01332461)
Timeframe: Maximum of 1 year after index date (Jan 1, 2004 through May 30, 2008)
| Intervention | United States (US) dollars (Mean) | ||
|---|---|---|---|
| COPD-related total costs | COPD-related pharmacy costs | COPD-related medical costs | |
| Fluticasone/Salmeterol Combination (FSC) Cohort | 205 | 121 | 84 |
| Other Maintenance Therapies Cohort | 297 | 126 | 171 |
The number of participants having a COPD-related event was computed during the follow-up and was standardized by dividing by the total days of follow-up in each cohort since patients had different lengths of follow-up. Four types of COPD events were defined: COPD-related hospitalization, emergency room (ER) visit, physician visit with a prescription (Rx) for oral corticosteroid or antibiotic within 3 days of the visit, or combined occurrence of any of the aforementioned three types. (NCT01332461)
Timeframe: Maximum of 1 year after index date (Jan 1, 2004 through May 30, 2008)
| Intervention | participants per 100 person-years (Number) | |||
|---|---|---|---|---|
| COPD-related hospitalization | COPD-related ER visit | COPD-related physician + Rx visit | COPD-related hospitalization/ER visit/physician+Rx | |
| Fluticasone/Salmeterol Combination (FSC) Cohort | 2.8 | 6.6 | 27.2 | 34.6 |
| Other Maintenance Therapies Cohort | 6.0 | 12.0 | 37.4 | 50.7 |
The 12-week Endpoint is defined as the last scheduled measurement of PWV during the 12-week double-blind treatment period (from Visits 3-5; Weeks 4, 8, and 12, respectively), and Baseline is defined as the PWV measure from Visit 2 (Randomization). Change from Baseline was calculated as the Endpoint value minus the Baseline Value. PWV is used as a measure of arterial stiffness, which is a measure of the cushioning functioning of major vessels like the aorta. The velocity of the PW along an artery is dependent on the stiffness of that artery. (NCT00857766)
Timeframe: Baseline and the 12-Week Endpoint (up to Week 12)
| Intervention | meters per second (m/s) (Mean) | ||
|---|---|---|---|
| Baseline, n=118, 122 | 12-Week Endpoint, n=113, 110 | Change from Baseline | |
| FSC DISKUS 250/50 mcg | 10.06 | 9.83 | -0.24 |
| Matching Placebo | 9.87 | 9.95 | 0.13 |
AIx is a surrogate measure of peripheral (not aortic) arterial resistance and is measured by analysis of the pulse wave at the radial artery. AIx = ([delta P/Pulse Pressure] x 100); delta P is defined by a notch near the peak of the pulse wave. Change from Baseline was calculated as the Endpoint value minus the Baseline Value. (NCT00857766)
Timeframe: Baseline and the 12-Week Endpoint (up to Week 12)
| Intervention | % of total height of peak pulse pressure (Mean) | ||
|---|---|---|---|
| Baseline, n=121, 122 | 12-Week Endpoint, n=114, 111 | Change from Baseline | |
| FSC DISKUS 250/50 mcg | 27.9 | 27.2 | -0.7 |
| Matching Placebo | 27.8 | 27.6 | -0.4 |
FEV1 is a measure of air flow via spirometry. Change from Baseline was calculated as the Endpoint value minus the Baseline Value. (NCT00857766)
Timeframe: Baseline and the 12-Week Endpoint (up to Week 12)
| Intervention | milliliters (Mean) | ||
|---|---|---|---|
| Baseline, n=123, 125 | 12-Week Endpoint, n=105, 102 | Change from Baseline | |
| FSC DISKUS 250/50 mcg | 1444 | 1588 | 136 |
| Matching Placebo | 1480 | 1500 | -3 |
FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 10 minutes and 23 hours 45 minutes post-dose at the end of treatment. The analysis included baseline FEV1, FEV1 pre-dose and 30 minutes post-dose of salbutamol during screening, and FEV1 pre-dose and 1 hour post-dose of ipratropium during screening as covariates. (NCT00624286)
Timeframe: 24 hours post-dose at the end of the study (Week 12 + 1 day, Day 85)
| Intervention | Liters (Least Squares Mean) |
|---|---|
| Indacaterol 150 μg | 1.48 |
| Placebo to Indacaterol | 1.35 |
FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 10 minutes and 23 hours 45 minutes post-dose at the end of treatment. The analysis included baseline FEV1, FEV1 pre-dose and 30 minutes post-dose of salbutamol during screening, and FEV1 pre-dose and 1 hour post-dose of ipratropium during screening as covariates. (NCT00624286)
Timeframe: 24 hours post-dose on Day 2
| Intervention | Liters (Least Squares Mean) |
|---|---|
| Indacaterol 150 μg | 1.47 |
| Placebo to Indacaterol | 1.38 |
Change from baseline was calculated as the Endpoint (defined as the last recorded measure of 2 hour post-dose FEV1 for each participant) value minus the baseline value. FEV1 is defined as the amount of air expelled from the lungs in one second after a full inspiration and is a measure of pulmonary function. (NCT00784550)
Timeframe: Baseline and Endpoint (defined as the last recorded measure [taken up to Week 24] of 2 hour post-dose FEV1 for each participant)
| Intervention | ml (Mean) |
|---|---|
| FSC + Tio | 233 |
| Tiotropium | 77 |
Change from baseline was calculated as the Endpoint (defined as the last recorded measure of 2 hour post-dose FVC for each participant) value minus the baseline value. FVC is defined as the amount of air that can forcibly be blown out after a full inspiration (FVC). (NCT00784550)
Timeframe: Baseline and Endpoint (defined as the last recorded measure of 2 hour post-dose FVC [up to Week 24] for each participant)
| Intervention | ml (Mean) |
|---|---|
| FSC + Tio | 265 |
| Tiotropium | 87 |
Change from baseline was calculated as the Endpoint (defined as the last recorded measure of AM pre-dose FEV1 for each participant) value minus the baseline value. FEV1 is defined as the amount of air expelled from the lungs in one second after a full inspiration and is a measure of pulmonary function. (NCT00784550)
Timeframe: Baseline and Endpoint (defined as the last recorded measure [taken up to Week 24] of AM pre-dose FEV1 for each participant)
| Intervention | milliliters (ml) (Mean) |
|---|---|
| FSC + Tio | 101 |
| Tiotropium | -16 |
Change from baseline was calculated as the Endpoint (defined as the last recorded measure of AM pre-dose FVC fore each participant) value minus the baseline value. FVC is defined as the amount of air that can forcibly be blown out after a full inspiration. (NCT00784550)
Timeframe: Baseline and Endpoint (defined as the last recorded measure [up to Week 24] of AM pre-dose FVC for each participant)
| Intervention | ml (Mean) |
|---|---|
| FSC + Tio | 95 |
| Tiotropium | -28 |
Change from baseline was calculated as the Endpoint (defined as the last recorded measure of AM pre-dose IC for each participant) value minus the baseline value. IC is defined as the amount of air that can be inhaled after a normal expiration. IC is a measure of pulmonary function. (NCT00784550)
Timeframe: Baseline and Endpoint (defined as the last recorded measure of AM pre-dose IC [up to Week 24] for each participant)
| Intervention | ml (Mean) |
|---|---|
| FSC + Tio | 107 |
| Tiotropium | -8 |
The CRQ-SAS measures 4 domains of functioning of participants with COPD: mastery (amount of control the participant feels he/she has over COPD symptoms); fatigue (how tired the participant feels); emotional function (how anxious/depressed the participant feels); and dyspnea (how short of breath the participant feels during physical activities). Each domain is measured on a scale of 1-7 (1=maximum impairment; 7=no impairment). Each domain score is calculated separately. (NCT00784550)
Timeframe: Baseline and Endpoint (defined as the last recorded score [up to Week 24 or the early withdrawal visit] on each of the questions on this questionnaire)
| Intervention | points on a scale (Mean) | |||
|---|---|---|---|---|
| Mastery | Fatigue | Emotional Function | Dyspnea | |
| FSC + Tio | 0.28 | 0.23 | 0.24 | 0.21 |
| Tiotropium | 0.04 | 0.17 | 0.16 | 0.19 |
An independent (where feasible), trained assessor interviewed the patient and rated the degree of impairment due to dyspnea on a scale from -3 (major deterioration) to 3 (major improvement) on 3 domains (functional impairment, magnitude of task, and magnitude of effort) in comparison with baseline. A total score of the 3 domains ranged from -9 to 9; minus scores indicate deterioration. The analysis included baseline dyspnea index, FEV1 pre-dose and 10-15 minutes post-dose of albuterol during screening, and FEV1 pre-dose and 50-70 minutes post-dose of ipratropium during screening as covariates. (NCT01072448)
Timeframe: End of the study (Week 12, Day 84)
| Intervention | Units on a scale (Least Squares Mean) |
|---|---|
| Indacaterol 75 μg | 1.34 |
| Placebo to Indacaterol | 0.11 |
FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 10 minutes and 23 hours 45 minutes post-dose at the end of treatment. The analysis included baseline FEV1, FEV1 pre-dose and 10-15 minutes post-dose of albuterol during screening, and FEV1 pre-dose and 50-70 minutes post-dose of ipratropium during screening as covariates. (NCT01072448)
Timeframe: 24 hours post-dose at the end of the study (Week 12 + 1 day, Day 85)
| Intervention | Liters (Least Squares Mean) |
|---|---|
| Indacaterol 75 μg | 1.38 |
| Placebo to Indacaterol | 1.26 |
TDI focal score is based on three domains: functional impairment, magnitude of task and magnitude of effort. Each domain is scored from -3 (major deterioration) to 3 (major improvement) to give an overall TDI focal score of -9 to 9 with a negative score indicating a deterioration from baseline. A 1 unit difference in the TDI focal score is clinically significant. Mixed model used baseline dyspnoea index, FEV1 prior to and 10-15 minutes post inhalation of albuterol, and FEV1 prior to and 50-70 minutes post inhalation of ipratropium as covariates. (NCT01068600)
Timeframe: after 12 weeks
| Intervention | Score on a scale (Least Squares Mean) |
|---|---|
| Indacaterol 75 µg | 1.22 |
| Placebo | 0.76 |
Spirometry was conducted according to internationally accepted standards. Trough FEV1 was defined as the average of the 23 hour 10 minute and 23 hour 45 minute post-dose FEV1 readings. Mixed model used baseline FEV1, FEV1 prior to and 10-15 minutes post inhalation of albuterol, and FEV1 prior to and 50-70 minutes post inhalation of ipratropium as covariates. (NCT01068600)
Timeframe: after 12 weeks
| Intervention | Liters (Least Squares Mean) |
|---|---|
| Indacaterol 75 µg | 1.49 |
| Placebo | 1.35 |
Number of participants with at least 1 AE. (NCT01048333)
Timeframe: At baseline and at each day of treatment
| Intervention | Participants (Number) |
|---|---|
| Formoterol | 6 |
| Salmeterol | 6 |
| Placebo | 2 |
Average FEV1 during 120 minutes post dose, change versus pre dose FEV1 (NCT01048333)
Timeframe: Pre dose and 120 minutes post dose
| Intervention | percentage change (Geometric Mean) |
|---|---|
| Formoterol | 1.096 |
| Salmeterol | 1.082 |
| Placebo | 1.014 |
Average FEV1 during the first 15 minutes post dose, change versus pre dose FEV1 (NCT01048333)
Timeframe: Pre dose and 15 minutes post dose
| Intervention | percentage change (Geometric Mean) |
|---|---|
| Formoterol | 1.064 |
| Salmeterol | 1.041 |
| Placebo | 1.012 |
FEV1(Forced Expiratory Volume in 1 second) measured by spirometry 5 minutes post dose, percentage change versus pre dose FEV1 (NCT01048333)
Timeframe: Pre-dose and 5 minutes post-dose
| Intervention | percentage change (Geometric Mean) |
|---|---|
| Formoterol | 1.072 |
| Salmeterol | 1.041 |
| Placebo | 1.007 |
Percentage of patients who has achieved at least 12 % increase in FEV1 at each time point between 5 to 120 minutes post dose, change versus pre dose FEV1 (NCT01048333)
Timeframe: Pre dose, 5, 10, 15, 20, 30, 40, 50, 60 and 120 minutes post dose
| Intervention | Percentage of Participants (Number) | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| 5 min | 10 min | 15 min | 20 min | 30 min | 40 min | 50 min | 60 min | 120 min | |
| Formoterol | 23.1 | 38.0 | 39.8 | 44.4 | 45.4 | 49.1 | 53.7 | 54.6 | 55.6 |
| Placebo | 6.4 | 7.3 | 9.2 | 10.1 | 13.8 | 15.6 | 16.5 | 18.3 | 20.2 |
| Salmeterol | 9.2 | 17.6 | 23.9 | 27.5 | 32.1 | 36.7 | 40.4 | 43.1 | 48.6 |
Peak Borg dyspnea scale after 8 weeks, Unit on a Scale (min. 0, max 10) (NCT00530842)
Timeframe: 8 weeks
| Intervention | Unit on a Scale (Mean) |
|---|---|
| Tiotropium + Salmeterol | 6.52 |
| Fluticasone + Salmeterol | 6.61 |
Peak Borg leg discomfort scale after 8 weeks, Unit on a Scale (min. 0, max 10) (NCT00530842)
Timeframe: 8 weeks
| Intervention | Unit on a Scale (Mean) |
|---|---|
| Tiotropium + Salmeterol | 6.10 |
| Fluticasone + Salmeterol | 5.86 |
Endurance time to the point of symptom limitation after 4 weeks during a constant work rate exercise test at 75% Wcap (co-primary endpoint) (NCT00530842)
Timeframe: 4 weeks
| Intervention | Seconds (Median) |
|---|---|
| Tiotropium + Salmeterol | 458 |
| Fluticasone + Salmeterol | 450 |
Endurance time to the point of symptom limitation after 8 weeks during a constant work rate exercise test at 75% Wcap (co-primary endpoint) (NCT00530842)
Timeframe: 8 weeks
| Intervention | Seconds (Median) |
|---|---|
| Tiotropium + Salmeterol | 463 |
| Fluticasone + Salmeterol | 453 |
Post-dose FEV1 (Forced Expiratory Volume in 1 second) over FVC (Forced Vital Capacity) after 4 weeks (measured by spirometry) (NCT00530842)
Timeframe: 4 weeks
| Intervention | Percent of FEV1 over FVC (Mean) |
|---|---|
| Tiotropium + Salmeterol | 50.90 |
| Fluticasone + Salmeterol | 50.91 |
Post-dose FEV1 (Forced Expiratory Volume in 1 second) over FVC (Forced Vital Capacity) after 8 weeks (measured by spirometry) (NCT00530842)
Timeframe: 8 weeks
| Intervention | Percent of FEV1 over FVC (Mean) |
|---|---|
| Tiotropium + Salmeterol | 50.77 |
| Fluticasone + Salmeterol | 50.66 |
Trough FEV1 (Forced Expiratory Volume in 1 second) over FVC (Forced Vital Capacity) after 4 weeks (measured by spirometry) (NCT00530842)
Timeframe: 4 weeks
| Intervention | Percent of FEV1 over FVC (Mean) |
|---|---|
| Tiotropium + Salmeterol | 49.74 |
| Fluticasone + Salmeterol | 50.62 |
Trough FEV1 (Forced Expiratory Volume in 1 second) over FVC (Forced Vital Capacity) after 8 weeks (measured by spirometry) (NCT00530842)
Timeframe: 8 weeks
| Intervention | Percent of FEV1 over FVC (Mean) |
|---|---|
| Tiotropium + Salmeterol | 49.16 |
| Fluticasone + Salmeterol | 49.67 |
Post-dose FEV1 (Forced Expiratory Volume in 1 second) after 4 weeks (measured by spirometry) (NCT00530842)
Timeframe: 4 weeks
| Intervention | Litres (Mean) |
|---|---|
| Tiotropium + Salmeterol | 1.62 |
| Fluticasone + Salmeterol | 1.55 |
Post-dose FEV1 (Forced Expiratory Volume in 1 second) after 8 weeks (measured by spirometry) (NCT00530842)
Timeframe: 8 weeks
| Intervention | Litres (Mean) |
|---|---|
| Tiotropium + Salmeterol | 1.62 |
| Fluticasone + Salmeterol | 1.55 |
Post-dose percent predicted FEV1 (Forced Expiratory Volume in 1 second) according to ECCS after 4 weeks (measured by spirometry) (NCT00530842)
Timeframe: 4 weeks
| Intervention | Percent of predicted FEV1 (Mean) |
|---|---|
| Tiotropium + Salmeterol | 54.96 |
| Fluticasone + Salmeterol | 52.64 |
Post-dose percent predicted FEV1 (Forced Expiratory Volume in 1 second) according to ECCS after 8 weeks (measured by spirometry) (NCT00530842)
Timeframe: 8 weeks
| Intervention | Percent of predicted FEV1 (Mean) |
|---|---|
| Tiotropium + Salmeterol | 54.99 |
| Fluticasone + Salmeterol | 52.59 |
Trough FEV1 (Forced Expiratory Volume in 1 second) after 4 weeks (measured by spirometry) (NCT00530842)
Timeframe: 4 weeks
| Intervention | Litres (Mean) |
|---|---|
| Tiotropium + Salmeterol | 1.48 |
| Fluticasone + Salmeterol | 1.45 |
Trough FEV1 (Forced Expiratory Volume in 1 second) after 8 weeks (measured by spirometry) (NCT00530842)
Timeframe: 8 weeks
| Intervention | Litres (Mean) |
|---|---|
| Tiotropium + Salmeterol | 1.48 |
| Fluticasone + Salmeterol | 1.44 |
Trough percent predicted FEV1 (Forced Expiratory Volume in 1 second) according to ECCS after 4 weeks (measured by spirometry) (NCT00530842)
Timeframe: 4 weeks
| Intervention | Percent of predicted FEV1 (Mean) |
|---|---|
| Tiotropium + Salmeterol | 50.40 |
| Fluticasone + Salmeterol | 49.26 |
Trough percent predicted FEV1 (Forced Expiratory Volume in 1 second) according to ECCS after 8 weeks (measured by spirometry) (NCT00530842)
Timeframe: 8 weeks
| Intervention | Percent of predicted FEV1 (Mean) |
|---|---|
| Tiotropium + Salmeterol | 50.27 |
| Fluticasone + Salmeterol | 49.12 |
Post-dose FVC (Forced Vital Capacity) after 4 weeks (measured by spirometry) (NCT00530842)
Timeframe: 4 weeks
| Intervention | Litres (Mean) |
|---|---|
| Tiotropium + Salmeterol | 3.25 |
| Fluticasone + Salmeterol | 3.11 |
Post-dose FVC (Forced Vital Capacity) after 8 weeks (measured by spirometry) (NCT00530842)
Timeframe: 8 weeks
| Intervention | Litres (Mean) |
|---|---|
| Tiotropium + Salmeterol | 3.26 |
| Fluticasone + Salmeterol | 3.11 |
Trough FVC (Forced Vital Capacity) after 4 weeks (measured by spirometry) (NCT00530842)
Timeframe: 4 weeks
| Intervention | Litres (Mean) |
|---|---|
| Tiotropium + Salmeterol | 3.04 |
| Fluticasone + Salmeterol | 2.93 |
Trough FVC (Forced Vital Capacity) after 8 weeks (measured by spirometry) (NCT00530842)
Timeframe: 8 weeks
| Intervention | Litres (Mean) |
|---|---|
| Tiotropium + Salmeterol | 3.06 |
| Fluticasone + Salmeterol | 2.94 |
Post-dose TGV(FRC) (Thoracic Gas Volume) after 4 weeks (NCT00530842)
Timeframe: 4 weeks
| Intervention | Litres (Mean) |
|---|---|
| Tiotropium + Salmeterol | 5.00 |
| Fluticasone + Salmeterol | 5.19 |
Post-dose TGV(FRC) (Thoracic Gas Volume; co-primary endpoint) after 8 weeks (NCT00530842)
Timeframe: 8 weeks
| Intervention | Litres (Mean) |
|---|---|
| Tiotropium + Salmeterol | 4.99 |
| Fluticasone + Salmeterol | 5.07 |
Post-dose SVC (Slow Vital Capacity) after 4 weeks (measured by spirometry) (NCT00530842)
Timeframe: 4 weeks
| Intervention | Litres (Mean) |
|---|---|
| Tiotropium + Salmeterol | 3.39 |
| Fluticasone + Salmeterol | 3.27 |
Post-dose SVC (Slow Vital Capacity) after 8 weeks (measured by spirometry) (NCT00530842)
Timeframe: 8 weeks
| Intervention | Litres (Mean) |
|---|---|
| Tiotropium + Salmeterol | 3.42 |
| Fluticasone + Salmeterol | 3.28 |
Trough SVC (Slow Vital Capacity) after 4 weeks (measured by spirometry) (NCT00530842)
Timeframe: 4 weeks
| Intervention | Litres (Mean) |
|---|---|
| Tiotropium + Salmeterol | 3.19 |
| Fluticasone + Salmeterol | 3.12 |
Trough SVC (Slow Vital Capacity) after 8 weeks (measured by spirometry) (NCT00530842)
Timeframe: 8 weeks
| Intervention | Litres (Mean) |
|---|---|
| Tiotropium + Salmeterol | 3.22 |
| Fluticasone + Salmeterol | 3.12 |
Post-dose IC (Inspiratory Capacity) after 4 weeks (measured by bodyphlethysmography) (NCT00530842)
Timeframe: 4 weeks
| Intervention | Litres (Mean) |
|---|---|
| Tiotropium + Salmeterol | 2.46 |
| Fluticasone + Salmeterol | 2.37 |
Post-dose IC (Inspiratory Capacity) after 8 weeks (measured by bodyphlethysmography) (NCT00530842)
Timeframe: 8 weeks
| Intervention | Litres (Mean) |
|---|---|
| Tiotropium + Salmeterol | 2.47 |
| Fluticasone + Salmeterol | 2.35 |
Post-dose IRV (Inspiratory Reserve Volume) after 4 weeks (measured by bodyphlethysmography) (NCT00530842)
Timeframe: 4 weeks
| Intervention | Litres (Mean) |
|---|---|
| Tiotropium + Salmeterol | 1.62 |
| Fluticasone + Salmeterol | 1.55 |
Post-dose IRV (Inspiratory Reserve Volume) after 8 weeks (measured by bodyphlethysmography) (NCT00530842)
Timeframe: 8 weeks
| Intervention | Litres (Mean) |
|---|---|
| Tiotropium + Salmeterol | 1.62 |
| Fluticasone + Salmeterol | 1.55 |
Post-dose RV (Residual Volume) after 4 weeks (measured by bodyphlethysmography) (NCT00530842)
Timeframe: 4 weeks
| Intervention | Litres (Mean) |
|---|---|
| Tiotropium + Salmeterol | 3.91 |
| Fluticasone + Salmeterol | 4.14 |
Post-dose RV (Residual Volume) after 8 weeks (measured by bodyphlethysmography) (NCT00530842)
Timeframe: 8 weeks
| Intervention | Litres (Mean) |
|---|---|
| Tiotropium + Salmeterol | 3.92 |
| Fluticasone + Salmeterol | 4.07 |
Post-dose TLC (Total Lung Capacity) after 4 weeks (measured by bodyphlethysmography) (NCT00530842)
Timeframe: 4 weeks
| Intervention | Litres (Mean) |
|---|---|
| Tiotropium + Salmeterol | 7.33 |
| Fluticasone + Salmeterol | 7.47 |
Post-dose TLC (Total Lung Capacity) after 8 weeks (measured by bodyphlethysmography) (NCT00530842)
Timeframe: 8 weeks
| Intervention | Litres (Mean) |
|---|---|
| Tiotropium + Salmeterol | 7.36 |
| Fluticasone + Salmeterol | 7.36 |
Trough IC (Inspiratory Capacity) after 4 weeks (measured by bodyphlethysmography) (NCT00530842)
Timeframe: 4 weeks
| Intervention | Litres (Mean) |
|---|---|
| Tiotropium + Salmeterol | 2.28 |
| Fluticasone + Salmeterol | 2.23 |
Trough IC (Inspiratory Capacity) after 8 weeks (measured by bodyphlethysmography) (NCT00530842)
Timeframe: 8 weeks
| Intervention | Litres (Mean) |
|---|---|
| Tiotropium + Salmeterol | 2.33 |
| Fluticasone + Salmeterol | 2.23 |
Trough IRV (Inspiratory Reserve Volume) after 4 weeks (measured by bodyphlethysmography) (NCT00530842)
Timeframe: 4 weeks
| Intervention | Litres (Mean) |
|---|---|
| Tiotropium + Salmeterol | 1.47 |
| Fluticasone + Salmeterol | 1.42 |
Trough IRV (Inspiratory Reserve Volume) after 8 weeks (measured by bodyphlethysmography) (NCT00530842)
Timeframe: 8 weeks
| Intervention | Litres (Mean) |
|---|---|
| Tiotropium + Salmeterol | 1.48 |
| Fluticasone + Salmeterol | 1.41 |
Trough RV (Residual Volume) after 4 weeks (measured by bodyphlethysmography) (NCT00530842)
Timeframe: 4 weeks
| Intervention | Litres (Mean) |
|---|---|
| Tiotropium + Salmeterol | 4.28 |
| Fluticasone + Salmeterol | 4.35 |
Trough RV (Residual Volume) after 8 weeks (measured by bodyphlethysmography) (NCT00530842)
Timeframe: 8 weeks
| Intervention | Litres (Mean) |
|---|---|
| Tiotropium + Salmeterol | 4.23 |
| Fluticasone + Salmeterol | 4.25 |
Trough TGV(FRC) (Thoracic Gas Volume) after 4 weeks (measured by bodyphlethysmography) (NCT00530842)
Timeframe: 4 weeks
| Intervention | Litres (Mean) |
|---|---|
| Tiotropium + Salmeterol | 5.32 |
| Fluticasone + Salmeterol | 5.34 |
Trough TGV(FRC) (Thoracic Gas Volume) after 8 weeks (measured by bodyphlethysmography) (NCT00530842)
Timeframe: 8 weeks
| Intervention | Litres (Mean) |
|---|---|
| Tiotropium + Salmeterol | 5.24 |
| Fluticasone + Salmeterol | 5.25 |
Trough TLC (Total Lung Capacity) after 4 weeks (measured by bodyphlethysmography) (NCT00530842)
Timeframe: 4 weeks
| Intervention | Litres (Mean) |
|---|---|
| Tiotropium + Salmeterol | 7.52 |
| Fluticasone + Salmeterol | 7.51 |
Trough TLC (Total Lung Capacity) after 8 weeks (measured by bodyphlethysmography) (NCT00530842)
Timeframe: 8 weeks
| Intervention | Litres (Mean) |
|---|---|
| Tiotropium + Salmeterol | 7.47 |
| Fluticasone + Salmeterol | 7.39 |
Post-dose RV/TLC (Residual Volume over Total Lung Capacity) after 4 weeks (measured by bodyphlethysmography) (NCT00530842)
Timeframe: 4 weeks
| Intervention | Percent of RV over TLC (Mean) |
|---|---|
| Tiotropium + Salmeterol | 53.09 |
| Fluticasone + Salmeterol | 55.07 |
Post-dose RV/TLC (Residual Volume over Total Lung Capacity) after 8 weeks (measured by bodyphlethysmography) (NCT00530842)
Timeframe: 8 weeks
| Intervention | Percent of RV over TLC (Mean) |
|---|---|
| Tiotropium + Salmeterol | 52.79 |
| Fluticasone + Salmeterol | 55.02 |
Post-dose TGV/TLC (Thoracic Gas Volume over Total Lung Capacity) after 4 weeks (measured by bodyphlethysmography) (NCT00530842)
Timeframe: 4 weeks
| Intervention | Percent of TGV over TLC (Mean) |
|---|---|
| Tiotropium + Salmeterol | 68.43 |
| Fluticasone + Salmeterol | 69.22 |
Post-dose TGV/TLC (Thoracic Gas Volume over Total Lung Capacity) after 8 weeks (measured by bodyphlethysmography) (NCT00530842)
Timeframe: 8 weeks
| Intervention | Percent of TGV over TLC (Mean) |
|---|---|
| Tiotropium + Salmeterol | 67.65 |
| Fluticasone + Salmeterol | 68.85 |
Trough RV/TLC (Residual Volume over Total Lung Capacity) after 4 weeks (measured by bodyphlethysmography) (NCT00530842)
Timeframe: 4 weeks
| Intervention | Percent of RV over TLC (Mean) |
|---|---|
| Tiotropium + Salmeterol | 56.57 |
| Fluticasone + Salmeterol | 57.47 |
Trough RV/TLC (Residual Volume over Total Lung Capacity) after 8 weeks (measured by bodyphlethysmography) (NCT00530842)
Timeframe: 8 weeks
| Intervention | Percent of RV over TLC (Mean) |
|---|---|
| Tiotropium + Salmeterol | 56.10 |
| Fluticasone + Salmeterol | 57.18 |
Trough TGV/TLC (Thoracic Gas Volume over Total Lung Capacity) after 4 weeks (measured by bodyphlethysmography) (NCT00530842)
Timeframe: 4 weeks
| Intervention | Percent of TGV over TLC (Mean) |
|---|---|
| Tiotropium + Salmeterol | 70.59 |
| Fluticasone + Salmeterol | 70.99 |
Trough TGV/TLC (Thoracic Gas Volume over Total Lung Capacity) after 8 weeks (measured by bodyphlethysmography) (NCT00530842)
Timeframe: 8 weeks
| Intervention | Percent of TGV over TLC (Mean) |
|---|---|
| Tiotropium + Salmeterol | 69.87 |
| Fluticasone + Salmeterol | 70.94 |
Isotime Borg dyspnea scale after 4 weeks, Unit on a Scale (min. 0, max. 10), 0 = no dyspnea, 10 = worst imaginable dyspnea (NCT00530842)
Timeframe: 4 weeks
| Intervention | Unit on a Scale (Mean) |
|---|---|
| Tiotropium + Salmeterol | 4.80 |
| Fluticasone + Salmeterol | 5.02 |
Isotime Borg dyspnea scale after 8 weeks, Unit on a Scale (min. 0, max 10), 0 = no dyspnea, 10 = worst imaginable dyspnea (NCT00530842)
Timeframe: 8 weeks
| Intervention | Unit on a Scale (Mean) |
|---|---|
| Tiotropium + Salmeterol | 4.77 |
| Fluticasone + Salmeterol | 4.98 |
Isotime Borg leg discomfort scale after 4 weeks, Unit on a Scale (min. 0, max. 10), 0 = no leg dyscomfort, 10 = worst imaginable leg dyscomfort (NCT00530842)
Timeframe: 4 weeks
| Intervention | Unit on a Scale (Mean) |
|---|---|
| Tiotropium + Salmeterol | 4.63 |
| Fluticasone + Salmeterol | 4.63 |
Isotime Borg leg discomfort scale after 8 weeks, Unit on a Scale (min. 0, max. 10), 0 = no leg dyscomfort, 10 = worst imaginable leg dyscomfort (NCT00530842)
Timeframe: 8 weeks
| Intervention | Unit on a Scale (Mean) |
|---|---|
| Tiotropium + Salmeterol | 4.64 |
| Fluticasone + Salmeterol | 4.53 |
Reason for stopping exercise after 4 weeks (leg discomfort, breathing discomfort, both or none) (NCT00530842)
Timeframe: 4 weeks
| Intervention | Participants (Number) | |||
|---|---|---|---|---|
| Leg discomfort | Breathing discomfort | Both (leg and breathing discomfort) | None | |
| Fluticasone + Salmeterol | 72 | 119 | 78 | 40 |
| Tiotropium + Salmeterol | 89 | 104 | 78 | 38 |
Reason for stopping exercise after 8 weeks (leg discomfort, breathing discomfort, both or none) (NCT00530842)
Timeframe: 8 weeks
| Intervention | Participants (Number) | |||
|---|---|---|---|---|
| Leg discomfort | Breathing discomfort | Both (leg and breathing discomfort) | None | |
| Fluticasone + Salmeterol | 72 | 131 | 78 | 28 |
| Tiotropium + Salmeterol | 88 | 112 | 82 | 27 |
Reason for stopping exercise at baseline (leg discomfort, breathing discomfort, both or none) (NCT00530842)
Timeframe: baseline
| Intervention | Participants (Number) | |||
|---|---|---|---|---|
| Leg discomfort | Breathing discomfort | Both (leg and breathing discomfort) | None | |
| Fluticasone + Salmeterol | 53 | 132 | 92 | 32 |
| Tiotropium + Salmeterol | 53 | 132 | 92 | 32 |
Compliance is calculated as the ratio (in percent) between the number of actual doses taken during the total treatment period divided by the number of doses that should have been taken during the total treatment period. (NCT00527826)
Timeframe: Baseline through Week 52
| Intervention | percentage of doses (Mean) |
|---|---|
| Salmeterol Xinafoate/FP in Fixed Combination (SFC) 50/500 µg | 97.08 |
| Sal 50 µg | 98.44 |
| FP 500 µg | 98.33 |
The total number of COPD-related visits, i.e., from baseline through week 52, the number of visits at physician's office, the number of home visits made by physician, the number of visits at an emergency outpatient clinic, as well as the number of home visits by an emergency physician were summed up. (NCT00527826)
Timeframe: Baseline through Week 52
| Intervention | number of visits (Mean) |
|---|---|
| Salmeterol Xinafoate/FP in Fixed Combination (SFC) 50/500 µg | 1.39 |
| Salmeterol Xinafoate/FP Separately (Sal/FP) 50/500 µg | 1.06 |
| Total | 1.23 |
During regular visits, participants were asked whether they experienced any exacerbation since last contact. Between visits, COPD participants were contacted by phone by the staff and asked about exacerbation details. Exacerbations were defined according to Rodriguez-Roisin: moderate (grade II) exacerbations include a worsening of COPD symptoms that require both a change of respiratory medication (increased dose of prescribed or addition of new drugs) and medical assistance; severe (grade III) exacerbations include deterioration in COPD resulting in hospitalization or emergency room treatment. (NCT00527826)
Timeframe: Baseline through Week 52
| Intervention | Number of exacerbations per year (Least Squares Mean) |
|---|---|
| Salmeterol Xinafoate/FP in Fixed Combination (SFC) 50/500 µg | 0.864 |
| Salmeterol Xinafoate/FP Separately (Sal/FP) 50/500 µg | 0.862 |
During regular visits, participants were asked whether they experienced any exacerbation since last contact. Between visits, COPD participants were contacted by phone by the staff and asked about exacerbation details. Exacerbations were defined according to Rodriguez-Roisin: moderate (grade II) exacerbations include a worsening of COPD symptoms that require both a change of respiratory medication (increased dose of prescribed or addition of new drugs) and medical assistance; severe (grade III) exacerbations include deterioration in COPD resulting in hospitalization or emergency room treatment. (NCT00527826)
Timeframe: Baseline through Week 52
| Intervention | Number of exacerbations per year (Least Squares Mean) |
|---|---|
| Salmeterol Xinafoate/FP in Fixed Combination (SFC) 50/500 µg | 0.863 |
| Salmeterol Xinafoate/FP Separately (Sal/FP) 50/500 µg | 0.830 |
"Total costs include costs for hospitalization, medication, and visits to/by physician. Medications that were used as required were assumed to be used every second day." (NCT00527826)
Timeframe: Baseline through Week 52
| Intervention | Euros per participant (Mean) |
|---|---|
| Salmeterol Xinafoate/FP in Fixed Combination (SFC) 50/500 µg | 1453 |
| Salmeterol Xinafoate/FP Separately (Sal/FP) 50/500 µg | 1166 |
| Total | 1311 |
Change from baseline was calculated as the FEV1 percent predicted value at Week 52 minus the percent predicted value at baseline. The post-bronchodilator lung function test was performed to measure FEV1 30 minutes after inhaling salbutamol. The most reliable result of three different consecutive measurements was documented. (NCT00527826)
Timeframe: Baseline and Week 52
| Intervention | percent of predicted value (Mean) | ||
|---|---|---|---|
| Baseline | Week 52 | Mean change from baseline | |
| Salmeterol Xinafoate/FP in Fixed Combination (SFC) 50/500 µg | 36.82 | 38.98 | 2.17 |
| Salmeterol Xinafoate/FP Separately (Sal/FP) 50/500 µg | 38.15 | 41.22 | 3.08 |
| Total | 37.47 | 40.09 | 2.62 |
Change from baseline was measured as the IVC value at Week 52 minus the value at baseline. The post-bronchodilator lung function test was performed to measure IVC 30 minutes after inhaling salbutamol. The most reliable result of three different, consecutive measurements was documented. (NCT00527826)
Timeframe: Baseline and Week 52
| Intervention | liters (Mean) | ||
|---|---|---|---|
| Baseline | Week 52 | Mean change from baseline | |
| Salmeterol Xinafoate/FP in Fixed Combination (SFC) 50/500 µg | 2.17 | 2.14 | -0.02 |
| Salmeterol Xinafoate/FP Separately (Sal/FP) 50/500 µg | 2.29 | 2.27 | -0.02 |
| Total | 2.23 | 2.21 | -0.02 |
Change from baseline is calculated as the activity score at Week 52 minus the score at baseline. The SGRQ (a self-administered questionnaire) subscale activity score ranges from 0 to 100% and is concerned with activities that cause or are limited by breathlessness (summed weights of 2 questions). A score of 0 indicates the best possible status. (NCT00527826)
Timeframe: Baseline and Week 52
| Intervention | percent (Mean) | ||
|---|---|---|---|
| Baseline | Week 52 | Mean change from baseline | |
| Salmeterol Xinafoate/FP in Fixed Combination (SFC) 50/500 µg | 72.80 | 71.17 | -1.63 |
| Salmeterol Xinafoate/FP Separately (Sal/FP) 50/500 µg | 70.64 | 68.53 | -2.11 |
| Total | 71.73 | 69.86 | -1.87 |
Change from baseline was calculated as the impact score at Week 52 minus the score at baseline. The SGRQ (a self-administered questionnaire) subscale impact score ranges from 0 to 100% and is concerned with social functioning and psychological disturbances (summed weights of 5 questions). A score of 0 indicates the best possible status. (NCT00527826)
Timeframe: Baseline and Week 52
| Intervention | percent (Mean) | ||
|---|---|---|---|
| Baseline | Week 52 | Mean change from baseline | |
| Salmeterol Xinafoate/FP in Fixed Combination (SFC) 50/500 µg | 46.03 | 44.66 | -1.37 |
| Salmeterol Xinafoate/FP Separately (Sal/FP) 50/500 µg | 43.58 | 41.26 | -2.32 |
| Total | 44.82 | 42.98 | -1.84 |
Change from baseline is calculated as the symptom score at Week 52 minus the symptom score at baseline. The SGRQ (a self-administered questionnaire) subscale symptom score ranges from 0 to 100% and measures the effect of respiratory symptoms, frequency, and severity on quality of life (summed weights of 8 questions). A score of 0 indicates the best possible status. (NCT00527826)
Timeframe: Baseline and Week 52
| Intervention | percent (Mean) | ||
|---|---|---|---|
| Baseline | Week 52 | Mean change from baseline | |
| Salmeterol Xinafoate/FP in Fixed Combination (SFC) 50/500 µg | 68.80 | 65.42 | -3.38 |
| Salmeterol Xinafoate/FP Separately (Sal/FP) 50/500 µg | 68.95 | 63.77 | -5.18 |
| Total | 68.88 | 64.61 | -4.27 |
The Tiffeneau index is defined as the FEV1 divided by the IVC (i.e., forced expiratory volume in one second relative to the inspiratory capacity) in percent. Change from baseline is calculated as the FEV1/IVC value at Week 52 minus the value at baseline. (NCT00527826)
Timeframe: Baseline and Week 52
| Intervention | percent of IVC (Mean) | ||
|---|---|---|---|
| Baseline | Week 52 | Mean change from baseline | |
| Salmeterol Xinafoate/FP in Fixed Combination (SFC) 50/500 µg | 48.90 | 50.82 | 1.92 |
| Salmeterol Xinafoate/FP Separately (Sal/FP) 50/500 µg | 49.05 | 52.83 | 3.78 |
| Total | 48.98 | 51.81 | 2.84 |
Change from baseline was calculated as the total score at Week 52 minus the score at baseline. The SGRQ (a self-administered questionnaire) total score ranges from 0 to 100% and summarizes the impact of COPD on overall health status (summed weights of 15 questions). A total score of 0 indicates the best possible status. (NCT00527826)
Timeframe: Baseline and Week 52
| Intervention | percent (Mean) | ||
|---|---|---|---|
| Baseline | Week 52 | Mean change from baseline | |
| Salmeterol Xinafoate/FP in Fixed Combination (SFC) 50/500 µg | 57.82 | 56.02 | -1.80 |
| Salmeterol Xinafoate/FP Separately (Sal/FP) 50/500 µg | 55.89 | 53.25 | -2.64 |
| Total | 56.87 | 54.65 | -2.22 |
Participants were asked for the number of days they used rescue medication within the 7 days before Week 8 and Week 52. (NCT00527826)
Timeframe: The 7 days before baseline (=Visit 2 [Week 8]) and the last 7 days of study (=Visit 6 [Week 52])
| Intervention | number of days (Mean) | |
|---|---|---|
| Visit 2 (Week 8) | Final visit (Week 52) | |
| Salmeterol Xinafoate/FP in Fixed Combination (SFC) 50/500 µg | 4.73 | 5.03 |
| Salmeterol Xinafoate/FP Separately (Sal/FP) 50/500 µg | 4.11 | 4.69 |
| Total | 4.43 | 4.86 |
The number participants with the indicated number of days at the ICU was recorded. (NCT00527826)
Timeframe: Baseline through Week 52
| Intervention | participants (Number) | ||||
|---|---|---|---|---|---|
| 0 days | 1-5 days | 6-10 days | 11-30 days | >30 days | |
| Salmeterol Xinafoate/FP in Fixed Combination (SFC) 50/500 µg | 19 | 4 | 1 | 0 | 1 |
| Salmeterol Xinafoate/FP Separately (Sal/FP) 50/500 µg | 13 | 2 | 1 | 0 | 0 |
| Total | 32 | 6 | 2 | 0 | 1 |
The number of participants with the indicated number of hospitalizations was recorded. (NCT00527826)
Timeframe: Baseline through Week 52
| Intervention | participants (Number) | |||||
|---|---|---|---|---|---|---|
| 0 hospital stays | 1 hospital stay | 2 hospital stays | 3 hospital stays | 4 hospital stays | 5 or more hospital stays | |
| Salmeterol Xinafoate/FP in Fixed Combination (SFC) 50/500 µg | 82 | 11 | 9 | 4 | 0 | 1 |
| Salmeterol Xinafoate/FP Separately (Sal/FP) 50/500 µg | 87 | 13 | 3 | 1 | 1 | 0 |
| Total | 169 | 24 | 12 | 5 | 1 | 1 |
For all outcome measures, treatment group estimates are LS Means across visits (change between 2 or more time points, calculated as the value at the later time point minus the value at the earlier time point, e.g. LS means across visits up to Visit 5 minus pre-dose Visit 2 value). Estimate for difference = LS Mean (Symbicort pMDI 160mcg/4.5ug) - LS Mean (placebo). (NCT02533505)
Timeframe: Assessment (60 minutes pre and post dose) at Visit 2 (Day 0), Visit 3 (Day 7), Visit 4 (Day 14), and Visit 5 (Day 21); change from baseline pre-dose to Day 21 post-dose reported.
| Intervention | ΔHR: beats/min (Least Squares Mean) |
|---|---|
| Symbicort pMDI | -2.481 |
| Placebo | -2.831 |
For all outcome measures, treatment group estimates are LS Means across visits (change between 2 or more time points, calculated as the value at the later time point minus the value at the earlier time point, e.g. LS means across visits up to Visit 5 minus pre-dose Visit 2 value). Estimate for difference = LS Mean (Symbicort pMDI 160mcg/4.5ug) - LS Mean (placebo). (NCT02533505)
Timeframe: Assessment (60 minutes pre and post dose) at Visit 2 (Day 0), Visit 3 (Day 7), Visit 4 (Day 14), and Visit 5 (Day 21); change from baseline pre-dose to Day 21 post-dose reported.
| Intervention | SaO2: % (Least Squares Mean) |
|---|---|
| Symbicort pMDI | 0.422 |
| Placebo | 0.181 |
For all outcome measures, treatment group estimates are LS Means across visits (change between 2 or more time points, calculated as the value at the later time point minus the value at the earlier time point, e.g. LS means across visits up to Visit 5 minus pre-dose Visit 2 value). Estimate for difference = LS Mean (Symbicort pMDI 160mcg/4.5ug) - LS Mean (placebo). (NCT02533505)
Timeframe: Assessment (60 minutes pre and post dose) at Visit 2 (Day 0), Visit 3 (Day 7), Visit 4 (Day 14), and Visit 5 (Day 21); change from baseline pre-dose to Day 21 post-dose reported.
| Intervention | ΔVCO2: mL/min (Least Squares Mean) |
|---|---|
| Symbicort pMDI | 5.994 |
| Placebo | -4.251 |
For all outcome measures, treatment group estimates are LS Means across visits (change between 2 or more time points, calculated as the value at the later time point minus the value at the earlier time point, e.g. LS means across visits up to Visit 5 minus pre-dose Visit 2 value). Estimate for difference = LS Mean (Symbicort pMDI 160mcg/4.5ug) - LS Mean (placebo). (NCT02533505)
Timeframe: Assessment (60 minutes pre and post dose) at Visit 2 (Day 0), Visit 3 (Day 7), Visit 4 (Day 14), and Visit 5 (Day 21); change from baseline pre-dose to Day 21 post-dose reported.
| Intervention | mL/min (Least Squares Mean) |
|---|---|
| Symbicort pMDI | 11.366 |
| Placebo | 1.252 |
For all outcome measures, treatment group estimates are LS Means across visits (change between 2 or more time points, calculated as the value at the later time point minus the value at the earlier time point, e.g. LS means across visits up to Visit 5 minus pre-dose Visit 2 value). Estimate for difference = LS Mean (Symbicort pMDI 160mcg/4.5ug) - LS Mean (placebo). (NCT02533505)
Timeframe: Assessment (60 minutes pre and post dose) at Visit 2 (Day 0), Visit 3 (Day 7), Visit 4 (Day 14), and Visit 5 (Day 21); change from baseline pre-dose to Day 21 post-dose reported.
| Intervention | mL/min/beats/min (Least Squares Mean) |
|---|---|
| Symbicort pMDI | 0.256 |
| Placebo | 0.168 |
FEV1/FVC. For all outcome measures, treatment group estimates are LS Means across visits (change between 2 or more time points, calculated as the value at the later time point minus the value at the earlier time point, e.g. LS means across visits up to Visit 5 minus pre-dose Visit 2 value). Estimate for difference = LS Mean (Symbicort pMDI 160mcg/4.5ug) - LS Mean (placebo). (NCT02533505)
Timeframe: Assessment (60 minutes pre and post dose) at Visit 2 (Day 0), Visit 3 (Day 7), Visit 4 (Day 14), and Visit 5 (Day 21); change from baseline pre-dose to Day 21 post-dose reported.
| Intervention | ratio (Least Squares Mean) |
|---|---|
| Symbicort pMDI | 0.017 |
| Placebo | -0.002 |
For all outcome measures, treatment group estimates are LS Means across visits (change between 2 or more time points, calculated as the value at the later time point minus the value at the earlier time point, e.g. LS means across visits up to Visit 5 minus pre-dose Visit 2 value). Estimate for difference = LS Mean (Symbicort pMDI 160mcg/4.5ug) - LS Mean (placebo). Modified Borg scale for dyspnea was self-administered at Visit 2 (Day 0), Visit 3 (Day 7), Visit 4 (Day 14), and Visit 5 (Day 21). The Borg scale is a 1-item instrument through which a subject reports dyspnea symptoms on a scale of 0-10 to quantify the intensity of dyspnea (where 10 is most intense). (NCT02533505)
Timeframe: Assessment (60 minutes pre and post dose) at Visit 2 (Day 0), Visit 3 (Day 7), Visit 4 (Day 14), and Visit 5 (Day 21); change from baseline pre-dose to Day 21 post-dose reported.
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Symbicort pMDI | -0.452 |
| Placebo | -0.248 |
For all outcome measures, treatment group estimates are LS Means across visits (change between 2 or more time points, calculated as the value at the later time point minus the value at the earlier time point, e.g. LS means across visits up to Visit 5 minus pre-dose Visit 2 value). Estimate for difference = LS Mean (Symbicort pMDI 160mcg/4.5ug) - LS Mean (placebo). (NCT02533505)
Timeframe: Assessment (60 minutes pre and post dose) at Visit 2 (Day 0), Visit 3 (Day 7), Visit 4 (Day 14), and Visit 5 (Day 21); change from baseline pre-dose to Day 21 post-dose reported.
| Intervention | breaths/min (Least Squares Mean) |
|---|---|
| Symbicort pMDI | -0.193 |
| Placebo | -0.430 |
Change from pre-dose (Visit 2) to post-dose (Visit 5) assessment in fractional inspiratory time (Ti/total cycle time [Ttot]). For all outcome measures, treatment group estimates are LS Means across visits (change between 2 or more time points, calculated as the value at the later time point minus the value at the earlier time point, e.g. LS means across visits up to Visit 5 minus pre-dose Visit 2 value). Estimate for difference = LS Mean (Symbicort pMDI 160mcg/4.5ug) - LS Mean (placebo). (NCT02533505)
Timeframe: Assessment (60 minutes pre and post dose) at Visit 2 (Day 0), Visit 3 (Day 7), Visit 4 (Day 14), and Visit 5 (Day 21); change from baseline pre-dose to Day 21 post-dose reported.
| Intervention | ratio (Least Squares Mean) |
|---|---|
| Symbicort pMDI | 0.012 |
| Placebo | -0.004 |
Change from pre-dose (Visit 2) to post-dose (Visit 5) assessment in minute ventilation (Ve). For all outcome measures, treatment group estimates are LS Means across visits (change between 2 or more time points, calculated as the value at the later time point minus the value at the earlier time point, e.g. LS means across visits up to Visit 5 minus pre-dose Visit 2 value). Estimate for difference = LS Mean (Symbicort pMDI 160mcg/4.5ug) - LS Mean (placebo). (NCT02533505)
Timeframe: Assessment (60 minutes pre and post dose) at Visit 2 (Day 0), Visit 3 (Day 7), Visit 4 (Day 14), and Visit 5 (Day 21); change from baseline pre-dose to Day 21 post-dose reported.
| Intervention | mL/min (Least Squares Mean) |
|---|---|
| Symbicort pMDI | 838.232 |
| Placebo | -23.924 |
Change from pre-dose (Visit 2) to post-dose (Visit 5) assessment in tidal volume (Vt). For all outcome measures, treatment group estimates are LS Means across visits (change between 2 or more time points, calculated as the value at the later time point minus the value at the earlier time point, e.g. LS means across visits up to Visit 5 minus pre-dose Visit 2 value). Estimate for difference = LS Mean (Symbicort pMDI 160mcg/4.5ug) - LS Mean (placebo). (NCT02533505)
Timeframe: Assessment (60 minutes pre and post dose) at Visit 2 (Day 0), Visit 3 (Day 7), Visit 4 (Day 14), and Visit 5 (Day 21); change from baseline pre-dose to Day 21 post-dose reported.
| Intervention | mL (Least Squares Mean) |
|---|---|
| Symbicort pMDI | 71.904 |
| Placebo | 14.281 |
Change from pre-dose (Visit 2) to post-dose (Visit 5) assessment in mean inspiratory flow (tidal volume [Vt]/inspiratory time [Ti]). For all outcome measures, treatment group estimates are LS Means across visits (change between 2 or more time points, calculated as the value at the later time point minus the value at the earlier time point, e.g. LS means across visits up to Visit 5 minus pre-dose Visit 2 value). Estimate for difference = LS Mean (Symbicort pMDI 160mcg/4.5ug) - LS Mean (placebo). (NCT02533505)
Timeframe: Assessment (60 minutes pre and post dose) at Visit 2 (Day 0), Visit 3 (Day 7), Visit 4 (Day 14), and Visit 5 (Day 21); change from baseline pre-dose to Day 21 post-dose reported.
| Intervention | mL/sec (Least Squares Mean) |
|---|---|
| Symbicort pMDI | 26.533 |
| Placebo | 3.217 |
Forced expiratory volume in the first second (FEV1), forced vital capacity (FVC), and IC (using an slow vital capacity [SVC] maneuver; IC/total lung capacity [TLC] will be used as a measure of resting hyperinflation). For all outcome measures, treatment group estimates are LS Means across visits (change between 2 or more time points, calculated as the value at the later time point minus the value at the earlier time point, e.g. LS means across visits up to Visit 5 minus pre-dose Visit 2 value). Estimate for difference = LS Mean (Symbicort pMDI 160mcg/4.5ug) - LS Mean (placebo). (NCT02533505)
Timeframe: Assessment (60 minutes pre and post dose) at Visit 2 (Day 0), Visit 3 (Day 7), Visit 4 (Day 14), and Visit 5 (Day 21); change from baseline pre-dose to Day 21 post-dose reported.
| Intervention | FEV1: L; ΔFVC: L; ΔIC: L (Least Squares Mean) | ||
|---|---|---|---|
| ΔFEV1 | ΔFVC | ΔIC | |
| Placebo | -0.004 | -0.052 | -0.024 |
| Symbicort pMDI | 0.187 | 0.259 | 0.256 |
Changes in CXCL8 concentrations in sputum compared to screening visit. (NCT01787097)
Timeframe: Screening visit and 2 hours post inhalation of treatment
| Intervention | ng/mL (Mean) |
|---|---|
| Formoterol (FORM) Total Dose 24ug | -0.04 |
| Symbicort® Total Dose 400ug/12ug | -2.1 |
| Symbicort® Total Dose 800ug/24ug | -2.2 |
| Pulmicort 800 | -1.5 |
Changes in IL-6 Levels in the sputum supernatant compared to screening visit (NCT01787097)
Timeframe: Screening visit and 2 hours post inhalation of treatment
| Intervention | pg/mL (Mean) |
|---|---|
| Formoterol (FORM) Total Dose 24ug | -29 |
| Symbicort® Total Dose 400ug/12ug | -14 |
| Symbicort® Total Dose 800ug/24ug | -28 |
| Pulmicort 800 | -29 |
Improvement in FEV1 compared to baseline levels. (NCT01787097)
Timeframe: Baseline and 2 hours post inhalation
| Intervention | mL (Mean) |
|---|---|
| Formoterol (FORM) Total Dose 24ug | 160 |
| Symbicort® Total Dose 400ug/12ug | 120 |
| Symbicort® Total Dose 800ug/24ug: | 200 |
| Pulmicort 800ug | 52 |
Sputum TNF-alpha levels obtained from induced sputum compared to screening visit. (NCT01787097)
Timeframe: Screening visit and 2 hours post inhalation of treatment
| Intervention | pg/mL (Mean) |
|---|---|
| Formoterol (FORM) Total Dose 24ug | -4.8 |
| Symbicort® Total Dose 400ug/12ug | -5.7 |
| Symbicort® Total Dose 800ug/24ug | -7.8 |
| Pulmicort 800ug | -9.4 |
Enzyme immunosorbent assay system (NCT01787097)
Timeframe: Screening visit and 2 hours post inhalation of treatment
| Intervention | Fold activation (Mean) |
|---|---|
| Formoterol (FORM) Total Dose 24ug | 1.1 |
| Symbicort® Total Dose 400ug/12ug | 1.8 |
| Symbicort® Total Dose 800ug/24ug | 2.3 |
| Pulmicort 800ug | 2.1 |
Airway Blood flow (Qaw) will be measured before and 15 minutes after albuterol inhalation (delta Qaw). (NCT01216735)
Timeframe: 3 weeks treatment period of ICS or placebo
| Intervention | % change (Mean) |
|---|---|
| Fluticasone | 40.9 |
| Placebo | 0.0 |
Flow-mediated vasodilation response in the brachial artery will be measured before and 15 minutes.after albuterol inhalation (NCT01216735)
Timeframe: 3 weeks of treatment
| Intervention | % change (Mean) |
|---|---|
| Fluticasone | 3.9 |
| Placebo | 4.8 |
accuracy of diagnosis was the outcome measure. The results of the spirometry test (done in the beginning for the intervention group and ant the end of 1 year for the usual care groups) were reviewed in conjunction with the initial physician diagnosis of COPD and/or asthma to confirm whether the diagnosis was accurate, not accurate, or indeterminate. Accuracy of diagnosis of COPD was determined by spirometry results if the FEV1/FVC ratio was <0.7. (NCT01833026)
Timeframe: spirometry was performed at the first visit for intervention group and at 1 year from recruitment for the usual care group, one time assessment for both groups
| Intervention | Participants (Count of Participants) |
|---|---|
| COPD Assessment and Management Recommendations | 10 |
| Usual Care | 5 |
Lung function studies (mean +/- SD) peak Peak FRC/TLC after 30 days (+2h)of tiotropium versus placebo in 29 moderate COPD patients. Functional residual capacity/total lung capacity - percentage (NCT00569270)
Timeframe: 30 days
| Intervention | percentage of FRC/TLC (Mean) |
|---|---|
| Placebo | 0.65 |
| Tiotropium | 0.66 |
Lung function studies (mean +/- SD) of peak forced vital capaciy (L) after 30 days (+2h) of tiotropium versus placebo in 29 moderate COPD patients. Forced vital capacity - liters (NCT00569270)
Timeframe: 30 days
| Intervention | liters (Mean) |
|---|---|
| Placebo | 3.17 |
| Tiotropium 18 µg Capsule, Bronchodilator | 3.27 |
Lung function studies (mean +/- SD) - Peak inspiratory capacity after 30 days (+2h)of tiotropium versus placebo in 29 moderate COPD patients. Inspiratory capacity- liters (NCT00569270)
Timeframe: 30 days
| Intervention | liters (Mean) |
|---|---|
| Placebo | 2.12 |
| Tiotropium | 2.24 |
Net change in lung function studies (mean +/- SE) from baseline to trough (-1h) and peak (+2h) after 30 days of tiotropium versus placebo in 29 moderate COPD patients. Total lung capacity - liters (NCT00569270)
Timeframe: 30 days
| Intervention | liters (Mean) |
|---|---|
| Placebo | 5.91 |
| Tiotropium | 5.82 |
Lung function studies Trough FEV1(mean +/- SD) after 30 days(-1h) of tiotropium versus placebo in 29 moderate COPD patients. Forced expiratory volume in 1s (liters) (NCT00569270)
Timeframe: 30 days
| Intervention | liters (Mean) |
|---|---|
| Placebo | 1.68 |
| Tiotropium | 1.71 |
Lung function studies Trough FRC(mean +/- SD) after 30 days(-1h) of tiotropium versus placebo in 29 moderate COPD patients. Functional residual capacity(liters) (NCT00569270)
Timeframe: 30 days
| Intervention | liters (Mean) |
|---|---|
| Placebo | 3.84 |
| Tiotropium | 3.66 |
Lung function studies Trough FRC/TLC(mean +/- SD) after 30 days(-1h) of tiotropium versus placebo in 29 moderate COPD patients Trough Functional residual capacity/total lung capacity - percentage (NCT00569270)
Timeframe: 30 days
| Intervention | percentage of FRC/TLC (Mean) |
|---|---|
| Placebo | 0.64 |
| Tiotropium | 0.62 |
Lung function studies Trough FVC(mean +/- SD) after 30 days(-1h) of tiotropium versus placebo in 29 moderate COPD patients (NCT00569270)
Timeframe: 30 days
| Intervention | liters (Mean) |
|---|---|
| Placebo | 3.12 |
| Tiotropium | 3.15 |
Lung function studies (Trough IC(mean +/- SD) after 30 days(-1h) of tiotropium versus placebo in 29 moderate COPD patients Trough inspiratory capacity- liters (NCT00569270)
Timeframe: 30 days
| Intervention | liters (Mean) |
|---|---|
| Placebo | 2.17 |
| Tiotropium | 2.11 |
Lung function studies Trough TLC(mean +/- SD) after 30 days(-1h) of tiotropium versus placebo in 29 moderate COPD patients (NCT00569270)
Timeframe: 30 days
| Intervention | liters (Mean) |
|---|---|
| Placebo | 5.99 |
| Tiotropium | 5.86 |
Lung function studies (mean +/- SD): peak FEV1 (+2h) after 30 days of placebo or tiotropium in 29 moderate COPD patients. FEV1 = Forced expiratory volume in one second (NCT00569270)
Timeframe: 30 days
| Intervention | liters (Mean) |
|---|---|
| Placebo | 1.74 |
| Tiotropium | 1.82 |
Lung function studies (mean +/- SD): peak FRC after 30 days (+2h) of placebo or tiotropium in 29 moderate COPD patients. (NCT00569270)
Timeframe: 30 days
| Intervention | Liters (Mean) |
|---|---|
| Placebo | 3.80 |
| Tiotropium | 3.72 |
Correlation between improved lung function after tiotropium and extent of lung CT scored emphysema with respect to FEV 1; correlation of tiotropium induced bronchodilation and extent of lung ct scored emphysema; measures include increase in FEV1 from baseline to peak tiotropium (NCT00569270)
Timeframe: baseline to 30 days
| Intervention | percentage of lung tissue (Mean) |
|---|---|
| Lung CT Scored Emphysema and FEV1 | 13.68 |
Correlation between improved lung function after tiotropium and extent of lung CT scored emphysema with respect to ratio functional residual capacity divided by total lung capacity. Specifically, correlation of tiotropium induced bronchodilation and extent of lung ct scored emphysema (NCT00569270)
Timeframe: baseline to trough tiotropium
| Intervention | percentage of lung tissue (Mean) |
|---|---|
| Lung CT Scored Emphysema and FRC/TLC | 13.68 |
Correlation between change in inspiratory capacity (L) post metronome paced hyperventilation induced dynamic hyperinflation and extent of lung ct scored emphysema (NCT00569270)
Timeframe: baseline to 30 days
| Intervention | percentage of lung tissue (Mean) |
|---|---|
| Lung CT Scored Emphysema and IC | 13.68 |
IC measurement before and after metronome paced hyperventilation-induced dynamic hyperinflation at baseline and in tiotropium and placebo groups. Measure ratio of functional residual capacity divided by total lung capacity at baseline and after 30 days of tiotropium versus placebo (NCT00569270)
Timeframe: baseline and 30 days (+2h) post dose
| Intervention | liters (Mean) | ||
|---|---|---|---|
| Baseline IC (inspiratory capacity) | Placebo IC | Tiotropium IC | |
| After DH (Dynamic Hyperinflation | 1.76 | 1.80 | 1.80 |
| Before DH (Dynamic Hyperinflation) | 2.09 | 2.17 | 2.24 |
Total lung capacity before and after metronome paced hyperventilation induced dynamic hyperinflation in tiotropium cohort versus placebo. Difference between TLC measured at one hour before intervention & 2 hrs. after after 30 days of treatment with either placebo or tiotropium (NCT00569270)
Timeframe: one hour before intervention & 2 hrs. after after 30 days
| Intervention | liters (Mean) | |
|---|---|---|
| Before DH (dynamic hyperinflation) | After DH | |
| 2h Post Placebo TLC(L) | 5.96 | 5.84 |
| TLC (L) 2h Post Tiotropium | 5.84 | 5.78 |
98 reviews available for albuterol and Airflow Obstruction, Chronic
| Article | Year |
|---|---|
Recent Advances in β
Topics: Adrenergic beta-2 Receptor Agonists; Asthma; Clinical Trials as Topic; Heart Failure; Humans; Muscle | 2020 |
Potential Mechanisms Between HF and COPD: New Insights From Bioinformatics.
Topics: Albuterol; Computational Biology; Heart Failure; Humans; MicroRNAs; Pulmonary Disease, Chronic Obstr | 2023 |
Potential Mechanisms Between HF and COPD: New Insights From Bioinformatics.
Topics: Albuterol; Computational Biology; Heart Failure; Humans; MicroRNAs; Pulmonary Disease, Chronic Obstr | 2023 |
Potential Mechanisms Between HF and COPD: New Insights From Bioinformatics.
Topics: Albuterol; Computational Biology; Heart Failure; Humans; MicroRNAs; Pulmonary Disease, Chronic Obstr | 2023 |
Potential Mechanisms Between HF and COPD: New Insights From Bioinformatics.
Topics: Albuterol; Computational Biology; Heart Failure; Humans; MicroRNAs; Pulmonary Disease, Chronic Obstr | 2023 |
Acute severe asthma (status asthmaticus).
Topics: Adrenal Cortex Hormones; Albuterol; Drug Therapy, Combination; Emergency Medicine; Forced Expiratory | 2019 |
Improving the quality of life in patients with chronic obstructive pulmonary disease: focus on indacaterol.
Topics: Adrenergic beta-2 Receptor Agonists; Albuterol; Bronchodilator Agents; Clinical Trials as Topic; Dys | 2013 |
Ten years of tiotropium: clinical impact and patient perspectives.
Topics: Adrenergic beta-2 Receptor Agonists; Albuterol; Bronchodilator Agents; Dyspnea; Ethanolamines; Formo | 2013 |
Efficacy and safety of eco-friendly inhalers: focus on combination ipratropium bromide and albuterol in chronic obstructive pulmonary disease.
Topics: Albuterol; Bronchodilator Agents; Chlorofluorocarbons; Drug Combinations; Equipment Design; Humans; | 2013 |
Combination inhaled steroid and long-acting beta2-agonist versus tiotropium for chronic obstructive pulmonary disease.
Topics: Administration, Inhalation; Adrenergic beta-2 Receptor Agonists; Albuterol; Androstadienes; Bronchod | 2013 |
Evaluation of salmeterol xinafoate plus fluticasone propionate for the treatment of chronic obstructive pulmonary disease.
Topics: Albuterol; Androstadienes; Costs and Cost Analysis; Drug Combinations; Fluticasone-Salmeterol Drug C | 2013 |
Combined corticosteroid and long-acting beta(2)-agonist in one inhaler versus inhaled corticosteroids alone for chronic obstructive pulmonary disease.
Topics: Adrenal Cortex Hormones; Adrenergic beta-2 Receptor Agonists; Albuterol; Androstadienes; Bronchodila | 2013 |
Comparative efficacy of long-acting bronchodilators for COPD: a network meta-analysis.
Topics: Albuterol; Bayes Theorem; Bronchodilator Agents; Delayed-Action Preparations; Dose-Response Relation | 2013 |
[Influence of inhaler and fine particle on efficacy of inhalation therapy in COPD].
Topics: Administration, Inhalation; Adrenergic beta-Agonists; Aerosol Propellants; Aerosols; Albuterol; Asth | 2014 |
Recent advances in COPD disease management with fixed-dose long-acting combination therapies.
Topics: Adrenal Cortex Hormones; Adrenergic beta-Agonists; Albuterol; Benzyl Alcohols; Bronchodilator Agents | 2014 |
Benefits of adding fluticasone propionate/salmeterol to tiotropium in COPD: a meta-analysis.
Topics: Albuterol; Androstadienes; Disease Progression; Drug Combinations; Drug Therapy, Combination; Flutic | 2014 |
A Systematic Review of the Efficacy and Safety of a Fixed-Dose Combination of Umeclidinium and Vilanterol for the Treatment of COPD.
Topics: Adrenergic beta-2 Receptor Agonists; Albuterol; Androstadienes; Benzyl Alcohols; Chlorobenzenes; Dru | 2015 |
Early chronic obstructive pulmonary disease: definition, assessment, and prevention.
Topics: Albuterol; Androstadienes; Anti-Inflammatory Agents; Bronchodilator Agents; Disease Progression; Dru | 2015 |
Long-acting beta2-agonist in addition to tiotropium versus either tiotropium or long-acting beta2-agonist alone for chronic obstructive pulmonary disease.
Topics: Adrenergic beta-2 Receptor Agonists; Aged; Albuterol; Bronchodilator Agents; Ethanolamines; Formoter | 2015 |
Mortality and drug therapy in patients with chronic obstructive pulmonary disease: a network meta-analysis.
Topics: Albuterol; Aminopyridines; Beclomethasone; Benzamides; Benzyl Alcohols; Bronchodilator Agents; Budes | 2015 |
Treating and preventing acute exacerbations of COPD.
Topics: Acidosis, Respiratory; Acute Disease; Administration, Inhalation; Albuterol; Anti-Bacterial Agents; | 2016 |
Umeclidinium Plus Vilanterol Versus Placebo, Umeclidinium, or Vilanterol Monotherapies for Chronic Obstructive Pulmonary Disease: A Meta-Analysis of Randomized Controlled Trials.
Topics: Albuterol; Benzyl Alcohols; Bronchodilator Agents; Chlorobenzenes; Forced Expiratory Volume; Humans; | 2016 |
The risk of asthma mortality with inhaled long acting beta-agonists.
Topics: Administration, Inhalation; Adolescent; Adrenergic beta-Agonists; Adult; Albuterol; Anti-Asthmatic A | 2008 |
Use of dry powder inhalers in acute exacerbations of asthma and COPD.
Topics: Adrenergic beta-Agonists; Albuterol; Asthma; Bronchodilator Agents; Disease Progression; Ethanolamin | 2009 |
Seretide: a pharmacoeconomic analysis.
Topics: Albuterol; Androstadienes; Asthma; Bronchodilator Agents; Drug Combinations; Fluticasone-Salmeterol | 2008 |
[Long-acting beta(2)-adrenoceptor agonists for asthma and COPD].
Topics: Administration, Inhalation; Adrenal Cortex Hormones; Adrenergic beta-Agonists; Adult; Albuterol; Ant | 1997 |
Insights into interventions in managing COPD patients: lessons from the TORCH and UPLIFT studies.
Topics: Adrenergic beta-Agonists; Aged; Albuterol; Androstadienes; Bronchodilator Agents; Cholinergic Antago | 2009 |
Current options in the treatment of acute bronchospasm.
Topics: Adrenal Cortex Hormones; Adrenergic beta-2 Receptor Agonists; Adrenergic beta-Agonists; Albuterol; A | 2005 |
Management of chronic obstructive pulmonary disease: moving beyond the asthma algorithm.
Topics: Administration, Inhalation; Adrenal Cortex Hormones; Adrenergic beta-Antagonists; Albuterol; Androst | 2009 |
Inhaled albuterol/salbutamol and ipratropium bromide and their combination in the treatment of chronic obstructive pulmonary disease.
Topics: Albuterol; Albuterol, Ipratropium Drug Combination; Bronchodilator Agents; Clinical Trials as Topic; | 2010 |
Management of COPD exacerbations.
Topics: Albuterol; Anti-Bacterial Agents; Bronchodilator Agents; Comorbidity; Disease Progression; Glucocort | 2010 |
[Long-term trials assessing pharmacological treatments in COPD: lessons and limitations].
Topics: Administration, Inhalation; Adrenal Cortex Hormones; Adult; Aged; Albuterol; Androstadienes; Broncho | 2010 |
Combination inhaled steroid and long-acting beta2-agonist versus tiotropium for chronic obstructive pulmonary disease.
Topics: Administration, Inhalation; Adrenergic beta-Agonists; Albuterol; Androstadienes; Bronchodilator Agen | 2010 |
The role of fluticasone propionate/salmeterol combination therapy in preventing exacerbations of COPD.
Topics: Albuterol; Androstadienes; Anti-Inflammatory Agents; Bronchodilator Agents; Cost-Benefit Analysis; D | 2010 |
Do we need different treatments for very elderly COPD patients?
Topics: Adrenergic beta-2 Receptor Agonists; Aged; Aging; Albuterol; Bronchodilator Agents; Glucocorticoids; | 2010 |
Adherence to controller therapy for chronic obstructive pulmonary disease: a review.
Topics: Albuterol; Androstadienes; Bronchodilator Agents; Fluticasone; Humans; Medication Adherence; Patient | 2010 |
Does tiotropium lower exacerbation and hospitalization frequency in COPD patients: results of a meta-analysis.
Topics: Albuterol; Bronchodilator Agents; Cholinergic Antagonists; Disease Progression; Hospitalization; Hum | 2010 |
The use of long acting β₂-agonists, alone or in combination with inhaled corticosteroids, in chronic obstructive pulmonary disease (COPD): a risk-benefit analysis.
Topics: Administration, Inhalation; Adrenal Cortex Hormones; Adrenergic beta-2 Receptor Agonists; Albuterol; | 2011 |
[Clinical profile of roflumilast].
Topics: Adrenal Cortex Hormones; Adrenergic beta-Agonists; Adult; Aged; Albuterol; Aminopyridines; Animals; | 2010 |
[Triple therapy in chronic obstructive pulmonary disease].
Topics: Administration, Inhalation; Administration, Oral; Adrenal Cortex Hormones; Adrenergic beta-2 Recepto | 2010 |
(R)-salbutamol in the treatment of asthma and chronic obstructive airways disease.
Topics: Adrenergic beta-2 Receptor Agonists; Albuterol; Asthma; Bronchodilator Agents; Humans; Pulmonary Dis | 2011 |
Chronic obstructive pulmonary disease megatrials: taking the results into office practice.
Topics: Aged; Albuterol; Androstadienes; Bronchodilator Agents; Clinical Trials as Topic; Drug Therapy, Comb | 2011 |
Budesonide/formoterol vs. salmeterol/fluticasone in COPD: a systematic review and adjusted indirect comparison of pneumonia in randomised controlled trials.
Topics: Administration, Inhalation; Albuterol; Androstadienes; Bronchodilator Agents; Budesonide; Drug Thera | 2011 |
Comparative efficacy of indacaterol 150 μg and 300 μg versus fixed-dose combinations of formoterol + budesonide or salmeterol + fluticasone for the treatment of chronic obstructive pulmonary disease--a network meta-analysis.
Topics: Albuterol; Androstadienes; Bronchodilator Agents; Budesonide; Drug Combinations; Ethanolamines; Flut | 2011 |
Effect of long-acting beta-agonists on the frequency of COPD exacerbations: a meta-analysis.
Topics: Administration, Inhalation; Adrenergic beta-2 Receptor Agonists; Albuterol; Bronchodilator Agents; D | 2012 |
Efficacy of indacaterol in the treatment of patients with COPD.
Topics: Aged; Albuterol; Bronchodilator Agents; Clinical Trials as Topic; Female; Humans; Indans; Male; Midd | 2011 |
Inhaled corticosteroids versus long-acting beta(2)-agonists for chronic obstructive pulmonary disease.
Topics: Adrenal Cortex Hormones; Adrenergic beta-2 Receptor Agonists; Albuterol; Androstadienes; Bronchodila | 2011 |
Bronchodilator efficacy and safety of indacaterol 150 μg once daily in patients with COPD: an analysis of pooled data.
Topics: Administration, Inhalation; Adrenergic beta-2 Receptor Agonists; Aged; Albuterol; Bronchodilator Age | 2011 |
Bronchodilator efficacy and safety of indacaterol 150 μg once daily in patients with COPD: an analysis of pooled data.
Topics: Administration, Inhalation; Adrenergic beta-2 Receptor Agonists; Aged; Albuterol; Bronchodilator Age | 2011 |
Bronchodilator efficacy and safety of indacaterol 150 μg once daily in patients with COPD: an analysis of pooled data.
Topics: Administration, Inhalation; Adrenergic beta-2 Receptor Agonists; Aged; Albuterol; Bronchodilator Age | 2011 |
Bronchodilator efficacy and safety of indacaterol 150 μg once daily in patients with COPD: an analysis of pooled data.
Topics: Administration, Inhalation; Adrenergic beta-2 Receptor Agonists; Aged; Albuterol; Bronchodilator Age | 2011 |
[Evidence of pharmacotherapy in COPD--key findings from recently-conducted randomized clinical studies].
Topics: Adrenergic beta-2 Receptor Agonists; Aged; Albuterol; Androstadienes; Bronchodilator Agents; Drug Th | 2011 |
Inhaled corticosteroids versus long-acting beta(2)-agonists for chronic obstructive pulmonary disease.
Topics: Adrenal Cortex Hormones; Adrenergic beta-2 Receptor Agonists; Albuterol; Androstadienes; Bronchodila | 2011 |
Long-acting beta(2)-agonist in addition to tiotropium versus either tiotropium or long-acting beta(2)-agonist alone for chronic obstructive pulmonary disease.
Topics: Adrenergic beta-2 Receptor Agonists; Aged; Albuterol; Bronchodilator Agents; Ethanolamines; Formoter | 2012 |
Efficacy of once-daily indacaterol 75 μg relative to alternative bronchodilators in COPD: a study level and a patient level network meta-analysis.
Topics: Adrenergic beta-2 Receptor Antagonists; Adult; Aged; Aged, 80 and over; Albuterol; Bronchodilator Ag | 2012 |
Efficacy of indacaterol 75 μg versus fixed-dose combinations of formoterol-budesonide or salmeterol-fluticasone for COPD: a network meta-analysis.
Topics: Albuterol; Androstadienes; Bronchodilator Agents; Budesonide; Drug Combinations; Drug Therapy, Combi | 2012 |
Combined corticosteroid and long-acting beta(2)-agonist in one inhaler versus long-acting beta(2)-agonists for chronic obstructive pulmonary disease.
Topics: Adrenal Cortex Hormones; Adrenergic beta-Agonists; Adult; Albuterol; Androstadienes; Bronchodilator | 2012 |
Tiotropium versus long-acting beta-agonists for stable chronic obstructive pulmonary disease.
Topics: Adrenergic beta-2 Receptor Agonists; Albuterol; Bronchodilator Agents; Cost-Benefit Analysis; Diseas | 2012 |
Longitudinal FEV1 dose-response model for inhaled PF-00610355 and salmeterol in patients with chronic obstructive pulmonary disease.
Topics: Administration, Inhalation; Adrenergic beta-2 Receptor Agonists; Albuterol; Circadian Clocks; Cross- | 2012 |
Comparative safety of inhaled medications in patients with chronic obstructive pulmonary disease: systematic review and mixed treatment comparison meta-analysis of randomised controlled trials.
Topics: Administration, Inhalation; Adrenal Cortex Hormones; Albuterol; Bronchodilator Agents; Dose-Response | 2013 |
Which long-acting bronchodilator is most cost-effective for the treatment of COPD?
Topics: Albuterol; Bronchodilator Agents; Cost-Benefit Analysis; Disease Progression; Humans; Markov Chains; | 2012 |
Effects of long-acting bronchodilators in COPD patients according to COPD severity and ICS use.
Topics: Administration, Inhalation; Adrenergic beta-2 Receptor Agonists; Adult; Aged; Albuterol; Bronchodila | 2013 |
The safety of long-acting β2-agonists in the treatment of stable chronic obstructive pulmonary disease.
Topics: Adrenergic beta-2 Receptor Agonists; Albuterol; Blood Glucose; Cough; Ethanolamines; Formoterol Fuma | 2013 |
Safety of sputum induction.
Topics: Administration, Inhalation; Albuterol; Asthma; Bronchial Provocation Tests; Bronchoalveolar Lavage; | 2002 |
[Dyspnea and quality of life in chronic obstructive pulmonary disease].
Topics: Albuterol; Bronchodilator Agents; Clinical Trials as Topic; Dyspnea; Emotions; Exercise; Follow-Up S | 2002 |
Tiotropium bromide: a novel once-daily anticholinergic bronchodilator for the treatment of COPD.
Topics: Administration, Inhalation; Albuterol; Area Under Curve; Asthma; Biological Availability; Bronchodil | 2002 |
Tiotropium for chronic obstructive pulmonary disease.
Topics: Albuterol; Bronchodilator Agents; Humans; Ipratropium; Pulmonary Disease, Chronic Obstructive; Salme | 2003 |
Long-acting beta 2-adrenoceptor agonists or tiotropium bromide for patients with COPD: is combination therapy justified?
Topics: Adrenergic beta-2 Receptor Agonists; Adrenergic beta-Agonists; Albuterol; Anti-Inflammatory Agents; | 2003 |
Long-acting beta(2) agonists as potential option in the treatment of acute exacerbations of COPD.
Topics: Adrenergic beta-Agonists; Airway Obstruction; Albuterol; Bronchodilator Agents; Dose-Response Relati | 2003 |
[Pharmacological action and clinical aspects of salmeterol].
Topics: Administration, Inhalation; Adrenergic beta-2 Receptor Agonists; Adrenergic beta-Agonists; Albuterol | 2003 |
[Physiopathology of COPD: choosing the right therapeutic targets].
Topics: Adrenal Cortex Hormones; Aged; Albuterol; Animals; Bacterial Infections; Bronchodilator Agents; Carb | 2003 |
Combined corticosteroid and longacting beta-agonist in one inhaler for chronic obstructive pulmonary disease.
Topics: Adrenergic beta-Agonists; Albuterol; Androstadienes; Bronchodilator Agents; Budesonide; Drug Combina | 2003 |
Novolizer: a multidose dry powder inhaler.
Topics: Administration, Inhalation; Adult; Albuterol; Anti-Inflammatory Agents; Asthma; Bronchodilator Agent | 2003 |
State of the art in beta2-agonist therapy: a safety review of long-acting agents.
Topics: Adrenergic beta-Agonists; Albuterol; Asthma; Bronchodilator Agents; Drug Therapy, Combination; Drug | 2003 |
The role of long-acting bronchodilators in the management of stable COPD.
Topics: Adrenergic beta-Agonists; Albuterol; Bronchodilator Agents; Cholinergic Antagonists; Ethanolamines; | 2004 |
Inhaled salmeterol/fluticasone propionate combination in chronic obstructive pulmonary disease.
Topics: Administration, Inhalation; Albuterol; Androstadienes; Bronchodilator Agents; Drug Therapy, Combinat | 2002 |
Are Seretide and Symbicort useful in COPD?
Topics: Administration, Inhalation; Adrenal Cortex Hormones; Albuterol; Androstadienes; Budesonide; Budesoni | 2004 |
Fluticasone propionate/salmeterol for the treatment of chronic-obstructive pulmonary disease.
Topics: Adrenergic beta-2 Receptor Agonists; Albuterol; Androstadienes; Anti-Inflammatory Agents; Asthma; Br | 2004 |
Levalbuterol in the treatment of patients with asthma and chronic obstructive lung disease.
Topics: Albuterol; Asthma; Bronchodilator Agents; Humans; Molecular Structure; Pulmonary Disease, Chronic Ob | 2004 |
Inhaled salmeterol/fluticasone propionate: a review of its use in chronic obstructive pulmonary disease.
Topics: Administration, Inhalation; Albuterol; Androstadienes; Area Under Curve; Bronchodilator Agents; Clin | 2004 |
[Combined inhaled corticosteroid and long-acting beta-2-agonist in one inhaler in the treatment of chronic obstructive pulmonary disease].
Topics: Administration, Inhalation; Adrenal Cortex Hormones; Adrenergic beta-Agonists; Adult; Albuterol; And | 2005 |
Tiotropium: a bronchodilator for chronic obstructive pulmonary disease.
Topics: Albuterol; Bronchodilator Agents; Cholinergic Antagonists; Clinical Trials as Topic; Cost-Benefit An | 2005 |
Inhaled beta2-adrenoceptor agonists: cardiovascular safety in patients with obstructive lung disease.
Topics: Administration, Inhalation; Adrenergic beta-2 Receptor Agonists; Adrenergic beta-Agonists; Albuterol | 2005 |
Inhalation therapy with metered-dose inhalers and dry powder inhalers in mechanically ventilated patients.
Topics: Administration, Inhalation; Aerosols; Albuterol; Bronchodilator Agents; Humans; Ipratropium; Metered | 2005 |
Corticosteroids and adrenoceptor agonists: the compliments for combination therapy in chronic airways diseases.
Topics: Adrenal Cortex Hormones; Adrenergic beta-2 Receptor Agonists; Adrenergic beta-Agonists; Albuterol; A | 2006 |
[The beta2-adrenergic receptor agonists in the treatment of chronic obstructive pulmonary disease].
Topics: Adrenergic beta-2 Receptor Agonists; Adrenergic beta-Agonists; Albuterol; Delayed-Action Preparation | 2005 |
Beta-adrenoceptor responses of the airways: for better or worse?
Topics: Adrenergic beta-2 Receptor Agonists; Adrenergic beta-Agonists; Albuterol; Animals; Anti-Inflammatory | 2006 |
Something old, something new, something borrowed. COPD treatment today.
Topics: Adrenergic beta-Agonists; Airway Resistance; Albuterol; Anti-Inflammatory Agents; Beclomethasone; Br | 2006 |
Improving dyspnea in chronic obstructive pulmonary disease: optimal treatment strategies.
Topics: Adrenergic beta-Agonists; Albuterol; Cholinergic Antagonists; Dyspnea; Humans; Pulmonary Disease, Ch | 2006 |
Ipratropium bromide versus long-acting beta-2 agonists for stable chronic obstructive pulmonary disease.
Topics: Adrenergic beta-Agonists; Adult; Albuterol; Bronchodilator Agents; Ethanolamines; Formoterol Fumarat | 2006 |
Review of guidelines and the literature in the treatment of acute bronchospasm in chronic obstructive pulmonary disease.
Topics: Adrenergic beta-Agonists; Albuterol; Bronchial Spasm; Bronchodilator Agents; Hospitalization; Humans | 2006 |
Clinical course of chronic obstructive pulmonary disease: review of therapeutic interventions.
Topics: Administration, Inhalation; Adrenal Cortex Hormones; Adrenergic beta-Agonists; Albuterol; Bronchodil | 2006 |
The role of patient-centered outcomes in the course of chronic obstructive pulmonary disease: how long-term studies contribute to our understanding.
Topics: Acute Disease; Adrenal Cortex Hormones; Adrenergic beta-Agonists; Aged; Albuterol; Androstadienes; B | 2006 |
Improved outcomes in patients with chronic obstructive pulmonary disease treated with salmeterol compared with placebo/usual therapy: results of a meta-analysis.
Topics: Albuterol; Bronchodilator Agents; Humans; Placebo Effect; Pulmonary Disease, Chronic Obstructive; Ra | 2006 |
Clinical safety of long-acting beta2-agonist and inhaled corticosteroid combination therapy in COPD.
Topics: Administration, Inhalation; Adrenergic beta-Agonists; Albuterol; Bronchodilator Agents; Budesonide; | 2006 |
Do chronic inhaled steroids alone or in combination with a bronchodilator prolong life in chronic obstructive pulmonary disease patients?
Topics: Administration, Inhalation; Adrenal Cortex Hormones; Adrenergic beta-Agonists; Albuterol; Androstadi | 2007 |
Combination inhaled bronchodilator therapy in the management of chronic obstructive pulmonary disease.
Topics: Administration, Inhalation; Albuterol; Bronchodilator Agents; Drug Therapy, Combination; Ethanolamin | 2007 |
Update in chronic obstructive pulmonary disease 2006.
Topics: Albuterol; Androstadienes; Bronchodilator Agents; Diagnostic Imaging; Fluticasone; Humans; Immunity, | 2007 |
Salmeterol/fluticasone propionate: a review of its use in the treatment of chronic obstructive pulmonary disease.
Topics: Administration, Inhalation; Albuterol; Androstadienes; Anti-Inflammatory Agents; Bronchodilator Agen | 2007 |
Comparison and optimal use of fixed combinations in the management of COPD.
Topics: Administration, Inhalation; Adrenal Cortex Hormones; Adrenergic beta-Agonists; Albuterol; Androstadi | 2007 |
Salmeterol/fluticasone combination in the treatment of COPD.
Topics: Adrenergic beta-Agonists; Albuterol; Androstadienes; Bronchodilator Agents; Clinical Trials as Topic | 2006 |
Inhalatory therapy training: a priority challenge for the physician.
Topics: Administration, Inhalation; Adrenal Cortex Hormones; Adult; Aerosols; Aged; Albuterol; Androstadiene | 2007 |
New therapeutic drugs in the management of chronic obstructive pulmonary disease.
Topics: Albuterol; Bronchodilator Agents; Clinical Trials as Topic; Drug Therapy, Combination; Ethanolamines | 2002 |
Seretide for obstructive lung disease.
Topics: Administration, Inhalation; Albuterol; Androstadienes; Anti-Inflammatory Agents; Clinical Trials as | 2002 |
287 trials available for albuterol and Airflow Obstruction, Chronic
| Article | Year |
|---|---|
Efficacy and safety of combined doxofylline and salbutamol in treatment of acute exacerbation of chronic obstructive pulmonary disease.
Topics: Albuterol; Humans; Lung; Pulmonary Disease, Chronic Obstructive; Theophylline | 2021 |
The Effect of Albuterol Spray on Hypoxia and Bronchospasm in Patients with Chronic Obstructive Pulmonary Disease (COPD) under General Anesthesia: A bouble-Blind Randomized Clinical Trial.
Topics: Adult; Albuterol; Anesthesia, General; Bronchial Spasm; Bronchodilator Agents; Cough; Double-Blind M | 2023 |
Nebulized heparin and salbutamol versus salbutamol alone in acute exacerbations of chronic obstructive pulmonary disease requiring mechanical ventilation: a double-blind randomized controlled trial.
Topics: Adult; Albuterol; Bronchodilator Agents; Heparin; Humans; Nebulizers and Vaporizers; Pulmonary Disea | 2020 |
Long-acting dual bronchodilator therapy (indacaterol/glycopyrronium) versus nebulized short-acting dual bronchodilator (salbutamol/ipratropium) in chronic obstructive pulmonary disease: A double-blind, randomized, placebo-controlled trial.
Topics: Administration, Inhalation; Aged; Albuterol; Bronchodilator Agents; Cross-Over Studies; Delayed-Acti | 2020 |
Salbutamol use in relation to maintenance bronchodilator efficacy in COPD: a prospective subgroup analysis of the EMAX trial.
Topics: Adrenergic beta-2 Receptor Agonists; Aged; Albuterol; Bronchodilator Agents; Double-Blind Method; Dr | 2020 |
Effects of salbutamol on the kinetics of sevoflurane and the occurrence of early postoperative pulmonary complications in patients with mild-to-moderate chronic obstructive pulmonary disease: A randomized controlled study.
Topics: Aged; Albuterol; Female; Humans; Kinetics; Lung; Male; Postoperative Complications; Pulmonary Diseas | 2021 |
Inhaled salbutamol dose delivered by jet nebulizer, vibrating mesh nebulizer and metered dose inhaler with spacer during invasive mechanical ventilation.
Topics: Administration, Inhalation; Aerosols; Aged; Aged, 80 and over; Albuterol; Bronchodilator Agents; Dos | 2017 |
Bronchodilator efficacy of extrafine glycopyrronium bromide: the Glyco 2 study.
Topics: Administration, Inhalation; Adrenergic beta-2 Receptor Agonists; Adult; Aged; Albuterol; Bronchodila | 2017 |
The effect of umeclidinium on lung function and symptoms in patients with fixed airflow obstruction and reversibility to salbutamol: A randomised, 3-phase study.
Topics: Adult; Aged; Albuterol; Androstadienes; Asthma; Benzyl Alcohols; Bronchodilator Agents; Chlorobenzen | 2017 |
Inhaled nebulised unfractionated heparin improves lung function in moderate to very severe COPD: A pilot study.
Topics: Administration, Inhalation; Aged; Aged, 80 and over; Albuterol; Animals; Beclomethasone; Bronchodila | 2018 |
Sensory-mechanical effects of a dual bronchodilator and its anticholinergic component in COPD.
Topics: Adrenergic beta-2 Receptor Agonists; Aged; Airway Resistance; Albuterol; Benzyl Alcohols; Bronchodil | 2018 |
Effect of adding roflumilast or ciclesonide to glycopyrronium on lung volumes and exercise tolerance in patients with severe COPD: A pilot study.
Topics: Administration, Inhalation; Administration, Oral; Aged; Albuterol; Aminopyridines; Benzamides; Cyclo | 2018 |
Comparison of two methods of determining lung de-recruitment, using the forced oscillation technique.
Topics: Adult; Aged; Albuterol; Asthma; Bronchodilator Agents; Female; Humans; Male; Middle Aged; Pulmonary | 2018 |
Performance of Large Spacer Versus Nebulizer T-Piece in Single-Limb Noninvasive Ventilation.
Topics: Aged; Albuterol; Biological Availability; Bronchodilator Agents; Cross-Over Studies; Female; Humans; | 2018 |
The short-term bronchodilator effects of the dual phosphodiesterase 3 and 4 inhibitor RPL554 in COPD.
Topics: Administration, Inhalation; Aged; Albuterol; Bronchodilator Agents; Cross-Over Studies; Double-Blind | 2018 |
The short-term bronchodilator effects of the dual phosphodiesterase 3 and 4 inhibitor RPL554 in COPD.
Topics: Administration, Inhalation; Aged; Albuterol; Bronchodilator Agents; Cross-Over Studies; Double-Blind | 2018 |
The short-term bronchodilator effects of the dual phosphodiesterase 3 and 4 inhibitor RPL554 in COPD.
Topics: Administration, Inhalation; Aged; Albuterol; Bronchodilator Agents; Cross-Over Studies; Double-Blind | 2018 |
The short-term bronchodilator effects of the dual phosphodiesterase 3 and 4 inhibitor RPL554 in COPD.
Topics: Administration, Inhalation; Aged; Albuterol; Bronchodilator Agents; Cross-Over Studies; Double-Blind | 2018 |
Development of a novel digital breath-activated inhaler: Initial particle size characterization and clinical testing.
Topics: Administration, Inhalation; Aerosols; Aged; Albuterol; Bronchodilator Agents; Drug Combinations; Dru | 2018 |
Oxygen versus air-driven nebulisers for exacerbations of chronic obstructive pulmonary disease: a randomised controlled trial.
Topics: Aged; Aged, 80 and over; Albuterol; Blood Gas Monitoring, Transcutaneous; Bronchodilator Agents; Car | 2018 |
Salbutamol Nebulization During Noninvasive Ventilation in Exacerbated Chronic Obstructive Pulmonary Disease Patients: A Randomized Controlled Trial.
Topics: Administration, Inhalation; Adrenergic beta-2 Receptor Agonists; Aerosols; Aged; Albuterol; Bronchod | 2019 |
Aerosol Delivery Through an Adult High-Flow Nasal Cannula Circuit Using Low-Flow Oxygen.
Topics: Administration, Inhalation; Adult; Aerosols; Albuterol; Bronchodilator Agents; Dose-Response Relatio | 2019 |
A mesh nebulizer is more effective than jet nebulizer to nebulize bronchodilators during non-invasive ventilation of subjects with COPD: A randomized controlled trial with radiolabeled aerosols.
Topics: Acute Disease; Administration, Inhalation; Aerosols; Aged; Albuterol; Bronchodilator Agents; Cross-O | 2019 |
Effect of fluticasone/salmeterol combination on dyspnea and respiratory mechanics in mild-to-moderate COPD.
Topics: Administration, Inhalation; Adult; Aged; Albuterol; Androstadienes; Cross-Over Studies; Double-Blind | 2013 |
A new class of bronchodilator improves lung function in COPD: a trial with GSK961081.
Topics: Aged; Albuterol; Bronchodilator Agents; Carbamates; Double-Blind Method; Drug Administration Schedul | 2013 |
Chronic treatment with indacaterol and airway response to salbutamol in stable COPD.
Topics: Adrenergic beta-2 Receptor Agonists; Aged; Aged, 80 and over; Albuterol; Bronchodilator Agents; Cros | 2013 |
Bronchodilation and safety of supratherapeutic doses of salbutamol or ipratropium bromide added to single dose GSK961081 in patients with moderate to severe COPD.
Topics: Aged; Albuterol; Bronchodilator Agents; Carbamates; Cross-Over Studies; Delayed-Action Preparations; | 2013 |
Pharmacodynamics of GSK961081, a bi-functional molecule, in patients with COPD.
Topics: Adrenergic beta-2 Receptor Agonists; Adult; Aged; Albuterol; Bronchodilator Agents; Carbamates; Cros | 2013 |
The effect of indacaterol during an acute exacerbation of COPD.
Topics: Acute Disease; Administration, Inhalation; Adrenergic beta-2 Receptor Agonists; Aged; Albuterol; Bro | 2013 |
COPD patient satisfaction with ipratropium bromide/albuterol delivered via Respimat: a randomized, controlled study.
Topics: Adult; Aged; Airway Management; Albuterol; Bronchodilator Agents; Drug Combinations; Drug Delivery S | 2013 |
Pneumonia and pneumonia related mortality in patients with COPD treated with fixed combinations of inhaled corticosteroid and long acting β2 agonist: observational matched cohort study (PATHOS).
Topics: Adrenergic beta-2 Receptor Agonists; Albuterol; Androstadienes; Budesonide; Cohort Studies; Ethanola | 2013 |
Comparison of dry powder versus nebulized beta-agonist in patients with COPD who have suboptimal peak inspiratory flow rate.
Topics: Administration, Inhalation; Adrenergic beta-2 Receptor Agonists; Aerosols; Aged; Aged, 80 and over; | 2014 |
The effect of bronchodilators administered via aerochamber or a nebulizer on inspiratory lung function parameters.
Topics: Administration, Inhalation; Adult; Aged; Aged, 80 and over; Albuterol; Bronchodilator Agents; Cross- | 2013 |
Effects of bronchodilators on regional lung sound distribution in patients with chronic obstructive pulmonary disease.
Topics: Adult; Aged; Aged, 80 and over; Albuterol; Bronchodilator Agents; Cross-Over Studies; Double-Blind M | 2014 |
Effects of tiotropium and salmeterol/fluticasone propionate on airway wall thickness in chronic obstructive pulmonary disease.
Topics: Aged; Aged, 80 and over; Albuterol; Androstadienes; Bronchodilator Agents; Drug Therapy, Combination | 2013 |
Effect of fluticasone propionate/salmeterol plus tiotropium versus tiotropium on walking endurance in COPD.
Topics: Aged; Albuterol; Androstadienes; Bronchodilator Agents; Double-Blind Method; Drug Combinations; Exer | 2013 |
Airway gene expression in COPD is dynamic with inhaled corticosteroid treatment and reflects biological pathways associated with disease activity.
Topics: Aged; Albuterol; Androstadienes; Anti-Inflammatory Agents; Disease Progression; Drug Therapy, Combin | 2014 |
Annual rates of change in pre- vs. post-bronchodilator FEV1 and FVC over 4 years in moderate to very severe COPD.
Topics: Administration, Inhalation; Albuterol; Bronchodilator Agents; Drug Administration Schedule; Drug The | 2013 |
Inhaler competence and patient satisfaction with Easyhaler®: results of two real-life multicentre studies in asthma and COPD.
Topics: Administration, Inhalation; Adolescent; Adult; Aged; Aged, 80 and over; Albuterol; Asthma; Bronchodi | 2013 |
A pilot study assessing the effect of bronchodilator on dynamic hyperinflation in LAM.
Topics: Adrenergic beta-2 Receptor Agonists; Adult; Albuterol; Bronchodilator Agents; Cross-Over Studies; Do | 2013 |
Pharmacokinetics and pharmacodynamics of fluticasone propionate and salmeterol delivered as a combination dry powder from a capsule-based inhaler and a multidose inhaler in asthma and COPD patients.
Topics: Administration, Inhalation; Adrenergic beta-2 Receptor Agonists; Adult; Aerosols; Aged; Albuterol; A | 2014 |
Effects of long-acting bronchodilators and prednisolone on inspiratory lung function parameters in stable COPD.
Topics: Administration, Oral; Aged; Aged, 80 and over; Albuterol; Bronchodilator Agents; Delayed-Action Prep | 2014 |
A comparison of the efficacy and safety of once-daily fluticasone furoate/vilanterol with twice-daily fluticasone propionate/salmeterol in moderate to very severe COPD.
Topics: Administration, Inhalation; Adrenal Cortex Hormones; Adult; Aged; Albuterol; Androstadienes; Anti-In | 2014 |
A study to assess COPD Symptom-based Management and to Optimise treatment Strategy in Japan (COSMOS-J) based on GOLD 2011.
Topics: Adrenergic beta-2 Receptor Agonists; Albuterol; Androstadienes; Bronchodilator Agents; Cholinergic A | 2013 |
Comparing dynamic hyperinflation and associated dyspnea induced by metronome-paced tachypnea versus incremental exercise.
Topics: Aged; Albuterol; Albuterol, Ipratropium Drug Combination; Bronchodilator Agents; Cross-Over Studies; | 2014 |
Characterisation of exacerbation risk and exacerbator phenotypes in the POET-COPD trial.
Topics: Administration, Inhalation; Aged; Aged, 80 and over; Albuterol; Disease Progression; Double-Blind Me | 2013 |
Priming of beta-2 agonist and antimuscarinic induced physiological responses induced by 1200mg/day NAC in moderate to severe COPD patients: A pilot study.
Topics: Acetylcysteine; Aged; Albuterol; Antioxidants; Bronchodilator Agents; Dose-Response Relationship, Dr | 2014 |
Efficacy and safety of once-daily QVA149 compared with twice-daily salmeterol-fluticasone in patients with chronic obstructive pulmonary disease (ILLUMINATE): a randomised, double-blind, parallel group study.
Topics: Administration, Inhalation; Albuterol; Androstadienes; Bronchodilator Agents; Double-Blind Method; D | 2013 |
Effect of ADRB2 polymorphisms on the efficacy of salmeterol and tiotropium in preventing COPD exacerbations: a prespecified substudy of the POET-COPD trial.
Topics: Acute Disease; Albuterol; Bronchodilator Agents; Double-Blind Method; Female; Forced Expiratory Volu | 2014 |
Extrafine beclomethasone/formoterol compared to fluticasone/salmeterol combination therapy in COPD.
Topics: Albuterol; Androstadienes; Beclomethasone; Bronchodilator Agents; Double-Blind Method; Drug Combinat | 2014 |
Partial versus maximal forced exhalations in COPD: enhanced signal detection for novel therapies.
Topics: Administration, Inhalation; Adrenergic beta-2 Receptor Agonists; Aged; Albuterol; Bronchodilator Age | 2014 |
Safety and tolerability of inhaled loxapine in subjects with asthma and chronic obstructive pulmonary disease--two randomized controlled trials.
Topics: Administration, Inhalation; Adolescent; Adult; Aerosols; Aged; Albuterol; Antipsychotic Agents; Asth | 2014 |
Safety and tolerability of inhaled loxapine in subjects with asthma and chronic obstructive pulmonary disease--two randomized controlled trials.
Topics: Administration, Inhalation; Adolescent; Adult; Aerosols; Aged; Albuterol; Antipsychotic Agents; Asth | 2014 |
Safety and tolerability of inhaled loxapine in subjects with asthma and chronic obstructive pulmonary disease--two randomized controlled trials.
Topics: Administration, Inhalation; Adolescent; Adult; Aerosols; Aged; Albuterol; Antipsychotic Agents; Asth | 2014 |
Safety and tolerability of inhaled loxapine in subjects with asthma and chronic obstructive pulmonary disease--two randomized controlled trials.
Topics: Administration, Inhalation; Adolescent; Adult; Aerosols; Aged; Albuterol; Antipsychotic Agents; Asth | 2014 |
Interleukin-32, not reduced by salmeterol/fluticasone propionate in smokers with chronic obstructive pulmonary disease.
Topics: Adult; Aged; Aged, 80 and over; Albuterol; Androstadienes; Anti-Inflammatory Agents; Drug Combinatio | 2014 |
Comparison of conventional medicine, TCM treatment, and combination of both conventional medicine and TCM treatment for patients with chronic obstructive pulmonary disease: study protocol of a randomized comparative effectiveness research trial.
Topics: Adolescent; Adult; Aged; Aged, 80 and over; Albuterol; Androstadienes; Bronchodilator Agents; China; | 2014 |
Efficacy and safety of once-daily fluticasone furoate/vilanterol (100/25 mcg) versus twice-daily fluticasone propionate/salmeterol (250/50 mcg) in COPD patients.
Topics: Administration, Inhalation; Adrenergic beta-2 Receptor Agonists; Albuterol; Androstadienes; Benzyl A | 2014 |
Efficacy and safety of once-daily fluticasone furoate/vilanterol (100/25 mcg) versus twice-daily fluticasone propionate/salmeterol (250/50 mcg) in COPD patients.
Topics: Administration, Inhalation; Adrenergic beta-2 Receptor Agonists; Albuterol; Androstadienes; Benzyl A | 2014 |
Efficacy and safety of once-daily fluticasone furoate/vilanterol (100/25 mcg) versus twice-daily fluticasone propionate/salmeterol (250/50 mcg) in COPD patients.
Topics: Administration, Inhalation; Adrenergic beta-2 Receptor Agonists; Albuterol; Androstadienes; Benzyl A | 2014 |
Efficacy and safety of once-daily fluticasone furoate/vilanterol (100/25 mcg) versus twice-daily fluticasone propionate/salmeterol (250/50 mcg) in COPD patients.
Topics: Administration, Inhalation; Adrenergic beta-2 Receptor Agonists; Albuterol; Androstadienes; Benzyl A | 2014 |
Efficacy and safety of once-daily fluticasone furoate/vilanterol (100/25 mcg) versus twice-daily fluticasone propionate/salmeterol (250/50 mcg) in COPD patients.
Topics: Administration, Inhalation; Adrenergic beta-2 Receptor Agonists; Albuterol; Androstadienes; Benzyl A | 2014 |
Efficacy and safety of once-daily fluticasone furoate/vilanterol (100/25 mcg) versus twice-daily fluticasone propionate/salmeterol (250/50 mcg) in COPD patients.
Topics: Administration, Inhalation; Adrenergic beta-2 Receptor Agonists; Albuterol; Androstadienes; Benzyl A | 2014 |
Efficacy and safety of once-daily fluticasone furoate/vilanterol (100/25 mcg) versus twice-daily fluticasone propionate/salmeterol (250/50 mcg) in COPD patients.
Topics: Administration, Inhalation; Adrenergic beta-2 Receptor Agonists; Albuterol; Androstadienes; Benzyl A | 2014 |
Efficacy and safety of once-daily fluticasone furoate/vilanterol (100/25 mcg) versus twice-daily fluticasone propionate/salmeterol (250/50 mcg) in COPD patients.
Topics: Administration, Inhalation; Adrenergic beta-2 Receptor Agonists; Albuterol; Androstadienes; Benzyl A | 2014 |
Efficacy and safety of once-daily fluticasone furoate/vilanterol (100/25 mcg) versus twice-daily fluticasone propionate/salmeterol (250/50 mcg) in COPD patients.
Topics: Administration, Inhalation; Adrenergic beta-2 Receptor Agonists; Albuterol; Androstadienes; Benzyl A | 2014 |
Dependence of bronchoconstrictor and bronchodilator responses on thoracic gas compression volume.
Topics: Adult; Aged; Albuterol; Asthma; Body Height; Bronchial Provocation Tests; Bronchoconstrictor Agents; | 2014 |
The application of impulse oscillation system for the evaluation of treatment effects in patients with COPD.
Topics: Aged; Albuterol; Bronchodilator Agents; Drug Therapy, Combination; Female; Follow-Up Studies; Humans | 2014 |
Comparison of airway dimensions with once daily tiotropium plus indacaterol versus twice daily Advair(®) in chronic obstructive pulmonary disease.
Topics: Aged; Albuterol; Androstadienes; Bronchodilator Agents; Drug Administration Schedule; Drug Combinati | 2015 |
Withdrawal of inhaled glucocorticoids and exacerbations of COPD.
Topics: Administration, Inhalation; Aged; Albuterol; Androstadienes; Bronchodilator Agents; Double-Blind Met | 2014 |
Withdrawal of inhaled glucocorticoids and exacerbations of COPD.
Topics: Administration, Inhalation; Aged; Albuterol; Androstadienes; Bronchodilator Agents; Double-Blind Met | 2014 |
Withdrawal of inhaled glucocorticoids and exacerbations of COPD.
Topics: Administration, Inhalation; Aged; Albuterol; Androstadienes; Bronchodilator Agents; Double-Blind Met | 2014 |
Withdrawal of inhaled glucocorticoids and exacerbations of COPD.
Topics: Administration, Inhalation; Aged; Albuterol; Androstadienes; Bronchodilator Agents; Double-Blind Met | 2014 |
Daily variation in lung function in COPD patients with combined albuterol and ipratropium: results from a 4-week, randomized, crossover study.
Topics: Administration, Inhalation; Aged; Albuterol; Bronchodilator Agents; Cross-Over Studies; Drug Adminis | 2015 |
Daily variation in lung function in COPD patients with combined albuterol and ipratropium: results from a 4-week, randomized, crossover study.
Topics: Administration, Inhalation; Aged; Albuterol; Bronchodilator Agents; Cross-Over Studies; Drug Adminis | 2015 |
Daily variation in lung function in COPD patients with combined albuterol and ipratropium: results from a 4-week, randomized, crossover study.
Topics: Administration, Inhalation; Aged; Albuterol; Bronchodilator Agents; Cross-Over Studies; Drug Adminis | 2015 |
Daily variation in lung function in COPD patients with combined albuterol and ipratropium: results from a 4-week, randomized, crossover study.
Topics: Administration, Inhalation; Aged; Albuterol; Bronchodilator Agents; Cross-Over Studies; Drug Adminis | 2015 |
Fluticasone propionate/salmeterol 250/50 μg versus salmeterol 50 μg after chronic obstructive pulmonary disease exacerbation.
Topics: Administration, Inhalation; Aged; Albuterol; Androstadienes; Bronchodilator Agents; Disease Progress | 2014 |
Cost-effectiveness of the LABA/LAMA dual bronchodilator indacaterol/glycopyrronium in a Swedish healthcare setting.
Topics: Aged; Albuterol; Androstadienes; Bronchodilator Agents; Cost-Benefit Analysis; Double-Blind Method; | 2014 |
INSTEAD: a randomised switch trial of indacaterol versus salmeterol/fluticasone in moderate COPD.
Topics: Administration, Inhalation; Aged; Albuterol; Androstadienes; Bronchodilator Agents; Disease Progress | 2014 |
[Efficacy on chronic obstructive pulmonary disease at stable stage treated with cutting method and western medication].
Topics: Acupuncture Points; Acupuncture Therapy; Aged; Albuterol; Androstadienes; Combined Modality Therapy; | 2014 |
Treatment responsiveness of phenotypes of symptomatic airways obstruction in adults.
Topics: Adolescent; Adrenergic beta-2 Receptor Agonists; Adult; Aged; Airway Obstruction; Albuterol; Anti-As | 2015 |
Efficacy and safety of fluticasone furoate/vilanterol (50/25 mcg; 100/25 mcg; 200/25 mcg) in Asian patients with chronic obstructive pulmonary disease: a randomized placebo-controlled trial.
Topics: Administration, Inhalation; Aged; Albuterol; Androstadienes; Asian People; Benzyl Alcohols; Chlorobe | 2015 |
Relapse in FEV1 Decline After Steroid Withdrawal in COPD.
Topics: Administration, Inhalation; Aged; Albuterol; Androstadienes; Bronchodilator Agents; Cohort Studies; | 2015 |
Glycopyrronium once-daily significantly improves lung function and health status when combined with salmeterol/fluticasone in patients with COPD: the GLISTEN study, a randomised controlled trial.
Topics: Administration, Inhalation; Aged; Albuterol; Androstadienes; Australia; Bronchodilator Agents; Dose- | 2015 |
Glycopyrronium once-daily significantly improves lung function and health status when combined with salmeterol/fluticasone in patients with COPD: the GLISTEN study, a randomised controlled trial.
Topics: Administration, Inhalation; Aged; Albuterol; Androstadienes; Australia; Bronchodilator Agents; Dose- | 2015 |
Glycopyrronium once-daily significantly improves lung function and health status when combined with salmeterol/fluticasone in patients with COPD: the GLISTEN study, a randomised controlled trial.
Topics: Administration, Inhalation; Aged; Albuterol; Androstadienes; Australia; Bronchodilator Agents; Dose- | 2015 |
Glycopyrronium once-daily significantly improves lung function and health status when combined with salmeterol/fluticasone in patients with COPD: the GLISTEN study, a randomised controlled trial.
Topics: Administration, Inhalation; Aged; Albuterol; Androstadienes; Australia; Bronchodilator Agents; Dose- | 2015 |
Glycopyrronium once-daily significantly improves lung function and health status when combined with salmeterol/fluticasone in patients with COPD: the GLISTEN study, a randomised controlled trial.
Topics: Administration, Inhalation; Aged; Albuterol; Androstadienes; Australia; Bronchodilator Agents; Dose- | 2015 |
Glycopyrronium once-daily significantly improves lung function and health status when combined with salmeterol/fluticasone in patients with COPD: the GLISTEN study, a randomised controlled trial.
Topics: Administration, Inhalation; Aged; Albuterol; Androstadienes; Australia; Bronchodilator Agents; Dose- | 2015 |
Glycopyrronium once-daily significantly improves lung function and health status when combined with salmeterol/fluticasone in patients with COPD: the GLISTEN study, a randomised controlled trial.
Topics: Administration, Inhalation; Aged; Albuterol; Androstadienes; Australia; Bronchodilator Agents; Dose- | 2015 |
Glycopyrronium once-daily significantly improves lung function and health status when combined with salmeterol/fluticasone in patients with COPD: the GLISTEN study, a randomised controlled trial.
Topics: Administration, Inhalation; Aged; Albuterol; Androstadienes; Australia; Bronchodilator Agents; Dose- | 2015 |
Glycopyrronium once-daily significantly improves lung function and health status when combined with salmeterol/fluticasone in patients with COPD: the GLISTEN study, a randomised controlled trial.
Topics: Administration, Inhalation; Aged; Albuterol; Androstadienes; Australia; Bronchodilator Agents; Dose- | 2015 |
Glycopyrronium once-daily significantly improves lung function and health status when combined with salmeterol/fluticasone in patients with COPD: the GLISTEN study, a randomised controlled trial.
Topics: Administration, Inhalation; Aged; Albuterol; Androstadienes; Australia; Bronchodilator Agents; Dose- | 2015 |
Glycopyrronium once-daily significantly improves lung function and health status when combined with salmeterol/fluticasone in patients with COPD: the GLISTEN study, a randomised controlled trial.
Topics: Administration, Inhalation; Aged; Albuterol; Androstadienes; Australia; Bronchodilator Agents; Dose- | 2015 |
Glycopyrronium once-daily significantly improves lung function and health status when combined with salmeterol/fluticasone in patients with COPD: the GLISTEN study, a randomised controlled trial.
Topics: Administration, Inhalation; Aged; Albuterol; Androstadienes; Australia; Bronchodilator Agents; Dose- | 2015 |
Glycopyrronium once-daily significantly improves lung function and health status when combined with salmeterol/fluticasone in patients with COPD: the GLISTEN study, a randomised controlled trial.
Topics: Administration, Inhalation; Aged; Albuterol; Androstadienes; Australia; Bronchodilator Agents; Dose- | 2015 |
Glycopyrronium once-daily significantly improves lung function and health status when combined with salmeterol/fluticasone in patients with COPD: the GLISTEN study, a randomised controlled trial.
Topics: Administration, Inhalation; Aged; Albuterol; Androstadienes; Australia; Bronchodilator Agents; Dose- | 2015 |
Glycopyrronium once-daily significantly improves lung function and health status when combined with salmeterol/fluticasone in patients with COPD: the GLISTEN study, a randomised controlled trial.
Topics: Administration, Inhalation; Aged; Albuterol; Androstadienes; Australia; Bronchodilator Agents; Dose- | 2015 |
Glycopyrronium once-daily significantly improves lung function and health status when combined with salmeterol/fluticasone in patients with COPD: the GLISTEN study, a randomised controlled trial.
Topics: Administration, Inhalation; Aged; Albuterol; Androstadienes; Australia; Bronchodilator Agents; Dose- | 2015 |
Clinical outcomes and treatment cost comparison of levalbuterol versus albuterol in hospitalized adults with chronic obstructive pulmonary disease or asthma.
Topics: Adolescent; Adult; Aged; Albuterol; Asthma; Bronchodilator Agents; Female; Hospitalization; Humans; | 2015 |
Efficacy of erdosteine 900 versus 600 mg/day in reducing oxidative stress in patients with COPD exacerbations: Results of a double blind, placebo-controlled trial.
Topics: Administration, Oral; Adult; Aged; Albuterol; Antioxidants; Bronchodilator Agents; Dose-Response Rel | 2015 |
Reliever salbutamol use as a measure of exacerbation risk in chronic obstructive pulmonary disease.
Topics: Administration, Inhalation; Adult; Aged; Aged, 80 and over; Albuterol; Bronchodilator Agents; Female | 2015 |
Efficacy and Safety of Umeclidinium Added to Fluticasone Propionate/Salmeterol in Patients with COPD: Results of Two Randomized, Double-Blind Studies.
Topics: Administration, Inhalation; Aged; Albuterol; Bronchodilator Agents; Double-Blind Method; Drug Therap | 2016 |
Efficacy and Safety of Umeclidinium Added to Fluticasone Propionate/Salmeterol in Patients with COPD: Results of Two Randomized, Double-Blind Studies.
Topics: Administration, Inhalation; Aged; Albuterol; Bronchodilator Agents; Double-Blind Method; Drug Therap | 2016 |
Efficacy and Safety of Umeclidinium Added to Fluticasone Propionate/Salmeterol in Patients with COPD: Results of Two Randomized, Double-Blind Studies.
Topics: Administration, Inhalation; Aged; Albuterol; Bronchodilator Agents; Double-Blind Method; Drug Therap | 2016 |
Efficacy and Safety of Umeclidinium Added to Fluticasone Propionate/Salmeterol in Patients with COPD: Results of Two Randomized, Double-Blind Studies.
Topics: Administration, Inhalation; Aged; Albuterol; Bronchodilator Agents; Double-Blind Method; Drug Therap | 2016 |
Efficacy and Safety of Umeclidinium Added to Fluticasone Propionate/Salmeterol in Patients with COPD: Results of Two Randomized, Double-Blind Studies.
Topics: Administration, Inhalation; Aged; Albuterol; Bronchodilator Agents; Double-Blind Method; Drug Therap | 2016 |
Efficacy and Safety of Umeclidinium Added to Fluticasone Propionate/Salmeterol in Patients with COPD: Results of Two Randomized, Double-Blind Studies.
Topics: Administration, Inhalation; Aged; Albuterol; Bronchodilator Agents; Double-Blind Method; Drug Therap | 2016 |
Efficacy and Safety of Umeclidinium Added to Fluticasone Propionate/Salmeterol in Patients with COPD: Results of Two Randomized, Double-Blind Studies.
Topics: Administration, Inhalation; Aged; Albuterol; Bronchodilator Agents; Double-Blind Method; Drug Therap | 2016 |
Efficacy and Safety of Umeclidinium Added to Fluticasone Propionate/Salmeterol in Patients with COPD: Results of Two Randomized, Double-Blind Studies.
Topics: Administration, Inhalation; Aged; Albuterol; Bronchodilator Agents; Double-Blind Method; Drug Therap | 2016 |
Efficacy and Safety of Umeclidinium Added to Fluticasone Propionate/Salmeterol in Patients with COPD: Results of Two Randomized, Double-Blind Studies.
Topics: Administration, Inhalation; Aged; Albuterol; Bronchodilator Agents; Double-Blind Method; Drug Therap | 2016 |
Prospective, open-label evaluation of a new albuterol multidose dry powder inhaler with integrated dose counter.
Topics: Adolescent; Adult; Albuterol; Asthma; Child; Child, Preschool; Drug Tolerance; Dry Powder Inhalers; | 2016 |
Intravenous magnesium sulphate as an adjuvant therapy in acute exacerbations of chronic obstructive pulmonary disease: a single centre, randomised, double-blinded, parallel group, placebo-controlled trial: a pilot study.
Topics: Administration, Inhalation; Administration, Intravenous; Aged; Aged, 80 and over; Albuterol; Broncho | 2015 |
[Effects of inhaled short-acting bronchodilators on diaphragm function and neural respiratory drive during maximal isocapnic ventilation in patients with chronic obstructive pulmonary disease].
Topics: Administration, Inhalation; Albuterol; Bronchodilator Agents; Diaphragm; Humans; Ipratropium; Pulmon | 2016 |
Effect of tiotropium on night-time awakening and daily rescue medication use in patients with COPD.
Topics: Administration, Inhalation; Aged; Albuterol; Bronchodilator Agents; Double-Blind Method; Drug Admini | 2016 |
A randomized, parallel-group study to evaluate the efficacy of umeclidinium/vilanterol 62.5/25 μg on health-related quality of life in patients with COPD.
Topics: Administration, Inhalation; Adrenergic beta-2 Receptor Agonists; Aged; Albuterol; Benzyl Alcohols; B | 2016 |
Efficacy and safety of ipratropium bromide/salbutamol sulphate administered in a hydrofluoroalkane metered-dose inhaler for the treatment of COPD.
Topics: Administration, Inhalation; Adrenergic beta-2 Receptor Agonists; Adult; Aerosol Propellants; Aged; A | 2016 |
Bronchodilator reversibility in patients with COPD revisited: short-term reproducibility.
Topics: Administration, Inhalation; Adrenergic beta-2 Receptor Agonists; Aged; Albuterol; Bronchodilator Age | 2016 |
Modelling of in-vitro and in-vivo performance of aerosol emitted from different vibrating mesh nebulisers in non-invasive ventilation circuit.
Topics: Adult; Aerosols; Albuterol; Bronchodilator Agents; Drug Delivery Systems; Female; Humans; Male; Midd | 2017 |
Immediate salbutamol responsiveness does not predict long-term benefits of indacaterol in patients with chronic obstructive pulmonary disease.
Topics: Administration, Inhalation; Adrenergic beta-2 Receptor Agonists; Aged; Albuterol; Dose-Response Rela | 2017 |
Effect of pharmacotherapy on rate of decline of lung function in chronic obstructive pulmonary disease: results from the TORCH study.
Topics: Administration, Inhalation; Aged; Albuterol; Androstadienes; Body Mass Index; Bronchodilator Agents; | 2008 |
Effect of fluticasone propionate/salmeterol (250/50 microg) or salmeterol (50 microg) on COPD exacerbations.
Topics: Adult; Aged; Albuterol; Androstadienes; Bronchodilator Agents; Double-Blind Method; Drug Combination | 2008 |
Effect of fluticasone propionate/salmeterol (250/50 microg) or salmeterol (50 microg) on COPD exacerbations.
Topics: Adult; Aged; Albuterol; Androstadienes; Bronchodilator Agents; Double-Blind Method; Drug Combination | 2008 |
Effect of fluticasone propionate/salmeterol (250/50 microg) or salmeterol (50 microg) on COPD exacerbations.
Topics: Adult; Aged; Albuterol; Androstadienes; Bronchodilator Agents; Double-Blind Method; Drug Combination | 2008 |
Effect of fluticasone propionate/salmeterol (250/50 microg) or salmeterol (50 microg) on COPD exacerbations.
Topics: Adult; Aged; Albuterol; Androstadienes; Bronchodilator Agents; Double-Blind Method; Drug Combination | 2008 |
Effect of fluticasone propionate/salmeterol (250/50 microg) or salmeterol (50 microg) on COPD exacerbations.
Topics: Adult; Aged; Albuterol; Androstadienes; Bronchodilator Agents; Double-Blind Method; Drug Combination | 2008 |
Effect of fluticasone propionate/salmeterol (250/50 microg) or salmeterol (50 microg) on COPD exacerbations.
Topics: Adult; Aged; Albuterol; Androstadienes; Bronchodilator Agents; Double-Blind Method; Drug Combination | 2008 |
Effect of fluticasone propionate/salmeterol (250/50 microg) or salmeterol (50 microg) on COPD exacerbations.
Topics: Adult; Aged; Albuterol; Androstadienes; Bronchodilator Agents; Double-Blind Method; Drug Combination | 2008 |
Effect of fluticasone propionate/salmeterol (250/50 microg) or salmeterol (50 microg) on COPD exacerbations.
Topics: Adult; Aged; Albuterol; Androstadienes; Bronchodilator Agents; Double-Blind Method; Drug Combination | 2008 |
Effect of fluticasone propionate/salmeterol (250/50 microg) or salmeterol (50 microg) on COPD exacerbations.
Topics: Adult; Aged; Albuterol; Androstadienes; Bronchodilator Agents; Double-Blind Method; Drug Combination | 2008 |
Effect of fluticasone propionate/salmeterol (250/50 microg) or salmeterol (50 microg) on COPD exacerbations.
Topics: Adult; Aged; Albuterol; Androstadienes; Bronchodilator Agents; Double-Blind Method; Drug Combination | 2008 |
Effect of fluticasone propionate/salmeterol (250/50 microg) or salmeterol (50 microg) on COPD exacerbations.
Topics: Adult; Aged; Albuterol; Androstadienes; Bronchodilator Agents; Double-Blind Method; Drug Combination | 2008 |
Effect of fluticasone propionate/salmeterol (250/50 microg) or salmeterol (50 microg) on COPD exacerbations.
Topics: Adult; Aged; Albuterol; Androstadienes; Bronchodilator Agents; Double-Blind Method; Drug Combination | 2008 |
Effect of fluticasone propionate/salmeterol (250/50 microg) or salmeterol (50 microg) on COPD exacerbations.
Topics: Adult; Aged; Albuterol; Androstadienes; Bronchodilator Agents; Double-Blind Method; Drug Combination | 2008 |
Effect of fluticasone propionate/salmeterol (250/50 microg) or salmeterol (50 microg) on COPD exacerbations.
Topics: Adult; Aged; Albuterol; Androstadienes; Bronchodilator Agents; Double-Blind Method; Drug Combination | 2008 |
Effect of fluticasone propionate/salmeterol (250/50 microg) or salmeterol (50 microg) on COPD exacerbations.
Topics: Adult; Aged; Albuterol; Androstadienes; Bronchodilator Agents; Double-Blind Method; Drug Combination | 2008 |
Effect of fluticasone propionate/salmeterol (250/50 microg) or salmeterol (50 microg) on COPD exacerbations.
Topics: Adult; Aged; Albuterol; Androstadienes; Bronchodilator Agents; Double-Blind Method; Drug Combination | 2008 |
Cost effectiveness of therapy with combinations of long acting bronchodilators and inhaled steroids for treatment of COPD.
Topics: Administration, Inhalation; Albuterol; Androstadienes; Bronchodilator Agents; Cost-Benefit Analysis; | 2008 |
Comparison of levalbuterol and racemic albuterol in hospitalized patients with acute asthma or COPD: a 2-week, multicenter, randomized, open-label study.
Topics: Acute Disease; Aged; Albuterol; Asthma; Bronchodilator Agents; Female; Hospital Costs; Hospitalizati | 2008 |
A double-blind crossover study comparing the safety and efficacy of three weeks of Flu/Sal 250/50 bid plus albuterol 180 ug prn q4 hours to Flu/Sal 250/50 bid plus albuterol/Ipratropium bromide 2 puffs prn q4 hours in patients with chronic obstructive pul
Topics: Administration, Inhalation; Aged; Albuterol; Androstadienes; Bronchodilator Agents; Cross-Over Studi | 2008 |
Modulation of operational lung volumes with the use of salbutamol in COPD patients accomplishing upper limbs exercise tests.
Topics: Administration, Inhalation; Albuterol; Bronchodilator Agents; Double-Blind Method; Exercise Test; Fe | 2009 |
Arrhythmias in patients with chronic obstructive pulmonary disease (COPD): occurrence frequency and the effect of treatment with the inhaled long-acting beta2-agonists arformoterol and salmeterol.
Topics: Administration, Inhalation; Adrenergic beta-2 Receptor Agonists; Adrenergic beta-Agonists; Aged; Alb | 2008 |
Duration of salmeterol-induced bronchodilation in mechanically ventilated chronic obstructive pulmonary disease patients: a prospective clinical study.
Topics: Administration, Inhalation; Aged; Albuterol; Bronchodilator Agents; Humans; Male; Middle Aged; Nebul | 2008 |
Faster onset of action of formoterol versus salmeterol in patients with chronic obstructive pulmonary disease: a multicenter, randomized study.
Topics: Adrenergic beta-Agonists; Aged; Albuterol; Bronchodilator Agents; Ethanolamines; Exercise Test; Fema | 2009 |
[Combination of inhaled salmeterol/fluticasone and tiotropium in the treatment of chronic obstructive pulmonary disease: a randomised controlled trial].
Topics: Administration, Inhalation; Adrenergic beta-Agonists; Aged; Albuterol; Androstadienes; Cholinergic A | 2008 |
Arformoterol and salmeterol in the treatment of chronic obstructive pulmonary disease: a one year evaluation of safety and tolerance.
Topics: Albuterol; Arrhythmias, Cardiac; Bronchitis; Bronchodilator Agents; Ethanolamines; Female; Forced Ex | 2008 |
Exhaled nitric oxide, systemic inflammation, and the spirometric response to inhaled fluticasone propionate in severe chronic obstructive pulmonary disease: a prospective study.
Topics: Administration, Inhalation; Aged; Albuterol; Androstadienes; Biomarkers; Bronchodilator Agents; C-Re | 2008 |
Erdosteine enhances airway response to salbutamol in patients with mild-to-moderate COPD.
Topics: Adrenergic beta-Agonists; Aged; Albuterol; Bronchi; Drug Synergism; Expectorants; Female; Forced Exp | 2008 |
Anti-inflammatory effects of salmeterol/fluticasone, tiotropium/fluticasone or tiotropium in COPD.
Topics: Administration, Inhalation; Adult; Aged; Aged, 80 and over; Albuterol; Androstadienes; Biomarkers; C | 2009 |
Anti-inflammatory effects of salmeterol/fluticasone, tiotropium/fluticasone or tiotropium in COPD.
Topics: Administration, Inhalation; Adult; Aged; Aged, 80 and over; Albuterol; Androstadienes; Biomarkers; C | 2009 |
Anti-inflammatory effects of salmeterol/fluticasone, tiotropium/fluticasone or tiotropium in COPD.
Topics: Administration, Inhalation; Adult; Aged; Aged, 80 and over; Albuterol; Androstadienes; Biomarkers; C | 2009 |
Anti-inflammatory effects of salmeterol/fluticasone, tiotropium/fluticasone or tiotropium in COPD.
Topics: Administration, Inhalation; Adult; Aged; Aged, 80 and over; Albuterol; Androstadienes; Biomarkers; C | 2009 |
Effects of arformoterol twice daily, tiotropium once daily, and their combination in patients with COPD.
Topics: Administration, Inhalation; Aged; Albuterol; Bronchodilator Agents; Double-Blind Method; Drug Admini | 2009 |
Changes in lung function and health status in patients with COPD treated with tiotropium or salmeterol plus fluticasone.
Topics: Aged; Albuterol; Androstadienes; Bronchodilator Agents; Cross-Over Studies; Drug Therapy, Combinatio | 2009 |
Endogenous opioids modify dyspnoea during treadmill exercise in patients with COPD.
Topics: Adrenal Cortex Hormones; Adrenergic beta-Agonists; Albuterol; beta-Endorphin; Bronchodilator Agents; | 2009 |
Nebulized formoterol effect on bronchodilation and satisfaction in COPD patients compared to QID ipratropium/albuterol MDI.
Topics: Albuterol; Bronchodilator Agents; Cross-Over Studies; Drug Administration Schedule; Ethanolamines; F | 2009 |
Treatment of moderate chronic obstructive pulmonary disease (stable) with doxofylline compared with slow release theophylline--a multicentre trial.
Topics: Adult; Aged; Albuterol; Bronchodilator Agents; Female; Forced Expiratory Volume; Humans; Male; Middl | 2008 |
Study design considerations in a large COPD trial comparing effects of tiotropium with salmeterol on exacerbations.
Topics: Adrenergic beta-Agonists; Adult; Aged; Albuterol; Bronchodilator Agents; Cholinergic Antagonists; Do | 2009 |
Value of adding a polyvalent mechanical bacterial lysate to therapy of COPD patients under regular treatment with salmeterol/fluticasone.
Topics: Adjuvants, Immunologic; Aged; Albuterol; Androstadienes; Bacteria; Bronchodilator Agents; Cell Extra | 2009 |
Pneumonia risk in COPD patients receiving inhaled corticosteroids alone or in combination: TORCH study results.
Topics: Administration, Inhalation; Aged; Albuterol; Androstadienes; Anti-Inflammatory Agents; Bronchodilato | 2009 |
Pneumonia risk in COPD patients receiving inhaled corticosteroids alone or in combination: TORCH study results.
Topics: Administration, Inhalation; Aged; Albuterol; Androstadienes; Anti-Inflammatory Agents; Bronchodilato | 2009 |
Pneumonia risk in COPD patients receiving inhaled corticosteroids alone or in combination: TORCH study results.
Topics: Administration, Inhalation; Aged; Albuterol; Androstadienes; Anti-Inflammatory Agents; Bronchodilato | 2009 |
Pneumonia risk in COPD patients receiving inhaled corticosteroids alone or in combination: TORCH study results.
Topics: Administration, Inhalation; Aged; Albuterol; Androstadienes; Anti-Inflammatory Agents; Bronchodilato | 2009 |
Pneumonia risk in COPD patients receiving inhaled corticosteroids alone or in combination: TORCH study results.
Topics: Administration, Inhalation; Aged; Albuterol; Androstadienes; Anti-Inflammatory Agents; Bronchodilato | 2009 |
Pneumonia risk in COPD patients receiving inhaled corticosteroids alone or in combination: TORCH study results.
Topics: Administration, Inhalation; Aged; Albuterol; Androstadienes; Anti-Inflammatory Agents; Bronchodilato | 2009 |
Pneumonia risk in COPD patients receiving inhaled corticosteroids alone or in combination: TORCH study results.
Topics: Administration, Inhalation; Aged; Albuterol; Androstadienes; Anti-Inflammatory Agents; Bronchodilato | 2009 |
Pneumonia risk in COPD patients receiving inhaled corticosteroids alone or in combination: TORCH study results.
Topics: Administration, Inhalation; Aged; Albuterol; Androstadienes; Anti-Inflammatory Agents; Bronchodilato | 2009 |
Pneumonia risk in COPD patients receiving inhaled corticosteroids alone or in combination: TORCH study results.
Topics: Administration, Inhalation; Aged; Albuterol; Androstadienes; Anti-Inflammatory Agents; Bronchodilato | 2009 |
Pneumonia risk in COPD patients receiving inhaled corticosteroids alone or in combination: TORCH study results.
Topics: Administration, Inhalation; Aged; Albuterol; Androstadienes; Anti-Inflammatory Agents; Bronchodilato | 2009 |
Pneumonia risk in COPD patients receiving inhaled corticosteroids alone or in combination: TORCH study results.
Topics: Administration, Inhalation; Aged; Albuterol; Androstadienes; Anti-Inflammatory Agents; Bronchodilato | 2009 |
Pneumonia risk in COPD patients receiving inhaled corticosteroids alone or in combination: TORCH study results.
Topics: Administration, Inhalation; Aged; Albuterol; Androstadienes; Anti-Inflammatory Agents; Bronchodilato | 2009 |
Pneumonia risk in COPD patients receiving inhaled corticosteroids alone or in combination: TORCH study results.
Topics: Administration, Inhalation; Aged; Albuterol; Androstadienes; Anti-Inflammatory Agents; Bronchodilato | 2009 |
Pneumonia risk in COPD patients receiving inhaled corticosteroids alone or in combination: TORCH study results.
Topics: Administration, Inhalation; Aged; Albuterol; Androstadienes; Anti-Inflammatory Agents; Bronchodilato | 2009 |
Pneumonia risk in COPD patients receiving inhaled corticosteroids alone or in combination: TORCH study results.
Topics: Administration, Inhalation; Aged; Albuterol; Androstadienes; Anti-Inflammatory Agents; Bronchodilato | 2009 |
Pneumonia risk in COPD patients receiving inhaled corticosteroids alone or in combination: TORCH study results.
Topics: Administration, Inhalation; Aged; Albuterol; Androstadienes; Anti-Inflammatory Agents; Bronchodilato | 2009 |
Comparison of adherence and efficacy between inhaled salmeterol and transdermal tulobuterol patch in elderly patients with chronic obstructive pulmonary disorder.
Topics: Administration, Cutaneous; Administration, Inhalation; Aged; Albuterol; Bronchodilator Agents; Cross | 2009 |
Efficacy and safety of nebulized formoterol as add-on therapy in COPD patients receiving maintenance tiotropium bromide: Results from a 6-week, randomized, placebo-controlled, clinical trial.
Topics: Adrenal Cortex Hormones; Adrenergic beta-Agonists; Adult; Aged; Albuterol; Area Under Curve; Broncho | 2009 |
Efficacy of salmeterol/fluticasone propionate by GOLD stage of chronic obstructive pulmonary disease: analysis from the randomised, placebo-controlled TORCH study.
Topics: Aged; Albuterol; Androstadienes; Bronchodilator Agents; Disease Progression; Double-Blind Method; Dr | 2009 |
Prevalence and progression of osteoporosis in patients with COPD: results from the TOwards a Revolution in COPD Health study.
Topics: Aged; Albuterol; Androstadienes; Bone Density; Bone Diseases, Metabolic; Bronchodilator Agents; Dise | 2009 |
Prevalence and progression of osteoporosis in patients with COPD: results from the TOwards a Revolution in COPD Health study.
Topics: Aged; Albuterol; Androstadienes; Bone Density; Bone Diseases, Metabolic; Bronchodilator Agents; Dise | 2009 |
Prevalence and progression of osteoporosis in patients with COPD: results from the TOwards a Revolution in COPD Health study.
Topics: Aged; Albuterol; Androstadienes; Bone Density; Bone Diseases, Metabolic; Bronchodilator Agents; Dise | 2009 |
Prevalence and progression of osteoporosis in patients with COPD: results from the TOwards a Revolution in COPD Health study.
Topics: Aged; Albuterol; Androstadienes; Bone Density; Bone Diseases, Metabolic; Bronchodilator Agents; Dise | 2009 |
Prevalence and progression of osteoporosis in patients with COPD: results from the TOwards a Revolution in COPD Health study.
Topics: Aged; Albuterol; Androstadienes; Bone Density; Bone Diseases, Metabolic; Bronchodilator Agents; Dise | 2009 |
Prevalence and progression of osteoporosis in patients with COPD: results from the TOwards a Revolution in COPD Health study.
Topics: Aged; Albuterol; Androstadienes; Bone Density; Bone Diseases, Metabolic; Bronchodilator Agents; Dise | 2009 |
Prevalence and progression of osteoporosis in patients with COPD: results from the TOwards a Revolution in COPD Health study.
Topics: Aged; Albuterol; Androstadienes; Bone Density; Bone Diseases, Metabolic; Bronchodilator Agents; Dise | 2009 |
Prevalence and progression of osteoporosis in patients with COPD: results from the TOwards a Revolution in COPD Health study.
Topics: Aged; Albuterol; Androstadienes; Bone Density; Bone Diseases, Metabolic; Bronchodilator Agents; Dise | 2009 |
Prevalence and progression of osteoporosis in patients with COPD: results from the TOwards a Revolution in COPD Health study.
Topics: Aged; Albuterol; Androstadienes; Bone Density; Bone Diseases, Metabolic; Bronchodilator Agents; Dise | 2009 |
Prevalence and progression of osteoporosis in patients with COPD: results from the TOwards a Revolution in COPD Health study.
Topics: Aged; Albuterol; Androstadienes; Bone Density; Bone Diseases, Metabolic; Bronchodilator Agents; Dise | 2009 |
Prevalence and progression of osteoporosis in patients with COPD: results from the TOwards a Revolution in COPD Health study.
Topics: Aged; Albuterol; Androstadienes; Bone Density; Bone Diseases, Metabolic; Bronchodilator Agents; Dise | 2009 |
Prevalence and progression of osteoporosis in patients with COPD: results from the TOwards a Revolution in COPD Health study.
Topics: Aged; Albuterol; Androstadienes; Bone Density; Bone Diseases, Metabolic; Bronchodilator Agents; Dise | 2009 |
Prevalence and progression of osteoporosis in patients with COPD: results from the TOwards a Revolution in COPD Health study.
Topics: Aged; Albuterol; Androstadienes; Bone Density; Bone Diseases, Metabolic; Bronchodilator Agents; Dise | 2009 |
Prevalence and progression of osteoporosis in patients with COPD: results from the TOwards a Revolution in COPD Health study.
Topics: Aged; Albuterol; Androstadienes; Bone Density; Bone Diseases, Metabolic; Bronchodilator Agents; Dise | 2009 |
Prevalence and progression of osteoporosis in patients with COPD: results from the TOwards a Revolution in COPD Health study.
Topics: Aged; Albuterol; Androstadienes; Bone Density; Bone Diseases, Metabolic; Bronchodilator Agents; Dise | 2009 |
Prevalence and progression of osteoporosis in patients with COPD: results from the TOwards a Revolution in COPD Health study.
Topics: Aged; Albuterol; Androstadienes; Bone Density; Bone Diseases, Metabolic; Bronchodilator Agents; Dise | 2009 |
Prevalence and progression of osteoporosis in patients with COPD: results from the TOwards a Revolution in COPD Health study.
Topics: Aged; Albuterol; Androstadienes; Bone Density; Bone Diseases, Metabolic; Bronchodilator Agents; Dise | 2009 |
Prevalence and progression of osteoporosis in patients with COPD: results from the TOwards a Revolution in COPD Health study.
Topics: Aged; Albuterol; Androstadienes; Bone Density; Bone Diseases, Metabolic; Bronchodilator Agents; Dise | 2009 |
Prevalence and progression of osteoporosis in patients with COPD: results from the TOwards a Revolution in COPD Health study.
Topics: Aged; Albuterol; Androstadienes; Bone Density; Bone Diseases, Metabolic; Bronchodilator Agents; Dise | 2009 |
Prevalence and progression of osteoporosis in patients with COPD: results from the TOwards a Revolution in COPD Health study.
Topics: Aged; Albuterol; Androstadienes; Bone Density; Bone Diseases, Metabolic; Bronchodilator Agents; Dise | 2009 |
Prevalence and progression of osteoporosis in patients with COPD: results from the TOwards a Revolution in COPD Health study.
Topics: Aged; Albuterol; Androstadienes; Bone Density; Bone Diseases, Metabolic; Bronchodilator Agents; Dise | 2009 |
Prevalence and progression of osteoporosis in patients with COPD: results from the TOwards a Revolution in COPD Health study.
Topics: Aged; Albuterol; Androstadienes; Bone Density; Bone Diseases, Metabolic; Bronchodilator Agents; Dise | 2009 |
Prevalence and progression of osteoporosis in patients with COPD: results from the TOwards a Revolution in COPD Health study.
Topics: Aged; Albuterol; Androstadienes; Bone Density; Bone Diseases, Metabolic; Bronchodilator Agents; Dise | 2009 |
Prevalence and progression of osteoporosis in patients with COPD: results from the TOwards a Revolution in COPD Health study.
Topics: Aged; Albuterol; Androstadienes; Bone Density; Bone Diseases, Metabolic; Bronchodilator Agents; Dise | 2009 |
Prevalence and progression of osteoporosis in patients with COPD: results from the TOwards a Revolution in COPD Health study.
Topics: Aged; Albuterol; Androstadienes; Bone Density; Bone Diseases, Metabolic; Bronchodilator Agents; Dise | 2009 |
Seretide withdrawal increases airway inflammation in moderate COPD patients.
Topics: Aged; Airway Obstruction; Albuterol; Androstadienes; Drug Combinations; Fluticasone-Salmeterol Drug | 2009 |
Additional effects of pranlukast in salmeterol/fluticasone combination therapy for the asthmatic distal airway in a randomized crossover study.
Topics: Aged; Albuterol; Androstadienes; Anti-Asthmatic Agents; Anti-Inflammatory Agents; Bronchodilator Age | 2009 |
Effects of salmeterol on sleeping oxygen saturation in chronic obstructive pulmonary disease.
Topics: Administration, Inhalation; Adrenergic beta-Agonists; Aged; Albuterol; Bronchodilator Agents; Cross- | 2010 |
Adherence to inhaled therapy, mortality and hospital admission in COPD.
Topics: Administration, Inhalation; Adult; Aged; Aged, 80 and over; Albuterol; Androstadienes; Bronchodilato | 2009 |
Roflumilast in moderate-to-severe chronic obstructive pulmonary disease treated with longacting bronchodilators: two randomised clinical trials.
Topics: Administration, Inhalation; Administration, Oral; Aged; Albuterol; Aminopyridines; Analysis of Varia | 2009 |
Roflumilast in moderate-to-severe chronic obstructive pulmonary disease treated with longacting bronchodilators: two randomised clinical trials.
Topics: Administration, Inhalation; Administration, Oral; Aged; Albuterol; Aminopyridines; Analysis of Varia | 2009 |
Roflumilast in moderate-to-severe chronic obstructive pulmonary disease treated with longacting bronchodilators: two randomised clinical trials.
Topics: Administration, Inhalation; Administration, Oral; Aged; Albuterol; Aminopyridines; Analysis of Varia | 2009 |
Roflumilast in moderate-to-severe chronic obstructive pulmonary disease treated with longacting bronchodilators: two randomised clinical trials.
Topics: Administration, Inhalation; Administration, Oral; Aged; Albuterol; Aminopyridines; Analysis of Varia | 2009 |
Roflumilast in moderate-to-severe chronic obstructive pulmonary disease treated with longacting bronchodilators: two randomised clinical trials.
Topics: Administration, Inhalation; Administration, Oral; Aged; Albuterol; Aminopyridines; Analysis of Varia | 2009 |
Roflumilast in moderate-to-severe chronic obstructive pulmonary disease treated with longacting bronchodilators: two randomised clinical trials.
Topics: Administration, Inhalation; Administration, Oral; Aged; Albuterol; Aminopyridines; Analysis of Varia | 2009 |
Roflumilast in moderate-to-severe chronic obstructive pulmonary disease treated with longacting bronchodilators: two randomised clinical trials.
Topics: Administration, Inhalation; Administration, Oral; Aged; Albuterol; Aminopyridines; Analysis of Varia | 2009 |
Roflumilast in moderate-to-severe chronic obstructive pulmonary disease treated with longacting bronchodilators: two randomised clinical trials.
Topics: Administration, Inhalation; Administration, Oral; Aged; Albuterol; Aminopyridines; Analysis of Varia | 2009 |
Roflumilast in moderate-to-severe chronic obstructive pulmonary disease treated with longacting bronchodilators: two randomised clinical trials.
Topics: Administration, Inhalation; Administration, Oral; Aged; Albuterol; Aminopyridines; Analysis of Varia | 2009 |
Is treatment with ICS and LABA cost-effective for COPD? Multinational economic analysis of the TORCH study.
Topics: Administration, Inhalation; Adrenal Cortex Hormones; Aged; Albuterol; Androstadienes; Bronchodilator | 2010 |
Effect on lung function and morning activities of budesonide/formoterol versus salmeterol/fluticasone in patients with COPD.
Topics: Activities of Daily Living; Adult; Aged; Aged, 80 and over; Albuterol; Androstadienes; Anti-Inflamma | 2009 |
Therapeutic conversion of the combination of ipratropium and albuterol to tiotropium in patients with chronic obstructive pulmonary disease.
Topics: Aged; Albuterol; Bronchodilator Agents; Double-Blind Method; Drug Therapy, Combination; Female; Forc | 2009 |
Effect of fluticasone with and without salmeterol on pulmonary outcomes in chronic obstructive pulmonary disease: a randomized trial.
Topics: Administration, Inhalation; Aged; Albuterol; Androstadienes; Bronchi; Bronchodilator Agents; Cell Co | 2009 |
Effect of fluticasone propionate/salmeterol (250/50) on COPD exacerbations and impact on patient outcomes.
Topics: Administration, Inhalation; Aged; Albuterol; Androstadienes; Bronchodilator Agents; Dose-Response Re | 2009 |
The bioavailability and airway clearance of the steroid component of budesonide/formoterol and salmeterol/fluticasone after inhaled administration in patients with COPD and healthy subjects: a randomized controlled trial.
Topics: Administration, Inhalation; Adrenal Cortex Hormones; Adrenergic beta-2 Receptor Agonists; Adrenergic | 2009 |
The bioavailability and airway clearance of the steroid component of budesonide/formoterol and salmeterol/fluticasone after inhaled administration in patients with COPD and healthy subjects: a randomized controlled trial.
Topics: Administration, Inhalation; Adrenal Cortex Hormones; Adrenergic beta-2 Receptor Agonists; Adrenergic | 2009 |
The bioavailability and airway clearance of the steroid component of budesonide/formoterol and salmeterol/fluticasone after inhaled administration in patients with COPD and healthy subjects: a randomized controlled trial.
Topics: Administration, Inhalation; Adrenal Cortex Hormones; Adrenergic beta-2 Receptor Agonists; Adrenergic | 2009 |
The bioavailability and airway clearance of the steroid component of budesonide/formoterol and salmeterol/fluticasone after inhaled administration in patients with COPD and healthy subjects: a randomized controlled trial.
Topics: Administration, Inhalation; Adrenal Cortex Hormones; Adrenergic beta-2 Receptor Agonists; Adrenergic | 2009 |
Methods for therapeutic trials in COPD: lessons from the TORCH trial.
Topics: Administration, Inhalation; Albuterol; Androstadienes; Bronchodilator Agents; Drug Therapy, Combinat | 2009 |
Combining triple therapy and pulmonary rehabilitation in patients with advanced COPD: a pilot study.
Topics: Aged; Albuterol; Androstadienes; Bronchodilator Agents; Combined Modality Therapy; Drug Administrati | 2010 |
Does low-dose seretide reverse chronic obstructive pulmonary disease and are the benefits sustained over time? An open-label Swedish crossover cohort study between 1999 and 2005.
Topics: Albuterol; Androstadienes; Bronchodilator Agents; Cohort Studies; Cross-Over Studies; Drug Combinati | 2010 |
Efficacy and safety of ipratropium bromide/albuterol delivered via Respimat inhaler versus MDI.
Topics: Administration, Inhalation; Albuterol; Albuterol, Ipratropium Drug Combination; Bronchodilator Agent | 2010 |
Combining tiotropium and salmeterol in COPD: Effects on airflow obstruction and symptoms.
Topics: Adult; Airway Obstruction; Albuterol; Bronchodilator Agents; Cross-Over Studies; Double-Blind Method | 2010 |
Accuracy of death certificates in COPD: analysis from the TORCH trial.
Topics: Administration, Inhalation; Aged; Albuterol; Androstadienes; Bronchodilator Agents; Cause of Death; | 2010 |
Reported pneumonia in patients with COPD: findings from the INSPIRE study.
Topics: Administration, Inhalation; Adrenal Cortex Hormones; Aged; Albuterol; Androstadienes; Bronchodilator | 2011 |
Reversibility of inspiratory lung function parameters after short-term bronchodilators in COPD.
Topics: Adult; Aged; Aged, 80 and over; Albuterol; Analysis of Variance; Bronchodilator Agents; Cross-Over S | 2010 |
Bronchodilators accelerate the dynamics of muscle O2 delivery and utilisation during exercise in COPD.
Topics: Adrenergic beta-Agonists; Aged; Albuterol; Brazil; Bronchodilator Agents; Cholinergic Antagonists; C | 2010 |
Cardiovascular events in patients with COPD: TORCH study results.
Topics: Adrenergic beta-Agonists; Adult; Aged; Aged, 80 and over; Albuterol; Androstadienes; Bronchodilator | 2010 |
Once-daily indacaterol versus twice-daily salmeterol for COPD: a placebo-controlled comparison.
Topics: Adrenal Cortex Hormones; Aged; Albuterol; Bronchodilator Agents; Drug Administration Schedule; Dyspn | 2011 |
Sex differences in mortality and clinical expressions of patients with chronic obstructive pulmonary disease. The TORCH experience.
Topics: Adult; Aged; Aged, 80 and over; Albuterol; Androstadienes; Bronchodilator Agents; Cause of Death; Ch | 2011 |
Salmeterol/fluticasone treatment reduces circulating C-reactive protein level in patients with stable chronic obstructive pulmonary disease.
Topics: Albuterol; Androstadienes; C-Reactive Protein; Female; Fluticasone; Humans; Male; Middle Aged; Pulmo | 2010 |
Onset of action of indacaterol in patients with COPD: comparison with salbutamol and salmeterol-fluticasone.
Topics: Adult; Aged; Albuterol; Androstadienes; Bronchodilator Agents; Cross-Over Studies; Female; Fluticaso | 2010 |
The effect of inhaled salmeterol, alone and in combination with fluticasone propionate, on management of COPD patients.
Topics: Administration, Inhalation; Adrenergic beta-2 Receptor Agonists; Aged; Albuterol; Androstadienes; Dr | 2010 |
Effects of adding salmeterol/fluticasone propionate to tiotropium on airway dimensions in patients with chronic obstructive pulmonary disease.
Topics: Aged; Aged, 80 and over; Albuterol; Androstadienes; Bronchi; Bronchodilator Agents; Drug Combination | 2011 |
Beclomethasone/formoterol in the management of COPD: a randomised controlled trial.
Topics: Albuterol; Beclomethasone; Bronchodilator Agents; Double-Blind Method; Drug Combinations; Ethanolami | 2010 |
Acute bronchodilator responsiveness and health outcomes in COPD patients in the UPLIFT trial.
Topics: Aged; Albuterol; Albuterol, Ipratropium Drug Combination; Bronchodilator Agents; Drug Administration | 2011 |
Indacaterol once-daily provides superior efficacy to salmeterol twice-daily in COPD: a 12-week study.
Topics: Albuterol; Bronchodilator Agents; Dose-Response Relationship, Drug; Double-Blind Method; Drug Admini | 2011 |
Profiling the effects of indacaterol on dyspnoea and health status in patients with COPD.
Topics: Adrenergic beta-2 Receptor Agonists; Aged; Albuterol; Double-Blind Method; Dyspnea; Ethanolamines; F | 2011 |
Profiling the effects of indacaterol on dyspnoea and health status in patients with COPD.
Topics: Adrenergic beta-2 Receptor Agonists; Aged; Albuterol; Double-Blind Method; Dyspnea; Ethanolamines; F | 2011 |
Profiling the effects of indacaterol on dyspnoea and health status in patients with COPD.
Topics: Adrenergic beta-2 Receptor Agonists; Aged; Albuterol; Double-Blind Method; Dyspnea; Ethanolamines; F | 2011 |
Profiling the effects of indacaterol on dyspnoea and health status in patients with COPD.
Topics: Adrenergic beta-2 Receptor Agonists; Aged; Albuterol; Double-Blind Method; Dyspnea; Ethanolamines; F | 2011 |
Profiling the effects of indacaterol on dyspnoea and health status in patients with COPD.
Topics: Adrenergic beta-2 Receptor Agonists; Aged; Albuterol; Double-Blind Method; Dyspnea; Ethanolamines; F | 2011 |
Profiling the effects of indacaterol on dyspnoea and health status in patients with COPD.
Topics: Adrenergic beta-2 Receptor Agonists; Aged; Albuterol; Double-Blind Method; Dyspnea; Ethanolamines; F | 2011 |
Profiling the effects of indacaterol on dyspnoea and health status in patients with COPD.
Topics: Adrenergic beta-2 Receptor Agonists; Aged; Albuterol; Double-Blind Method; Dyspnea; Ethanolamines; F | 2011 |
Profiling the effects of indacaterol on dyspnoea and health status in patients with COPD.
Topics: Adrenergic beta-2 Receptor Agonists; Aged; Albuterol; Double-Blind Method; Dyspnea; Ethanolamines; F | 2011 |
Profiling the effects of indacaterol on dyspnoea and health status in patients with COPD.
Topics: Adrenergic beta-2 Receptor Agonists; Aged; Albuterol; Double-Blind Method; Dyspnea; Ethanolamines; F | 2011 |
Tiotropium versus salmeterol for the prevention of exacerbations of COPD.
Topics: Administration, Inhalation; Adrenergic beta-2 Receptor Agonists; Aged; Albuterol; Bronchodilator Age | 2011 |
Tiotropium versus salmeterol for the prevention of exacerbations of COPD.
Topics: Administration, Inhalation; Adrenergic beta-2 Receptor Agonists; Aged; Albuterol; Bronchodilator Age | 2011 |
Tiotropium versus salmeterol for the prevention of exacerbations of COPD.
Topics: Administration, Inhalation; Adrenergic beta-2 Receptor Agonists; Aged; Albuterol; Bronchodilator Age | 2011 |
Tiotropium versus salmeterol for the prevention of exacerbations of COPD.
Topics: Administration, Inhalation; Adrenergic beta-2 Receptor Agonists; Aged; Albuterol; Bronchodilator Age | 2011 |
Tiotropium versus salmeterol for the prevention of exacerbations of COPD.
Topics: Administration, Inhalation; Adrenergic beta-2 Receptor Agonists; Aged; Albuterol; Bronchodilator Age | 2011 |
Tiotropium versus salmeterol for the prevention of exacerbations of COPD.
Topics: Administration, Inhalation; Adrenergic beta-2 Receptor Agonists; Aged; Albuterol; Bronchodilator Age | 2011 |
Tiotropium versus salmeterol for the prevention of exacerbations of COPD.
Topics: Administration, Inhalation; Adrenergic beta-2 Receptor Agonists; Aged; Albuterol; Bronchodilator Age | 2011 |
Tiotropium versus salmeterol for the prevention of exacerbations of COPD.
Topics: Administration, Inhalation; Adrenergic beta-2 Receptor Agonists; Aged; Albuterol; Bronchodilator Age | 2011 |
Tiotropium versus salmeterol for the prevention of exacerbations of COPD.
Topics: Administration, Inhalation; Adrenergic beta-2 Receptor Agonists; Aged; Albuterol; Bronchodilator Age | 2011 |
Improved respiratory system conductance following bronchodilator predicts reduced exertional dyspnoea.
Topics: Aged; Aged, 80 and over; Albuterol; Bronchodilator Agents; Cross-Over Studies; Double-Blind Method; | 2011 |
Health status in the TORCH study of COPD: treatment efficacy and other determinants of change.
Topics: Adrenergic beta-2 Receptor Agonists; Age Factors; Aged; Albuterol; Androstadienes; Asia; Bronchodila | 2011 |
Bronchodilation improves endurance but not muscular efficiency in chronic obstructive pulmonary disease.
Topics: Aged; Albuterol; Bronchodilator Agents; Cross-Over Studies; Double-Blind Method; Energy Metabolism; | 2011 |
Effect of fluticasone propionate/salmeterol on arterial stiffness in patients with COPD.
Topics: Albuterol; Androstadienes; Arteries; Blood Flow Velocity; Cardiovascular Diseases; Double-Blind Meth | 2011 |
Application of latent growth and growth mixture modeling to identify and characterize differential responders to treatment for COPD.
Topics: Administration, Inhalation; Albuterol; Bronchodilator Agents; Delayed-Action Preparations; Dose-Resp | 2011 |
Predictors of accuracy of diagnosis of chronic obstructive pulmonary disease in general practice.
Topics: Adrenergic beta-2 Receptor Agonists; Adult; Aged; Albuterol; Asthma; Bronchodilator Agents; Comorbid | 2011 |
Dose-response curve to salbutamol during acute and chronic treatment with formoterol in COPD.
Topics: Administration, Inhalation; Aged; Albuterol; Biological Availability; Bronchodilator Agents; Dose-Re | 2011 |
Comparison of tiotropium plus fluticasone propionate/salmeterol with tiotropium in COPD: a randomized controlled study.
Topics: Acute Disease; Aged; Albuterol; Algorithms; Androstadienes; Bronchodilator Agents; Drug Combinations | 2012 |
Relationship between the anti-inflammatory properties of salmeterol/fluticasone and the expression of CD4⁺CD25⁺Foxp3⁺ regulatory T cells in COPD.
Topics: Adult; Aged; Albuterol; Androstadienes; Anti-Inflammatory Agents; Bronchodilator Agents; CD4 Antigen | 2011 |
Benefits of adding fluticasone propionate/salmeterol to tiotropium in moderate to severe COPD.
Topics: Albuterol; Androstadienes; Bronchodilator Agents; Double-Blind Method; Drug Combinations; Drug Thera | 2012 |
Benefits of adding fluticasone propionate/salmeterol to tiotropium in moderate to severe COPD.
Topics: Albuterol; Androstadienes; Bronchodilator Agents; Double-Blind Method; Drug Combinations; Drug Thera | 2012 |
Benefits of adding fluticasone propionate/salmeterol to tiotropium in moderate to severe COPD.
Topics: Albuterol; Androstadienes; Bronchodilator Agents; Double-Blind Method; Drug Combinations; Drug Thera | 2012 |
Benefits of adding fluticasone propionate/salmeterol to tiotropium in moderate to severe COPD.
Topics: Albuterol; Androstadienes; Bronchodilator Agents; Double-Blind Method; Drug Combinations; Drug Thera | 2012 |
Benefits of adding fluticasone propionate/salmeterol to tiotropium in moderate to severe COPD.
Topics: Albuterol; Androstadienes; Bronchodilator Agents; Double-Blind Method; Drug Combinations; Drug Thera | 2012 |
Benefits of adding fluticasone propionate/salmeterol to tiotropium in moderate to severe COPD.
Topics: Albuterol; Androstadienes; Bronchodilator Agents; Double-Blind Method; Drug Combinations; Drug Thera | 2012 |
Benefits of adding fluticasone propionate/salmeterol to tiotropium in moderate to severe COPD.
Topics: Albuterol; Androstadienes; Bronchodilator Agents; Double-Blind Method; Drug Combinations; Drug Thera | 2012 |
Benefits of adding fluticasone propionate/salmeterol to tiotropium in moderate to severe COPD.
Topics: Albuterol; Androstadienes; Bronchodilator Agents; Double-Blind Method; Drug Combinations; Drug Thera | 2012 |
Benefits of adding fluticasone propionate/salmeterol to tiotropium in moderate to severe COPD.
Topics: Albuterol; Androstadienes; Bronchodilator Agents; Double-Blind Method; Drug Combinations; Drug Thera | 2012 |
Benefits of adding fluticasone propionate/salmeterol to tiotropium in moderate to severe COPD.
Topics: Albuterol; Androstadienes; Bronchodilator Agents; Double-Blind Method; Drug Combinations; Drug Thera | 2012 |
Benefits of adding fluticasone propionate/salmeterol to tiotropium in moderate to severe COPD.
Topics: Albuterol; Androstadienes; Bronchodilator Agents; Double-Blind Method; Drug Combinations; Drug Thera | 2012 |
Benefits of adding fluticasone propionate/salmeterol to tiotropium in moderate to severe COPD.
Topics: Albuterol; Androstadienes; Bronchodilator Agents; Double-Blind Method; Drug Combinations; Drug Thera | 2012 |
Benefits of adding fluticasone propionate/salmeterol to tiotropium in moderate to severe COPD.
Topics: Albuterol; Androstadienes; Bronchodilator Agents; Double-Blind Method; Drug Combinations; Drug Thera | 2012 |
Benefits of adding fluticasone propionate/salmeterol to tiotropium in moderate to severe COPD.
Topics: Albuterol; Androstadienes; Bronchodilator Agents; Double-Blind Method; Drug Combinations; Drug Thera | 2012 |
Benefits of adding fluticasone propionate/salmeterol to tiotropium in moderate to severe COPD.
Topics: Albuterol; Androstadienes; Bronchodilator Agents; Double-Blind Method; Drug Combinations; Drug Thera | 2012 |
Benefits of adding fluticasone propionate/salmeterol to tiotropium in moderate to severe COPD.
Topics: Albuterol; Androstadienes; Bronchodilator Agents; Double-Blind Method; Drug Combinations; Drug Thera | 2012 |
Benefits of adding fluticasone propionate/salmeterol to tiotropium in moderate to severe COPD.
Topics: Albuterol; Androstadienes; Bronchodilator Agents; Double-Blind Method; Drug Combinations; Drug Thera | 2012 |
Benefits of adding fluticasone propionate/salmeterol to tiotropium in moderate to severe COPD.
Topics: Albuterol; Androstadienes; Bronchodilator Agents; Double-Blind Method; Drug Combinations; Drug Thera | 2012 |
Benefits of adding fluticasone propionate/salmeterol to tiotropium in moderate to severe COPD.
Topics: Albuterol; Androstadienes; Bronchodilator Agents; Double-Blind Method; Drug Combinations; Drug Thera | 2012 |
Benefits of adding fluticasone propionate/salmeterol to tiotropium in moderate to severe COPD.
Topics: Albuterol; Androstadienes; Bronchodilator Agents; Double-Blind Method; Drug Combinations; Drug Thera | 2012 |
Benefits of adding fluticasone propionate/salmeterol to tiotropium in moderate to severe COPD.
Topics: Albuterol; Androstadienes; Bronchodilator Agents; Double-Blind Method; Drug Combinations; Drug Thera | 2012 |
Benefits of adding fluticasone propionate/salmeterol to tiotropium in moderate to severe COPD.
Topics: Albuterol; Androstadienes; Bronchodilator Agents; Double-Blind Method; Drug Combinations; Drug Thera | 2012 |
Benefits of adding fluticasone propionate/salmeterol to tiotropium in moderate to severe COPD.
Topics: Albuterol; Androstadienes; Bronchodilator Agents; Double-Blind Method; Drug Combinations; Drug Thera | 2012 |
Benefits of adding fluticasone propionate/salmeterol to tiotropium in moderate to severe COPD.
Topics: Albuterol; Androstadienes; Bronchodilator Agents; Double-Blind Method; Drug Combinations; Drug Thera | 2012 |
Benefits of adding fluticasone propionate/salmeterol to tiotropium in moderate to severe COPD.
Topics: Albuterol; Androstadienes; Bronchodilator Agents; Double-Blind Method; Drug Combinations; Drug Thera | 2012 |
Benefits of adding fluticasone propionate/salmeterol to tiotropium in moderate to severe COPD.
Topics: Albuterol; Androstadienes; Bronchodilator Agents; Double-Blind Method; Drug Combinations; Drug Thera | 2012 |
Benefits of adding fluticasone propionate/salmeterol to tiotropium in moderate to severe COPD.
Topics: Albuterol; Androstadienes; Bronchodilator Agents; Double-Blind Method; Drug Combinations; Drug Thera | 2012 |
Benefits of adding fluticasone propionate/salmeterol to tiotropium in moderate to severe COPD.
Topics: Albuterol; Androstadienes; Bronchodilator Agents; Double-Blind Method; Drug Combinations; Drug Thera | 2012 |
Benefits of adding fluticasone propionate/salmeterol to tiotropium in moderate to severe COPD.
Topics: Albuterol; Androstadienes; Bronchodilator Agents; Double-Blind Method; Drug Combinations; Drug Thera | 2012 |
Benefits of adding fluticasone propionate/salmeterol to tiotropium in moderate to severe COPD.
Topics: Albuterol; Androstadienes; Bronchodilator Agents; Double-Blind Method; Drug Combinations; Drug Thera | 2012 |
Benefits of adding fluticasone propionate/salmeterol to tiotropium in moderate to severe COPD.
Topics: Albuterol; Androstadienes; Bronchodilator Agents; Double-Blind Method; Drug Combinations; Drug Thera | 2012 |
Benefits of adding fluticasone propionate/salmeterol to tiotropium in moderate to severe COPD.
Topics: Albuterol; Androstadienes; Bronchodilator Agents; Double-Blind Method; Drug Combinations; Drug Thera | 2012 |
Benefits of adding fluticasone propionate/salmeterol to tiotropium in moderate to severe COPD.
Topics: Albuterol; Androstadienes; Bronchodilator Agents; Double-Blind Method; Drug Combinations; Drug Thera | 2012 |
Benefits of adding fluticasone propionate/salmeterol to tiotropium in moderate to severe COPD.
Topics: Albuterol; Androstadienes; Bronchodilator Agents; Double-Blind Method; Drug Combinations; Drug Thera | 2012 |
Benefits of adding fluticasone propionate/salmeterol to tiotropium in moderate to severe COPD.
Topics: Albuterol; Androstadienes; Bronchodilator Agents; Double-Blind Method; Drug Combinations; Drug Thera | 2012 |
Benefits of adding fluticasone propionate/salmeterol to tiotropium in moderate to severe COPD.
Topics: Albuterol; Androstadienes; Bronchodilator Agents; Double-Blind Method; Drug Combinations; Drug Thera | 2012 |
Effects of beclomethasone/formoterol fixed combination on lung hyperinflation and dyspnea in COPD patients.
Topics: Adrenergic beta-2 Receptor Agonists; Aged; Albuterol; Androstadienes; Beclomethasone; Bronchodilator | 2011 |
[Evidence of pharmacotherapy in COPD--key findings from recently-conducted randomized clinical studies].
Topics: Adrenergic beta-2 Receptor Agonists; Aged; Albuterol; Androstadienes; Bronchodilator Agents; Drug Th | 2011 |
An oral inhibitor of p38 MAP kinase reduces plasma fibrinogen in patients with chronic obstructive pulmonary disease.
Topics: Administration, Oral; Aged; Albuterol; Androstadienes; Cyclopropanes; Double-Blind Method; Drug Comb | 2012 |
Functional imaging using computer methods to compare the effect of salbutamol and ipratropium bromide in patient-specific airway models of COPD.
Topics: Aged; Albuterol; Bronchodilator Agents; Cross-Over Studies; Female; Humans; Hydrodynamics; Ipratropi | 2011 |
Efficacy and tolerability of indacaterol 75 μg once daily in patients aged ≥40 years with chronic obstructive pulmonary disease: results from 2 double-blind, placebo-controlled 12-week studies.
Topics: Adrenergic beta-2 Receptor Agonists; Adult; Aged; Albuterol; Analysis of Variance; Bronchodilator Ag | 2011 |
Efficacy and tolerability of indacaterol 75 μg once daily in patients aged ≥40 years with chronic obstructive pulmonary disease: results from 2 double-blind, placebo-controlled 12-week studies.
Topics: Adrenergic beta-2 Receptor Agonists; Adult; Aged; Albuterol; Analysis of Variance; Bronchodilator Ag | 2011 |
Efficacy and tolerability of indacaterol 75 μg once daily in patients aged ≥40 years with chronic obstructive pulmonary disease: results from 2 double-blind, placebo-controlled 12-week studies.
Topics: Adrenergic beta-2 Receptor Agonists; Adult; Aged; Albuterol; Analysis of Variance; Bronchodilator Ag | 2011 |
Efficacy and tolerability of indacaterol 75 μg once daily in patients aged ≥40 years with chronic obstructive pulmonary disease: results from 2 double-blind, placebo-controlled 12-week studies.
Topics: Adrenergic beta-2 Receptor Agonists; Adult; Aged; Albuterol; Analysis of Variance; Bronchodilator Ag | 2011 |
Onset of action of formoterol versus salmeterol via dry powder inhalers in moderate chronic obstructive pulmonary disease: a randomized, placebo-controlled, double-blind, crossover study.
Topics: Adult; Aged; Aged, 80 and over; Albuterol; Bronchodilator Agents; Cross-Over Studies; Double-Blind M | 2012 |
Salmeterol improves fluid clearance from alveolar-capillary membrane in COPD patients: a pilot study.
Topics: Adult; Aged; Aged, 80 and over; Albuterol; Body Fluids; Bronchodilator Agents; Capillaries; Carbon M | 2012 |
Randomized controlled trial of a breath-activated nebulizer in patients with exacerbation of COPD.
Topics: Aged; Aged, 80 and over; Albuterol; Bronchodilator Agents; Dyspnea; Female; Humans; Inspiratory Capa | 2012 |
Safety and efficacy of dual therapy with GSK233705 and salmeterol versus monotherapy with salmeterol, tiotropium, or placebo in a crossover pilot study in partially reversible COPD patients.
Topics: Administration, Inhalation; Adrenergic beta-2 Receptor Agonists; Aged; Albuterol; Bronchodilator Age | 2012 |
Safety and efficacy of dual therapy with GSK233705 and salmeterol versus monotherapy with salmeterol, tiotropium, or placebo in a crossover pilot study in partially reversible COPD patients.
Topics: Administration, Inhalation; Adrenergic beta-2 Receptor Agonists; Aged; Albuterol; Bronchodilator Age | 2012 |
Safety and efficacy of dual therapy with GSK233705 and salmeterol versus monotherapy with salmeterol, tiotropium, or placebo in a crossover pilot study in partially reversible COPD patients.
Topics: Administration, Inhalation; Adrenergic beta-2 Receptor Agonists; Aged; Albuterol; Bronchodilator Age | 2012 |
Safety and efficacy of dual therapy with GSK233705 and salmeterol versus monotherapy with salmeterol, tiotropium, or placebo in a crossover pilot study in partially reversible COPD patients.
Topics: Administration, Inhalation; Adrenergic beta-2 Receptor Agonists; Aged; Albuterol; Bronchodilator Age | 2012 |
Detection of air trapping in chronic obstructive pulmonary disease by low frequency ultrasound.
Topics: Adult; Aged; Airway Resistance; Albuterol; Analysis of Variance; Bronchodilator Agents; Exhalation; | 2012 |
β2-adrenergic receptor haplotype may be associated with susceptibility to desensitization to long-acting β2-agonists in COPD patients.
Topics: Administration, Inhalation; Adrenergic beta-2 Receptor Agonists; Aged; Albuterol; Cross-Over Studies | 2012 |
Observational study of the outcomes and costs of initiating maintenance therapies in patients with moderate exacerbations of COPD.
Topics: Albuterol; Androstadienes; Cholinergic Antagonists; Drug Combinations; Female; Fluticasone-Salmetero | 2012 |
Prediction and course of symptoms and lung function around an exacerbation in chronic obstructive pulmonary disease.
Topics: Aged; Albuterol; Androstadienes; Bronchodilator Agents; Disease Progression; Drug Combinations; Fema | 2012 |
Cost-effectiveness of tiotropium versus salmeterol: the POET-COPD trial.
Topics: Aged; Albuterol; Bayes Theorem; Bronchodilator Agents; Cost-Benefit Analysis; Double-Blind Method; F | 2013 |
Effect of combination treatment on lung volumes and exercise endurance time in COPD.
Topics: Adult; Aged; Albuterol; Androstadienes; Bronchodilator Agents; Cross-Over Studies; Double-Blind Meth | 2012 |
Better adherence to a transdermal tulobuterol patch than inhaled salmeterol in elderly chronic obstructive pulmonary disease patients.
Topics: Administration, Cutaneous; Administration, Inhalation; Adrenergic beta-2 Receptor Agonists; Adrenerg | 2013 |
Multidrug resistance-associated protein 1 and lung function decline with or without long-term corticosteroids treatment in COPD.
Topics: Adrenal Cortex Hormones; Adrenergic beta-2 Receptor Agonists; Aged; Albuterol; Androstadienes; Bronc | 2012 |
Walking exercise response to bronchodilation in mild COPD: a randomized trial.
Topics: Administration, Inhalation; Aged; Albuterol; Analysis of Variance; Bronchodilator Agents; Cross-Over | 2012 |
Effect of tiotropium vs. salmeterol on exacerbations: GOLD II and maintenance therapy naïve patients.
Topics: Adult; Aged; Albuterol; Bronchodilator Agents; Double-Blind Method; Female; Hospitalization; Humans; | 2013 |
Use of nebulised magnesium sulphate as an adjuvant in the treatment of acute exacerbations of COPD in adults: a randomised double-blind placebo-controlled trial.
Topics: Aged; Albuterol; Bronchodilator Agents; Disease Progression; Double-Blind Method; Female; Forced Exp | 2013 |
Influence of salmeterol/fluticasone via single versus separate inhalers on exacerbations in severe/very severe COPD.
Topics: Administration, Inhalation; Adrenergic beta-2 Receptor Agonists; Adult; Aged; Albuterol; Androstadie | 2013 |
A 6-month, placebo-controlled study comparing lung function and health status changes in COPD patients treated with tiotropium or salmeterol.
Topics: Aged; Albuterol; Bronchodilator Agents; Double-Blind Method; Female; Humans; Male; Middle Aged; Pulm | 2002 |
Addition of an extra dose of salmeterol Diskus to conventional dose of salmeterol Diskus in patients with COPD.
Topics: Albuterol; Bronchodilator Agents; Cross-Over Studies; Double-Blind Method; Forced Expiratory Volume; | 2002 |
Effectiveness of fluticasone propionate and salmeterol combination delivered via the Diskus device in the treatment of chronic obstructive pulmonary disease.
Topics: Administration, Inhalation; Administration, Topical; Adrenergic beta-Agonists; Adult; Aged; Aged, 80 | 2002 |
Effects of exercise and beta 2-agonists on lung function in chronic obstructive pulmonary disease.
Topics: Adrenergic beta-Agonists; Aged; Albuterol; Bronchoconstriction; Cross-Over Studies; Dyspnea; Exercis | 2002 |
Acute effects of higher than customary doses of salmeterol and salbutamol in patients with acute exacerbation of COPD.
Topics: Acute Disease; Administration, Inhalation; Adrenergic beta-Agonists; Aged; Albuterol; Bronchodilator | 2002 |
[A comparison between the effects of albuterol and isoproterenol in bronchodilation test].
Topics: Adult; Albuterol; Asthma; Bronchodilator Agents; Female; Forced Expiratory Volume; Humans; Male; Max | 2001 |
Cost-effectiveness of salmeterol in patients with chronic obstructive pulmonary disease: an economic evaluation.
Topics: Administration, Inhalation; Adult; Aged; Albuterol; Bronchodilator Agents; Cost-Benefit Analysis; Do | 2003 |
Effect of inhaled bronchodilators on inspiratory capacity and dyspnoea at rest in COPD.
Topics: Administration, Inhalation; Adrenergic beta-Agonists; Aged; Albuterol; Bronchodilator Agents; Cross- | 2003 |
Combined salmeterol and fluticasone in the treatment of chronic obstructive pulmonary disease: a randomised controlled trial.
Topics: Adrenergic beta-Agonists; Aged; Albuterol; Androstadienes; Anti-Inflammatory Agents; Contusions; Dou | 2003 |
Combined salmeterol and fluticasone in the treatment of chronic obstructive pulmonary disease: a randomised controlled trial.
Topics: Adrenergic beta-Agonists; Aged; Albuterol; Androstadienes; Anti-Inflammatory Agents; Contusions; Dou | 2003 |
Combined salmeterol and fluticasone in the treatment of chronic obstructive pulmonary disease: a randomised controlled trial.
Topics: Adrenergic beta-Agonists; Aged; Albuterol; Androstadienes; Anti-Inflammatory Agents; Contusions; Dou | 2003 |
Combined salmeterol and fluticasone in the treatment of chronic obstructive pulmonary disease: a randomised controlled trial.
Topics: Adrenergic beta-Agonists; Aged; Albuterol; Androstadienes; Anti-Inflammatory Agents; Contusions; Dou | 2003 |
Does a single dose of the phosphodiesterase 4 inhibitor, cilomilast (15 mg), induce bronchodilation in patients with chronic obstructive pulmonary disease?
Topics: 3',5'-Cyclic-AMP Phosphodiesterases; Albuterol; Analysis of Variance; Area Under Curve; Bronchodilat | 2003 |
Health outcomes following treatment for six months with once daily tiotropium compared with twice daily salmeterol in patients with COPD.
Topics: Administration, Inhalation; Albuterol; Bronchodilator Agents; Double-Blind Method; Dyspnea; Female; | 2003 |
Bronchodilator effect of an inhaled combination therapy with salmeterol + fluticasone and formoterol + budesonide in patients with COPD.
Topics: Adrenergic beta-Agonists; Aged; Albuterol; Androstadienes; Bronchodilator Agents; Budesonide; Cross- | 2003 |
Treatment of chronic obstructive pulmonary disease: Combination or component therapy?
Topics: Albuterol; Androstadienes; Bronchodilator Agents; Double-Blind Method; Drug Therapy, Combination; Fe | 2003 |
A comparison of the effects of salbutamol and ipratropium bromide on exercise endurance in patients with COPD.
Topics: Adrenergic beta-Agonists; Aged; Aged, 80 and over; Albuterol; Bronchodilator Agents; Cholinergic Ant | 2003 |
Cardiovascular safety of salmeterol in COPD.
Topics: Adrenergic beta-Agonists; Aged; Albuterol; Bronchodilator Agents; Cardiovascular Diseases; Cardiovas | 2003 |
Reversibility to a beta2-agonist in COPD: relationship to atopy and neutrophil activation.
Topics: Adrenergic beta-Agonists; Adult; Aged; Albuterol; Asthma; Dose-Response Relationship, Drug; Eosinoph | 2003 |
Inhalation profiles in asthmatics and COPD patients: reproducibility and effect of instruction.
Topics: Administration, Inhalation; Adrenergic beta-Agonists; Aged; Albuterol; Asthma; Female; Humans; Male; | 2003 |
Salmeterol & fluticasone 50 microg/250 microg bid in combination provides a better long-term control than salmeterol 50 microg bid alone and placebo in COPD patients already treated with theophylline.
Topics: Aged; Albuterol; Analysis of Variance; Androstadienes; Bronchodilator Agents; Double-Blind Method; D | 2003 |
Bronchodilator effect of zafirlukast in subjects with chronic obstructive pulmonary disease.
Topics: Administration, Oral; Aged; Albuterol; Bronchodilator Agents; Female; Humans; Indoles; Lung; Male; M | 2003 |
Does the inhalation device affect the bronchodilatory dose response curve of salbutamol in asthma and chronic obstructive pulmonary disease patients?
Topics: Albuterol; Asthma; Bronchodilator Agents; Dose-Response Relationship, Drug; Drug Delivery Systems; F | 2003 |
[Inhalation of beta-2 agonists or corticosteroids as single drugs in comparison with combination therapy of patients with COPD].
Topics: Adrenergic beta-2 Receptor Agonists; Adrenergic beta-Agonists; Aged; Albuterol; Androstadienes; Bron | 2003 |
The efficacy and safety of fluticasone propionate (250 microg)/salmeterol (50 microg) combined in the Diskus inhaler for the treatment of COPD.
Topics: Adrenergic beta-Agonists; Adult; Aged; Aged, 80 and over; Albuterol; Androstadienes; Anti-Asthmatic | 2003 |
The efficacy and safety of fluticasone propionate (250 microg)/salmeterol (50 microg) combined in the Diskus inhaler for the treatment of COPD.
Topics: Adrenergic beta-Agonists; Adult; Aged; Aged, 80 and over; Albuterol; Androstadienes; Anti-Asthmatic | 2003 |
The efficacy and safety of fluticasone propionate (250 microg)/salmeterol (50 microg) combined in the Diskus inhaler for the treatment of COPD.
Topics: Adrenergic beta-Agonists; Adult; Aged; Aged, 80 and over; Albuterol; Androstadienes; Anti-Asthmatic | 2003 |
The efficacy and safety of fluticasone propionate (250 microg)/salmeterol (50 microg) combined in the Diskus inhaler for the treatment of COPD.
Topics: Adrenergic beta-Agonists; Adult; Aged; Aged, 80 and over; Albuterol; Androstadienes; Anti-Asthmatic | 2003 |
An evaluation of nebulized levalbuterol in stable COPD.
Topics: Administration, Inhalation; Adrenergic beta-Agonists; Aged; Albuterol; Bronchodilator Agents; Cross- | 2003 |
Tolerance to bronchodilating effects of salmeterol in COPD.
Topics: Aged; Albuterol; Analysis of Variance; Bronchodilator Agents; Double-Blind Method; Female; Forced Ex | 2003 |
Montelukast attenuates the airway response to hypertonic saline in moderate-to-severe COPD.
Topics: Acetates; Administration, Inhalation; Administration, Oral; Aged; Airway Obstruction; Albuterol; Bro | 2003 |
[Combined salmeterol and fluticasone in the treatment of chronic obstructive pulmonary disease].
Topics: Adrenergic beta-Agonists; Aged; Albuterol; Androstadienes; Anti-Inflammatory Agents; Contusions; Dou | 2004 |
The pulmonary and extra-pulmonary effects of high-dose formoterol in COPD: a comparison with salbutamol.
Topics: Adrenergic beta-Agonists; Aged; Albuterol; Blood Pressure; Cross-Over Studies; Double-Blind Method; | 2004 |
Salmeterol/fluticasone propionate in a Single Inhaler Device versus theophylline+fluticasone propionate in patients with COPD.
Topics: Aged; Albuterol; Androstadienes; Bronchodilator Agents; Drug Combinations; Female; Fluticasone; Flut | 2004 |
[Inhalation combination therapy in chronic obstructive lung disease. TRISTAN-study].
Topics: Administration, Inhalation; Adrenergic beta-Agonists; Aerosols; Albuterol; Androstadienes; Bronchodi | 2004 |
Effects of formoterol and salmeterol on resting inspiratory capacity in COPD patients with poor FEV(1) reversibility.
Topics: Administration, Inhalation; Albuterol; Analysis of Variance; Area Under Curve; Bronchodilator Agents | 2004 |
[Effects of salbutamol and ipratropium bromide on arterial blood gases in patients with stable COPD].
Topics: Administration, Inhalation; Aged; Aged, 80 and over; Albuterol; Blood Gas Analysis; Bronchodilator A | 2003 |
Effect of salmeterol on respiratory muscle activity during exercise in poorly reversible COPD.
Topics: Aged; Albuterol; Bronchodilator Agents; Double-Blind Method; Exercise; Female; Forced Expiratory Vol | 2004 |
A short-term comparison of fluticasone propionate/salmeterol with ipratropium bromide/albuterol for the treatment of COPD.
Topics: Administration, Inhalation; Adrenergic beta-Agonists; Adult; Aged; Aged, 80 and over; Albuterol; And | 2004 |
Effect of salmeterol on the ventilatory response to exercise in chronic obstructive pulmonary disease.
Topics: Administration, Inhalation; Aged; Airway Resistance; Albuterol; Bronchodilator Agents; Cross-Over St | 2004 |
The TORCH (towards a revolution in COPD health) survival study protocol.
Topics: Administration, Inhalation; Adolescent; Adult; Aged; Albuterol; Androstadienes; Dose-Response Relati | 2004 |
The TORCH (towards a revolution in COPD health) survival study protocol.
Topics: Administration, Inhalation; Adolescent; Adult; Aged; Albuterol; Androstadienes; Dose-Response Relati | 2004 |
The TORCH (towards a revolution in COPD health) survival study protocol.
Topics: Administration, Inhalation; Adolescent; Adult; Aged; Albuterol; Androstadienes; Dose-Response Relati | 2004 |
The TORCH (towards a revolution in COPD health) survival study protocol.
Topics: Administration, Inhalation; Adolescent; Adult; Aged; Albuterol; Androstadienes; Dose-Response Relati | 2004 |
The TORCH (towards a revolution in COPD health) survival study protocol.
Topics: Administration, Inhalation; Adolescent; Adult; Aged; Albuterol; Androstadienes; Dose-Response Relati | 2004 |
The TORCH (towards a revolution in COPD health) survival study protocol.
Topics: Administration, Inhalation; Adolescent; Adult; Aged; Albuterol; Androstadienes; Dose-Response Relati | 2004 |
The TORCH (towards a revolution in COPD health) survival study protocol.
Topics: Administration, Inhalation; Adolescent; Adult; Aged; Albuterol; Androstadienes; Dose-Response Relati | 2004 |
The TORCH (towards a revolution in COPD health) survival study protocol.
Topics: Administration, Inhalation; Adolescent; Adult; Aged; Albuterol; Androstadienes; Dose-Response Relati | 2004 |
The TORCH (towards a revolution in COPD health) survival study protocol.
Topics: Administration, Inhalation; Adolescent; Adult; Aged; Albuterol; Androstadienes; Dose-Response Relati | 2004 |
Gender does not influence the response to the combination of salmeterol and fluticasone propionate in COPD.
Topics: Adrenergic beta-Agonists; Adult; Aged; Albuterol; Androstadienes; Bronchodilator Agents; Double-Blin | 2004 |
The functional impact of adding salmeterol and tiotropium in patients with stable COPD.
Topics: Aged; Aged, 80 and over; Albuterol; Anthropometry; Bronchodilator Agents; Cross-Over Studies; Double | 2004 |
The bronchodilator response to salmeterol is maintained with regular, long-term use in patients with COPD.
Topics: Administration, Inhalation; Albuterol; Androstadienes; Bronchodilator Agents; Double-Blind Method; D | 2005 |
A comparison between inhaled salmeterol and theophylline in the short-term treatment of stable chronic obstructive pulmonary disease.
Topics: Administration, Inhalation; Aged; Albuterol; Bronchodilator Agents; Cross-Over Studies; Delayed-Acti | 2005 |
Mucociliary clearance in COPD can be increased by both a D2/beta2 and a standard beta2 agonists.
Topics: Administration, Inhalation; Adrenergic beta-Agonists; Aged; Albuterol; Double-Blind Method; Female; | 2005 |
Comparison of the effects of nebulised and inhaled salbutamol on breathlessness in severe COPD.
Topics: Aged; Aged, 80 and over; Albuterol; Anesthetics, Local; Bronchodilator Agents; Cross-Over Studies; F | 2005 |
[Bronchodilator efficacy of combined salmeterol and tiotropium in patients with chronic obstructive pulmonary disease].
Topics: Albuterol; Androstadienes; Bronchodilator Agents; Cross-Over Studies; Data Interpretation, Statistic | 2005 |
Early onset of effect of salmeterol and fluticasone propionate in chronic obstructive pulmonary disease.
Topics: Administration, Inhalation; Albuterol; Analysis of Variance; Androstadienes; Bronchodilator Agents; | 2005 |
Responsiveness of continuous ratings of dyspnea during exercise in patients with COPD.
Topics: Aged; Albuterol; Bronchodilator Agents; Computers; Double-Blind Method; Dyspnea; Exercise Test; Fema | 2005 |
Total reversibility testing as indicator of the clinical efficacy of formoterol in COPD.
Topics: Administration, Inhalation; Adrenergic beta-Agonists; Aged; Albuterol; Bronchodilator Agents; Drug A | 2005 |
Plant-based formulation in the management of chronic obstructive pulmonary disease: a randomized double-blind study.
Topics: Adult; Aged; Aged, 80 and over; Albuterol; Blood Gas Analysis; Bromhexine; Bronchodilator Agents; Br | 2006 |
Withdrawal of fluticasone propionate from combined salmeterol/fluticasone treatment in patients with COPD causes immediate and sustained disease deterioration: a randomised controlled trial.
Topics: Administration, Inhalation; Albuterol; Analysis of Variance; Androstadienes; Bronchodilator Agents; | 2005 |
Withdrawal of fluticasone propionate from combined salmeterol/fluticasone treatment in patients with COPD causes immediate and sustained disease deterioration: a randomised controlled trial.
Topics: Administration, Inhalation; Albuterol; Analysis of Variance; Androstadienes; Bronchodilator Agents; | 2005 |
Withdrawal of fluticasone propionate from combined salmeterol/fluticasone treatment in patients with COPD causes immediate and sustained disease deterioration: a randomised controlled trial.
Topics: Administration, Inhalation; Albuterol; Analysis of Variance; Androstadienes; Bronchodilator Agents; | 2005 |
Withdrawal of fluticasone propionate from combined salmeterol/fluticasone treatment in patients with COPD causes immediate and sustained disease deterioration: a randomised controlled trial.
Topics: Administration, Inhalation; Albuterol; Analysis of Variance; Androstadienes; Bronchodilator Agents; | 2005 |
The influence of inhaled corticosteroids on exhaled nitric oxide in stable chronic obstructive pulmonary disease.
Topics: Administration, Inhalation; Adrenal Cortex Hormones; Albuterol; Breath Tests; Bronchodilator Agents; | 2005 |
The efficacy and safety of inhaled fluticasone propionate/salmeterol and ipratropium/albuterol for the treatment of chronic obstructive pulmonary disease: an eight-week, multicenter, randomized, double-blind, double-dummy, parallel-group study.
Topics: Administration, Inhalation; Adult; Aged; Aged, 80 and over; Albuterol; Androstadienes; Area Under Cu | 2005 |
Effect of salbutamol on lung function and chest wall volumes at rest and during exercise in COPD.
Topics: Aged; Albuterol; Bronchodilator Agents; Cross-Over Studies; Cross-Sectional Studies; Double-Blind Me | 2005 |
A randomized controlled trial to assess the optimal dose and effect of nebulized albuterol in acute exacerbations of COPD.
Topics: Acute Disease; Aged; Albuterol; Bronchodilator Agents; Chi-Square Distribution; Dose-Response Relati | 2005 |
Improved daytime spirometric efficacy of tiotropium compared with salmeterol in patients with COPD.
Topics: Aged; Albuterol; Bronchodilator Agents; Double-Blind Method; Drug Administration Schedule; Female; F | 2005 |
Effect of inhaled salbutamol on dynamic intrinsic positive end-expiratory pressure in spontaneously breathing patients with stable severe chronic obstructive pulmonary disease.
Topics: Administration, Inhalation; Aged; Albuterol; Bronchodilator Agents; Female; Humans; Male; Middle Age | 2005 |
Eformoterol n-of-1 trials in chronic obstructive pulmonary disease poorly reversible to salbutamol.
Topics: Adrenergic beta-Agonists; Aged, 80 and over; Albuterol; Autacoids; Bronchodilator Agents; Cross-Over | 2004 |
Efficacy of nebulized flunisolide combined with salbutamol and ipratropium bromide in stable patients with moderate-to-severe chronic obstructive pulmonary disease.
Topics: Aged; Albuterol; Anti-Asthmatic Agents; Bronchodilator Agents; Double-Blind Method; Drug Therapy, Co | 2006 |
Safety and tolerability of high-dose formoterol (via Aerolizer) and salbutamol in patients with chronic obstructive pulmonary disease.
Topics: Administration, Inhalation; Albuterol; Area Under Curve; Blood Glucose; Bronchodilator Agents; Cross | 2006 |
Clinical efficacy and safety of transdermal tulobuterol in the treatment of stable COPD: an open-label comparison with inhaled salmeterol.
Topics: Administration, Cutaneous; Administration, Inhalation; Adult; Aged; Albuterol; Bronchodilator Agents | 2005 |
[Clinical and functional benefits of adding theophylline to a standard treatment with short acting bronchodilators in patients with COPD].
Topics: Administration, Inhalation; Administration, Oral; Aged; Albuterol; Bronchodilator Agents; Double-Bli | 2005 |
Airway blood flow reactivity in smokers.
Topics: Administration, Inhalation; Albuterol; Androstadienes; Bronchodilator Agents; Endothelium, Vascular; | 2007 |
Antiinflammatory effects of salmeterol/fluticasone propionate in chronic obstructive lung disease.
Topics: Administration, Inhalation; Adrenergic beta-Agonists; Adult; Aged; Aged, 80 and over; Albuterol; And | 2006 |
Addition of salmeterol to existing treatment in patients with COPD: a 12 month study.
Topics: Albuterol; Bronchodilator Agents; Double-Blind Method; Dyspnea; Exercise Tolerance; Female; Forced E | 2006 |
Can inhaled fluticasone alone or in combination with salmeterol reduce systemic inflammation in chronic obstructive pulmonary disease? Study protocol for a randomized controlled trial [NCT00120978].
Topics: Administration, Inhalation; Adult; Aged; Albuterol; Androstadienes; Anti-Inflammatory Agents; Bronch | 2006 |
Doppler echocardiographic assessment of the effects of inhaled long-acting beta2-agonists on pulmonary artery pressure in COPD patients.
Topics: Administration, Inhalation; Adrenergic beta-2 Receptor Agonists; Adrenergic beta-Agonists; Aged; Age | 2007 |
Airway blood flow reactivity in healthy smokers and in ex-smokers with or without COPD.
Topics: Adult; Albuterol; Androstadienes; Bronchodilator Agents; Case-Control Studies; Cross-Over Studies; E | 2006 |
Evidence of tachyphylaxis associated with salmeterol treatment of chronic obstructive pulmonary disease patients.
Topics: Adrenergic beta-Agonists; Aged; Albuterol; Bronchodilator Agents; Cross-Over Studies; Female; Forced | 2006 |
Influence of respiratory efforts on b2-agonist induced bronchodilation in mechanically ventilated COPD patients: a prospective clinical study.
Topics: Adrenergic beta-Agonists; Aged; Airway Resistance; Albuterol; Bronchi; Bronchodilator Agents; Cross- | 2007 |
Additional clinical benefit of enoxaparin in COPD patients receiving salmeterol and fluticasone propionate in combination.
Topics: Aged; Albuterol; Androstadienes; Anticoagulants; Blood Gas Analysis; Bronchodilator Agents; Double-B | 2006 |
Effects of rac-albuterol on arterial blood gases in patients with stable hypercapnic chronic obstructive pulmonary disease.
Topics: Adrenergic beta-Agonists; Adult; Aged; Aged, 80 and over; Albuterol; Area Under Curve; Bronchodilato | 2006 |
A pilot study to assess the effects of combining fluticasone propionate/salmeterol and tiotropium on the airflow obstruction of patients with severe-to-very severe COPD.
Topics: Administration, Inhalation; Aged; Albuterol; Androstadienes; Bronchodilator Agents; Double-Blind Met | 2007 |
Management of chronic obstructive pulmonary disease associated with chronic bronchitis with inhaled fluticasone propionate/salmeterol (ADVAIR DISKUS) 250/50: results of a patient experience trial.
Topics: Administration, Inhalation; Albuterol; Androstadienes; Bronchitis, Chronic; Drug Combinations; Femal | 2006 |
Additive benefits of tiotropium in COPD patients treated with long-acting beta agonists and corticosteroids.
Topics: Aged; Albuterol; Bronchodilator Agents; Drug Therapy, Combination; Female; Forced Expiratory Volume; | 2006 |
Effect of fluticasone propionate/salmeterol on lung hyperinflation and exercise endurance in COPD.
Topics: Adrenergic beta-Agonists; Aged; Albuterol; Androstadienes; Bronchodilator Agents; Dose-Response Rela | 2006 |
Fluticasone propionate/salmeterol hydrofluoroalkane via metered-dose inhaler with integrated dose counter: Performance and patient satisfaction.
Topics: Administration, Inhalation; Adolescent; Adult; Aged; Albuterol; Androstadienes; Anti-Asthmatic Agent | 2006 |
The effect of bronchodilators and oxygen alone and in combination on self-paced exercise performance in stable COPD.
Topics: Aged; Albuterol; Bronchodilator Agents; Combined Modality Therapy; Cross-Over Studies; Dyspnea; Exer | 2007 |
Impact of salmeterol/fluticasone propionate versus salmeterol on exacerbations in severe chronic obstructive pulmonary disease.
Topics: Aged; Albuterol; Androstadienes; Bronchodilator Agents; Double-Blind Method; Drug Administration Sch | 2007 |
Impact of salmeterol/fluticasone propionate versus salmeterol on exacerbations in severe chronic obstructive pulmonary disease.
Topics: Aged; Albuterol; Androstadienes; Bronchodilator Agents; Double-Blind Method; Drug Administration Sch | 2007 |
Impact of salmeterol/fluticasone propionate versus salmeterol on exacerbations in severe chronic obstructive pulmonary disease.
Topics: Aged; Albuterol; Androstadienes; Bronchodilator Agents; Double-Blind Method; Drug Administration Sch | 2007 |
Impact of salmeterol/fluticasone propionate versus salmeterol on exacerbations in severe chronic obstructive pulmonary disease.
Topics: Aged; Albuterol; Androstadienes; Bronchodilator Agents; Double-Blind Method; Drug Administration Sch | 2007 |
Impact of salmeterol/fluticasone propionate versus salmeterol on exacerbations in severe chronic obstructive pulmonary disease.
Topics: Aged; Albuterol; Androstadienes; Bronchodilator Agents; Double-Blind Method; Drug Administration Sch | 2007 |
Impact of salmeterol/fluticasone propionate versus salmeterol on exacerbations in severe chronic obstructive pulmonary disease.
Topics: Aged; Albuterol; Androstadienes; Bronchodilator Agents; Double-Blind Method; Drug Administration Sch | 2007 |
Impact of salmeterol/fluticasone propionate versus salmeterol on exacerbations in severe chronic obstructive pulmonary disease.
Topics: Aged; Albuterol; Androstadienes; Bronchodilator Agents; Double-Blind Method; Drug Administration Sch | 2007 |
Impact of salmeterol/fluticasone propionate versus salmeterol on exacerbations in severe chronic obstructive pulmonary disease.
Topics: Aged; Albuterol; Androstadienes; Bronchodilator Agents; Double-Blind Method; Drug Administration Sch | 2007 |
Impact of salmeterol/fluticasone propionate versus salmeterol on exacerbations in severe chronic obstructive pulmonary disease.
Topics: Aged; Albuterol; Androstadienes; Bronchodilator Agents; Double-Blind Method; Drug Administration Sch | 2007 |
The additive effect of theophylline on a combination of formoterol and tiotropium in stable COPD: a pilot study.
Topics: Aged; Albuterol; Bronchodilator Agents; Drug Administration Schedule; Drug Interactions; Drug Therap | 2007 |
Once versus twice daily formoterol via Novolizer for patients with moderate to severe COPD--a double-blind, randomised, controlled trial.
Topics: Adult; Aged; Albuterol; Bronchodilator Agents; Double-Blind Method; Drug Administration Schedule; Et | 2008 |
Comparable spirometric efficacy of tiotropium compared with salmeterol plus fluticasone in patients with COPD: a pilot study.
Topics: Adult; Albuterol; Androstadienes; Bronchodilator Agents; Double-Blind Method; Drug Administration Sc | 2008 |
Evaluation of the efficacy and safety of levalbuterol in subjects with COPD.
Topics: Adrenergic beta-Agonists; Adult; Albuterol; Area Under Curve; Double-Blind Method; Female; Humans; M | 2006 |
Lower inhaled steroid requirement with a fluticasone/salmeterol combination in family practice patients with asthma or COPD.
Topics: Adult; Aged; Albuterol; Androstadienes; Asthma; Bronchodilator Agents; Dose-Response Relationship, D | 2007 |
Correlation between bronchodilator responsiveness and quality of life in chronic obstructive pulmonary disease.
Topics: Activities of Daily Living; Aged; Albuterol; Bronchodilator Agents; Female; Forced Expiratory Volume | 2007 |
Tiotropium in combination with placebo, salmeterol, or fluticasone-salmeterol for treatment of chronic obstructive pulmonary disease: a randomized trial.
Topics: Administration, Inhalation; Adrenergic beta-Agonists; Aged; Albuterol; Androstadienes; Bronchodilato | 2007 |
Tiotropium in combination with placebo, salmeterol, or fluticasone-salmeterol for treatment of chronic obstructive pulmonary disease: a randomized trial.
Topics: Administration, Inhalation; Adrenergic beta-Agonists; Aged; Albuterol; Androstadienes; Bronchodilato | 2007 |
Tiotropium in combination with placebo, salmeterol, or fluticasone-salmeterol for treatment of chronic obstructive pulmonary disease: a randomized trial.
Topics: Administration, Inhalation; Adrenergic beta-Agonists; Aged; Albuterol; Androstadienes; Bronchodilato | 2007 |
Tiotropium in combination with placebo, salmeterol, or fluticasone-salmeterol for treatment of chronic obstructive pulmonary disease: a randomized trial.
Topics: Administration, Inhalation; Adrenergic beta-Agonists; Aged; Albuterol; Androstadienes; Bronchodilato | 2007 |
Tiotropium in combination with placebo, salmeterol, or fluticasone-salmeterol for treatment of chronic obstructive pulmonary disease: a randomized trial.
Topics: Administration, Inhalation; Adrenergic beta-Agonists; Aged; Albuterol; Androstadienes; Bronchodilato | 2007 |
Tiotropium in combination with placebo, salmeterol, or fluticasone-salmeterol for treatment of chronic obstructive pulmonary disease: a randomized trial.
Topics: Administration, Inhalation; Adrenergic beta-Agonists; Aged; Albuterol; Androstadienes; Bronchodilato | 2007 |
Tiotropium in combination with placebo, salmeterol, or fluticasone-salmeterol for treatment of chronic obstructive pulmonary disease: a randomized trial.
Topics: Administration, Inhalation; Adrenergic beta-Agonists; Aged; Albuterol; Androstadienes; Bronchodilato | 2007 |
Tiotropium in combination with placebo, salmeterol, or fluticasone-salmeterol for treatment of chronic obstructive pulmonary disease: a randomized trial.
Topics: Administration, Inhalation; Adrenergic beta-Agonists; Aged; Albuterol; Androstadienes; Bronchodilato | 2007 |
Tiotropium in combination with placebo, salmeterol, or fluticasone-salmeterol for treatment of chronic obstructive pulmonary disease: a randomized trial.
Topics: Administration, Inhalation; Adrenergic beta-Agonists; Aged; Albuterol; Androstadienes; Bronchodilato | 2007 |
Tiotropium in combination with placebo, salmeterol, or fluticasone-salmeterol for treatment of chronic obstructive pulmonary disease: a randomized trial.
Topics: Administration, Inhalation; Adrenergic beta-Agonists; Aged; Albuterol; Androstadienes; Bronchodilato | 2007 |
Tiotropium in combination with placebo, salmeterol, or fluticasone-salmeterol for treatment of chronic obstructive pulmonary disease: a randomized trial.
Topics: Administration, Inhalation; Adrenergic beta-Agonists; Aged; Albuterol; Androstadienes; Bronchodilato | 2007 |
Tiotropium in combination with placebo, salmeterol, or fluticasone-salmeterol for treatment of chronic obstructive pulmonary disease: a randomized trial.
Topics: Administration, Inhalation; Adrenergic beta-Agonists; Aged; Albuterol; Androstadienes; Bronchodilato | 2007 |
Tiotropium in combination with placebo, salmeterol, or fluticasone-salmeterol for treatment of chronic obstructive pulmonary disease: a randomized trial.
Topics: Administration, Inhalation; Adrenergic beta-Agonists; Aged; Albuterol; Androstadienes; Bronchodilato | 2007 |
Tiotropium in combination with placebo, salmeterol, or fluticasone-salmeterol for treatment of chronic obstructive pulmonary disease: a randomized trial.
Topics: Administration, Inhalation; Adrenergic beta-Agonists; Aged; Albuterol; Androstadienes; Bronchodilato | 2007 |
Tiotropium in combination with placebo, salmeterol, or fluticasone-salmeterol for treatment of chronic obstructive pulmonary disease: a randomized trial.
Topics: Administration, Inhalation; Adrenergic beta-Agonists; Aged; Albuterol; Androstadienes; Bronchodilato | 2007 |
Tiotropium in combination with placebo, salmeterol, or fluticasone-salmeterol for treatment of chronic obstructive pulmonary disease: a randomized trial.
Topics: Administration, Inhalation; Adrenergic beta-Agonists; Aged; Albuterol; Androstadienes; Bronchodilato | 2007 |
Tiotropium in combination with placebo, salmeterol, or fluticasone-salmeterol for treatment of chronic obstructive pulmonary disease: a randomized trial.
Topics: Administration, Inhalation; Adrenergic beta-Agonists; Aged; Albuterol; Androstadienes; Bronchodilato | 2007 |
Tiotropium in combination with placebo, salmeterol, or fluticasone-salmeterol for treatment of chronic obstructive pulmonary disease: a randomized trial.
Topics: Administration, Inhalation; Adrenergic beta-Agonists; Aged; Albuterol; Androstadienes; Bronchodilato | 2007 |
Tiotropium in combination with placebo, salmeterol, or fluticasone-salmeterol for treatment of chronic obstructive pulmonary disease: a randomized trial.
Topics: Administration, Inhalation; Adrenergic beta-Agonists; Aged; Albuterol; Androstadienes; Bronchodilato | 2007 |
Tiotropium in combination with placebo, salmeterol, or fluticasone-salmeterol for treatment of chronic obstructive pulmonary disease: a randomized trial.
Topics: Administration, Inhalation; Adrenergic beta-Agonists; Aged; Albuterol; Androstadienes; Bronchodilato | 2007 |
Tiotropium in combination with placebo, salmeterol, or fluticasone-salmeterol for treatment of chronic obstructive pulmonary disease: a randomized trial.
Topics: Administration, Inhalation; Adrenergic beta-Agonists; Aged; Albuterol; Androstadienes; Bronchodilato | 2007 |
Tiotropium in combination with placebo, salmeterol, or fluticasone-salmeterol for treatment of chronic obstructive pulmonary disease: a randomized trial.
Topics: Administration, Inhalation; Adrenergic beta-Agonists; Aged; Albuterol; Androstadienes; Bronchodilato | 2007 |
Tiotropium in combination with placebo, salmeterol, or fluticasone-salmeterol for treatment of chronic obstructive pulmonary disease: a randomized trial.
Topics: Administration, Inhalation; Adrenergic beta-Agonists; Aged; Albuterol; Androstadienes; Bronchodilato | 2007 |
Tiotropium in combination with placebo, salmeterol, or fluticasone-salmeterol for treatment of chronic obstructive pulmonary disease: a randomized trial.
Topics: Administration, Inhalation; Adrenergic beta-Agonists; Aged; Albuterol; Androstadienes; Bronchodilato | 2007 |
Tiotropium in combination with placebo, salmeterol, or fluticasone-salmeterol for treatment of chronic obstructive pulmonary disease: a randomized trial.
Topics: Administration, Inhalation; Adrenergic beta-Agonists; Aged; Albuterol; Androstadienes; Bronchodilato | 2007 |
Salmeterol and fluticasone propionate and survival in chronic obstructive pulmonary disease.
Topics: Administration, Inhalation; Adrenergic beta-Agonists; Aged; Albuterol; Androstadienes; Anti-Inflamma | 2007 |
Salmeterol and fluticasone propionate and survival in chronic obstructive pulmonary disease.
Topics: Administration, Inhalation; Adrenergic beta-Agonists; Aged; Albuterol; Androstadienes; Anti-Inflamma | 2007 |
Salmeterol and fluticasone propionate and survival in chronic obstructive pulmonary disease.
Topics: Administration, Inhalation; Adrenergic beta-Agonists; Aged; Albuterol; Androstadienes; Anti-Inflamma | 2007 |
Salmeterol and fluticasone propionate and survival in chronic obstructive pulmonary disease.
Topics: Administration, Inhalation; Adrenergic beta-Agonists; Aged; Albuterol; Androstadienes; Anti-Inflamma | 2007 |
Salmeterol and fluticasone propionate and survival in chronic obstructive pulmonary disease.
Topics: Administration, Inhalation; Adrenergic beta-Agonists; Aged; Albuterol; Androstadienes; Anti-Inflamma | 2007 |
Salmeterol and fluticasone propionate and survival in chronic obstructive pulmonary disease.
Topics: Administration, Inhalation; Adrenergic beta-Agonists; Aged; Albuterol; Androstadienes; Anti-Inflamma | 2007 |
Salmeterol and fluticasone propionate and survival in chronic obstructive pulmonary disease.
Topics: Administration, Inhalation; Adrenergic beta-Agonists; Aged; Albuterol; Androstadienes; Anti-Inflamma | 2007 |
Salmeterol and fluticasone propionate and survival in chronic obstructive pulmonary disease.
Topics: Administration, Inhalation; Adrenergic beta-Agonists; Aged; Albuterol; Androstadienes; Anti-Inflamma | 2007 |
Salmeterol and fluticasone propionate and survival in chronic obstructive pulmonary disease.
Topics: Administration, Inhalation; Adrenergic beta-Agonists; Aged; Albuterol; Androstadienes; Anti-Inflamma | 2007 |
Salmeterol and fluticasone propionate and survival in chronic obstructive pulmonary disease.
Topics: Administration, Inhalation; Adrenergic beta-Agonists; Aged; Albuterol; Androstadienes; Anti-Inflamma | 2007 |
Salmeterol and fluticasone propionate and survival in chronic obstructive pulmonary disease.
Topics: Administration, Inhalation; Adrenergic beta-Agonists; Aged; Albuterol; Androstadienes; Anti-Inflamma | 2007 |
Salmeterol and fluticasone propionate and survival in chronic obstructive pulmonary disease.
Topics: Administration, Inhalation; Adrenergic beta-Agonists; Aged; Albuterol; Androstadienes; Anti-Inflamma | 2007 |
Salmeterol and fluticasone propionate and survival in chronic obstructive pulmonary disease.
Topics: Administration, Inhalation; Adrenergic beta-Agonists; Aged; Albuterol; Androstadienes; Anti-Inflamma | 2007 |
Salmeterol and fluticasone propionate and survival in chronic obstructive pulmonary disease.
Topics: Administration, Inhalation; Adrenergic beta-Agonists; Aged; Albuterol; Androstadienes; Anti-Inflamma | 2007 |
Salmeterol and fluticasone propionate and survival in chronic obstructive pulmonary disease.
Topics: Administration, Inhalation; Adrenergic beta-Agonists; Aged; Albuterol; Androstadienes; Anti-Inflamma | 2007 |
Salmeterol and fluticasone propionate and survival in chronic obstructive pulmonary disease.
Topics: Administration, Inhalation; Adrenergic beta-Agonists; Aged; Albuterol; Androstadienes; Anti-Inflamma | 2007 |
Salmeterol and fluticasone propionate and survival in chronic obstructive pulmonary disease.
Topics: Administration, Inhalation; Adrenergic beta-Agonists; Aged; Albuterol; Androstadienes; Anti-Inflamma | 2007 |
Salmeterol and fluticasone propionate and survival in chronic obstructive pulmonary disease.
Topics: Administration, Inhalation; Adrenergic beta-Agonists; Aged; Albuterol; Androstadienes; Anti-Inflamma | 2007 |
Salmeterol and fluticasone propionate and survival in chronic obstructive pulmonary disease.
Topics: Administration, Inhalation; Adrenergic beta-Agonists; Aged; Albuterol; Androstadienes; Anti-Inflamma | 2007 |
Salmeterol and fluticasone propionate and survival in chronic obstructive pulmonary disease.
Topics: Administration, Inhalation; Adrenergic beta-Agonists; Aged; Albuterol; Androstadienes; Anti-Inflamma | 2007 |
Salmeterol and fluticasone propionate and survival in chronic obstructive pulmonary disease.
Topics: Administration, Inhalation; Adrenergic beta-Agonists; Aged; Albuterol; Androstadienes; Anti-Inflamma | 2007 |
Salmeterol and fluticasone propionate and survival in chronic obstructive pulmonary disease.
Topics: Administration, Inhalation; Adrenergic beta-Agonists; Aged; Albuterol; Androstadienes; Anti-Inflamma | 2007 |
Salmeterol and fluticasone propionate and survival in chronic obstructive pulmonary disease.
Topics: Administration, Inhalation; Adrenergic beta-Agonists; Aged; Albuterol; Androstadienes; Anti-Inflamma | 2007 |
Salmeterol and fluticasone propionate and survival in chronic obstructive pulmonary disease.
Topics: Administration, Inhalation; Adrenergic beta-Agonists; Aged; Albuterol; Androstadienes; Anti-Inflamma | 2007 |
Salmeterol and fluticasone propionate and survival in chronic obstructive pulmonary disease.
Topics: Administration, Inhalation; Adrenergic beta-Agonists; Aged; Albuterol; Androstadienes; Anti-Inflamma | 2007 |
A randomized, placebo-controlled trial of bronchodilators for bronchoscopy in patients with COPD.
Topics: Administration, Inhalation; Adult; Aged; Aged, 80 and over; Albuterol; Bronchodilator Agents; Bronch | 2007 |
Modelling the 5-year cost effectiveness of tiotropium, salmeterol and ipratropium for the treatment of chronic obstructive pulmonary disease in Spain.
Topics: Albuterol; Bronchodilator Agents; Cost-Benefit Analysis; Humans; Ipratropium; Markov Chains; Nationa | 2007 |
Tiotropium is less likely to induce oxygen desaturation in stable COPD patients compared to long-acting beta2-agonists.
Topics: Adrenergic beta-2 Receptor Agonists; Adrenergic beta-Agonists; Aged; Aged, 80 and over; Albuterol; B | 2007 |
Comparing COPD treatment: nebulizer, metered dose inhaler, and concomitant therapy.
Topics: Albuterol; Bronchodilator Agents; Humans; Ipratropium; Metered Dose Inhalers; Middle Aged; Nebulizer | 2007 |
Nebulized arformoterol in patients with COPD: a 12-week, multicenter, randomized, double-blind, double-dummy, placebo- and active-controlled trial.
Topics: Administration, Inhalation; Adrenergic beta-Agonists; Aged; Albuterol; Bronchodilator Agents; Dose-R | 2007 |
Effect of salmeterol/fluticasone propionate on airway inflammation in COPD: a randomised controlled trial.
Topics: Administration, Inhalation; Aged; Albuterol; Androstadienes; Bronchitis; Bronchodilator Agents; CD8- | 2007 |
[Clinical study of the month: the TORCH study (TOwards a Revolution in COPD Health)].
Topics: Aged; Albuterol; Androstadienes; Bronchodilator Agents; Cause of Death; Double-Blind Method; Drug Co | 2007 |
Comparison of bronchodilatory properties of transdermal and inhaled long-acting beta 2-agonists.
Topics: Administration, Cutaneous; Administration, Inhalation; Adrenergic beta-2 Receptor Agonists; Aged; Al | 2008 |
Effects of tiotropium or combined therapy with salmeterol on hyperinflation in COPD.
Topics: Aged; Albuterol; Bronchodilator Agents; Dose-Response Relationship, Drug; Drug Therapy, Combination; | 2007 |
Fast onset of effect of budesonide/formoterol versus salmeterol/fluticasone and salbutamol in patients with chronic obstructive pulmonary disease and reversible airway obstruction.
Topics: Adrenal Cortex Hormones; Adult; Aged; Airway Obstruction; Albuterol; Androstadienes; Anti-Asthmatic | 2007 |
The prevention of chronic obstructive pulmonary disease exacerbations by salmeterol/fluticasone propionate or tiotropium bromide.
Topics: Administration, Inhalation; Aged; Albuterol; Androstadienes; Anti-Inflammatory Agents; Bronchodilato | 2008 |
The prevention of chronic obstructive pulmonary disease exacerbations by salmeterol/fluticasone propionate or tiotropium bromide.
Topics: Administration, Inhalation; Aged; Albuterol; Androstadienes; Anti-Inflammatory Agents; Bronchodilato | 2008 |
The prevention of chronic obstructive pulmonary disease exacerbations by salmeterol/fluticasone propionate or tiotropium bromide.
Topics: Administration, Inhalation; Aged; Albuterol; Androstadienes; Anti-Inflammatory Agents; Bronchodilato | 2008 |
The prevention of chronic obstructive pulmonary disease exacerbations by salmeterol/fluticasone propionate or tiotropium bromide.
Topics: Administration, Inhalation; Aged; Albuterol; Androstadienes; Anti-Inflammatory Agents; Bronchodilato | 2008 |
The efficacy and safety of combination salmeterol (50 microg)/fluticasone propionate (500 microg) inhalation twice daily via accuhaler in Chinese patients with COPD.
Topics: Administration, Inhalation; Adult; Aged; Aged, 80 and over; Albuterol; Androstadienes; Bronchodilato | 2007 |
[Impact of COPD therapy on patient survival: the TORCH Study (TOwards a Revolution in COPD Health)].
Topics: Aged; Albuterol; Androstadienes; Anti-Inflammatory Agents; Bronchodilator Agents; Dose-Response Rela | 2007 |
[Benefits of a home-based pulmonary rehabilitation program for patients with severe chronic obstructive pulmonary disease].
Topics: Aged; Albuterol; Anthropometry; Anti-Inflammatory Agents; Bronchodilator Agents; Female; Home Care S | 2007 |
Randomized placebo controlled assessment of airway inflammation due to racemic albuterol and levalbuterol via exhaled nitric oxide testing.
Topics: Adrenergic beta-Agonists; Aged; Aged, 80 and over; Albuterol; Exhalation; Female; Humans; Inflammati | 2006 |
Effect of bronchodilatation on single breath pulmonary uptake of carbon monoxide in chronic obstructive pulmonary disease.
Topics: Administration, Inhalation; Aged; Albuterol; Bronchodilator Agents; Carbon Monoxide; Emphysema; Fema | 2006 |
Endurance shuttle walking test: responsiveness to salmeterol in COPD.
Topics: Aged; Albuterol; Bronchodilator Agents; Cohort Studies; Cross-Over Studies; Double-Blind Method; Dys | 2008 |
Superiority of "triple" therapy with salmeterol/fluticasone propionate and tiotropium bromide versus individual components in moderate to severe COPD.
Topics: Adult; Aged; Albuterol; Androstadienes; Bronchodilator Agents; Cross-Over Studies; Double-Blind Meth | 2008 |
Superiority of "triple" therapy with salmeterol/fluticasone propionate and tiotropium bromide versus individual components in moderate to severe COPD.
Topics: Adult; Aged; Albuterol; Androstadienes; Bronchodilator Agents; Cross-Over Studies; Double-Blind Meth | 2008 |
Superiority of "triple" therapy with salmeterol/fluticasone propionate and tiotropium bromide versus individual components in moderate to severe COPD.
Topics: Adult; Aged; Albuterol; Androstadienes; Bronchodilator Agents; Cross-Over Studies; Double-Blind Meth | 2008 |
Superiority of "triple" therapy with salmeterol/fluticasone propionate and tiotropium bromide versus individual components in moderate to severe COPD.
Topics: Adult; Aged; Albuterol; Androstadienes; Bronchodilator Agents; Cross-Over Studies; Double-Blind Meth | 2008 |
Superiority of "triple" therapy with salmeterol/fluticasone propionate and tiotropium bromide versus individual components in moderate to severe COPD.
Topics: Adult; Aged; Albuterol; Androstadienes; Bronchodilator Agents; Cross-Over Studies; Double-Blind Meth | 2008 |
Superiority of "triple" therapy with salmeterol/fluticasone propionate and tiotropium bromide versus individual components in moderate to severe COPD.
Topics: Adult; Aged; Albuterol; Androstadienes; Bronchodilator Agents; Cross-Over Studies; Double-Blind Meth | 2008 |
Superiority of "triple" therapy with salmeterol/fluticasone propionate and tiotropium bromide versus individual components in moderate to severe COPD.
Topics: Adult; Aged; Albuterol; Androstadienes; Bronchodilator Agents; Cross-Over Studies; Double-Blind Meth | 2008 |
Superiority of "triple" therapy with salmeterol/fluticasone propionate and tiotropium bromide versus individual components in moderate to severe COPD.
Topics: Adult; Aged; Albuterol; Androstadienes; Bronchodilator Agents; Cross-Over Studies; Double-Blind Meth | 2008 |
Superiority of "triple" therapy with salmeterol/fluticasone propionate and tiotropium bromide versus individual components in moderate to severe COPD.
Topics: Adult; Aged; Albuterol; Androstadienes; Bronchodilator Agents; Cross-Over Studies; Double-Blind Meth | 2008 |
Superiority of "triple" therapy with salmeterol/fluticasone propionate and tiotropium bromide versus individual components in moderate to severe COPD.
Topics: Adult; Aged; Albuterol; Androstadienes; Bronchodilator Agents; Cross-Over Studies; Double-Blind Meth | 2008 |
Superiority of "triple" therapy with salmeterol/fluticasone propionate and tiotropium bromide versus individual components in moderate to severe COPD.
Topics: Adult; Aged; Albuterol; Androstadienes; Bronchodilator Agents; Cross-Over Studies; Double-Blind Meth | 2008 |
Superiority of "triple" therapy with salmeterol/fluticasone propionate and tiotropium bromide versus individual components in moderate to severe COPD.
Topics: Adult; Aged; Albuterol; Androstadienes; Bronchodilator Agents; Cross-Over Studies; Double-Blind Meth | 2008 |
Superiority of "triple" therapy with salmeterol/fluticasone propionate and tiotropium bromide versus individual components in moderate to severe COPD.
Topics: Adult; Aged; Albuterol; Androstadienes; Bronchodilator Agents; Cross-Over Studies; Double-Blind Meth | 2008 |
Superiority of "triple" therapy with salmeterol/fluticasone propionate and tiotropium bromide versus individual components in moderate to severe COPD.
Topics: Adult; Aged; Albuterol; Androstadienes; Bronchodilator Agents; Cross-Over Studies; Double-Blind Meth | 2008 |
Superiority of "triple" therapy with salmeterol/fluticasone propionate and tiotropium bromide versus individual components in moderate to severe COPD.
Topics: Adult; Aged; Albuterol; Androstadienes; Bronchodilator Agents; Cross-Over Studies; Double-Blind Meth | 2008 |
Superiority of "triple" therapy with salmeterol/fluticasone propionate and tiotropium bromide versus individual components in moderate to severe COPD.
Topics: Adult; Aged; Albuterol; Androstadienes; Bronchodilator Agents; Cross-Over Studies; Double-Blind Meth | 2008 |
Bronchodilator responsiveness in patients with COPD.
Topics: Aged; Albuterol; Bronchodilator Agents; Cholinergic Antagonists; Double-Blind Method; Drug Therapy, | 2008 |
Quality of life measurements and bronchodilator responsiveness in prescribing nebulizer therapy in COPD.
Topics: Administration, Inhalation; Aged; Albuterol; Albuterol, Ipratropium Drug Combination; Bronchodilator | 2008 |
The effects of fluticasone with or without salmeterol on systemic biomarkers of inflammation in chronic obstructive pulmonary disease.
Topics: Administration, Inhalation; Adrenergic beta-Agonists; Aged; Albuterol; Androstadienes; Anti-Inflamma | 2008 |
Inhaled corticosteroids as additional treatment in alpha-1-antitrypsin-deficiency-related COPD.
Topics: Administration, Inhalation; Aged; Albuterol; alpha 1-Antitrypsin Deficiency; Beclomethasone; Broncho | 2008 |
Tiotropium and salmeterol/fluticasone combination do not cause oxygen desaturation in COPD.
Topics: Adrenergic beta-Agonists; Albuterol; Androstadienes; Anti-Inflammatory Agents; Bronchodilator Agents | 2008 |
Association of beta2-adrenoreceptor genotypes with bronchodilatory effect of tiotropium in COPD.
Topics: Administration, Inhalation; Aged; Aged, 80 and over; Albuterol; Alleles; Bronchodilator Agents; Dose | 2008 |
Comparison of a combination of tiotropium plus formoterol to salmeterol plus fluticasone in moderate COPD.
Topics: Aged; Albuterol; Androstadienes; Bronchodilator Agents; Double-Blind Method; Drug Administration Sch | 2008 |
Comparison of the efficacy of formoterol and salmeterol in patients with reversible obstructive airway disease: a multicenter, randomized, open-label trial.
Topics: Adolescent; Adrenergic beta-Agonists; Adult; Aged; Albuterol; Ethanolamines; Female; Formoterol Fuma | 2001 |
Duration of salbutamol-induced bronchodilation delivered by metered-dose inhaler in mechanically ventilated COPD patients.
Topics: Administration, Inhalation; Aged; Airway Resistance; Albuterol; Analysis of Variance; Bronchodilator | 2001 |
Salbutamol delivery during non-invasive mechanical ventilation in patients with chronic obstructive pulmonary disease: a randomized, controlled study.
Topics: Administration, Inhalation; Aged; Albuterol; Blood Gas Analysis; Bronchodilator Agents; Critical Car | 2001 |
Comparison of the bronchodilating effect of salmeterol and zafirlukast in combination with that of their use as single treatments in asthma and chronic obstructive pulmonary disease.
Topics: Adrenergic beta-Agonists; Adult; Aged; Albuterol; Asthma; Bronchi; Bronchodilator Agents; Cross-Over | 2001 |
Airway response to inhaled hypertonic saline in patients with moderate to severe chronic obstructive pulmonary disease.
Topics: Administration, Inhalation; Aged; Airway Resistance; Albuterol; Bronchoconstriction; Bronchodilator | 2001 |
The incremental shuttle walking test in elderly people with chronic airflow limitation.
Topics: Administration, Inhalation; Aged; Aged, 80 and over; Albuterol; Asthma; Bronchodilator Agents; Drug | 2002 |
Treatment of patients hospitalized for exacerbations of chronic obstructive pulmonary disease: comparison of an oral/metered-dose inhaler regimen and an intravenous/nebulizer regimen.
Topics: Administration, Inhalation; Administration, Oral; Aged; Albuterol; Bronchodilator Agents; Cefuroxime | 2002 |
Use of a mucus clearance device enhances the bronchodilator response in patients with stable COPD.
Topics: Aged; Albuterol; Bronchodilator Agents; Cross-Over Studies; Drug Therapy, Combination; Female; Force | 2002 |
Supine hypoxemia following nebulizated salbutamol in patients with chronic airway obstruction.
Topics: Adrenergic beta-Agonists; Aerosols; Albuterol; Bronchodilator Agents; Cross-Over Studies; Double-Bli | 2001 |
Formoterol as dry powder oral inhalation compared with salbutamol metered-dose inhaler in acute exacerbations of chronic obstructive pulmonary disease.
Topics: Administration, Inhalation; Aged; Albuterol; Bronchodilator Agents; Cross-Over Studies; Dose-Respons | 2002 |
What is the optimal treatment strategy for chronic obstructive pulmonary disease exacerbations?
Topics: Acute Disease; Aged; Albuterol; Bronchodilator Agents; Dyspnea; Female; Fenoterol; Glucocorticoids; | 2002 |
Onset of action following formoterol Turbuhaler and salbutamol pMDI in reversible chronic airway obstruction.
Topics: Adult; Aged; Albuterol; Analysis of Variance; Asthma; Bronchodilator Agents; Cross-Over Studies; Dou | 2002 |
310 other studies available for albuterol and Airflow Obstruction, Chronic
| Article | Year |
|---|---|
A multivalent approach to the discovery of long-acting β(2)-adrenoceptor agonists for the treatment of asthma and COPD.
Topics: Adrenergic beta-2 Receptor Agonists; Animals; Anti-Asthmatic Agents; Asthma; Cell Line; Drug Discove | 2012 |
Aerosol delivery of inhalation devices with different add-on connections to invasively ventilated COPD subjects: An in-vivo study.
Topics: Administration, Inhalation; Adult; Aerosols; Albuterol; Bronchodilator Agents; Female; Humans; Nebul | 2021 |
Balance impairment and lower limbs strength in patients with COPD who fell in the previous year.
Topics: Accidental Falls; Albuterol; Bronchodilator Agents; Cross-Sectional Studies; Fatigue; Humans; Lower | 2022 |
Nebulizer versus metered dose inhaler with space chamber (MDI spacer) for acute asthma and chronic obstructive pulmonary disease exacerbation: attitudes of patients and healthcare providers in the COVID-19 era.
Topics: Administration, Inhalation; Adult; Albuterol; Asthma; Attitude of Health Personnel; Bronchodilator A | 2023 |
Efficacy of salmeterol and magnesium isoglycyrrhizinate combination treatment in rats with chronic obstructive pulmonary disease.
Topics: Administration, Inhalation; Albuterol; Androstadienes; Animals; Anti-Inflammatory Agents; Bronchodil | 2022 |
Bronchodilator Responsiveness Over Time: Is This Clinically Meaningful in Tobacco-Exposed Individuals?
Topics: Albuterol; Bronchodilator Agents; Forced Expiratory Volume; Humans; Nicotiana; Pulmonary Disease, Ch | 2023 |
[Availability and affordability of diagnosis and treatment for asthma and COPD in Ouagadougou, Burkina Faso].
Topics: Albuterol; Asthma; Burkina Faso; Costs and Cost Analysis; Cross-Sectional Studies; Health Services A | 2023 |
Response to Bronchodilators Administered via Different Nebulizers in Patients With COPD Exacerbation.
Topics: Administration, Inhalation; Albuterol; Bronchodilator Agents; Dyspnea; Humans; Nebulizers and Vapori | 2023 |
Acute salbutamol bronchoprotection against methacholine: Asthma compared with chronic obstructive pulmonary disease.
Topics: Albuterol; Asthma; Bronchoconstrictor Agents; Disease Management; Female; Humans; Male; Methacholine | 2020 |
COVID-19: Time to embrace MDI+ valved-holding chambers!
Topics: Administration, Inhalation; Albuterol; Asthma; Betacoronavirus; Bronchodilator Agents; Coronavirus I | 2020 |
Management of COPD exacerbations: pharmacotherapeutics of medications.
Topics: Albuterol; Amoxicillin; Disease Progression; Humans; Pulmonary Disease, Chronic Obstructive | 2020 |
Adult Patients with Respiratory Distress: Current Evidence-based Recommendations for Prehospital Care.
Topics: Adult; Albuterol; Asthma; Bronchodilator Agents; California; Dyspnea; Emergency Medical Services; Ho | 2020 |
Pressure pulsations enhance penetration index in COPD.
Topics: Administration, Inhalation; Aerosols; Albuterol; Humans; Lung; Nebulizers and Vaporizers; Pulmonary | 2022 |
Early use of noninvasive techniques for clearing respiratory secretions during noninvasive positive-pressure ventilation in patients with acute exacerbation of chronic obstructive pulmonary disease and hypercapnic encephalopathy: A prospective cohort stud
Topics: Aged; Albuterol; Ambroxol; Brain Diseases; Equipment Design; Feasibility Studies; Female; Humans; Hy | 2017 |
Modeling Seasonal and Spatiotemporal Variation: The Example of Respiratory Prescribing.
Topics: Age Distribution; Air Pollution; Albuterol; Asthma; Bronchodilator Agents; Chronic Disease; Drug Uti | 2017 |
Acute bronchodilator responses to β2-agonist and anticholinergic agent in COPD: Their different associations with exacerbation.
Topics: Administration, Inhalation; Adrenergic beta-2 Receptor Agonists; Aged; Aged, 80 and over; Albuterol; | 2017 |
The success and safety profile of sputum induction in patients with chronic obstructive pulmonary disease: An Indian experience.
Topics: Aged; Albuterol; Bronchodilator Agents; Eosinophils; Female; Forced Expiratory Volume; Humans; India | 2017 |
Use of a Remote Inhaler Monitoring Device to Measure Change in Inhaler Use with Chronic Obstructive Pulmonary Disease Exacerbations.
Topics: Aged; Albuterol; Female; Humans; Male; Middle Aged; Monitoring, Physiologic; Nebulizers and Vaporize | 2018 |
Access to affordable medicines and diagnostic tests for asthma and COPD in sub Saharan Africa: the Ugandan perspective.
Topics: Administration, Inhalation; Adrenal Cortex Hormones; Adrenergic beta-Agonists; Albuterol; Anti-Asthm | 2017 |
Fluticasone propionate and increased risk of pneumonia in COPD: is it PAFR-dependent?
Topics: Administration, Inhalation; Albuterol; Androstadienes; Bronchodilator Agents; Double-Blind Method; F | 2017 |
Whole-genome methylation profiling of peripheral blood mononuclear cell for acute exacerbations of chronic obstructive pulmonary disease treated with corticosteroid.
Topics: Adrenal Cortex Hormones; Aged; Albuterol; Bromhexine; CpG Islands; DNA Methylation; Female; Genome, | 2018 |
Real-life effectiveness and safety of salbutamol Steri-Neb™ vs. Ventolin Nebules® for exacerbations in patients with COPD: Historical cohort study.
Topics: Administration, Inhalation; Adrenergic beta-2 Receptor Agonists; Adult; Aged; Aged, 80 and over; Alb | 2018 |
Prevalence of paradoxical bronchoconstriction after inhaled albuterol.
Topics: Administration, Inhalation; Adrenergic beta-2 Receptor Agonists; Albuterol; Asthma; Bronchoconstrict | 2018 |
Effects of Fill Volume and Humidification on Aerosol Delivery During Single-Limb Noninvasive Ventilation.
Topics: Aerosols; Aged; Albuterol; Bronchodilator Agents; Female; Humans; Humidity; Male; Middle Aged; Nebul | 2018 |
Myoclonus induced by salbutamol: A case report
Topics: Adrenergic beta-2 Receptor Agonists; Albuterol; Combined Modality Therapy; Drug Synergism; Drug Ther | 2018 |
Changes in biomarkers of cardiac dysfunction during exacerbations of chronic obstructive pulmonary disease.
Topics: Administration, Inhalation; Adrenergic beta-2 Receptor Agonists; Aged; Albuterol; Biomarkers; Bronch | 2018 |
Real-world use of rescue inhaler sensors, electronic symptom questionnaires and physical activity monitors in COPD.
Topics: Administration, Inhalation; Aged; Aged, 80 and over; Albuterol; Bronchodilator Agents; Exercise; Fem | 2019 |
Regional airflow obstruction after bronchoconstriction and subsequent bronchodilation in subjects without pulmonary disease.
Topics: Administration, Inhalation; Adult; Albuterol; Asthma; Bronchial Provocation Tests; Bronchoconstricti | 2019 |
Bronchodilator reversibility in asthma and COPD: findings from three large population studies.
Topics: Administration, Inhalation; Adolescent; Adult; Aged; Aged, 80 and over; Albuterol; Asthma; Bronchodi | 2019 |
I Say IOS You Say AOS: Comparative Bias in Respiratory Impedance Measurements.
Topics: Aged; Airway Resistance; Albuterol; Asthma; Bronchodilator Agents; Equipment Design; Female; Forced | 2019 |
Ultra-LAMA, ultra-LABA, ultra-inhaled steroids? The future has landed.
Topics: Administration, Inhalation; Adrenergic beta-2 Receptor Agonists; Albuterol; Asthma; Ethanolamines; F | 2013 |
Combination of budesonide/formoterol more effective than fluticasone/salmeterol in preventing exacerbations in chronic obstructive pulmonary disease: the PATHOS study.
Topics: Administration, Inhalation; Adrenergic beta-2 Receptor Agonists; Aged; Albuterol; Androstadienes; Br | 2013 |
A UK-based cost-utility analysis of indacaterol, a once-daily maintenance bronchodilator for patients with COPD, using real world evidence on resource use.
Topics: Aged; Albuterol; Bronchodilator Agents; Cost-Benefit Analysis; Drug Administration Schedule; Drug Co | 2013 |
Inspiratory drive is related to dynamic pulmonary hyperinflation in COPD patients.
Topics: Aged; Albuterol; Bronchodilator Agents; Female; Humans; Inspiratory Capacity; Lung Volume Measuremen | 2013 |
ACP Journal Club. Review: inhaled medications vary substantively in their effects on mortality in COPD.
Topics: Adrenal Cortex Hormones; Albuterol; Bronchodilator Agents; Female; Humans; Male; Pulmonary Disease, | 2013 |
Do we need three players in COPD treatment?
Topics: Albuterol; Androstadienes; Bronchodilator Agents; Female; Fluticasone; Humans; Male; Pulmonary Disea | 2013 |
The association between inhaled long-acting bronchodilators and less in-hospital care in newly-diagnosed COPD patients.
Topics: Administration, Inhalation; Aged; Albuterol; Bronchodilator Agents; Delayed-Action Preparations; Dis | 2014 |
Inhaled β-agonist therapy and respiratory muscle fatigue as under-recognised causes of lactic acidosis.
Topics: Acidosis, Lactic; Administration, Inhalation; Adrenergic beta-2 Receptor Agonists; Albuterol; Diagno | 2013 |
Changes in oscillatory impedance and nitrogen washout with combination fluticasone/salmeterol therapy in COPD.
Topics: Administration, Inhalation; Aged; Albuterol; Analysis of Variance; Androstadienes; Bronchi; Bronchod | 2014 |
PGE 2 desensitizes β -agonist effect on human lung fibroblast-mediated collagen gel contraction through upregulating PDE4.
Topics: Adrenergic beta-2 Receptor Agonists; Albuterol; Anti-Inflammatory Agents, Non-Steroidal; Collagen; C | 2013 |
A woman with breathlessness: a practical approach to diagnosis and management.
Topics: Albuterol; Bronchodilator Agents; Diagnosis, Differential; Disease Progression; Dyspnea; Female; Hea | 2013 |
Association between respiratory prescribing, air pollution and deprivation, in primary health care.
Topics: Adult; Air Pollution; Albuterol; Asthma; Bronchodilator Agents; Drug Prescriptions; Female; Humans; | 2013 |
Future of fixed-dose longacting β2-agonist and antimuscarinic combination therapy in COPD.
Topics: Albuterol; Androstadienes; Bronchodilator Agents; Drug Combinations; Female; Fluticasone-Salmeterol | 2013 |
Hospital readmissions following initiation of nebulized arformoterol tartrate or nebulized short-acting beta-agonists among inpatients treated for COPD.
Topics: Administration, Inhalation; Adrenergic beta-2 Receptor Agonists; Adult; Aged; Albuterol; Bronchodila | 2013 |
Heliox as a driving gas to atomize inhaled drugs on acute exacerbation of chronic obstructive pulmonary disease: a prospective clinical study.
Topics: Administration, Inhalation; Aged; Albuterol; Budesonide; Drug Interactions; Female; Helium; Humans; | 2014 |
Pharmacogenetics of COPD: a role for the β2-adrenergic receptor gene?
Topics: Albuterol; Bronchodilator Agents; Female; Humans; Male; Polymorphism, Genetic; Pulmonary Disease, Ch | 2014 |
ECG response: March 25, 2014.
Topics: Aged; Albuterol; Bronchodilator Agents; Diagnosis, Differential; Electrocardiography; Humans; Male; | 2014 |
Impact of adherence to treatment with tiotropium and fluticasone propionate/salmeterol in chronic obstructive pulmonary diseases patients.
Topics: Adrenal Cortex Hormones; Adult; Aged; Aged, 80 and over; Albuterol; Androstadienes; Bronchodilator A | 2014 |
Real-life use of fluticasone propionate/salmeterol in patients with chronic obstructive pulmonary disease: a French observational study.
Topics: Aged; Albuterol; Androstadienes; Drug Combinations; Drug Utilization; Female; Fluticasone-Salmeterol | 2014 |
New therapy for managing moderate to severe chronic obstructive pulmonary disease.
Topics: Adrenergic beta-2 Receptor Agonists; Albuterol; Aminopyridines; Benzamides; Bronchodilator Agents; C | 2014 |
The beta-2-adrenoreceptor agonists, formoterol and indacaterol, but not salbutamol, effectively suppress the reactivity of human neutrophils in vitro.
Topics: Adrenergic beta-2 Receptor Antagonists; Albuterol; Calcium; Cell Survival; Cyclic AMP; Cytosol; Etha | 2014 |
Point: were industry-sponsored roflumilast trials appropriate? Yes.
Topics: Albuterol; Aminopyridines; Anti-Inflammatory Agents; Benzamides; Bronchodilator Agents; Female; Huma | 2014 |
Counterpoint: were industry-sponsored roflumilast trials appropriate? No.
Topics: Albuterol; Aminopyridines; Anti-Inflammatory Agents; Benzamides; Bronchodilator Agents; Female; Huma | 2014 |
Rebuttal from Drs Suissa and Rabe.
Topics: Albuterol; Aminopyridines; Anti-Inflammatory Agents; Benzamides; Bronchodilator Agents; Female; Huma | 2014 |
Rebuttal from Dr Rho et al.
Topics: Albuterol; Aminopyridines; Anti-Inflammatory Agents; Benzamides; Bronchodilator Agents; Female; Huma | 2014 |
Pulmonary ventilation defects in older never-smokers.
Topics: Aged; Albuterol; Female; Forced Expiratory Volume; Helium; Humans; Inhalation; Lung; Magnetic Resona | 2014 |
Hyperpolarized (3)He ventilation defects used to predict pulmonary exacerbations in mild to moderate chronic obstructive pulmonary disease.
Topics: Aged; Aged, 80 and over; Albuterol; Bronchodilator Agents; Diffusion Magnetic Resonance Imaging; Fem | 2014 |
Respiratory impedance and response to salbutamol in healthy individuals and patients with COPD.
Topics: Aged; Albuterol; Bronchodilator Agents; Case-Control Studies; Electric Impedance; Female; Humans; Ma | 2014 |
A simple rule to identify patients with chronic obstructive pulmonary disease who may need treatment reevaluation.
Topics: Adrenergic beta-2 Receptor Agonists; Aged; Albuterol; Bronchodilator Agents; Comorbidity; Databases, | 2014 |
Stepping down therapy in COPD.
Topics: Albuterol; Androstadienes; Bronchodilator Agents; Female; Fluticasone; Glucocorticoids; Humans; Male | 2014 |
Paradoxical response to bronchodilators in COPD: curious enigma or clinically important phenotype?
Topics: Adrenergic beta-2 Receptor Agonists; Albuterol; Female; Humans; Male; Pulmonary Disease, Chronic Obs | 2014 |
Radiological correlates and clinical implications of the paradoxical lung function response to β₂ agonists: an observational study.
Topics: Adrenergic beta-2 Receptor Agonists; Aged; Albuterol; Black or African American; Body Mass Index; Di | 2014 |
Impact of multiple-dose versus single-dose inhaler devices on COPD patients' persistence with long-acting β₂-agonists: a dispensing database analysis.
Topics: Adrenergic beta-2 Receptor Agonists; Aged; Albuterol; Cohort Studies; Databases, Factual; Ethanolami | 2014 |
What to use INSTEAD of inhaled corticosteroids in COPD?
Topics: Albuterol; Androstadienes; Bronchodilator Agents; Female; Glucocorticoids; Humans; Indans; Male; Pul | 2014 |
Inhaled glucocorticoids and COPD exacerbations.
Topics: Albuterol; Androstadienes; Bronchodilator Agents; Female; Glucocorticoids; Humans; Male; Pulmonary D | 2015 |
Inhaled glucocorticoids and COPD exacerbations.
Topics: Albuterol; Androstadienes; Bronchodilator Agents; Female; Glucocorticoids; Humans; Male; Pulmonary D | 2015 |
Inhaled glucocorticoids and COPD exacerbations.
Topics: Albuterol; Androstadienes; Bronchodilator Agents; Female; Glucocorticoids; Humans; Male; Pulmonary D | 2015 |
Inhaled glucocorticoids and COPD exacerbations.
Topics: Albuterol; Androstadienes; Bronchodilator Agents; Female; Glucocorticoids; Humans; Male; Pulmonary D | 2015 |
Discontinuing inhaled steroids might not be safe in severe COPD cases.
Topics: Albuterol; Androstadienes; Bronchodilator Agents; Female; Glucocorticoids; Humans; Male; Pulmonary D | 2015 |
Bronchogenic stress cardiomyopathy: a case series.
Topics: Adrenergic beta-2 Receptor Agonists; Aged; Aged, 80 and over; Albuterol; Chest Pain; Diagnosis, Diff | 2015 |
A score to predict short-term risk of COPD exacerbations (SCOPEX).
Topics: Adrenergic beta-2 Receptor Agonists; Aged; Albuterol; Area Under Curve; Bronchodilator Agents; Budes | 2015 |
A score to predict short-term risk of COPD exacerbations (SCOPEX).
Topics: Adrenergic beta-2 Receptor Agonists; Aged; Albuterol; Area Under Curve; Bronchodilator Agents; Budes | 2015 |
A score to predict short-term risk of COPD exacerbations (SCOPEX).
Topics: Adrenergic beta-2 Receptor Agonists; Aged; Albuterol; Area Under Curve; Bronchodilator Agents; Budes | 2015 |
A score to predict short-term risk of COPD exacerbations (SCOPEX).
Topics: Adrenergic beta-2 Receptor Agonists; Aged; Albuterol; Area Under Curve; Bronchodilator Agents; Budes | 2015 |
A score to predict short-term risk of COPD exacerbations (SCOPEX).
Topics: Adrenergic beta-2 Receptor Agonists; Aged; Albuterol; Area Under Curve; Bronchodilator Agents; Budes | 2015 |
A score to predict short-term risk of COPD exacerbations (SCOPEX).
Topics: Adrenergic beta-2 Receptor Agonists; Aged; Albuterol; Area Under Curve; Bronchodilator Agents; Budes | 2015 |
A score to predict short-term risk of COPD exacerbations (SCOPEX).
Topics: Adrenergic beta-2 Receptor Agonists; Aged; Albuterol; Area Under Curve; Bronchodilator Agents; Budes | 2015 |
A score to predict short-term risk of COPD exacerbations (SCOPEX).
Topics: Adrenergic beta-2 Receptor Agonists; Aged; Albuterol; Area Under Curve; Bronchodilator Agents; Budes | 2015 |
A score to predict short-term risk of COPD exacerbations (SCOPEX).
Topics: Adrenergic beta-2 Receptor Agonists; Aged; Albuterol; Area Under Curve; Bronchodilator Agents; Budes | 2015 |
ACP journal club. For preventing exacerbations of COPD, withdrawal of inhaled glucocorticoids was noninferior to continuation.
Topics: Albuterol; Androstadienes; Bronchodilator Agents; Female; Glucocorticoids; Humans; Male; Pulmonary D | 2015 |
Salmeterol/fluticasone combination instead of indacaterol or vice-versa?
Topics: Albuterol; Androstadienes; Bronchodilator Agents; Female; Glucocorticoids; Humans; Indans; Male; Pul | 2015 |
Salmeterol/fluticasone combination instead of indacaterol or vice-versa?
Topics: Albuterol; Androstadienes; Bronchodilator Agents; Female; Glucocorticoids; Humans; Indans; Male; Pul | 2015 |
Efficacy of indacaterol as a single therapy versus salmeterol/fluticasone therapy in patients with milder chronic obstructive pulmonary disease.
Topics: Albuterol; Androstadienes; Bronchodilator Agents; Female; Glucocorticoids; Humans; Indans; Male; Pul | 2015 |
'Bronchogenic Stress Cardiomyopathy', a Subset of Takotsubo Syndrome.
Topics: Adrenergic beta-2 Receptor Agonists; Albuterol; Female; Humans; Pulmonary Disease, Chronic Obstructi | 2015 |
Authors' Reply to the Letter by Madias Entitled '"Bronchogenic Stress Cardiomyopathy", a subset of Takotsubo Syndrome'.
Topics: Adrenergic beta-2 Receptor Agonists; Albuterol; Female; Humans; Pulmonary Disease, Chronic Obstructi | 2015 |
Albuterol inhalation increases FeNO level in steroid-naive asthmatics but not COPD patients with reversibility.
Topics: Administration, Inhalation; Adrenal Cortex Hormones; Adrenergic beta-2 Receptor Agonists; Adult; Alb | 2017 |
Triple inhaler therapy for COPD.
Topics: Albuterol; Androstadienes; Bronchodilator Agents; Female; Forced Expiratory Volume; Glycopyrrolate; | 2015 |
Effects of ageing and smoking on pulmonary computed tomography scans using parametric response mapping.
Topics: Adult; Aging; Albuterol; Algorithms; Female; Forced Expiratory Volume; Humans; Inflammation; Linear | 2015 |
Roflumilast in COPD.
Topics: Albuterol; Aminopyridines; Anti-Inflammatory Agents; Benzamides; Bronchodilator Agents; Female; Huma | 2015 |
Response.
Topics: Albuterol; Aminopyridines; Anti-Inflammatory Agents; Benzamides; Bronchodilator Agents; Female; Huma | 2015 |
Small airway dysfunction and flow and volume bronchodilator responsiveness in patients with chronic obstructive pulmonary disease.
Topics: Adrenergic beta-2 Receptor Agonists; Aged; Airway Resistance; Albuterol; Bronchi; Bronchodilator Age | 2015 |
Physical activity in COPD patients decreases short-acting bronchodilator use and the number of exacerbations.
Topics: Adrenal Cortex Hormones; Adrenergic beta-2 Receptor Agonists; Aged; Albuterol; Bronchodilator Agents | 2015 |
Acinar ventilation heterogeneity in COPD relates to diffusion capacity, resistance and reactance.
Topics: Adrenergic beta-2 Receptor Agonists; Aged; Albuterol; Breath Tests; Case-Control Studies; Cholinergi | 2016 |
Characteristics of reversible and nonreversible COPD and asthma and COPD overlap syndrome patients: an analysis of salbutamol Easyhaler data.
Topics: Administration, Inhalation; Aged; Airway Obstruction; Albuterol; Asthma; Bronchodilator Agents; Cros | 2016 |
[Asthma-COPD overlap syndrome].
Topics: Adult; Aged; Albuterol; Asthma; Comorbidity; Disease Progression; Female; Humans; Male; Prevalence; | 2015 |
Smoke and viruses-a hindrance to relaxing the airways?
Topics: Albuterol; Animals; Asthma; Humans; Pulmonary Disease, Chronic Obstructive; Smoke; Viruses | 2016 |
Regional lung response to bronchodilator reversibility testing determined by electrical impedance tomography in chronic obstructive pulmonary disease.
Topics: Administration, Inhalation; Aged; Aged, 80 and over; Albuterol; Bronchodilator Agents; Electric Impe | 2016 |
Factors Determining In Vitro Lung Deposition of Albuterol Aerosol Delivered by Ventolin Metered-Dose Inhaler.
Topics: Administration, Inhalation; Adolescent; Adult; Aerosols; Aged; Aged, 80 and over; Albuterol; Asthma; | 2017 |
Lung function and symptom improvement with fluticasone propionate/salmeterol and ipratropium bromide/albuterol in COPD: response by beta-agonist reversibility.
Topics: Adrenergic beta-Agonists; Aged; Albuterol; Albuterol, Ipratropium Drug Combination; Androstadienes; | 2008 |
The forgotten message from gold: FVC is a primary clinical outcome measure of bronchodilator reversibility in COPD.
Topics: Administration, Inhalation; Adrenergic beta-2 Receptor Agonists; Aged; Albuterol; Bronchodilator Age | 2008 |
Is salmeterol/fluticasone propionate equivalent to tiotropium bromide in the treatment of COPD?
Topics: Albuterol; Androstadienes; Bronchodilator Agents; Drug Combinations; Fluticasone-Salmeterol Drug Com | 2008 |
Treatment step down should be avoided at entry in COPD therapeutic trials.
Topics: Albuterol; Androstadienes; Bronchodilator Agents; Clinical Trials as Topic; Drug Combinations; Fluti | 2008 |
Management of patients with COPD: a comparison of the INSPIRE and TORCH studies.
Topics: Albuterol; Androstadienes; Anti-Inflammatory Agents; Drug Combinations; Fluticasone-Salmeterol Drug | 2008 |
Management of patients with COPD: a comparison of the INSPIRE and TORCH studies.
Topics: Albuterol; Androstadienes; Anti-Inflammatory Agents; Drug Combinations; Fluticasone-Salmeterol Drug | 2008 |
Management of patients with COPD: a comparison of the INSPIRE and TORCH studies.
Topics: Albuterol; Androstadienes; Anti-Inflammatory Agents; Drug Combinations; Fluticasone-Salmeterol Drug | 2008 |
Management of patients with COPD: a comparison of the INSPIRE and TORCH studies.
Topics: Albuterol; Androstadienes; Anti-Inflammatory Agents; Drug Combinations; Fluticasone-Salmeterol Drug | 2008 |
The volumetric response to bronchodilators in stable chronic obstructive pulmonary disease.
Topics: Aged; Albuterol; Bronchodilator Agents; Female; Forced Expiratory Volume; Humans; Male; Middle Aged; | 2008 |
Salmeterol with fluticasone enhances the suppression of IL-8 release and increases the translocation of glucocorticoid receptor by human neutrophils stimulated with cigarette smoke.
Topics: Adrenergic beta-Agonists; Albuterol; Androstadienes; Animals; Bronchodilator Agents; Dual Specificit | 2008 |
Economic assessment of initial maintenance therapy for chronic obstructive pulmonary disease.
Topics: Administration, Inhalation; Aged; Albuterol; Androstadienes; Bronchodilator Agents; Cost-Benefit Ana | 2008 |
Beta2-adrenergic receptor haplotype and bronchodilator response to salbutamol in patients with acute exacerbations of COPD.
Topics: Adult; Aged; Albuterol; Bronchodilator Agents; Codon; Demography; Female; Glutamic Acid; Glycine; Ha | 2008 |
Medications to modify lung function decline in chronic obstructive pulmonary disease: some hopeful signs.
Topics: Administration, Inhalation; Albuterol; Androstadienes; Bronchodilator Agents; Drug Therapy, Combinat | 2008 |
The INSPIRE study: influence of prior use and discontinuation of inhaled corticosteroids.
Topics: Administration, Inhalation; Albuterol; Androstadienes; Bronchodilator Agents; Drug Therapy, Combinat | 2008 |
Transient anisocoria caused by aerosolized ipratropium bromide exposure from an ill-fitting face mask.
Topics: Administration, Inhalation; Albuterol; Anisocoria; Bronchodilator Agents; Cholecystectomy, Laparosco | 2008 |
Steroids completely reverse albuterol-induced beta(2)-adrenergic receptor tolerance in human small airways.
Topics: Adrenergic beta-2 Receptor Agonists; Adrenergic beta-Agonists; Albuterol; Anti-Inflammatory Agents; | 2008 |
Risk of hospitalizations/emergency department visits and treatment costs associated with initial maintenance therapy using fluticasone propionate 500 microg/salmeterol 50 microg compared with ipratropium for chronic obstructive pulmonary disease in older
Topics: Aged; Albuterol; Androstadienes; Bronchodilator Agents; Cohort Studies; Costs and Cost Analysis; Dat | 2008 |
Assessing mortality risk in COPD.
Topics: Actuarial Analysis; Albuterol; Androstadienes; Body Mass Index; Bronchial Hyperreactivity; Bronchodi | 2008 |
Risk of adverse gastrointestinal events from inhaled corticosteroids.
Topics: Administration, Inhalation; Adolescent; Adrenal Cortex Hormones; Adult; Albuterol; Anti-Asthmatic Ag | 2008 |
Cost-effectiveness of fluticasone propionate/salmeterol (500/50 microg) in the treatment of COPD.
Topics: Adult; Aged; Aged, 80 and over; Albuterol; Androstadienes; Anti-Asthmatic Agents; Cost-Benefit Analy | 2009 |
Acute effects of higher than standard doses of salbutamol and ipratropium on tiotropium-induced bronchodilation in patients with stable COPD.
Topics: Aged; Albuterol; Bronchi; Bronchodilator Agents; Dose-Response Relationship, Drug; Female; Forced Ex | 2009 |
The INSPIRE trial results: are they truly breathtaking?
Topics: Albuterol; Androstadienes; Bronchodilator Agents; Drug Combinations; Fluticasone-Salmeterol Drug Com | 2009 |
Genetic association analysis of COPD candidate genes with bronchodilator responsiveness.
Topics: Adult; Aged; Albuterol; Boston; Bronchodilator Agents; Female; Forced Expiratory Volume; Genetic Pre | 2009 |
Effect of bronchodilation on expiratory flow limitation and resting lung mechanics in COPD.
Topics: Albuterol; Bronchodilator Agents; Female; Forced Expiratory Volume; Humans; Inspiratory Capacity; Le | 2009 |
Effect of bronchodilation on expiratory flow limitation and resting lung mechanics in COPD.
Topics: Albuterol; Bronchodilator Agents; Female; Forced Expiratory Volume; Humans; Inspiratory Capacity; Le | 2009 |
Effect of bronchodilation on expiratory flow limitation and resting lung mechanics in COPD.
Topics: Albuterol; Bronchodilator Agents; Female; Forced Expiratory Volume; Humans; Inspiratory Capacity; Le | 2009 |
Effect of bronchodilation on expiratory flow limitation and resting lung mechanics in COPD.
Topics: Albuterol; Bronchodilator Agents; Female; Forced Expiratory Volume; Humans; Inspiratory Capacity; Le | 2009 |
Effect of bronchodilation on expiratory flow limitation and resting lung mechanics in COPD.
Topics: Albuterol; Bronchodilator Agents; Female; Forced Expiratory Volume; Humans; Inspiratory Capacity; Le | 2009 |
Effect of bronchodilation on expiratory flow limitation and resting lung mechanics in COPD.
Topics: Albuterol; Bronchodilator Agents; Female; Forced Expiratory Volume; Humans; Inspiratory Capacity; Le | 2009 |
Effect of bronchodilation on expiratory flow limitation and resting lung mechanics in COPD.
Topics: Albuterol; Bronchodilator Agents; Female; Forced Expiratory Volume; Humans; Inspiratory Capacity; Le | 2009 |
Effect of bronchodilation on expiratory flow limitation and resting lung mechanics in COPD.
Topics: Albuterol; Bronchodilator Agents; Female; Forced Expiratory Volume; Humans; Inspiratory Capacity; Le | 2009 |
Effect of bronchodilation on expiratory flow limitation and resting lung mechanics in COPD.
Topics: Albuterol; Bronchodilator Agents; Female; Forced Expiratory Volume; Humans; Inspiratory Capacity; Le | 2009 |
Effect of bronchodilation on expiratory flow limitation and resting lung mechanics in COPD.
Topics: Albuterol; Bronchodilator Agents; Female; Forced Expiratory Volume; Humans; Inspiratory Capacity; Le | 2009 |
Effect of bronchodilation on expiratory flow limitation and resting lung mechanics in COPD.
Topics: Albuterol; Bronchodilator Agents; Female; Forced Expiratory Volume; Humans; Inspiratory Capacity; Le | 2009 |
Effect of bronchodilation on expiratory flow limitation and resting lung mechanics in COPD.
Topics: Albuterol; Bronchodilator Agents; Female; Forced Expiratory Volume; Humans; Inspiratory Capacity; Le | 2009 |
Effect of bronchodilation on expiratory flow limitation and resting lung mechanics in COPD.
Topics: Albuterol; Bronchodilator Agents; Female; Forced Expiratory Volume; Humans; Inspiratory Capacity; Le | 2009 |
Effect of bronchodilation on expiratory flow limitation and resting lung mechanics in COPD.
Topics: Albuterol; Bronchodilator Agents; Female; Forced Expiratory Volume; Humans; Inspiratory Capacity; Le | 2009 |
Effect of bronchodilation on expiratory flow limitation and resting lung mechanics in COPD.
Topics: Albuterol; Bronchodilator Agents; Female; Forced Expiratory Volume; Humans; Inspiratory Capacity; Le | 2009 |
Effect of bronchodilation on expiratory flow limitation and resting lung mechanics in COPD.
Topics: Albuterol; Bronchodilator Agents; Female; Forced Expiratory Volume; Humans; Inspiratory Capacity; Le | 2009 |
Effect of bronchodilation on expiratory flow limitation and resting lung mechanics in COPD.
Topics: Albuterol; Bronchodilator Agents; Female; Forced Expiratory Volume; Humans; Inspiratory Capacity; Le | 2009 |
Effect of bronchodilation on expiratory flow limitation and resting lung mechanics in COPD.
Topics: Albuterol; Bronchodilator Agents; Female; Forced Expiratory Volume; Humans; Inspiratory Capacity; Le | 2009 |
Effect of bronchodilation on expiratory flow limitation and resting lung mechanics in COPD.
Topics: Albuterol; Bronchodilator Agents; Female; Forced Expiratory Volume; Humans; Inspiratory Capacity; Le | 2009 |
Effect of bronchodilation on expiratory flow limitation and resting lung mechanics in COPD.
Topics: Albuterol; Bronchodilator Agents; Female; Forced Expiratory Volume; Humans; Inspiratory Capacity; Le | 2009 |
Effect of bronchodilation on expiratory flow limitation and resting lung mechanics in COPD.
Topics: Albuterol; Bronchodilator Agents; Female; Forced Expiratory Volume; Humans; Inspiratory Capacity; Le | 2009 |
Effect of bronchodilation on expiratory flow limitation and resting lung mechanics in COPD.
Topics: Albuterol; Bronchodilator Agents; Female; Forced Expiratory Volume; Humans; Inspiratory Capacity; Le | 2009 |
Effect of bronchodilation on expiratory flow limitation and resting lung mechanics in COPD.
Topics: Albuterol; Bronchodilator Agents; Female; Forced Expiratory Volume; Humans; Inspiratory Capacity; Le | 2009 |
Effect of bronchodilation on expiratory flow limitation and resting lung mechanics in COPD.
Topics: Albuterol; Bronchodilator Agents; Female; Forced Expiratory Volume; Humans; Inspiratory Capacity; Le | 2009 |
Effect of bronchodilation on expiratory flow limitation and resting lung mechanics in COPD.
Topics: Albuterol; Bronchodilator Agents; Female; Forced Expiratory Volume; Humans; Inspiratory Capacity; Le | 2009 |
Association between CRHR1 polymorphism and improved lung function in response to inhaled corticosteroid in patients with COPD.
Topics: Administration, Inhalation; Adrenal Cortex Hormones; Aged; Albuterol; Androstadienes; Bronchodilator | 2009 |
TORCH and UPLIFT: what has been learned from the COPD "mega-trials"?
Topics: Albuterol; Androstadienes; Bronchodilator Agents; Drug Combinations; Fluticasone-Salmeterol Drug Com | 2009 |
Effect of pharmacotherapy on rate of decline of FEV(1) in the TORCH study.
Topics: Albuterol; Androstadienes; Bronchodilator Agents; Disease Progression; Fluticasone; Forced Expirator | 2009 |
Diagnostic value of post-bronchodilator pulmonary function testing to distinguish between stable, moderate to severe COPD and asthma.
Topics: Administration, Inhalation; Albuterol; Asthma; Bronchodilator Agents; Diagnosis, Differential; Femal | 2008 |
Reflections on TORCH: potential mechanisms for the survival benefit of salmeterol/fluticasone propionate in COPD patients.
Topics: Albuterol; Androstadienes; Anti-Inflammatory Agents; Bronchodilator Agents; Drug Combinations; Fluti | 2008 |
Cost-effectiveness of salmeterol, fluticasone, and combination therapy for COPD.
Topics: Aged; Albuterol; Androstadienes; Bronchodilator Agents; Cost-Benefit Analysis; Drug Therapy, Combina | 2009 |
Fluticasone/salmeterol: labeling change.
Topics: Albuterol; Androstadienes; Asthma; Bronchodilator Agents; Drug Approval; Drug Labeling; Drug Therapy | 2008 |
Bronchodilation in COPD: beyond FEV1-the effect of albuterol on resistive and reactive properties of the respiratory system.
Topics: Aged; Airway Resistance; Albuterol; Bronchodilator Agents; Female; Forced Expiratory Volume; Humans; | 2009 |
An analysis of the utilisation and expenditure of medicines dispensed for the management of severe asthma.
Topics: Adrenal Cortex Hormones; Adrenergic beta-Agonists; Adult; Aged; Albuterol; Anti-Asthmatic Agents; As | 2009 |
Expected value of perfect information: an empirical example of reducing decision uncertainty by conducting additional research.
Topics: Albuterol; Bronchodilator Agents; Cost-Benefit Analysis; Ipratropium; Markov Chains; Models, Econome | 2008 |
Effects of inhalational bronchodilator treatment during noninvasive ventilation in severe chronic obstructive pulmonary disease exacerbations.
Topics: Acute Disease; Administration, Inhalation; Aged; Aged, 80 and over; Albuterol; Blood Gas Analysis; B | 2009 |
Treatment of acute bronchospasm in elderly patients.
Topics: Acute Disease; Adrenal Cortex Hormones; Age Factors; Aged; Aged, 80 and over; Aging; Albuterol; Asth | 2005 |
Acute bronchospasm from the patient's perspective.
Topics: Acute Disease; Adrenal Cortex Hormones; Adrenergic beta-Agonists; Albuterol; Asthma; Bronchial Spasm | 2005 |
Hospital and emergency department utilization associated with treatment for chronic obstructive pulmonary disease in a managed-care Medicare population.
Topics: Administration, Inhalation; Adult; Aged; Albuterol; Androstadienes; Comoros; Cost of Illness; Drug C | 2009 |
[Diagnostic value of peak flow variability in patients with suspected diagnosis of bronchial asthma in general practice].
Topics: Albuterol; Asthma; Bronchial Provocation Tests; Bronchoconstrictor Agents; Bronchodilator Agents; Di | 2009 |
Parasternal muscle activity decreases in severe COPD with salmeterol-fluticasone propionate.
Topics: Administration, Inhalation; Adrenergic beta-Agonists; Aged; Albuterol; Androstadienes; Bronchodilato | 2010 |
Healthcare costs associated with initial maintenance therapy with fluticasone propionate 250 μg/salmeterol 50 μg combination versus anticholinergic bronchodilators in elderly US Medicare-eligible beneficiaries with COPD.
Topics: Aged; Albuterol; Androstadienes; Bronchodilator Agents; Disease Progression; Drug Therapy, Combinati | 2009 |
Summaries for patients. Effect of treatment with fluticasone with and without salmeterol on airway inflammation and lung function in patients with chronic obstructive pulmonary disease: a randomized trial.
Topics: Administration, Inhalation; Aged; Albuterol; Androstadienes; Bronchodilator Agents; Drug Administrat | 2009 |
Nebulized formoterol provides added benefits to tiotropium treatment in chronic obstructive pulmonary disease.
Topics: Aged; Albuterol; Bronchodilator Agents; Double-Blind Method; Drug Therapy, Combination; Dyspnea; Eth | 2009 |
Pneumonia among COPD patients using inhaled corticosteroids and long-acting bronchodilators.
Topics: Administration, Inhalation; Adrenal Cortex Hormones; Adult; Age Factors; Aged; Albuterol; Androstadi | 2010 |
Economic analyses comparing tiotropium with ipratropium or salmeterol in UK patients with COPD.
Topics: Albuterol; Bronchodilator Agents; Cost-Benefit Analysis; Humans; Ipratropium; Models, Econometric; M | 2010 |
[Debates surrounding COPD].
Topics: Administration, Inhalation; Adrenal Cortex Hormones; Albuterol; Androstadienes; Anti-Inflammatory Ag | 2010 |
New evidence in pulmonary and preventive medicine.
Topics: Adrenergic beta-Agonists; Albuterol; Aminopyridines; Benzamides; Breast Neoplasms; Bronchodilator Ag | 2010 |
[Agonists of beta2 adrenergic receptor in the therapy of obstructive diseases].
Topics: Adrenergic beta-2 Receptor Agonists; Adrenergic beta-Agonists; Albuterol; Arrhythmias, Cardiac; Card | 2010 |
Use of ozone-depleting substances; removal of essential-use designation (flunisolide, etc.). Final rule.
Topics: Air Pollutants; Air Pollution; Albuterol; Anti-Asthmatic Agents; Asthma; Atmosphere; Bronchodilator | 2010 |
TORCH study results: pharmacotherapy reduces lung function decline in patients with chronic obstructive pulmonary disease.
Topics: Administration, Inhalation; Aged; Albuterol; Androstadienes; Body Mass Index; Bronchodilator Agents; | 2010 |
beta2-agonists promote host defense against bacterial infection in primary human bronchial epithelial cells.
Topics: Adrenergic Agonists; Adrenergic beta-2 Receptor Agonists; Adult; Aged; Albuterol; Asthma; Bacterial | 2010 |
Safety of inhaled corticosteroids in chronic obstructive pulmonary disease (COPD).
Topics: Administration, Inhalation; Adrenal Cortex Hormones; Albuterol; Androstadienes; Budesonide; Budesoni | 2010 |
Outpatient management of severe COPD.
Topics: Administration, Inhalation; Albuterol; Bronchodilator Agents; Drug Therapy, Combination; Humans; Myo | 2010 |
Relative effectiveness of budesonide/formoterol and fluticasone propionate/salmeterol in a 1-year, population-based, matched cohort study of patients with chronic obstructive pulmonary disease (COPD): Effect on COPD-related exacerbations, emergency depart
Topics: Administration, Inhalation; Adult; Aged; Aged, 80 and over; Albuterol; Androstadienes; Bronchodilato | 2010 |
Predictive factors for evaluation of response to fluticasone propionate/salmeterol combination in severe COPD.
Topics: Administration, Inhalation; Aged; Albuterol; Androstadienes; Bronchodilator Agents; Drug Combination | 2011 |
Cost-effectiveness of combination fluticasone propionate-salmeterol 250/50 microg versus salmeterol in severe COPD patients.
Topics: Aged; Albuterol; Androstadienes; Bronchodilator Agents; Cost-Benefit Analysis; Drug Combinations; Dr | 2010 |
A new method for examining the cost savings of reducing COPD exacerbations.
Topics: Adult; Age Factors; Aged; Aged, 80 and over; Albuterol; Bronchodilator Agents; Computer Simulation; | 2010 |
Rosiglitazone reverses salbutamol-induced β(2) -adrenoceptor tolerance in airway smooth muscle.
Topics: Adrenergic beta-2 Receptor Agonists; Albuterol; Animals; Asthma; Carbachol; Cells, Cultured; Dexamet | 2011 |
Best evidence topic reports. BET 2: Should I use 2.5 mg or 5 mg nebulised salbutamol in acute exacerbations of COPD?
Topics: Acute Disease; Administration, Inhalation; Albuterol; Evidence-Based Medicine; Humans; Nebulizers an | 2010 |
Disease severity and symptoms among patients receiving monotherapy for COPD.
Topics: Administration, Inhalation; Adult; Age Factors; Aged; Albuterol; Bronchodilator Agents; Comorbidity; | 2011 |
Long-term use of fluticasone propionate/salmeterol fixed-dose combination and incidence of nonvertebral fractures among patients with COPD in the UK General Practice Research Database.
Topics: Administration, Inhalation; Aged; Aged, 80 and over; Albuterol; Androstadienes; Anti-Inflammatory Ag | 2010 |
Bias due to withdrawal in long-term randomised trials in COPD: evidence from the TORCH study.
Topics: Albuterol; Androstadienes; Bias; Bronchodilator Agents; Drug Combinations; Fluticasone-Salmeterol Dr | 2011 |
Lung hyperinflation and its reversibility in patients with airway obstruction of varying severity.
Topics: Aged; Airway Obstruction; Albuterol; Asthma; Bronchodilator Agents; Female; Humans; Lung Volume Meas | 2010 |
Cardio- and cerebrovascular safety of indacaterol vs formoterol, salmeterol, tiotropium and placebo in COPD.
Topics: Adult; Albuterol; Bronchodilator Agents; Cardiovascular Diseases; Cerebrovascular Disorders; Ethanol | 2011 |
Cardio- and cerebrovascular safety of indacaterol vs formoterol, salmeterol, tiotropium and placebo in COPD.
Topics: Adult; Albuterol; Bronchodilator Agents; Cardiovascular Diseases; Cerebrovascular Disorders; Ethanol | 2011 |
Cardio- and cerebrovascular safety of indacaterol vs formoterol, salmeterol, tiotropium and placebo in COPD.
Topics: Adult; Albuterol; Bronchodilator Agents; Cardiovascular Diseases; Cerebrovascular Disorders; Ethanol | 2011 |
Cardio- and cerebrovascular safety of indacaterol vs formoterol, salmeterol, tiotropium and placebo in COPD.
Topics: Adult; Albuterol; Bronchodilator Agents; Cardiovascular Diseases; Cerebrovascular Disorders; Ethanol | 2011 |
Cardio- and cerebrovascular safety of indacaterol vs formoterol, salmeterol, tiotropium and placebo in COPD.
Topics: Adult; Albuterol; Bronchodilator Agents; Cardiovascular Diseases; Cerebrovascular Disorders; Ethanol | 2011 |
Cardio- and cerebrovascular safety of indacaterol vs formoterol, salmeterol, tiotropium and placebo in COPD.
Topics: Adult; Albuterol; Bronchodilator Agents; Cardiovascular Diseases; Cerebrovascular Disorders; Ethanol | 2011 |
Cardio- and cerebrovascular safety of indacaterol vs formoterol, salmeterol, tiotropium and placebo in COPD.
Topics: Adult; Albuterol; Bronchodilator Agents; Cardiovascular Diseases; Cerebrovascular Disorders; Ethanol | 2011 |
Cardio- and cerebrovascular safety of indacaterol vs formoterol, salmeterol, tiotropium and placebo in COPD.
Topics: Adult; Albuterol; Bronchodilator Agents; Cardiovascular Diseases; Cerebrovascular Disorders; Ethanol | 2011 |
Cardio- and cerebrovascular safety of indacaterol vs formoterol, salmeterol, tiotropium and placebo in COPD.
Topics: Adult; Albuterol; Bronchodilator Agents; Cardiovascular Diseases; Cerebrovascular Disorders; Ethanol | 2011 |
Effect of albuterol on expiratory resistance in mechanically ventilated patients.
Topics: Administration, Inhalation; Aged; Airway Resistance; Albuterol; Bronchodilator Agents; Dose-Response | 2011 |
Comparative cost-effectiveness of a fluticasone-propionate/salmeterol combination versus anticholinergics as initial maintenance therapy for chronic obstructive pulmonary disease.
Topics: Aged; Albuterol; Ambulatory Care; Androstadienes; Cholinergic Antagonists; Cost-Benefit Analysis; Dr | 2010 |
Albuterol and levalbuterol use and spending in Medicare beneficiaries with chronic obstructive pulmonary disease.
Topics: Adrenergic beta-2 Receptor Agonists; Age Factors; Aged; Aged, 80 and over; Albuterol; Bronchodilator | 2010 |
Functional and biochemical rationales for the 24-hour-long duration of action of olodaterol.
Topics: Administration, Inhalation; Adrenergic beta-2 Receptor Agonists; Albuterol; Animals; Asthma; Benzoxa | 2011 |
Predictors of pulmonary function response to treatment with salmeterol/fluticasone in patients with chronic obstructive pulmonary disease.
Topics: Aged; Albuterol; Androstadienes; Bronchodilator Agents; Emphysema; Female; Fluticasone; Humans; Line | 2011 |
Choice of bronchodilator therapy for patients with COPD.
Topics: Adrenergic beta-2 Receptor Agonists; Albuterol; Bronchodilator Agents; Cholinergic Antagonists; Drug | 2011 |
Fast-track pulmonary conditioning before urgent cardiac surgery in patients with insufficiently treated chronic obstructive pulmonary disease.
Topics: Aged; Airway Resistance; Albuterol; Ambroxol; Bronchodilator Agents; Budesonide; Cardiac Surgical Pr | 2011 |
COPD-related healthcare utilization and costs after discharge from a hospitalization or emergency department visit on a regimen of fluticasone propionate-salmeterol combination versus other maintenance therapies.
Topics: Aged; Albuterol; Androstadienes; Cohort Studies; Databases, Factual; Drug Combinations; Drug Costs; | 2011 |
Comparison of efficacy of long-acting bronchodilators in emphysema dominant and emphysema nondominant chronic obstructive pulmonary disease.
Topics: Adrenergic beta-2 Receptor Agonists; Aged; Albuterol; Bronchodilator Agents; Exercise Test; Exercise | 2011 |
Tiotropium versus salmeterol in COPD.
Topics: Administration, Inhalation; Adrenergic beta-2 Receptor Agonists; Albuterol; Bronchodilator Agents; C | 2011 |
Tiotropium versus salmeterol in COPD.
Topics: Administration, Inhalation; Adrenergic beta-2 Receptor Agonists; Albuterol; Bronchodilator Agents; C | 2011 |
Tiotropium versus salmeterol in COPD.
Topics: Adrenergic beta-2 Receptor Agonists; Albuterol; Bronchodilator Agents; Cholinergic Antagonists; Drug | 2011 |
Tiotropium versus salmeterol in COPD.
Topics: Administration, Inhalation; Albuterol; Bronchodilator Agents; Humans; Pulmonary Disease, Chronic Obs | 2011 |
Cost-utility analysis of indacaterol in Germany: a once-daily maintenance bronchodilator for patients with COPD.
Topics: Albuterol; Bronchodilator Agents; Cost-Benefit Analysis; Female; Forced Expiratory Volume; Germany; | 2011 |
Chronic obstructive pulmonary disease: quantification of bronchodilator effects by using hyperpolarized ³He MR imaging.
Topics: Aged; Albuterol; Bronchodilator Agents; Female; Helium; Humans; Isotopes; Magnetic Resonance Imaging | 2011 |
Beta2-adrenergic receptor polymorphisms as a determinant of preferential bronchodilator responses to β2-agonist and anticholinergic agents in Japanese patients with chronic obstructive pulmonary disease.
Topics: Adrenergic beta-2 Receptor Agonists; Aged; Albuterol; Asian People; Bronchodilator Agents; Cholinerg | 2011 |
Outcomes and costs associated with initial maintenance therapy with fluticasone propionate-salmeterol xinafoate 250 microg/50 microg combination versus tiotropium in commercially insured patients with COPD.
Topics: Adult; Aged; Aged, 80 and over; Albuterol; Androstadienes; Cohort Studies; Drug Combinations; Drug C | 2011 |
Comparative effectiveness of budesonide/formoterol and fluticasone/salmeterol for COPD management.
Topics: Aged; Albuterol; Androstadienes; Bronchodilator Agents; Budesonide; Comorbidity; Costs and Cost Anal | 2011 |
Long-term use of fluticasone propionate/salmeterol fixed-dose combination and incidence of cataracts and glaucoma among chronic obstructive pulmonary disease patients in the UK General Practice Research Database.
Topics: Adrenergic beta-2 Receptor Agonists; Aged; Aged, 80 and over; Albuterol; Androstadienes; Bronchodila | 2011 |
Long-term use of fluticasone propionate/salmeterol fixed-dose combination and incidence of cataracts and glaucoma among chronic obstructive pulmonary disease patients in the UK General Practice Research Database.
Topics: Adrenergic beta-2 Receptor Agonists; Aged; Aged, 80 and over; Albuterol; Androstadienes; Bronchodila | 2011 |
Long-term use of fluticasone propionate/salmeterol fixed-dose combination and incidence of cataracts and glaucoma among chronic obstructive pulmonary disease patients in the UK General Practice Research Database.
Topics: Adrenergic beta-2 Receptor Agonists; Aged; Aged, 80 and over; Albuterol; Androstadienes; Bronchodila | 2011 |
Long-term use of fluticasone propionate/salmeterol fixed-dose combination and incidence of cataracts and glaucoma among chronic obstructive pulmonary disease patients in the UK General Practice Research Database.
Topics: Adrenergic beta-2 Receptor Agonists; Aged; Aged, 80 and over; Albuterol; Androstadienes; Bronchodila | 2011 |
Long-term use of fluticasone propionate/salmeterol fixed-dose combination and incidence of cataracts and glaucoma among chronic obstructive pulmonary disease patients in the UK General Practice Research Database.
Topics: Adrenergic beta-2 Receptor Agonists; Aged; Aged, 80 and over; Albuterol; Androstadienes; Bronchodila | 2011 |
Long-term use of fluticasone propionate/salmeterol fixed-dose combination and incidence of cataracts and glaucoma among chronic obstructive pulmonary disease patients in the UK General Practice Research Database.
Topics: Adrenergic beta-2 Receptor Agonists; Aged; Aged, 80 and over; Albuterol; Androstadienes; Bronchodila | 2011 |
Long-term use of fluticasone propionate/salmeterol fixed-dose combination and incidence of cataracts and glaucoma among chronic obstructive pulmonary disease patients in the UK General Practice Research Database.
Topics: Adrenergic beta-2 Receptor Agonists; Aged; Aged, 80 and over; Albuterol; Androstadienes; Bronchodila | 2011 |
Long-term use of fluticasone propionate/salmeterol fixed-dose combination and incidence of cataracts and glaucoma among chronic obstructive pulmonary disease patients in the UK General Practice Research Database.
Topics: Adrenergic beta-2 Receptor Agonists; Aged; Aged, 80 and over; Albuterol; Androstadienes; Bronchodila | 2011 |
Long-term use of fluticasone propionate/salmeterol fixed-dose combination and incidence of cataracts and glaucoma among chronic obstructive pulmonary disease patients in the UK General Practice Research Database.
Topics: Adrenergic beta-2 Receptor Agonists; Aged; Aged, 80 and over; Albuterol; Androstadienes; Bronchodila | 2011 |
[Validation of the Spanish version of the Chronic Obstructive Pulmonary Disease-Population Screener (COPD-PS). Its usefulness and that of FEV₁/FEV₆ for the diagnosis of COPD].
Topics: Aged; Albuterol; Area Under Curve; Bronchodilator Agents; Cross-Sectional Studies; Female; Forced Ex | 2012 |
An evaluation of inhaled bronchodilator therapy in patients hospitalized for non-life-threatening COPD exacerbations.
Topics: Administration, Inhalation; Adult; Aged; Aged, 80 and over; Albuterol; Bronchodilator Agents; Drug A | 2011 |
Inhaled therapy for acute COPD exacerbation in the hospital: are we missing the low-hanging fruit?
Topics: Albuterol; Bronchodilator Agents; Ethanolamines; Female; Formoterol Fumarate; Guideline Adherence; H | 2011 |
Long-acting β-agonists in asthma management: what is the current status?
Topics: Administration, Inhalation; Adrenal Cortex Hormones; Adrenergic beta-Agonists; Albuterol; Anti-Asthm | 2011 |
Response patterns to bronchodilator and quantitative computed tomography in chronic obstructive pulmonary disease.
Topics: Administration, Inhalation; Aged; Albuterol; Bronchodilator Agents; Female; Forced Expiratory Volume | 2012 |
Evaluating bronchodilator effects in chronic obstructive pulmonary disease using diffusion-weighted hyperpolarized helium-3 magnetic resonance imaging.
Topics: Aged; Albuterol; Bronchodilator Agents; Female; Helium; Humans; Isotopes; Lung; Male; Middle Aged; P | 2012 |
Corticosteroid insensitivity is reversed by formoterol via phosphoinositide-3-kinase inhibition.
Topics: 1-Phosphatidylinositol 4-Kinase; Adenine; Adrenal Cortex Hormones; Adrenergic beta-2 Receptor Agonis | 2012 |
Clinical and economic outcomes for patients initiating fluticasone propionate/salmeterol combination therapy (250/50 mcg) versus anticholinergics in a comorbid COPD/depression population.
Topics: Adult; Albuterol; Androstadienes; Cholinergic Antagonists; Cost of Illness; Depression; Drug Combina | 2012 |
Not quite a breath of fresh air: use of combination inhalers in COPD.
Topics: Administration, Inhalation; Adrenergic beta-2 Receptor Agonists; Albuterol; Androstadienes; Canada; | 2012 |
Observational study on the impact of initiating tiotropium alone versus tiotropium with fluticasone propionate/salmeterol combination therapy on outcomes and costs in chronic obstructive pulmonary disease.
Topics: Aged; Albuterol; Androstadienes; Bronchodilator Agents; Disease Progression; Drug Combinations; Drug | 2012 |
Levosalbutamol for chronic obstructive pulmonary disease: a treatment evaluation.
Topics: Adrenergic beta-Agonists; Albuterol; Animals; Clinical Trials as Topic; Humans; Pulmonary Disease, C | 2012 |
Side-effects of roflumilast.
Topics: Albuterol; Aminopyridines; Benzamides; Bronchodilator Agents; Female; Humans; Male; Phosphodiesteras | 2012 |
Rehospitalization risks and outcomes in COPD patients receiving maintenance pharmacotherapy.
Topics: Adult; Aged; Albuterol; Androstadienes; Bronchodilator Agents; Cholinergic Antagonists; Drug Combina | 2012 |
Prevalence of chronic obstructive pulmonary disease in Cyprus: a population-based study.
Topics: Aged; Albuterol; Bronchodilator Agents; Cross-Sectional Studies; Cyprus; Female; Humans; Male; Middl | 2012 |
Clinical and economic outcomes in an observational study of COPD maintenance therapies: multivariable regression versus propensity score matching.
Topics: Adrenal Cortex Hormones; Adrenergic beta-2 Receptor Agonists; Aged; Albuterol; Ambulatory Care; Andr | 2012 |
Characteristics of AZD9708, a novel, selective β2-adrenoceptor agonist with rapid onset and long duration of action.
Topics: Adenosine Monophosphate; Adrenergic beta-2 Receptor Agonists; Albuterol; Animals; Asthma; Benzothiaz | 2012 |
Risperidone-related bilateral cystoid macular oedema.
Topics: Aged; Albuterol; Antipsychotic Agents; Bronchodilator Agents; Depressive Disorder; Female; Fluoresce | 2013 |
[Treatment of mild exacerbations of chronic obstructive pulmonary disease].
Topics: Adult; Aged; Albuterol; Bromhexine; Expectorants; Female; Humans; Male; Middle Aged; Pulmonary Disea | 2012 |
Bronchodilator responsiveness as a phenotypic characteristic of established chronic obstructive pulmonary disease.
Topics: Adult; Aged; Albuterol; Bronchodilator Agents; Female; Forced Expiratory Volume; Humans; Longitudina | 2012 |
Breath-actuated nebulizer for patients with exacerbation of COPD: efficiency and cost.
Topics: Albuterol; Bronchodilator Agents; Female; Humans; Ipratropium; Male; Nebulizers and Vaporizers; Pulm | 2012 |
Pharmacologic bronchodilation response to salbutamol in COPD patients.
Topics: Adrenergic beta-2 Receptor Agonists; Adult; Aged; Albuterol; Bronchi; Bronchial Provocation Tests; C | 2010 |
Acute bronchodilation increases ventilatory complexity during resting breathing in stable COPD: toward mathematical biomarkers of ventilatory function?
Topics: Aged; Albuterol; Bronchodilator Agents; Dose-Response Relationship, Drug; Female; Humans; Male; Midd | 2013 |
Attenuation of inhibitory prostaglandin E2 signaling in human lung fibroblasts is mediated by phosphodiesterase 4.
Topics: Adrenergic beta-2 Receptor Agonists; Albuterol; Aminopyridines; Benzamides; Cells, Cultured; Chemota | 2012 |
In vitro pharmacological characterization of vilanterol, a novel long-acting β2-adrenoceptor agonist with 24-hour duration of action.
Topics: Adrenergic beta-2 Receptor Agonists; Adrenergic beta-3 Receptor Antagonists; Albuterol; Animals; Ben | 2013 |
Management of COPD in general practice.
Topics: Aged; Albuterol; Asthma; Australia; Bronchodilator Agents; Comorbidity; Female; General Practice; Hu | 2012 |
[Diagnostic and treatment of chronic obstructive pulmonary disease based on GOLD statement 2011].
Topics: Albuterol; Bronchodilator Agents; Drug Therapy, Combination; Forced Expiratory Volume; Humans; Pract | 2012 |
Hybrids consisting of the pharmacophores of salmeterol and roflumilast or phthalazinone: dual β₂-adrenoceptor agonists-PDE4 inhibitors for the treatment of COPD.
Topics: Adrenergic beta-2 Receptor Agonists; Albuterol; Aminopyridines; Benzamides; Bronchodilator Agents; C | 2013 |
Beta-adrenergic receptor-mediated growth of human airway epithelial cell lines.
Topics: Adrenergic beta-Agonists; Albuterol; Blotting, Western; Bronchi; Cell Division; Cell Line; Cyclic AM | 2002 |
[Beta mimetic drug plus steroid. Powerful duo also in COPD].
Topics: Albuterol; Androstadienes; Clinical Trials as Topic; Drug Combinations; Fluticasone; Humans; Pulmona | 2002 |
Delivery of ipratropium and albuterol combination therapy for chronic obstructive pulmonary disease: effectiveness of a two-in-one inhaler versus separate inhalers.
Topics: Administration, Inhalation; Adult; Aged; Albuterol; Bronchodilator Agents; Cohort Studies; Drug Ther | 2002 |
Medical therapy for COPD: lessons from the real world.
Topics: Administration, Inhalation; Aged; Albuterol; Androstadienes; Female; Fluticasone; Humans; Male; Midd | 2002 |
Survival in COPD patients after regular use of fluticasone propionate and salmeterol in general practice.
Topics: Administration, Inhalation; Aged; Albuterol; Androstadienes; Anti-Inflammatory Agents; Case-Control | 2002 |
Selecting the best method to evaluate bronchodilation when analysing bronchodilator studies.
Topics: Age Factors; Aged; Albuterol; Asthma; Bronchodilator Agents; Female; Forced Expiratory Volume; Human | 2002 |
In vitro evaluation of aerosol bronchodilator delivery during noninvasive positive pressure ventilation: effect of ventilator settings and nebulizer position.
Topics: Aerosols; Albuterol; Analysis of Variance; Asthma; Bronchodilator Agents; Drug Delivery Systems; Hum | 2002 |
Inspiratory capacity and decrease in lung hyperinflation with albuterol in COPD.
Topics: Administration, Inhalation; Aged; Albuterol; Bronchodilator Agents; Forced Expiratory Flow Rates; Fu | 2002 |
[Combination of beta-1 agonist and corticosteroid is advantageous not only in asthma. COPD patients spared exacerbations].
Topics: Administration, Inhalation; Administration, Topical; Adrenergic beta-Agonists; Albuterol; Androstadi | 2002 |
Levalbuterol compared to racemic albuterol: efficacy and outcomes in patients hospitalized with COPD or asthma.
Topics: Adrenergic beta-Agonists; Albuterol; Asthma; Female; Hospitalization; Humans; Male; Middle Aged; Pul | 2003 |
Bronchodilation test in COPD: effect of inspiratory manoeuvre preceding forced expiration.
Topics: Adrenergic beta-Agonists; Aged; Albuterol; Bronchodilator Agents; Female; Forced Expiratory Volume; | 2003 |
COPD: treatments benefit patients.
Topics: Administration, Inhalation; Adrenergic beta-Agonists; Albuterol; Androstadienes; Anti-Inflammatory A | 2003 |
[The MMW Drug Prize 2002: Prize for a new classic with innovation potential].
Topics: Administration, Topical; Adrenergic beta-Agonists; Albuterol; Androstadienes; Anti-Inflammatory Agen | 2002 |
Survival in COPD patients after regular use of fluticasone propionate and salmeterol.
Topics: Administration, Inhalation; Albuterol; Androstadienes; Cause of Death; Dose-Response Relationship, D | 2003 |
[Acoustic follow-up of nocturnal bronchial obstruction therapy].
Topics: Adrenergic beta-Agonists; Adult; Aged; Albuterol; Bronchodilator Agents; Female; Humans; Male; Middl | 2003 |
Long-term treatment benefits with tiotropium in COPD patients with and without short-term bronchodilator responses.
Topics: Adrenergic beta-Agonists; Aged; Albuterol; Bronchodilator Agents; Cholinergic Antagonists; Female; F | 2003 |
Combined salmeterol and fluticasone for COPD.
Topics: Administration, Inhalation; Albuterol; Androstadienes; Bronchodilator Agents; Drug Therapy, Combinat | 2003 |
Combined salmeterol and fluticasone for COPD.
Topics: Albuterol; Androstadienes; Clinical Trials as Topic; Cost-Benefit Analysis; Drug Therapy, Combinatio | 2003 |
Combined salmeterol and fluticasone for COPD.
Topics: Albuterol; Androstadienes; Drug Therapy, Combination; Endpoint Determination; Fluticasone; Humans; P | 2003 |
Combined salmeterol and fluticasone for COPD.
Topics: Albuterol; Androstadienes; Fluticasone; Humans; Patient Dropouts; Pulmonary Disease, Chronic Obstruc | 2003 |
Combined salmeterol and fluticasone for COPD.
Topics: Albuterol; Androstadienes; Fluticasone; Forced Expiratory Volume; Humans; Pulmonary Disease, Chronic | 2003 |
Combined salmeterol and fluticasone for COPD.
Topics: Administration, Inhalation; Albuterol; Androstadienes; Bronchodilator Agents; Cholinergic Antagonist | 2003 |
Prescribing and administration of nebulized bronchodilators: a prospective audit in a university hospital.
Topics: Administration, Inhalation; Adolescent; Adult; Aged; Aged, 80 and over; Albuterol; Bronchodilator Ag | 2003 |
[New studies refute steroid opponents. COPD--after all a case for corticosteroids?].
Topics: Administration, Inhalation; Administration, Oral; Adrenergic beta-Agonists; Albuterol; Androstadiene | 2003 |
Bronchodilator reversibility testing in chronic obstructive pulmonary disease.
Topics: Adult; Aged; Albuterol; Bronchodilator Agents; Female; Follow-Up Studies; Forced Expiratory Volume; | 2003 |
[Efficacy of bronchodilators: searching for objective criteria].
Topics: Administration, Inhalation; Adrenergic beta-Agonists; Albuterol; Bronchodilator Agents; Dyspnea; Exe | 2003 |
Levalbuterol is not more cost-effective than albuterol for COPD.
Topics: Albuterol; Asthma; Bias; Bronchodilator Agents; Cost-Benefit Analysis; Hospitalization; Humans; Pulm | 2003 |
[Influence of orthopnoea position on spirometric and plethysmographic parameters in patients with chronic obstructive pulmonary disease ].
Topics: Adrenergic beta-Agonists; Aged; Albuterol; Bronchodilator Agents; Case-Control Studies; Dyspnea; Fem | 2003 |
[Salmeterol + fluticasone in COPD. Complementary treatment principles hold true in the COPD management, too].
Topics: Adrenergic beta-Agonists; Albuterol; Androstadienes; Anti-Inflammatory Agents; Bronchodilator Agents | 2003 |
The use of inhaled and related respiratory medications in Christchurch rest homes.
Topics: Administration, Inhalation; Adrenal Cortex Hormones; Adrenergic beta-Agonists; Aged; Aged, 80 and ov | 2003 |
Risk factors of emergency care and admissions in COPD patients with high consumption of health resources.
Topics: Administration, Inhalation; Aged; Albuterol; Arrhythmias, Cardiac; Bronchodilator Agents; Case-Contr | 2004 |
A nitric oxide-releasing salbutamol elicits potent relaxant and anti-inflammatory activities.
Topics: Albuterol; Animals; Anti-Inflammatory Agents; Bronchoalveolar Lavage; Bronchodilator Agents; Cell Mo | 2004 |
Breathlessness during exercise in COPD: how do the drugs work?
Topics: Albuterol; Bronchodilator Agents; Dyspnea; Exercise; Humans; Pulmonary Disease, Chronic Obstructive; | 2004 |
Effect of heliox breathing on dynamic hyperinflation in COPD patients.
Topics: Aged; Airway Resistance; Albuterol; Bronchodilator Agents; Female; Helium; Humans; Inspiratory Capac | 2004 |
A comparison of lung function methods for assessing dose-response effects of salbutamol.
Topics: Adult; Aged; Albuterol; Asthma; Bronchodilator Agents; Dose-Response Relationship, Drug; Female; For | 2004 |
Differentiating asthma and COPD patients.
Topics: Albuterol; Androstadienes; Asthma; Drug Therapy, Combination; Fluticasone; Forced Expiratory Volume; | 2004 |
Tiotropium: a new, long-acting agent for the management of COPD--a clinical review.
Topics: Administration, Inhalation; Aged; Albuterol; Bronchodilator Agents; Cholinergic Antagonists; Hospita | 2004 |
Tremor side effects of salbutamol, quantified by a laser pointer technique.
Topics: Adolescent; Adult; Aged; Aged, 80 and over; Albuterol; Asthma; Bronchodilator Agents; Child; Child, | 2004 |
[Spirometric reversibility to salbutamol in chronic obstructive pulmonary disease (COPD). Differential effects on FEV1 and on lung volumes].
Topics: Administration, Inhalation; Aged; Aged, 80 and over; Albuterol; Bronchodilator Agents; Female; Force | 2004 |
Evaluating assumptions for least squares analysis using the general linear model: a guide for the pharmaceutical industry statistician.
Topics: Aging; Albuterol; Androstadienes; Bronchodilator Agents; Data Interpretation, Statistical; Drug Indu | 2004 |
Acute myocardial infarction associated with albuterol.
Topics: Adrenergic beta-Agonists; Aged; Aged, 80 and over; Albuterol; Dose-Response Relationship, Drug; Elec | 2004 |
[Lung function and exercise tolerance after treatment with salmeterol or ipratropium bromide in chronic obstructive pulmonary disease].
Topics: Aged; Albuterol; Bronchodilator Agents; Drug Therapy, Combination; Exercise Tolerance; Female; Human | 2004 |
Effects of salmeterol on cilia and mucus in COPD and pneumonia patients.
Topics: Albuterol; Cilia; Community-Acquired Infections; Female; Humans; Male; Mucus; Pneumonia; Pulmonary D | 2005 |
Short-acting inhaled beta-2-agonists increased the mortality from chronic obstructive pulmonary disease in observational designs.
Topics: Adrenergic beta-Agonists; Aged; Aged, 80 and over; Albuterol; Bronchodilator Agents; Dose-Response R | 2005 |
Ventolin Diskus and Inspyril Turbuhaler: an in vitro comparison.
Topics: Administration, Inhalation; Aged; Albuterol; Asthma; Computer Simulation; Equipment Design; Female; | 2005 |
A respiratory therapist-directed protocol for managing inpatients with asthma and COPD incorporating a long-acting bronchodilator.
Topics: Albuterol; Asthma; Bronchodilator Agents; Clinical Protocols; Delayed-Action Preparations; Drug Ther | 2005 |
Measuring bronchodilation in COPD clinical trials.
Topics: Albuterol; Bronchi; Bronchodilator Agents; Clinical Trials as Topic; Dose-Response Relationship, Dru | 2005 |
A comparison of the risk of hospitalizations due to chronicobstructive pulmonary disease in medicaid patients with various medication regimens, including ipratropium, inhaled corticosteroids, salmeterol, or their combination.
Topics: Administration, Inhalation; Albuterol; Bronchodilator Agents; Drug Therapy, Combination; Female; Glu | 2005 |
Automatic replacement of albuterol nebulizer therapy by metered-dose inhaler and valved holding chamber.
Topics: Adult; Aged; Albuterol; Bronchodilator Agents; Child; Child, Preschool; Dose-Response Relationship, | 2005 |
[Cost-effectiveness analysis of tiotropium compared to ipratropium and salmeterol].
Topics: Adult; Aged; Albuterol; Bronchodilator Agents; Cost-Benefit Analysis; Drug Costs; Economics, Pharmac | 2005 |
Inhibition of in vitro neutrophil migration through a bilayer of endothelial and epithelial cells using beta2-agonists: concomitant effects on IL-8 and elastase secretion and impact of glucocorticosteroids.
Topics: Adrenergic beta-Agonists; Albuterol; Anti-Inflammatory Agents; Bronchodilator Agents; Budesonide; Do | 2005 |
Acute electrophysiologic effects of inhaled salbutamol in humans.
Topics: Administration, Inhalation; Adrenergic beta-Agonists; Albuterol; Asthma; Atrioventricular Node; Dose | 2005 |
High resolution CT and bronchial reversibility test for diagnosing COPD.
Topics: Administration, Inhalation; Aged; Albuterol; Bronchial Provocation Tests; Bronchodilator Agents; Fem | 2005 |
Development of an economic model to assess the cost effectiveness of treatment interventions for chronic obstructive pulmonary disease.
Topics: Adrenergic beta-Agonists; Albuterol; Androstadienes; Bronchodilator Agents; Cost-Benefit Analysis; D | 2005 |
Acute bronchodilator response has limited value in differentiating bronchial asthma from COPD.
Topics: Administration, Inhalation; Adult; Aged; Albuterol; Area Under Curve; Asthma; Bronchodilator Agents; | 2005 |
The effects of nebulized salbutamol, external positive end-expiratory pressure, and their combination on respiratory mechanics, hemodynamics, and gas exchange in mechanically ventilated chronic obstructive pulmonary disease patients.
Topics: Aerosols; Aged; Albuterol; Body Weight; Bronchodilator Agents; Electrocardiography; Female; Function | 2005 |
Long-acting inhaled bronchodilators for COPD--lack of logic continues.
Topics: Administration, Inhalation; Albuterol; Asthma; Bronchodilator Agents; Drug Approval; Ethanolamines; | 2005 |
[Economic value of tiotropium in the treatment of chronic obstructive pulmonary disease].
Topics: Albuterol; Bronchodilator Agents; Cost-Benefit Analysis; Hospitalization; Humans; Insurance, Health; | 2005 |
Health outcomes following treatment for 6 months with once daily tiotropium compared with twice daily salmeterol in patients with COPD.
Topics: Albuterol; Bronchodilator Agents; Humans; Pulmonary Disease, Chronic Obstructive; Scopolamine Deriva | 2006 |
Paradoxical bronchospasm: a potentially life threatening adverse effect of albuterol.
Topics: Administration, Inhalation; Aged, 80 and over; Albuterol; Bronchial Spasm; Bronchodilator Agents; Ep | 2006 |
Post-bronchodilator spirometry reference values in adults and implications for disease management.
Topics: Adult; Age Factors; Aged; Aged, 80 and over; Albuterol; Body Height; Bronchodilator Agents; Cohort S | 2006 |
[FEV1 after three years of observation in patients with bronchial asthma and patients with chronic obstructive pulmonary disease].
Topics: Adult; Aged; Airway Obstruction; Albuterol; Asthma; Bronchodilator Agents; Female; Follow-Up Studies | 2005 |
Lessons from structure-function studies in asthma: myths and truths about what we teach.
Topics: Adrenergic beta-Agonists; Albuterol; Asthma; Bronchoconstriction; Bronchodilator Agents; Forced Expi | 2006 |
Cost reduction strategies used by elderly patients with chronic obstructive pulmonary disease to cope with a generic-only pharmacy benefit.
Topics: Aged; Albuterol; Albuterol, Ipratropium Drug Combination; Bronchodilator Agents; California; Cost Co | 2006 |
Economic evaluation of tiotropium and salmeterol in the treatment of chronic obstructive pulmonary disease (COPD) in Greece.
Topics: Albuterol; Bronchodilator Agents; Computer Simulation; Cost-Benefit Analysis; Drug Therapy, Combinat | 2006 |
Adherence and persistence with fluticasone propionate/salmeterol combination therapy.
Topics: Adolescent; Adult; Age Factors; Aged; Aged, 80 and over; Albuterol; Androstadienes; Asthma; Bronchod | 2006 |
Flow and volume responses after routine salbutamol reversibility testing in mild to very severe COPD.
Topics: Adult; Aged; Aged, 80 and over; Albuterol; Bronchodilator Agents; Cross-Sectional Studies; Family Pr | 2007 |
Inflammatory changes, recovery and recurrence at COPD exacerbation.
Topics: Administration, Inhalation; Adrenergic beta-Agonists; Aged; Albuterol; Biomarkers; C-Reactive Protei | 2007 |
The confounding effects of thoracic gas compression on measurement of acute bronchodilator response.
Topics: Adult; Albuterol; Asthma; Bronchodilator Agents; Female; Humans; Male; Middle Aged; Nebulizers and V | 2007 |
[Acute angle-closure glaucoma resulting from treatment with nebulised bronchodilators].
Topics: Aged; Albuterol; Bronchodilator Agents; Female; Glaucoma, Angle-Closure; Humans; Ipratropium; Pulmon | 2006 |
Safety of sputum induction in moderate-to-severe smoking-related chronic obstructive pulmonary disease.
Topics: Adrenergic beta-Agonists; Aged; Albuterol; Area Under Curve; Cross-Sectional Studies; Female; Forced | 2006 |
[Bronchial obstruction reversibility test in the assessment of COPD severity--controversies].
Topics: Aged; Albuterol; Bronchoconstriction; Bronchodilator Agents; Female; Forced Expiratory Volume; Human | 2006 |
Summaries for patients. Combination inhaler therapy for chronic obstructive pulmonary disease.
Topics: Administration, Inhalation; Adrenergic beta-Agonists; Aged; Albuterol; Androstadienes; Bronchodilato | 2007 |
Tiotropium and simplified detection of dynamic hyperinflation.
Topics: Aged; Albuterol; Bronchodilator Agents; Female; Forced Expiratory Volume; Functional Residual Capaci | 2007 |
Tiotropium and simplified detection of dynamic hyperinflation.
Topics: Aged; Albuterol; Bronchodilator Agents; Female; Forced Expiratory Volume; Functional Residual Capaci | 2007 |
Tiotropium and simplified detection of dynamic hyperinflation.
Topics: Aged; Albuterol; Bronchodilator Agents; Female; Forced Expiratory Volume; Functional Residual Capaci | 2007 |
Tiotropium and simplified detection of dynamic hyperinflation.
Topics: Aged; Albuterol; Bronchodilator Agents; Female; Forced Expiratory Volume; Functional Residual Capaci | 2007 |
Corticosteroids and beta2 agonists differentially regulate rhinovirus-induced interleukin-6 via distinct Cis-acting elements.
Topics: Adrenal Cortex Hormones; Adrenergic beta-Agonists; Albuterol; Androstadienes; Anti-Inflammatory Agen | 2007 |
Gas exchange response to short-acting beta2-agonists in chronic obstructive pulmonary disease severe exacerbations.
Topics: Adrenergic beta-Agonists; Aged; Albuterol; Cardiac Output; Female; Hospitalization; Humans; Male; Ne | 2007 |
Cost-effectiveness of long-acting bronchodilators for chronic obstructive pulmonary disease.
Topics: Aged; Albuterol; Bronchodilator Agents; Cost Savings; Cost-Benefit Analysis; Female; Hospitalization | 2007 |
Hospitalizations with severe COPD.
Topics: Albuterol; Androstadienes; Bronchodilator Agents; Drug Therapy, Combination; Fluticasone; Germany; H | 2007 |
Prevention of death in COPD.
Topics: Administration, Inhalation; Adrenal Cortex Hormones; Albuterol; Androstadienes; Bronchodilator Agent | 2007 |
Prevention of death in COPD.
Topics: Albuterol; Androstadienes; Bronchodilator Agents; Drug Therapy, Combination; Fluticasone; Forced Exp | 2007 |
Prevention of death in COPD.
Topics: Administration, Inhalation; Albuterol; Androstadienes; Bronchodilator Agents; Data Interpretation, S | 2007 |
Prevention of death in COPD.
Topics: Albuterol; Androstadienes; Bronchodilator Agents; Drug Therapy, Combination; Factor Analysis, Statis | 2007 |
Survival among COPD patients using fluticasone/salmeterol in combination versus other inhaled steroids and bronchodilators alone.
Topics: Administration, Inhalation; Adrenergic beta-Agonists; Adult; Aged; Albuterol; Androstadienes; Bronch | 2007 |
Avoiding mistakes in calculating the number needed to treat in severe COPD.
Topics: Albuterol; Androstadienes; Bronchodilator Agents; Fluticasone; Humans; Outcome Assessment, Health Ca | 2007 |
Gender and chronic obstructive pulmonary disease: why it matters.
Topics: Administration, Inhalation; Albuterol; Anti-Inflammatory Agents; Bronchodilator Agents; Female; Huma | 2007 |
Are beta2-agonists safe in patients with acute exacerbations of COPD?
Topics: Adrenergic beta-Agonists; Albuterol; Cholinergic Antagonists; Humans; Nebulizers and Vaporizers; Pul | 2007 |
Comparison of hospitalizations, emergency department visits, and costs in a historical cohort of Texas Medicaid patients with chronic obstructive pulmonary disease, by initial medication regimen.
Topics: Adrenal Cortex Hormones; Adult; Albuterol; Androstadienes; Bronchodilator Agents; Cohort Studies; Co | 2007 |
A modified prescription-event monitoring study to assess the introduction of Seretide Evohaler in England: an example of studying risk monitoring in pharmacovigilance.
Topics: Adult; Aerosol Propellants; Aged; Albuterol; Androstadienes; Asthma; Bronchodilator Agents; Drug Com | 2007 |
Investigating new standards for prophylaxis in reduction of exacerbations--the INSPIRE study methodology.
Topics: Adult; Aged; Aged, 80 and over; Albuterol; Androstadienes; Bronchodilator Agents; Cholinergic Antago | 2007 |
COPD guidelines: the important thing is not to stop questioning.
Topics: Administration, Inhalation; Albuterol; Androstadienes; Bronchodilator Agents; Fluticasone; Guideline | 2007 |
Rebuttal: should we avoid beta-agonists for moderate and severe chronic obstructive pulmonary disease? Yes.
Topics: Adrenergic beta-Agonists; Albuterol; Bronchodilator Agents; Cholinergic Antagonists; Contraindicatio | 2007 |
Rebuttal: should we avoid beta-agonists for moderate and severe chronic obstructive pulmonary disease? No.
Topics: Adrenergic beta-Agonists; Albuterol; Bronchodilator Agents; Contraindications; Drug Evaluation; Huma | 2007 |
Beta2-adrenergic receptor genetic polymorphisms and short-term bronchodilator responses in patients with COPD.
Topics: Adrenergic beta-Agonists; Aged; Albuterol; Alleles; Bronchodilator Agents; Codon; Female; Genotype; | 2007 |
The discovery of indole-derived long acting beta2-adrenoceptor agonists for the treatment of asthma and COPD.
Topics: Adrenergic beta-Agonists; Albuterol; Animals; Asthma; Biological Availability; Caco-2 Cells; CHO Cel | 2007 |
Relative lung deposition of salbutamol following inhalation from a spacer and a Sidestream jet nebulizer following an acute exacerbation.
Topics: Acute Disease; Adult; Aged; Albuterol; Asthma; Female; Humans; Inhalation Spacers; Lung; Male; Meter | 2008 |
The value of early diagnosis for effective management of chronic obstructive pulmonary disease.
Topics: Adrenal Cortex Hormones; Albuterol; Androstadienes; Bronchodilator Agents; Cholinergic Antagonists; | 2007 |
[Inhaled corticosteroids in patients with COPD: maintain current guidelines].
Topics: Administration, Inhalation; Adrenal Cortex Hormones; Adrenergic beta-Agonists; Albuterol; Androstadi | 2007 |
Epithelial expression of TLR4 is modulated in COPD and by steroids, salmeterol and cigarette smoke.
Topics: Adrenal Cortex Hormones; Adrenergic beta-Agonists; Adult; Aged; Albuterol; Androstadienes; beta-Defe | 2007 |
Comparative safety of long-acting inhaled bronchodilators: a cohort study using the UK THIN primary care database.
Topics: Administration, Intranasal; Adult; Aged; Aged, 80 and over; Albuterol; Bronchodilator Agents; Cardio | 2007 |
Cost-effectiveness and healthcare budget impact in Italy of inhaled corticosteroids and bronchodilators for severe and very severe COPD patients.
Topics: Administration, Inhalation; Adrenal Cortex Hormones; Albuterol; Androstadienes; Bronchodilator Agent | 2007 |
Outcomes in COPD patients receiving tiotropium or salmeterol plus treatment with inhaled corticosteroids.
Topics: Administration, Inhalation; Adrenal Cortex Hormones; Adrenergic beta-Agonists; Adult; Albuterol; Bro | 2007 |
[Chronic obstructive pulmonary disease. No increased survival with combination therapy].
Topics: Albuterol; Androstadienes; Anti-Inflammatory Agents; Bronchodilator Agents; Drug Therapy, Combinatio | 2007 |
Tiotropium in combination with placebo, salmeterol, or fluticasone salmeterol for chronic obstructive pulmonary disease: possible confounding effect of treatment withdrawal?
Topics: Adrenal Cortex Hormones; Adrenergic beta-Agonists; Albuterol; Androstadienes; Bronchodilator Agents; | 2007 |
COPD: don't use fluticasone + salmeterol. Patients treated with inhaled fluticasone for chronic obstructive pulmonary disease (COPD) are more prone to pneumonia.
Topics: Albuterol; Androstadienes; Bronchodilator Agents; Drug Therapy, Combination; Humans; Maximal Expirat | 2007 |
The effects of Heliox on the output and particle-size distribution of salbutamol using jet and vibrating mesh nebulizers.
Topics: Administration, Inhalation; Albuterol; Asthma; Bronchodilator Agents; Drug Carriers; Equipment Desig | 2007 |
Cytoplasm-nuclear trafficking of CREB and CREB phosphorylation at Ser133 during therapy of chronic obstructive pulmonary disease.
Topics: Albuterol; Blotting, Western; Bronchodilator Agents; Cell Nucleus; Cyclic AMP Response Element-Bindi | 2007 |
Physicochemical compatibility of fluticasone-17- propionate nebulizer suspension with ipratropium and albuterol nebulizer solutions.
Topics: Albuterol; Androstadienes; Bronchodilator Agents; Drug Combinations; Drug Incompatibility; Drug Stor | 2007 |
Comparison of tiotropium bromide and combined ipratropium/salbutamol for the treatment of COPD: a UK General Practice Research Database 12-month follow-up study.
Topics: Aged; Albuterol; Albuterol, Ipratropium Drug Combination; Bronchodilator Agents; Databases, Factual; | 2008 |
Salmeterol 100 microg: an analysis of its tolerability in single- and chronic-dose studies.
Topics: Adolescent; Adrenergic beta-Agonists; Adult; Albuterol; Asthma; Bronchodilator Agents; Child; Child, | 2001 |
Responsiveness to intravenous administration of salbutamol in chronic obstructive pulmonary disease patients with acute respiratory failure.
Topics: Acute Disease; Aged; Airway Resistance; Albuterol; Bronchodilator Agents; Female; Humans; Infusions, | 2001 |
Evaluation of bronchodilator responses in patients with "irreversible" emphysema.
Topics: Aged; Albuterol; Bronchodilator Agents; Emphysema; Female; Forced Expiratory Volume; Functional Resi | 2001 |
Response of lung volumes to inhaled salbutamol in a large population of patients with severe hyperinflation.
Topics: Aged; Airway Resistance; Albuterol; Asthma; Bronchodilator Agents; Female; Humans; Lung Volume Measu | 2002 |
Volume effect and exertional dyspnoea after bronchodilator in patients with COPD with and without expiratory flow limitation at rest.
Topics: Administration, Inhalation; Adult; Aged; Albuterol; Bronchodilator Agents; Chronic Disease; Dyspnea; | 2002 |