combivent-respimat and Pulmonary-Disease--Chronic-Obstructive

Successful treatment for respiratory diseases relies on effective delivery of medication to the lungs using an inhalation device. Different inhalers have distinct characteristics affecting drug administration and patient adherence, which can impact clinical outcomes. We report on the development of the Respimat

Topics: Administration, Inhalation; Albuterol, Ipratropium Drug Combination; Asthma; Bronchodilator Agents; Drug Delivery Systems; Equipment Design; Humans; Metered Dose Inhalers; Pulmonary Disease, Chronic Obstructive

The aim of the review was to explore patient and family caregiver perspectives on key issues for ensuring quality of end-of-life care for people with chronic obstructive pulmonary disease (COPD). The growing evidence on the value of specialist palliative care services demonstrates significant improvements in treatments and provisions; however, much of the literature is generic in nature or centred on people with a cancer diagnosis. In this review, we examine the literature to ascertain the views and needs of patients and carers affected by advanced COPD, a highly debilitating condition that can have a profoundly negative impact on the quality of end-of-life experience.. A total of 19 papers were included in the review. The main themes in the literature were Holistic Care, Illness Trajectory and Technology.. Areas of unmet need emphasized across physical, psychosocial and spiritual domains were identified, particularly in relation to appropriate and timely conversations. Positive developments in the care and treatment of advanced COPD include the use of the STIOLTO Respimat inhaler, a brief educative and psychosocial intervention based on cognitive-behavioural therapy, and high-intensity exercise training. There is some evidence regarding the use of technology in end-stage COPD.

Topics: Albuterol, Ipratropium Drug Combination; Caregivers; Cognitive Behavioral Therapy; Communication; Holistic Health; Humans; Palliative Care; Patient Education as Topic; Pulmonary Disease, Chronic Obstructive; Religion; Terminal Care

Chronic obstructive pulmonary disease (COPD) is a major cause of morbidity and mortality throughout the world. Combination therapy with albuterol and ipratropium bromide was approved > 15 years ago for the treatment of COPD. We review the mechanism of action, clinical efficacy, and safety of albuterol, ipratropium and combined albuterol-ipratropium therapy.. We conducted a PubMed literature search using the keywords COPD, albuterol, ipratropium bromide and Combivent (Boehringer Ingelheim Corp., Ridgefield, CT, USA); pertinent references within the identified citations are included in the review. Data from the manufacturers are also evaluated.. At the time of its approval, albuterol/ipratropium bromide was an innovative combination of existing medications for the treatment of COPD. The combined formulation provides better improvement in airflow than either component alone and, by reducing the number of separate inhalers, simplifies therapy and improves compliance compared with the individual components.. The recent development and approval of longer acting and more potent beta agonists, anticholinergics and newer combination treatments have surpassed many of the advantages of combined albuterol-ipratropium for the treatment of patients with stable COPD.

Topics: Albuterol; Albuterol, Ipratropium Drug Combination; Bronchodilator Agents; Clinical Trials as Topic; Humans; Ipratropium; Pulmonary Disease, Chronic Obstructive

The TIOtropium Safety and Performance In Respimat (TIOSPIR) trial showed similar safety and exacerbation efficacy profiles for tiotropium Respimat and HandiHaler in patients with COPD. The TIOSPIR results for patients in Asia are presented here.. TIOSPIR evaluated once-daily tiotropium Respimat 5 and 2.5 µg with HandiHaler 18 µg in patients with COPD. Primary endpoints included time to death and time to first COPD exacerbation. Safety and exacerbation efficacy profiles were determined for the Asian region, and for Asia (all treatment arms pooled) versus the rest of the world (RoW).. In Asia (n = 2356), time to death was similar for Respimat 5 and 2.5 µg versus HandiHaler 18 µg (hazard ratio (HR) (95% CI): 0.96 (0.67, 1.38) and 1.23 (0.87, 1.73)). Risk of COPD exacerbation was similar for Respimat 5 µg, but increased for 2.5 µg versus HandiHaler 18 µg (HR (95% CI): 0.99 (0.85, 1.15) and 1.17 (1.00, 1.35)). Time to death in Asia and RoW was similar (HR (95% CI): 1.15 (0.99, 1.35)). Time to first COPD exacerbation was longer (HR (95% CI): 0.84 (0.78, 0.89)) and exacerbation rates were lower in Asia, but severe exacerbations were more frequent than in the RoW. Risk of major adverse cardiovascular events was similar for both regions.. Similar safety and exacerbation efficacy profiles were observed for tiotropium Respimat 5 µg and HandiHaler 18 µg in patients with COPD from Asia, analogous to the global analysis. Asian patients had lower risk of, and fewer exacerbations overall, but a higher proportion of severe exacerbations than in the RoW.

Topics: Administration, Inhalation; Aged; Albuterol, Ipratropium Drug Combination; Asia; Bronchodilator Agents; Double-Blind Method; Drug Monitoring; Female; Forced Expiratory Volume; Humans; Maintenance Chemotherapy; Male; Middle Aged; Mortality; Proportional Hazards Models; Pulmonary Disease, Chronic Obstructive; Tiotropium Bromide; Treatment Outcome

Dynamic hyperinflation (DH) during exercise is associated with both dyspnea and exercise limitation in COPD. Metronome-paced tachypnoea (MPT) is a simple alternative for studying DH. We compared MPT with exercise testing (XT) as methods of provoking DH, and assessed their relationship with dyspnea. We studied 24 patients with moderate COPD (FEV1 59 ± 9% predicted) after inhalation of ipratropium/salbutamol combination or placebo in a double-blind, crossover design. Inspiratory capacity (IC) was measured at baseline and after 30 seconds of MPT with breathing frequencies (fR) of 20, 30 and 40 breaths/min and metronome-defined I:E ratios of 1:1 and 1:2, in random sequence, followed by incremental cycle ergometry with interval determinations of IC. DH was defined as a decline in IC from baseline (∆IC) for both methods. Dyspnea was assessed using a Borg CR-10 scale. ∆IC during MPT was greater with higher fR and I:E ratio of 1:1 versus 1:2, and less when patients were treated with bronchodilator rather than placebo (P = 0.032). DH occurred during 19 (40%) XTs, and during 35 (73%) tests using MPT. Eleven of 18 (61%) non-congruent XTs (where DH occurred on MPT but not XT) terminated before fR of 40 breaths/min was reached. Although greater during XT, the intensity of dyspnea bore no relationship to DH during either MPT and XT. MPT at 40 breaths/min and I:E of 1:1 elicits the greatest ∆IC, and is a more sensitive method for demonstrating DH. The relationship between DH and dyspnea is complex and not determined by DH alone.

Topics: Aged; Albuterol; Albuterol, Ipratropium Drug Combination; Bronchodilator Agents; Cross-Over Studies; Double-Blind Method; Dyspnea; Exercise; Exercise Test; Exercise Tolerance; Female; Humans; Inspiratory Capacity; Ipratropium; Lung; Male; Middle Aged; Pulmonary Disease, Chronic Obstructive; Respiratory Mechanics; Respiratory Rate; Tachypnea

Debate continues as to whether acute bronchodilator responsiveness (BDR) predicts long-term outcomes in COPD. Furthermore, there is no consensus on a threshold for BDR.. At baseline and during the 4-year Understanding Potential Long-term Improvements in Function with Tiotropium (UPLIFT®) trial, patients had spirometry performed before and after administration of ipratropium bromide 80 mcg and albuterol 400 mcg. Patients were split according to three BDR thresholds: ≥ 12% + ≥ 200 mL above baseline (criterion A), ≥ 15% above baseline (criterion B); and ≥ 10% absolute increase in percent predicted FEV1 values (criterion C). Several outcomes (pre-dose spirometry, exacerbations, St. George's Respiratory Questionnaire [SGRQ] total score) were assessed according to presence or absence of BDR in the treatment groups.. 5783 of 5993 randomized patients had evaluable pre- and post-bronchodilator spirometry at baseline. Mean age (SD) was 64 (8) years, with 75% men, mean post-bronchodilator FEV1 1.33 ± 0.44 L (47.6 ± 12.7% predicted) and 30% current smokers. At baseline, 52%, 66%, and 39% of patients had acute BDR using criterion A, B, and C, respectively. The presence of BDR was variable at follow-up visits. Statistically significant improvements in spirometry and health outcomes occurred with tiotropium regardless of the baseline BDR or criterion used.. A large proportion of COPD patients demonstrate significant acute BDR. BDR in these patients is variable over time and differs according to the criterion used. BDR status at baseline does not predict long-term response to tiotropium. Assessment of acute BDR should not be used as a decision-making tool when prescribing tiotropium to patients with COPD.

Topics: Aged; Albuterol; Albuterol, Ipratropium Drug Combination; Bronchodilator Agents; Drug Administration Schedule; Female; Forced Expiratory Volume; Humans; Ipratropium; Lung; Male; Middle Aged; Outcome and Process Assessment, Health Care; Proportional Hazards Models; Pulmonary Disease, Chronic Obstructive; Quality of Life; Scopolamine Derivatives; Spirometry; Surveys and Questionnaires; Time Factors; Tiotropium Bromide; Treatment Outcome; Vital Capacity

We compared the efficacy and safety of ipratropium bromide/albuterol delivered via Respimat inhaler, a novel propellant-free inhaler, versus chlorofluorocarbon (CFC)-metered dose inhaler (MDI) and ipratropium Respimat inhaler in patients with COPD. This was a multinational, randomized, double-blind, double-dummy, 12-week, parallel-group, active-controlled study. 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. Each medication was administered four times daily. Serial spirometry was performed over 6h (0.15min, then hourly) on 4 test days. The primary efficacy variable was forced expiratory volume in 1s (FEV(1)) change from test day baseline at 12 weeks. A total of 1209 of 1480 randomized, treated patients completed the study; the majority were male (65%) with a mean age of 64 yrs and a mean screening pre-bronchodilator FEV(1) (percent predicted) of 41%. Ipratropium bromide/albuterol Respimat inhaler had comparable efficacy to ipratropium bromide/albuterol MDI for FEV(1) area under the curve at 0-6h (AUC(0-6)), superior efficacy to ipratropium Respimat inhaler for FEV(1) AUC(0-4) and comparable efficacy to ipratropium Respimat inhaler for FEV(1) AUC(4-6). All active treatments were well tolerated. This study demonstrates that ipratropium bromide/albuterol 20/100mcg inhaler administered four times daily for 12 weeks had equivalent bronchodilator efficacy and comparable safety to ipratropium bromide/albuterol 36mcg/206mcg MDI, and significantly improved lung function compared with the mono-component ipratropium bromide 20 mcg Respimat inhaler. [Clinical Trial Identifier Number: NCT00400153].

Topics: Administration, Inhalation; Albuterol; Albuterol, Ipratropium Drug Combination; Bronchodilator Agents; Double-Blind Method; Female; Forced Expiratory Volume; Humans; Ipratropium; Male; Middle Aged; Nebulizers and Vaporizers; Pulmonary Disease, Chronic Obstructive; Respiratory Function Tests; Treatment Outcome

Nebulized bronchodilators are widely regarded as the optimal treatment for maintenance therapy in patients with severe chronic obstructive pulmonary disease (COPD). The aim of the study was to assess whether detailed physiological, functional and quality of life-related measurements can assist in determining the requirement for nebulized bronchodilator therapy in patients with moderate to severe COPD. This was an unblinded, randomized, crossover study that compared intermediate (120 mcg ipratropium bromide and 600 mcg of salbutamol using metered dose inhaler (MDI) and spacer) and high dose (nebulized 500 mcg ipratropium bromide and 2.5 mg salbutamol) bronchodilator therapy, on physiological, functional and quality of life-related measurements in patients with COPD. A total of 25 patients (12 female), mean (SD) age 68 (7) years, FEV(1) 45 (10) % predicted completed the study. There was no statistically significant difference between the treatments in the pre- and post-bronchodilator lung function values, six-minute walk distance, breathlessness score or quality of life questionnaires. Fifteen patients preferred bronchodilator therapy with nebulizer and 10 with MDI and spacer. In 20 patients at least one positive response in quality of life score, lung function or six-minute walk, was observed on the preferred treatment. Only a proportion of patients with moderate or severe COPD prefer nebulized bronchodilator therapy. This study found that none of the parameters singly or in combination were consistently predictive of patients' preference for nebulized bronchodilator therapy. Therefore, we suggest that clinicians institute a trial of stepping up to an intermediate dose of bronchodilators prior to introducing nebulized therapy.

Topics: Administration, Inhalation; Aged; Albuterol; Albuterol, Ipratropium Drug Combination; Bronchodilator Agents; Cross-Over Studies; Female; Humans; Ipratropium; Male; Metered Dose Inhalers; Middle Aged; Pulmonary Disease, Chronic Obstructive; Quality of Life; Respiratory Function Tests; Treatment Outcome

Physicians consider ease of use, satisfaction, and preferences when prescribing an inhaler device. These factors may impact appropriate usage and compliance.. The objectives were to quantify the relative importance of inhaler attributes in patients currently using Combivent Respimat by eliciting preferences for performance and convenience attributes assessed by items in the Patient Satisfaction and Preference Questionnaire (PASAPQ). Using a pharmacy database, 19,964 adults in the United States who filled ≥2 Combivent Respimat prescriptions were identified. Of those, 8150 patients were randomly selected to receive invitation letters. The online cross-sectional survey included the PASAPQ and best-worst scaling (BWS) questions. The PASAPQ measures satisfaction with medication attributes across two domains: performance and convenience. BWS questions asked participants to select the most and least important device attributes. A descriptive statistics analysis of the PASAPQ and a random-parameters logit model of BWS responses were conducted.. The survey was completed by 503 participants. Most were female (57.3%), white (88.5%), and 51-70 years old (67.6%). Approximately 47% reported a chronic obstructive pulmonary disease diagnosis, 21.9% asthma, 8.2% other lung disease, and 23.1% more than one lung disease. PASAPQ scores indicated that the majority were satisfied or very satisfied; up to 20% reported being dissatisfied with Combivent Respimat. The three most important inhaler attributes were Feeling that your medicine gets into your lungs, Inhaler works reliably, and Inhaler makes inhaling your medicine easy. The most important attributes corresponded to six of seven items in the PASAPQ performance domain.. Most participants reported satisfaction with Combivent Respimat. Performance attributes were more important than convenience attributes.

Topics: Administration, Inhalation; Adult; Aged; Albuterol, Ipratropium Drug Combination; Asthma; Cross-Sectional Studies; Equipment Design; Female; Humans; Logistic Models; Male; Middle Aged; Nebulizers and Vaporizers; Patient Satisfaction; Pulmonary Disease, Chronic Obstructive; Quality of Life; Surveys and Questionnaires

Topics: Albuterol, Ipratropium Drug Combination; Benzoxazines; Drug Approval; Drug Combinations; Germany; Humans; Long-Term Care; Pulmonary Disease, Chronic Obstructive; Tiotropium Bromide; Treatment Outcome

This retrospective analysis of data from two multi-center, randomized, double-blind, parallel group studies compared the efficacy of fluticasone propionate/salmeterol (FSC) 250/50 mcg twice daily with ipratropium bromide/albuterol (IB/ALB) 36/206 mcg four times daily in albuterol-reversible (n=320 [44%]) and non-reversible (n=399 [56%]) patients with COPD. In reversible and non-reversible patients, both treatments significantly increased FEV(1)AUC(0-6h) from baseline and the magnitude of improvement was larger in reversible patients. FSC increased FEV(1)AUC(0-6h) by 1.46+/-0.08 and 1.98+/-0.13 l-h at Day 1 and Week 8, respectively, in reversible patients, compared with 0.71+/-0.06 and 0.94+/-0.10 l-h in non-reversible patients (p<0.001). With IB/ALB, increases were 1.46+/-0.08 and 1.19+/-0.11 l-h at Day 1 in reversible patients and Week 8, respectively, and 0.89+/-0.06 and 0.74+/-0.09 l-h (p < or = 0.041) in non-reversible patients. After 8 weeks, in both the reversible and non-reversible populations, the FEV(1) AUC(0-6h) significantly increased with FSC treatment (p < or = 0.002) and significantly decreased with IB/ALB (p < or = 0.010). In both reversibility groups, improvement in Transition Dyspnea Index (TDI) scores, overall daytime diary symptom scores and nocturnal symptom measures were significantly greater with FSC treatment compared with IB/ALB (p < or = 0.044). Reversibility status was not predictive of the magnitude of reduction in symptom scores. We conclude that both reversible and non-reversible patients receive greater clinical benefit with FSC compared with IB/ALB and acute bronchodilator reversibility is not useful for differentiating patients based on symptomatic responses to FSC compared with IB/ALB.

Topics: Adrenergic beta-Agonists; Aged; Albuterol; Albuterol, Ipratropium Drug Combination; Androstadienes; Area Under Curve; Bronchodilator Agents; Drug Combinations; Female; Fluticasone-Salmeterol Drug Combination; Forced Expiratory Volume; Humans; Ipratropium; Male; Middle Aged; Multicenter Studies as Topic; Pulmonary Disease, Chronic Obstructive; Randomized Controlled Trials as Topic; Respiratory Function Tests; Retrospective Studies; Severity of Illness Index; Time Factors

To compare the effectiveness of the long-acting anticholinergic, tiotropium with ipratropium/salbutamol in reducing the risk of exacerbations and COPD-related referrals in patients with COPD.. Data were obtained from the General Practice Research Database (GPRD). Propensity score matching was used to balance prognostic covariates between treatment groups. Incidence rate ratios and 95% confidence intervals during a 12-month follow-up period were estimated.. 4193 patients (3385, tiotropium; 808, ipratropium/salbutamol) in the GPRD met the inclusion/exclusion criteria. Patients treated with tiotropium had more severe COPD than patients treated with ipratropium/salbutamol. Following propensity score matching, 1222 tiotropium-treated patients and 633 ipratropium/salbutamol-treated patients were included in the final analysis. Incidence rate ratios (95% confidence intervals) were 0.74 (0.64-0.85; p=0.0086) for exacerbations and 0.57 (0.46-0.70; p=0.004) for COPD-related referrals/hospitalisations.. Tiotropium is associated with a reduced risk of exacerbations and COPD-related referrals and hospitalisation compared to combined ipratropium/salbutamol in patients with COPD.

Topics: Aged; Albuterol; Albuterol, Ipratropium Drug Combination; Bronchodilator Agents; Databases, Factual; Family Practice; Female; Follow-Up Studies; Hospitalization; Humans; Ipratropium; Male; Middle Aged; Pulmonary Disease, Chronic Obstructive; Referral and Consultation; Retrospective Studies; Scopolamine Derivatives; Tiotropium Bromide; Treatment Outcome; United Kingdom

Generic-only pharmacy benefits may present more of a burden to patients with chronic disease conditions such as chronic obstructive pulmonary disease (COPD), where generic drug therapy choices are more limited.. To evaluate the strategies that elderly patients with COPD use to manage their out-of-pocket (OOP) prescription expenses in a generic-only pharmacy benefit compared with similar patients with a single-tier copayment or a 2-tier pharmacy benefit with coverage of brand formulary drugs.. Surveys were mailed to a sample of 3,000 Kaiser Permanente (California) patients (aged > or = 65 years) who had a diagnosis for COPD and received at least 1 prescription for a COPD-related medication during 2003. The sample was stratified by type of pharmacy benefit: generic-only, single copayment tier, and 2 copayment tiers. The survey contained questions about strategies used to reduce OOP prescription expenses, such as stop taking a prescribed medication, purchase prescriptions out of the country, or discuss OOP prescription expenses with a physician. The likelihood of using specific strategies to reduce OOP prescription expenses was modeled using logistic regression. Covariates included social support, quality of life, smoking status, socioeconomic status, total prescription costs, and demographics.. A total of 1,624 surveys were returned, for a 54% response rate. Results from logistic regressions indicate that COPD patients with a generic-only benefit are significantly more likely to report that they discussed their OOP costs with their physician (odds ratio [OR]=9.02; 95% confidence interval [CI], 6.15- 13.22), purchased their medications from another country (OR=6.70; 95% CI, 3.17-14.16) and reduced spending on food and clothing (OR=4.06; 95% CI, 2.70-6.12). They are also more likely to report that they had taken less than the prescribed amount of a regular medication (OR=1.70; 95% CI, 1.25-2.31) and that they stopped taking one or more of their regular medications (OR=1.77; CI, 1.27-2.47). Patients with low annual household incomes (<25,000 US dollars) were significantly more likely to discuss their OOP costs with their physician (OR=1.47; 95% CI, 1.08-2.00 ) and to reduce spending on food and clothing (OR=1.97; 95% CI, 1.42-2.73) than those with higher incomes. 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. Overall, patients in the generic-only pharmacy benefit used an average of 3 methods to reduce OOP pharmacy costs compared with approximately 1.5 cost reduction methods used by patients in single-tier and 2-tier copayment designs who had coverage of formulary brand as well as generic drugs.. Elderly patients with COPD and a generic-drug-only pharmacy benefit are more likely to report using a variety of strategies to reduce their OOP costs compared with similar patients with single-tier copayment or 2-tier copayment pharmacy benefits. The most common strategy was discussing OOP costs with their physician, and use of this strategy was inversely related to household income. There was no difference in the proportion of COPD patients among the 3 pharmacy benefit groups that used drug samples from their physicians as a means to reduce OOP costs.

Topics: Aged; Albuterol; Albuterol, Ipratropium Drug Combination; Bronchodilator Agents; California; Cost Control; Cost Sharing; Data Collection; Drugs, Generic; Female; Humans; Insurance, Pharmaceutical Services; Ipratropium; Male; Pulmonary Disease, Chronic Obstructive; Scopolamine Derivatives; Tiotropium Bromide