fluticasone-propionate--salmeterol-xinafoate-drug-combination and Airway-Obstruction

Little is known about the effect of inhaled corticosteroids (ICS)/long-acting beta2 agonists (LABA) in combination on inflammatory markers in asthma. In addition, therapeutic equivalence of generic salmeterol/fluticasone combination (SFC) and original SFC is as yet unknown.. To determine the effects of SFC and the effects of generic and original SFC on airway inflammation in patients with mild-to moderate stable asthma.. A randomized double-blinded, crossover non-inferiority study was conducted to compare the antiinflammatory effects of generic SFC and original SFC on sputum eosinophils as a primary outcome and fractional exhaled nitric oxide (FENO) as a secondary outcome.. The authors studied 51 mild-to-moderate asthmatic patients who ranged from 18 to 80 years of age and were treated with ICS or ICS/LABA of any dose, and whose asthma was stable without an exacerbation episode for at least 3 months prior to study entry.. Both sputum eosinophils percentage and absolute eosinophil counts well correlated with FENO levels at baseline prior to the initiation of study medications. Significant reduction in sputum eosinophil percentage was observed following generic SFC and original SFC treatment. The degree of sputum eosinophil suppression by generic SFC was not inferior to original SFC, and this was not affected by treatments with the sequence of generic SFC first vs. original SFC second or original SFC first vs. generic SFC. In addition, there was no significant difference between treatments in terms of normalized gain in asthma control scores, including the number of patients found to have improved asthma control, irrespective of sequence, as change from baseline. However, this was not the case for the magnitude of FENO reduction that occurred after generic SFC treatment to a significantly larger extent than original SFC treatment.. This short-term study demonstrated that there was no significant difference between generic SFC and original SFC in terms of anti-inflammatory activity and the control of asthma symptoms. However, it is completely unknown whether generic SFC could effectively prevent the development of asthma exacerbations on a long-term basis. Therefore, longer-term studies are indicated to evaluate generic SFC's relative efficacy on asthma exacerbations.

Topics: Adult; Aged; Airway Obstruction; Albuterol; Androstadienes; Anti-Inflammatory Agents; Asthma; Cross-Over Studies; Double-Blind Method; Drug Combinations; Drugs, Generic; Eosinophils; Female; Fluticasone-Salmeterol Drug Combination; Glucocorticoids; Humans; Leukocyte Count; Male; Middle Aged; Sputum

Topics: Aged; Airway Obstruction; Albuterol; Androstadienes; Drug Combinations; Fluticasone-Salmeterol Drug Combination; Forced Expiratory Volume; Humans; Inflammation; Pulmonary Disease, Chronic Obstructive; Substance Withdrawal Syndrome

Data on the onset of action of COPD medications are lacking. This study compared the onset of bronchodilation following different inhaled therapies in patients with moderate-to-severe COPD and reversible airway obstruction.. In this double-blind, double-dummy, crossover study, 90 patients (aged >or=40 years; FEV(1) 30-70% predicted) were randomized to a single dose (two inhalations) of budesonide/formoterol 160/4.5 microg, salmeterol/fluticasone 25/250 microg, salbutamol 100 microg or placebo (via pressurized metered-dose inhalers) on four visits. The primary end-point was change in FEV(1) 5 min after drug inhalation; secondary end-points included inspiratory capacity (IC) and perception of onset of effect.. Budesonide/formoterol significantly improved FEV(1) at 5 min compared with placebo (P < 0.0001) and salmeterol/fluticasone (P = 0.0001). Significant differences were first observed at 3 min. Onset of effect was similar with budesonide/formoterol and salbutamol. Improvements in FEV(1) following active treatments were superior to placebo after 180 min (all P < 0.0001); both combinations were better than salbutamol at maintaining FEV(1) improvements (P

Topics: Adrenal Cortex Hormones; Adult; Aged; Airway Obstruction; Albuterol; Androstadienes; Anti-Asthmatic Agents; Bronchodilator Agents; Budesonide; Budesonide, Formoterol Fumarate Drug Combination; Cross-Over Studies; Double-Blind Method; Drug Combinations; Ethanolamines; Female; Fluticasone-Salmeterol Drug Combination; Forced Expiratory Volume; Humans; Male; Middle Aged; Pulmonary Disease, Chronic Obstructive; Spirometry; Time Factors

There is presently no clear evidence on the effect of combined treatment for non-cystic fibrosis (non-CF) bronchiectasis with inhaled corticosteroid (ICS) and long-acting β2-adrenergic agonist (LABA). The objective of this study is to assess the efficacy and safety of salmeterol-fluticasone combined inhaled therapy for non-CF bronchiectasis with airflow limitation.. An observational study was performed in 120 non-CF bronchiectasis patients diagnosed by high-resolution computed tomography (HRCT) scanning of the chest. Patients received either routine therapy or salmeterol-fluticasone (100/500 μg daily) combined inhaled therapy on the basis of routine therapy. Clinical symptoms, health-related quality of life (HRQL), lung function, short-acting β2-adrenergic agonist (SABA) use, and safety were monitored throughout the study.. OF the 120 subjects, 60 received combined inhaled therapy and 60 received routine therapy. Compared to the control group, the combined inhaled therapy group showed significant improvement in their clinical symptom scores (-2.21 vs. -0.31, P = 0.002) and a reduction in number of weekly SABA usage (-4.2 vs. 0.1, P < 0.01). In addition, patients in the inhaled therapy group achieved a significant improvement in HRQL based on mMRC (-1.51 vs. -0.31, P < 0.005) and SGRQ (-7.83 vs. -2.16, P < 0.01) scoring accompanied with no severe adverse events. There were fewer exacerbation frequencies in the combined inhaled therapy group over the 12 months of treatment compared to the control group (1 [0-2] vs. 2 [1-4], P = 0.017). Furthermore, stratified analysis indicated that combined inhaled therapy partially improve lung function for patients for whom it is severely impaired and those with pseudomonas aeruginosa isolated.. Our results show that salmeterol-fluticasone combined inhaled therapy should be effective and safe for non-CF bronchiectasis patients especially for those patients with poor lung function or pseudomonas aeruginosa isolated.

Topics: Administration, Inhalation; Adrenergic beta-2 Receptor Agonists; Airway Obstruction; Bronchiectasis; Delayed-Action Preparations; Drug Therapy, Combination; Female; Fluticasone-Salmeterol Drug Combination; Follow-Up Studies; Forced Expiratory Volume; Glucocorticoids; Humans; Male; Middle Aged; Pulmonary Fibrosis; Retrospective Studies; Treatment Outcome