International journal of chronic obstructive pulmonary disease
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Int J Chron Obstruct Pulmon Dis · Jan 2014
Randomized Controlled Trial Multicenter Study Comparative StudyEfficacy and safety of coadministration of once-daily indacaterol and glycopyrronium versus indacaterol alone in COPD patients: the GLOW6 study.
Addition of a second bronchodilator from a different pharmacological class may benefit patients with moderate-to-severe chronic obstructive pulmonary disease (COPD) whose symptoms are insufficiently controlled by bronchodilator monotherapy. GLOW6 evaluated the efficacy and safety of once-daily coadministration of the long-acting β2-agonist indacaterol (IND) and the long-acting muscarinic antagonist glycopyrronium (GLY) versus IND alone in patients with moderate-to-severe COPD. ⋯ In patients with moderate-to-severe COPD, once-daily coadministration of IND and GLY provides significant and sustained improvement in bronchodilation versus IND alone from day 1, with significant improvements in patient-centered outcomes.
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Int J Chron Obstruct Pulmon Dis · Jan 2014
Randomized Controlled Trial Multicenter StudyA randomized controlled trial of inhaled corticosteroids (ICS) on markers of epithelial-mesenchymal transition (EMT) in large airway samples in COPD: an exploratory proof of concept study.
We recently reported that epithelial-mesenchymal transition (EMT) is active in the airways in chronic obstructive pulmonary disease (COPD), suggesting presence of an active profibrotic and promalignant stroma. With no data available on potential treatment effects, we undertook a blinded analysis of inhaled corticosteroids (ICS) effects versus placebo on EMT markers in previously obtained endobronchial biopsies in COPD patients, as a "proof of concept" study. ⋯ Although only a pilot "proof of concept" study, this trial provided strong suggestive support for an anti-EMT effect of ICS in COPD airways. A larger and fully powered prospective study is now indicated as this issue is likely to be extremely important. Such studies may clarify the links between ICS use and better clinical outcomes and protection against lung cancer in COPD.
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Int J Chron Obstruct Pulmon Dis · Jan 2014
Randomized Controlled Trial Multicenter Study Comparative StudyLung function efficacy and symptomatic benefit of olodaterol once daily delivered via Respimat® versus placebo and formoterol twice daily in patients with GOLD 2-4 COPD: results from two replicate 48-week studies.
Two replicate, multicenter, randomized, double-blind, placebo-controlled, parallel-group, Phase III studies investigated the long-term efficacy and safety of once-daily olodaterol via Respimat® versus placebo and formoterol over 48 weeks in patients with moderate to very severe chronic obstructive pulmonary disease receiving usual-care background therapy. Patients received once-daily olodaterol 5 or 10 μg, twice-daily formoterol 12 μg, or placebo. Co-primary end points were forced expiratory volume in 1 second (FEV1) area under the curve from 0-3 hours response, FEV1 trough response, and Mahler transition dyspnea index total score after 24 weeks; secondary end points included St George's Respiratory Questionnaire. ⋯ St George's Respiratory Questionnaire total score was significantly improved with olodaterol, but not formoterol, versus placebo. No safety signals were identified from adverse-event or other safety data. Once-daily olodaterol 5 μg and 10 μg is efficacious in patients with moderate to very severe chronic obstructive pulmonary disease on usual-care maintenance therapy, with a satisfactory safety profile.
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Int J Chron Obstruct Pulmon Dis · Jan 2014
Randomized Controlled TrialChronic disease self-management and exercise in COPD as pulmonary rehabilitation: a randomized controlled trial.
Both exercise and self-management are advocated in pulmonary rehabilitation for people with chronic obstructive pulmonary disease (COPD). The widely used 6-week, group-based Chronic Disease Self-Management Program (CDSMP) increases self-reported exercise, despite supervised exercise not being a program component. This has been little explored in COPD. Whether adding supervised exercise to the CDSMP would add benefit is unknown. We investigated the CDSMP in COPD, with and without a formal supervised exercise component, to address this question. ⋯ The CDSMP produced à small statistically significant increase in 6MWD. The addition of a single supervised exercise session did not further increase exercise capacity. Our findings confirm the efficacy of a behaviorally based intervention in COPD, but this would seem to be less than expected from conventional exercise-based pulmonary rehabilitation, raising the question of how, if at all, the small gains observed in this study may be augmented.
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Int J Chron Obstruct Pulmon Dis · Jan 2014
Randomized Controlled Trial Multicenter StudyOnce-daily indacaterol 75 μg in moderate- to-severe COPD: results of a Phase IV study assessing time until patients' perceived onset of effect.
Indacaterol 75 μg once daily is a long-acting β2 agonist approved for maintenance bronchodilator treatment in patients with chronic obstructive pulmonary disease (COPD). The purpose of this study was to evaluate patients' perception of onset of effect with a single dose. ⋯ A single dose of indacaterol 75 μg did not separate from placebo in terms of patient perception of onset, although there was an improvement in FEV1 for indacaterol compared with placebo. Development and use of a validated questionnaire may be needed to address the inconsistency in evaluating this patient-related outcome.