International journal of chronic obstructive pulmonary disease
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Int J Chron Obstruct Pulmon Dis · Jan 2014
Randomized Controlled Trial Multicenter StudyEfficacy and safety of combining olodaterol Respimat(®) and tiotropium HandiHaler(®) in patients with COPD: results of two randomized, double-blind, active-controlled studies.
Combining bronchodilators with different mechanisms of action may improve efficacy and reduce risk of side effects compared to increasing the dose of a single agent in chronic obstructive pulmonary disease (COPD). We investigated this by combining two long-acting bronchodilators: once-daily muscarinic antagonist tiotropium and once-daily β2-agonist olodaterol. ⋯ These studies demonstrated that olodaterol (Respimat(®)) and tiotropium (HandiHaler(®)) provided bronchodilatory effects above tiotropium alone in patients with COPD. In general, both treatments were well tolerated.
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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 TrialAdjunctive treatment with oral AKL1, a botanical nutraceutical, in chronic obstructive pulmonary disease.
The objective of this pilot trial was to evaluate the safety and efficacy of AKL1, a patented botanical formulation containing extracts of Picrorhiza kurroa, Ginkgo biloba, and Zingiber officinale, as add-on therapy for patients with chronic obstructive pulmonary disease (COPD) and chronic cough. ⋯ Further study is needed with a larger patient population and over a longer duration to better assess the effects of add-on therapy with AKL1 in COPD.
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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.