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A Multiple Dose, Randomised, Double-blind, Placebo Controlled, 2 Period Crossover Clinical Trial to Assess the Effect of Aclidinium Bromide 400 μg BID on Exercise Endurance in Patients With Stable Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
The aim of the present study is to evaluate the effect of aclidinium bromide 400 μg twice a day (BID) administered twice a day versus placebo on exercise endurance and on hyperinflation and dyspnoea at rest and during exercise after 3 weeks of treatment.
Details
| Lead sponsor | AstraZeneca |
|---|---|
| Phase | Phase 3 |
| Status | COMPLETED |
| Enrolment | 112 |
| Start date | 2011-11 |
| Completion | 2012-06 |
Conditions
- Chronic Obstructive Pulmonary Disease (COPD)
Interventions
- Aclidinium Bromide
- Placebo
Primary outcomes
- Change From Baseline in Endurance Time (Seconds) — Week 3
Change from baseline in endurance time during constant work rate cycle ergometry to symptom limitation at 75% of Maximum Work load (Wmax) after 3 weeks of treatment.
Countries
Germany, Spain, United Kingdom