At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 112 enrolled
Drug / intervention
Aclidinium Bromide +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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)
In Brief
A Phase 3 clinical trial evaluating Aclidinium Bromide and Placebo for Chronic Obstructive Pulmonary Disease (COPD). Completed, enrolled 112 participants across 14 sites in 3 countries.
Detailed Summary
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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesGermany, Spain, United Kingdom
Collaborators--
Timeline
Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
Enrollment StartNov 2011
First PostedNov 2011
Primary CompletionJun 2012
TodayJul 2026
First PostedNov 15, 2011
Enrollment StartNov 1, 2011
Primary CompletionJun 1, 2012
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 14.6 years ago
Interventions
Aclidinium Bromidedrug
1 puff of 400 micro grams in the morning (09:00 ± 1h) and in the evening (21:00 ± 1h)
Placebodrug
1 puff of placebo in the morning (09:00 ± 1h) and 1 puff in the evening (21:00 ± 1h)