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A Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy, Safety, and Tolerability of 2 Doses of Aclidinium Bromide Compared With Placebo for 12 Weeks in Patients With Moderate to Severe, Stable Chronic Obstructive Pulmonary Disease Followed by a 40-Week Evaluation of the Higher Aclidinium Bromide Dose (LAS-MD-38)
The purpose of this study is to evaluate the efficacy, safety and tolerability of aclidinium bromide doses compared with placebo in the treatment of moderate to severe, stable chronic obstructive pulmonary disease. The study will be 56 weeks in duration; a 2-week run-in period followed by a 12-week double-blind, placebo-controlled treatment period. This will be followed by an open-label 40-week treatment period and a 2-week follow up phone call. All patients will receive the higher Aclidinium Bromide during the 40-week open label treatment period.
Details
| Lead sponsor | AstraZeneca |
|---|---|
| Phase | Phase 3 |
| Status | COMPLETED |
| Enrolment | 544 |
| Start date | 2009-03 |
| Completion | 2011-06 |
Conditions
- Chronic Obstructive Pulmonary Disease
Interventions
- Aclidinium bromide
- Placebo
Primary outcomes
- Part A: Morning Predose (Trough) Forced Expiratory Volume in 1 Second (FEV1) — Change from baseline (Week 0) to Week 12
Change from baseline in Trough forced expiratory volume in 1 second before the morning dose of aclidinium bromide, Last Observation Carried Forward (LOCF) - Part B: Morning Predose (Trough) FEV1 — Change from baseline (Week 0) to 52 Weeks
Change from Baseline in Morning Pre-dose (trough) Forced Expiratory Volume in 1 Second (FEV1) at Week 52, Lost Observation Carried Forward (LOCF)
Countries
United States, Canada