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A Long-Term, Randomized, Double-Blind Study of the Safety, Tolerability and Efficacy of Aclidinium Bromide At Two Dosage Levels When Administered to Patients With Moderate to Severe, Stable Chronic Obstructive Pulmonary Disease (LAS-MD-35)
The purpose of this study is to evaluate the safety, tolerability and efficacy of inhaled aclidinium bromide at two dose levels in patients with moderate to severe, stable chronic obstructive pulmonary disease. The study will be 56 weeks in duration; a 2-week rin-in period, a 52-week treatment period and a 2-week follow up phone call. All patients will be randomized to one of two doses of aclidinium bromide.
Details
| Lead sponsor | AstraZeneca |
|---|---|
| Phase | Phase 3 |
| Status | COMPLETED |
| Enrolment | 605 |
| Start date | 2009-11 |
| Completion | 2011-04 |
Conditions
- Chronic Obstructive Pulmonary Disease
Interventions
- Aclidinium Bromide 200 µg
- Aclidinium Bromide 400 µg
Primary outcomes
- Change From Baseline in Morning Pre-dose (Trough) Forced Expiratory Volume in One Second (FEV1) — From baseline to 52 weeks
Change From Baseline in Morning Predose (Trough) FEV1 in liters at Week 52.
Countries
United States, Canada