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To Assess the Long-term Safety, Efficacy and Tolerability of Inhaled Aclidinium Bromide in the Treatment of Moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD)

2014-08-27 03:16:47 | BioPortfolio

Summary

The purpose of this study is to evaluate the efficacy, safety and tolerability 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 run-in period followed by a 12-week placebo-controlled lead-in treatment period. This will be followed by a 40-week treatment period and a 2-week follow up phone call. All patients from the placebo group will be randomized to one of two doses of aclidinium bromide from the 12-week placebo-controlled lead-in study.

Study Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Conditions

Chronic Obstructive Pulmonary Disease

Intervention

Aclidinium bromide, Aclidinium bromide, Placebo

Location

Forest Investigative Site 1493
Birmingham
Alabama
United States
35209

Status

Recruiting

Source

Forest Laboratories

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:16:47-0400

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