drugset / Trial / NCT00500318

A Study of Exercise Endurance and Lung Hyperinflation in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)

NCT00500318 ↗

Phase 3 Completed 181 enrolled AstraZeneca
RandomizedParallel-groupTriple-blindTreatment

Summary

This study evaluated the effect of inhaled aclidinium bromide on exercise endurance and in reducing resting and dynamic lung hyperinflation in patients with moderate to severe COPD. It was 9 weeks in duration, consisting of; a 2-week run-in period, 6 weeks of double-blind treatment, and a 1-week follow-up phone call. All patients meeting the eligibility criteria were randomized to one of two treatment groups: aclidinium bromide or placebo.

Timeline

Start
2007-07
Primary completion
2008-12
Completion
2010-09

Outcome

Met primary endpoint

registry analysis (superiority or other test); Aclidinium vs Placebo; p = 0.0042; Least Square Mean 116.44 (95% CI 37.280 to 195.610); ANCOVA NCT00500318 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Aclidinium Unknown 200 ug Inhaled