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

• Status: Completed
• Trial end date: 2010-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca
• Treatments: Bromides

Criteria

Inclusion Criteria:

• A diagnosis of stable moderate to severe COPD (GOLD 2006); post-levalbuterol FEV1 >=30% and < 80% predicted and FEV1/FVC<70% predicted

• Current or former cigarette smoker

• Functional Residual Capacity (FRC) measured by body plethysmography >= 120% of predicted value

• Baseline Dyspnea Index (BDI) focal score ≤ 7 at Visit 4

Exclusion Criteria:

• History of presence of asthma, allergic rhinitis, or atopy

• Hospitalization for acute COPD exacerbation in the 3 months prior to study entry

• Respiratory tract infection (including the upper respiratory tract) or COPD exacerbation in the 6 weeks prior to study entry

• Clinically significant respiratory conditions other than COPD

• Chronic use of oxygen therapy >= 15 hours a day