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

AstraZeneca

Status and phase

Completed

Phase 3

Conditions

Pulmonary Disease, Chronic Obstructive

Treatments

Drug: Aclidinium Bromide

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT00500318

LAS-MD-CL26

Details and patient eligibility

About

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.

Enrollment

181 patients

Sex

All

Ages

40+ years old

Volunteers

No Healthy Volunteers

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