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

Completed · Phase 3 · Has a placebo group

Conditions studied: Pulmonary Disease, Chronic Obstructive

In brief

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.

Key facts

Study ID

NCT00500318

Run by

AstraZeneca

People needed

181

Starts

2007-07-01

Expected to finish

2010-09-01

Last updated by the study team

2017-01-06

Who can join

Age: 40 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Forest Investigative Site 0909 — Phoenix, Arizona, United States
• Forest Investigative Site 0957 — Long Beach, California, United States
• Forest Investigative Site 0973 — Los Angeles, California, United States
• Forest Investigative Site 0887 — Los Angeles, California, United States
• Forest Investigative Site 0988 — Sacramento, California, United States
• Forest Investigative Site 0885 — Torrance, California, United States
• Forest Investigative Site 2663 — Clearwater, Florida, United States
• Forest Investigative Site 1030 — Jacksonville, Florida, United States
• Forest Investigative Site 0974 — Pensacola, Florida, United States
• Forest Investigative Site 0980 — Atlanta, Georgia, United States
• Forest Investigative Site 0991 — Atlanta, Georgia, United States
• Forest Investigative Site 0987 — Austell, Georgia, United States
• Forest Investigative Site 2008 — Marietta, Georgia, United States
• Forest Investigative Site 0984 — Iowa City, Iowa, United States
• Forest Investigative Site 1080 — Topeka, Kansas, United States
• Forest Investigative Site 0898 — Baltimore, Maryland, United States
• Forest Investigative Site 0886 — Boston, Massachusetts, United States
• Forest Investigative Site 1029 — North Dartmouth, Massachusetts, United States
• Forest Investigative Site 0889 — Livonia, Michigan, United States
• Forest Investigative Site 2079 — Saint Charles, Missouri, United States
• Forest Investigative Site 2071 — Omaha, Nebraska, United States
• Forest Investigative Site 0972 — Brooklyn, New York, United States
• Forest Investigative Site 0971 — Great Neck, New York, United States
• Forest Investigative Site 1114 — New York, New York, United States
• Forest Investigative Site 2088 — Jasper, Alabama, United States

Full record on ClinicalTrials.gov

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