A Study of Exercise Endurance and Lung Hyperinflation in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Interventions
- Drug: Placebo
- Registration Number
- NCT00500318
- Lead Sponsor
- AstraZeneca
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 181
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo - Aclidinium Aclidinium Bromide -
- Primary Outcome Measures
Name Time Method Change From Baseline in Exercise Endurance Time (ET) From baseline Week 0 (Visit 4) to Week 6 (Visit 6) Exercise endurance time is defined as the time from the increase in work rate at 75% Wmax (watts) to the point of symptom limitation. The Wmax is defined as the highest work rate the patients were able to maintain for at least 30 seconds.
- Secondary Outcome Measures
Name Time Method Trough Forced Expiratory Volume in 1 Second (FEV1) Change from baseline (Visit 4) at Week 6 (Visit 6) Change in trough Forced Expiratory Volume in 1 second. FEV1 was assessed at the end of the daily dosing interval (Trough).
Trough Inspiratory Capacity (IC) Change from baseline Week 0 (Visit 4) to Week 6 (Visit 6) Change in trough Inspiratory Capacity. Inspiratory Capacity was measured as part of the spirometry procedures performed at each visit. IC was assessed at the end of the daily dosing interval (Trough).
Functional Residual Capacity (FRC) Change from baseline Week 0 (Visit 4) to Week 6 (Visit 6) Change in trough Functional Residual Capacity. FRC was assessed at the end of the daily dosing interval (Trough).
Inspiratory Capacity (IC)/Total Lung Capacity (TLC) Ratio Change from baseline Week 0 (Visit 4) to Week 6 (Visit 6) Ratio of trough Inspiratory Capacity verses Total Lung Capacity.
Trial Locations
- Locations (52)
Forest Investigative Site 2088
🇺🇸Jasper, Alabama, United States
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
Scroll for more (42 remaining)Forest Investigative Site 2088🇺🇸Jasper, Alabama, United States