A Study of Exercise Endurance and Lung Hyperinflation in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
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|ClinicalTrials.gov Identifier: NCT00500318|
Recruitment Status : Completed
First Posted : July 12, 2007
Results First Posted : December 17, 2012
Last Update Posted : January 6, 2017
|Condition or disease||Intervention/treatment||Phase|
|Pulmonary Disease, Chronic Obstructive||Drug: Aclidinium Bromide Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||181 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, 6-Week Clinical Study to Assess the Effect of Inhaled Aclidinium Bromide (LAS34273) 200 ug on Exercise Endurance and Lung Hyperinflation in Patients With Moderate to Severe COPD|
|Study Start Date :||July 2007|
|Actual Primary Completion Date :||December 2008|
|Actual Study Completion Date :||September 2010|
Drug: Aclidinium Bromide
Aclidinium Bromide, 200μg. Once daily oral inhalation.
|Placebo Comparator: Placebo||
Dose matched placebo, once daily oral inhalation.
- Change From Baseline in Exercise Endurance Time (ET) [ Time Frame: 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.
- Trough Forced Expiratory Volume in 1 Second (FEV1) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: Change from baseline Week 0 (Visit 4) to Week 6 (Visit 6) ]Ratio of trough Inspiratory Capacity verses Total Lung Capacity.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00500318
|Study Director:||Esther Garcia, MD||AstraZeneca|