A Study of Exercise Endurance and Lung Hyperinflation in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
This study has been completed.
Sponsor:
Forest Laboratories
Collaborator:
Almirall, S.A.
Information provided by (Responsible Party):
Forest Laboratories
ClinicalTrials.gov Identifier:
NCT00500318
First received: July 10, 2007
Last updated: November 16, 2012
Last verified: November 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Pulmonary Disease, Chronic Obstructive |
Drug: Aclidinium Bromide Drug: Placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Forest Laboratories:
Primary Outcome Measures:
- Change From Baseline in Exercise Endurance Time (ET) [ Time Frame: From baseline Week 0 (Visit 4) to Week 6 (Visit 6) ] [ Designated as safety issue: No ]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:
- Trough Forced Expiratory Volume in 1 Second (FEV1) [ Time Frame: Change from baseline (Visit 4) at Week 6 (Visit 6) ] [ Designated as safety issue: No ]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) ] [ Designated as safety issue: No ]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) ] [ Designated as safety issue: No ]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) ] [ Designated as safety issue: No ]Ratio of trough Inspiratory Capacity verses Total Lung Capacity.
| Enrollment: | 181 |
| Study Start Date: | July 2007 |
| Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Aclidinium |
Drug: Aclidinium Bromide
Aclidinium Bromide, 200μg. Once daily oral inhalation.
|
| Placebo Comparator: Placebo |
Drug: Placebo
Dose matched placebo, once daily oral inhalation.
|
Eligibility| Ages Eligible for Study: | 40 Years and older (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00500318
Show 52 Study Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00500318
Show 52 Study Locations
Sponsors and Collaborators
Forest Laboratories
Almirall, S.A.
Investigators
| Study Director: | Brian T Maurer, M.S. | Forest Laboratories |
More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Forest Laboratories |
| ClinicalTrials.gov Identifier: | NCT00500318 History of Changes |
| Other Study ID Numbers: | LAS-MD-CL26 |
| Study First Received: | July 10, 2007 |
| Results First Received: | August 14, 2012 |
| Last Updated: | November 16, 2012 |
| Health Authority: | United States: Food and Drug Administration Canada: Health Canada |
Keywords provided by Forest Laboratories:
|
Bronchitis, Chronic; Emphysema |
Additional relevant MeSH terms:
|
Lung Diseases Pulmonary Disease, Chronic Obstructive Chronic Disease Respiratory Tract Diseases Lung Diseases, Obstructive |
Disease Attributes Pathologic Processes Bromides Anticonvulsants |
ClinicalTrials.gov processed this record on September 23, 2016