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

Pulmonary Disease, Chronic Obstructive Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00500318
• Other study ID #: LAS-MD-CL26
• Status: Completed
• Phase: Phase 3
• First received: July 10, 2007
• Last updated: November 16, 2012
• Start date: July 2007

Study information

• Verified date: November 2012
• Source: Forest Laboratories
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationCanada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 181
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Disease
• Lung Diseases
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• Aclidinium Bromide
Aclidinium Bromide, 200µg. Once daily oral inhalation.
• Placebo
Dose matched placebo, once daily oral inhalation.

Locations

Country	Name	City	State
Canada	Forest Investigative Site 0968	Edmonton	Alberta
Canada	Forest Investigative Site 0891	Hamilton	Ontario
Canada	Forest Investigative Site 0960	Kelowna	British Columbia
Canada	Forest Investigative Site 2205	Montreal	Quebec
Canada	Forest Investigative Site 2204	Ottawa	Ontario
Canada	Forest Investigative Site 0943	Saskatoon	Saskatchewan
Canada	Forest Investigative Site 0893	Ste-Foy	Quebec
Canada	Forest Investigative Site 0905	Vancouver	British Columbia
Canada	Forest Investigative Site 0969	Windsor	Ontario
Canada	Forest Investigative Site 0976	Winnipeg	Manitoba
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 0898	Baltimore	Maryland
United States	Forest Investigative Site 0886	Boston	Massachusetts
United States	Forest Investigative Site 0972	Brooklyn	New York
United States	Forest Investigative Site 2072	Charleston	South Carolina
United States	Forest Investigative Site 0688	Charlotte	North Carolina
United States	Forest Investigative Site 2081	Charlotte	North Carolina
United States	Forest Investigative Site 2663	Clearwater	Florida
United States	Forest Investigative Site 0979	Columbia	South Carolina
United States	Forest Investigative Site 1107	Columbia	South Carolina
United States	Forest Investigative Site 1082	Dallas	Texas
United States	Forest Investigative Site 2058	Dallas	Texas
United States	Forest Investigative Site 0971	Great Neck	New York
United States	Forest Investigative Site 1078	Greenville	South Carolina
United States	Forest Investigative Site 1057	Hershey	Pennsylvania
United States	Forest Investigative Site 0890	Houston	Texas
United States	Forest Investigative Site 0984	Iowa City	Iowa
United States	Forest Investigative Site 1030	Jacksonville	Florida
United States	Forest Investigative Site 2088	Jasper	Alabama
United States	Forest Investigative Site 0889	Livonia	Michigan
United States	Forest Investigative Site 0957	Long Beach	California
United States	Forest Investigative Site 0887	Los Angeles	California
United States	Forest Investigative Site 0973	Los Angeles,	California
United States	Forest Investigative Site 2008	Marietta	Georgia
United States	Forest Investigative Site 0977	Midvale	Utah
United States	Forest Investigative Site 1029	N. Dartmouth	Massachusetts
United States	Forest Investigative Site 0962	Nashville	Tennessee
United States	Forest Investigative Site 1114	New York	New York
United States	Forest Investigative Site 2665	New York	New York
United States	Forest Investigative Site 2071	Omaha	Nebraska
United States	Forest Investigative Site 0974	Pensacola	Florida
United States	Forest Investigative Site 0888	Philadelphia	Pennsylvania
United States	Forest Investigative Site 0909	Phoenix	Arizona
United States	Forest Investigative Site 0988	Sacramento	California
United States	Forest Investigative Site 0983	Scranton	Pennsylvania
United States	Forest Investigative Site 0900	Spartanburg	South Carolina
United States	Forest Investigative Site 2079	St. Charles	Missouri
United States	Forest Investigative Site 0981	Toledo	Ohio
United States	Forest Investigative Site 1080	Topeka	Kansas
United States	Forest Investigative Site 0885	Torrance	California

Sponsors (2)

Lead Sponsor	Collaborator
Forest Laboratories	Almirall, S.A.

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Exercise Endurance Time (ET)	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.	From baseline Week 0 (Visit 4) to Week 6 (Visit 6)	No
Secondary	Trough Forced Expiratory Volume in 1 Second (FEV1)	Change in trough Forced Expiratory Volume in 1 second. FEV1 was assessed at the end of the daily dosing interval (Trough).	Change from baseline (Visit 4) at Week 6 (Visit 6)	No
Secondary	Trough Inspiratory Capacity (IC)	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).	Change from baseline Week 0 (Visit 4) to Week 6 (Visit 6)	No
Secondary	Functional Residual Capacity (FRC)	Change in trough Functional Residual Capacity. FRC was assessed at the end of the daily dosing interval (Trough).	Change from baseline Week 0 (Visit 4) to Week 6 (Visit 6)	No
Secondary	Inspiratory Capacity (IC)/Total Lung Capacity (TLC) Ratio	Ratio of trough Inspiratory Capacity verses Total Lung Capacity.	Change from baseline Week 0 (Visit 4) to Week 6 (Visit 6)	No