A Study of Exercise Endurance and Lung Hyperinflation in Patients With Moderate to Severe COPD

This study is ongoing, but not recruiting participants.

Sponsors and Collaborators:	Forest Laboratories Laboratorios Almirall, SA
Information provided by:	Forest Laboratories
ClinicalTrials.gov Identifier:	NCT00500318

Purpose

This study will evaluate 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 will be 9 weeks in duration; 2-week run-in period, 6-week double-blind treatment, and 1-week follow-up phone call. All patients meeting the eligibility criteria will be randomized to one of two treatment groups: aclidinium bromide or placebo.

Condition	Intervention	Phase
Pulmonary Disease, Chronic Obstructive	Drug: Aclidinium Bromide	Phase III

MedlinePlus related topics: Bronchitis COPD (Chronic Obstructive Pulmonary Disease) Exercise and Physical Fitness

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Double-Blind, Placebo Control, Parallel Assignment
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

Further study details as provided by Forest Laboratories:

Primary Outcome Measures:

Endurance time (ET) at 75% Wmax

Secondary Outcome Measures:

Trough Forced Expiratory Volume in 1 second (FEV1), Inspiratory Capacity (IC), Functional Residual Capacity (FRC), IC/Total Lung Capacity (TLC) ratio, Safety

Study Start Date:

July 2007

Eligibility

Ages Eligible for Study:	40 Years and older
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

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00500318

Locations

United States, Missouri
For information regarding investigative sites, contact Forest Professional Affairs
St. Louis, Missouri, United States, 63045

Sponsors and Collaborators

Forest Laboratories

Laboratorios Almirall, SA

More Information

Study ID Numbers:	LAS-MD-CL26
Study First Received:	July 10, 2007
Last Updated:	October 7, 2008
ClinicalTrials.gov Identifier:	NCT00500318
Health Authority:	United States: Food and Drug Administration; Canada: Health Canada

Keywords provided by Forest Laboratories:

Bronchitis, Chronic; Emphysema

Study placed in the following topic categories:

Pulmonary Emphysema
Emphysema
Bronchitis, Chronic
Lung Diseases, Obstructive
Respiratory Tract Diseases

Bromides
Lung Diseases
Chronic Disease
Bronchitis
Pulmonary Disease, Chronic Obstructive

Additional relevant MeSH terms:

Disease Attributes
Pathologic Processes
Therapeutic Uses

Central Nervous System Agents
Pharmacologic Actions
Anticonvulsants

ClinicalTrials.gov processed this record on January 14, 2009