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

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

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

NCT00500318•AstraZeneca

View on ClinicalTrials.gov

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.

Eligibility

Age

40 - No limit years

Sex

ALL

Healthy Volunteers

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

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

Key Dates

Start Date

July 1, 2007

Primary Completion Date

December 1, 2008

Completion Date

September 1, 2010

Last Updated

January 6, 2017

Enrollment

181

ACTUAL participants

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Aclidinium Bromide

DRUG

Placebo

DRUG

Digital Implementation of the German S3 Clinical Practice Guideline for Multimorbidity

NCT06831994

Asthma BronchialeBreast Neoplasms+11 more

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RECRUITING

The London COPD Exacerbation Cohort

NCT02755974

Pulmonary Disease, Chronic Obstructive

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ACTIVE_NOT_RECRUITING

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 6, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Digital Implementation of the German S3 Clinical Practice Guideline for Multimorbidity

The London COPD Exacerbation Cohort

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