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

NCT ID: NCT00500318

Last Updated: 2017-01-06

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

181 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-07-31

Study Completion Date

2010-09-30

Brief Summary

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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.

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Efficacy and Safety of Aclidinium Bromide for Treatment of Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) (LAS-MD-33)

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Detailed Description

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Conditions

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Pulmonary Disease, Chronic Obstructive

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Aclidinium

Group Type EXPERIMENTAL

Aclidinium Bromide

Intervention Type DRUG

Aclidinium Bromide, 200μg. Once daily oral inhalation.

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Dose matched placebo, once daily oral inhalation.

Interventions

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Aclidinium Bromide

Aclidinium Bromide, 200μg. Once daily oral inhalation.

Intervention Type DRUG

Placebo

Dose matched placebo, once daily oral inhalation.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Esther Garcia, MD

Role: STUDY_DIRECTOR

AstraZeneca

Locations

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Forest Investigative Site 2088

Jasper, Alabama, United States

Site Status

Forest Investigative Site 0909

Phoenix, Arizona, United States

Site Status

Forest Investigative Site 0957

Long Beach, California, United States

Site Status

Forest Investigative Site 0973

Los Angeles, California, United States

Site Status

Forest Investigative Site 0887

Los Angeles, California, United States

Site Status

Forest Investigative Site 0988

Sacramento, California, United States

Site Status

Forest Investigative Site 0885

Torrance, California, United States

Site Status

Forest Investigative Site 2663

Clearwater, Florida, United States

Site Status

Forest Investigative Site 1030

Jacksonville, Florida, United States

Site Status

Forest Investigative Site 0974

Pensacola, Florida, United States

Site Status

Forest Investigative Site 0980

Atlanta, Georgia, United States

Site Status

Forest Investigative Site 0991

Atlanta, Georgia, United States

Site Status

Forest Investigative Site 0987

Austell, Georgia, United States

Site Status

Forest Investigative Site 2008

Marietta, Georgia, United States

Site Status

Forest Investigative Site 0984

Iowa City, Iowa, United States

Site Status

Forest Investigative Site 1080

Topeka, Kansas, United States

Site Status

Forest Investigative Site 0898

Baltimore, Maryland, United States

Site Status

Forest Investigative Site 0886

Boston, Massachusetts, United States

Site Status

Forest Investigative Site 1029

North Dartmouth, Massachusetts, United States

Site Status

Forest Investigative Site 0889

Livonia, Michigan, United States

Site Status

Forest Investigative Site 2079

Saint Charles, Missouri, United States

Site Status

Forest Investigative Site 2071

Omaha, Nebraska, United States

Site Status

Forest Investigative Site 0972

Brooklyn, New York, United States

Site Status

Forest Investigative Site 0971

Great Neck, New York, United States

Site Status

Forest Investigative Site 1114

New York, New York, United States

Site Status

Forest Investigative Site 2665

New York, New York, United States

Site Status

Forest Investigative Site 2081

Charlotte, North Carolina, United States

Site Status

Forest Investigative Site 0688

Charlotte, North Carolina, United States

Site Status

Forest Investigative Site 0981

Toledo, Ohio, United States

Site Status

Forest Investigative Site 1057

Hershey, Pennsylvania, United States

Site Status

Forest Investigative Site 0888

Philadelphia, Pennsylvania, United States

Site Status

Forest Investigative Site 0983

Scranton, Pennsylvania, United States

Site Status

Forest Investigative Site 2072

Charleston, South Carolina, United States

Site Status

Forest Investigative Site 1107

Columbia, South Carolina, United States

Site Status

Forest Investigative Site 0979

Columbia, South Carolina, United States

Site Status

Forest Investigative Site 1078

Greenville, South Carolina, United States

Site Status

Forest Investigative Site 0900

Spartanburg, South Carolina, United States

Site Status

Forest Investigative Site 0962

Nashville, Tennessee, United States

Site Status

Forest Investigative Site 1082

Dallas, Texas, United States

Site Status

Forest Investigative Site 2058

Dallas, Texas, United States

Site Status

Forest Investigative Site 0890

Houston, Texas, United States

Site Status

Forest Investigative Site 0977

Midvale, Utah, United States

Site Status

Forest Investigative Site 0968

Edmonton, Alberta, Canada

Site Status

Forest Investigative Site 0960

Kelowna, British Columbia, Canada

Site Status

Forest Investigative Site 0905

Vancouver, British Columbia, Canada

Site Status

Forest Investigative Site 0976

Winnipeg, Manitoba, Canada

Site Status

Forest Investigative Site 0891

Hamilton, Ontario, Canada

Site Status

Forest Investigative Site 2204

Ottawa, Ontario, Canada

Site Status

Forest Investigative Site 0969

Windsor, Ontario, Canada

Site Status

Forest Investigative Site 2205

Montreal, Quebec, Canada

Site Status

Forest Investigative Site 0893

Ste-Foy, Quebec, Canada

Site Status

Forest Investigative Site 0943

Saskatoon, Saskatchewan, Canada

Site Status

Countries

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United States Canada

References

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Maltais F, Celli B, Casaburi R, Porszasz J, Jarreta D, Seoane B, Caracta C. Aclidinium bromide improves exercise endurance and lung hyperinflation in patients with moderate to severe COPD. Respir Med. 2011 Apr;105(4):580-7. doi: 10.1016/j.rmed.2010.11.019. Epub 2010 Dec 22.

Reference Type DERIVED
PMID: 21183326 (View on PubMed)

Other Identifiers

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LAS-MD-CL26

Identifier Type: -

Identifier Source: org_study_id

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