Efficacy and Safety of LAS 34273 in Patients With Moderate to Severe Stable Chronic Obstructive Pulmonary Disease(COPD)

NCT ID: NCT00358436

Last Updated: 2017-01-04

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

804 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-08-31

Study Completion Date

2008-06-30

Brief Summary

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To evaluate the efficacy and safety of LAS 34273 compared to placebo in patients with moderate to severe COPD during one year of treatment.

Detailed Description

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Conditions

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Chronic Obstructive Pulmonary Disease (COPD)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Aclidinium 200 μg once-daily

Aclidinium bromide 200 μg once-daily by inhalation

Group Type EXPERIMENTAL

Aclidinium bromide

Intervention Type DRUG

Aclidinium bromide 200 μg once-daily via inhalation by the Eklira Genuair® inhaler: 1 puff in the morning for 52 weeks

Placebo

Placebo by inhalation

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo once-daily via inhalation: 1 puff in the morning for 52 weeks

Interventions

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Aclidinium bromide

Aclidinium bromide 200 μg once-daily via inhalation by the Eklira Genuair® inhaler: 1 puff in the morning for 52 weeks

Intervention Type DRUG

Placebo

Placebo once-daily via inhalation: 1 puff in the morning for 52 weeks

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Males and females aged ≥ 40 years with a clinical diagnosis of moderate to severe stable COPD

Exclusion Criteria

* History or current diagnosis of asthma, recent respiratory tract infection or acute COPD exacerbation, life expectancy of less than 1 year, known symptomatic prostatic hypertrophy, bladder neck obstruction or narrow-angle glaucoma
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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Almirall Investigational Sites#926

Jasper, Alabama, United States

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Ozark, Alabama, United States

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Phoenix, Arizona, United States

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Tucson, Arizona, United States

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Tucson, Arizona, United States

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Little Rock, Arkansas, United States

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Carmichael, California, United States

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Encinitas, California, United States

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Fullerton, California, United States

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Los Angeles, California, United States

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Los Angeles, California, United States

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North Hills, California, United States

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Rancho Mirage, California, United States

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Riverside, California, United States

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San Diego, California, United States

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San Diego, California, United States

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Torrance, California, United States

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Walnut Creek, California, United States

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Denver, Colorado, United States

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Fort Collins, Colorado, United States

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Wheat Ridge, Colorado, United States

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Waterbury, Connecticut, United States

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Bay Pines, Florida, United States

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Clearwater, Florida, United States

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DeLand, Florida, United States

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Melbourne, Florida, United States

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Tamarac, Florida, United States

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Tampa, Florida, United States

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Tampa, Florida, United States

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Atlanta, Georgia, United States

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Decatur, Georgia, United States

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Gainesville, Georgia, United States

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Marietta, Georgia, United States

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Chicago, Illinois, United States

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Hines, Illinois, United States

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River Forest, Illinois, United States

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Evansville, Indiana, United States

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Bowling Green, Kentucky, United States

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Florence, Kentucky, United States

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Lafayette, Louisiana, United States

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Shreveport, Louisiana, United States

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Biddeford, Maine, United States

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Lewiston, Maine, United States

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Baltimore, Maryland, United States

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Cadillac, Michigan, United States

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Minneapolis, Minnesota, United States

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Saint Charles, Missouri, United States

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Butte, Montana, United States

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Omaha, Nebraska, United States

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Cherry Hill, New Jersey, United States

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Newark, New Jersey, United States

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Summit, New Jersey, United States

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Albuquerque, New Mexico, United States

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Chapel Hill, North Carolina, United States

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Charlotte, North Carolina, United States

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Elizabeth City, North Carolina, United States

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Williamston, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Cincinnati, Ohio, United States

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Cincinnati, Ohio, United States

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Columbus, Ohio, United States

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Sylvania, Ohio, United States

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Eugene, Oregon, United States

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Medford, Oregon, United States

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Medford, Oregon, United States

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Charleston, South Carolina, United States

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Greer, South Carolina, United States

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Dallas, Texas, United States

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Fort Worth, Texas, United States

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Houston, Texas, United States

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San Antonio, Texas, United States

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Richmond, Virginia, United States

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Milwaukee, Wisconsin, United States

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Buenos Aires, , Argentina

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Buenos Aires, , Argentina

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El Palomar, , Argentina

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La Plata, , Argentina

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Rosario, , Argentina

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San Miguel de Tucumán, , Argentina

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Vicente López, , Argentina

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Adelaide, , Australia

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Auchenflower, , Australia

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Bankstown, , Australia

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Boxhill, , Australia

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Cairns, , Australia

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Camperdown, , Australia

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Carina Heights, , Australia

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Clayton, , Australia

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Kippa-Ring, , Australia

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Nedlands, , Australia

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Nedlands, , Australia

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Toorak Gardens, , Australia

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Woodville, , Australia

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Edmonton, , Canada

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Kelowna, , Canada

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Montreal, , Canada

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Niagara Falls, , Canada

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Ottawa, , Canada

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Ottawa, , Canada

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Toronto, Ontario, , Canada

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Monterrey, , Mexico

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Zapopan, , Mexico

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Auckland, , New Zealand

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Grafton, , New Zealand

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Tauranga, , New Zealand

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Bloemfontain, , South Africa

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Bloemfontein, , South Africa

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Cape Town, , South Africa

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Cape Town, , South Africa

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Cape Town, , South Africa

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Cape Town, , South Africa

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Durban, , South Africa

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eManzimtoti, , South Africa

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Johannesburg, , South Africa

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Countries

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United States Argentina Australia Canada Mexico New Zealand South Africa

References

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Jones PW, Rennard SI, Agusti A, Chanez P, Magnussen H, Fabbri L, Donohue JF, Bateman ED, Gross NJ, Lamarca R, Caracta C, Gil EG. Efficacy and safety of once-daily aclidinium in chronic obstructive pulmonary disease. Respir Res. 2011 Apr 26;12(1):55. doi: 10.1186/1465-9921-12-55.

Reference Type DERIVED
PMID: 21518460 (View on PubMed)

Related Links

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Other Identifiers

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ACCLAIM II

Identifier Type: OTHER

Identifier Source: secondary_id

CT000742

Identifier Type: OTHER

Identifier Source: secondary_id

M/34273/31

Identifier Type: -

Identifier Source: org_study_id

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