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

NCT ID: NCT00891462

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

561 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-04-30

Study Completion Date

2009-11-30

Brief Summary

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The purpose of this study is to assess the efficacy (effectiveness) and safety of aclidinium bromide doses as compared to placebo in the treatment of moderate to severe chronic obstructive pulmonary disease. The study will be 16 weeks in duration; 2-week run-in period, 12-week double-blind treatment, and 2-week follow-up phone visit.

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Detailed Description

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Conditions

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Chronic Obstructive Pulmonary Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Aclidinium bromide dose, inhaled, for 12 weeks of treatment

Group Type EXPERIMENTAL

Aclidinium bromide

Intervention Type DRUG

Aclidinium bromide 200 μg, oral inhalation twice per day for 12 weeks of treatment

2

Aclidinium bromide dose, inhaled, for 12 weeks of treatment

Group Type EXPERIMENTAL

Aclidinium bromide

Intervention Type DRUG

Aclidinium bromide 400 μg, oral inhalation twice per day for 12 weeks of treatment

3

Inhaled placebo for 12 weeks

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Dose-matched placebo, oral inhalation twice per day for 12 weeks of treatment

Interventions

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Aclidinium bromide

Aclidinium bromide 200 μg, oral inhalation twice per day for 12 weeks of treatment

Intervention Type DRUG

Aclidinium bromide

Aclidinium bromide 400 μg, oral inhalation twice per day for 12 weeks of treatment

Intervention Type DRUG

Placebo

Dose-matched placebo, oral inhalation twice per day for 12 weeks of treatment

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* A diagnosis of stable moderate to severe COPD as defined by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines, 2009; postbronchodilator FEV1/FVC \< 70%, and postbronchodilator FEV1 ≥ 30% and \< 80% predicted
* Current or former cigarette smokers

Exclusion Criteria

* Patients who have been hospitalized for an acute COPD exacerbation within 3 months before the first visit
* Respiratory tract infection or COPD exacerbation in the 6 weeks before Visit 1
* Patient with any clinically significant respiratory conditions other than COPD, cardiovascular conditions or mental illness
* History or presence of asthma verified from medical records
* Chronic use of oxygen therapy greater than or equal to 15 hours per day
* Patient with uncontrolled infection due to HIV and/or active hepatitis
* Patients with a history of hypersensitivity reaction to inhaled anticholinergics
* Patients with clinically significant cardiovascular conditions, including myocardial infarction during the previous 6 months, newly diagnosed arrhythmia within the previous 3 months, unstable angina, unstable arrhythmia that had required changes in pharmacological therapy or other intervention.
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

Birmingham, Alabama, United States

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Jasper, Alabama, United States

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Mobile, Alabama, United States

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Mesa, Arizona, United States

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Phoenix, Arizona, United States

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Phoenix, Arizona, United States

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Anaheim, California, United States

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Encinitas, California, United States

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Fresno, California, United States

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Fullerton, California, United States

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Lakewood, California, United States

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Orange, California, United States

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Palo Alto, California, United States

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Rancho Mirage, California, United States

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Sacramento, 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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Colorado Springs, Colorado, United States

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Denver, Colorado, United States

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Wheat Ridge, Colorado, United States

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Waterbury, Connecticut, United States

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Brandon, Florida, United States

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Clearwater, Florida, United States

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DeLand, Florida, United States

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Fort Lauderdale, Florida, United States

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Melbourne, Florida, United States

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Melbourne, Florida, United States

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Ormond Beach, Florida, United States

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Panama City, Florida, United States

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Pensacola, 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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Austell, Georgia, United States

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Blue Ridge, Georgia, United States

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Duluth, Georgia, United States

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Marietta, Georgia, United States

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River Forest, Illinois, United States

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Skokie, Illinois, United States

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South Bend, Indiana, United States

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Crescent Springs, Kentucky, United States

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Lexington, Kentucky, United States

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Lafayette, Louisiana, United States

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Bangor, Maine, United States

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Baltimore, Maryland, United States

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Baltimore, Maryland, United States

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Hagerstown, Maryland, United States

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North Dartmouth, Massachusetts, United States

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Livonia, Michigan, United States

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Edina, Minnesota, United States

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Minneapolis, Minnesota, United States

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Minneapolis, Minnesota, United States

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Florissant, Missouri, United States

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Saint Charles, Missouri, United States

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Billings, Montana, United States

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Butte, Montana, United States

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Papillion, Nebraska, United States

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Berlin, New Jersey, United States

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Summit, New Jersey, United States

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Brooklyn, New York, United States

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Buffalo, New York, United States

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Great Neck, New York, United States

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Ithaca, New York, United States

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New Hyde Park, New York, United States

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New York, New York, United States

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New York, New York, United States

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Asheville, North Carolina, United States

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Charlotte, North Carolina, United States

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Raleigh, North Carolina, United States

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Canton, Ohio, United States

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Cincinnati, Ohio, 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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Toledo, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Medford, Oregon, United States

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Portland, Oregon, United States

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Bethlehem, Pennsylvania, United States

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Erie, Pennsylvania, United States

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Hershey, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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Upland, Pennsylvania, United States

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East Providence, Rhode Island, United States

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Johnston, Rhode Island, United States

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Charleston, South Carolina, United States

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Greenville, South Carolina, United States

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Greer, South Carolina, United States

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Spartanburg, South Carolina, United States

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Nashville, Tennessee, United States

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Dallas, Texas, 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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Tyler, Texas, United States

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Waco, Texas, United States

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Midvale, Utah, United States

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Richmond, Virginia, United States

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Richmond, Virginia, United States

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Bellingham, Washington, United States

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Spokane, Washington, United States

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Tacoma, Washington, United States

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Milwaukee, Wisconsin, United States

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Saskatoon, Saskatchewan, Canada

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Edmonton, , Canada

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Hamilton, , Canada

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Kelowna, , Canada

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Niagara Falls, , Canada

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Sainte-Foy, , Canada

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Toronto, , Canada

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Toronto, , Canada

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Countries

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United States Canada

References

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Kerwin EM, D'Urzo AD, Gelb AF, Lakkis H, Garcia Gil E, Caracta CF; ACCORD I study investigators. Efficacy and safety of a 12-week treatment with twice-daily aclidinium bromide in COPD patients (ACCORD COPD I). COPD. 2012 Apr;9(2):90-101. doi: 10.3109/15412555.2012.661492. Epub 2012 Feb 9.

Reference Type DERIVED
PMID: 22320148 (View on PubMed)

McGarvey L, Morice AH, Smith JA, Birring SS, Chuecos F, Seoane B, Jarreta D. Effect of aclidinium bromide on cough and sputum symptoms in moderate-to-severe COPD in three phase III trials. BMJ Open Respir Res. 2016 Dec 8;3(1):e000148. doi: 10.1136/bmjresp-2016-000148. eCollection 2016.

Reference Type DERIVED
PMID: 28074135 (View on PubMed)

Other Identifiers

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ACCORD COPD I

Identifier Type: -

Identifier Source: secondary_id

LAS-MD-33

Identifier Type: -

Identifier Source: org_study_id

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