Efficacy and Safety of Aclidinium Bromide for Treatment of Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) (LAS-MD-33)
November 16, 2016 updated by: AstraZeneca
Efficacy and Safety of Aclidinium Bromide at Two Dose Levels (200 μg Twice Daily, 400 μg Twice Daily) vs. Placebo When Administered to Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
561
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Edmonton, Canada, T5J 3S9
- Forest Investigative Site
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Hamilton, Canada, L8N 4A6
- Forest Investigative Site
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Kelowna, Canada, V1Y 8E7
- Forest Investigative Site
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Niagara Falls, Canada, L2G 1J4
- Forest Investigative Site
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Sainte-Foy, Canada, G1V 4G5
- Forest Investigative Site
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Toronto, Canada, M5g 1N8
- Forest Investigative Site
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Toronto, Canada, M6H 3M2
- Forest Investigative Site
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Saskatchewan
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Saskatoon, Saskatchewan, Canada, S7N 0W8
- Forest Investigative Site
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Alabama
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Birmingham, Alabama, United States, 35209
- Forest Investigative Site
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Jasper, Alabama, United States, 35501
- Forest Investigative Site
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Mobile, Alabama, United States, 18020
- Forest Investigative Site
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Arizona
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Mesa, Arizona, United States, 85210
- Forest Investigative Site
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Phoenix, Arizona, United States, 85006
- Forest Investigative Site
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Phoenix, Arizona, United States, 85023
- Forest Investigative Site
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California
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Anaheim, California, United States, 92801
- Forest Investigative Site
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Encinitas, California, United States, 92024
- Forest Investigative Site
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Fresno, California, United States, 93726
- Forest Investigative Site
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Fullerton, California, United States, 92835
- Forest Investigative Site
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Lakewood, California, United States, 90712
- Forest Investigative Site
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Orange, California, United States, 92868
- Forest Investigative Site
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Palo Alto, California, United States, 94304
- Forest Investigative Site
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Rancho Mirage, California, United States, 92270
- Forest Investigative Site
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Sacramento, California, United States, 95831
- Forest Investigative Site
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San Diego, California, United States, 92120
- Forest Investigative Site
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San Diego, California, United States, 92103-8415
- Forest Investigative Site
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Colorado
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Colorado Springs, Colorado, United States, 80907
- Forest Investigative Site
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Denver, Colorado, United States, 80206
- Forest Investigative Site
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Wheat Ridge, Colorado, United States, 80033
- Forest Investigative Site
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Connecticut
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Waterbury, Connecticut, United States, 06708
- Forest Investigative Site
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Florida
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Brandon, Florida, United States, 33511
- Forest Investigative Site
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Clearwater, Florida, United States, 33765
- Forest Investigative Site
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DeLand, Florida, United States, 32720
- Forest Investigative Site
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Fort Lauderdale, Florida, United States, 33316
- Forest Investigative Site
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Melbourne, Florida, United States, 32901
- Forest Investigative Site
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Melbourne, Florida, United States, 32935
- Forest Investigative Site
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Ormond Beach, Florida, United States, 32174
- Forest Investigative Site
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Panama City, Florida, United States, 32405
- Forest Investigative Site
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Pensacola, Florida, United States, 32504
- Forest Investigative Site
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Tamarac, Florida, United States, 33321
- Forest Investigative Site
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Tampa, Florida, United States, 33603
- Forest Investigative Site
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Tampa, Florida, United States, 33613
- Forest Investigative Site
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Georgia
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Austell, Georgia, United States, 30106
- Forest Investigative Site
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Blue Ridge, Georgia, United States, 30513
- Forest Investigative Site
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Duluth, Georgia, United States, 30096
- Forest Investigative Site
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Marietta, Georgia, United States, 30060
- Forest Investigative Site
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Illinois
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River Forest, Illinois, United States, 60305
- Forest Investigative Site
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Skokie, Illinois, United States, 60076
- Forest Investigative Site
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Indiana
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South Bend, Indiana, United States, 46617
- Forest Investigative Site
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Kentucky
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Crescent Springs, Kentucky, United States, 41017
- Forest Investigative Site
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Lexington, Kentucky, United States, 40504
- Forest Investigative Site
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Louisiana
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Lafayette, Louisiana, United States, 70503
- Forest Investigative Site
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Maine
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Bangor, Maine, United States, 04401
- Forest Investigative Site
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Maryland
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Baltimore, Maryland, United States, 21201
- Forest Investigative Site
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Baltimore, Maryland, United States, 21224
- Forest Investigative Site
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Hagerstown, Maryland, United States, 21740
- Forest Investigative Site
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Massachusetts
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North Dartmouth, Massachusetts, United States, 02747
- Forest Investigative Site
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Michigan
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Livonia, Michigan, United States, 48152
- Forest Investigative Site
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Minnesota
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Edina, Minnesota, United States, 55435
- Forest Investigative Site
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Minneapolis, Minnesota, United States, 55407
- Forest Investigative Site
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Minneapolis, Minnesota, United States, 55402
- Forest Investigative Site
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Missouri
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Florissant, Missouri, United States, 63033
- Forest Investigative Site
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Saint Charles, Missouri, United States, 63301
- Forest Investigative Site
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Montana
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Billings, Montana, United States, 59102
- Forest Investigative Site
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Butte, Montana, United States, 59701
- Forest Investigative Site
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Nebraska
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Papillion, Nebraska, United States, 68046
- Forest Investigative Site
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New Jersey
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Berlin, New Jersey, United States, 08009
- Forest Investigative Site
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Summit, New Jersey, United States, 07901
- Forest Investigative Site
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New York
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Brooklyn, New York, United States, 11234
- Forest Investigative Site
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Buffalo, New York, United States, 14215
- Forest Investigative Site
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Great Neck, New York, United States, 11023
- Forest Investigative Site
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Ithaca, New York, United States, 14580
- Forest Investigative Site
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New Hyde Park, New York, United States, 11040
- Forest Investigative Site
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New York, New York, United States, 10004
- Forest Investigative Site
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New York, New York, United States, 10016
- Forest Investigative Site
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North Carolina
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Asheville, North Carolina, United States, 28801
- Forest Investigative Site
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Charlotte, North Carolina, United States, 28207
- Forest Investigative Site
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Raleigh, North Carolina, United States, 27607
- Forest Investigative Site
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Ohio
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Canton, Ohio, United States, 44718
- Forest Investigative Site
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Cincinnati, Ohio, United States, 45231
- Forest Investigative Site
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Cincinnati, Ohio, United States, 45242
- Forest Investigative Site
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Cincinnati, Ohio, United States, 45227
- Forest Investigative Site
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Columbus, Ohio, United States, 43215
- Forest Investigative Site
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Toledo, Ohio, United States, 43606
- Forest Investigative Site
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Oklahoma
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Oklahoma City, Oklahoma, United States, 73120
- Forest Investigative Site
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Oregon
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Medford, Oregon, United States, 97504
- Forest Investigative Site
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Portland, Oregon, United States, 97213
- Forest Investigative Site
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Pennsylvania
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Bethlehem, Pennsylvania, United States, 18020
- Forest Investigative Site
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Erie, Pennsylvania, United States, 16506
- Forest Investigative Site
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Hershey, Pennsylvania, United States, 17033
- Forest Investigative Site
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Pittsburgh, Pennsylvania, United States, 15243
- Forest Investigative Site
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Upland, Pennsylvania, United States, 19013
- Forest Investigative Site
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Rhode Island
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East Providence, Rhode Island, United States, 02914
- Forest Investigative Site
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Johnston, Rhode Island, United States, 02919
- Forest Investigative Site
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South Carolina
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Charleston, South Carolina, United States, 29406
- Forest Investigative Site
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Greenville, South Carolina, United States, 29615
- Forest Investigative Site
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Greer, South Carolina, United States, 29651
- Forest Investigative Site
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Spartanburg, South Carolina, United States, 29303
- Forest Investigative Site
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Tennessee
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Nashville, Tennessee, United States, 37232-2650
- Forest Investigative Site
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Texas
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Dallas, Texas, United States, 75231
- Forest Investigative Site
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Dallas, Texas, United States, 75246
- Forest Investigative Site
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Fort Worth, Texas, United States, 76104
- Forest Investigative Site
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Houston, Texas, United States, 77024
- Forest Investigative Site
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San Antonio, Texas, United States, 78229
- Forest Investigative Site
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Tyler, Texas, United States, 75708
- Forest Investigative Site
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Waco, Texas, United States, 76712
- Forest Investigative Site
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Utah
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Midvale, Utah, United States, 84047
- Forest Investigative Site
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Virginia
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Richmond, Virginia, United States, 23225
- Forest Investigative Site
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Richmond, Virginia, United States, 23249
- Forest Investigative Site
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Washington
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Bellingham, Washington, United States, 98225
- Forest Investigative Site
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Spokane, Washington, United States, 99204
- Forest Investigative Site
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Tacoma, Washington, United States, 98405
- Forest Investigative Site
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Wisconsin
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Milwaukee, Wisconsin, United States, 53209
- Forest Investigative Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: 1
Aclidinium bromide dose, inhaled, for 12 weeks of treatment
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Aclidinium bromide 200 μg, oral inhalation twice per day for 12 weeks of treatment
Aclidinium bromide 400 μg, oral inhalation twice per day for 12 weeks of treatment
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Experimental: 2
Aclidinium bromide dose, inhaled, for 12 weeks of treatment
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Aclidinium bromide 200 μg, oral inhalation twice per day for 12 weeks of treatment
Aclidinium bromide 400 μg, oral inhalation twice per day for 12 weeks of treatment
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Placebo Comparator: 3
Inhaled placebo for 12 weeks
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Dose-matched placebo, oral inhalation twice per day for 12 weeks of treatment
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change From Baseline in Morning Pre-dose Forced Expiratory Volume in 1 Second (FEV1)
Time Frame: Change from Baseline to 12 weeks
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Change from baseline in trough forced expiratory volume in 1 second before the morning dose of aclidinium bromide, Last Observation Carried Forward (LOCF)
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Change from Baseline to 12 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change From Baseline in Peak Forced Expiratory Volume in 1 Second (FEV1)
Time Frame: Change from Baseline to 12 weeks
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Change From Baseline in Peak FEV1 (L) at Week 12, Last Observation Carried Forward (LOCF)
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Change from Baseline to 12 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2009
Primary Completion (Actual)
November 1, 2009
Study Completion (Actual)
November 1, 2009
Study Registration Dates
First Submitted
April 30, 2009
First Submitted That Met QC Criteria
April 30, 2009
First Posted (Estimate)
May 1, 2009
Study Record Updates
Last Update Posted (Estimate)
January 6, 2017
Last Update Submitted That Met QC Criteria
November 16, 2016
Last Verified
November 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- LAS-MD-33
- ACCORD COPD I
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.