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

NCT00891462 | Completed Phase 3 Results

• 2 other identifiers: LAS-MD-33ACCORD COPD I
• Study Type: interventional
• Target: 561
• Locations: 2 countries
• Sites: 112

Brief Summary

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.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

COPD; Chronic Obstructive Pulmonary Disease; Chronic Bronchitis; Emphysema; Airflow Obstruction, Chronic; Chronic Airflow Obstruction; Chronic Obstructive Airway Disease; Chronic Obstructive Lung Disease

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Morning Pre-dose Forced Expiratory Volume in 1 Second (FEV1)

  Change from baseline in trough forced expiratory volume in 1 second before the morning dose of aclidinium bromide, Last Observation Carried Forward (LOCF)

  Change from Baseline to 12 weeks

Secondary Outcomes (1)

• Change From Baseline in Peak Forced Expiratory Volume in 1 Second (FEV1)

  Change from Baseline to 12 weeks

Study Arms (3)

1

EXPERIMENTAL

Aclidinium bromide dose, inhaled, for 12 weeks of treatment

Drug: Aclidinium bromide

2

EXPERIMENTAL

Aclidinium bromide dose, inhaled, for 12 weeks of treatment

Drug: Aclidinium bromide

3

PLACEBO COMPARATOR

Inhaled placebo for 12 weeks

Drug: Placebo

Interventions

Aclidinium bromide DRUG

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

1

Placebo DRUG

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

3

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (112)

Forest Investigative Site

Birmingham, Alabama, 35209, United States

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Forest Investigative Site

Jasper, Alabama, 35501, United States

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Forest Investigative Site

Mobile, Alabama, 18020, United States

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Forest Investigative Site

Mesa, Arizona, 85210, United States

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Forest Investigative Site

Phoenix, Arizona, 85006, United States

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Forest Investigative Site

Phoenix, Arizona, 85023, United States

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Forest Investigative Site

Anaheim, California, 92801, United States

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Forest Investigative Site

Encinitas, California, 92024, United States

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Forest Investigative Site

Fresno, California, 93726, United States

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Forest Investigative Site

Fullerton, California, 92835, United States

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Forest Investigative Site

Lakewood, California, 90712, United States

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Forest Investigative Site

Orange, California, 92868, United States

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Forest Investigative Site

Palo Alto, California, 94304, United States

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Forest Investigative Site

Rancho Mirage, California, 92270, United States

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Forest Investigative Site

Sacramento, California, 95831, United States

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Forest Investigative Site

San Diego, California, 92103-8415, United States

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Forest Investigative Site

San Diego, California, 92120, United States

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Forest Investigative Site

Colorado Springs, Colorado, 80907, United States

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Forest Investigative Site

Denver, Colorado, 80206, United States

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Forest Investigative Site

Wheat Ridge, Colorado, 80033, United States

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Forest Investigative Site

Waterbury, Connecticut, 06708, United States

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Forest Investigative Site

Brandon, Florida, 33511, United States

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Forest Investigative Site

Clearwater, Florida, 33765, United States

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Forest Investigative Site

DeLand, Florida, 32720, United States

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Forest Investigative Site

Fort Lauderdale, Florida, 33316, United States

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Forest Investigative Site

Melbourne, Florida, 32901, United States

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Forest Investigative Site

Melbourne, Florida, 32935, United States

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Forest Investigative Site

Ormond Beach, Florida, 32174, United States

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Forest Investigative Site

Panama City, Florida, 32405, United States

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Forest Investigative Site

Pensacola, Florida, 32504, United States

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Forest Investigative Site

Tamarac, Florida, 33321, United States

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Forest Investigative Site

Tampa, Florida, 33603, United States

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Forest Investigative Site

Tampa, Florida, 33613, United States

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Forest Investigative Site

Austell, Georgia, 30106, United States

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Forest Investigative Site

Blue Ridge, Georgia, 30513, United States

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Forest Investigative Site

Duluth, Georgia, 30096, United States

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Forest Investigative Site

Marietta, Georgia, 30060, United States

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Forest Investigative Site

River Forest, Illinois, 60305, United States

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Forest Investigative Site

Skokie, Illinois, 60076, United States

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Forest Investigative Site

South Bend, Indiana, 46617, United States

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Forest Investigative Site

Crescent Springs, Kentucky, 41017, United States

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Forest Investigative Site

Lexington, Kentucky, 40504, United States

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Forest Investigative Site

Lafayette, Louisiana, 70503, United States

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Forest Investigative Site

Bangor, Maine, 04401, United States

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Forest Investigative Site

Baltimore, Maryland, 21201, United States

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Forest Investigative Site

Baltimore, Maryland, 21224, United States

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Forest Investigative Site

Hagerstown, Maryland, 21740, United States

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Forest Investigative Site

North Dartmouth, Massachusetts, 02747, United States

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Forest Investigative Site

Livonia, Michigan, 48152, United States

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Forest Investigative Site

Edina, Minnesota, 55435, United States

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Forest Investigative Site

Minneapolis, Minnesota, 55402, United States

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Forest Investigative Site

Minneapolis, Minnesota, 55407, United States

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Forest Investigative Site

Florissant, Missouri, 63033, United States

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Forest Investigative Site

Saint Charles, Missouri, 63301, United States

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Forest Investigative Site

Billings, Montana, 59102, United States

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Forest Investigative Site

Butte, Montana, 59701, United States

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Forest Investigative Site

Papillion, Nebraska, 68046, United States

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Forest Investigative Site

Berlin, New Jersey, 08009, United States

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Forest Investigative Site

Summit, New Jersey, 07901, United States

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Forest Investigative Site

Brooklyn, New York, 11234, United States

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Forest Investigative Site

Buffalo, New York, 14215, United States

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Forest Investigative Site

Great Neck, New York, 11023, United States

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Forest Investigative Site

Ithaca, New York, 14580, United States

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Forest Investigative Site

New Hyde Park, New York, 11040, United States

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Forest Investigative Site

New York, New York, 10004, United States

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Forest Investigative Site

New York, New York, 10016, United States

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Forest Investigative Site

Asheville, North Carolina, 28801, United States

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Forest Investigative Site

Charlotte, North Carolina, 28207, United States

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Forest Investigative Site

Raleigh, North Carolina, 27607, United States

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Forest Investigative Site

Canton, Ohio, 44718, United States

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Forest Investigative Site

Cincinnati, Ohio, 45227, United States

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Forest Investigative Site

Cincinnati, Ohio, 45231, United States

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Forest Investigative Site

Cincinnati, Ohio, 45242, United States

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Forest Investigative Site

Columbus, Ohio, 43215, United States

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Forest Investigative Site

Toledo, Ohio, 43606, United States

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Forest Investigative Site

Oklahoma City, Oklahoma, 73120, United States

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Forest Investigative Site

Medford, Oregon, 97504, United States

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Forest Investigative Site

Portland, Oregon, 97213, United States

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Forest Investigative Site

Bethlehem, Pennsylvania, 18020, United States

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Forest Investigative Site

Erie, Pennsylvania, 16506, United States

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Forest Investigative Site

Hershey, Pennsylvania, 17033, United States

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Forest Investigative Site

Pittsburgh, Pennsylvania, 15243, United States

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Forest Investigative Site

Upland, Pennsylvania, 19013, United States

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Forest Investigative Site

East Providence, Rhode Island, 02914, United States

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Forest Investigative Site

Johnston, Rhode Island, 02919, United States

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Forest Investigative Site

Charleston, South Carolina, 29406, United States

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Forest Investigative Site

Greenville, South Carolina, 29615, United States

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Forest Investigative Site

Greer, South Carolina, 29651, United States

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Forest Investigative Site

Spartanburg, South Carolina, 29303, United States

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Forest Investigative Site

Nashville, Tennessee, 37232-2650, United States

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Forest Investigative Site

Dallas, Texas, 75231, United States

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Forest Investigative Site

Dallas, Texas, 75246, United States

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Forest Investigative Site

Fort Worth, Texas, 76104, United States

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Forest Investigative Site

Houston, Texas, 77024, United States

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Forest Investigative Site

San Antonio, Texas, 78229, United States

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Forest Investigative Site

Tyler, Texas, 75708, United States

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Forest Investigative Site

Waco, Texas, 76712, United States

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Forest Investigative Site

Midvale, Utah, 84047, United States

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Forest Investigative Site

Richmond, Virginia, 23225, United States

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Forest Investigative Site

Richmond, Virginia, 23249, United States

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Forest Investigative Site

Bellingham, Washington, 98225, United States

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Forest Investigative Site

Spokane, Washington, 99204, United States

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Forest Investigative Site

Tacoma, Washington, 98405, United States

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Forest Investigative Site

Milwaukee, Wisconsin, 53209, United States

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Forest Investigative Site

Saskatoon, Saskatchewan, S7N 0W8, Canada

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Forest Investigative Site

Edmonton, T5J 3S9, Canada

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Forest Investigative Site

Hamilton, L8N 4A6, Canada

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Forest Investigative Site

Kelowna, V1Y 8E7, Canada

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Forest Investigative Site

Niagara Falls, L2G 1J4, Canada

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Forest Investigative Site

Sainte-Foy, G1V 4G5, Canada

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Forest Investigative Site

Toronto, M5g 1N8, Canada

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Forest Investigative Site

Toronto, M6H 3M2, Canada

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Related Publications (2)

• 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.

  PMID: 28074135 DERIVED

• 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.

  PMID: 22320148 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Bronchitis, Chronic; Emphysema

Interventions

aclidinium bromide

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Bronchitis; Respiratory Tract Infections; Infections; Bronchial Diseases

Results Point of Contact

• Title: AstraZeneca Clinical
• Organization: Study Information Center

information.center@astrazeneca.com

1-877-240-9479

Study Officials

• Esther Garcia, MD

  AstraZeneca

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2009
• First Posted: May 1, 2009
• Study Start: April 1, 2009
• Primary Completion: November 1, 2009
• Study Completion: November 1, 2009
• Last Updated: January 6, 2017
• Results First Posted: September 13, 2012

Record last verified: 2016-11

Locations

US (104); CA (8)