Chronic Obstructive Pulmonary Disease Clinical Trial
Official title:
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.
Status | Completed |
Enrollment | 561 |
Est. completion date | November 2009 |
Est. primary completion date | November 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 40 Years and older |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Canada | Forest Investigative Site | Edmonton | Alberta |
Canada | Forest Investigative Site | Hamilton | Ontario |
Canada | Forest Investigative Site | Kelowna | British Columbia |
Canada | Forest Investigative Site | Niagara Falls | Ontario |
Canada | Forest Investigative Site | Sainte-Foy | Quebec |
Canada | Forest Investigative Site | Saskatoon | Saskatchewan |
Canada | Forest Investigative Site | Toronto | Ontario |
Canada | Forest Investigative Site | Toronto | Ontario |
United States | Forest Investigative Site | Anaheim | California |
United States | Forest Investigative Site | Asheville | North Carolina |
United States | Forest Investigative Site | Austell | Georgia |
United States | Forest Investigative Site | Baltimore | Maryland |
United States | Forest Investigative Site | Baltimore | Maryland |
United States | Forest Investigative Site | Bangor | Maine |
United States | Forest Investigative Site | Bellingham | Washington |
United States | Forest Investigative Site | Berlin | New Jersey |
United States | Forest Investigative Site | Bethlehem | Pennsylvania |
United States | Forest Investigative Site | Billings | Montana |
United States | Forest Investigative Site | Birmingham | Alabama |
United States | Forest Investigative Site | Blue Ridge | Georgia |
United States | Forest Investigative Site | Brandon | Florida |
United States | Forest Investigative Site | Brooklyn | New York |
United States | Forest Investigative Site | Buffalo | New York |
United States | Forest Investigative Site | Butte | Montana |
United States | Forest Investigative Site | Canton | Ohio |
United States | Forest Investigative Site | Charleston | South Carolina |
United States | Forest Investigative Site | Charlotte | North Carolina |
United States | Forest Investigative Site | Cincinnati | Ohio |
United States | Forest Investigative Site | Cincinnati | Ohio |
United States | Forest Investigative Site | Cincinnati | Ohio |
United States | Forest Investigative Site | Clearwater | Florida |
United States | Forest Investigative Site | Colorado Springs | Colorado |
United States | Forest Investigative Site | Columbus | Ohio |
United States | Forest Investigative Site | Crescent Springs | Kentucky |
United States | Forest Investigative Site | Dallas | Texas |
United States | Forest Investigative Site | Dallas | Texas |
United States | Forest Investigative Site | DeLand | Florida |
United States | Forest Investigative Site | Denver | Colorado |
United States | Forest Investigative Site | Duluth | Georgia |
United States | Forest Investigative Site | East Providence | Rhode Island |
United States | Forest Investigative Site | Edina | Minnesota |
United States | Forest Investigative Site | Encinitas | California |
United States | Forest Investigative Site | Erie | Pennsylvania |
United States | Forest Investigative Site | Florissant | Missouri |
United States | Forest Investigative Site | Fort Lauderdale | Florida |
United States | Forest Investigative Site | Fort Worth | Texas |
United States | Forest Investigative Site | Fresno | California |
United States | Forest Investigative Site | Fullerton | California |
United States | Forest Investigative Site | Great Neck | New York |
United States | Forest Investigative Site | Greenville | South Carolina |
United States | Forest Investigative Site | Greer | South Carolina |
United States | Forest Investigative Site | Hagerstown | Maryland |
United States | Forest Investigative Site | Hershey | Pennsylvania |
United States | Forest Investigative Site | Houston | Texas |
United States | Forest Investigative Site | Ithaca | New York |
United States | Forest Investigative Site | Jasper | Alabama |
United States | Forest Investigative Site | Johnston | Rhode Island |
United States | Forest Investigative Site | Lafayette | Louisiana |
United States | Forest Investigative Site | Lakewood | California |
United States | Forest Investigative Site | Lexington | Kentucky |
United States | Forest Investigative Site | Livonia | Michigan |
United States | Forest Investigative Site | Marietta | Georgia |
United States | Forest Investigative Site | Medford | Oregon |
United States | Forest Investigative Site | Melbourne | Florida |
United States | Forest Investigative Site | Melbourne | Florida |
United States | Forest Investigative Site | Mesa | Arizona |
United States | Forest Investigative Site | Midvale | Utah |
United States | Forest Investigative Site | Milwaukee | Wisconsin |
United States | Forest Investigative Site | Minneapolis | Minnesota |
United States | Forest Investigative Site | Minneapolis | Minnesota |
United States | Forest Investigative Site | Mobile | Alabama |
United States | Forest Investigative Site | Nashville | Tennessee |
United States | Forest Investigative Site | New Hyde Park | New York |
United States | Forest Investigative Site | New York | New York |
United States | Forest Investigative Site | New York | New York |
United States | Forest Investigative Site | North Dartmouth | Massachusetts |
United States | Forest Investigative Site | Oklahoma City | Oklahoma |
United States | Forest Investigative Site | Orange | California |
United States | Forest Investigative Site | Ormond Beach | Florida |
United States | Forest Investigative Site | Palo Alto | California |
United States | Forest Investigative Site | Panama City | Florida |
United States | Forest Investigative Site | Papillion | Nebraska |
United States | Forest Investigative Site | Pensacola | Florida |
United States | Forest Investigative Site | Phoenix | Arizona |
United States | Forest Investigative Site | Phoenix | Arizona |
United States | Forest Investigative Site | Pittsburgh | Pennsylvania |
United States | Forest Investigative Site | Portland | Oregon |
United States | Forest Investigative Site | Raleigh | North Carolina |
United States | Forest Investigative Site | Rancho Mirage | California |
United States | Forest Investigative Site | Richmond | Virginia |
United States | Forest Investigative Site | Richmond | Virginia |
United States | Forest Investigative Site | River Forest | Illinois |
United States | Forest Investigative Site | Sacramento | California |
United States | Forest Investigative Site | San Antonio | Texas |
United States | Forest Investigative Site | San Diego | California |
United States | Forest Investigative Site | San Diego | California |
United States | Forest Investigative Site | Skokie | Illinois |
United States | Forest Investigative Site | South Bend | Indiana |
United States | Forest Investigative Site | Spartanburg | South Carolina |
United States | Forest Investigative Site | Spokane | Washington |
United States | Forest Investigative Site | St. Charles | Missouri |
United States | Forest Investigative Site | Summit | New Jersey |
United States | Forest Investigative Site | Tacoma | Washington |
United States | Forest Investigative Site | Tamarac | Florida |
United States | Forest Investigative Site | Tampa | Florida |
United States | Forest Investigative Site | Tampa | Florida |
United States | Forest Investigative Site | Toledo | Ohio |
United States | Forest Investigative Site | Tyler | Texas |
United States | Forest Investigative Site | Upland | Pennsylvania |
United States | Forest Investigative Site | Waco | Texas |
United States | Forest Investigative Site | Waterbury | Connecticut |
United States | Forest Investigative Site | Wheat Ridge | Colorado |
Lead Sponsor | Collaborator |
---|---|
Forest Laboratories | Almirall, S.A. |
United States, Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No |
Secondary | Change From Baseline in Peak Forced Expiratory Volume in 1 Second (FEV1) | Change From Baseline in Peak FEV1 (L) at Week 12, Last Observation Carried Forward (LOCF) | Change from Baseline to 12 weeks | No |
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