Chronic Obstructive Pulmonary Disease Clinical Trial
— LAS-MD-35Official title:
A Long-Term, Randomized, Double-Blind Study of the Safety, Tolerability and Efficacy of Aclidinium Bromide At Two Dosage Levels When Administered to Patients With Moderate to Severe, Stable Chronic Obstructive Pulmonary Disease
The purpose of this study is to evaluate the safety, tolerability and efficacy of inhaled aclidinium bromide at two dose levels in patients with moderate to severe, stable chronic obstructive pulmonary disease. The study will be 56 weeks in duration; a 2-week rin-in period, a 52-week treatment period and a 2-week follow up phone call. All patients will be randomized to one of two doses of aclidinium bromide.
Status | Completed |
Enrollment | 605 |
Est. completion date | April 2011 |
Est. primary completion date | April 2011 |
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, 2010; 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: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Canada | Forest Investigative Site 2201 | Kelowna | British Columbia |
Canada | Forest Investigative Site 1157 | Toronto | Ontario |
Canada | Forest Investigative Site 1168 | Toronto | Ontario |
United States | Forest Investigative Site 0980 | Atlanta | Georgia |
United States | Forest Investigative Site 1491 | Atlanta | Georgia |
United States | Forest Investigative Site 0987 | Austell | Georgia |
United States | Forest Investigative Site 1436 | Avon | Indiana |
United States | Forest Investigative Site 1333 | Baltimore | Maryland |
United States | Forest Investigative Site 1120 | Bellingham | Washington |
United States | Forest Investigative Site 1348 | Bend | Oregon |
United States | Forest Investigative Site 1150 | Berlin | New Jersey |
United States | Forest Investigative Site 1162 | Birmingham | Alabama |
United States | Forest Investigative Site 1154 | Brandon | Florida |
United States | Forest Investigative Site 1368 | Bronx | New York |
United States | Forest Investigative Site 2062 | Bronxville | New York |
United States | Forest Investigative Site 1147 | Brooklyn | New York |
United States | Forest Investigative Site 1483 | Buena Park | California |
United States | Forest Investigative Site 1134 | Canton | Ohio |
United States | Forest Investigative Site 2072 | Charleston | South Carolina |
United States | Forest Investigative Site 1334 | Charlotte | North Carolina |
United States | Forest Investigative Site 2081 | Charlotte | North Carolina |
United States | Forest Investigative Site 1339 | Cherry Hill | New Jersey |
United States | Forest Investigative Site 2007 | Cincinnati | Ohio |
United States | Forest Investigative Site 1152 | Clearwater | Florida |
United States | Forest Investigative Site 1434 | Cleveland | Ohio |
United States | Forest Investigative Site 0959 | Columbus | Ohio |
United States | Forest Investigative Site 1433 | Columbus | Ohio |
United States | Forest Investigative Site 1505 | Columbus | Ohio |
United States | Forest Investigative Site 1532 | Columbus | Georgia |
United States | Forest Investigative Site 1514 | Coral Gables | Florida |
United States | Forest Investigative Site 2085 | Crescent Springs | Kentucky |
United States | Forest Investigative Site 1520 | Crestview Hills | Kentucky |
United States | Forest Investigative Site 1155 | Dallas | Texas |
United States | Forest Investigative Site 1328 | Dallas | Texas |
United States | Forest Investigative Site 1435 | Dayton | Ohio |
United States | Forest Investigative Site 0670 | DeLand | Florida |
United States | Forest Investigative Site 1516 | Edgewater | Florida |
United States | Forest Investigative Site 1332 | El Paso | Texas |
United States | Forest Investigative Site 1515 | Elizabeth | New Jersey |
United States | Forest Investigative Site 1421 | Fall River | Massachusetts |
United States | Forest Investigative Site 1100 | Florissant | Missouri |
United States | Forest Investigative Site 1350 | Foothill Ranch | California |
United States | Forest Investigative Site 2037 | Fort Collins | Colorado |
United States | Forest Investigative Site 0990 | Fort Lauderdale | Florida |
United States | Forest Investigative Site 1509 | Fresno | California |
United States | Forest Investigative Site 2065 | Fullerton | California |
United States | Forest Investigative Site 1104 | Hartford | Connecticut |
United States | Forest Investigative Site 1504 | Hershey | Pennsylvania |
United States | Forest Investigative Site 1513 | Hialeah | Florida |
United States | Forest Investigative Site 1366 | HighPoint | North Carolina |
United States | Forest Investigative Site 1337 | Houston | Texas |
United States | Forest Investigative Site 1502 | Huntington Park | California |
United States | Forest Investigative Site 2024 | Lafayette | Louisiana |
United States | Forest Investigative Site 1088 | Lakewood | California |
United States | Forest Investigative Site 0539 | Lexington | Kentucky |
United States | Forest Investigative Site 1534 | Long Beach | California |
United States | Forest Investigative Site 2209 | Los Angeles | California |
United States | Forest Investigative Site 1336 | Louisville | Kentucky |
United States | Forest Investigative Site 1478 | Louisville | Kentucky |
United States | Forest Investigative Site 1420 | Miami | Florida |
United States | Forest Investigative Site 1432 | Miami | Florida |
United States | Forest Investigative Site 2041 | Minneapolis | Minnesota |
United States | Forest Investigative Site 1484 | Miramar | Florida |
United States | Forest Investigative Site 1127 | Mobile | Alabama |
United States | Forest Investigative Site 0962 | Nashville | Tennessee |
United States | Forest Investigative Site 1151 | New Hyde Park | New York |
United States | Forest Investigative Site 1114 | New York | New York |
United States | Forest Investigative Site 1163 | New York | New York |
United States | Forest Investigative Site 1346 | Newark | Delaware |
United States | Forest Investigative Site 1481 | Newburgh | New York |
United States | Forest Investigative Site 1340 | Ocala | Florida |
United States | Forest Investigative Site 1394 | Ocean | New Jersey |
United States | Forest Investigative Site 1122 | Orange | California |
United States | Forest Investigative Site 1508 | Palm Springs | California |
United States | Forest Investigative Site 1367 | Papillion | Nebraska |
United States | Forest Investigative Site 1488 | Pembroke Pines | Florida |
United States | Forest Investigative Site 0974 | Pensacola | Florida |
United States | Forest Investigative Site 1351 | Plymouth | Minnesota |
United States | Forest Investigative Site 1397 | Port Charlotte | Florida |
United States | Forest Investigative Site 1383 | Port Orange | Florida |
United States | Forest Investigative Site 1365 | Rapid City | South Dakota |
United States | Forest Investigative Site 2051 | River Forest | Illinois |
United States | Forest Investigative Site 2064 | Riverside | California |
United States | Forest Investigative Site 0479 | Rochester | New York |
United States | Forest Investigative Site 1533 | Sacramento | California |
United States | Forest Investigative Site 1384 | San Antonio | Texas |
United States | Forest Investigative Site 1396 | San Antonio | Texas |
United States | Forest Investigative Site 1439 | San Diego | California |
United States | Forest Investigative Site 1503 | San Diego | California |
United States | Forest Investigative Site 2009 | San Diego | California |
United States | Forest Investigative Site 1347 | San Jose | California |
United States | Forest Investigative Site 1475 | Scottsdale | Arizona |
United States | Forest Investigative Site 0989 | Skokie | Illinois |
United States | Forest Investigative Site 1330 | South Burlington | Vermont |
United States | Forest Investigative Site 0900 | Spartanburg | South Carolina |
United States | Forest Investigative Site 1344 | Spring Valley | California |
United States | Forest Investigative Site 2079 | St. Charles | Missouri |
United States | Forest Investigative Site 1329 | St. Louis | Missouri |
United States | Forest Investigative Site 1335 | St. Louis | Missouri |
United States | Forest Investigative Site 1343 | St. Louis | Missouri |
United States | Forest Investigative Site 1369 | St. Louis | Missouri |
United States | Forest Investigative Site 1482 | Stamford | Connecticut |
United States | Forest Investigative Site 1382 | Statesville | North Carolina |
United States | Forest Investigative Site 1342 | Stevensville | Michigan |
United States | Forest Investigative Site 1531 | Tacoma | Washington |
United States | Forest Investigative Site 2082 | Tamarac | Florida |
United States | Forest Investigative Site 2047 | Tampa | Florida |
United States | Forest Investigative Site 1338 | Tempe | Arizona |
United States | Forest Investigative Site 1349 | Tucson | Arizona |
United States | Forest Investigative Site 1395 | Valrico | Florida |
United States | Forest Investigative Site 2039 | Walnut Creek | California |
United States | Forest Investigative Site 1327 | Wheat Ridge | Colorado |
United States | Forest Investigative Site 1438 | Ypsilanti | Michigan |
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 (Trough) Forced Expiratory Volume in One Second (FEV1) | Change From Baseline in Morning Predose (Trough) FEV1 in liters at Week 52. | From baseline to 52 weeks | No |
Secondary | Change From Baseline in Peak FEV1 | Change From Baseline in Peak FEV1 in liters at Week 52. | 52 weeks | No |
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