Long-term Safety, Tolerability and Efficacy of Aclidinium Bromide in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) (LAS-MD-35)
- Conditions
- Chronic Obstructive Pulmonary Disease
- Interventions
- Registration Number
- NCT01044459
- Lead Sponsor
- AstraZeneca
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 605
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Aclidinium Bromide 400 µg Aclidinium Bromide 400 µg aclidinium bromide, inhaled, 52 weeks of treatment Aclidinium Bromide 200 µg Aclidinium Bromide 200 µg aclidinium bromide, inhaled, 52 weeks of treatment
- Primary Outcome Measures
Name Time Method Change From Baseline in Morning Pre-dose (Trough) Forced Expiratory Volume in One Second (FEV1) From baseline to 52 weeks Change From Baseline in Morning Predose (Trough) FEV1 in liters at Week 52.
- Secondary Outcome Measures
Name Time Method Change From Baseline in Peak FEV1 52 weeks Change From Baseline in Peak FEV1 in liters at Week 52.
Trial Locations
- Locations (113)
Forest Investigative Site 1328
🇺🇸Dallas, Texas, United States
Forest Investigative Site 1168
🇨🇦Toronto, Ontario, Canada
Forest Investigative Site 1432
🇺🇸Miami, Florida, United States
Forest Investigative Site 1435
🇺🇸Dayton, Ohio, United States
Forest Investigative Site 2201
🇨🇦Kelowna, British Columbia, Canada
Forest Investigative Site 1504
🇺🇸Hershey, Pennsylvania, United States
Forest Investigative Site 1434
🇺🇸Cleveland, Ohio, United States
Forest Investigative Site 1505
🇺🇸Columbus, Ohio, United States
Forest Investigative Site 1337
🇺🇸Houston, Texas, United States
Forest Investigative Site 1330
🇺🇸South Burlington, Vermont, United States
Forest Investigative Site 1433
🇺🇸Columbus, Ohio, United States
Forest Investigative Site 0959
🇺🇸Columbus, Ohio, United States
Forest Investigative Site 1348
🇺🇸Bend, Oregon, United States
Forest Investigative Site 1531
🇺🇸Tacoma, Washington, United States
Forest Investigative Site 1120
🇺🇸Bellingham, Washington, United States
Forest Investigative Site 1155
🇺🇸Dallas, Texas, United States
Forest Investigative Site 1365
🇺🇸Rapid City, South Dakota, United States
Forest Investigative Site 1439
🇺🇸San Diego, California, United States
Forest Investigative Site 2009
🇺🇸San Diego, California, United States
Forest Investigative Site 1503
🇺🇸San Diego, California, United States
Forest Investigative Site 2007
🇺🇸Cincinnati, Ohio, United States
Forest Investigative Site 0962
🇺🇸Nashville, Tennessee, United States
Forest Investigative Site 1396
🇺🇸San Antonio, Texas, United States
Forest Investigative Site 1384
🇺🇸San Antonio, Texas, United States
Forest Investigative Site 1157
🇨🇦Toronto, Ontario, Canada
Forest Investigative Site 1162
🇺🇸Birmingham, Alabama, United States
Forest Investigative Site 1475
🇺🇸Scottsdale, Arizona, United States
Forest Investigative Site 1338
🇺🇸Tempe, Arizona, United States
Forest Investigative Site 1127
🇺🇸Mobile, Alabama, United States
Forest Investigative Site 1483
🇺🇸Buena Park, California, United States
Forest Investigative Site 1509
🇺🇸Fresno, California, United States
Forest Investigative Site 1350
🇺🇸Foothill Ranch, California, United States
Forest Investigative Site 1349
🇺🇸Tucson, Arizona, United States
Forest Investigative Site 2065
🇺🇸Fullerton, California, United States
Forest Investigative Site 1122
🇺🇸Orange, California, United States
Forest Investigative Site 1502
🇺🇸Huntington Park, California, United States
Forest Investigative Site 1508
🇺🇸Palm Springs, California, United States
Forest Investigative Site 1534
🇺🇸Long Beach, California, United States
Forest Investigative Site 2209
🇺🇸Los Angeles, California, United States
Forest Investigative Site 1088
🇺🇸Lakewood, California, United States
Forest Investigative Site 2064
🇺🇸Riverside, California, United States
Forest Investigative Site 1347
🇺🇸San Jose, California, United States
Forest Investigative Site 1344
🇺🇸Spring Valley, California, United States
Forest Investigative Site 2039
🇺🇸Walnut Creek, California, United States
Forest Investigative Site 1104
🇺🇸Hartford, Connecticut, United States
Forest Investigative Site 2037
🇺🇸Fort Collins, Colorado, United States
Forest Investigative Site 1154
🇺🇸Brandon, Florida, United States
Forest Investigative Site 1346
🇺🇸Newark, Delaware, United States
Forest Investigative Site 1327
🇺🇸Wheat Ridge, Colorado, United States
Forest Investigative Site 1482
🇺🇸Stamford, Connecticut, United States
Forest Investigative Site 1514
🇺🇸Coral Gables, Florida, United States
Forest Investigative Site 1152
🇺🇸Clearwater, Florida, United States
Forest Investigative Site 1513
🇺🇸Hialeah, Florida, United States
Forest Investigative Site 1516
🇺🇸Edgewater, Florida, United States
Forest Investigative Site 0974
🇺🇸Pensacola, Florida, United States
Forest Investigative Site 1488
🇺🇸Pembroke Pines, Florida, United States
Forest Investigative Site 2082
🇺🇸Tamarac, Florida, United States
Forest Investigative Site 1397
🇺🇸Port Charlotte, Florida, United States
Forest Investigative Site 1383
🇺🇸Port Orange, Florida, United States
Forest Investigative Site 1395
🇺🇸Valrico, Florida, United States
Forest Investigative Site 0980
🇺🇸Atlanta, Georgia, United States
Forest Investigative Site 1532
🇺🇸Columbus, Georgia, United States
Forest Investigative Site 1491
🇺🇸Atlanta, Georgia, United States
Forest Investigative Site 0987
🇺🇸Austell, Georgia, United States
Forest Investigative Site 0989
🇺🇸Skokie, Illinois, United States
Forest Investigative Site 2085
🇺🇸Crescent Springs, Kentucky, United States
Forest Investigative Site 1436
🇺🇸Avon, Indiana, United States
Forest Investigative Site 1333
🇺🇸Baltimore, Maryland, United States
Forest Investigative Site 2024
🇺🇸Lafayette, Louisiana, United States
Forest Investigative Site 1342
🇺🇸Stevensville, Michigan, United States
Forest Investigative Site 1438
🇺🇸Ypsilanti, Michigan, United States
Forest Investigative Site 2041
🇺🇸Minneapolis, Minnesota, United States
Forest Investigative Site 1100
🇺🇸Florissant, Missouri, United States
Forest Investigative Site 2079
🇺🇸St. Charles, Missouri, United States
Forest Investigative Site 1343
🇺🇸St. Louis, Missouri, United States
Forest Investigative Site 1329
🇺🇸St. Louis, Missouri, United States
Forest Investigative Site 1150
🇺🇸Berlin, New Jersey, United States
Forest Investigative Site 1335
🇺🇸St. Louis, Missouri, United States
Forest Investigative Site 2062
🇺🇸Bronxville, New York, United States
Forest Investigative Site 1339
🇺🇸Cherry Hill, New Jersey, United States
Forest Investigative Site 1394
🇺🇸Ocean, New Jersey, United States
Forest Investigative Site 1515
🇺🇸Elizabeth, New Jersey, United States
Forest Investigative Site 1147
🇺🇸Brooklyn, New York, United States
Forest Investigative Site 1151
🇺🇸New Hyde Park, New York, United States
Forest Investigative Site 1163
🇺🇸New York, New York, United States
Forest Investigative Site 1114
🇺🇸New York, New York, United States
Forest Investigative Site 0479
🇺🇸Rochester, New York, United States
Forest Investigative Site 1366
🇺🇸HighPoint, North Carolina, United States
Forest Investigative Site 1334
🇺🇸Charlotte, North Carolina, United States
Forest Investigative Site 1382
🇺🇸Statesville, North Carolina, United States
Forest Investigative Site 1134
🇺🇸Canton, Ohio, United States
Forest Investigative Site 0900
🇺🇸Spartanburg, South Carolina, United States
Forest Investigative Site 1332
🇺🇸El Paso, Texas, United States
Forest Investigative Site 0670
🇺🇸DeLand, Florida, United States
Forest Investigative Site 2081
🇺🇸Charlotte, North Carolina, United States
Forest Investigative Site 1481
🇺🇸Newburgh, New York, United States
Forest Investigative Site 1340
🇺🇸Ocala, Florida, United States
Forest Investigative Site 0990
🇺🇸Fort Lauderdale, Florida, United States
Forest Investigative Site 1420
🇺🇸Miami, Florida, United States
Forest Investigative Site 1484
🇺🇸Miramar, Florida, United States
Forest Investigative Site 2051
🇺🇸River Forest, Illinois, United States
Forest Investigative Site 1520
🇺🇸Crestview Hills, Kentucky, United States
Forest Investigative Site 1351
🇺🇸Plymouth, Minnesota, United States
Forest Investigative Site 1367
🇺🇸Papillion, Nebraska, United States
Forest Investigative Site 1369
🇺🇸St. Louis, Missouri, United States
Forest Investigative Site 1421
🇺🇸Fall River, Massachusetts, United States
Forest Investigative Site 0539
🇺🇸Lexington, Kentucky, United States
Forest Investigative Site 1533
🇺🇸Sacramento, California, United States
Forest Investigative Site 2047
🇺🇸Tampa, Florida, United States
Forest Investigative Site 1336
🇺🇸Louisville, Kentucky, United States
Forest Investigative Site 1478
🇺🇸Louisville, Kentucky, United States
Forest Investigative Site 1368
🇺🇸Bronx, New York, United States
Forest Investigative Site 2072
🇺🇸Charleston, South Carolina, United States