Safety and Tolerability of Aclidinium Bromide/Formoterol Fumarate Compared With Formoterol Fumarate in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease
- Conditions
- Chronic Obstructive Pulmonary Disease
- Interventions
- Registration Number
- NCT01437540
- Lead Sponsor
- AstraZeneca
- Brief Summary
The purpose of this study is to assess the long-term safety and tolerability of inhaled aclidinium bromide/formoterol in patients with moderate to severe, stable chronic obstructive pulmonary disease (COPD).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 590
- Current or former cigarette smokers with a cigarette smoking history of at least 10 pack-years
- A diagnosis of stable moderate to severe COPD and stable airway obstruction as defined by the Global Initiative for Chronic Obstructive Lung Disease guidelines and stable airway obstruction.
- Patients who have been hospitalized for an acute COPD exacerbation within three months prior to Visit 1
- Any respiratory tract infection (including the upper respiratory tract) or COPD exacerbation in the six weeks before Visit 1.
- Patients with any clinically significant respiratory conditions other than COPD
- Clinical history that suggests that the patient has asthma as opposed to COPD
- Chronic use of oxygen therapy ≥ 15 hours/day
- Patients with clinically significant cardiovascular conditions
- Patients with uncontrolled infection that may place the patient at risk resulting from human immunodeficiency virus (HIV), active hepatitis and/or patients with diagnosed active tuberculosis
- Patients with a history of hypersensitivity reaction to inhaled anticholinergics,
- Patients with Stage II hypertension, defined as systolic pressure of 160 and above, and/or diastolic pressure of 100 and above
- Current diagnosis of cancer other than basal or squamous cell skin cancer
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 Aclidinium Bromide/Formoterol Fumarate Inhaled aclidinium bromide 400 μg/formoterol fumarate 12 μg fixed dose combination (FDC), high dose twice per day 2 Formoterol Fumarate Inhaled formoterol fumarate 12 μg, twice per day
- Primary Outcome Measures
Name Time Method Percentage of Patients to Experience at Least One Treatment-emergent Adverse Event (TEAE) Up to study Week 56 ± 3 days TEAEs were coded Version 16.0 of the Medical Dictionary for Regulatory Activities (MedDRA)
- Secondary Outcome Measures
Name Time Method Percentage of Patients to Experience a Potentially Clinically Significant (PCS) Change in Pulse Rate, Systolic and Diastolic Blood Pressure Up to study Week 56 ± 3 days Systolic BP ≥180 mmHg and increase ≥20 mmHg from baseline or ≤90 mmHg and decrease ≥20 mmHg from baseline; Diastolic BP ≥105 mmHg and increase ≥15 mmHg from baseline or ≤50 mmHg and decrease ≥15 mmHg from baseline; Pulse rate ≥ 110 bpm and increase ≥ 15% from baseline or ≤ 50 bpm and decrease ≥15% from baseline
Percentage of Patients to Experience Potentially Clinically Significant Changes in ECG From Baseline Up to study Week 56 ± 3 days Potentially clinically significant changes were defined as listed in the table below for QT interval, QTcB, QTcF, QRS interval, PR interval and heart rate (HR)
Percentage of Patients to Experience Any Potentially Clinically Significant (PCS) Post-baseline Change in Clinical Laboratory Values for Hematology, Chemistry or Urinalysis at the End of the Study Up to study Week 52 \<0.85 x lower limit of normal (LLN) or \> 1.15 upper limit of normal (ULN) for hemoglobin, hematocrit, red blood cell, platelet, white blood cell, neutrophil and lymphocyte counts \>1.15 × ULN for eosinophil, basophil and monocyte counts
\>1.15 x ULN for aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, gamma glutamyl transferase, total bilirubin, creatinine kinase, lactate dehydrogenase, blood urea nitrogen, creatinine, uric acid, total cholesterol, triglycerides \<0.85 x LLN or \>1.15 ULN for fasting glucose, calcium, phosphorus, total protein and albumin \<0.95 x LLN or \>1.05 x ULN for sodium, potassium and chloride
Urinary blood, ketones or pH \<0.85 x LLN or \> 1.15 ULN
Trial Locations
- Locations (137)
Forest Investigative Site 1927
🇺🇸Los Angeles, California, United States
Forest Investigative Site 1851
🇺🇸Atlanta, Georgia, United States
Forest Investigative Site 1567
🇺🇸Atlanta, Georgia, United States
Forest Investigative Site 1088
🇺🇸Lakewood, California, United States
Forest Investigative Site 1388
🇺🇸Paramount, California, United States
Forest Investigative Site 1327
🇺🇸Wheat Ridge, Colorado, United States
Forest Investigative Site 1154
🇺🇸Brandon, Florida, United States
Forest Investigative Site 0974
🇺🇸Pensacola, Florida, United States
Forest Investigative Site 1599
🇺🇸St. Louis, Missouri, United States
Forest Investigative Site 2037
🇺🇸Fort Collins, Colorado, United States
Forest Investigative Site 1624
🇺🇸Los Angeles, California, United States
Forest Investigative Site 2045
🇺🇸Wheat Ridge, Colorado, United States
Forest Investigative Site 1590
🇺🇸Towson, Maryland, United States
Forest Investigative Site 1547
🇺🇸Encinitas, California, United States
Forest Investigative Site 1622
🇺🇸Columbia, Maryland, United States
Forest Investigative Site 2039
🇺🇸Walnut Creek, California, United States
Forest Investigative Site 1597
🇺🇸Boulder, Colorado, United States
Forest Investigative Site 1409
🇺🇸O'Fallon, Illinois, United States
Forest Investigative Site 1554
🇺🇸Newburgh, New York, United States
Forest Investigative Site 1333
🇺🇸Baltimore, Maryland, United States
Forest Investigative Site 1374
🇺🇸Torrance, California, United States
Forest Investigative Site 1137
🇺🇸Colorado Springs, Colorado, United States
Forest Investigative Site 1163
🇺🇸New York, New York, United States
Forest Investigative Site 1516
🇺🇸Edgewater, Florida, United States
Forest Investigative Site 1831
🇺🇸Bozeman, Montana, United States
Forest Investigative Site 1553
🇺🇸Wilmington, North Carolina, United States
Forest Investigative Site 1029
🇺🇸North Dartmouth, Massachusetts, United States
Forest Investigative Site 1400
🇺🇸Missoula, Montana, United States
Forest Investigative Site 1587
🇺🇸Chesterfield, Missouri, United States
Forest Investigative Site 1559
🇺🇸Cherry Hill, New Jersey, United States
Forest Investigative Site 1134
🇺🇸Canton, Ohio, United States
Forest Investigative Site 1449
🇺🇸Tipton, Pennsylvania, United States
Forest Investigative Site 0972
🇺🇸Brooklyn, New York, United States
Forest Investigative Site 1563
🇺🇸Syracuse, New York, United States
Forest Investigative Site 1530
🇺🇸Toledo, Ohio, United States
Forest Investigative Site 1575
🇺🇸Corvallis, Oregon, United States
Forest Investigative Site 1600
🇺🇸Magna, Utah, United States
Forest Investigative Site 2012
🇺🇸Fort Worth, Texas, United States
Forest Investigative Site 1601
🇺🇸Greer, South Carolina, United States
Forest Investigative Site 1440
🇺🇸Arlington, Texas, United States
Forest Investigative Site 1596
🇺🇸Fort Smith, Arkansas, United States
Forest Investigative Site 1331
🇺🇸Vista, California, United States
Forest Investigative Site 1617
🇺🇸Debary, Florida, United States
Forest Investigative Site 2085
🇺🇸Crescent Springs, Kentucky, United States
Forest Investigative Site 1360
🇺🇸Sunset, Louisiana, United States
Forest Investigative Site 1566
🇺🇸Auburn, Maine, United States
Forest Investigative Site 1605
🇺🇸Traverse City, Michigan, United States
Forest Investigative Site 1572
🇺🇸Jefferson City, Missouri, United States
Forest Investigative Site 1425
🇺🇸New York, New York, United States
Forest Investigative Site 1557
🇺🇸Raleigh, North Carolina, United States
Forest Investigative Site 1393
🇺🇸Zanesville, Ohio, United States
Forest Investigative Site 1081
🇺🇸Eugene, Oregon, United States
Forest Investigative Site 1612
🇺🇸Ashland, Oregon, United States
Forest Investigative Site 1423
🇺🇸Erie, Pennsylvania, United States
Forest Investigative Site 1577
🇺🇸Beaver, Pennsylvania, United States
Forest Investigative Site 1564
🇺🇸Uniontown, Pennsylvania, United States
Forest Investigative Site 1506
🇺🇸Greenville, South Carolina, United States
Forest Investigative Site 1142
🇺🇸Spokane, Washington, United States
Forest Investigative Site 1573
🇺🇸Spokane, Washington, United States
Forest Investigative Site 1503
🇺🇸San Diego, California, United States
Forest Investigative Site 1594
🇺🇸Cincinnati, Ohio, United States
Forest Investigative Site 2028
🇺🇸Cincinnati, Ohio, United States
Forest Investigative Site 1124
🇺🇸Minneapolis, Minnesota, United States
Forest Investigative Site 1614
🇺🇸San Antonio, Texas, United States
Forest Investigative Site 1906
🇺🇸San Antonio, Texas, United States
Forest Investigative Site 2004
🇺🇸San Antonio, Texas, United States
Forest Investigative Site 1379
🇺🇸Phoenix, Arizona, United States
Forest Investigative Site 1571
🇺🇸Phoenix, Arizona, United States
Forest Investigative Site 1581
🇺🇸Phoenix, Arizona, United States
Forest Investigative Site 1582
🇺🇸Phoenix, Arizona, United States
Forest Investigative Site 1609
🇺🇸Bellevue, Nebraska, United States
Forest Investigative Site 1623
🇺🇸Peoria, Arizona, United States
Forest Investigative Site 1616
🇺🇸Lincoln, Nebraska, United States
Forest Investigative Site 1610
🇺🇸Rochester, New Hampshire, United States
Forest Investigative Site 1450
🇺🇸Union, South Carolina, United States
Forest Investigative Site 1394
🇺🇸Ocean, New Jersey, United States
Forest Investigative Site 1598
🇺🇸Stamford, Connecticut, United States
Forest Investigative Site 0900
🇺🇸Spartanburg, South Carolina, United States
Forest Investigative Site 1568
🇺🇸Easley, South Carolina, United States
Forest Investigative Site 1558
🇺🇸Brick, New Jersey, United States
Forest Investigative Site 1562
🇺🇸Las Vegas, Nevada, United States
Forest Investigative Site 2084
🇺🇸Summit, New Jersey, United States
Forest Investigative Site 1589
🇺🇸Norwalk, Connecticut, United States
Forest Investigative Site 1430
🇺🇸New Orleans, Louisiana, United States
Forest Investigative Site 1613
🇺🇸Chandler, Arizona, United States
Forest Investigative Site 2024
🇺🇸Lafayette, Louisiana, United States
Forest Investigative Site 1365
🇺🇸Rapid City, South Dakota, United States
Forest Investigative Site 1162
🇺🇸Birmingham, Alabama, United States
Forest Investigative Site 1620
🇺🇸Birmingham, Alabama, United States
Forest Investigative Site 1493
🇺🇸Birmingham, Alabama, United States
Forest Investigative Site 0892
🇺🇸Denver, Colorado, United States
Forest Investigative Site 1615
🇺🇸Omaha, Nebraska, United States
Forest Investigative Site 1552
🇺🇸Portland, Oregon, United States
Forest Investigative Site 2047
🇺🇸Tampa, Florida, United States
Forest Investigative Site 1127
🇺🇸Mobile, Alabama, United States
Forest Investigative Site 1399
🇺🇸St. Louis, Missouri, United States
Forest Investigative Site 1527
🇺🇸Fridley, Minnesota, United States
Forest Investigative Site 1944
🇺🇸Brandon, Florida, United States
Forest Investigative Site 1152
🇺🇸Clearwater, Florida, United States
Forest Investigative Site 1959
🇺🇸Debary, Florida, United States
Forest Investigative Site 1403
🇺🇸Hollywood, Florida, United States
Forest Investigative Site 1542
🇺🇸Ormond Beach, Florida, United States
Forest Investigative Site 1565
🇺🇸Venice, Florida, United States
Forest Investigative Site 1607
🇺🇸Lawrenceville, Georgia, United States
Forest Investigative Site 1570
🇺🇸Fall River, Massachusetts, United States
Forest Investigative Site 2051
🇺🇸River Forest, Illinois, United States
Forest Investigative Site 1604
🇺🇸Springfield, Illinois, United States
Forest Investigative Site 2033
🇺🇸Bowling Green, Kentucky, United States
Forest Investigative Site 1546
🇺🇸Haverhill, Massachusetts, United States
Forest Investigative Site 1595
🇺🇸Worcestor, Massachusetts, United States
Forest Investigative Site 1588
🇺🇸Shelby, North Carolina, United States
Forest Investigative Site 1541
🇺🇸Marion, Ohio, United States
Forest Investigative Site 1569
🇺🇸Pittsburgh, Pennsylvania, United States
Forest Investigative Site 1580
🇺🇸Portland, Oregon, United States
Forest Investigative Site 1504
🇺🇸Hershey, Pennsylvania, United States
Forest Investigative Site 1548
🇺🇸Pittsburgh, Pennsylvania, United States
Forest Investigative Site 1146
🇺🇸Pittsburgh, Pennsylvania, United States
Forest Investigative Site 1560
🇺🇸Pittsburgh, Pennsylvania, United States
Forest Investigative Site 1144
🇺🇸Johnston, Rhode Island, United States
Forest Investigative Site 1155
🇺🇸Dallas, Texas, United States
Forest Investigative Site 1954
🇺🇸Austin, Texas, United States
Forest Investigative Site 1328
🇺🇸Dallas, Texas, United States
Forest Investigative Site 1332
🇺🇸El Paso, Texas, United States
Forest Investigative Site 1498
🇺🇸San Antonio, Texas, United States
Forest Investigative Site 1480
🇺🇸Abingdon, Virginia, United States
Forest Investigative Site 1579
🇺🇸Alexandria, Virginia, United States
Forest Investigative Site 1619
🇺🇸Plymouth, Minnesota, United States
Forest Investigative Site 0980
🇺🇸Atlanta, Georgia, United States
Forest Investigative Site 1576
🇺🇸Evansville, Indiana, United States
Forest Investigative Site 1549
🇺🇸Council Bluffs, Iowa, United States
Forest Investigative Site 1556
🇺🇸Orlando, Florida, United States
Forest Investigative Site 1336
🇺🇸Louisville, Kentucky, United States
Forest Investigative Site 1550
🇺🇸Winston-Salem, North Carolina, United States
Forest Investigative Site 2072
🇺🇸Charleston, South Carolina, United States
Forest Investigative Site 1574
🇺🇸Beaver, Pennsylvania, United States
Forest Investigative Site 1126
🇺🇸Bethlehem, Pennsylvania, United States
Forest Investigative Site 1902
🇺🇸Killeen, Texas, United States