Efficacy, Safety and Tolerability of Two Fixed Dose Combinations of Aclidinium Bromide/Formoterol Fumarate, Aclidinium Bromide, Formoterol Fumarate and Placebo for 28-Weeks Treatment in Patients With Moderate to Severe, Stable Chronic Obstructive Pulmonary Disease (COPD)
- Conditions
- Chronic Obstructive Pulmonary Disease
- Interventions
- Registration Number
- NCT01572792
- Lead Sponsor
- AstraZeneca
- Brief Summary
The purpose of this Phase III study is to evaluate the long-term safety and tolerability of two fixed-dose combinations of inhaled aclidinium bromide/formoterol fumarate, aclidinium bromide, formoterol fumarate and placebo in patients with moderate to severe Chronic Obstructive Pulmonary Disease (COPD). Long-term efficacy, pharmacoeconomic and health-related quality of life assessments will also be evaluated. This extension study will include a 28 week treatment period, followed by a four week follow up visit. All patients will remain in the same treatment group as for the lead-in study and continue on one of the four treatment arms or placebo.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 921
- Completion of the treatment phase of the lead-in study, LAC-MD-31
- Written informed consent obtained from the patient before the initiation of any study specific procedures
- No medical contraindication as judged by the PI
- Compliance with LAC-MD-31 study procedures and IP dosing.
- No specific exclusion criteria
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 3 Aclidinium bromide Aclidinium bromide 400 μg 2 Aclidinium bromide/formoterol Fixed-Dose Combination (FDC) Aclidinium bromide/formoterol Fixed-Dose Combination (FDC) low dose 1 Aclidinium bromide/formoterol Fixed-Dose Combination (FDC) Aclidinium bromide/formoterol Fixed-Dose Combination (FDC) high dose 4 Formoterol Fumarate Formoterol Fumarate 12 μg 5 Placebo Placebo
- Primary Outcome Measures
Name Time Method Percentage of Patients to Experience Any Treatment-emergent Adverse Event Baseline of lead-in study to follow-up call 14±3 days after last dose of investigational product (up to Week 52) For each safety parameter, the last assessment made before the first dose of investigational product in the lead-in study (LAC MD-31) was used as the baseline for all analyses of that safety parameter in this extension study
- Secondary Outcome Measures
Name Time Method Percentage of Patients to Experience Potentially Clinically Significant Post-baseline Clinical Laboratory Values for Hematology, Chemistry or Urinalysis Baseline of lead-in study to end of treatment (up to Week 52) Potentially clinically significant change:
\>1.15 × upper limit of normal (ULN) for absolute cell count of basophils, eosinophils or monocytes, blood alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, total bilirubin, blood urea nitrogen, total cholesterol, creatine kinase, creatinine, gamma glutamyl transferase, lactate dehydrogenase, triglycerides or uric acid \<0.85 x lower limit of normal (LLN) or \> 1.15 ULN for hematocrit ratio, haemoglobin, lymphocytes or neutrophils absolute cell count, platelet count (thrombocytes), red or white blood cell count, calcium, fasting glucose, phosphorus, total protein, or urinary pH \<0.95 x LLN or \>1.05 x ULN for chloride, potassium, sodium Urinary glucose ≥0.015, blood or ketones or protein ≥1 or specific gravity \>1.1 × ULN
The last assessment made before the first dose of investigational product in the lead-in study was used as the baseline for all safety analyses in the extension studyPercentage of Patients to Experience a Potentially Significant Post-baseline 12-lead ECG Value Baseline of lead-in study to end of treatment (up to Week 52) Percentage of Patients to Experience Potentially Clinically Significant Post-baseline Vital Signs (Pulse Rate, Systolic or Diastolic Blood Pressure or Weight) Baseline of lead-in study to end of treatment (up to Week 52) Potentially clinically significant change:
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 Weight increase or decrease ≥7% from baseline
The last assessment made before the first dose of investigational product in the lead-in study was used as the baseline for all safety analyses in the extension study
Trial Locations
- Locations (208)
Forest Investigative Site 1852
🇺🇸Fall River, Massachusetts, United States
Forest Investigative Site 1924
🇺🇸Baltimore, Maryland, United States
Forest Investigative Site 2203
🇨🇦Toronto, Ontario, Canada
Forest Investigative Site 1146
🇺🇸Pittsburgh, Pennsylvania, United States
Forest Investigative Site 1432
🇺🇸Miami, Florida, United States
Forest Investigative Site 1125
🇺🇸San Diego, California, United States
Forest Investigative Site 2009
🇺🇸San Diego, California, United States
Forest Investigative Site 1562
🇺🇸Las Vegas, Nevada, United States
Forest Investigative Site 905
🇨🇦Vancouver, British Columbia, Canada
Forest Investigative Site 1831
🇺🇸Bozeman, Montana, United States
Forest Investigative Site 1400
🇺🇸Missoula, Montana, United States
Forest Investigative Site 1904
🇨🇦Langley, British Columbia, Canada
Forest Investigative Site 1379
🇺🇸Phoenix, Arizona, United States
Forest Investigative Site 1915
🇺🇸Oklahoma City, Oklahoma, United States
Forest Investigative Site 1936
🇺🇸Salt Lake City, Utah, United States
Forest Investigative Site 1162
🇺🇸Birmingham, Alabama, United States
Forest Investigative Site 1493
🇺🇸Birmingham, Alabama, United States
Forest Investigative Site 1920
🇺🇸Athens, Alabama, United States
Forest Investigative Site 1937
🇺🇸Birmingham, Alabama, United States
Forest Investigative Site 1824
🇺🇸Gulf Shores, Alabama, United States
Forest Investigative Site 2064
🇺🇸Riverside, California, United States
Forest Investigative Site 1918
🇺🇸Scottsboro, Alabama, United States
Forest Investigative Site 1871
🇺🇸Lincoln, California, United States
Forest Investigative Site 1883
🇺🇸Vista, California, United States
Forest Investigative Site 1854
🇺🇸Hialeah, Florida, United States
Forest Investigative Site 1976
🇺🇸Waterbury, Connecticut, United States
Forest Investigative Site 1811
🇺🇸Covington, Florida, United States
Forest Investigative Site 1813
🇺🇸Tustin, California, United States
Forest Investigative Site 1380
🇺🇸Golden, Colorado, United States
Forest Investigative Site 1821
🇺🇸Bay Pines, Florida, United States
Forest Investigative Site 1874
🇺🇸St. Petersburg, Florida, United States
Forest Investigative Site 1416
🇺🇸Kissimmee, Florida, United States
Forest Investigative Site 1559
🇺🇸Cherry Hill, New Jersey, United States
Forest Investigative Site 1900
🇺🇸Atlanta, Georgia, United States
Forest Investigative Site 0987
🇺🇸Austell, Georgia, United States
Forest Investigative Site 0679
🇺🇸Coeur d Alene, Idaho, United States
Forest Investigative Site 1872
🇺🇸Wheaton, Maryland, United States
Forest Investigative Site 1570
🇺🇸Fall River, Massachusetts, United States
Forest Investigative Site 1431
🇺🇸No. Dartmouth, Massachusetts, United States
Forest Investigative Site 1527
🇺🇸Fridley, Minnesota, United States
Forest Investigative Site 1392
🇺🇸Charlotte, North Carolina, United States
Forest Investigative Site 1489
🇺🇸Larchmont, New York, United States
Forest Investigative Site 1124
🇺🇸Minneapolis, Minnesota, United States
Forest Investigative Site 1856
🇺🇸Springfield, Missouri, United States
Forest Investigative Site 550
🇺🇸New York, New York, United States
Forest Investigative Site 2079
🇺🇸St. Charles, Missouri, United States
Forest Investigative Site 1399
🇺🇸St. Louis, Missouri, United States
Forest Investigative Site 1134
🇺🇸Canton, Ohio, United States
Forest Investigative Site 1806
🇺🇸Cincinnati, Ohio, United States
Forest Investigative Site 1807
🇺🇸Henderson, Nevada, United States
Forest Investigative Site 1823
🇺🇸Salisbury, North Carolina, United States
Forest Investigative Site 2043
🇺🇸Medford, Oregon, United States
Forest Investigative Site 2090
🇺🇸Sylvania, Ohio, United States
Forest Investigative Site 1530
🇺🇸Toledo, Ohio, United States
Forest Investigative Site 1885
🇺🇸Cincinnati, Ohio, United States
Forest Investigative Site 2028
🇺🇸Cincinnati, Ohio, United States
Forest Investigative Site 1820
🇺🇸Downington, Pennsylvania, United States
Forest Investigative Site 1089
🇺🇸East Providence, Rhode Island, United States
Forest Investigative Site 2012
🇺🇸Fort Worth, Texas, United States
Forest Investigative Site 1443
🇺🇸Philadelphia, Pennsylvania, United States
Forest Investigative Site 1361
🇺🇸Columbus, Ohio, United States
Forest Investigative Site 1423
🇺🇸Erie, Pennsylvania, United States
Forest Investigative Site 1433
🇺🇸Columbus, Ohio, United States
Forest Investigative Site 1393
🇺🇸Zanesville, Ohio, United States
Forest Investigative Site 1889
🇺🇸Bend, Oregon, United States
Forest Investigative Site 1440
🇺🇸Arlington, Texas, United States
Forest Investigative Site 1914
🇺🇸Fort Mill, South Carolina, United States
Forest Investigative Site 1526
🇺🇸Fayetteville, Tennessee, United States
Forest Investigative Site 1895
🇺🇸San Antonio, Texas, United States
Forest Investigative Site 1899
🇺🇸Langhorne, Pennsylvania, United States
Forest Investigative Site 1832
🇺🇸Cumberland, Rhode Island, United States
Forest Investigative Site 1121
🇺🇸Spartanburg, South Carolina, United States
Forest Investigative Site 1913
🇺🇸Gaffney, South Carolina, United States
Forest Investigative Site 1861
🇺🇸Carrollton, Texas, United States
Forest Investigative Site 1879
🇺🇸Boerne, Texas, United States
Forest Investigative Site 1332
🇺🇸El Paso, Texas, United States
Forest Investigative Site 1991
🇦🇺New Lambton, New South Wales, Australia
Forest Investigative Site 0988
🇺🇸Tacoma, Washington, United States
Forest Investigative Site 1951
🇺🇸Houston, Texas, United States
Forest Investigative Site 1091
🇺🇸McKinney, Texas, United States
Forest Investigative Site 1404
🇺🇸Norfolk, Virginia, United States
Forest Investigative Site 1878
🇺🇸Spokane, Washington, United States
Forest Investigative Site 2251
🇦🇺Toorak Gardens, South Australia, Australia
Forest Investigative Site 1330
🇺🇸South Burlington, Vermont, United States
Forest Investigative Site 1945
🇺🇸Newport News, Virginia, United States
Forest Investigative Site 1120
🇺🇸Bellingham, Washington, United States
Forest Investigative Site 1977
🇺🇸Spokane, Washington, United States
Forest Investigative Site 1870
🇺🇸Tacoma, Washington, United States
Forest Investigative Site 1573
🇺🇸Spokane, Washington, United States
Forest Investigative Site 1027
🇳🇿Auckland, New Zealand
Forest Investigative Site 1859
🇨🇦Quebec, Canada
Forest Investigative Site 1555
🇺🇸Morgantown, West Virginia, United States
Forest Investigative Site 2250
🇦🇺Clayton, Victoria, Australia
Forest Investigative Site 1986
🇦🇺Geelong, Victoria, Australia
Forest Investigative Site 2253
🇦🇺Adelaide, South Australia, Australia
Forest Investigative Site 1987
🇦🇺Redcliffe, Queensland, Australia
Forest Investigative Site 1171
🇨🇦Toronto, Ontario, Canada
Forest Investigative Site 1896
🇨🇦Sarnia, Ontario, Canada
Forest Investigative Site 0976
🇨🇦Winnipeg, Manitoba, Canada
Forest Investigative Site 0943
🇨🇦Saskatoon, Saskatchewan, Canada
Forest Investigative Site 1970
🇳🇿Christchurch, New Zealand
Forest Investigative Site 1980
🇳🇿Tauranga, New Zealand
Forest Investigative Site 1964
🇳🇿Dunedin, New Zealand
Forest Investigative Site 1968
🇳🇿Hamilton, New Zealand
Forest Investigative Site 1118
🇺🇸Rochester, Minnesota, United States
Forest Investigative Site 1877
🇨🇦Sarina, Ontario, Canada
Forest Investigative Site 1425
🇺🇸New York, New York, United States
Forest Investigative Site 1363
🇺🇸Omaha, Nebraska, United States
Forest Investigative Site 1907
🇺🇸Omaha, Nebraska, United States
Forest Investigative Site 1911
🇺🇸Omaha, Nebraska, United States
Forest Investigative Site 1908
🇺🇸Omaha, Nebraska, United States
Forest Investigative Site 1804
🇺🇸Omaha, Nebraska, United States
Forest Investigative Site 1981
🇦🇺Bedford Park, South Australia, Australia
Forest Investigative Site 1972
🇦🇺Fitzroy, Victoria, Australia
Forest Investigative Site 1985
🇦🇺Parkville, Victoria, Australia
Forest Investigative Site 1967
🇳🇿Dunedin, New Zealand
Forest Investigative Site 1965
🇳🇿Tauranga, New Zealand
Forest Investigative Site 1025
🇳🇿Wellington, New Zealand
Forest Investigative Site 1903
🇺🇸Cincinnati, Ohio, United States
Forest Investigative Site 1882
🇺🇸Hollywood, Florida, United States
Forest Investigative Site 1863
🇺🇸Phoenixville, Pennsylvania, United States
Forest Investigative Site 1449
🇺🇸Tipton, Pennsylvania, United States
Forest Investigative Site 1862
🇺🇸Uniontown, Pennsylvania, United States
Forest Investigative Site 1827
🇺🇸Anniston, Alabama, United States
Forest Investigative Site 2088
🇺🇸Jasper, Alabama, United States
Forest Investigative Site 0909
🇺🇸Glendale, Arizona, United States
Forest Investigative Site 1822
🇺🇸Anaheim, California, United States
Forest Investigative Site 1483
🇺🇸Buena Park, California, United States
Forest Investigative Site 1156
🇺🇸Fresno, California, United States
Forest Investigative Site 1873
🇺🇸Los Angeles, California, United States
Forest Investigative Site 1374
🇺🇸Torrance, California, United States
Forest Investigative Site 1154
🇺🇸Brandon, Florida, United States
Forest Investigative Site 1327
🇺🇸Wheat Ridge, Colorado, United States
Forest Investigative Site 1137
🇺🇸Pueblo, Colorado, United States
Forest Investigative Site 1944
🇺🇸Brandon, Florida, United States
Forest Investigative Site 1364
🇺🇸Clearwater, Florida, United States
Forest Investigative Site 0670
🇺🇸DeLand, Florida, United States
Forest Investigative Site 1875
🇺🇸Clearwater, Florida, United States
Forest Investigative Site 1516
🇺🇸Edgewater, Florida, United States
Forest Investigative Site 1152
🇺🇸Clearwater, Florida, United States
Forest Investigative Site 0990
🇺🇸Fort Lauderdale, Florida, United States
Forest Investigative Site 1513
🇺🇸Hialeah, Florida, United States
Forest Investigative Site 1543
🇺🇸Jacksonville, Florida, United States
Forest Investigative Site 1808
🇺🇸N. Miami, Florida, United States
Forest Investigative Site 1167
🇺🇸Melbourne, Florida, United States
Forest Investigative Site 1950
🇺🇸Oldsmar, Florida, United States
Forest Investigative Site 1145
🇺🇸Ormond Beach, Florida, United States
Forest Investigative Site 1819
🇺🇸Naples, Florida, United States
Forest Investigative Site 1094
🇺🇸Panama City, Florida, United States
Forest Investigative Site 1803
🇺🇸Pembroke Pines, Florida, United States
Forest Investigative Site 0974
🇺🇸Pensacola, Florida, United States
Forest Investigative Site 2082
🇺🇸Tamarac, Florida, United States
Forest Investigative Site 1817
🇺🇸Sarasota, Florida, United States
Forest Investigative Site 1185
🇺🇸Winter Park, Florida, United States
Forest Investigative Site 1830
🇺🇸Marietta, Georgia, United States
Forest Investigative Site 1828
🇺🇸Canton, Georgia, United States
Forest Investigative Site 1860
🇺🇸Winter Park, Florida, United States
Forest Investigative Site 2089
🇺🇸Woodstock, Georgia, United States
Forest Investigative Site 1858
🇺🇸Eagle, Idaho, United States
Forest Investigative Site 1095
🇺🇸Normal, Illinois, United States
Forest Investigative Site 2033
🇺🇸Bowling Green, Kentucky, United States
Forest Investigative Site 2085
🇺🇸Fort Mitchell, Kentucky, United States
Forest Investigative Site 2051
🇺🇸River Forest, Illinois, United States
Forest Investigative Site 1912
🇺🇸Normal, Illinois, United States
Forest Investigative Site 1812
🇺🇸Opelousas, Louisiana, United States
Forest Investigative Site 1519
🇺🇸Owensboro, Kentucky, United States
Forest Investigative Site 1814
🇺🇸Bangor, Maine, United States
Forest Investigative Site 1342
🇺🇸Stevensville, Michigan, United States
Forest Investigative Site 1487
🇺🇸Troy, Michigan, United States
Forest Investigative Site 1128
🇺🇸Edina, Minnesota, United States
Forest Investigative Site 2041
🇺🇸Minneapolis, Minnesota, United States
Forest Investigative Site 1587
🇺🇸N. Chesterfield, Missouri, United States
Forest Investigative Site 1619
🇺🇸Plymouth, Minnesota, United States
Forest Investigative Site 1884
🇺🇸Olive Branch, Mississippi, United States
Forest Investigative Site 1867
🇺🇸Springfield, Missouri, United States
Forest Investigative Site 1599
🇺🇸St. Louis, Missouri, United States
Forest Investigative Site 1609
🇺🇸Bellevue, Nebraska, United States
Forest Investigative Site 1948
🇺🇸Fremont, Nebraska, United States
Forest Investigative Site 1815
🇺🇸Lincoln, Nebraska, United States
Forest Investigative Site 1834
🇺🇸Las Vegas, Nevada, United States
Forest Investigative Site 1151
🇺🇸Great Neck, New York, United States
Forest Investigative Site 1923
🇺🇸Hackensack, New Jersey, United States
Forest Investigative Site 1891
🇺🇸Cadiz, Ohio, United States
Forest Investigative Site 1366
🇺🇸High Point, North Carolina, United States
Forest Investigative Site 2035
🇺🇸Elizabeth City, North Carolina, United States
Forest Investigative Site 1153
🇺🇸Raleigh, North Carolina, United States
Forest Investigative Site 1833
🇺🇸Altoona, Pennsylvania, United States
Forest Investigative Site 1816
🇺🇸Corsicana, Texas, United States
Forest Investigative Site 1890
🇺🇸Dallas, Texas, United States
Forest Investigative Site 1826
🇺🇸Plano, Texas, United States
Forest Investigative Site 1973
🇦🇺Woolloongabba, Queensland, Australia
Forest Investigative Site 1990
🇦🇺Daw Park, South Australia, Australia
Forest Investigative Site 1952
🇨🇦Montreal, Quebec, Canada
Forest Investigative Site 1427
🇺🇸Sacramento, California, United States
Forest Investigative Site 1866
🇺🇸Sacramento, California, United States
Forest Investigative Site 2047
🇺🇸Tampa, Florida, United States
Forest Investigative Site 2053
🇺🇸Tampa, Florida, United States
Forest Investigative Site 1478
🇺🇸Louisville, Kentucky, United States
Forest Investigative Site 1892
🇺🇸Ann Arbor, Michigan, United States
Forest Investigative Site 1602
🇺🇸Kansas City, Missouri, United States
Forest Investigative Site 2072
🇺🇸Charleston, South Carolina, United States
Forest Investigative Site 1802
🇺🇸Charleston, South Carolina, United States
Forest Investigative Site 1905
🇺🇸Charleston, South Carolina, United States
Forest Investigative Site 1430
🇺🇸New Orleans, Louisiana, United States
Forest Investigative Site 0539
🇺🇸Lexington, Kentucky, United States
Forest Investigative Site 1949
🇺🇸Albuquerque, New Mexico, United States
Forest Investigative Site 2098
🇺🇸Rochester, New York, United States
Forest Investigative Site 1957
🇺🇸Brentwood, Tennessee, United States