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)

This study has been completed.
Sponsor:
Collaborator:
Almirall, S.A.
Information provided by (Responsible Party):
Forest Laboratories
ClinicalTrials.gov Identifier:
NCT01572792
First received: April 4, 2012
Last updated: June 30, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention Phase
Chronic Obstructive Pulmonary Disease
Drug: Aclidinium Bromide/Formoterol Fumarate
Drug: Aclidinium Bromide
Drug: Formoterol Fumarate
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase III, Long-term, Randomized, Double-blind, Extension Study of the 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)

Resource links provided by NLM:


Further study details as provided by Forest Laboratories:

Primary Outcome Measures:
  • Safety and tolerability [ Time Frame: 28 weeks ] [ Designated as safety issue: Yes ]
    Adverse Events, Clinical Laboratory Parameters, Vital Sign Measurement, and electrocardiogram parameters


Enrollment: 909
Study Start Date: April 2012
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Aclidinium/formoterol Fixed-Dose Combination (FDC) high dose
Drug: Aclidinium Bromide/Formoterol Fumarate
Inhaled Aclidinium/formoterol FDC high dose, twice per day
Experimental: 2
Aclidinium/formoterol FDC low dose, twice per day
Drug: Aclidinium Bromide/Formoterol Fumarate
Inhaled Aclidinium/formoterol FDC high dose, twice per day
Active Comparator: 3
Aclidinium monotherapy 400 μg
Drug: Aclidinium Bromide
Inhaled Aclidinium 400 μg, twice per day
Active Comparator: 4
Formoterol monotherapy 12 μg
Drug: Formoterol Fumarate
Inhaled Formoterol 12 μg, twice per day
Placebo Comparator: 5
Placebo
Drug: Placebo
Inhaled dose-matched placebo, twice per day

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • No specific exclusion criteria
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01572792

  Hide Study Locations
Locations
United States, Alabama
Forest Investigative Site 1827
Anniston, Alabama, United States, 36207
Forest Investigative Site 1920
Athens, Alabama, United States, 35611
Forest Investigative Site 1162
Birmingham, Alabama, United States, 35209
Forest Investigative Site 1493
Birmingham, Alabama, United States, 35209
Forest Investigative Site 1937
Birmingham, Alabama, United States, 35216
Forest Investigative Site 1824
Gulf Shores, Alabama, United States, 36542
Forest Investigative Site 2088
Jasper, Alabama, United States, 35501
Forest Investigative Site 1918
Scottsboro, Alabama, United States, 35768
United States, Arizona
Forest Investigative Site 0909
Glendale, Arizona, United States, 85306
Forest Investigative Site 1379
Phoenix, Arizona, United States, 85018
United States, California
Forest Investigative Site 1822
Anaheim, California, United States, 92801
Forest Investigative Site 1483
Buena Park, California, United States, 90620
Forest Investigative Site 1156
Fresno, California, United States, 93726
Forest Investigative Site 1871
Lincoln, California, United States, 95648
Forest Investigative Site 1873
Los Angeles, California, United States, 90073
Forest Investigative Site 2064
Riverside, California, United States, 92506
Forest Investigative Site 1427
Sacramento, California, United States, 95817
Forest Investigative Site 1866
Sacramento, California, United States, 95842
Forest Investigative Site 2009
San Diego, California, United States, 92120
Forest Investigative Site 1125
San Diego, California, United States, 92103
Forest Investigative Site 1374
Torrance, California, United States, 90505
Forest Investigative Site 1813
Tustin, California, United States, 92780
Forest Investigative Site 1883
Vista, California, United States, 92083
United States, Colorado
Forest Investigative Site 1380
Golden, Colorado, United States, 80401
Forest Investigative Site 1137
Pueblo, Colorado, United States, 81001
Forest Investigative Site 1327
Wheat Ridge, Colorado, United States, 80033
United States, Connecticut
Forest Investigative Site 1976
Waterbury, Connecticut, United States, 06708
United States, Florida
Forest Investigative Site 1821
Bay Pines, Florida, United States, 33744
Forest Investigative Site 1944
Brandon, Florida, United States, 33511
Forest Investigative Site 1154
Brandon, Florida, United States, 33511
Forest Investigative Site 1364
Clearwater, Florida, United States, 33756
Forest Investigative Site 1152
Clearwater, Florida, United States, 33765
Forest Investigative Site 1875
Clearwater, Florida, United States, 33765
Forest Investigative Site 1811
Covington, Florida, United States, 70433
Forest Investigative Site 0670
DeLand, Florida, United States, 32720
Forest Investigative Site 1516
Edgewater, Florida, United States, 32132
Forest Investigative Site 0990
Fort Lauderdale, Florida, United States, 33316
Forest Investigative Site 1854
Hialeah, Florida, United States, 33012
Forest Investigative Site 1513
Hialeah, Florida, United States, 33012
Forest Investigative Site 1882
Hollywood, Florida, United States, 33024
Forest Investigative Site 1543
Jacksonville, Florida, United States, 32216
Forest Investigative Site 1416
Kissimmee, Florida, United States, 34741
Forest Investigative Site 1167
Melbourne, Florida, United States, 32935
Forest Investigative Site 1432
Miami, Florida, United States, 33143
Forest Investigative Site 1808
N. Miami, Florida, United States, 33179
Forest Investigative Site 1819
Naples, Florida, United States, 34119
Forest Investigative Site 1950
Oldsmar, Florida, United States, 34677
Forest Investigative Site 1145
Ormond Beach, Florida, United States, 32174
Forest Investigative Site 1094
Panama City, Florida, United States, 32405
Forest Investigative Site 1803
Pembroke Pines, Florida, United States, 32028
Forest Investigative Site 0974
Pensacola, Florida, United States, 32504
Forest Investigative Site 1817
Sarasota, Florida, United States, 34233
Forest Investigative Site 1874
St. Petersburg, Florida, United States, 33704
Forest Investigative Site 2082
Tamarac, Florida, United States, 33321
Forest Investigative Site 2047
Tampa, Florida, United States, 33613
Forest Investigative Site 2053
Tampa, Florida, United States, 33603
Forest Investigative Site 1185
Winter Park, Florida, United States, 32789
Forest Investigative Site 1860
Winter Park, Florida, United States, 32792
United States, Georgia
Forest Investigative Site 1900
Atlanta, Georgia, United States, 30312
Forest Investigative Site 0987
Austell, Georgia, United States, 30106
Forest Investigative Site 1828
Canton, Georgia, United States, 30114
Forest Investigative Site 1830
Marietta, Georgia, United States, 30066
Forest Investigative Site 2089
Woodstock, Georgia, United States, 30189
United States, Idaho
Forest Investigative Site 0679
Coeur d' Alene, Idaho, United States, 83814
Forest Investigative Site 1858
Eagle, Idaho, United States, 83616
United States, Illinois
Forest Investigative Site 1095
Normal, Illinois, United States, 61761
Forest Investigative Site 1912
Normal, Illinois, United States, 61761
Forest Investigative Site 2051
River Forest, Illinois, United States, 60305
United States, Kentucky
Forest Investigative Site 2033
Bowling Green, Kentucky, United States, 42101
Forest Investigative Site 2085
Fort Mitchell, Kentucky, United States, 41017
Forest Investigative Site 0539
Lexington, Kentucky, United States, 40504
Forest Investigative Site 1478
Louisville, Kentucky, United States, 40217
Forest Investigative Site 1519
Owensboro, Kentucky, United States, 42303
United States, Louisiana
Forest Investigative Site 1430
New Orleans, Louisiana, United States, 70115
Forest Investigative Site 1812
Opelousas, Louisiana, United States, 70570
United States, Maine
Forest Investigative Site 1814
Bangor, Maine, United States, 04401
United States, Maryland
Forest Investigative Site 1924
Baltimore, Maryland, United States, 21237
Forest Investigative Site 1872
Wheaton, Maryland, United States, 20902
United States, Massachusetts
Forest Investigative Site 1570
Fall River, Massachusetts, United States, 02720
Forest Investigative Site 1852
Fall River, Massachusetts, United States, 02720
Forest Investigative Site 1431
No. Dartmouth, Massachusetts, United States, 02747
United States, Michigan
Forest Investigative Site 1892
Ann Arbor, Michigan, United States, 48106
Forest Investigative Site 1342
Stevensville, Michigan, United States, 49127
Forest Investigative Site 1487
Troy, Michigan, United States, 48085
United States, Minnesota
Forest Investigative Site 1128
Edina, Minnesota, United States, 55435
Forest Investigative Site 1527
Fridley, Minnesota, United States, 55432
Forest Investigative Site 2041
Minneapolis, Minnesota, United States, 55402
Forest Investigative Site 1124
Minneapolis, Minnesota, United States, 55407
Forest Investigative Site 1619
Plymouth, Minnesota, United States, 55441
Forest Investigative Site 1118
Rochester, Minnesota, United States, 55905
United States, Mississippi
Forest Investigative Site 1884
Olive Branch, Mississippi, United States, 38654
United States, Missouri
Forest Investigative Site 1602
Kansas City, Missouri, United States, 64128
Forest Investigative Site 1587
N. Chesterfield, Missouri, United States, 63017
Forest Investigative Site 1856
Springfield, Missouri, United States, 65807
Forest Investigative Site 1867
Springfield, Missouri, United States, 65807
Forest Investigative Site 2079
St. Charles, Missouri, United States, 63301
Forest Investigative Site 1399
St. Louis, Missouri, United States, 63141
Forest Investigative Site 1599
St. Louis, Missouri, United States, 63141
United States, Montana
Forest Investigative Site 1831
Bozeman, Montana, United States, 59718
Forest Investigative Site 1400
Missoula, Montana, United States, 59808
United States, Nebraska
Forest Investigative Site 1609
Bellevue, Nebraska, United States, 68123
Forest Investigative Site 1948
Fremont, Nebraska, United States, 68025
Forest Investigative Site 1815
Lincoln, Nebraska, United States, 68510
Forest Investigative Site 1363
Omaha, Nebraska, United States, 68114
Forest Investigative Site 1908
Omaha, Nebraska, United States, 68134
Forest Investigative Site 1804
Omaha, Nebraska, United States, 68144
Forest Investigative Site 1907
Omaha, Nebraska, United States, 68130
Forest Investigative Site 1911
Omaha, Nebraska, United States, 68131
United States, Nevada
Forest Investigative Site 1807
Henderson, Nevada, United States, 89052
Forest Investigative Site 1562
Las Vegas, Nevada, United States, 89183
Forest Investigative Site 1834
Las Vegas, Nevada, United States, 89128
United States, New Jersey
Forest Investigative Site 1559
Cherry Hill, New Jersey, United States, 08003
Forest Investigative Site 1923
Hackensack, New Jersey, United States, 07601
United States, New Mexico
Forest Investigative Site 1949
Albuquerque, New Mexico, United States, 87106
United States, New York
Forest Investigative Site 1151
Great Neck, New York, United States, 11021
Forest Investigative Site 1489
Larchmont, New York, United States, 10538
Forest Investigative Site 1425
New York, New York, United States, 10028
Forest Investigative Site 550
New York, New York, United States, 10003
Forest Investigative Site 2098
Rochester, New York, United States, 14618
United States, North Carolina
Forest Investigative Site 1392
Charlotte, North Carolina, United States, 28277
Forest Investigative Site 2035
Elizabeth City, North Carolina, United States, 27909
Forest Investigative Site 1366
High Point, North Carolina, United States, 27262
Forest Investigative Site 1153
Raleigh, North Carolina, United States, 27607
Forest Investigative Site 1823
Salisbury, North Carolina, United States, 28144
United States, Ohio
Forest Investigative Site 1891
Cadiz, Ohio, United States, 43907
Forest Investigative Site 1134
Canton, Ohio, United States, 44718
Forest Investigative Site 2028
Cincinnati, Ohio, United States, 45242
Forest Investigative Site 1885
Cincinnati, Ohio, United States, 45219
Forest Investigative Site 1806
Cincinnati, Ohio, United States, 45231
Forest Investigative Site 1903
Cincinnati, Ohio, United States, 45255
Forest Investigative Site 1361
Columbus, Ohio, United States, 43207
Forest Investigative Site 1433
Columbus, Ohio, United States, 43213
Forest Investigative Site 2090
Sylvania, Ohio, United States, 43560
Forest Investigative Site 1530
Toledo, Ohio, United States, 43608
Forest Investigative Site 1393
Zanesville, Ohio, United States, 43701
United States, Oklahoma
Forest Investigative Site 1915
Oklahoma City, Oklahoma, United States, 73103
United States, Oregon
Forest Investigative Site 1889
Bend, Oregon, United States, 97701
Forest Investigative Site 2043
Medford, Oregon, United States, 97504
United States, Pennsylvania
Forest Investigative Site 1833
Altoona, Pennsylvania, United States, 16601
Forest Investigative Site 1820
Downington, Pennsylvania, United States, 19335
Forest Investigative Site 1423
Erie, Pennsylvania, United States, 16508
Forest Investigative Site 1899
Langhorne, Pennsylvania, United States, 19047
Forest Investigative Site 1443
Philadelphia, Pennsylvania, United States, 19107
Forest Investigative Site 1863
Phoenixville, Pennsylvania, United States, 19460
Forest Investigative Site 1146
Pittsburgh, Pennsylvania, United States, 15243
Forest Investigative Site 1449
Tipton, Pennsylvania, United States, 16684
Forest Investigative Site 1862
Uniontown, Pennsylvania, United States, 15473
United States, Rhode Island
Forest Investigative Site 1832
Cumberland, Rhode Island, United States, 02864
Forest Investigative Site 1089
East Providence, Rhode Island, United States, 02914
United States, South Carolina
Forest Investigative Site 2072
Charleston, South Carolina, United States, 29406
Forest Investigative Site 1802
Charleston, South Carolina, United States, 29412
Forest Investigative Site 1905
Charleston, South Carolina, United States, 29407
Forest Investigative Site 1914
Fort Mill, South Carolina, United States, 29707
Forest Investigative Site 1913
Gaffney, South Carolina, United States, 29340
Forest Investigative Site 1121
Spartanburg, South Carolina, United States, 29303
United States, Tennessee
Forest Investigative Site 1957
Brentwood, Tennessee, United States, 37027
Forest Investigative Site 1526
Fayetteville, Tennessee, United States, 37334
United States, Texas
Forest Investigative Site 1440
Arlington, Texas, United States, 76012
Forest Investigative Site 1879
Boerne, Texas, United States, 78006
Forest Investigative Site 1861
Carrollton, Texas, United States, 75007
Forest Investigative Site 1816
Corsicana, Texas, United States, 75110
Forest Investigative Site 1890
Dallas, Texas, United States, 75220
Forest Investigative Site 1332
El Paso, Texas, United States, 79903
Forest Investigative Site 2012
Fort Worth, Texas, United States, 76104
Forest Investigative Site 1951
Houston, Texas, United States, 77070
Forest Investigative Site 1091
McKinney, Texas, United States, 75069
Forest Investigative Site 1826
Plano, Texas, United States, 75001
Forest Investigative Site 1895
San Antonio, Texas, United States, 78212
United States, Utah
Forest Investigative Site 1936
Salt Lake City, Utah, United States, 84102
United States, Vermont
Forest Investigative Site 1330
South Burlington, Vermont, United States, 05403
United States, Virginia
Forest Investigative Site 1945
Newport News, Virginia, United States, 23606
Forest Investigative Site 1404
Norfolk, Virginia, United States, 23502
United States, Washington
Forest Investigative Site 1120
Bellingham, Washington, United States, 98225
Forest Investigative Site 1977
Spokane, Washington, United States, 99202
Forest Investigative Site 1573
Spokane, Washington, United States, 99216
Forest Investigative Site 1878
Spokane, Washington, United States, 99204
Forest Investigative Site 1870
Tacoma, Washington, United States, 98405
Forest Investigative Site 0988
Tacoma, Washington, United States, 98405
United States, West Virginia
Forest Investigative Site 1555
Morgantown, West Virginia, United States, 26505
Australia, New South Wales
Forest Investigative Site 1991
New Lambton, New South Wales, Australia, 2305
Australia, Queensland
Forest Investigative Site 1987
Redcliffe, Queensland, Australia, 4020
Forest Investigative Site 1973
Woolloongabba, Queensland, Australia, 4102
Australia, South Australia
Forest Investigative Site 2253
Adelaide, South Australia, Australia, 5000
Forest Investigative Site 1981
Bedford Park, South Australia, Australia, 5042
Forest Investigative Site 1990
Daw Park, South Australia, Australia, 5041
Forest Investigative Site 2251
Toorak Gardens, South Australia, Australia, 5065
Australia, Victoria
Forest Investigative Site 2250
Clayton, Victoria, Australia, 3168
Forest Investigative Site 1972
Fitzroy, Victoria, Australia, 3065
Forest Investigative Site 1986
Geelong, Victoria, Australia, 3220
Forest Investigative Site 1985
Parkville, Victoria, Australia, 3050
Canada, British Columbia
Forest Investigative Site 1904
Langley, British Columbia, Canada, V3A 4H9
Forest Investigative Site 905
Vancouver, British Columbia, Canada, V5Z 1M9
Canada, Manitoba
Forest Investigative Site 0976
Winnipeg, Manitoba, Canada, R2K 3S8
Canada, Ontario
Forest Investigative Site 1877
Sarina, Ontario, Canada, N7T 4X3
Forest Investigative Site 1896
Sarnia, Ontario, Canada, N7T 4X3
Forest Investigative Site 1171
Toronto, Ontario, Canada, M5T 3A9
Forest Investigative Site 2203
Toronto, Ontario, Canada, M6H 3M2
Canada, Quebec
Forest Investigative Site 1952
Montreal, Quebec, Canada, H2R 1V6
Canada, Saskatchewan
Forest Investigative Site 0943
Saskatoon, Saskatchewan, Canada, S7N 0W8
Canada
Forest Investigative Site 1859
Quebec, Canada, G1V 4M6
New Zealand
Forest Investigative Site 1027
Auckland, New Zealand, 1051
Forest Investigative Site 1970
Christchurch, New Zealand, 8011
Forest Investigative Site 1964
Dunedin, New Zealand, 9058
Forest Investigative Site 1967
Dunedin, New Zealand, 9012
Forest Investigative Site 1968
Hamilton, New Zealand, 3240
Forest Investigative Site 1965
Tauranga, New Zealand, 3110
Forest Investigative Site 1980
Tauranga, New Zealand, 3112
Forest Investigative Site 1025
Wellington, New Zealand, 7366
Sponsors and Collaborators
Forest Laboratories
Almirall, S.A.
Investigators
Study Director: Carrie D'Andrea, MS Forest Laboratories
  More Information

No publications provided

Responsible Party: Forest Laboratories
ClinicalTrials.gov Identifier: NCT01572792     History of Changes
Other Study ID Numbers: LAC-MD-36
Study First Received: April 4, 2012
Last Updated: June 30, 2013
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

Keywords provided by Forest Laboratories:
COPD
Chronic Obstructive Pulmonary Disease
Chronic Bronchitis
Emphysema
Airflow Obstruction, Chronic
Chronic Airflow Obstruction
Chronic Obstructive Airway Disease
Chronic Obstructive Lung Disease

Additional relevant MeSH terms:
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Lung Diseases
Respiratory Tract Diseases
Formoterol
Bromides
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anticonvulsants
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 16, 2014