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)

March 9, 2017 updated by: AstraZeneca

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)

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.

Study Overview

Status

Completed

Conditions

Chronic Obstructive Pulmonary Disease

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

921

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Quadruple

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: 5 Placebo	Drug: Placebo Inhaled dose-matched placebo, twice per day
Experimental: 1 Aclidinium bromide/formoterol Fixed-Dose Combination (FDC) high dose	Drug: Aclidinium bromide/formoterol Fixed-Dose Combination (FDC) Inhaled Aclidinium bromide/formoterol Fixed-Dose Combination (FDC) high dose, twice per day Drug: Aclidinium bromide/formoterol Fixed-Dose Combination (FDC) Inhaled Aclidinium bromide/formoterol Fixed-Dose Combination (FDC) low dose, twice per day
Experimental: 2 Aclidinium bromide/formoterol Fixed-Dose Combination (FDC) low dose	Drug: Aclidinium bromide/formoterol Fixed-Dose Combination (FDC) Inhaled Aclidinium bromide/formoterol Fixed-Dose Combination (FDC) high dose, twice per day Drug: Aclidinium bromide/formoterol Fixed-Dose Combination (FDC) Inhaled Aclidinium bromide/formoterol Fixed-Dose Combination (FDC) low dose, twice per day
Active Comparator: 3 Aclidinium bromide 400 μg	Drug: Aclidinium bromide Inhaled Aclidinium bromide 400 μg, twice per day
Active Comparator: 4 Formoterol Fumarate 12 μg	Drug: Formoterol Fumarate Inhaled Formoterol Fumarate 12 μg, twice per day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Patients to Experience Any Treatment-emergent Adverse Event Time Frame: 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	Baseline of lead-in study to follow-up call 14±3 days after last dose of investigational product (up to Week 52)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Patients to Experience Potentially Clinically Significant Post-baseline Clinical Laboratory Values for Hematology, Chemistry or Urinalysis Time Frame: 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 study	Baseline of lead-in study to end of treatment (up to Week 52)
Percentage of Patients to Experience a Potentially Significant Post-baseline 12-lead ECG Value Time Frame: Baseline of lead-in study to end of treatment (up to Week 52)		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) Time Frame: 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	Baseline of lead-in study to end of treatment (up to Week 52)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in 1-hour Morning Post-dose Forced Expiratory Volume in One Second (FEV1) Time Frame: Baseline of lead-in study to Week 52 of treatment		Baseline of lead-in study to Week 52 of treatment
Change From Baseline in Morning Predose (Trough) Forced Expiratory Volume in One Second (FEV1) Time Frame: Baseline of lead-in study to Week 52 of treatment		Baseline of lead-in study to Week 52 of treatment
Transition Dyspnea Index (TDI) Focal Score at End of Study Time Frame: Baseline of lead-in study to Week 52 of treatment	The TDI measures the change from baseline in severity of breathlessness in symptomatic patients. The TDI contains a rating for 3 categories (functional impairment, magnitude of task, magnitude of effort). TDI scale ranges from -3 (major deterioration) to +3 (major improvement) including a 0 score to indicate "no change". The 3 categories are added to obtain a focal score ranging from -9 (including 0) to +9.	Baseline of lead-in study to Week 52 of treatment
Change From Baseline in St George's Respiratory Questionnaire (SGRQ) Total Score Time Frame: Baseline of lead-in study to Week 52 of treatment	St George's Respiratory Questionnaire (SGRQ) measures COPD-specific health outcomes and consists of 3 dimension scores (symptom, activity and impact). SGRQ total score is the sum of these scores and ranges from 0 (best health status) to 100 (worst health status).	Baseline of lead-in study to Week 52 of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

D'Urzo A, Rennard S, Kerwin E, Donohue JF, Lei A, Molins E, Leselbaum A. A randomised double-blind, placebo-controlled, long-term extension study of the efficacy, safety and tolerability of fixed-dose combinations of aclidinium/formoterol or monotherapy in the treatment of chronic obstructive pulmonary disease. Respir Med. 2017 Apr;125:39-48. doi: 10.1016/j.rmed.2017.02.008. Epub 2017 Feb 16.

Helpful Links

lac-md-36-synopsis

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2012

Primary Completion (Actual)

June 1, 2013

Study Completion (Actual)

June 1, 2013

Study Registration Dates

First Submitted

April 4, 2012

First Submitted That Met QC Criteria

April 4, 2012

First Posted (Estimate)

April 6, 2012

Study Record Updates

Last Update Posted (Actual)

April 21, 2017

Last Update Submitted That Met QC Criteria

March 9, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

LAC-MD-36

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Chronic Obstructive Pulmonary Disease Moderate | Acute Exacerbation of COPD | Chronic Obstructive Pulmonary Disease Severe
Cukurova University

Completed

Effect Of Ketamine Infusion In Patients With COPD Applied One Lung Ventilation

Anesthesia | Chronic Obstructive Pulmonary Disease Moderate | Lungcancer | Chronic Obstructive Pulmonary Disease Severe | Chronic Obstructive Pulmonary Disease Mild

Turkey
Taipei Medical University

Unknown

Effects of a Comprehensive Health Coaching Program in Advanced Chronic Obstructive Pulmonary Disease.

Chronic Obstructive Pulmonary Disease Severe | Chronic Obstructive Pulmonary Disease End Stage

Taiwan
Hopital Foch
Air Liquide SA

Recruiting

Exploration of the VOLATOLOM in the Stable Severe COPD (Chronic Obstructive Pulmonary Disease) (VOC-BPCO)

Chronic Obstructive Pulmonary Disease Severe

France
Fundación para la Investigación del Hospital Clínico...

Not yet recruiting

GOLD 0 - DLCO 1: A Look Beyond the Obstruction. Is Spirometry Enough for COPD (Chronic Obstructive Pulmonary Disease) Screening?

COPD, Chronic Obstructive Pulmonary Disease

Spain
Canandaigua VA Medical Center

Recruiting

Manual Therapy in Addition to Pulmonary Rehabilitation in Moderate Chronic Obstructive Pulmonary Disease.

Chronic Obstructive Pulmonary Disease Moderate

United States

Clinical Trials on Placebo

Galderma R&D

Completed

Effect of CD07805/47 Gel in Rosacea Flushing

Rosacea

Germany
SamA Pharmaceutical Co., Ltd

Unknown

Clinical Trials to Assess the Efficacy and Safety of HLIM

Acute Bronchitis | Acute Upper Respiratory Tract Infection

Korea, Republic of
National Institute on Drug Abuse (NIDA)

Completed

Effects of Cannabis Administration Routes on Human Performance and Pharmacokinetics

Cannabis Use

United States
Akeso

Not yet recruiting

A Clinical Study of AK120 in Adolescents With Moderate-to-severe Atopic Dermatitis

Atopic Dermatitis

China
AstraZeneca
Parexel; Spandauer Damm 130; 14050; Berlin, Germany

Completed

Assessment of the Safety, Tolerability and Pharmacodynamics After Administration of One Dose of AZD8601 to Male Patients With Type II Diabetes Mellitus (T2DM)

Male Subjects With Type II Diabetes (T2DM)

Germany
Heptares Therapeutics Limited

Completed

Pharmacokinetics of Oral Capsule in Healthy Japanese vs. Caucasian Subjects (HTL0018318)

Pharmacokinetics | Safety Issues

United Kingdom
GlaxoSmithKline

Completed

A Clinical Study Assessing Critical Errors, Training/Teaching Time, and Preference Attributes of the ELLIPTA® Dry Powder Inhaler, in Comparison to Combinations of Dry Powder Inhalers Used to Provide Triple Therapy, in Patients With Chronic Obstructive Pulmonary Disease

Pulmonary Disease, Chronic Obstructive

United Kingdom, Netherlands
Chong Kun Dang Pharmaceutical

Unknown

Clinical Study to Evaluate the Efficacy and Safety of CKD-348(CKD-828, D326, D337) Tablet

Hypertension | Dyslipidemias

Korea, Republic of
Shijiazhuang Yiling Pharmaceutical Co. Ltd
Xuanwu Hospital, Beijing

Completed

Study on the Safety, Tolerance and Pharmacokinetics of Phenlarmide Tablets

Parkinson Disease

China
GlaxoSmithKline

Completed

A Study to Investigate the Safety, Tolerability and Pharmacokinetics of Oral and Intravenous GSK1322322 in Healthy Subjects

Infections, Bacterial

United States

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)

Study Overview

Status

Conditions

Intervention / Treatment

Study Type

Enrollment (Actual)

Phase

Contacts and Locations

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Genders Eligible for Study

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Other Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Publications and helpful links

General Publications

Helpful Links

Study record dates

Study Major Dates

Study Start

Primary Completion (Actual)

Study Completion (Actual)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Estimate)

Study Record Updates

Last Update Posted (Actual)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Clinical Trials on Chronic Obstructive Pulmonary Disease

Clinical Trials on Placebo

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