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)
Primary Purpose
Chronic Obstructive Pulmonary Disease
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Aclidinium bromide/formoterol Fixed-Dose Combination (FDC)
Aclidinium bromide/formoterol Fixed-Dose Combination (FDC)
Aclidinium bromide
Formoterol Fumarate
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring COPD, Chronic Obstructive Pulmonary Disease, Chronic Bronchitis, Emphysema, Airflow Obstruction, Chronic, Chronic Airflow Obstruction, Chronic Obstructive Airway Disease, Chronic Obstructive Lung Disease
Eligibility 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
Sites / Locations
- Forest Investigative Site 1827
- Forest Investigative Site 1920
- Forest Investigative Site 1162
- Forest Investigative Site 1493
- Forest Investigative Site 1937
- Forest Investigative Site 1824
- Forest Investigative Site 2088
- Forest Investigative Site 1918
- Forest Investigative Site 0909
- Forest Investigative Site 1379
- Forest Investigative Site 1822
- Forest Investigative Site 1483
- Forest Investigative Site 1156
- Forest Investigative Site 1871
- Forest Investigative Site 1873
- Forest Investigative Site 2064
- Forest Investigative Site 1427
- Forest Investigative Site 1866
- Forest Investigative Site 1125
- Forest Investigative Site 2009
- Forest Investigative Site 1374
- Forest Investigative Site 1813
- Forest Investigative Site 1883
- Forest Investigative Site 1380
- Forest Investigative Site 1137
- Forest Investigative Site 1327
- Forest Investigative Site 1976
- Forest Investigative Site 1821
- Forest Investigative Site 1154
- Forest Investigative Site 1944
- Forest Investigative Site 1364
- Forest Investigative Site 1152
- Forest Investigative Site 1875
- Forest Investigative Site 1811
- Forest Investigative Site 0670
- Forest Investigative Site 1516
- Forest Investigative Site 0990
- Forest Investigative Site 1513
- Forest Investigative Site 1854
- Forest Investigative Site 1882
- Forest Investigative Site 1543
- Forest Investigative Site 1416
- Forest Investigative Site 1167
- Forest Investigative Site 1432
- Forest Investigative Site 1808
- Forest Investigative Site 1819
- Forest Investigative Site 1950
- Forest Investigative Site 1145
- Forest Investigative Site 1094
- Forest Investigative Site 1803
- Forest Investigative Site 0974
- Forest Investigative Site 1817
- Forest Investigative Site 1874
- Forest Investigative Site 2082
- Forest Investigative Site 2053
- Forest Investigative Site 2047
- Forest Investigative Site 1185
- Forest Investigative Site 1860
- Forest Investigative Site 1900
- Forest Investigative Site 0987
- Forest Investigative Site 1828
- Forest Investigative Site 1830
- Forest Investigative Site 2089
- Forest Investigative Site 0679
- Forest Investigative Site 1858
- Forest Investigative Site 1095
- Forest Investigative Site 1912
- Forest Investigative Site 2051
- Forest Investigative Site 2033
- Forest Investigative Site 2085
- Forest Investigative Site 0539
- Forest Investigative Site 1478
- Forest Investigative Site 1519
- Forest Investigative Site 1430
- Forest Investigative Site 1812
- Forest Investigative Site 1814
- Forest Investigative Site 1924
- Forest Investigative Site 1872
- Forest Investigative Site 1570
- Forest Investigative Site 1852
- Forest Investigative Site 1431
- Forest Investigative Site 1892
- Forest Investigative Site 1342
- Forest Investigative Site 1487
- Forest Investigative Site 1128
- Forest Investigative Site 1527
- Forest Investigative Site 2041
- Forest Investigative Site 1124
- Forest Investigative Site 1619
- Forest Investigative Site 1118
- Forest Investigative Site 1884
- Forest Investigative Site 1602
- Forest Investigative Site 1587
- Forest Investigative Site 1856
- Forest Investigative Site 1867
- Forest Investigative Site 2079
- Forest Investigative Site 1399
- Forest Investigative Site 1599
- Forest Investigative Site 1831
- Forest Investigative Site 1400
- Forest Investigative Site 1609
- Forest Investigative Site 1948
- Forest Investigative Site 1815
- Forest Investigative Site 1363
- Forest Investigative Site 1907
- Forest Investigative Site 1911
- Forest Investigative Site 1908
- Forest Investigative Site 1804
- Forest Investigative Site 1807
- Forest Investigative Site 1834
- Forest Investigative Site 1562
- Forest Investigative Site 1559
- Forest Investigative Site 1923
- Forest Investigative Site 1949
- Forest Investigative Site 1151
- Forest Investigative Site 1489
- Forest Investigative Site 550
- Forest Investigative Site 1425
- Forest Investigative Site 2098
- Forest Investigative Site 1392
- Forest Investigative Site 2035
- Forest Investigative Site 1366
- Forest Investigative Site 1153
- Forest Investigative Site 1823
- Forest Investigative Site 1891
- Forest Investigative Site 1134
- Forest Investigative Site 1885
- Forest Investigative Site 1806
- Forest Investigative Site 2028
- Forest Investigative Site 1903
- Forest Investigative Site 1361
- Forest Investigative Site 1433
- Forest Investigative Site 2090
- Forest Investigative Site 1530
- Forest Investigative Site 1393
- Forest Investigative Site 1915
- Forest Investigative Site 1889
- Forest Investigative Site 2043
- Forest Investigative Site 1833
- Forest Investigative Site 1820
- Forest Investigative Site 1423
- Forest Investigative Site 1899
- Forest Investigative Site 1443
- Forest Investigative Site 1863
- Forest Investigative Site 1146
- Forest Investigative Site 1449
- Forest Investigative Site 1862
- Forest Investigative Site 1832
- Forest Investigative Site 1089
- Forest Investigative Site 2072
- Forest Investigative Site 1905
- Forest Investigative Site 1802
- Forest Investigative Site 1914
- Forest Investigative Site 1913
- Forest Investigative Site 1121
- Forest Investigative Site 1957
- Forest Investigative Site 1526
- Forest Investigative Site 1440
- Forest Investigative Site 1879
- Forest Investigative Site 1861
- Forest Investigative Site 1816
- Forest Investigative Site 1890
- Forest Investigative Site 1332
- Forest Investigative Site 2012
- Forest Investigative Site 1951
- Forest Investigative Site 1091
- Forest Investigative Site 1826
- Forest Investigative Site 1895
- Forest Investigative Site 1936
- Forest Investigative Site 1330
- Forest Investigative Site 1945
- Forest Investigative Site 1404
- Forest Investigative Site 1120
- Forest Investigative Site 1977
- Forest Investigative Site 1878
- Forest Investigative Site 1573
- Forest Investigative Site 0988
- Forest Investigative Site 1870
- Forest Investigative Site 1555
- Forest Investigative Site 1991
- Forest Investigative Site 1987
- Forest Investigative Site 1973
- Forest Investigative Site 2253
- Forest Investigative Site 1981
- Forest Investigative Site 1990
- Forest Investigative Site 2251
- Forest Investigative Site 2250
- Forest Investigative Site 1972
- Forest Investigative Site 1986
- Forest Investigative Site 1985
- Forest Investigative Site 1904
- Forest Investigative Site 905
- Forest Investigative Site 0976
- Forest Investigative Site 1877
- Forest Investigative Site 1896
- Forest Investigative Site 1171
- Forest Investigative Site 2203
- Forest Investigative Site 1952
- Forest Investigative Site 0943
- Forest Investigative Site 1859
- Forest Investigative Site 1027
- Forest Investigative Site 1970
- Forest Investigative Site 1967
- Forest Investigative Site 1964
- Forest Investigative Site 1968
- Forest Investigative Site 1965
- Forest Investigative Site 1980
- Forest Investigative Site 1025
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Experimental
Experimental
Active Comparator
Active Comparator
Placebo Comparator
Arm Label
1
2
3
4
5
Arm Description
Aclidinium bromide/formoterol Fixed-Dose Combination (FDC) high dose
Aclidinium bromide/formoterol Fixed-Dose Combination (FDC) low dose
Aclidinium bromide 400 μg
Formoterol Fumarate 12 μg
Placebo
Outcomes
Primary Outcome Measures
Percentage of Patients to Experience Any Treatment-emergent Adverse Event
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
Percentage of Patients to Experience Potentially Clinically Significant Post-baseline Clinical Laboratory Values for Hematology, Chemistry or Urinalysis
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
Percentage of Patients to Experience a Potentially Significant Post-baseline 12-lead ECG Value
Percentage of Patients to Experience Potentially Clinically Significant Post-baseline Vital Signs (Pulse Rate, Systolic or Diastolic Blood Pressure or Weight)
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01572792
Brief Title
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)
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)
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
April 2012 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
June 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
COPD, Chronic Obstructive Pulmonary Disease, Chronic Bronchitis, Emphysema, Airflow Obstruction, Chronic, Chronic Airflow Obstruction, Chronic Obstructive Airway Disease, Chronic Obstructive Lung Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
921 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Aclidinium bromide/formoterol Fixed-Dose Combination (FDC) high dose
Arm Title
2
Arm Type
Experimental
Arm Description
Aclidinium bromide/formoterol Fixed-Dose Combination (FDC) low dose
Arm Title
3
Arm Type
Active Comparator
Arm Description
Aclidinium bromide 400 μg
Arm Title
4
Arm Type
Active Comparator
Arm Description
Formoterol Fumarate 12 μg
Arm Title
5
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
Aclidinium bromide/formoterol Fixed-Dose Combination (FDC)
Intervention Description
Inhaled Aclidinium bromide/formoterol Fixed-Dose Combination (FDC) high dose, twice per day
Intervention Type
Drug
Intervention Name(s)
Aclidinium bromide/formoterol Fixed-Dose Combination (FDC)
Intervention Description
Inhaled Aclidinium bromide/formoterol Fixed-Dose Combination (FDC) low dose, twice per day
Intervention Type
Drug
Intervention Name(s)
Aclidinium bromide
Intervention Description
Inhaled Aclidinium bromide 400 μg, twice per day
Intervention Type
Drug
Intervention Name(s)
Formoterol Fumarate
Intervention Description
Inhaled Formoterol Fumarate 12 μg, twice per day
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Inhaled dose-matched placebo, twice per day
Primary Outcome Measure Information:
Title
Percentage of Patients to Experience Any Treatment-emergent Adverse Event
Description
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
Time Frame
Baseline of lead-in study to follow-up call 14±3 days after last dose of investigational product (up to Week 52)
Secondary Outcome Measure Information:
Title
Percentage of Patients to Experience Potentially Clinically Significant Post-baseline Clinical Laboratory Values for Hematology, Chemistry or Urinalysis
Description
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
Time Frame
Baseline of lead-in study to end of treatment (up to Week 52)
Title
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)
Title
Percentage of Patients to Experience Potentially Clinically Significant Post-baseline Vital Signs (Pulse Rate, Systolic or Diastolic Blood Pressure or Weight)
Description
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
Time Frame
Baseline of lead-in study to end of treatment (up to Week 52)
Other Pre-specified Outcome Measures:
Title
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
Title
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
Title
Transition Dyspnea Index (TDI) Focal Score at End of Study
Description
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.
Time Frame
Baseline of lead-in study to Week 52 of treatment
Title
Change From Baseline in St George's Respiratory Questionnaire (SGRQ) Total Score
Description
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).
Time Frame
Baseline of lead-in study to Week 52 of treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Esther Garcia, MD
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
Facility Information:
Facility Name
Forest Investigative Site 1827
City
Anniston
State/Province
Alabama
ZIP/Postal Code
36207
Country
United States
Facility Name
Forest Investigative Site 1920
City
Athens
State/Province
Alabama
ZIP/Postal Code
35611
Country
United States
Facility Name
Forest Investigative Site 1162
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35209
Country
United States
Facility Name
Forest Investigative Site 1493
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35209
Country
United States
Facility Name
Forest Investigative Site 1937
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35216
Country
United States
Facility Name
Forest Investigative Site 1824
City
Gulf Shores
State/Province
Alabama
ZIP/Postal Code
36542
Country
United States
Facility Name
Forest Investigative Site 2088
City
Jasper
State/Province
Alabama
ZIP/Postal Code
35501
Country
United States
Facility Name
Forest Investigative Site 1918
City
Scottsboro
State/Province
Alabama
ZIP/Postal Code
35768
Country
United States
Facility Name
Forest Investigative Site 0909
City
Glendale
State/Province
Arizona
ZIP/Postal Code
85306
Country
United States
Facility Name
Forest Investigative Site 1379
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85018
Country
United States
Facility Name
Forest Investigative Site 1822
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Facility Name
Forest Investigative Site 1483
City
Buena Park
State/Province
California
ZIP/Postal Code
90620
Country
United States
Facility Name
Forest Investigative Site 1156
City
Fresno
State/Province
California
ZIP/Postal Code
93726
Country
United States
Facility Name
Forest Investigative Site 1871
City
Lincoln
State/Province
California
ZIP/Postal Code
95648
Country
United States
Facility Name
Forest Investigative Site 1873
City
Los Angeles
State/Province
California
ZIP/Postal Code
90073
Country
United States
Facility Name
Forest Investigative Site 2064
City
Riverside
State/Province
California
ZIP/Postal Code
92506
Country
United States
Facility Name
Forest Investigative Site 1427
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
Forest Investigative Site 1866
City
Sacramento
State/Province
California
ZIP/Postal Code
95842
Country
United States
Facility Name
Forest Investigative Site 1125
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Forest Investigative Site 2009
City
San Diego
State/Province
California
ZIP/Postal Code
92120
Country
United States
Facility Name
Forest Investigative Site 1374
City
Torrance
State/Province
California
ZIP/Postal Code
90505
Country
United States
Facility Name
Forest Investigative Site 1813
City
Tustin
State/Province
California
ZIP/Postal Code
92780
Country
United States
Facility Name
Forest Investigative Site 1883
City
Vista
State/Province
California
ZIP/Postal Code
92083
Country
United States
Facility Name
Forest Investigative Site 1380
City
Golden
State/Province
Colorado
ZIP/Postal Code
80401
Country
United States
Facility Name
Forest Investigative Site 1137
City
Pueblo
State/Province
Colorado
ZIP/Postal Code
81001
Country
United States
Facility Name
Forest Investigative Site 1327
City
Wheat Ridge
State/Province
Colorado
ZIP/Postal Code
80033
Country
United States
Facility Name
Forest Investigative Site 1976
City
Waterbury
State/Province
Connecticut
ZIP/Postal Code
06708
Country
United States
Facility Name
Forest Investigative Site 1821
City
Bay Pines
State/Province
Florida
ZIP/Postal Code
33744
Country
United States
Facility Name
Forest Investigative Site 1154
City
Brandon
State/Province
Florida
ZIP/Postal Code
33511
Country
United States
Facility Name
Forest Investigative Site 1944
City
Brandon
State/Province
Florida
ZIP/Postal Code
33511
Country
United States
Facility Name
Forest Investigative Site 1364
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33756
Country
United States
Facility Name
Forest Investigative Site 1152
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33765
Country
United States
Facility Name
Forest Investigative Site 1875
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33765
Country
United States
Facility Name
Forest Investigative Site 1811
City
Covington
State/Province
Florida
ZIP/Postal Code
70433
Country
United States
Facility Name
Forest Investigative Site 0670
City
DeLand
State/Province
Florida
ZIP/Postal Code
32720
Country
United States
Facility Name
Forest Investigative Site 1516
City
Edgewater
State/Province
Florida
ZIP/Postal Code
32132
Country
United States
Facility Name
Forest Investigative Site 0990
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33316
Country
United States
Facility Name
Forest Investigative Site 1513
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33012
Country
United States
Facility Name
Forest Investigative Site 1854
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33012
Country
United States
Facility Name
Forest Investigative Site 1882
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33024
Country
United States
Facility Name
Forest Investigative Site 1543
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
Facility Name
Forest Investigative Site 1416
City
Kissimmee
State/Province
Florida
ZIP/Postal Code
34741
Country
United States
Facility Name
Forest Investigative Site 1167
City
Melbourne
State/Province
Florida
ZIP/Postal Code
32935
Country
United States
Facility Name
Forest Investigative Site 1432
City
Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Facility Name
Forest Investigative Site 1808
City
N. Miami
State/Province
Florida
ZIP/Postal Code
33179
Country
United States
Facility Name
Forest Investigative Site 1819
City
Naples
State/Province
Florida
ZIP/Postal Code
34119
Country
United States
Facility Name
Forest Investigative Site 1950
City
Oldsmar
State/Province
Florida
ZIP/Postal Code
34677
Country
United States
Facility Name
Forest Investigative Site 1145
City
Ormond Beach
State/Province
Florida
ZIP/Postal Code
32174
Country
United States
Facility Name
Forest Investigative Site 1094
City
Panama City
State/Province
Florida
ZIP/Postal Code
32405
Country
United States
Facility Name
Forest Investigative Site 1803
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
32028
Country
United States
Facility Name
Forest Investigative Site 0974
City
Pensacola
State/Province
Florida
ZIP/Postal Code
32504
Country
United States
Facility Name
Forest Investigative Site 1817
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34233
Country
United States
Facility Name
Forest Investigative Site 1874
City
St. Petersburg
State/Province
Florida
ZIP/Postal Code
33704
Country
United States
Facility Name
Forest Investigative Site 2082
City
Tamarac
State/Province
Florida
ZIP/Postal Code
33321
Country
United States
Facility Name
Forest Investigative Site 2053
City
Tampa
State/Province
Florida
ZIP/Postal Code
33603
Country
United States
Facility Name
Forest Investigative Site 2047
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Facility Name
Forest Investigative Site 1185
City
Winter Park
State/Province
Florida
ZIP/Postal Code
32789
Country
United States
Facility Name
Forest Investigative Site 1860
City
Winter Park
State/Province
Florida
ZIP/Postal Code
32792
Country
United States
Facility Name
Forest Investigative Site 1900
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30312
Country
United States
Facility Name
Forest Investigative Site 0987
City
Austell
State/Province
Georgia
ZIP/Postal Code
30106
Country
United States
Facility Name
Forest Investigative Site 1828
City
Canton
State/Province
Georgia
ZIP/Postal Code
30114
Country
United States
Facility Name
Forest Investigative Site 1830
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30066
Country
United States
Facility Name
Forest Investigative Site 2089
City
Woodstock
State/Province
Georgia
ZIP/Postal Code
30189
Country
United States
Facility Name
Forest Investigative Site 0679
City
Coeur d Alene
State/Province
Idaho
ZIP/Postal Code
83814
Country
United States
Facility Name
Forest Investigative Site 1858
City
Eagle
State/Province
Idaho
ZIP/Postal Code
83616
Country
United States
Facility Name
Forest Investigative Site 1095
City
Normal
State/Province
Illinois
ZIP/Postal Code
61761
Country
United States
Facility Name
Forest Investigative Site 1912
City
Normal
State/Province
Illinois
ZIP/Postal Code
61761
Country
United States
Facility Name
Forest Investigative Site 2051
City
River Forest
State/Province
Illinois
ZIP/Postal Code
60305
Country
United States
Facility Name
Forest Investigative Site 2033
City
Bowling Green
State/Province
Kentucky
ZIP/Postal Code
42101
Country
United States
Facility Name
Forest Investigative Site 2085
City
Fort Mitchell
State/Province
Kentucky
ZIP/Postal Code
41017
Country
United States
Facility Name
Forest Investigative Site 0539
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40504
Country
United States
Facility Name
Forest Investigative Site 1478
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40217
Country
United States
Facility Name
Forest Investigative Site 1519
City
Owensboro
State/Province
Kentucky
ZIP/Postal Code
42303
Country
United States
Facility Name
Forest Investigative Site 1430
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70115
Country
United States
Facility Name
Forest Investigative Site 1812
City
Opelousas
State/Province
Louisiana
ZIP/Postal Code
70570
Country
United States
Facility Name
Forest Investigative Site 1814
City
Bangor
State/Province
Maine
ZIP/Postal Code
04401
Country
United States
Facility Name
Forest Investigative Site 1924
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21237
Country
United States
Facility Name
Forest Investigative Site 1872
City
Wheaton
State/Province
Maryland
ZIP/Postal Code
20902
Country
United States
Facility Name
Forest Investigative Site 1570
City
Fall River
State/Province
Massachusetts
ZIP/Postal Code
02720
Country
United States
Facility Name
Forest Investigative Site 1852
City
Fall River
State/Province
Massachusetts
ZIP/Postal Code
02720
Country
United States
Facility Name
Forest Investigative Site 1431
City
No. Dartmouth
State/Province
Massachusetts
ZIP/Postal Code
02747
Country
United States
Facility Name
Forest Investigative Site 1892
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48106
Country
United States
Facility Name
Forest Investigative Site 1342
City
Stevensville
State/Province
Michigan
ZIP/Postal Code
49127
Country
United States
Facility Name
Forest Investigative Site 1487
City
Troy
State/Province
Michigan
ZIP/Postal Code
48085
Country
United States
Facility Name
Forest Investigative Site 1128
City
Edina
State/Province
Minnesota
ZIP/Postal Code
55435
Country
United States
Facility Name
Forest Investigative Site 1527
City
Fridley
State/Province
Minnesota
ZIP/Postal Code
55432
Country
United States
Facility Name
Forest Investigative Site 2041
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55402
Country
United States
Facility Name
Forest Investigative Site 1124
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55407
Country
United States
Facility Name
Forest Investigative Site 1619
City
Plymouth
State/Province
Minnesota
ZIP/Postal Code
55441
Country
United States
Facility Name
Forest Investigative Site 1118
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Forest Investigative Site 1884
City
Olive Branch
State/Province
Mississippi
ZIP/Postal Code
38654
Country
United States
Facility Name
Forest Investigative Site 1602
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64128
Country
United States
Facility Name
Forest Investigative Site 1587
City
N. Chesterfield
State/Province
Missouri
ZIP/Postal Code
63017
Country
United States
Facility Name
Forest Investigative Site 1856
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65807
Country
United States
Facility Name
Forest Investigative Site 1867
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65807
Country
United States
Facility Name
Forest Investigative Site 2079
City
St. Charles
State/Province
Missouri
ZIP/Postal Code
63301
Country
United States
Facility Name
Forest Investigative Site 1399
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Forest Investigative Site 1599
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Forest Investigative Site 1831
City
Bozeman
State/Province
Montana
ZIP/Postal Code
59718
Country
United States
Facility Name
Forest Investigative Site 1400
City
Missoula
State/Province
Montana
ZIP/Postal Code
59808
Country
United States
Facility Name
Forest Investigative Site 1609
City
Bellevue
State/Province
Nebraska
ZIP/Postal Code
68123
Country
United States
Facility Name
Forest Investigative Site 1948
City
Fremont
State/Province
Nebraska
ZIP/Postal Code
68025
Country
United States
Facility Name
Forest Investigative Site 1815
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68510
Country
United States
Facility Name
Forest Investigative Site 1363
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
Facility Name
Forest Investigative Site 1907
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68130
Country
United States
Facility Name
Forest Investigative Site 1911
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68131
Country
United States
Facility Name
Forest Investigative Site 1908
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68134
Country
United States
Facility Name
Forest Investigative Site 1804
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68144
Country
United States
Facility Name
Forest Investigative Site 1807
City
Henderson
State/Province
Nevada
ZIP/Postal Code
89052
Country
United States
Facility Name
Forest Investigative Site 1834
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89128
Country
United States
Facility Name
Forest Investigative Site 1562
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89183
Country
United States
Facility Name
Forest Investigative Site 1559
City
Cherry Hill
State/Province
New Jersey
ZIP/Postal Code
08003
Country
United States
Facility Name
Forest Investigative Site 1923
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
Forest Investigative Site 1949
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87106
Country
United States
Facility Name
Forest Investigative Site 1151
City
Great Neck
State/Province
New York
ZIP/Postal Code
11021
Country
United States
Facility Name
Forest Investigative Site 1489
City
Larchmont
State/Province
New York
ZIP/Postal Code
10538
Country
United States
Facility Name
Forest Investigative Site 550
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Facility Name
Forest Investigative Site 1425
City
New York
State/Province
New York
ZIP/Postal Code
10028
Country
United States
Facility Name
Forest Investigative Site 2098
City
Rochester
State/Province
New York
ZIP/Postal Code
14618
Country
United States
Facility Name
Forest Investigative Site 1392
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28277
Country
United States
Facility Name
Forest Investigative Site 2035
City
Elizabeth City
State/Province
North Carolina
ZIP/Postal Code
27909
Country
United States
Facility Name
Forest Investigative Site 1366
City
High Point
State/Province
North Carolina
ZIP/Postal Code
27262
Country
United States
Facility Name
Forest Investigative Site 1153
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27607
Country
United States
Facility Name
Forest Investigative Site 1823
City
Salisbury
State/Province
North Carolina
ZIP/Postal Code
28144
Country
United States
Facility Name
Forest Investigative Site 1891
City
Cadiz
State/Province
Ohio
ZIP/Postal Code
43907
Country
United States
Facility Name
Forest Investigative Site 1134
City
Canton
State/Province
Ohio
ZIP/Postal Code
44718
Country
United States
Facility Name
Forest Investigative Site 1885
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Forest Investigative Site 1806
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45231
Country
United States
Facility Name
Forest Investigative Site 2028
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States
Facility Name
Forest Investigative Site 1903
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45255
Country
United States
Facility Name
Forest Investigative Site 1361
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43207
Country
United States
Facility Name
Forest Investigative Site 1433
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43213
Country
United States
Facility Name
Forest Investigative Site 2090
City
Sylvania
State/Province
Ohio
ZIP/Postal Code
43560
Country
United States
Facility Name
Forest Investigative Site 1530
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43608
Country
United States
Facility Name
Forest Investigative Site 1393
City
Zanesville
State/Province
Ohio
ZIP/Postal Code
43701
Country
United States
Facility Name
Forest Investigative Site 1915
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73103
Country
United States
Facility Name
Forest Investigative Site 1889
City
Bend
State/Province
Oregon
ZIP/Postal Code
97701
Country
United States
Facility Name
Forest Investigative Site 2043
City
Medford
State/Province
Oregon
ZIP/Postal Code
97504
Country
United States
Facility Name
Forest Investigative Site 1833
City
Altoona
State/Province
Pennsylvania
ZIP/Postal Code
16601
Country
United States
Facility Name
Forest Investigative Site 1820
City
Downington
State/Province
Pennsylvania
ZIP/Postal Code
19335
Country
United States
Facility Name
Forest Investigative Site 1423
City
Erie
State/Province
Pennsylvania
ZIP/Postal Code
16508
Country
United States
Facility Name
Forest Investigative Site 1899
City
Langhorne
State/Province
Pennsylvania
ZIP/Postal Code
19047
Country
United States
Facility Name
Forest Investigative Site 1443
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Forest Investigative Site 1863
City
Phoenixville
State/Province
Pennsylvania
ZIP/Postal Code
19460
Country
United States
Facility Name
Forest Investigative Site 1146
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15243
Country
United States
Facility Name
Forest Investigative Site 1449
City
Tipton
State/Province
Pennsylvania
ZIP/Postal Code
16684
Country
United States
Facility Name
Forest Investigative Site 1862
City
Uniontown
State/Province
Pennsylvania
ZIP/Postal Code
15473
Country
United States
Facility Name
Forest Investigative Site 1832
City
Cumberland
State/Province
Rhode Island
ZIP/Postal Code
02864
Country
United States
Facility Name
Forest Investigative Site 1089
City
East Providence
State/Province
Rhode Island
ZIP/Postal Code
02914
Country
United States
Facility Name
Forest Investigative Site 2072
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29406
Country
United States
Facility Name
Forest Investigative Site 1905
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29407
Country
United States
Facility Name
Forest Investigative Site 1802
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29412
Country
United States
Facility Name
Forest Investigative Site 1914
City
Fort Mill
State/Province
South Carolina
ZIP/Postal Code
29707
Country
United States
Facility Name
Forest Investigative Site 1913
City
Gaffney
State/Province
South Carolina
ZIP/Postal Code
29340
Country
United States
Facility Name
Forest Investigative Site 1121
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29303
Country
United States
Facility Name
Forest Investigative Site 1957
City
Brentwood
State/Province
Tennessee
ZIP/Postal Code
37027
Country
United States
Facility Name
Forest Investigative Site 1526
City
Fayetteville
State/Province
Tennessee
ZIP/Postal Code
37334
Country
United States
Facility Name
Forest Investigative Site 1440
City
Arlington
State/Province
Texas
ZIP/Postal Code
76012
Country
United States
Facility Name
Forest Investigative Site 1879
City
Boerne
State/Province
Texas
ZIP/Postal Code
78006
Country
United States
Facility Name
Forest Investigative Site 1861
City
Carrollton
State/Province
Texas
ZIP/Postal Code
75007
Country
United States
Facility Name
Forest Investigative Site 1816
City
Corsicana
State/Province
Texas
ZIP/Postal Code
75110
Country
United States
Facility Name
Forest Investigative Site 1890
City
Dallas
State/Province
Texas
ZIP/Postal Code
75220
Country
United States
Facility Name
Forest Investigative Site 1332
City
El Paso
State/Province
Texas
ZIP/Postal Code
79903
Country
United States
Facility Name
Forest Investigative Site 2012
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
Forest Investigative Site 1951
City
Houston
State/Province
Texas
ZIP/Postal Code
77070
Country
United States
Facility Name
Forest Investigative Site 1091
City
McKinney
State/Province
Texas
ZIP/Postal Code
75069
Country
United States
Facility Name
Forest Investigative Site 1826
City
Plano
State/Province
Texas
ZIP/Postal Code
75001
Country
United States
Facility Name
Forest Investigative Site 1895
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78212
Country
United States
Facility Name
Forest Investigative Site 1936
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84102
Country
United States
Facility Name
Forest Investigative Site 1330
City
South Burlington
State/Province
Vermont
ZIP/Postal Code
05403
Country
United States
Facility Name
Forest Investigative Site 1945
City
Newport News
State/Province
Virginia
ZIP/Postal Code
23606
Country
United States
Facility Name
Forest Investigative Site 1404
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Facility Name
Forest Investigative Site 1120
City
Bellingham
State/Province
Washington
ZIP/Postal Code
98225
Country
United States
Facility Name
Forest Investigative Site 1977
City
Spokane
State/Province
Washington
ZIP/Postal Code
99202
Country
United States
Facility Name
Forest Investigative Site 1878
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States
Facility Name
Forest Investigative Site 1573
City
Spokane
State/Province
Washington
ZIP/Postal Code
99216
Country
United States
Facility Name
Forest Investigative Site 0988
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
Forest Investigative Site 1870
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
Forest Investigative Site 1555
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26505
Country
United States
Facility Name
Forest Investigative Site 1991
City
New Lambton
State/Province
New South Wales
ZIP/Postal Code
2305
Country
Australia
Facility Name
Forest Investigative Site 1987
City
Redcliffe
State/Province
Queensland
ZIP/Postal Code
4020
Country
Australia
Facility Name
Forest Investigative Site 1973
City
Woolloongabba
State/Province
Queensland
ZIP/Postal Code
4102
Country
Australia
Facility Name
Forest Investigative Site 2253
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
Forest Investigative Site 1981
City
Bedford Park
State/Province
South Australia
ZIP/Postal Code
5042
Country
Australia
Facility Name
Forest Investigative Site 1990
City
Daw Park
State/Province
South Australia
ZIP/Postal Code
5041
Country
Australia
Facility Name
Forest Investigative Site 2251
City
Toorak Gardens
State/Province
South Australia
ZIP/Postal Code
5065
Country
Australia
Facility Name
Forest Investigative Site 2250
City
Clayton
State/Province
Victoria
ZIP/Postal Code
3168
Country
Australia
Facility Name
Forest Investigative Site 1972
City
Fitzroy
State/Province
Victoria
ZIP/Postal Code
3065
Country
Australia
Facility Name
Forest Investigative Site 1986
City
Geelong
State/Province
Victoria
ZIP/Postal Code
3220
Country
Australia
Facility Name
Forest Investigative Site 1985
City
Parkville
State/Province
Victoria
ZIP/Postal Code
3050
Country
Australia
Facility Name
Forest Investigative Site 1904
City
Langley
State/Province
British Columbia
ZIP/Postal Code
V3A 4H9
Country
Canada
Facility Name
Forest Investigative Site 905
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1M9
Country
Canada
Facility Name
Forest Investigative Site 0976
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R2K 3S8
Country
Canada
Facility Name
Forest Investigative Site 1877
City
Sarina
State/Province
Ontario
ZIP/Postal Code
N7T 4X3
Country
Canada
Facility Name
Forest Investigative Site 1896
City
Sarnia
State/Province
Ontario
ZIP/Postal Code
N7T 4X3
Country
Canada
Facility Name
Forest Investigative Site 1171
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T 3A9
Country
Canada
Facility Name
Forest Investigative Site 2203
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M6H 3M2
Country
Canada
Facility Name
Forest Investigative Site 1952
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2R 1V6
Country
Canada
Facility Name
Forest Investigative Site 0943
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7N 0W8
Country
Canada
Facility Name
Forest Investigative Site 1859
City
Quebec
ZIP/Postal Code
G1V 4M6
Country
Canada
Facility Name
Forest Investigative Site 1027
City
Auckland
ZIP/Postal Code
1051
Country
New Zealand
Facility Name
Forest Investigative Site 1970
City
Christchurch
ZIP/Postal Code
8011
Country
New Zealand
Facility Name
Forest Investigative Site 1967
City
Dunedin
ZIP/Postal Code
9012
Country
New Zealand
Facility Name
Forest Investigative Site 1964
City
Dunedin
ZIP/Postal Code
9058
Country
New Zealand
Facility Name
Forest Investigative Site 1968
City
Hamilton
ZIP/Postal Code
3240
Country
New Zealand
Facility Name
Forest Investigative Site 1965
City
Tauranga
ZIP/Postal Code
3110
Country
New Zealand
Facility Name
Forest Investigative Site 1980
City
Tauranga
ZIP/Postal Code
3112
Country
New Zealand
Facility Name
Forest Investigative Site 1025
City
Wellington
ZIP/Postal Code
7366
Country
New Zealand
12. IPD Sharing Statement
Citations:
PubMed Identifier
28340861
Citation
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.
Results Reference
derived
Links:
URL
http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=4062&filename=lac-md-36-synopsis.pdf
Description
lac-md-36-synopsis
Learn more about this trial
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)
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