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Safety and Tolerability of Aclidinium Bromide/Formoterol Fumarate Compared With Formoterol Fumarate in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Aclidinium Bromide/Formoterol Fumarate
Formoterol Fumarate
Sponsored by
AstraZeneca
About
Eligibility
Locations
Arms
Outcomes
Full info

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

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Current or former cigarette smokers with a cigarette smoking history of at least 10 pack-years
  • A diagnosis of stable moderate to severe COPD and stable airway obstruction as defined by the Global Initiative for Chronic Obstructive Lung Disease guidelines and stable airway obstruction.

Exclusion Criteria:

  • Patients who have been hospitalized for an acute COPD exacerbation within three months prior to Visit 1
  • Any respiratory tract infection (including the upper respiratory tract) or COPD exacerbation in the six weeks before Visit 1.
  • Patients with any clinically significant respiratory conditions other than COPD
  • Clinical history that suggests that the patient has asthma as opposed to COPD
  • Chronic use of oxygen therapy ≥ 15 hours/day
  • Patients with clinically significant cardiovascular conditions
  • Patients with uncontrolled infection that may place the patient at risk resulting from human immunodeficiency virus (HIV), active hepatitis and/or patients with diagnosed active tuberculosis
  • Patients with a history of hypersensitivity reaction to inhaled anticholinergics,
  • Patients with Stage II hypertension, defined as systolic pressure of 160 and above, and/or diastolic pressure of 100 and above
  • Current diagnosis of cancer other than basal or squamous cell skin cancer

Sites / Locations

  • Forest Investigative Site 1162
  • Forest Investigative Site 1493
  • Forest Investigative Site 1620
  • Forest Investigative Site 1127
  • Forest Investigative Site 1613
  • Forest Investigative Site 1623
  • Forest Investigative Site 1582
  • Forest Investigative Site 1379
  • Forest Investigative Site 1581
  • Forest Investigative Site 1571
  • Forest Investigative Site 1596
  • Forest Investigative Site 1547
  • Forest Investigative Site 1088
  • Forest Investigative Site 1624
  • Forest Investigative Site 1927
  • Forest Investigative Site 1388
  • Forest Investigative Site 1503
  • Forest Investigative Site 1374
  • Forest Investigative Site 1331
  • Forest Investigative Site 2039
  • Forest Investigative Site 1597
  • Forest Investigative Site 1137
  • Forest Investigative Site 0892
  • Forest Investigative Site 2037
  • Forest Investigative Site 1327
  • Forest Investigative Site 2045
  • Forest Investigative Site 1589
  • Forest Investigative Site 1598
  • Forest Investigative Site 1154
  • Forest Investigative Site 1944
  • Forest Investigative Site 1152
  • Forest Investigative Site 1617
  • Forest Investigative Site 1959
  • Forest Investigative Site 1516
  • Forest Investigative Site 1403
  • Forest Investigative Site 1556
  • Forest Investigative Site 1542
  • Forest Investigative Site 0974
  • Forest Investigative Site 2047
  • Forest Investigative Site 1565
  • Forest Investigative Site 1851
  • Forest Investigative Site 0980
  • Forest Investigative Site 1567
  • Forest Investigative Site 1607
  • Forest Investigative Site 1409
  • Forest Investigative Site 2051
  • Forest Investigative Site 1604
  • Forest Investigative Site 1576
  • Forest Investigative Site 1549
  • Forest Investigative Site 2033
  • Forest Investigative Site 2085
  • Forest Investigative Site 1336
  • Forest Investigative Site 2024
  • Forest Investigative Site 1430
  • Forest Investigative Site 1360
  • Forest Investigative Site 1566
  • Forest Investigative Site 1333
  • Forest Investigative Site 1622
  • Forest Investigative Site 1590
  • Forest Investigative Site 1570
  • Forest Investigative Site 1546
  • Forest Investigative Site 1029
  • Forest Investigative Site 1595
  • Forest Investigative Site 1605
  • Forest Investigative Site 1527
  • Forest Investigative Site 1124
  • Forest Investigative Site 1619
  • Forest Investigative Site 1587
  • Forest Investigative Site 1572
  • Forest Investigative Site 1399
  • Forest Investigative Site 1599
  • Forest Investigative Site 1831
  • Forest Investigative Site 1400
  • Forest Investigative Site 1609
  • Forest Investigative Site 1616
  • Forest Investigative Site 1615
  • Forest Investigative Site 1562
  • Forest Investigative Site 1610
  • Forest Investigative Site 1558
  • Forest Investigative Site 1559
  • Forest Investigative Site 1394
  • Forest Investigative Site 2084
  • Forest Investigative Site 0972
  • Forest Investigative Site 1163
  • Forest Investigative Site 1425
  • Forest Investigative Site 1554
  • Forest Investigative Site 1563
  • Forest Investigative Site 1557
  • Forest Investigative Site 1588
  • Forest Investigative Site 1553
  • Forest Investigative Site 1550
  • Forest Investigative Site 1134
  • Forest Investigative Site 1594
  • Forest Investigative Site 2028
  • Forest Investigative Site 1541
  • Forest Investigative Site 1530
  • Forest Investigative Site 1393
  • Forest Investigative Site 1612
  • Forest Investigative Site 1575
  • Forest Investigative Site 1081
  • Forest Investigative Site 1580
  • Forest Investigative Site 1552
  • Forest Investigative Site 1574
  • Forest Investigative Site 1577
  • Forest Investigative Site 1126
  • Forest Investigative Site 1423
  • Forest Investigative Site 1504
  • Forest Investigative Site 1569
  • Forest Investigative Site 1548
  • Forest Investigative Site 1146
  • Forest Investigative Site 1560
  • Forest Investigative Site 1449
  • Forest Investigative Site 1564
  • Forest Investigative Site 1144
  • Forest Investigative Site 2072
  • Forest Investigative Site 1568
  • Forest Investigative Site 1506
  • Forest Investigative Site 1601
  • Forest Investigative Site 0900
  • Forest Investigative Site 1450
  • Forest Investigative Site 1365
  • Forest Investigative Site 1440
  • Forest Investigative Site 1954
  • Forest Investigative Site 1155
  • Forest Investigative Site 1328
  • Forest Investigative Site 1332
  • Forest Investigative Site 2012
  • Forest Investigative Site 1902
  • Forest Investigative Site 1498
  • Forest Investigative Site 1614
  • Forest Investigative Site 1906
  • Forest Investigative Site 2004
  • Forest Investigative Site 1600
  • Forest Investigative Site 1480
  • Forest Investigative Site 1579
  • Forest Investigative Site 1142
  • Forest Investigative Site 1573

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

Inhaled aclidinium bromide 400 μg/formoterol fumarate 12 μg fixed dose combination (FDC), high dose twice per day

Inhaled formoterol fumarate 12 μg, twice per day

Outcomes

Primary Outcome Measures

Percentage of Patients to Experience at Least One Treatment-emergent Adverse Event (TEAE)
TEAEs were coded Version 16.0 of the Medical Dictionary for Regulatory Activities (MedDRA)

Secondary Outcome Measures

Percentage of Patients to Experience Any Potentially Clinically Significant (PCS) Post-baseline Change in Clinical Laboratory Values for Hematology, Chemistry or Urinalysis at the End of the Study
<0.85 x lower limit of normal (LLN) or > 1.15 upper limit of normal (ULN) for hemoglobin, hematocrit, red blood cell, platelet, white blood cell, neutrophil and lymphocyte counts >1.15 × ULN for eosinophil, basophil and monocyte counts >1.15 x ULN for aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, gamma glutamyl transferase, total bilirubin, creatinine kinase, lactate dehydrogenase, blood urea nitrogen, creatinine, uric acid, total cholesterol, triglycerides <0.85 x LLN or >1.15 ULN for fasting glucose, calcium, phosphorus, total protein and albumin <0.95 x LLN or >1.05 x ULN for sodium, potassium and chloride Urinary blood, ketones or pH <0.85 x LLN or > 1.15 ULN
Percentage of Patients to Experience a Potentially Clinically Significant (PCS) Change in Pulse Rate, Systolic and Diastolic Blood Pressure
Systolic BP ≥180 mmHg and increase ≥20 mmHg from baseline or ≤90 mmHg and decrease ≥20 mmHg from baseline; Diastolic BP ≥105 mmHg and increase ≥15 mmHg from baseline or ≤50 mmHg and decrease ≥15 mmHg from baseline; Pulse rate ≥ 110 bpm and increase ≥ 15% from baseline or ≤ 50 bpm and decrease ≥15% from baseline
Percentage of Patients to Experience Potentially Clinically Significant Changes in ECG From Baseline
Potentially clinically significant changes were defined as listed in the table below for QT interval, QTcB, QTcF, QRS interval, PR interval and heart rate (HR)

Full Information

First Posted
September 19, 2011
Last Updated
April 3, 2017
Sponsor
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT01437540
Brief Title
Safety and Tolerability of Aclidinium Bromide/Formoterol Fumarate Compared With Formoterol Fumarate in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease
Official Title
A Long-Term, Randomized, Study of the Safety and Tolerability of a Fixed-Dose Combination of Aclidinium Bromide/Formoterol Fumarate Compared With Formoterol Fumarate in Patients With Moderate to Severe, Stable Chronic Obstructive Pulmonary Disease (COPD)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
September 19, 2011 (Actual)
Primary Completion Date
March 31, 2013 (Actual)
Study Completion Date
April 30, 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to assess the long-term safety and tolerability of inhaled aclidinium bromide/formoterol in patients with moderate to severe, stable chronic obstructive pulmonary disease (COPD).

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
590 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Inhaled aclidinium bromide 400 μg/formoterol fumarate 12 μg fixed dose combination (FDC), high dose twice per day
Arm Title
2
Arm Type
Active Comparator
Arm Description
Inhaled formoterol fumarate 12 μg, twice per day
Intervention Type
Drug
Intervention Name(s)
Aclidinium Bromide/Formoterol Fumarate
Intervention Description
Inhaled aclidinium bromide 400 μg/formoterol fumarate 12 μg, high dose twice per day
Intervention Type
Drug
Intervention Name(s)
Formoterol Fumarate
Intervention Description
Inhaled formoterol fumarate 12 μg, twice per day
Primary Outcome Measure Information:
Title
Percentage of Patients to Experience at Least One Treatment-emergent Adverse Event (TEAE)
Description
TEAEs were coded Version 16.0 of the Medical Dictionary for Regulatory Activities (MedDRA)
Time Frame
Up to study Week 56 ± 3 days
Secondary Outcome Measure Information:
Title
Percentage of Patients to Experience Any Potentially Clinically Significant (PCS) Post-baseline Change in Clinical Laboratory Values for Hematology, Chemistry or Urinalysis at the End of the Study
Description
<0.85 x lower limit of normal (LLN) or > 1.15 upper limit of normal (ULN) for hemoglobin, hematocrit, red blood cell, platelet, white blood cell, neutrophil and lymphocyte counts >1.15 × ULN for eosinophil, basophil and monocyte counts >1.15 x ULN for aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, gamma glutamyl transferase, total bilirubin, creatinine kinase, lactate dehydrogenase, blood urea nitrogen, creatinine, uric acid, total cholesterol, triglycerides <0.85 x LLN or >1.15 ULN for fasting glucose, calcium, phosphorus, total protein and albumin <0.95 x LLN or >1.05 x ULN for sodium, potassium and chloride Urinary blood, ketones or pH <0.85 x LLN or > 1.15 ULN
Time Frame
Up to study Week 52
Title
Percentage of Patients to Experience a Potentially Clinically Significant (PCS) Change in Pulse Rate, Systolic and Diastolic Blood Pressure
Description
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
Time Frame
Up to study Week 56 ± 3 days
Title
Percentage of Patients to Experience Potentially Clinically Significant Changes in ECG From Baseline
Description
Potentially clinically significant changes were defined as listed in the table below for QT interval, QTcB, QTcF, QRS interval, PR interval and heart rate (HR)
Time Frame
Up to study Week 56 ± 3 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Current or former cigarette smokers with a cigarette smoking history of at least 10 pack-years A diagnosis of stable moderate to severe COPD and stable airway obstruction as defined by the Global Initiative for Chronic Obstructive Lung Disease guidelines and stable airway obstruction. Exclusion Criteria: Patients who have been hospitalized for an acute COPD exacerbation within three months prior to Visit 1 Any respiratory tract infection (including the upper respiratory tract) or COPD exacerbation in the six weeks before Visit 1. Patients with any clinically significant respiratory conditions other than COPD Clinical history that suggests that the patient has asthma as opposed to COPD Chronic use of oxygen therapy ≥ 15 hours/day Patients with clinically significant cardiovascular conditions Patients with uncontrolled infection that may place the patient at risk resulting from human immunodeficiency virus (HIV), active hepatitis and/or patients with diagnosed active tuberculosis Patients with a history of hypersensitivity reaction to inhaled anticholinergics, Patients with Stage II hypertension, defined as systolic pressure of 160 and above, and/or diastolic pressure of 100 and above Current diagnosis of cancer other than basal or squamous cell skin cancer
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 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 1620
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35235
Country
United States
Facility Name
Forest Investigative Site 1127
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608
Country
United States
Facility Name
Forest Investigative Site 1613
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85224
Country
United States
Facility Name
Forest Investigative Site 1623
City
Peoria
State/Province
Arizona
ZIP/Postal Code
85381
Country
United States
Facility Name
Forest Investigative Site 1582
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85012
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 1581
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85020
Country
United States
Facility Name
Forest Investigative Site 1571
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85050
Country
United States
Facility Name
Forest Investigative Site 1596
City
Fort Smith
State/Province
Arkansas
ZIP/Postal Code
72901
Country
United States
Facility Name
Forest Investigative Site 1547
City
Encinitas
State/Province
California
ZIP/Postal Code
92024
Country
United States
Facility Name
Forest Investigative Site 1088
City
Lakewood
State/Province
California
ZIP/Postal Code
90712
Country
United States
Facility Name
Forest Investigative Site 1624
City
Los Angeles
State/Province
California
ZIP/Postal Code
90025
Country
United States
Facility Name
Forest Investigative Site 1927
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Forest Investigative Site 1388
City
Paramount
State/Province
California
ZIP/Postal Code
90723
Country
United States
Facility Name
Forest Investigative Site 1503
City
San Diego
State/Province
California
ZIP/Postal Code
92128
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 1331
City
Vista
State/Province
California
ZIP/Postal Code
92083
Country
United States
Facility Name
Forest Investigative Site 2039
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94598
Country
United States
Facility Name
Forest Investigative Site 1597
City
Boulder
State/Province
Colorado
ZIP/Postal Code
80304
Country
United States
Facility Name
Forest Investigative Site 1137
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80907
Country
United States
Facility Name
Forest Investigative Site 0892
City
Denver
State/Province
Colorado
ZIP/Postal Code
80206
Country
United States
Facility Name
Forest Investigative Site 2037
City
Fort Collins
State/Province
Colorado
ZIP/Postal Code
80528
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 2045
City
Wheat Ridge
State/Province
Colorado
ZIP/Postal Code
80033
Country
United States
Facility Name
Forest Investigative Site 1589
City
Norwalk
State/Province
Connecticut
ZIP/Postal Code
06851
Country
United States
Facility Name
Forest Investigative Site 1598
City
Stamford
State/Province
Connecticut
ZIP/Postal Code
06902
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 1152
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33765
Country
United States
Facility Name
Forest Investigative Site 1617
City
Debary
State/Province
Florida
ZIP/Postal Code
32713
Country
United States
Facility Name
Forest Investigative Site 1959
City
Debary
State/Province
Florida
ZIP/Postal Code
32713
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 1403
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33024
Country
United States
Facility Name
Forest Investigative Site 1556
City
Orlando
State/Province
Florida
ZIP/Postal Code
32822
Country
United States
Facility Name
Forest Investigative Site 1542
City
Ormond Beach
State/Province
Florida
ZIP/Postal Code
32174
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 2047
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Facility Name
Forest Investigative Site 1565
City
Venice
State/Province
Florida
ZIP/Postal Code
34292
Country
United States
Facility Name
Forest Investigative Site 1851
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30329
Country
United States
Facility Name
Forest Investigative Site 0980
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Forest Investigative Site 1567
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Forest Investigative Site 1607
City
Lawrenceville
State/Province
Georgia
ZIP/Postal Code
30046
Country
United States
Facility Name
Forest Investigative Site 1409
City
O'Fallon
State/Province
Illinois
ZIP/Postal Code
62269
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 1604
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62702
Country
United States
Facility Name
Forest Investigative Site 1576
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47713
Country
United States
Facility Name
Forest Investigative Site 1549
City
Council Bluffs
State/Province
Iowa
ZIP/Postal Code
51503
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
Crescent Springs
State/Province
Kentucky
ZIP/Postal Code
41017
Country
United States
Facility Name
Forest Investigative Site 1336
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40215
Country
United States
Facility Name
Forest Investigative Site 2024
City
Lafayette
State/Province
Louisiana
ZIP/Postal Code
70503
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 1360
City
Sunset
State/Province
Louisiana
ZIP/Postal Code
70584
Country
United States
Facility Name
Forest Investigative Site 1566
City
Auburn
State/Province
Maine
ZIP/Postal Code
04210
Country
United States
Facility Name
Forest Investigative Site 1333
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21236
Country
United States
Facility Name
Forest Investigative Site 1622
City
Columbia
State/Province
Maryland
ZIP/Postal Code
21044
Country
United States
Facility Name
Forest Investigative Site 1590
City
Towson
State/Province
Maryland
ZIP/Postal Code
21204
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 1546
City
Haverhill
State/Province
Massachusetts
ZIP/Postal Code
01830
Country
United States
Facility Name
Forest Investigative Site 1029
City
North Dartmouth
State/Province
Massachusetts
ZIP/Postal Code
02747
Country
United States
Facility Name
Forest Investigative Site 1595
City
Worcestor
State/Province
Massachusetts
ZIP/Postal Code
01605
Country
United States
Facility Name
Forest Investigative Site 1605
City
Traverse City
State/Province
Michigan
ZIP/Postal Code
49684
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 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 1587
City
Chesterfield
State/Province
Missouri
ZIP/Postal Code
63017
Country
United States
Facility Name
Forest Investigative Site 1572
City
Jefferson City
State/Province
Missouri
ZIP/Postal Code
65109
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 1616
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68506
Country
United States
Facility Name
Forest Investigative Site 1615
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68134
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 1610
City
Rochester
State/Province
New Hampshire
ZIP/Postal Code
03867
Country
United States
Facility Name
Forest Investigative Site 1558
City
Brick
State/Province
New Jersey
ZIP/Postal Code
08723
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 1394
City
Ocean
State/Province
New Jersey
ZIP/Postal Code
07712
Country
United States
Facility Name
Forest Investigative Site 2084
City
Summit
State/Province
New Jersey
ZIP/Postal Code
07901
Country
United States
Facility Name
Forest Investigative Site 0972
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11229
Country
United States
Facility Name
Forest Investigative Site 1163
City
New York
State/Province
New York
ZIP/Postal Code
10016
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 1554
City
Newburgh
State/Province
New York
ZIP/Postal Code
12550
Country
United States
Facility Name
Forest Investigative Site 1563
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
Forest Investigative Site 1557
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Facility Name
Forest Investigative Site 1588
City
Shelby
State/Province
North Carolina
ZIP/Postal Code
28152
Country
United States
Facility Name
Forest Investigative Site 1553
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28401
Country
United States
Facility Name
Forest Investigative Site 1550
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
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 1594
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45224
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 1541
City
Marion
State/Province
Ohio
ZIP/Postal Code
43302
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 1612
City
Ashland
State/Province
Oregon
ZIP/Postal Code
97520
Country
United States
Facility Name
Forest Investigative Site 1575
City
Corvallis
State/Province
Oregon
ZIP/Postal Code
97330
Country
United States
Facility Name
Forest Investigative Site 1081
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97404
Country
United States
Facility Name
Forest Investigative Site 1580
City
Portland
State/Province
Oregon
ZIP/Postal Code
97213
Country
United States
Facility Name
Forest Investigative Site 1552
City
Portland
State/Province
Oregon
ZIP/Postal Code
97220
Country
United States
Facility Name
Forest Investigative Site 1574
City
Beaver
State/Province
Pennsylvania
ZIP/Postal Code
15009
Country
United States
Facility Name
Forest Investigative Site 1577
City
Beaver
State/Province
Pennsylvania
ZIP/Postal Code
15009
Country
United States
Facility Name
Forest Investigative Site 1126
City
Bethlehem
State/Province
Pennsylvania
ZIP/Postal Code
18020
Country
United States
Facility Name
Forest Investigative Site 1423
City
Erie
State/Province
Pennsylvania
ZIP/Postal Code
16506
Country
United States
Facility Name
Forest Investigative Site 1504
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
Forest Investigative Site 1569
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Forest Investigative Site 1548
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15236
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 1560
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 1564
City
Uniontown
State/Province
Pennsylvania
ZIP/Postal Code
15401
Country
United States
Facility Name
Forest Investigative Site 1144
City
Johnston
State/Province
Rhode Island
ZIP/Postal Code
02919
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 1568
City
Easley
State/Province
South Carolina
ZIP/Postal Code
29640
Country
United States
Facility Name
Forest Investigative Site 1506
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29615
Country
United States
Facility Name
Forest Investigative Site 1601
City
Greer
State/Province
South Carolina
ZIP/Postal Code
29651
Country
United States
Facility Name
Forest Investigative Site 0900
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29303
Country
United States
Facility Name
Forest Investigative Site 1450
City
Union
State/Province
South Carolina
ZIP/Postal Code
29379
Country
United States
Facility Name
Forest Investigative Site 1365
City
Rapid City
State/Province
South Dakota
ZIP/Postal Code
57702
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 1954
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Facility Name
Forest Investigative Site 1155
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Forest Investigative Site 1328
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
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 1902
City
Killeen
State/Province
Texas
ZIP/Postal Code
76543
Country
United States
Facility Name
Forest Investigative Site 1498
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78215
Country
United States
Facility Name
Forest Investigative Site 1614
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78228
Country
United States
Facility Name
Forest Investigative Site 1906
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Forest Investigative Site 2004
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Forest Investigative Site 1600
City
Magna
State/Province
Utah
ZIP/Postal Code
84044
Country
United States
Facility Name
Forest Investigative Site 1480
City
Abingdon
State/Province
Virginia
ZIP/Postal Code
24210
Country
United States
Facility Name
Forest Investigative Site 1579
City
Alexandria
State/Province
Virginia
ZIP/Postal Code
22304
Country
United States
Facility Name
Forest Investigative Site 1142
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

12. IPD Sharing Statement

Citations:
PubMed Identifier
27296819
Citation
Donohue JF, Soong W, Wu X, Shrestha P, Lei A. Long-term safety of aclidinium bromide/formoterol fumarate fixed-dose combination: Results of a randomized 1-year trial in patients with COPD. Respir Med. 2016 Jul;116:41-8. doi: 10.1016/j.rmed.2016.05.007. Epub 2016 May 7.
Results Reference
derived
Links:
URL
http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=4061&filename=lac-md-32-synopsis.pdf
Description
lac-md-32-synopsis

Learn more about this trial

Safety and Tolerability of Aclidinium Bromide/Formoterol Fumarate Compared With Formoterol Fumarate in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease

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