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Long-term Safety, Tolerability and Efficacy of Aclidinium Bromide in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) (LAS-MD-35) (LAS-MD-35)

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Aclidinium Bromide 200 µg
Aclidinium Bromide 400 µg
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 Chronic Obstructive Pulmonary Disease, COPD, 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:

  • A diagnosis of stable moderate to severe COPD as defined by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines, 2010; postbronchodilator FEV1/FVC < 70%, and postbronchodilator FEV1 ≥ 30% and < 80% predicted
  • Current or former cigarette smokers

Exclusion Criteria:

  • Patients who have been hospitalized for an acute COPD exacerbation within 3 months before the first visit
  • Respiratory tract infection or COPD exacerbation in the 6 weeks before Visit 1
  • Patient with any clinically significant respiratory conditions other than COPD, cardiovascular conditions or mental illness
  • History or presence of asthma verified from medical records
  • Chronic use of oxygen therapy greater than or equal to 15 hours per day
  • Patient with uncontrolled infection due to HIV and/or active hepatitis
  • Patients with a history of hypersensitivity reaction to inhaled anticholinergics
  • Patients with clinically significant cardiovascular conditions, including myocardial infarction during the previous 6 months, newly diagnosed arrhythmia within the previous 3 months, unstable angina, unstable arrhythmia that had required changes in pharmacological therapy or other intervention.

Sites / Locations

  • Forest Investigative Site 1162
  • Forest Investigative Site 1127
  • Forest Investigative Site 1475
  • Forest Investigative Site 1338
  • Forest Investigative Site 1349
  • Forest Investigative Site 1483
  • Forest Investigative Site 1350
  • Forest Investigative Site 1509
  • Forest Investigative Site 2065
  • Forest Investigative Site 1502
  • Forest Investigative Site 1088
  • Forest Investigative Site 1534
  • Forest Investigative Site 2209
  • Forest Investigative Site 1122
  • Forest Investigative Site 1508
  • Forest Investigative Site 2064
  • Forest Investigative Site 1533
  • Forest Investigative Site 2009
  • Forest Investigative Site 1439
  • Forest Investigative Site 1503
  • Forest Investigative Site 1347
  • Forest Investigative Site 1344
  • Forest Investigative Site 2039
  • Forest Investigative Site 2037
  • Forest Investigative Site 1327
  • Forest Investigative Site 1104
  • Forest Investigative Site 1482
  • Forest Investigative Site 1346
  • Forest Investigative Site 1154
  • Forest Investigative Site 1152
  • Forest Investigative Site 1514
  • Forest Investigative Site 0670
  • Forest Investigative Site 1516
  • Forest Investigative Site 0990
  • Forest Investigative Site 1513
  • Forest Investigative Site 1420
  • Forest Investigative Site 1432
  • Forest Investigative Site 1484
  • Forest Investigative Site 1340
  • Forest Investigative Site 1488
  • Forest Investigative Site 0974
  • Forest Investigative Site 1397
  • Forest Investigative Site 1383
  • Forest Investigative Site 2082
  • Forest Investigative Site 2047
  • Forest Investigative Site 1395
  • Forest Investigative Site 0980
  • Forest Investigative Site 1491
  • Forest Investigative Site 0987
  • Forest Investigative Site 1532
  • Forest Investigative Site 2051
  • Forest Investigative Site 0989
  • Forest Investigative Site 1436
  • Forest Investigative Site 2085
  • Forest Investigative Site 1520
  • Forest Investigative Site 0539
  • Forest Investigative Site 1336
  • Forest Investigative Site 1478
  • Forest Investigative Site 2024
  • Forest Investigative Site 1333
  • Forest Investigative Site 1421
  • Forest Investigative Site 1342
  • Forest Investigative Site 1438
  • Forest Investigative Site 2041
  • Forest Investigative Site 1351
  • Forest Investigative Site 1100
  • Forest Investigative Site 2079
  • Forest Investigative Site 1343
  • Forest Investigative Site 1329
  • Forest Investigative Site 1369
  • Forest Investigative Site 1335
  • Forest Investigative Site 1367
  • Forest Investigative Site 1150
  • Forest Investigative Site 1339
  • Forest Investigative Site 1515
  • Forest Investigative Site 1394
  • Forest Investigative Site 2062
  • Forest Investigative Site 1368
  • Forest Investigative Site 1147
  • Forest Investigative Site 1151
  • Forest Investigative Site 1114
  • Forest Investigative Site 1163
  • Forest Investigative Site 1481
  • Forest Investigative Site 0479
  • Forest Investigative Site 2081
  • Forest Investigative Site 1334
  • Forest Investigative Site 1366
  • Forest Investigative Site 1382
  • Forest Investigative Site 1134
  • Forest Investigative Site 2007
  • Forest Investigative Site 1434
  • Forest Investigative Site 1433
  • Forest Investigative Site 0959
  • Forest Investigative Site 1505
  • Forest Investigative Site 1435
  • Forest Investigative Site 1348
  • Forest Investigative Site 1504
  • Forest Investigative Site 2072
  • Forest Investigative Site 0900
  • Forest Investigative Site 1365
  • Forest Investigative Site 0962
  • Forest Investigative Site 1155
  • Forest Investigative Site 1328
  • Forest Investigative Site 1332
  • Forest Investigative Site 1337
  • Forest Investigative Site 1396
  • Forest Investigative Site 1384
  • Forest Investigative Site 1330
  • Forest Investigative Site 1120
  • Forest Investigative Site 1531
  • Forest Investigative Site 2201
  • Forest Investigative Site 1157
  • Forest Investigative Site 1168

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Aclidinium Bromide 200 µg

Aclidinium Bromide 400 µg

Arm Description

aclidinium bromide, inhaled, 52 weeks of treatment

aclidinium bromide, inhaled, 52 weeks of treatment

Outcomes

Primary Outcome Measures

Change From Baseline in Morning Pre-dose (Trough) Forced Expiratory Volume in One Second (FEV1)
Change From Baseline in Morning Predose (Trough) FEV1 in liters at Week 52.

Secondary Outcome Measures

Change From Baseline in Peak FEV1
Change From Baseline in Peak FEV1 in liters at Week 52.

Full Information

First Posted
January 5, 2010
Last Updated
March 9, 2017
Sponsor
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT01044459
Brief Title
Long-term Safety, Tolerability and Efficacy of Aclidinium Bromide in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) (LAS-MD-35)
Acronym
LAS-MD-35
Official Title
A Long-Term, Randomized, Double-Blind Study of the Safety, Tolerability and Efficacy of Aclidinium Bromide At Two Dosage Levels When Administered to Patients With Moderate to Severe, Stable Chronic Obstructive Pulmonary Disease
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
November 2009 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
April 2011 (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 study is to evaluate the safety, tolerability and efficacy of inhaled aclidinium bromide at two dose levels in patients with moderate to severe, stable chronic obstructive pulmonary disease. The study will be 56 weeks in duration; a 2-week rin-in period, a 52-week treatment period and a 2-week follow up phone call. All patients will be randomized to one of two doses of aclidinium bromide.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
Chronic Obstructive Pulmonary Disease, COPD, 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
605 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Aclidinium Bromide 200 µg
Arm Type
Experimental
Arm Description
aclidinium bromide, inhaled, 52 weeks of treatment
Arm Title
Aclidinium Bromide 400 µg
Arm Type
Experimental
Arm Description
aclidinium bromide, inhaled, 52 weeks of treatment
Intervention Type
Drug
Intervention Name(s)
Aclidinium Bromide 200 µg
Intervention Description
aclidinium bromide 200 μg, oral inhalation twice per day for 52 weeks of treatment
Intervention Type
Drug
Intervention Name(s)
Aclidinium Bromide 400 µg
Intervention Description
aclidinium bromide 400 μg, oral inhalation twice per day for 52 weeks of treatment
Primary Outcome Measure Information:
Title
Change From Baseline in Morning Pre-dose (Trough) Forced Expiratory Volume in One Second (FEV1)
Description
Change From Baseline in Morning Predose (Trough) FEV1 in liters at Week 52.
Time Frame
From baseline to 52 weeks
Secondary Outcome Measure Information:
Title
Change From Baseline in Peak FEV1
Description
Change From Baseline in Peak FEV1 in liters at Week 52.
Time Frame
52 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: A diagnosis of stable moderate to severe COPD as defined by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines, 2010; postbronchodilator FEV1/FVC < 70%, and postbronchodilator FEV1 ≥ 30% and < 80% predicted Current or former cigarette smokers Exclusion Criteria: Patients who have been hospitalized for an acute COPD exacerbation within 3 months before the first visit Respiratory tract infection or COPD exacerbation in the 6 weeks before Visit 1 Patient with any clinically significant respiratory conditions other than COPD, cardiovascular conditions or mental illness History or presence of asthma verified from medical records Chronic use of oxygen therapy greater than or equal to 15 hours per day Patient with uncontrolled infection due to HIV and/or active hepatitis Patients with a history of hypersensitivity reaction to inhaled anticholinergics Patients with clinically significant cardiovascular conditions, including myocardial infarction during the previous 6 months, newly diagnosed arrhythmia within the previous 3 months, unstable angina, unstable arrhythmia that had required changes in pharmacological therapy or other intervention.
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 1127
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608
Country
United States
Facility Name
Forest Investigative Site 1475
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85258
Country
United States
Facility Name
Forest Investigative Site 1338
City
Tempe
State/Province
Arizona
ZIP/Postal Code
85282
Country
United States
Facility Name
Forest Investigative Site 1349
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85710
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 1350
City
Foothill Ranch
State/Province
California
ZIP/Postal Code
92610
Country
United States
Facility Name
Forest Investigative Site 1509
City
Fresno
State/Province
California
ZIP/Postal Code
93720
Country
United States
Facility Name
Forest Investigative Site 2065
City
Fullerton
State/Province
California
ZIP/Postal Code
92835
Country
United States
Facility Name
Forest Investigative Site 1502
City
Huntington Park
State/Province
California
ZIP/Postal Code
90255
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 1534
City
Long Beach
State/Province
California
ZIP/Postal Code
90813
Country
United States
Facility Name
Forest Investigative Site 2209
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Forest Investigative Site 1122
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Forest Investigative Site 1508
City
Palm Springs
State/Province
California
ZIP/Postal Code
92262
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 1533
City
Sacramento
State/Province
California
ZIP/Postal Code
95825
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 1439
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Forest Investigative Site 1503
City
San Diego
State/Province
California
ZIP/Postal Code
92928
Country
United States
Facility Name
Forest Investigative Site 1347
City
San Jose
State/Province
California
ZIP/Postal Code
95117
Country
United States
Facility Name
Forest Investigative Site 1344
City
Spring Valley
State/Province
California
ZIP/Postal Code
91978
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 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 1104
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06105
Country
United States
Facility Name
Forest Investigative Site 1482
City
Stamford
State/Province
Connecticut
ZIP/Postal Code
06902-3633
Country
United States
Facility Name
Forest Investigative Site 1346
City
Newark
State/Province
Delaware
ZIP/Postal Code
19713
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 1152
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33765
Country
United States
Facility Name
Forest Investigative Site 1514
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33134
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
32141
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
33102
Country
United States
Facility Name
Forest Investigative Site 1420
City
Miami
State/Province
Florida
ZIP/Postal Code
33133
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 1484
City
Miramar
State/Province
Florida
ZIP/Postal Code
33025
Country
United States
Facility Name
Forest Investigative Site 1340
City
Ocala
State/Province
Florida
ZIP/Postal Code
34471
Country
United States
Facility Name
Forest Investigative Site 1488
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33027
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 1397
City
Port Charlotte
State/Province
Florida
ZIP/Postal Code
33952
Country
United States
Facility Name
Forest Investigative Site 1383
City
Port Orange
State/Province
Florida
ZIP/Postal Code
32127
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 2047
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Facility Name
Forest Investigative Site 1395
City
Valrico
State/Province
Florida
ZIP/Postal Code
33596
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 1491
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
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 1532
City
Columbus
State/Province
Georgia
ZIP/Postal Code
31904
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 0989
City
Skokie
State/Province
Illinois
ZIP/Postal Code
60076
Country
United States
Facility Name
Forest Investigative Site 1436
City
Avon
State/Province
Indiana
ZIP/Postal Code
46123
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 1520
City
Crestview Hills
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 1336
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40215
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 2024
City
Lafayette
State/Province
Louisiana
ZIP/Postal Code
70503
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 1421
City
Fall River
State/Province
Massachusetts
ZIP/Postal Code
02720
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 1438
City
Ypsilanti
State/Province
Michigan
ZIP/Postal Code
48197
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 1351
City
Plymouth
State/Province
Minnesota
ZIP/Postal Code
55441
Country
United States
Facility Name
Forest Investigative Site 1100
City
Florissant
State/Province
Missouri
ZIP/Postal Code
63033
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 1343
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63128
Country
United States
Facility Name
Forest Investigative Site 1329
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Forest Investigative Site 1369
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Forest Investigative Site 1335
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63143
Country
United States
Facility Name
Forest Investigative Site 1367
City
Papillion
State/Province
Nebraska
ZIP/Postal Code
68046
Country
United States
Facility Name
Forest Investigative Site 1150
City
Berlin
State/Province
New Jersey
ZIP/Postal Code
09009
Country
United States
Facility Name
Forest Investigative Site 1339
City
Cherry Hill
State/Province
New Jersey
ZIP/Postal Code
08003
Country
United States
Facility Name
Forest Investigative Site 1515
City
Elizabeth
State/Province
New Jersey
ZIP/Postal Code
07202
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 2062
City
Bronxville
State/Province
New York
ZIP/Postal Code
10708
Country
United States
Facility Name
Forest Investigative Site 1368
City
Bronx
State/Province
New York
ZIP/Postal Code
10457
Country
United States
Facility Name
Forest Investigative Site 1147
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11234
Country
United States
Facility Name
Forest Investigative Site 1151
City
New Hyde Park
State/Province
New York
ZIP/Postal Code
11040
Country
United States
Facility Name
Forest Investigative Site 1114
City
New York
State/Province
New York
ZIP/Postal Code
10010
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 1481
City
Newburgh
State/Province
New York
ZIP/Postal Code
12550
Country
United States
Facility Name
Forest Investigative Site 0479
City
Rochester
State/Province
New York
ZIP/Postal Code
14618
Country
United States
Facility Name
Forest Investigative Site 2081
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28207
Country
United States
Facility Name
Forest Investigative Site 1334
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28226
Country
United States
Facility Name
Forest Investigative Site 1366
City
HighPoint
State/Province
North Carolina
ZIP/Postal Code
27262
Country
United States
Facility Name
Forest Investigative Site 1382
City
Statesville
State/Province
North Carolina
ZIP/Postal Code
28625
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 2007
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45231
Country
United States
Facility Name
Forest Investigative Site 1434
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44122
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 0959
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43214
Country
United States
Facility Name
Forest Investigative Site 1505
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43235
Country
United States
Facility Name
Forest Investigative Site 1435
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45406
Country
United States
Facility Name
Forest Investigative Site 1348
City
Bend
State/Province
Oregon
ZIP/Postal Code
97701
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 2072
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29406
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 1365
City
Rapid City
State/Province
South Dakota
ZIP/Postal Code
57702
Country
United States
Facility Name
Forest Investigative Site 0962
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
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 1337
City
Houston
State/Province
Texas
ZIP/Postal Code
77054
Country
United States
Facility Name
Forest Investigative Site 1396
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78125
Country
United States
Facility Name
Forest Investigative Site 1384
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78328
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 1120
City
Bellingham
State/Province
Washington
ZIP/Postal Code
98225
Country
United States
Facility Name
Forest Investigative Site 1531
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
Forest Investigative Site 2201
City
Kelowna
State/Province
British Columbia
ZIP/Postal Code
V1Y 8E7
Country
Canada
Facility Name
Forest Investigative Site 1157
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M3H 5S4
Country
Canada
Facility Name
Forest Investigative Site 1168
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1N8
Country
Canada

12. IPD Sharing Statement

Links:
URL
http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=4068&filename=las-md-35-synopsis.pdf
Description
las-md-35-synopsis

Learn more about this trial

Long-term Safety, Tolerability and Efficacy of Aclidinium Bromide in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) (LAS-MD-35)

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