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Efficacy, Safety, and Tolerability of Aclidinium Bromide in the Treatment of Moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD) (LAS-MD-38) (LAS-MD-38)

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Aclidinium bromide
Placebo
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, 2008; 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 1493
  • Forest Investigative Site 1419
  • Forest Investigative Site 1413
  • Forest Investigative Site 1353
  • Forest Investigative Site 1379
  • Forest Investigative Site 2065
  • Forest Investigative Site 1451
  • Forest Investigative Site 1388
  • Forest Investigative Site 1424
  • Forest Investigative Site 1427
  • Forest Investigative Site 1418
  • Forest Investigative Site 2009
  • Forest Investigative Site 1374
  • Forest Investigative Site 1331
  • Forest Investigative Site 1380
  • Forest Investigative Site 1447
  • Forest Investigative Site 1364
  • Forest Investigative Site 1516
  • Forest Investigative Site 1403
  • Forest Investigative Site 1485
  • Forest Investigative Site 1352
  • Forest Investigative Site 1391
  • Forest Investigative Site 1376
  • Forest Investigative Site 1372
  • Forest Investigative Site 1407
  • Forest Investigative Site 1185
  • Forest Investigative Site 1386
  • Forest Investigative Site 1411
  • Forest Investigative Site 1528
  • Forest Investigative Site 0679
  • Forest Investigative Site 1385
  • Forest Investigative Site 1409
  • Forest Investigative Site 1479
  • Forest Investigative Site 2022
  • Forest Investigative Site 1441
  • Forest Investigative Site 1149
  • Forest Investigative Site 1406
  • Forest Investigative Site 1080
  • Forest Investigative Site 2033
  • Forest Investigative Site 1090
  • Forest Investigative Site 1430
  • Forest Investigative Site 1446
  • Forest Investigative Site 1360
  • Forest Investigative Site 1412
  • Forest Investigative Site 1518
  • Forest Investigative Site 1442
  • Forest Investigative Site 1421
  • Forest Investigative Site 1029
  • Forest Investigative Site 1405
  • Forest Investigative Site 0889
  • Forest Investigative Site 1487
  • Forest Investigative Site 1128
  • Forest Investigative Site 1527
  • Forest Investigative Site 1124
  • Forest Investigative Site 1118
  • Forest Investigative Site 1399
  • Forest Investigative Site 1400
  • Forest Investigative Site 1354
  • Forest Investigative Site 1367
  • Forest Investigative Site 1476
  • Forest Investigative Site 1363
  • Forest Investigative Site 1390
  • Forest Investigative Site 1422
  • Forest Investigative Site 1359
  • Forest Investigative Site 1355
  • Forest Investigative Site 1486
  • Forest Investigative Site 1489
  • Forest Investigative Site 1425
  • Forest Investigative Site 1373
  • Forest Investigative Site 1392
  • Forest Investigative Site 1366
  • Forest Investigative Site 1136
  • Forest Investigative Site 1371
  • Forest Investigative Site 1361
  • Forest Investigative Site 1433
  • Forest Investigative Site 1530
  • Forest Investigative Site 1393
  • Forest Investigative Site 1362
  • Forest Investigative Site 2018
  • Forest Investigative Site 2043
  • Forest Investigative Site 1377
  • Forest Investigative Site 1423
  • Forest Investigative Site 1428
  • Forest Investigative Site 1443
  • Forest Investigative Site 1510
  • Forest Investigative Site 1449
  • Forest Investigative Site 1445
  • Forest Investigative Site 1477
  • Forest Investigative Site 1144
  • Forest Investigative Site 1517
  • Forest Investigative Site 1506
  • Forest Investigative Site 1450
  • Forest Investigative Site 1526
  • Forest Investigative Site 1356
  • Forest Investigative Site 1417
  • Forest Investigative Site 1389
  • Forest Investigative Site 1440
  • Forest Investigative Site 1494
  • Forest Investigative Site 1375
  • Forest Investigative Site 1444
  • Forest Investigative Site 1401
  • Forest Investigative Site 1381
  • Forest Investigative Site 1357
  • Forest Investigative Site 1426
  • Forest Investigative Site 1410
  • Forest Investigative Site 1480
  • Forest Investigative Site 1402
  • Forest Investigative Site 1404
  • Forest Investigative Site 1358
  • Forest Investigative Site 0988
  • Forest Investigative Site 1177
  • Forest Investigative Site 0969

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

1

2

3

Arm Description

Aclidinium bromide 200 μg dose twice per day, inhaled for 12 weeks of treatment At week 12, patients who were on Aclidinium bromide 200 μg will receive open label 400µg aclidinium bromide for 40 weeks

Aclidinium bromide 400 μg dose twice per day, inhaled for 12 weeks of treatment. At week 12, patients who were on Aclidinium bromide 400 μg will continue to receive open label 400µg aclidinium bromide for 40 weeks

Dose-match placebo, oral inhalation twice per day for 12 weeks of treatment. At week 12, patients who were on placebo will receive open label 400µg aclidinium bromide for 40 weeks

Outcomes

Primary Outcome Measures

Part A: Morning Predose (Trough) Forced Expiratory Volume in 1 Second (FEV1)
Change from baseline in Trough forced expiratory volume in 1 second before the morning dose of aclidinium bromide, Last Observation Carried Forward (LOCF)
Part B: Morning Predose (Trough) FEV1
Change from Baseline in Morning Pre-dose (trough) Forced Expiratory Volume in 1 Second (FEV1) at Week 52, Lost Observation Carried Forward (LOCF)

Secondary Outcome Measures

Part A: Peak Forced Expiratory Volume in 1 Second (FEV1)
Change from baseline in peak FEV1 at week 12, Last Observation Carried Forward (LOCF)
Part B: Peak FEV1
Change from Baseline in Peak FEV1 (L) at Week 52, Last Observation Carried Forward (LOCF)

Full Information

First Posted
January 7, 2010
Last Updated
November 30, 2016
Sponsor
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT01045161
Brief Title
Efficacy, Safety, and Tolerability of Aclidinium Bromide in the Treatment of Moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD) (LAS-MD-38)
Acronym
LAS-MD-38
Official Title
A Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy, Safety, and Tolerability of 2 Doses of Aclidinium Bromide Compared With Placebo for 12 Weeks in Patients With Moderate to Severe, Stable Chronic Obstructive Pulmonary Disease Followed by a 40-Week Evaluation of the Higher Aclidinium Bromide Dose
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
June 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 efficacy, safety and tolerability of aclidinium bromide doses compared with placebo in the treatment of moderate to severe, stable chronic obstructive pulmonary disease. The study will be 56 weeks in duration; a 2-week run-in period followed by a 12-week double-blind, placebo-controlled treatment period. This will be followed by an open-label 40-week treatment period and a 2-week follow up phone call. All patients will receive the higher Aclidinium Bromide during the 40-week open label treatment period.

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
544 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Aclidinium bromide 200 μg dose twice per day, inhaled for 12 weeks of treatment At week 12, patients who were on Aclidinium bromide 200 μg will receive open label 400µg aclidinium bromide for 40 weeks
Arm Title
2
Arm Type
Experimental
Arm Description
Aclidinium bromide 400 μg dose twice per day, inhaled for 12 weeks of treatment. At week 12, patients who were on Aclidinium bromide 400 μg will continue to receive open label 400µg aclidinium bromide for 40 weeks
Arm Title
3
Arm Type
Placebo Comparator
Arm Description
Dose-match placebo, oral inhalation twice per day for 12 weeks of treatment. At week 12, patients who were on placebo will receive open label 400µg aclidinium bromide for 40 weeks
Intervention Type
Drug
Intervention Name(s)
Aclidinium bromide
Intervention Description
Aclidinium bromide 200 μg, oral inhalation twice per day 12 weeks of treatment. At week 12, patients who were on Aclidinium bromide 200 μg will receive open label 400µg aclidinium bromide for 40 weeks of treatment.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Dose-matched placebo, oral inhalation twice per day for 12 weeks. At week 12, patients who were on placebo will receive open label 400 µg aclidinium bromide for 40 weeks of treatment
Primary Outcome Measure Information:
Title
Part A: Morning Predose (Trough) Forced Expiratory Volume in 1 Second (FEV1)
Description
Change from baseline in Trough forced expiratory volume in 1 second before the morning dose of aclidinium bromide, Last Observation Carried Forward (LOCF)
Time Frame
Change from baseline (Week 0) to Week 12
Title
Part B: Morning Predose (Trough) FEV1
Description
Change from Baseline in Morning Pre-dose (trough) Forced Expiratory Volume in 1 Second (FEV1) at Week 52, Lost Observation Carried Forward (LOCF)
Time Frame
Change from baseline (Week 0) to 52 Weeks
Secondary Outcome Measure Information:
Title
Part A: Peak Forced Expiratory Volume in 1 Second (FEV1)
Description
Change from baseline in peak FEV1 at week 12, Last Observation Carried Forward (LOCF)
Time Frame
Change from baseline (Week 0) to Week 12
Title
Part B: Peak FEV1
Description
Change from Baseline in Peak FEV1 (L) at Week 52, Last Observation Carried Forward (LOCF)
Time Frame
Change from baseline (Week 0) to 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, 2008; 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, Ph. D.
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
Facility Information:
Facility Name
Forest Investigative Site 1493
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35209
Country
United States
Facility Name
Forest Investigative Site 1419
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
Forest Investigative Site 1413
City
Muscle Shoals
State/Province
Alabama
ZIP/Postal Code
35662
Country
United States
Facility Name
Forest Investigative Site 1353
City
Pell City
State/Province
Alabama
ZIP/Postal Code
35128
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 2065
City
Fullerton
State/Province
California
ZIP/Postal Code
92835
Country
United States
Facility Name
Forest Investigative Site 1451
City
National City
State/Province
California
ZIP/Postal Code
91950
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 1424
City
Rolling Hill Estates
State/Province
California
ZIP/Postal Code
90274
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 1418
City
San Diego
State/Province
California
ZIP/Postal Code
92120
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 1331
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 1447
City
Pueblo
State/Province
Colorado
ZIP/Postal Code
81001
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 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
33021
Country
United States
Facility Name
Forest Investigative Site 1485
City
Homestead
State/Province
Florida
ZIP/Postal Code
33032
Country
United States
Facility Name
Forest Investigative Site 1352
City
Miami
State/Province
Florida
ZIP/Postal Code
33126
Country
United States
Facility Name
Forest Investigative Site 1391
City
Naples
State/Province
Florida
ZIP/Postal Code
34110
Country
United States
Facility Name
Forest Investigative Site 1376
City
Port Orange
State/Province
Florida
ZIP/Postal Code
32129
Country
United States
Facility Name
Forest Investigative Site 1372
City
South Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Facility Name
Forest Investigative Site 1407
City
Trinity
State/Province
Florida
ZIP/Postal Code
34655
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 1386
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
Facility Name
Forest Investigative Site 1411
City
Calhoun
State/Province
Georgia
ZIP/Postal Code
30701
Country
United States
Facility Name
Forest Investigative Site 1528
City
Lawrenceville
State/Province
Georgia
ZIP/Postal Code
30046
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 1385
City
Elk Grove Village
State/Province
Illinois
ZIP/Postal Code
60007
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 1479
City
Anderson
State/Province
Indiana
ZIP/Postal Code
46011
Country
United States
Facility Name
Forest Investigative Site 2022
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47714
Country
United States
Facility Name
Forest Investigative Site 1441
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46256
Country
United States
Facility Name
Forest Investigative Site 1149
City
South Bend
State/Province
Indiana
ZIP/Postal Code
46617
Country
United States
Facility Name
Forest Investigative Site 1406
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52240
Country
United States
Facility Name
Forest Investigative Site 1080
City
Topeka
State/Province
Kansas
ZIP/Postal Code
66606
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 1090
City
Hazard
State/Province
Kentucky
ZIP/Postal Code
41701
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 1446
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70119
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 1412
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Forest Investigative Site 1518
City
North East
State/Province
Maryland
ZIP/Postal Code
21901
Country
United States
Facility Name
Forest Investigative Site 1442
City
Brockton
State/Province
Massachusetts
ZIP/Postal Code
02301
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 1029
City
North Dartmouth
State/Province
Massachusetts
ZIP/Postal Code
02747
Country
United States
Facility Name
Forest Investigative Site 1405
City
Chelsea
State/Province
Michigan
ZIP/Postal Code
48118
Country
United States
Facility Name
Forest Investigative Site 0889
City
Livonia
State/Province
Michigan
ZIP/Postal Code
48152
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
58435
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
55403
Country
United States
Facility Name
Forest Investigative Site 1118
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55904
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 1400
City
Missoula
State/Province
Montana
ZIP/Postal Code
59808
Country
United States
Facility Name
Forest Investigative Site 1354
City
Bellevue
State/Province
Nebraska
ZIP/Postal Code
68005
Country
United States
Facility Name
Forest Investigative Site 1367
City
Bellevue
State/Province
Nebraska
ZIP/Postal Code
68123
Country
United States
Facility Name
Forest Investigative Site 1476
City
Fremont
State/Province
Nebraska
ZIP/Postal Code
68025
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 1390
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68130
Country
United States
Facility Name
Forest Investigative Site 1422
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68134
Country
United States
Facility Name
Forest Investigative Site 1359
City
Henderson
State/Province
Nevada
ZIP/Postal Code
89014
Country
United States
Facility Name
Forest Investigative Site 1355
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89123
Country
United States
Facility Name
Forest Investigative Site 1486
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87108
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 1425
City
New York
State/Province
New York
ZIP/Postal Code
10028
Country
United States
Facility Name
Forest Investigative Site 1373
City
North Syracuse
State/Province
New York
ZIP/Postal Code
13212
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 1366
City
High Point
State/Province
North Carolina
ZIP/Postal Code
27262
Country
United States
Facility Name
Forest Investigative Site 1136
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45227
Country
United States
Facility Name
Forest Investigative Site 1371
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45245
Country
United States
Facility Name
Forest Investigative Site 1361
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43209
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 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 1362
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
Forest Investigative Site 2018
City
Medford
State/Province
Oregon
ZIP/Postal Code
97504
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 1377
City
Collegeville
State/Province
Pennsylvania
ZIP/Postal Code
19426
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 1428
City
Feasterville
State/Province
Pennsylvania
ZIP/Postal Code
19053
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 1510
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15221
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 1445
City
Johnston
State/Province
Rhode Island
ZIP/Postal Code
02919
Country
United States
Facility Name
Forest Investigative Site 1477
City
Lincoln
State/Province
Rhode Island
ZIP/Postal Code
02865
Country
United States
Facility Name
Forest Investigative Site 1144
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29201
Country
United States
Facility Name
Forest Investigative Site 1517
City
Easley
State/Province
South Carolina
ZIP/Postal Code
29640
Country
United States
Facility Name
Forest Investigative Site 1506
City
Grenville
State/Province
South Carolina
ZIP/Postal Code
29615
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 1526
City
Fayetteville
State/Province
Tennessee
ZIP/Postal Code
37337
Country
United States
Facility Name
Forest Investigative Site 1356
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37909
Country
United States
Facility Name
Forest Investigative Site 1417
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37920
Country
United States
Facility Name
Forest Investigative Site 1389
City
Amarillo
State/Province
Texas
ZIP/Postal Code
79106
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 1494
City
Austin
State/Province
Texas
ZIP/Postal Code
78756
Country
United States
Facility Name
Forest Investigative Site 1375
City
Houston
State/Province
Texas
ZIP/Postal Code
77074
Country
United States
Facility Name
Forest Investigative Site 1444
City
Houston
State/Province
Texas
ZIP/Postal Code
77079
Country
United States
Facility Name
Forest Investigative Site 1401
City
Houston
State/Province
Texas
ZIP/Postal Code
77083
Country
United States
Facility Name
Forest Investigative Site 1381
City
Houston
State/Province
Texas
ZIP/Postal Code
77479
Country
United States
Facility Name
Forest Investigative Site 1357
City
Hurst
State/Province
Texas
ZIP/Postal Code
76054
Country
United States
Facility Name
Forest Investigative Site 1426
City
Plano
State/Province
Texas
ZIP/Postal Code
75093
Country
United States
Facility Name
Forest Investigative Site 1410
City
Tomball
State/Province
Texas
ZIP/Postal Code
77375
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 1402
City
Lynchburg
State/Province
Virginia
ZIP/Postal Code
24501
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 1358
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23294
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 1177
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 4E1
Country
Canada
Facility Name
Forest Investigative Site 0969
City
Windsor
State/Province
Ontario
ZIP/Postal Code
N8X 5A6
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
24085591
Citation
Rennard SI, Scanlon PD, Ferguson GT, Rekeda L, Maurer BT, Garcia Gil E, Caracta CF. ACCORD COPD II: a randomized clinical trial to evaluate the 12-week efficacy and safety of twice-daily aclidinium bromide in chronic obstructive pulmonary disease patients. Clin Drug Investig. 2013 Dec;33(12):893-904. doi: 10.1007/s40261-013-0138-1.
Results Reference
derived
Links:
URL
http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=4070&filename=las-md-38-synopsis.pdf
Description
las-md-38-synopsis

Learn more about this trial

Efficacy, Safety, and Tolerability of Aclidinium Bromide in the Treatment of Moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD) (LAS-MD-38)

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