Back to resultsLong-term Extension Study of the Safety, Tolerability, and Efficacy of Aclidinium Bromide in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) (LAS-MD-36)
Primary Purpose
Chronic Obstructive Pulmonary Disease
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Aclidinium bromide
Aclidinium bromide
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 a lead-in study (NCT00891462)
Exclusion Criteria:
- Use or anticipated use of any medication prohibited in this study
- Evidence of abnormal clinical laboratory values, vital signs, or electrocardiographic (ECG) results or the presence of abnormities in physical examination findings
- The presence of anti-cholinergic effects (eg, dry mouth, urinary retention, narrow angle glaucoma)
- QTcB of >500 msec on both the pre-dose and post-dose ECG
- Women who are pregnant, intend to become pregnant, or are breast-feeding
- A life expectancy of less than 1 year
- Noncompliance with IP dosing and/or attending clinic visits during the lead-in study
- Significant interruption of double-blind therapy during the transition from the lead-in study into the extension study.
Sites / Locations
- Forest Investigative Site 1162
- Forest Investigative Site 1127
- Forest Investigative Site 0909
- Forest Investigative Site 2060
- Forest Investigative Site 2065
- Forest Investigative Site 1088
- Forest Investigative Site 1122
- Forest Investigative Site 2029
- Forets Investigative Site 2064
- Forest Investigative Site 0517
- Forest Investigative Site 2009
- Forest Investigative Site 1137
- Forest Investigative Site 2100
- Forest Investigative Site 1154
- Forest Investigative Site 1152
- Forest Investigative Site 0670
- Forest Investigative Site 0990
- Forest Investigative Site 1167
- Forest Investigative Site 1060
- Forest Investigative Site 0974
- Forest Investigative Site 2082
- Forest Investigative Site 2053
- Forest Investigative Site 2047
- Forest Investigative Site 1185
- Forest Investigative Site 1183
- Forest Investigative Site 0987
- Forest Investigative Site 1101
- Forest Investigative Site 1180
- Forest Investigative Site 1161
- Forest Investigative Site 2051
- Forest Investigative Site 0989
- Forest Investigative Site 1149
- Forest Investigative Site 2085
- Forest Investigative Site 0539
- Forest Investigative Site 2024
- Forest Investigative Site 2040
- Forest Investigative Site 1128
- Forest Investigative Site 2041
- Forest Investigative Site 1124
- Forest Investigative Site 1100
- Forest Investigative Site 2079
- Forest Investigative Site 2067
- Forest Investigative Site 1169
- Forest Investigative Site 1150
- Forest Investigative Site 2084
- Forest Investigative Site 1147
- Forest Investigative Site 1119
- Forest Investigative Site 1151
- Forest Investigative Site 1141
- Forest Investigative Site 1163
- Forest Investigative Site 1130
- Forest Investigative Site 1134
- Forest Investigative Site 1181
- Forest Investigative Site 1136
- Forest Investigative Site 2007
- Forest Investigative Site 2028
- Forest Investigative Site 0959
- Forest Investigative Site 2006
- Forest Investigative Site 2043
- Forest Investigative Site 1106
- Forest Investigative Site 1126
- Forest Investigative Site 2016
- Forest Investigative Site 1146
- Forest Investigative Site 1158
- Forest Investigative Site 1089
- Forest Investigative Site 1144
- Forest Investigative Site 2072
- Forest Investigative Site 1078
- Forest Investigative Site 2080
- Forest Investigative Site 1121
- Forest Investigative Site 1155
- Forest Investigative Site 2012
- Forest Investigative Site 1165
- Forest Investigative Site 1129
- Forest Investigative Site 2099
- Forest Investigative Site 1142
- Forest Investigative Site 0988
- Forest Investigative Site 2201
- Forest Investigative Site 1177
- Forest Investigative Site 2200
- Forest Investigative Site 1168
- Forest Investigative Site 1171
- Forest Investigative Site 2203
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
1
2
Arm Description
Aclidinium bromide dose, inhaled, for 52 weeks of treatment
Aclidinium bromide dose, inhaled, for 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 (Visit 2 of lead-in Study NCT00891462, [LAS-MD-33]) to Week 52 (Week 64 From Start of NCT00891462, [LAS-MD-33]) in Morning Predose (Trough) FEV1
Secondary Outcome Measures
Change From Baseline in Peak FEV1
Change From Baseline (Visit 2 of study NCT00891462, [LAS-MD-33])in Peak FEV1 in liters at Week 52 (Week 64 from the start of NCT00891462, [LAS-MD-33]).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00970268
Brief Title
Long-term Extension Study of the Safety, Tolerability, and Efficacy of Aclidinium Bromide in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) (LAS-MD-36)
Official Title
A Long-term, Randomized, Double-blind Extension Study of the Safety, Tolerability, and Efficacy of Aclidinium Bromide at Two Dose Levels When Administered to Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
August 2009 (undefined)
Primary Completion Date
October 2010 (Actual)
Study Completion Date
October 2010 (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 extension study is to evaluate the long-term safety, tolerability, and efficacy of inhaled aclidinium bromide at two dose levels in patients with moderate to severe chronic obstructive pulmonary disease (COPD). This study will be 54 weeks in duration; a 52-week double-blind treatment period and 2 week follow-up phone call, following a 12 week lead-in study. All patients will be randomized from the lead-in study at one of two doses of aclidinium.
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
291 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Aclidinium bromide dose, inhaled, for 52 weeks of treatment
Arm Title
2
Arm Type
Experimental
Arm Description
Aclidinium bromide dose, inhaled, for 52 weeks of treatment
Intervention Type
Drug
Intervention Name(s)
Aclidinium bromide
Intervention Description
Aclidinium bromide 200 μg, oral inhalation twice per day for 52 weeks of treatment
Intervention Type
Drug
Intervention Name(s)
Aclidinium bromide
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 (Visit 2 of lead-in Study NCT00891462, [LAS-MD-33]) to Week 52 (Week 64 From Start of NCT00891462, [LAS-MD-33]) in Morning Predose (Trough) FEV1
Time Frame
Change from baseline (visit 2 of lead-in study LAS-MD-33) to 52 weeks
Secondary Outcome Measure Information:
Title
Change From Baseline in Peak FEV1
Description
Change From Baseline (Visit 2 of study NCT00891462, [LAS-MD-33])in Peak FEV1 in liters at Week 52 (Week 64 from the start of NCT00891462, [LAS-MD-33]).
Time Frame
52 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Completion of a lead-in study (NCT00891462)
Exclusion Criteria:
Use or anticipated use of any medication prohibited in this study
Evidence of abnormal clinical laboratory values, vital signs, or electrocardiographic (ECG) results or the presence of abnormities in physical examination findings
The presence of anti-cholinergic effects (eg, dry mouth, urinary retention, narrow angle glaucoma)
QTcB of >500 msec on both the pre-dose and post-dose ECG
Women who are pregnant, intend to become pregnant, or are breast-feeding
A life expectancy of less than 1 year
Noncompliance with IP dosing and/or attending clinic visits during the lead-in study
Significant interruption of double-blind therapy during the transition from the lead-in study into the extension study.
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 0909
City
Glendale
State/Province
Arizona
ZIP/Postal Code
85306
Country
United States
Facility Name
Forest Investigative Site 2060
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85023
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 1088
City
Lakewood
State/Province
California
ZIP/Postal Code
90712
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 2029
City
Rancho Mirage
State/Province
California
ZIP/Postal Code
92270
Country
United States
Facility Name
Forets Investigative Site 2064
City
Riverside
State/Province
California
ZIP/Postal Code
92506
Country
United States
Facility Name
Forest Investigative Site 0517
City
Sacramento
State/Province
California
ZIP/Postal Code
95821
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 1137
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80907
Country
United States
Facility Name
Forest Investigative Site 2100
City
Waterbury
State/Province
Connecticut
ZIP/Postal Code
06708
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 0670
City
DeLand
State/Province
Florida
ZIP/Postal Code
32720
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 1167
City
Melbourne
State/Province
Florida
ZIP/Postal Code
32935
Country
United States
Facility Name
Forest Investigative Site 1060
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 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
33606
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 1183
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30329
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 1101
City
Blue Ridge
State/Province
Georgia
ZIP/Postal Code
30513
Country
United States
Facility Name
Forest Investigative Site 1180
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30033
Country
United States
Facility Name
Forest Investigative Site 1161
City
Duluth
State/Province
Georgia
ZIP/Postal Code
30096
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 1149
City
South Bend
State/Province
Indiana
ZIP/Postal Code
46617
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 0539
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40504
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 2040
City
Biddeford
State/Province
Maine
ZIP/Postal Code
04005
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 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 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 2067
City
Butte
State/Province
Montana
ZIP/Postal Code
59701
Country
United States
Facility Name
Forest Investigative Site 1169
City
Papillion
State/Province
Nebraska
ZIP/Postal Code
68406
Country
United States
Facility Name
Forest Investigative Site 1150
City
Berlin
State/Province
New Jersey
ZIP/Postal Code
08009
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 1147
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11234
Country
United States
Facility Name
Forest Investigative Site 1119
City
Elmira
State/Province
New York
ZIP/Postal Code
14901
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 1141
City
New York
State/Province
New York
ZIP/Postal Code
10016
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 1130
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28801
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 1181
City
Centerville
State/Province
Ohio
ZIP/Postal Code
45459
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 2007
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 0959
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43215
Country
United States
Facility Name
Forest Investigative Site 2006
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43215
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 1106
City
Portland
State/Province
Oregon
ZIP/Postal Code
97213
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 2016
City
Erie
State/Province
Pennsylvania
ZIP/Postal Code
16506
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 1158
City
Upland
State/Province
Pennsylvania
ZIP/Postal Code
19013
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 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 1078
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29615
Country
United States
Facility Name
Forest Investigative Site 2080
City
Greer
State/Province
South Carolina
ZIP/Postal Code
29651
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 1155
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
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 1165
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Forest Investigative Site 1129
City
Waco
State/Province
Texas
ZIP/Postal Code
76712
Country
United States
Facility Name
Forest Investigative Site 2099
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23225
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 0988
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 1177
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 4E1
Country
Canada
Facility Name
Forest Investigative Site 2200
City
Niagara Falls
State/Province
Ontario
ZIP/Postal Code
L2g 1J4
Country
Canada
Facility Name
Forest Investigative Site 1168
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1N8
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
12. IPD Sharing Statement
Citations:
PubMed Identifier
23679347
Citation
D'Urzo A, Kerwin E, Rennard S, He T, Gil EG, Caracta C. One-year extension study of ACCORD COPD I: safety and efficacy of two doses of twice-daily aclidinium bromide in patients with COPD. COPD. 2013 Aug;10(4):500-10. doi: 10.3109/15412555.2013.791809. Epub 2013 May 16.
Results Reference
derived
Learn more about this trial
Long-term Extension Study of the Safety, Tolerability, and Efficacy of Aclidinium Bromide in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) (LAS-MD-36)
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