Back to resultsA Study of Exercise Endurance and Lung Hyperinflation in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
Primary Purpose
Pulmonary Disease, Chronic Obstructive
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Aclidinium Bromide
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Pulmonary Disease, Chronic Obstructive focused on measuring Bronchitis, Chronic; Emphysema
Eligibility Criteria
Inclusion Criteria:
- A diagnosis of stable moderate to severe COPD (GOLD 2006); post-levalbuterol FEV1 >=30% and < 80% predicted and FEV1/FVC<70% predicted
- Current or former cigarette smoker
- Functional Residual Capacity (FRC) measured by body plethysmography >= 120% of predicted value
- Baseline Dyspnea Index (BDI) focal score ≤ 7 at Visit 4
Exclusion Criteria:
- History of presence of asthma, allergic rhinitis, or atopy
- Hospitalization for acute COPD exacerbation in the 3 months prior to study entry
- Respiratory tract infection (including the upper respiratory tract) or COPD exacerbation in the 6 weeks prior to study entry
- Clinically significant respiratory conditions other than COPD
- Chronic use of oxygen therapy >= 15 hours a day
Sites / Locations
- Forest Investigative Site 2088
- Forest Investigative Site 0909
- Forest Investigative Site 0957
- Forest Investigative Site 0973
- Forest Investigative Site 0887
- Forest Investigative Site 0988
- Forest Investigative Site 0885
- Forest Investigative Site 2663
- Forest Investigative Site 1030
- Forest Investigative Site 0974
- Forest Investigative Site 0980
- Forest Investigative Site 0991
- Forest Investigative Site 0987
- Forest Investigative Site 2008
- Forest Investigative Site 0984
- Forest Investigative Site 1080
- Forest Investigative Site 0898
- Forest Investigative Site 0886
- Forest Investigative Site 1029
- Forest Investigative Site 0889
- Forest Investigative Site 2079
- Forest Investigative Site 2071
- Forest Investigative Site 0972
- Forest Investigative Site 0971
- Forest Investigative Site 1114
- Forest Investigative Site 2665
- Forest Investigative Site 2081
- Forest Investigative Site 0688
- Forest Investigative Site 0981
- Forest Investigative Site 1057
- Forest Investigative Site 0888
- Forest Investigative Site 0983
- Forest Investigative Site 2072
- Forest Investigative Site 1107
- Forest Investigative Site 0979
- Forest Investigative Site 1078
- Forest Investigative Site 0900
- Forest Investigative Site 0962
- Forest Investigative Site 1082
- Forest Investigative Site 2058
- Forest Investigative Site 0890
- Forest Investigative Site 0977
- Forest Investigative Site 0968
- Forest Investigative Site 0960
- Forest Investigative Site 0905
- Forest Investigative Site 0976
- Forest Investigative Site 0891
- Forest Investigative Site 2204
- Forest Investigative Site 0969
- Forest Investigative Site 2205
- Forest Investigative Site 0893
- Forest Investigative Site 0943
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Aclidinium
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Change From Baseline in Exercise Endurance Time (ET)
Exercise endurance time is defined as the time from the increase in work rate at 75% Wmax (watts) to the point of symptom limitation. The Wmax is defined as the highest work rate the patients were able to maintain for at least 30 seconds.
Secondary Outcome Measures
Trough Forced Expiratory Volume in 1 Second (FEV1)
Change in trough Forced Expiratory Volume in 1 second. FEV1 was assessed at the end of the daily dosing interval (Trough).
Trough Inspiratory Capacity (IC)
Change in trough Inspiratory Capacity. Inspiratory Capacity was measured as part of the spirometry procedures performed at each visit. IC was assessed at the end of the daily dosing interval (Trough).
Functional Residual Capacity (FRC)
Change in trough Functional Residual Capacity. FRC was assessed at the end of the daily dosing interval (Trough).
Inspiratory Capacity (IC)/Total Lung Capacity (TLC) Ratio
Ratio of trough Inspiratory Capacity verses Total Lung Capacity.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00500318
Brief Title
A Study of Exercise Endurance and Lung Hyperinflation in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
Official Title
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, 6-Week Clinical Study to Assess the Effect of Inhaled Aclidinium Bromide (LAS34273) 200 ug on Exercise Endurance and Lung Hyperinflation in Patients With Moderate to Severe COPD
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
July 2007 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
September 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca
4. Oversight
5. Study Description
Brief Summary
This study evaluated the effect of inhaled aclidinium bromide on exercise endurance and in reducing resting and dynamic lung hyperinflation in patients with moderate to severe COPD. It was 9 weeks in duration, consisting of; a 2-week run-in period, 6 weeks of double-blind treatment, and a 1-week follow-up phone call. All patients meeting the eligibility criteria were randomized to one of two treatment groups: aclidinium bromide or placebo.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Disease, Chronic Obstructive
Keywords
Bronchitis, Chronic; Emphysema
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
181 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Aclidinium
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Aclidinium Bromide
Intervention Description
Aclidinium Bromide, 200μg. Once daily oral inhalation.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Dose matched placebo, once daily oral inhalation.
Primary Outcome Measure Information:
Title
Change From Baseline in Exercise Endurance Time (ET)
Description
Exercise endurance time is defined as the time from the increase in work rate at 75% Wmax (watts) to the point of symptom limitation. The Wmax is defined as the highest work rate the patients were able to maintain for at least 30 seconds.
Time Frame
From baseline Week 0 (Visit 4) to Week 6 (Visit 6)
Secondary Outcome Measure Information:
Title
Trough Forced Expiratory Volume in 1 Second (FEV1)
Description
Change in trough Forced Expiratory Volume in 1 second. FEV1 was assessed at the end of the daily dosing interval (Trough).
Time Frame
Change from baseline (Visit 4) at Week 6 (Visit 6)
Title
Trough Inspiratory Capacity (IC)
Description
Change in trough Inspiratory Capacity. Inspiratory Capacity was measured as part of the spirometry procedures performed at each visit. IC was assessed at the end of the daily dosing interval (Trough).
Time Frame
Change from baseline Week 0 (Visit 4) to Week 6 (Visit 6)
Title
Functional Residual Capacity (FRC)
Description
Change in trough Functional Residual Capacity. FRC was assessed at the end of the daily dosing interval (Trough).
Time Frame
Change from baseline Week 0 (Visit 4) to Week 6 (Visit 6)
Title
Inspiratory Capacity (IC)/Total Lung Capacity (TLC) Ratio
Description
Ratio of trough Inspiratory Capacity verses Total Lung Capacity.
Time Frame
Change from baseline Week 0 (Visit 4) to Week 6 (Visit 6)
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 (GOLD 2006); post-levalbuterol FEV1 >=30% and < 80% predicted and FEV1/FVC<70% predicted
Current or former cigarette smoker
Functional Residual Capacity (FRC) measured by body plethysmography >= 120% of predicted value
Baseline Dyspnea Index (BDI) focal score ≤ 7 at Visit 4
Exclusion Criteria:
History of presence of asthma, allergic rhinitis, or atopy
Hospitalization for acute COPD exacerbation in the 3 months prior to study entry
Respiratory tract infection (including the upper respiratory tract) or COPD exacerbation in the 6 weeks prior to study entry
Clinically significant respiratory conditions other than COPD
Chronic use of oxygen therapy >= 15 hours a day
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 2088
City
Jasper
State/Province
Alabama
ZIP/Postal Code
35501
Country
United States
Facility Name
Forest Investigative Site 0909
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006
Country
United States
Facility Name
Forest Investigative Site 0957
City
Long Beach
State/Province
California
ZIP/Postal Code
90822
Country
United States
Facility Name
Forest Investigative Site 0973
City
Los Angeles,
State/Province
California
ZIP/Postal Code
90073
Country
United States
Facility Name
Forest Investigative Site 0887
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095-1690
Country
United States
Facility Name
Forest Investigative Site 0988
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
Forest Investigative Site 0885
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
Facility Name
Forest Investigative Site 2663
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33756
Country
United States
Facility Name
Forest Investigative Site 1030
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
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 0980
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Forest Investigative Site 0991
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 2008
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Forest Investigative Site 0984
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
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 0898
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21224
Country
United States
Facility Name
Forest Investigative Site 0886
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02135
Country
United States
Facility Name
Forest Investigative Site 1029
City
N. Dartmouth
State/Province
Massachusetts
ZIP/Postal Code
02747
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 2079
City
St. Charles
State/Province
Missouri
ZIP/Postal Code
63301
Country
United States
Facility Name
Forest Investigative Site 2071
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198-2465
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 0971
City
Great Neck
State/Province
New York
ZIP/Postal Code
11023
Country
United States
Facility Name
Forest Investigative Site 1114
City
New York
State/Province
New York
ZIP/Postal Code
10001
Country
United States
Facility Name
Forest Investigative Site 2665
City
New York
State/Province
New York
ZIP/Postal Code
10010-7436
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 0688
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28262
Country
United States
Facility Name
Forest Investigative Site 0981
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43614
Country
United States
Facility Name
Forest Investigative Site 1057
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
Forest Investigative Site 0888
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19140
Country
United States
Facility Name
Forest Investigative Site 0983
City
Scranton
State/Province
Pennsylvania
ZIP/Postal Code
18509
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 1107
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29201
Country
United States
Facility Name
Forest Investigative Site 0979
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29203
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 0900
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29303
Country
United States
Facility Name
Forest Investigative Site 0962
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232-2650
Country
United States
Facility Name
Forest Investigative Site 1082
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Forest Investigative Site 2058
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
Forest Investigative Site 0890
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Forest Investigative Site 0977
City
Midvale
State/Province
Utah
ZIP/Postal Code
84047
Country
United States
Facility Name
Forest Investigative Site 0968
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2B7
Country
Canada
Facility Name
Forest Investigative Site 0960
City
Kelowna
State/Province
British Columbia
ZIP/Postal Code
V1Y 1E4
Country
Canada
Facility Name
Forest Investigative Site 0905
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1M9
Country
Canada
Facility Name
Forest Investigative Site 0976
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R2K 3S8
Country
Canada
Facility Name
Forest Investigative Site 0891
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 3Z5
Country
Canada
Facility Name
Forest Investigative Site 2204
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1Y4E9
Country
Canada
Facility Name
Forest Investigative Site 0969
City
Windsor
State/Province
Ontario
ZIP/Postal Code
N8X 3V6
Country
Canada
Facility Name
Forest Investigative Site 2205
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4J 1C5
Country
Canada
Facility Name
Forest Investigative Site 0893
City
Ste-Foy
State/Province
Quebec
ZIP/Postal Code
G1V 4G5
Country
Canada
Facility Name
Forest Investigative Site 0943
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7N 0W8
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
21183326
Citation
Maltais F, Celli B, Casaburi R, Porszasz J, Jarreta D, Seoane B, Caracta C. Aclidinium bromide improves exercise endurance and lung hyperinflation in patients with moderate to severe COPD. Respir Med. 2011 Apr;105(4):580-7. doi: 10.1016/j.rmed.2010.11.019. Epub 2010 Dec 22.
Results Reference
derived
Learn more about this trial
A Study of Exercise Endurance and Lung Hyperinflation in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
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