Back to resultsOPUS Study: Effect of Roflumilast on Exacerbation Rate in Patients With Chronic Obstructive Pulmonary Disease (BY217/M2-111)
Primary Purpose
Chronic Obstructive Pulmonary Disease, COPD
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Roflumilast
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring Roflumilast, Chronic obstructive pulmonary disease, COPD
Eligibility Criteria
Main Inclusion Criteria: FEV1/FVC ratio (post-bronchodilator) ≤70% FEV1 (post-bronchodilator) ≤50% of predicted Current smoker or ex-smoker Clinically stable COPD indicated by no exacerbation and no change in COPD treatment of within 4 weeks prior to baseline Availability of chest x-ray dated a maximum of 6 months prior to study baseline or a willingness to have a chest x-ray performed at baseline Main Exclusion Criteria: COPD exacerbation indicated by a treatment with systemic glucocorticoids not stopped 4 weeks prior to baseline Lower respiratory tract infection not resolved 4 weeks prior to baseline Diagnosis of asthma and/or other relevant lung disease Known alpha-1-antitrypsin deficiency Need for long-term oxygen therapy defined as ≥16 hours/day
Sites / Locations
- ALTANA Pharma
- ALTANA Pharma
- ALTANA Pharma
- ALTANA Pharma
- ALTANA Pharma
- ALTANA Pharma
- ALTANA Pharma
- ALTANA Pharma
- ALTANA Pharma
- ALTANA Pharma
- ALTANA Pharma
- ALTANA Pharma
- ALTANA Pharma
- ALTANA Pharma
- ALTANA Pharma
- ALTANA Pharma
- ALTANA Pharma
- ALTANA Pharma
- ALTANA Pharma
- ALTANA Pharma
- ALTANA Pharma
- ALTANA Pharma
- ALTANA Pharma
- ALTANA Pharma
- ALTANA Pharma
- ALTANA Pharma
- ALTANA Pharma
- ALTANA Pharma
- ALTANA Pharma
- ALTANA Pharma
- ALTANA Pharma
- ALTANA Pharma
- ALTANA Pharma
- ALTANA Pharma
- ALTANA Pharma
- ALTANA Pharma
- ALTANA Pharma
- ALTANA Pharma
- ALTANA Pharma
- ALTANA Pharma
Outcomes
Primary Outcome Measures
change in FEV1 from baseline during the treatment period; number of COPD exacerbations.
Secondary Outcome Measures
pulmonary function variables
number of COPD exacerbations of different type and various subgroups
quality of life variables
patient diary variables
time to study withdrawal
safety.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00076089
Brief Title
OPUS Study: Effect of Roflumilast on Exacerbation Rate in Patients With Chronic Obstructive Pulmonary Disease (BY217/M2-111)
Official Title
Effect of Roflumilast on Exacerbation Rate in Patients With Chronic Obstructive Pulmonary Disease. A 52-week, Multicenter, Double-blind Study With 500 mcg Roflumilast Once Daily Versus Placebo.
Study Type
Interventional
2. Study Status
Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
December 2003 (undefined)
Primary Completion Date
December 2005 (Actual)
Study Completion Date
December 2005 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to determine whether roflumilast is effective in the treatment of exacerbations in patients with 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, COPD
Keywords
Roflumilast, Chronic obstructive pulmonary disease, COPD
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
1100 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Roflumilast
Primary Outcome Measure Information:
Title
change in FEV1 from baseline during the treatment period; number of COPD exacerbations.
Secondary Outcome Measure Information:
Title
pulmonary function variables
Title
number of COPD exacerbations of different type and various subgroups
Title
quality of life variables
Title
patient diary variables
Title
time to study withdrawal
Title
safety.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Main Inclusion Criteria:
FEV1/FVC ratio (post-bronchodilator) ≤70%
FEV1 (post-bronchodilator) ≤50% of predicted
Current smoker or ex-smoker
Clinically stable COPD indicated by no exacerbation and no change in COPD treatment of within 4 weeks prior to baseline
Availability of chest x-ray dated a maximum of 6 months prior to study baseline or a willingness to have a chest x-ray performed at baseline
Main Exclusion Criteria:
COPD exacerbation indicated by a treatment with systemic glucocorticoids not stopped 4 weeks prior to baseline
Lower respiratory tract infection not resolved 4 weeks prior to baseline
Diagnosis of asthma and/or other relevant lung disease
Known alpha-1-antitrypsin deficiency
Need for long-term oxygen therapy defined as ≥16 hours/day
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AstraZeneca AstraZeneca
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
Facility Information:
Facility Name
ALTANA Pharma
City
Cities in Alabama
State/Province
Alabama
Country
United States
Facility Name
ALTANA Pharma
City
Cities in Arizona
State/Province
Arizona
Country
United States
Facility Name
ALTANA Pharma
City
Cities in Arkansas
State/Province
Arkansas
Country
United States
Facility Name
ALTANA Pharma
City
Cities in California
State/Province
California
Country
United States
Facility Name
ALTANA Pharma
City
Cities in Colorado
State/Province
Colorado
Country
United States
Facility Name
ALTANA Pharma
City
Cities in Connecticut
State/Province
Connecticut
Country
United States
Facility Name
ALTANA Pharma
City
Cities in Florida
State/Province
Florida
Country
United States
Facility Name
ALTANA Pharma
City
Cities in Georgia
State/Province
Georgia
Country
United States
Facility Name
ALTANA Pharma
City
Cities in Illionois
State/Province
Illinois
Country
United States
Facility Name
ALTANA Pharma
City
Cities in Iowa
State/Province
Iowa
Country
United States
Facility Name
ALTANA Pharma
City
Cities in Kentucky
State/Province
Kentucky
Country
United States
Facility Name
ALTANA Pharma
City
Cities in Louisiana
State/Province
Louisiana
Country
United States
Facility Name
ALTANA Pharma
City
Cities in Massachusetts
State/Province
Massachusetts
Country
United States
Facility Name
ALTANA Pharma
City
Cities in Minnesota
State/Province
Minnesota
Country
United States
Facility Name
ALTANA Pharma
City
Cities in Missouri
State/Province
Missouri
Country
United States
Facility Name
ALTANA Pharma
City
Cities in Montana
State/Province
Montana
Country
United States
Facility Name
ALTANA Pharma
City
Cities in Nebraska
State/Province
Nebraska
Country
United States
Facility Name
ALTANA Pharma
City
Cities in Nevada
State/Province
Nevada
Country
United States
Facility Name
ALTANA Pharma
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Cities in New Hampshire
State/Province
New Hampshire
Country
United States
Facility Name
ALTANA Pharma
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Cities in New Jersey
State/Province
New Jersey
Country
United States
Facility Name
ALTANA Pharma
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Cities in New York
State/Province
New York
Country
United States
Facility Name
ALTANA Pharma
City
Cities in North Carolina
State/Province
North Carolina
Country
United States
Facility Name
ALTANA Pharma
City
Cities in Ohio
State/Province
Ohio
Country
United States
Facility Name
ALTANA Pharma
City
Cities in Oklahoma
State/Province
Oklahoma
Country
United States
Facility Name
ALTANA Pharma
City
Cities in Oregon
State/Province
Oregon
Country
United States
Facility Name
ALTANA Pharma
City
Cities in Pennsylvania
State/Province
Pennsylvania
Country
United States
Facility Name
ALTANA Pharma
City
Cities in Rhode Island
State/Province
Rhode Island
Country
United States
Facility Name
ALTANA Pharma
City
Cities in South Carolina
State/Province
South Carolina
Country
United States
Facility Name
ALTANA Pharma
City
Cities in Tennessee
State/Province
Tennessee
Country
United States
Facility Name
ALTANA Pharma
City
Cities in Texas
State/Province
Texas
Country
United States
Facility Name
ALTANA Pharma
City
Cities in Utah
State/Province
Utah
Country
United States
Facility Name
ALTANA Pharma
City
Cities in Vermont
State/Province
Vermont
Country
United States
Facility Name
ALTANA Pharma
City
Cities in Virginia
State/Province
Virginia
Country
United States
Facility Name
ALTANA Pharma
City
Cities in West Virginia
State/Province
West Virginia
Country
United States
Facility Name
ALTANA Pharma
City
Cities in Wisconsin
State/Province
Wisconsin
Country
United States
Facility Name
ALTANA Pharma
City
Cities in Canada
Country
Canada
Facility Name
ALTANA Pharma
City
Cities in France
Country
France
Facility Name
ALTANA Pharma
City
Cities in Germany
Country
Germany
Facility Name
ALTANA Pharma
City
Cities in Poland
Country
Poland
Facility Name
ALTANA Pharma
City
Cities in South Africa
Country
South Africa
12. IPD Sharing Statement
Citations:
PubMed Identifier
28419462
Citation
Facius A, Krause A, Claret L, Bruno R, Lahu G. Modeling and Simulation of Pivotal Clinical Trials Using Linked Models for Multiple Endpoints in Chronic Obstructive Pulmonary Disease With Roflumilast. J Clin Pharmacol. 2017 Aug;57(8):1042-1052. doi: 10.1002/jcph.885. Epub 2017 Apr 17.
Results Reference
derived
PubMed Identifier
21272339
Citation
Rennard SI, Calverley PM, Goehring UM, Bredenbroker D, Martinez FJ. Reduction of exacerbations by the PDE4 inhibitor roflumilast--the importance of defining different subsets of patients with COPD. Respir Res. 2011 Jan 27;12(1):18. doi: 10.1186/1465-9921-12-18.
Results Reference
derived
Links:
URL
http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=4477&filename=BY217-M2-111-RDS-2008-12-23.pdf
Description
BY217-M2-111-RDS-2008-12-23.pdf
Learn more about this trial
OPUS Study: Effect of Roflumilast on Exacerbation Rate in Patients With Chronic Obstructive Pulmonary Disease (BY217/M2-111)
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