OPUS Study: Effect of Roflumilast on Exacerbation Rate in Patients With Chronic Obstructive Pulmonary Disease (BY217/M2-111)
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.
1 other identifier
interventional
1,100
6 countries
40
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 chronic-obstructive-pulmonary-disease
Started Dec 2003
Typical duration for phase_3 chronic-obstructive-pulmonary-disease
40 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2003
CompletedFirst Submitted
Initial submission to the registry
January 13, 2004
CompletedFirst Posted
Study publicly available on registry
January 15, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2005
CompletedDecember 2, 2016
September 1, 2016
2 years
January 13, 2004
December 1, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
change in FEV1 from baseline during the treatment period; number of COPD exacerbations.
Secondary Outcomes (6)
pulmonary function variables
number of COPD exacerbations of different type and various subgroups
quality of life variables
patient diary variables
time to study withdrawal
- +1 more secondary outcomes
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (40)
ALTANA Pharma
Cities in Alabama, Alabama, United States
ALTANA Pharma
Cities in Arizona, Arizona, United States
ALTANA Pharma
Cities in Arkansas, Arkansas, United States
ALTANA Pharma
Cities in California, California, United States
ALTANA Pharma
Cities in Colorado, Colorado, United States
ALTANA Pharma
Cities in Connecticut, Connecticut, United States
ALTANA Pharma
Cities in Florida, Florida, United States
ALTANA Pharma
Cities in Georgia, Georgia, United States
ALTANA Pharma
Cities in Illionois, Illinois, United States
ALTANA Pharma
Cities in Iowa, Iowa, United States
ALTANA Pharma
Cities in Kentucky, Kentucky, United States
ALTANA Pharma
Cities in Louisiana, Louisiana, United States
ALTANA Pharma
Cities in Massachusetts, Massachusetts, United States
ALTANA Pharma
Cities in Minnesota, Minnesota, United States
ALTANA Pharma
Cities in Missouri, Missouri, United States
ALTANA Pharma
Cities in Montana, Montana, United States
ALTANA Pharma
Cities in Nebraska, Nebraska, United States
ALTANA Pharma
Cities in Nevada, Nevada, United States
ALTANA Pharma
Cities in New Hampshire, New Hampshire, United States
ALTANA Pharma
Cities in New Jersey, New Jersey, United States
ALTANA Pharma
Cities in New York, New York, United States
ALTANA Pharma
Cities in North Carolina, North Carolina, United States
ALTANA Pharma
Cities in Ohio, Ohio, United States
ALTANA Pharma
Cities in Oklahoma, Oklahoma, United States
ALTANA Pharma
Cities in Oregon, Oregon, United States
ALTANA Pharma
Cities in Pennsylvania, Pennsylvania, United States
ALTANA Pharma
Cities in Rhode Island, Rhode Island, United States
ALTANA Pharma
Cities in South Carolina, South Carolina, United States
ALTANA Pharma
Cities in Tennessee, Tennessee, United States
ALTANA Pharma
Cities in Texas, Texas, United States
ALTANA Pharma
Cities in Utah, Utah, United States
ALTANA Pharma
Cities in Vermont, Vermont, United States
ALTANA Pharma
Cities in Virginia, Virginia, United States
ALTANA Pharma
Cities in West Virginia, West Virginia, United States
ALTANA Pharma
Cities in Wisconsin, Wisconsin, United States
ALTANA Pharma
Cities in Canada, Canada
ALTANA Pharma
Cities in France, France
ALTANA Pharma
Cities in Germany, Germany
ALTANA Pharma
Cities in Poland, Poland
ALTANA Pharma
Cities in South Africa, South Africa
Related Publications (2)
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.
PMID: 28419462DERIVEDRennard 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.
PMID: 21272339DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
AstraZeneca AstraZeneca
AstraZeneca
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 13, 2004
First Posted
January 15, 2004
Study Start
December 1, 2003
Primary Completion
December 1, 2005
Study Completion
December 1, 2005
Last Updated
December 2, 2016
Record last verified: 2016-09