OPUS Study: Effect of Roflumilast on Exacerbation Rate in Patients With Chronic Obstructive Pulmonary Disease (BY217/M2-111)
NCT ID: NCT00076089
Last Updated: 2016-12-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
1100 participants
INTERVENTIONAL
2003-12-31
2005-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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Roflumilast
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
40 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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AstraZeneca AstraZeneca
Role: STUDY_DIRECTOR
AstraZeneca
Locations
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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
Countries
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References
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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.
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.
Related Links
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BY217-M2-111-RDS-2008-12-23.pdf
Other Identifiers
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BY217/M2-111
Identifier Type: -
Identifier Source: org_study_id