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OPUS Study: Effect of Roflumilast on Exacerbation Rate in Patients With Chronic Obstructive Pulmonary Disease (BY217/M2-111)

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ClinicalTrials.gov Identifier: NCT00076089
Recruitment Status : Completed
First Posted : January 15, 2004
Last Update Posted : December 2, 2016
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

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).

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease COPD Drug: Roflumilast Phase 3

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Study Type : Interventional  (Clinical Trial)
Enrollment : 1100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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 Start Date : December 2003
Actual Primary Completion Date : December 2005
Actual Study Completion Date : December 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases
Drug Information available for: Roflumilast




Primary Outcome Measures :
  1. change in FEV1 from baseline during the treatment period; number of COPD exacerbations.

Secondary Outcome Measures :
  1. pulmonary function variables
  2. number of COPD exacerbations of different type and various subgroups
  3. quality of life variables
  4. patient diary variables
  5. time to study withdrawal
  6. safety.


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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00076089


Locations
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United States, Alabama
ALTANA Pharma
Cities in Alabama, Alabama, United States
United States, Arizona
ALTANA Pharma
Cities in Arizona, Arizona, United States
United States, Arkansas
ALTANA Pharma
Cities in Arkansas, Arkansas, United States
United States, California
ALTANA Pharma
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United States, Colorado
ALTANA Pharma
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United States, Connecticut
ALTANA Pharma
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United States, Florida
ALTANA Pharma
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United States, Georgia
ALTANA Pharma
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United States, Illinois
ALTANA Pharma
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United States, Iowa
ALTANA Pharma
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United States, Kentucky
ALTANA Pharma
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United States, Louisiana
ALTANA Pharma
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United States, Massachusetts
ALTANA Pharma
Cities in Massachusetts, Massachusetts, United States
United States, Minnesota
ALTANA Pharma
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United States, Missouri
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United States, Montana
ALTANA Pharma
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United States, Nebraska
ALTANA Pharma
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United States, Nevada
ALTANA Pharma
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United States, New Hampshire
ALTANA Pharma
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United States, New Jersey
ALTANA Pharma
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United States, New York
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United States, North Carolina
ALTANA Pharma
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United States, Ohio
ALTANA Pharma
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United States, Oklahoma
ALTANA Pharma
Cities in Oklahoma, Oklahoma, United States
United States, Oregon
ALTANA Pharma
Cities in Oregon, Oregon, United States
United States, Pennsylvania
ALTANA Pharma
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United States, Rhode Island
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United States, South Carolina
ALTANA Pharma
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United States, Tennessee
ALTANA Pharma
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United States, Texas
ALTANA Pharma
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United States, Utah
ALTANA Pharma
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United States, Vermont
ALTANA Pharma
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United States, Virginia
ALTANA Pharma
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United States, West Virginia
ALTANA Pharma
Cities in West Virginia, West Virginia, United States
United States, Wisconsin
ALTANA Pharma
Cities in Wisconsin, Wisconsin, United States
Canada
ALTANA Pharma
Cities in Canada, Canada
France
ALTANA Pharma
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Germany
ALTANA Pharma
Cities in Germany, Germany
Poland
ALTANA Pharma
Cities in Poland, Poland
South Africa
ALTANA Pharma
Cities in South Africa, South Africa
Sponsors and Collaborators
AstraZeneca
Investigators
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Study Director: AstraZeneca AstraZeneca AstraZeneca
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00076089    
Other Study ID Numbers: BY217/M2-111
First Posted: January 15, 2004    Key Record Dates
Last Update Posted: December 2, 2016
Last Verified: September 2016
Keywords provided by AstraZeneca:
Roflumilast
Chronic obstructive pulmonary disease
COPD
Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases