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

December 1, 2016 updated by: AstraZeneca

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.

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

1100

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • Cities in Canada, Canada
        • ALTANA Pharma
  • France
      • Cities in France, France
        • ALTANA Pharma
  • Germany
      • Cities in Germany, Germany
        • ALTANA Pharma
  • Poland
      • Cities in Poland, Poland
        • ALTANA Pharma
  • South Africa
      • Cities in South Africa, South Africa
        • ALTANA Pharma
  • United States
    • Alabama
      • Cities in Alabama, Alabama, United States
        • ALTANA Pharma
    • Arizona
      • Cities in Arizona, Arizona, United States
        • ALTANA Pharma
    • Arkansas
      • Cities in Arkansas, Arkansas, United States
        • ALTANA Pharma
    • California
      • Cities in California, California, United States
        • ALTANA Pharma
    • Colorado
      • Cities in Colorado, Colorado, United States
        • ALTANA Pharma
    • Connecticut
      • Cities in Connecticut, Connecticut, United States
        • ALTANA Pharma
    • Florida
      • Cities in Florida, Florida, United States
        • ALTANA Pharma
    • Georgia
      • Cities in Georgia, Georgia, United States
        • ALTANA Pharma
    • Illinois
      • Cities in Illionois, Illinois, United States
        • ALTANA Pharma
    • Iowa
      • Cities in Iowa, Iowa, United States
        • ALTANA Pharma
    • Kentucky
      • Cities in Kentucky, Kentucky, United States
        • ALTANA Pharma
    • Louisiana
      • Cities in Louisiana, Louisiana, United States
        • ALTANA Pharma
    • Massachusetts
      • Cities in Massachusetts, Massachusetts, United States
        • ALTANA Pharma
    • Minnesota
      • Cities in Minnesota, Minnesota, United States
        • ALTANA Pharma
    • Missouri
      • Cities in Missouri, Missouri, United States
        • ALTANA Pharma
    • Montana
      • Cities in Montana, Montana, United States
        • ALTANA Pharma
    • Nebraska
      • Cities in Nebraska, Nebraska, United States
        • ALTANA Pharma
    • Nevada
      • Cities in Nevada, Nevada, United States
        • ALTANA Pharma
    • New Hampshire
      • Cities in New Hampshire, New Hampshire, United States
        • ALTANA Pharma
    • New Jersey
      • Cities in New Jersey, New Jersey, United States
        • ALTANA Pharma
    • New York
      • Cities in New York, New York, United States
        • ALTANA Pharma
    • North Carolina
      • Cities in North Carolina, North Carolina, United States
        • ALTANA Pharma
    • Ohio
      • Cities in Ohio, Ohio, United States
        • ALTANA Pharma
    • Oklahoma
      • Cities in Oklahoma, Oklahoma, United States
        • ALTANA Pharma
    • Oregon
      • Cities in Oregon, Oregon, United States
        • ALTANA Pharma
    • Pennsylvania
      • Cities in Pennsylvania, Pennsylvania, United States
        • ALTANA Pharma
    • Rhode Island
      • Cities in Rhode Island, Rhode Island, United States
        • ALTANA Pharma
    • South Carolina
      • Cities in South Carolina, South Carolina, United States
        • ALTANA Pharma
    • Tennessee
      • Cities in Tennessee, Tennessee, United States
        • ALTANA Pharma
    • Texas
      • Cities in Texas, Texas, United States
        • ALTANA Pharma
    • Utah
      • Cities in Utah, Utah, United States
        • ALTANA Pharma
    • Vermont
      • Cities in Vermont, Vermont, United States
        • ALTANA Pharma
    • Virginia
      • Cities in Virginia, Virginia, United States
        • ALTANA Pharma
    • West Virginia
      • Cities in West Virginia, West Virginia, United States
        • ALTANA Pharma
    • Wisconsin
      • Cities in Wisconsin, Wisconsin, United States
        • ALTANA Pharma

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
change in FEV1 from baseline during the treatment period; number of COPD exacerbations.

Secondary Outcome Measures

Outcome Measure
safety.
pulmonary function variables
number of COPD exacerbations of different type and various subgroups
quality of life variables
patient diary variables
time to study withdrawal

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2003

Primary Completion (Actual)

December 1, 2005

Study Completion (Actual)

December 1, 2005

Study Registration Dates

First Submitted

January 13, 2004

First Submitted That Met QC Criteria

January 14, 2004

First Posted (Estimate)

January 15, 2004

Study Record Updates

Last Update Posted (Estimate)

December 2, 2016

Last Update Submitted That Met QC Criteria

December 1, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BY217/M2-111

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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