Effect of Roflumilast on Exacerbation Rate in Patients With Chronic Obstructive Pulmonary Disease. Ratio-Study. (BY217/M2-112)

November 29, 2016 updated by: AstraZeneca

Effect of Roflumilast on Exacerbation Rate in Patients With Chronic Obstructive Pulmonary Disease. A 52 Weeks Double Blind Study With 500mcg Roflumilast Once Daily Versus Placebo. Ratio-Study.

The purpose of this study is to investigate the effect of 500mcg roflumilast vs placebo on exacerbation rate and pulmonary function as well as quality of life 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

  • Australia
      • Cities in Australia, Australia
        • ALTANA Pharma
  • Austria
      • Cities in Austria, Austria
        • ALTANA Pharma
  • Canada
      • Cities in Canada, Canada
        • ALTANA Pharma
  • France
      • Cities in France, France
        • ALTANA Pharma
  • Hungary
      • Cities in Hungary, Hungary
        • ALTANA Pharma
  • Italy
      • Cities in Italy, Italy
        • ALTANA Pharma
  • Netherlands
      • Cities in the Netherlands, Netherlands
        • ALTANA Pharma
  • Poland
      • Cities in Poland, Poland
        • ALTANA Pharma
  • Portugal
      • Cities in Portugal, Portugal
        • ALTANA Pharma
  • Russian Federation
      • Cities in the Russian Federation, Russian Federation
        • ALTANA Pharma
  • South Africa
      • Cities in South Africa, South Africa
        • ALTANA Pharma
  • Spain
      • Cities in Spain, Spain
        • ALTANA Pharma
  • Switzerland
      • Cities in Switzerland, Switzerland
        • ALTANA Pharma
  • United Kingdom
      • Cities in the United Kingdom, United Kingdom
        • 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 a chest x-ray dated a maximum of 6 months prior to study baseline visit B0 or a willingness to have a chest x-ray performed before 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
The frequency of patients experiencing at least one moderate or severe exacerbation during the treatment period.
Change in FEV1 from baseline during the treatment period.

Secondary Outcome Measures

Outcome Measure
Pulmonary function variables; quality of life variables;patient diary variables;safety

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

January 1, 2003

Study Registration Dates

First Submitted

February 1, 2007

First Submitted That Met QC Criteria

February 1, 2007

First Posted (Estimate)

February 2, 2007

Study Record Updates

Last Update Posted (Estimate)

November 30, 2016

Last Update Submitted That Met QC Criteria

November 29, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BY217/M2-112

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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