Effect of Roflumilast on Pulmonary Function and Respiratory Symptoms in Patients With Chronic Obstructive Pulmonary Disease (COPD) (BY217/M2-110)

November 22, 2016 updated by: AstraZeneca

A 24 Week, Placebo-Controlled, Randomized, Parallel Group Study Comparing Roflumilast 500 mcg Daily vs Placebo on Pulmonary Function and Respiratory Symptoms in Patients With Chronic Obstructive Pulmonary Disease (COPD)

The aim of the study is to compare the effect of roflumilast and placebo on the lung function in patients with COPD.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

1000

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

  • Argentina
      • Cities in Argentina, Argentina
        • ALTANA Pharma
  • Canada
      • Cities in Canada, Canada
        • ALTANA Pharma
  • Colombia
      • Cities in Colombia, Colombia
        • ALTANA Pharma
  • Mexico
      • Cities in Mexico, Mexico
        • ALTANA Pharma
  • Peru
      • Cities in Peru, Peru
        • ALTANA Pharma
  • United States
    • Alabama
      • Cities in Alabama, Alabama, United States
        • ALTANA Pharma
    • Arizona
      • Cities in Arizona, Arizona, United States
        • ALTANA Pharma
    • California
      • Cities in California, California, United States
        • ALTANA Pharma
    • Colorado
      • Cities in Colorado, Colorado, United States
        • ATLANA Pharma
    • Connecticut
      • Cities in Conneticut, Connecticut, United States
        • ALTANA Pharma
    • Delaware
      • Cities in Delaware, Delaware, United States
        • ALTANA Pharma
    • Florida
      • Cities in Florida, Florida, United States
        • ALTANA Pharma
    • Georgia
      • Cities in Georgia, Georgia, United States
        • ALTANA Pharma
    • Idaho
      • Cities in Idaho, Idaho, United States
        • ALTANA Pharma
    • Indiana
      • Cities in Indiana, Indiana, United States
        • ALTANA Pharma
    • Iowa
      • Cities in Iowa, Iowa, United States
        • ALTANA Pharma
    • Kansas
      • Cities in Kansas, Kansas, United States
        • ALTANA Pharma
    • Kentucky
      • Cities in Kentucky, Kentucky, United States
        • ALTANA Pharma
    • Louisiana
      • Cities in Louisiana, Louisiana, United States
        • ALTANA Pharma
    • Maryland
      • Cities in Maryland, Maryland, United States
        • ALTANA Pharma
    • Michigan
      • Cities in Michigan, Michigan, United States
        • ALTANA Pharma
    • Missouri
      • Cities in Missouri, Missouri, United States
        • ALTANA Pharma
    • Nebraska
      • Cities in Nebraska, Nebraska, United States
        • ALTANA Pharma
    • Nevada
      • Cities in Nevada, Nevada, 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
    • 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
    • Texas
      • Cities in Texas, Texas, United States
        • ALTANA Pharma
    • Utah
      • Cities in Utah, Utah, United States
        • ALTANA Pharma
    • Virginia
      • Cities in Virginia, Virginia, United States
        • ALTANA Pharma
    • Washington
      • Cities in Washington, Washington, United States
        • ALTANA Pharma
    • West Virginia
      • Cities in West Virginia, West Virginia, 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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Main Inclusion Criteria:

  • Clinical diagnosis of COPD (Chronic Obstructive Pulmonary Disease)
  • Currently stable COPD with no change in COPD treatment in the prior 4 weeks

Main Exclusion Criteria:

  • Clinical diagnosis of asthma
  • Poorly controlled COPD
  • Regular need for daily oxygen therapy

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
pulmonary function.

Secondary Outcome Measures

Outcome Measure
quality of life
exacerbation rate
symptoms
use of rescue medication
safety and tolerability.

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.

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

June 1, 2003

Study Registration Dates

First Submitted

June 9, 2003

First Submitted That Met QC Criteria

June 9, 2003

First Posted (Estimate)

June 10, 2003

Study Record Updates

Last Update Posted (Estimate)

November 23, 2016

Last Update Submitted That Met QC Criteria

November 22, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BY217/M2-110

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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