The FLASH Study: A Study of Roflumilast Versus Placebo in Patients With Asthma (BY217/M2-023)

December 1, 2016 updated by: AstraZeneca

The FLASH Study: A Randomized, Controlled Study of Roflumilast 250 mcg and 500 mcg Versus Placebo in Patients With Asthma

The purpose of this study is to confirm the dose of roflumilast to be used for asthma management by comparing the effects of 250 mcg and 500 mcg oral roflumilast with placebo on pulmonary function and asthma symptoms.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

822

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

  • Russian Federation
      • Cities in Russia, Russian Federation
        • ALTANA Pharma
  • Ukraine
      • Cities in the Ukraine, Ukraine
        • 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
    • 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
    • Illinois
      • Cities in Illinois, Illinois, United States
        • ALTANA Pharma
    • Indiana
      • Cities in Indiana, Indiana, 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
    • Maine
      • Cities in Maine, Maine, United States
        • ALTANA Pharma
    • Maryland
      • Cities in Maryland, Maryland, United States
        • ALTANA Pharma
    • Massachusetts
      • Cities in Massachusetts, Massachusetts, United States
        • ALTANA Pharma
    • Michigan
      • Cities in Michigan, Michigan, 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 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
    • 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:

  • Diagnosis of persistent chronic bronchial asthma
  • Baseline lung function within specified parameters
  • No change in asthma treatment during the last 4 weeks prior to start of baseline period
  • Stable clinical state
  • Except for asthma, in good health
  • Non-smokers or ex-smokers

Main Exclusion Criteria:

  • Poorly controlled asthma
  • Diagnosis of chronic pulmonary disease and/or other relevant lung diseases
  • Patients using continuously (more than 3 days per week) > 8 puffs/day rescue medication

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 lung function.

Secondary Outcome Measures

Outcome Measure
asthma symptom score
change in morning PEF
rescue medication
time to withdrawal due to worsening asthma.

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

Study Completion (Actual)

June 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/M2-023

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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