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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
822

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
change in lung function.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2003

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2005

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 13, 2004

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 14, 2004

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 15, 2004

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 2, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 1, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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