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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00076076
Recruitment Status : Completed
First Posted : January 15, 2004
Last Update Posted : December 2, 2016
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Asthma Drug: Roflumilast Phase 3

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Study Type : Interventional  (Clinical Trial)
Enrollment : 822 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: The FLASH Study: A Randomized, Controlled Study of Roflumilast 250 mcg and 500 mcg Versus Placebo in Patients With Asthma
Study Start Date : December 2003
Actual Study Completion Date : June 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
Drug Information available for: Roflumilast




Primary Outcome Measures :
  1. change in lung function.

Secondary Outcome Measures :
  1. change in morning PEF
  2. asthma symptom score
  3. rescue medication
  4. time to withdrawal due to worsening asthma.


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00076076


Locations
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United States, Alabama
ALTANA Pharma
Cities in Alabama, Alabama, United States
United States, Arizona
ALTANA Pharma
Cities in Arizona, Arizona, United States
United States, Arkansas
ALTANA Pharma
Cities in Arkansas, Arkansas, United States
United States, California
ALTANA Pharma
Cities in California, California, United States
United States, Colorado
ALTANA Pharma
Cities in Colorado, Colorado, United States
United States, Connecticut
ALTANA Pharma
Cities in Connecticut, Connecticut, United States
United States, Delaware
ALTANA Pharma
Cities in Delaware, Delaware, United States
United States, Florida
ALTANA Pharma
Cities in Florida, Florida, United States
United States, Georgia
ALTANA Pharma
Cities in Georgia, Georgia, United States
United States, Illinois
ALTANA Pharma
Cities in Illinois, Illinois, United States
United States, Indiana
ALTANA Pharma
Cities in Indiana, Indiana, United States
United States, Kansas
ALTANA Pharma
Cities in Kansas, Kansas, United States
United States, Kentucky
ALTANA Pharma
Cities in Kentucky, Kentucky, United States
United States, Louisiana
ALTANA Pharma
Cities in Louisiana, Louisiana, United States
United States, Maine
ALTANA Pharma
Cities in Maine, Maine, United States
United States, Maryland
ALTANA Pharma
Cities in Maryland, Maryland, United States
United States, Massachusetts
ALTANA Pharma
Cities in Massachusetts, Massachusetts, United States
United States, Michigan
ALTANA Pharma
Cities in Michigan, Michigan, United States
United States, Minnesota
ALTANA Pharma
Cities in Minnesota, Minnesota, United States
United States, Missouri
ALTANA Pharma
Cities in Missouri, Missouri, United States
United States, Montana
ALTANA Pharma
Cities in Montana, Montana, United States
United States, Nebraska
ALTANA Pharma
Cities in Nebraska, Nebraska, United States
United States, Nevada
ALTANA Pharma
Cities in Nevada, Nevada, United States
United States, New Jersey
ALTANA Pharma
Cities in New Jersey, New Jersey, United States
United States, New York
ALTANA Pharma
Cities in New York, New York, United States
United States, North Carolina
ALTANA Pharma
Cities in North Carolina, North Carolina, United States
United States, Ohio
ALTANA Pharma
Cities in Ohio, Ohio, United States
United States, Oklahoma
ALTANA Pharma
Cities in Oklahoma, Oklahoma, United States
United States, Oregon
ALTANA Pharma
Cities in Oregon, Oregon, United States
United States, Pennsylvania
ALTANA Pharma
Cities in Pennsylvania, Pennsylvania, United States
United States, Rhode Island
ALTANA Pharma
Cities in Rhode Island, Rhode Island, United States
United States, South Carolina
ALTANA Pharma
Cities in South Carolina, South Carolina, United States
United States, Tennessee
ALTANA Pharma
Cities in Tennessee, Tennessee, United States
United States, Texas
ALTANA Pharma
Cities in Texas, Texas, United States
United States, Utah
ALTANA Pharma
Cities in Utah, Utah, United States
United States, Vermont
ALTANA Pharma
Cities in Vermont, Vermont, United States
United States, Virginia
ALTANA Pharma
Cities in Virginia, Virginia, United States
United States, Washington
ALTANA Pharma
Cities in Washington, Washington, United States
United States, West Virginia
ALTANA Pharma
Cities in West Virginia, West Virginia, United States
Russian Federation
ALTANA Pharma
Cities in Russia, Russian Federation
Ukraine
ALTANA Pharma
Cities in the Ukraine, Ukraine
Sponsors and Collaborators
AstraZeneca
Investigators
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Study Director: AstraZeneca AstraZeneca AstraZeneca

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00076076    
Other Study ID Numbers: BY217/M2-023
First Posted: January 15, 2004    Key Record Dates
Last Update Posted: December 2, 2016
Last Verified: September 2016
Keywords provided by AstraZeneca:
Roflumilast
Asthma
Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases