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. Identifier: NCT00076076
Recruitment Status : Completed
First Posted : January 15, 2004
Last Update Posted : December 2, 2016
Information provided by (Responsible Party):

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

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
U.S. FDA Resources

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

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

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 identifier (NCT number): NCT00076076

  Show 41 Study Locations
Sponsors and Collaborators
Study Director: AstraZeneca AstraZeneca AstraZeneca

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: AstraZeneca Identifier: NCT00076076     History of Changes
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:

Additional relevant MeSH terms:
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases