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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Takeda
ClinicalTrials.gov Identifier:
NCT00076076
First received: January 13, 2004
Last updated: May 4, 2012
Last verified: January 2012
  Purpose

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 Intervention Phase
Asthma
Drug: Roflumilast
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:


Further study details as provided by Takeda:

Primary Outcome Measures:
  • change in lung function.

Secondary Outcome Measures:
  • change in morning PEF
  • asthma symptom score
  • rescue medication
  • time to withdrawal due to worsening asthma.

Estimated Enrollment: 822
Study Start Date: December 2003
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00076076

  Show 41 Study Locations
Sponsors and Collaborators
Takeda
Investigators
Principal Investigator: Eli O. Meltzer, MD Allergy & Asthma Medical Group & Research Center, San Diego, Ca 92123, USA
  More Information

No publications provided

Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT00076076     History of Changes
Other Study ID Numbers: BY217/M2-023
Study First Received: January 13, 2004
Last Updated: May 4, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Takeda:
Roflumilast
Asthma

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

ClinicalTrials.gov processed this record on September 18, 2014