Status:

COMPLETED

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

Lead Sponsor:

AstraZeneca

Conditions:

Asthma

Eligibility:

All Genders

18+ years

Phase:

PHASE3

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...

Eligibility Criteria

Inclusion

  • Main
  • 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

  • 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

Key Trial Info

Start Date :

December 1 2003

Trial Type :

INTERVENTIONAL

End Date :

June 1 2005

Estimated Enrollment :

822 Patients enrolled

Trial Details

Trial ID

NCT00076076

Start Date

December 1 2003

End Date

June 1 2005

Last Update

December 2 2016

Active Locations (41)

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Page 1 of 11 (41 locations)

1

ALTANA Pharma

Cities in Alabama, Alabama, United States

2

ALTANA Pharma

Cities in Arizona, Arizona, United States

3

ALTANA Pharma

Cities in Arkansas, Arkansas, United States

4

ALTANA Pharma

Cities in California, California, United States