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

Phase 3

Completed

• Conditions: Asthma

• Registration Number: NCT00076076
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-12
• Study First Submitted: 2004-01-13
• Study First Submitted QC: 2004-01-14
• Study First Posted: 2004-01-15
• Study Completion: 2005-06
• Status Verified: 2016-09
• Last Update Submitted: 2016-12-01
• Last Update Posted: 2016-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 822

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
change in lung function.

Secondary Outcome Measures

Name	Time	Method
time to withdrawal due to worsening asthma.
rescue medication
change in morning PEF
asthma symptom score

Trial Locations

Locations (1)

ALTANA Pharma; 🇺🇦 Cities in the Ukraine, Ukraine

ALTANA Pharma

🇺🇦Cities in the Ukraine, Ukraine