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

The FLASH Study: A Randomized, Controlled Study of Roflumilast 250 mcg and 500 mcg Versus Placebo in Patients With Asthma

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00076076

Enrollment

822

Registered

2004-01-15

Start date

2003-12-31

Completion date

2005-06-30

Last updated

2016-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

Keywords

Roflumilast, Asthma

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.

Interventions

DRUGRoflumilast

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion 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

Design outcomes

Primary

Measure	Time frame
change in lung function.	—

Secondary

Measure	Time frame
change in morning PEF	—
asthma symptom score	—
rescue medication	—
time to withdrawal due to worsening asthma.	—

Countries

Russia, Ukraine, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 15, 2026