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

Home

Study Topics

Glossary


	Full Text View


	Tabular View


	Contacts and Locations


	No Study Results Posted


	Related Studies

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

This study has been completed.

Study NCT00076076. Last updated on December 15, 2006. Information provided by ALTANA Pharma

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

Brief Title ^†

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

Official Title ^†

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

Detailed Description

Study Phase

Phase III

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment

Primary Outcome Measure ^†

change in lung function.

Secondary Outcome Measure ^†

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

Condition ^†

Asthma

Intervention ^†

Drug: Roflumilast

MEDLINE PMIDs

Links

Recruitment Information Fields

Recruitment Status ^†

Completed

Enrollment ^†

822

Start Date ^†

December 2003

Completion Date

Eligibility 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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

United States, Russian Federation, Ukraine

Administrative Information Fields

NCT ID ^†

NCT00076076

Organization ID

BY217/M2-023

Secondary IDs ^††

Study Sponsor ^†

ALTANA Pharma

Collaborators ^††

Investigators ^†

Principal Investigator:

Eli O. Meltzer, MD

Allergy & Asthma Medical Group & Research Center, San Diego, Ca 92123, USA

Information Provided By

ALTANA Pharma

Verification Date

December 2006

First Received Date ^†

January 13, 2004

Last Updated Date

December 15, 2006

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.