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

Tracking Information

First Received Date ^ICMJE

January 13, 2004

Last Updated Date

December 15, 2006

Start Date ^ICMJE

December 2003

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

change in lung function.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00076076 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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 ^ICMJE

Interventional

Study Design ^ICMJE

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

Condition ^ICMJE

Asthma

Intervention ^ICMJE

Drug: Roflumilast

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

822

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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 ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Russian Federation, Ukraine

Administrative Information

NCT ID ^ICMJE

NCT00076076

Responsible Party

Study ID Numbers ^ICMJE

BY217/M2-023

Study Sponsor ^ICMJE

ALTANA Pharma

Collaborators ^ICMJE

Investigators ^ICMJE

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

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP