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

This study has been completed.

First Received on January 13, 2004. Last Updated on May 4, 2012 History of Changes

Sponsor:	ALTANA Pharma
Information provided by (Responsible Party):	ALTANA Pharma
ClinicalTrials.gov Identifier:	NCT00076076

Purpose

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.

Condition	Intervention	Phase
Asthma	Drug: Roflumilast	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	The FLASH Study: A Randomized, Controlled Study of Roflumilast 250 Mcg and 500 Mcg Versus Placebo in Patients With Asthma

Resource links provided by NLM:

MedlinePlus related topics: Asthma

Drug Information available for: Roflumilast

U.S. FDA Resources

Further study details as provided by ALTANA Pharma:

Primary Outcome Measures:

change in lung function.

Secondary Outcome Measures:

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

Estimated Enrollment:	822
Study Start Date:	December 2003

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00076076

Show 41 Study Locations

Sponsors and Collaborators

ALTANA Pharma

Investigators

Principal Investigator:

Eli O. Meltzer, MD

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

More Information

No publications provided

Responsible Party:	ALTANA Pharma
ClinicalTrials.gov Identifier:	NCT00076076 History of Changes
Other Study ID Numbers:	BY217/M2-023
Study First Received:	January 13, 2004
Last Updated:	May 4, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by ALTANA Pharma:

Roflumilast
Asthma

Additional relevant MeSH terms:

Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases

Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on May 21, 2012