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
1 other identifier
interventional
822
3 countries
41
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 asthma
Started Dec 2003
41 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2003
CompletedFirst Submitted
Initial submission to the registry
January 13, 2004
CompletedFirst Posted
Study publicly available on registry
January 15, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2005
CompletedDecember 2, 2016
September 1, 2016
January 13, 2004
December 1, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
change in lung function.
Secondary Outcomes (4)
change in morning PEF
asthma symptom score
rescue medication
time to withdrawal due to worsening asthma.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (41)
ALTANA Pharma
Cities in Alabama, Alabama, United States
ALTANA Pharma
Cities in Arizona, Arizona, United States
ALTANA Pharma
Cities in Arkansas, Arkansas, United States
ALTANA Pharma
Cities in California, California, United States
ALTANA Pharma
Cities in Colorado, Colorado, United States
ALTANA Pharma
Cities in Connecticut, Connecticut, United States
ALTANA Pharma
Cities in Delaware, Delaware, United States
ALTANA Pharma
Cities in Florida, Florida, United States
ALTANA Pharma
Cities in Georgia, Georgia, United States
ALTANA Pharma
Cities in Illinois, Illinois, United States
ALTANA Pharma
Cities in Indiana, Indiana, United States
ALTANA Pharma
Cities in Kansas, Kansas, United States
ALTANA Pharma
Cities in Kentucky, Kentucky, United States
ALTANA Pharma
Cities in Louisiana, Louisiana, United States
ALTANA Pharma
Cities in Maine, Maine, United States
ALTANA Pharma
Cities in Maryland, Maryland, United States
ALTANA Pharma
Cities in Massachusetts, Massachusetts, United States
ALTANA Pharma
Cities in Michigan, Michigan, United States
ALTANA Pharma
Cities in Minnesota, Minnesota, United States
ALTANA Pharma
Cities in Missouri, Missouri, United States
ALTANA Pharma
Cities in Montana, Montana, United States
ALTANA Pharma
Cities in Nebraska, Nebraska, United States
ALTANA Pharma
Cities in Nevada, Nevada, United States
ALTANA Pharma
Cities in New Jersey, New Jersey, United States
ALTANA Pharma
Cities in New York, New York, United States
ALTANA Pharma
Cities in North Carolina, North Carolina, United States
ALTANA Pharma
Cities in Ohio, Ohio, United States
ALTANA Pharma
Cities in Oklahoma, Oklahoma, United States
ALTANA Pharma
Cities in Oregon, Oregon, United States
ALTANA Pharma
Cities in Pennsylvania, Pennsylvania, United States
ALTANA Pharma
Cities in Rhode Island, Rhode Island, United States
ALTANA Pharma
Cities in South Carolina, South Carolina, United States
ALTANA Pharma
Cities in Tennessee, Tennessee, United States
ALTANA Pharma
Cities in Texas, Texas, United States
ALTANA Pharma
Cities in Utah, Utah, United States
ALTANA Pharma
Cities in Vermont, Vermont, United States
ALTANA Pharma
Cities in Virginia, Virginia, United States
ALTANA Pharma
Cities in Washington, Washington, United States
ALTANA Pharma
Cities in West Virginia, West Virginia, United States
ALTANA Pharma
Cities in Russia, Russia
ALTANA Pharma
Cities in the Ukraine, Ukraine
Related Publications (2)
Chervinsky P, Meltzer EO, Busse W, Ohta K, Bardin P, Bredenbroker D, Bateman ED. Roflumilast for asthma: Safety findings from a pooled analysis of ten clinical studies. Pulm Pharmacol Ther. 2015 Dec;35 Suppl:S28-34. doi: 10.1016/j.pupt.2015.11.003. Epub 2015 Nov 22.
PMID: 26612545DERIVEDMeltzer EO, Chervinsky P, Busse W, Ohta K, Bardin P, Bredenbroker D, Bateman ED. Roflumilast for asthma: Efficacy findings in placebo-controlled studies. Pulm Pharmacol Ther. 2015 Dec;35 Suppl:S20-7. doi: 10.1016/j.pupt.2015.10.006. Epub 2015 Oct 21.
PMID: 26498386DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
AstraZeneca AstraZeneca
AstraZeneca
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 13, 2004
First Posted
January 15, 2004
Study Start
December 1, 2003
Study Completion
June 1, 2005
Last Updated
December 2, 2016
Record last verified: 2016-09