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

Primary Purpose

Asthma

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Roflumilast
Sponsored by
AstraZeneca
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma focused on measuring Roflumilast, Asthma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • ALTANA Pharma
  • ALTANA Pharma
  • ALTANA Pharma
  • ALTANA Pharma
  • ALTANA Pharma
  • ALTANA Pharma
  • ALTANA Pharma
  • ALTANA Pharma
  • ALTANA Pharma
  • ALTANA Pharma
  • ALTANA Pharma
  • ALTANA Pharma
  • ALTANA Pharma
  • ALTANA Pharma
  • ALTANA Pharma
  • ALTANA Pharma
  • ALTANA Pharma
  • ALTANA Pharma
  • ALTANA Pharma
  • ALTANA Pharma
  • ALTANA Pharma
  • ALTANA Pharma
  • ALTANA Pharma
  • ALTANA Pharma
  • ALTANA Pharma
  • ALTANA Pharma
  • ALTANA Pharma
  • ALTANA Pharma
  • ALTANA Pharma
  • ALTANA Pharma
  • ALTANA Pharma
  • ALTANA Pharma
  • ALTANA Pharma
  • ALTANA Pharma
  • ALTANA Pharma
  • ALTANA Pharma
  • ALTANA Pharma
  • ALTANA Pharma
  • ALTANA Pharma
  • ALTANA Pharma
  • ALTANA Pharma

Outcomes

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.

Full Information

First Posted
January 13, 2004
Last Updated
December 1, 2016
Sponsor
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT00076076
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
December 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
Roflumilast, Asthma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
822 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Roflumilast
Primary Outcome Measure Information:
Title
change in lung function.
Secondary Outcome Measure Information:
Title
change in morning PEF
Title
asthma symptom score
Title
rescue medication
Title
time to withdrawal due to worsening asthma.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AstraZeneca AstraZeneca
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
Facility Information:
Facility Name
ALTANA Pharma
City
Cities in Alabama
State/Province
Alabama
Country
United States
Facility Name
ALTANA Pharma
City
Cities in Arizona
State/Province
Arizona
Country
United States
Facility Name
ALTANA Pharma
City
Cities in Arkansas
State/Province
Arkansas
Country
United States
Facility Name
ALTANA Pharma
City
Cities in California
State/Province
California
Country
United States
Facility Name
ALTANA Pharma
City
Cities in Colorado
State/Province
Colorado
Country
United States
Facility Name
ALTANA Pharma
City
Cities in Connecticut
State/Province
Connecticut
Country
United States
Facility Name
ALTANA Pharma
City
Cities in Delaware
State/Province
Delaware
Country
United States
Facility Name
ALTANA Pharma
City
Cities in Florida
State/Province
Florida
Country
United States
Facility Name
ALTANA Pharma
City
Cities in Georgia
State/Province
Georgia
Country
United States
Facility Name
ALTANA Pharma
City
Cities in Illinois
State/Province
Illinois
Country
United States
Facility Name
ALTANA Pharma
City
Cities in Indiana
State/Province
Indiana
Country
United States
Facility Name
ALTANA Pharma
City
Cities in Kansas
State/Province
Kansas
Country
United States
Facility Name
ALTANA Pharma
City
Cities in Kentucky
State/Province
Kentucky
Country
United States
Facility Name
ALTANA Pharma
City
Cities in Louisiana
State/Province
Louisiana
Country
United States
Facility Name
ALTANA Pharma
City
Cities in Maine
State/Province
Maine
Country
United States
Facility Name
ALTANA Pharma
City
Cities in Maryland
State/Province
Maryland
Country
United States
Facility Name
ALTANA Pharma
City
Cities in Massachusetts
State/Province
Massachusetts
Country
United States
Facility Name
ALTANA Pharma
City
Cities in Michigan
State/Province
Michigan
Country
United States
Facility Name
ALTANA Pharma
City
Cities in Minnesota
State/Province
Minnesota
Country
United States
Facility Name
ALTANA Pharma
City
Cities in Missouri
State/Province
Missouri
Country
United States
Facility Name
ALTANA Pharma
City
Cities in Montana
State/Province
Montana
Country
United States
Facility Name
ALTANA Pharma
City
Cities in Nebraska
State/Province
Nebraska
Country
United States
Facility Name
ALTANA Pharma
City
Cities in Nevada
State/Province
Nevada
Country
United States
Facility Name
ALTANA Pharma
City
Cities in New Jersey
State/Province
New Jersey
Country
United States
Facility Name
ALTANA Pharma
City
Cities in New York
State/Province
New York
Country
United States
Facility Name
ALTANA Pharma
City
Cities in North Carolina
State/Province
North Carolina
Country
United States
Facility Name
ALTANA Pharma
City
Cities in Ohio
State/Province
Ohio
Country
United States
Facility Name
ALTANA Pharma
City
Cities in Oklahoma
State/Province
Oklahoma
Country
United States
Facility Name
ALTANA Pharma
City
Cities in Oregon
State/Province
Oregon
Country
United States
Facility Name
ALTANA Pharma
City
Cities in Pennsylvania
State/Province
Pennsylvania
Country
United States
Facility Name
ALTANA Pharma
City
Cities in Rhode Island
State/Province
Rhode Island
Country
United States
Facility Name
ALTANA Pharma
City
Cities in South Carolina
State/Province
South Carolina
Country
United States
Facility Name
ALTANA Pharma
City
Cities in Tennessee
State/Province
Tennessee
Country
United States
Facility Name
ALTANA Pharma
City
Cities in Texas
State/Province
Texas
Country
United States
Facility Name
ALTANA Pharma
City
Cities in Utah
State/Province
Utah
Country
United States
Facility Name
ALTANA Pharma
City
Cities in Vermont
State/Province
Vermont
Country
United States
Facility Name
ALTANA Pharma
City
Cities in Virginia
State/Province
Virginia
Country
United States
Facility Name
ALTANA Pharma
City
Cities in Washington
State/Province
Washington
Country
United States
Facility Name
ALTANA Pharma
City
Cities in West Virginia
State/Province
West Virginia
Country
United States
Facility Name
ALTANA Pharma
City
Cities in Russia
Country
Russian Federation
Facility Name
ALTANA Pharma
City
Cities in the Ukraine
Country
Ukraine

12. IPD Sharing Statement

Citations:
PubMed Identifier
26612545
Citation
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.
Results Reference
derived
PubMed Identifier
26498386
Citation
Meltzer 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.
Results Reference
derived
Links:
URL
http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=4474&filename=BY217-M2-023-RDS-2007-01-23.pdf
Description
BY217-M2-023-RDS-2007-01-23.pdf

Learn more about this trial

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

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