Clinical trial NCT00076076: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Asthma
Keywords: Roflumilast
Asthma
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2004-01-15
Enrollment: 822
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: change in lung function.
Secondary outcomes:
measure: change in morning PEF
measure: asthma symptom score
measure: rescue medication
measure: time to withdrawal due to worsening asthma.
Other outcomes:
Locations:
city: Cities in Alabama
country: United States
facility: ALTANA Pharma
state: Alabama
city: Cities in Arizona
country: United States
facility: ALTANA Pharma
state: Arizona
city: Cities in Arkansas
country: United States
facility: ALTANA Pharma
state: Arkansas
city: Cities in California
country: United States
facility: ALTANA Pharma
state: California
city: Cities in Colorado
country: United States
facility: ALTANA Pharma
state: Colorado
city: Cities in Connecticut
country: United States
facility: ALTANA Pharma
state: Connecticut
city: Cities in Delaware
country: United States
facility: ALTANA Pharma
state: Delaware
city: Cities in Florida
country: United States
facility: ALTANA Pharma
state: Florida
city: Cities in Georgia
country: United States
facility: ALTANA Pharma
state: Georgia
city: Cities in Illinois
country: United States
facility: ALTANA Pharma
state: Illinois
city: Cities in Indiana
country: United States
facility: ALTANA Pharma
state: Indiana
city: Cities in Kansas
country: United States
facility: ALTANA Pharma
state: Kansas
city: Cities in Kentucky
country: United States
facility: ALTANA Pharma
state: Kentucky
city: Cities in Louisiana
country: United States
facility: ALTANA Pharma
state: Louisiana
city: Cities in Maine
country: United States
facility: ALTANA Pharma
state: Maine
city: Cities in Maryland
country: United States
facility: ALTANA Pharma
state: Maryland
city: Cities in Massachusetts
country: United States
facility: ALTANA Pharma
state: Massachusetts
city: Cities in Michigan
country: United States
facility: ALTANA Pharma
state: Michigan
city: Cities in Minnesota
country: United States
facility: ALTANA Pharma
state: Minnesota
city: Cities in Missouri
country: United States
facility: ALTANA Pharma
state: Missouri
city: Cities in Montana
country: United States
facility: ALTANA Pharma
state: Montana
city: Cities in Nebraska
country: United States
facility: ALTANA Pharma
state: Nebraska
city: Cities in Nevada
country: United States
facility: ALTANA Pharma
state: Nevada
city: Cities in New Jersey
country: United States
facility: ALTANA Pharma
state: New Jersey
city: Cities in New York
country: United States
facility: ALTANA Pharma
state: New York
city: Cities in North Carolina
country: United States
facility: ALTANA Pharma
state: North Carolina
city: Cities in Ohio
country: United States
facility: ALTANA Pharma
state: Ohio
city: Cities in Oklahoma
country: United States
facility: ALTANA Pharma
state: Oklahoma
city: Cities in Oregon
country: United States
facility: ALTANA Pharma
state: Oregon
city: Cities in Pennsylvania
country: United States
facility: ALTANA Pharma
state: Pennsylvania
city: Cities in Rhode Island
country: United States
facility: ALTANA Pharma
state: Rhode Island
city: Cities in South Carolina
country: United States
facility: ALTANA Pharma
state: South Carolina
city: Cities in Tennessee
country: United States
facility: ALTANA Pharma
state: Tennessee
city: Cities in Texas
country: United States
facility: ALTANA Pharma
state: Texas
city: Cities in Utah
country: United States
facility: ALTANA Pharma
state: Utah
city: Cities in Vermont
country: United States
facility: ALTANA Pharma
state: Vermont
city: Cities in Virginia
country: United States
facility: ALTANA Pharma
state: Virginia
city: Cities in Washington
country: United States
facility: ALTANA Pharma
state: Washington
city: Cities in West Virginia
country: United States
facility: ALTANA Pharma
state: West Virginia
city: Cities in Russia
country: Russian Federation
facility: ALTANA Pharma
city: Cities in the Ukraine
country: Ukraine
facility: ALTANA Pharma
Study officials:
affiliation: AstraZeneca
name: AstraZeneca AstraZeneca
role: STUDY_DIRECTOR
References:
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.
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.