Asthma Clinical Trial
Official title:
The FLASH Study: A Randomized, Controlled Study of Roflumilast 250 mcg and 500 mcg Versus Placebo in Patients With Asthma
| Verified date | September 2016 |
| Source | AstraZeneca |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 822 |
| Est. completion date | June 2005 |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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 |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Russian Federation | ALTANA Pharma | Cities in Russia | |
| Ukraine | ALTANA Pharma | Cities in the Ukraine | |
| United States | 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 |
| Lead Sponsor | Collaborator |
|---|---|
| AstraZeneca |
United States, Russian Federation, Ukraine,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | change in lung function. | |||
| Secondary | change in morning PEF | |||
| Secondary | asthma symptom score | |||
| Secondary | rescue medication | |||
| Secondary | time to withdrawal due to worsening asthma. |
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