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| Sponsor: | ALTANA Pharma |
|---|---|
| Information provided by: | 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 III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment |
| Official Title: | The FLASH Study: A Randomized, Controlled Study of Roflumilast 250 Mcg and 500 Mcg Versus Placebo in Patients With Asthma |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Main Inclusion Criteria:
Main Exclusion Criteria:
Contacts and Locations
Hide Study Locations| United States, Alabama | |
| ALTANA Pharma | |
| Cities in Alabama, Alabama, United States | |
| United States, Arizona | |
| ALTANA Pharma | |
| Cities in Arizona, Arizona, United States | |
| United States, Arkansas | |
| ALTANA Pharma | |
| Cities in Arkansas, Arkansas, United States | |
| United States, California | |
| ALTANA Pharma | |
| Cities in California, California, United States | |
| United States, Colorado | |
| ALTANA Pharma | |
| Cities in Colorado, Colorado, United States | |
| United States, Connecticut | |
| ALTANA Pharma | |
| Cities in Connecticut, Connecticut, United States | |
| United States, Delaware | |
| ALTANA Pharma | |
| Cities in Delaware, Delaware, United States | |
| United States, Florida | |
| ALTANA Pharma | |
| Cities in Florida, Florida, United States | |
| United States, Georgia | |
| ALTANA Pharma | |
| Cities in Georgia, Georgia, United States | |
| United States, Illinois | |
| ALTANA Pharma | |
| Cities in Illinois, Illinois, United States | |
| United States, Indiana | |
| ALTANA Pharma | |
| Cities in Indiana, Indiana, United States | |
| United States, Kansas | |
| ALTANA Pharma | |
| Cities in Kansas, Kansas, United States | |
| United States, Kentucky | |
| ALTANA Pharma | |
| Cities in Kentucky, Kentucky, United States | |
| United States, Louisiana | |
| ALTANA Pharma | |
| Cities in Louisiana, Louisiana, United States | |
| United States, Maine | |
| ALTANA Pharma | |
| Cities in Maine, Maine, United States | |
| United States, Maryland | |
| ALTANA Pharma | |
| Cities in Maryland, Maryland, United States | |
| United States, Massachusetts | |
| ALTANA Pharma | |
| Cities in Massachusetts, Massachusetts, United States | |
| United States, Michigan | |
| ALTANA Pharma | |
| Cities in Michigan, Michigan, United States | |
| United States, Minnesota | |
| ALTANA Pharma | |
| Cities in Minnesota, Minnesota, United States | |
| United States, Missouri | |
| ALTANA Pharma | |
| Cities in Missouri, Missouri, United States | |
| United States, Montana | |
| ALTANA Pharma | |
| Cities in Montana, Montana, United States | |
| United States, Nebraska | |
| ALTANA Pharma | |
| Cities in Nebraska, Nebraska, United States | |
| United States, Nevada | |
| ALTANA Pharma | |
| Cities in Nevada, Nevada, United States | |
| United States, New Jersey | |
| ALTANA Pharma | |
| Cities in New Jersey, New Jersey, United States | |
| United States, New York | |
| ALTANA Pharma | |
| Cities in New York, New York, United States | |
| United States, North Carolina | |
| ALTANA Pharma | |
| Cities in North Carolina, North Carolina, United States | |
| United States, Ohio | |
| ALTANA Pharma | |
| Cities in Ohio, Ohio, United States | |
| United States, Oklahoma | |
| ALTANA Pharma | |
| Cities in Oklahoma, Oklahoma, United States | |
| United States, Oregon | |
| ALTANA Pharma | |
| Cities in Oregon, Oregon, United States | |
| United States, Pennsylvania | |
| ALTANA Pharma | |
| Cities in Pennsylvania, Pennsylvania, United States | |
| United States, Rhode Island | |
| ALTANA Pharma | |
| Cities in Rhode Island, Rhode Island, United States | |
| United States, South Carolina | |
| ALTANA Pharma | |
| Cities in South Carolina, South Carolina, United States | |
| United States, Tennessee | |
| ALTANA Pharma | |
| Cities in Tennessee, Tennessee, United States | |
| United States, Texas | |
| ALTANA Pharma | |
| Cities in Texas, Texas, United States | |
| United States, Utah | |
| ALTANA Pharma | |
| Cities in Utah, Utah, United States | |
| United States, Vermont | |
| ALTANA Pharma | |
| Cities in Vermont, Vermont, United States | |
| United States, Virginia | |
| ALTANA Pharma | |
| Cities in Virginia, Virginia, United States | |
| United States, Washington | |
| ALTANA Pharma | |
| Cities in Washington, Washington, United States | |
| United States, West Virginia | |
| ALTANA Pharma | |
| Cities in West Virginia, West Virginia, United States | |
| Russian Federation | |
| ALTANA Pharma | |
| Cities in Russia, Russian Federation | |
| Ukraine | |
| ALTANA Pharma | |
| Cities in the Ukraine, Ukraine | |
| Principal Investigator: | Eli O. Meltzer, MD | Allergy & Asthma Medical Group & Research Center, San Diego, Ca 92123, USA |
More Information
| Study ID Numbers: | BY217/M2-023 |
| Study First Received: | January 13, 2004 |
| Last Updated: | December 15, 2006 |
| ClinicalTrials.gov Identifier: | NCT00076076 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Roflumilast Asthma |
|
Hypersensitivity Lung Diseases, Obstructive Immune System Diseases Respiratory Tract Diseases Bronchial Diseases |
Lung Diseases Hypersensitivity, Immediate Asthma Respiratory Hypersensitivity |
