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| Sponsor: | ALTANA Pharma |
|---|---|
| Information provided by: | ALTANA Pharma |
| ClinicalTrials.gov Identifier: | NCT00073177 |
Purpose
The aim of the study is to compare the effects of oral roflumilast with placebo on lung function in patients with asthma.
| Condition | Intervention | Phase |
|---|---|---|
|
Asthma |
Drug: Roflumilast |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment |
| Official Title: | A 24 Week, Double-Blind, Randomized, Placebo-Controlled Clinical Trial to Evaluate the Efficacy and Safety of Oral Roflumilast (250 Mcg or 500 Mcg) Daily in Patients With Asthma |
| Estimated Enrollment: | 819 |
| Study Start Date: | November 2003 |
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| 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, Florida | |
| ALTANA Pharma | |
| Cities in Florida, Florida, United States | |
| United States, Georgia | |
| ALTANA Pharma | |
| Cities in Georgia, Georgia, United States | |
| United States, Idaho | |
| ALTANA Pharma | |
| Cities in Idaho, Idaho, 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, Iowa | |
| ALTANA Pharma | |
| Cities in Iowa, Iowa, 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, Maryland | |
| ALTANA Pharma | |
| Cities in Maryland, Maryland, United States | |
| United States, Massachusetts | |
| ALTANA Pharma | |
| 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, Mississippi | |
| ALTANA Pharma | |
| Cities in Mississippi, Mississippi, 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, North Dakota | |
| ALTANA Pharma | |
| Cities in North Dakota, North Dakota, 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, Virginia | |
| ALTANA Pharma | |
| Cities in Virginia, Virginia, United States | |
| United States, Washington | |
| ALTANA Pharma | |
| Cities in Washington, Washington, United States | |
| United States, Wisconsin | |
| ALTANA Pharma | |
| Cities in Wisconsin, Wisconsin, United States | |
| Argentina | |
| ALTANA Pharma | |
| Cities in Argentina, Argentina | |
| Colombia | |
| ALTANA Pharma | |
| Cities in Colombia, Colombia | |
| Mexico | |
| ALTANA Pharma | |
| Cities in Mexico, Mexico | |
| Peru | |
| ALTANA Pharma | |
| Cities in Peru, Peru | |
| Study Director: | Dirk Bredenbröker, MD | ALTANA Pharma, D-78467 Konstanz, Germany |
More Information
| Study ID Numbers: | BY217/M2-012 |
| Study First Received: | November 17, 2003 |
| Last Updated: | April 2, 2007 |
| ClinicalTrials.gov Identifier: | NCT00073177 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Hypersensitivity Lung Diseases, Obstructive Immune System Diseases Respiratory Tract Diseases Bronchial Diseases |
Lung Diseases Hypersensitivity, Immediate Asthma Respiratory Hypersensitivity |