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Sponsored by: |
ALTANA Pharma |
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Information provided by: | ALTANA Pharma |
ClinicalTrials.gov Identifier: | NCT00108823 |
The purpose of this trial is to study the effects of roflumilast on lung function parameters indicative of hyperinflation in patients with COPD.
Condition | Intervention | Phase |
---|---|---|
Chronic Obstructive Pulmonary Disease, COPD |
Drug: Roflumilast |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A 24-Week, Double Blind, Randomized Study to Investigate the Effect of 500 µg Roflumilast Tablets Once Daily Versus Placebo on Parameters Indicative of Hyperinflation in Patients With Chronic Obstructive Pulmonary Disease |
Estimated Enrollment: | 550 |
Study Start Date: | October 2004 |
Ages Eligible for Study: | 40 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Main Inclusion Criteria:
Main Exclusion Criteria:
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, Missouri | |
ALTANA Pharma | |
Cities in Missouri, Missouri, United States | |
United States, New Mexico | |
ALTANA Pharma | |
Cities in New Mexico, New Mexico, United States | |
United States, New York | |
ALTANA Pharma | |
Cities in New York, New York, United States | |
United States, Oregon | |
ALTANA Pharma | |
Cities in Oregeon, Oregon, United States | |
United States, South Carolina | |
ALTANA Pharma | |
Cities in South Carolina, South Carolina, United States | |
United States, Texas | |
ALTANA Pharma | |
Cities in Texas, Texas, United States | |
United States, Washington | |
ALTANA Pharma | |
Cities in Washington, Washington, United States | |
Canada | |
ALTANA Pharma | |
Cities in Canada, Canada | |
France | |
ALTANA Pharma | |
Cities in France, France | |
Poland | |
ALTANA Pharma | |
Cities in Poland, Poland | |
South Africa | |
ALTANA Pharma | |
Cities in South Africa, South Africa | |
Spain | |
ALTANA Pharma | |
Cities in Spain, Spain | |
United Kingdom | |
ALTANA Pharma | |
Cities in the United Kingdom, United Kingdom |
Study Director: | D. Bredenbröker, MD | ALTANA Pharma AG |
Study ID Numbers: | BY217/M2-121 |
Study First Received: | April 19, 2005 |
Last Updated: | December 15, 2006 |
ClinicalTrials.gov Identifier: | NCT00108823 |
Health Authority: | United States: Food and Drug Administration |
Lung Diseases, Obstructive Respiratory Tract Diseases Lung Diseases Respiration Disorders Pulmonary Disease, Chronic Obstructive |