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Sponsored by: |
Dey |
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Information provided by: | Dey |
ClinicalTrials.gov Identifier: | NCT00308191 |
The purpose of this study is to evaluate the safety and efficacy of the concomitant treatment of formoterol fumarate with tiotropium bromide compared to treatment with tiotropium bromide alone.
Condition | Intervention | Phase |
---|---|---|
COPD |
Drug: Formoterol Fumarate Drug: Tiotropium Bromide |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A 6-Week Double-Blind, Parallel-Group, Active-Controlled Trial to Compare the Efficacy and Safety of Concomitant Treatment of Formoterol Fumarate Inhalation Solution 20 Mcg Twice Daily and Tiotropium 18 Mcg Once Daily to Tiotropium 18 Mcg Once Daily Alone in the Treatment of Patients With Chronic Obstructive Pulmonary Disease |
Estimated Enrollment: | 128 |
Study Start Date: | April 2006 |
Study Completion Date: | December 2006 |
Primary Completion Date: | May 2006 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 40 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Arizona | |
Research Site | |
Phoenix, Arizona, United States, 85006 | |
United States, California | |
Research Site | |
Walnut Creek, California, United States, 94598 | |
Research Site | |
Sepulveda, California, United States, 91343 | |
Research Site | |
Los Angeles, California, United States, 90095 | |
United States, Colorado | |
Research Site | |
Colorado Springs, Colorado, United States, 80907 | |
United States, Florida | |
Research Site | |
Tamarac, Florida, United States, 33321 | |
United States, Georgia | |
Research Site | |
Gainesville, Georgia, United States, 30501 | |
United States, Maine | |
Research Site | |
Auburn, Maine, United States, 04210 | |
United States, Michigan | |
Research Site | |
Livonia, Michigan, United States, 48152 | |
Research Site | |
Ann Arbor, Michigan, United States, 48105 | |
United States, Missouri | |
Research Site | |
St. Louis, Missouri, United States, 63141 | |
United States, New York | |
Research Site | |
Rochester, New York, United States, 14618 | |
Research Site | |
Liverpool, New York, United States, 13088 | |
United States, Oregon | |
Research Site | |
Medford, Oregon, United States, 97504 | |
United States, Pennsylvania | |
Research Site | |
Collegeville, Pennsylvania, United States, 19426 | |
United States, Texas | |
Research Site | |
San Antonio, Texas, United States, 78229 | |
Research Site | |
El Paso, Texas, United States, 79902 |
Responsible Party: | Dey L.P. ( Director, Clinical Affairs ) |
Study ID Numbers: | 201-070 |
Study First Received: | March 27, 2006 |
Last Updated: | March 5, 2008 |
ClinicalTrials.gov Identifier: | NCT00308191 |
Health Authority: | United States: Food and Drug Administration |
COPD Formoterol Tiotropium |
Lung Diseases, Obstructive Respiratory Tract Diseases Bromides Lung Diseases |
Formoterol Tiotropium Pulmonary Disease, Chronic Obstructive |
Parasympatholytics Respiratory System Agents Neurotransmitter Agents Cholinergic Antagonists Adrenergic beta-Agonists Adrenergic Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs |
Anti-Asthmatic Agents Cholinergic Agents Adrenergic Agonists Pharmacologic Actions Autonomic Agents Therapeutic Uses Peripheral Nervous System Agents Bronchodilator Agents |