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| Sponsored by: |
Dey |
|---|---|
| Information provided by: | Dey |
| ClinicalTrials.gov Identifier: | NCT00462540 |
Purpose
The purpose of this study is to compare the efficacy of Formoterol Fumarate Inhalation Solution (FFIS) 20 mcg BID to Combivent® Inhalation Aerosol [2 inhalations from metered dose inhaler (MDI)of 18 mcg ipratropium bromide and 103 mcg albuterol sulfate QID], and to Compare the preference/compliance of BID nebulization to QID use of MDI
| Condition | Intervention | Phase |
|---|---|---|
|
Chronic Obstructive Pulmonary Disease |
Drug: Formoterol Fumurate inhalation solution 20 mcg Drug: Ipratropium bromide 18 mcg and albuterol sulfate 103 mcg |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Safety/Efficacy Study |
| Estimated Enrollment: | 100 |
| Study Start Date: | May 2007 |
| Study Completion Date: | October 2007 |
| Primary Completion Date: | September 2007 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 40 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, California | |
| Research Site | |
| San Diego, California, United States, 92120 | |
| United States, Colorado | |
| Research Site | |
| Wheat Ridge, Colorado, United States, 80033 | |
| Research Site | |
| Denver, Colorado, United States, 80206 | |
| United States, Florida | |
| Research Site | |
| Pensacola, Florida, United States, 32504 | |
| Research Site | |
| Panama City, Florida, United States, 32405 | |
| United States, Idaho | |
| Research Site | |
| Coeur d'Alene, Idaho, United States, 83814 | |
| United States, Louisiana | |
| Research Site | |
| Sunset, Louisiana, United States, 70584 | |
| United States, North Carolina | |
| Research Site | |
| Charlotte, North Carolina, United States, 28207 | |
| United States, Oregon | |
| Research Site | |
| Portland, Oregon, United States, 97213 | |
| United States, South Carolina | |
| Research Site | |
| Spartanburg, South Carolina, United States, 29303 | |
| Research Site | |
| Gaffney, South Carolina, United States, 29340 | |
| United States, Tennessee | |
| Research Site | |
| Johnson City, Tennessee, United States, 37601 | |
| United States, Texas | |
| Research Site | |
| San Antonio, Texas, United States, 78205 | |
| United States, Washington | |
| Research Site | |
| Spokane, Washington, United States, 99204 | |
| United States, West Virginia | |
| Research Site | |
| Morgantown, West Virginia, United States, 26505 | |
More Information
| Responsible Party: | Dey ( Director, Clinical Affairs ) |
| Study ID Numbers: | 201-081 |
| Study First Received: | April 17, 2007 |
| Last Updated: | March 5, 2008 |
| ClinicalTrials.gov Identifier: | NCT00462540 |
| Health Authority: | United States: Food and Drug Administration |
|
COPD Formoterol Ipratropium Crossover |
|
Lung Diseases, Obstructive Ipratropium Respiratory Tract Diseases Bromides |
Lung Diseases Albuterol Formoterol Pulmonary Disease, Chronic Obstructive |
|
Respiratory System Agents Neurotransmitter Agents Cholinergic Antagonists Molecular Mechanisms of Pharmacological Action Adrenergic beta-Agonists Adrenergic Agents Physiological Effects of Drugs Anti-Asthmatic Agents Reproductive Control Agents |
Cholinergic Agents Pharmacologic Actions Adrenergic Agonists Tocolytic Agents Autonomic Agents Therapeutic Uses Peripheral Nervous System Agents Bronchodilator Agents |
