A Crossover Study in the Treatment of Patients With COPD
Phase 3
Completed
- Conditions
- Chronic Obstructive Pulmonary Disease
- Registration Number
- NCT00462540
- Lead Sponsor
- Dey
- Brief Summary
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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 100
Inclusion Criteria
- Diagnosis of COPD
- Smoker or exsmoker with at least 10 years smoking at least one pack of cigarettes per day
- Meet lung function requirements
Exclusion Criteria
- Diagnosis of Asthma
- Significant disease other than COPD
- Female pregnant or lactating or planning to become pregnant
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method Lung function after 2 weeks of treatment
- Secondary Outcome Measures
Name Time Method Lung function at each time point, patient questionnaires, medication compliance, adverse events, clinical labs, vital signs, ECGs, physical exams
Trial Locations
- Locations (1)
Research Site
🇺🇸Morgantown, West Virginia, United States