Study to Demonstrate Equivalence of Formoterol 12 and 24 µg Delivered Via Two Types of Single Dose Dry Powder Inhalers (Concept1 and Aerolizer)
Phase 2
Completed
- Conditions
- Asthma
- Registration Number
- NCT00443482
- Lead Sponsor
- Novartis
- Brief Summary
This study is designed to demonstrate that formoterol 12µg and 24µg delivered by a new inhalation device (Concept1) are equivalent to the corresponding dose of formoterol delivered by the Aerolizer device in terms of efficacy, in patients with persistent asthma.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
Inclusion Criteria
- History of asthma attacks
- Forced expiratory volume in 1 second (measure of how well the lungs are working) is greater than 60% of the predicted value
Exclusion Criteria
- Asthma is not stable: patients were admitted to hospital or received emergency room treatment
- Patients whose asthma drugs need changing within the month prior to the start of the study
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method • Efficacy assessed by 12 hour Area Under the Curve (AUC) of FEV1 (forced expiratory volume in 1 second, is a measure of how well the lungs are working)
- Secondary Outcome Measures
Name Time Method • Efficacy assessed by forced expiratory volume in 1 second at pre-dose, 15, 30 minutes, 1, 2, 3, 4, 6, 8, 10, 11 and 12 hours post dose
Trial Locations
- Locations (1)
Novartis Investigative Site
🇩🇪Wiesbaden, Germany