Overview

Study to Demonstrate Equivalence of Formoterol 12 and 24 µg Delivered Via Two Types of Single Dose Dry Powder Inhalers (Concept1 and Aerolizer)

Status:
Completed
Trial end date:
2007-05-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Details
Lead Sponsor:
Novartis
Treatments:
Formoterol Fumarate
Criteria
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