NCT00443482

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

A Randomized, Multi-centre, Double-blind, Double Dummy Placebo Controlled Single-dose Cross-over Study to Demonstrate That 12 and 24 µg of Formoterol Delivered by Concept1 Has a Bronchodilator Efficacy Which is Equivalent to the Same Dose of Formoterol Delivered by Aerolizer in Adult Patients With Persistent Asthma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Novartis · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

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.

Conditions

• Asthma

Interventions

Type	Name	Description
DRUG	formoterol

Timeline

• Start date: 2007-02-01
• Primary completion: 2007-05-01
• Completion: 2007-05-01
• First posted: 2007-03-06
• Last updated: 2017-03-28

Locations

4 sites across 1 country: Germany