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

Sponsor

Novartis (Industry)

Overall Status

Completed

CT.gov ID

NCT00443482

Collaborator

(none)

Enrollment

Locations

2.9

Duration (Months)

12.5

Patients Per Site

4.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Asthma	Drug: formoterol	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Double

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Feb 1, 2007

Actual Primary Completion Date :

May 1, 2007

Actual Study Completion Date :

May 1, 2007

Outcome Measures

Primary Outcome Measures

• 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

• 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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

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

Contacts and Locations

Locations

	Site	City	Country
1	Novartis Investigative Site	Berlin	Germany
2	Novartis Investigative Site	Bovenden--Lengler	Germany
3	Novartis Investigative Site	Marburg	Germany
4	Novartis Investigative Site	Wiesbaden	Germany