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NCT00443482 Clinical Trial

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

Asthma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00443482
Other study ID # CFOR258D2201
Secondary ID
Status Completed
Phase Phase 2
First received March 5, 2007
Last updated March 24, 2017
Start date February 2007
Est. completion date May 2007

Study information
Verified date March 2017
Source Novartis
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 50
Est. completion date May 2007
Est. primary completion date May 2007
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• formoterol

Locations
Country Name City State
Germany Novartis Investigative Site Berlin
Germany Novartis Investigative Site Bovenden--Lengler
Germany Novartis Investigative Site Marburg
Germany Novartis Investigative Site Wiesbaden

Sponsors (1)
Lead Sponsor Collaborator
Novartis

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary • 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 • 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
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