Who is sponsoring NCT00442351?

NCT00442351 is sponsored by Organon and Co.

What drugs are being tested in NCT00442351?

Interventions: Asmanex twisthaler, Placebo for Asmanex twisthaler.

What is the status of NCT00442351?

NCT00442351 is currently TERMINATED.

Last reviewed 2022-02-07 · How we verify

A Comparative Study of The Efficacy and Tolerability of Maintenance Treatment of Patients With Mild/Moderate Persistent Asthma With Asmanex Twisthaler 220 mcg QD PM Versus "Asmanex" Placebo QD PM

NCT00442351 Phase 4 TERMINATED Results posted

This is a randomized, multicenter, placebo-controlled, double-blind, parallel-group study evaluating Asmanex Twisthaler 220 mcg once daily (QD) in the evening (PM) compared with "Asmanex" Placebo QD PM for 12 weeks. Efficacy will be measured for the changes in forced expiratory volume in 1 second (FEV1) from baseline to the end of treatment period (Week 12 or end of the study).

Details

Lead sponsor	Organon and Co
Phase	Phase 4
Status	TERMINATED
Enrolment	26
Start date	2006-09
Completion	2007-04

Conditions

Asthma

Interventions

Asmanex twisthaler
Placebo for Asmanex twisthaler

Primary outcomes

Change From Baseline to Final/Terminal Visit in Forced Expiratory Value in 1 Second (FEV1) in Morning Office Measurements. — Twelve (12) weeks
The baseline value for this outcome measure was evaluated at the baseline visit prior to randomization. The change from Baseline to final/terminal visit in FEV1 was to be analyzed using an Analysis of Covariance (ANCOVA) model.