Efficacy and Tolerability of Maintenance Treatment With Asmanex Twisthaler Versus Placebo in Mild/Moderate Persistent Asthmatics (Study P04654)(TERMINATED)
Terminated
Merck Sharp & Dohme Corp.
Phase 4
2006-09-01
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).
Efficacy and Safety of Mometasone Furoate for Persistent Asthma Previously Treated With Low-Dose Inhaled Glucocorticosteroids (ICS) (Study P06115)
Withdrawn
Merck Sharp & Dohme Corp.
Phase 3
2012-06-01
Mometasone furoate (MF) is a synthetic glucocorticosteroid that, when administered to asthma
patients with a dry powder inhaler (Asmanex® Twisthaler®) at dosages of 100 to 400 mcg twice
daily, has been shown to improve lung function, reduce symptoms of asthma, and reduce
frequency and severity of exacerbations by reducing airway inflammation, with a relatively
low potential to cause systemic side effects such as hypothalamic-pituitary-adrenal (HPA)
axis suppression.
An experimental formulation of MF 100 mcg delivered twice daily via a pressurized
metered-dose inhaler (MDI) also has been shown to be effective in improving lung function of
asthma patients as measured by forced expiratory volume in 1 second (FEV1). This trial is
designed to verify the effectiveness of twice daily MF MDI 100 mcg in treating asthma in
adults and adolescents previously treated with low dosages of inhaled corticosteroids (ICS),
as measured by improvement in morning FEV1 and time to first asthma exacerbation over 12
weeks of treatment.
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