NCT01026870

Efficacy and Safety of Mometasone Furoate for Persistent Asthma Previously Treated With Low-Dose Inhaled Glucocorticosteroids (ICS) (Study P06115)

A 12-Week Placebo-Controlled Efficacy and Safety Study of Mometasone Furoate Monotherapy in Subjects With Persistent Asthma Previously Treated With Low-Dose Inhaled Glucocorticosteroids

• Status: Withdrawn
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Organon and Co · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Asthma

Interventions

Type	Name	Description
DRUG	SCH 32088 mometasone furoate (MF) metered-dose inhaler	2 inhalations from a MF 50 mcg inhaler each morning and evening, approximately 12 hours apart, for 12 weeks.
DRUG	Placebo metered-dose inhaler BID	2 inhalations from a placebo metered-dose inhaler each morning and evening, approximately 12 hours apart, for 12 weeks.

Timeline

• Start date: 2012-06-01
• Primary completion: 2013-12-01
• Completion: 2013-12-01
• First posted: 2009-12-07
• Last updated: 2022-02-16