Efficacy and Safety of Mometasone Furoate for Persistent Asthma Previously Treated With Low-Dose Inhaled Glucocorticosteroids (ICS) (Study P06115)
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.
|Asthma||Drug: SCH 32088 mometasone furoate (MF) metered-dose inhaler Drug: Placebo metered-dose inhaler BID||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||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|
- Change from Baseline to Endpoint in the morning (AM trough) forced expiratory volume in 1 second (FEV1) [ Time Frame: Endpoint: last non-missing post-Baseline observation carried forward over 12 weeks of treatment ]
- Time to first severe asthma exacerbation during the 12 week Treatment Period [ Time Frame: 12 weeks ]
|Study Start Date:||June 2012|
|Estimated Study Completion Date:||December 2013|
|Estimated Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
Active Comparator: Mometasone furoate (MF) metered-dose inhaler 100 mcg BID
2 inhalations from a MF 50 mcg inhaler each morning and evening, approximately 12 hours apart, for 12 weeks
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.
Other Name: SCH 032088
Placebo Comparator: Placebo metered-dose inhaler BID
2 inhalations from a matching placebo 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.