Conditions: Asthma
Keywords: Asthma Children Persistent
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 583
Healthy volunteers: no

Brief summary:
The primary objective of this study is to demonstrate the dose-related efficacy, by evaluating morning (AM) lung function at the end of the dosing interval (AM pre-dose percent predicted forced expiratory volume in one second \[FEV1\]) across 12 weeks of treatment, of three doses (50 mcg, 100 mcg, and 200 mcg) of Mometasone Furoate (MF) Metered Dose Inhaler (MDI) twice a day (BID) compared with Placebo in children 5 to 11 years of age, inclusive, with persistent asthma. The primary hypothesis of this study is that at least one dose of MF MDI BID increases lung function, defined as a significant increase in percent predicted FEV1, when compared to Placebo.

Detailed description:

Arms:
arm 1: Participants receive MF MDI 25 mcg x 2 inhalations (50 mcg total dose) BID PLUS Placebo dry powder inhaler (DPI) x 1 inhalation once daily (QD) in the evening for 12 weeks. arm 2: Participants receive MF MDI 50 mcg x 2 inhalations (100 mcg total dose) BID PLUS Placebo DPI x 1 inhalation QD in the evening for 12 weeks. arm 3: Participants receive MF MDI 100 mcg x 2 inhalations (200 mcg total dose) BID PLUS Placebo DPI x 1 inhalation QD in the evening for 12 weeks. arm 4: Participants receive Placebo MDI x 2 inhalations BID PLUS MF DPI x 1 inhalation QD in the evening for 12 weeks. arm 5: Participants receive Placebo MDI x 2 inhalations BID PLUS Placebo DPI x 1 inhalation QD in the evening for 12 weeks.

Interventions: intervention 1: Mometasone Furoate (MF) Metered Dose Inhaler (MDI), 25 mcg intervention 2: Mometasone Furoate (MF) Metered Dose Inhaler (MDI), 50 mcg intervention 3: Mometasone Furoate (MF) Metered Dose Inhaler (MDI), 100 mcg intervention 4: Mometasone Furoate (MF) Dry Powder Inhaler (DPI), 100 mcg intervention 5: Placebo Metered Dose Inhaler (MDI) intervention 6: Placebo Dry Powder Inhaler (DPI)
Intervention descriptions: intervention 1: MF MDI 25 mcg (per inhalation), 2 puffs BID for 12 weeks intervention 2: MF MDI 50 mcg (per inhalation), 2 puffs BID for 12 weeks intervention 3: MF MDI 100 mcg (per inhalation), 2 puffs BID for 12 weeks intervention 4: MF DPI 100 mcg (per inhalation), 1 puff QD for 12 weeks intervention 5: Placebo MDI, 2 puffs BID for 12 weeks intervention 6: Placebo DPI, 1 puff QD for 12 weeks

Protocol document: