Conditions: Rhinitis, Allergic, Seasonal
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 679
Healthy volunteers: no

Brief summary:
The purpose of this study was to identify the lowest dosage of mometasone furoate nasal spray (MFNS) that provided adequate efficacy with an acceptable safety profile for children (ages 6-11) with seasonal allergic rhinitis (SAR). The MFNS dose levels of 25, 100, and 200 mcg QD were compared with beclomethasone dipropionate (BDP), as an active control, and placebo.

Detailed description:

Arms:
arm 1: Mometasone furoate nasal spray 12.5 mcg/spray was administered intranasally, one spray per nostril in the morning (upon awakening), daily for 4 weeks. A matching placebo nasal spray was administered intranasally (1 spray per nostril) in the evening. Chlorpheniramine maleate syrup 2 mg/5 mL was to be used for relief of intolerable SAR symptoms. arm 2: Mometasone furoate nasal spray 50 mcg/spray was administered intranasally, one spray per nostril in the morning (upon awakening), daily for 4 weeks. A matching placebo nasal spray was administered intranasally (1 spray per nostril) in the evening. Chlorpheniramine maleate syrup 2 mg/5 mL was to be used for relief of intolerable SAR symptoms. arm 3: Mometasone furoate nasal spray 100 mcg/spray was administered intranasally, one spray per nostril in the morning (upon awakening), daily for 4 weeks. A matching placebo nasal spray was administered intranasally (1 spray per nostril) in the evening. Chlorpheniramine maleate syrup 2 mg/5 mL was to be used for relief of intolerable SAR symptoms. arm 4: Beclomethasone dipropionate nasal spray 42 mcg/spray was administered intranasally, one spray per nostril in the morning (upon awakening) and in the evening, daily for 4 weeks. Chlorpheniramine maleate syrup 2 mg/5 mL was to be used for relief of intolerable SAR symptoms. arm 5: Matching placebo nasal spray was administered intranasally, one spray per nostril in the morning (upon awakening) and in the evening, daily for 4 weeks. Chlorpheniramine maleate syrup 2 mg/5 mL was to be used for relief of intolerable SAR symptoms.

Interventions: intervention 1: Mometasone furoate nasal spray intervention 2: Beclomethasone dipropionate nasal spray intervention 3: Placebo nasal spray intervention 4: Chlorpheniramine maleate syrup
Intervention descriptions: intervention 1: intranasal administration intervention 2: intranasal administration intervention 3: intranasal administration intervention 4: oral administration

Protocol document: