Conditions: Seasonal Allergic Rhinitis SAR
Keywords: Allergies Hayfever
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 715
Healthy volunteers: no

Brief summary:
The purpose of this study is to assess the safety and efficacy of an investigational nasal aerosol at two doses compared with placebo nasal aerosol in the treatment of seasonal allergic rhinitis in children (6-11 years of age).

Detailed description:

Arms:
arm 1: Participants/parents administer 40 mcg of beclomethasone dipropionate hydrofluoroalkane (BDP HFA) (one spray per nostril) once daily for 15 days. arm 2: Participants/parents administer 80 mcg of beclomethasone dipropionate hydrofluoroalkane (BDP HFA) (one spray per nostril) once daily for 15 days. arm 3: Participants/parents administer placebo (a spray with no medication in each nostril) once daily for 15 days.

Interventions: intervention 1: BDP HFA intervention 2: Placebo nasal aerosol
Intervention descriptions: intervention 1: BDP (beclomethasone dipropionate) HFA (hydrofluoroalkane) nasal aerosol administered as a single actuation in each nostril daily for the 15 day treatment period. Each actuation contains either 40 or 80 mcg for a total daily dose of either 80 or 160 mcg depending upon the assigned treatment arm. intervention 2: Placebo formulated as a nasal aerosol spray and administered as a single actuation in each nostril daily for the 15 day treatment period.

Protocol document: