Conditions: Seasonal Allergic Rhinitis Hayfever
Keywords: Seasonal Allergic Rhinitis Hayfever
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 487
Healthy volunteers: no

Brief summary:
This is a phase 2, randomized, double-blind, placebo-controlled, parallel-group, 2-week, multi-center, dose-range-finding study in male or female patients (12 years and older) with SAR.

Detailed description:

Arms:
arm 1: During the 2-week double-blind Treatment Period participants self-administered two actuations (one per nostril) of 40 micrograms (µg) BDP HFA and two actuations of placebo HFA once daily. arm 2: During the 2-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of 40 µg BDP HFA once daily. arm 3: During the 2-week double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 µg BDP HFA once daily. arm 4: During the 2-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily.

Interventions: intervention 1: Beclomethasone dipropionate HFA Nasal Aerosol intervention 2: Placebo
Intervention descriptions: intervention 1: Beclomethasone dipropionate (BDP) Hydrofluoroalkane (HFA) Nasal Aerosol intervention 2: HFA Vehicle Aerosol

Protocol document: