Conditions: Rhinitis, Allergic, Perennial and Seasonal
Keywords: cetirizine seasonal allergic rhinitis Quality of Life fluticasone propionate nasal spray
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 682
Healthy volunteers: no

Brief summary:
This phase IV investigational trial is being conducted to evaluate the efficacy of a 2-week treatment of fluticasone propionate nasal spray (FPNS) vs. cetirizine on allergic nasal and ocular symptoms and quality of life in adult subjects with SAR. It is hypothesized that FPNS provides greater nasal symptom relief than cetirizine. The primary measure used to test this hypothesis is the change from baseline over two weeks in reflective total nasal symptom score (rTNSS) compared between FPNS and cetirizine. Approximately 648 subjects will be randomized into a 1:1:1:1 ratio of treatment allocation across approximately twenty-five to thirty-five sites in the US during the 2013 fall allergy season. All subjects will be outpatients. The total duration of study will be approximately 21 days including 7 days of screening period, and 14 days of treatment period.

Detailed description:

Arms:
arm 1: Subject will receive two sprays (200 mcg per day)of FP into each nostril once daily (OD) every morning for 14 days arm 2: Subject will receive two sprays of FP placebo into each nostril OD every morning for 14 days arm 3: Subject will receive Cetirizine capsule by mouth OD in the morning for 14 days arm 4: Subject will receive Cetirizine Placebo capsule by mouth OD in the morning for 14 days

Interventions: intervention 1: FPNS intervention 2: FPNS Placebo intervention 3: Cetirizine intervention 4: Cetirizine Placebo
Intervention descriptions: intervention 1: Bottled, 16 gm net fill weight for 120 metered sprays with unit dose strength of 50 mcg per spray. intervention 2: Bottled placebo nasal spray (vehicle for Fluticasone propionate aqueous nasal spray), 16 gm net fill weight for 120 metered sprays. intervention 3: Over-encapsulated Cetirizine tablet with unit dose strength of 10 mg in High Density Poly Ethylene Bottles (20 count per bottle). intervention 4: Over-encapsulated Cetirizine matching tablet High Density Poly Ethylene Bottles (20 count per bottle).

Protocol document: