NCT01916226

A Comparator Study of Fluticasone Propionate Nasal Spray Verses (vs) Cetirizine in the Treatment of Seasonal Allergic Rhinitis

Study 200165, A Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Parallel-Group Study to Compare the Efficacy of a 2-Week Treatment With Fluticasone Propionate Nasal Spray Versus Cetirizine in Adult Subjects With Seasonal Allergic Rhinitis (SAR)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 682 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Rhinitis, Allergic, Perennial and Seasonal

Interventions

Type	Name	Description
DRUG	FPNS	Bottled, 16 gm net fill weight for 120 metered sprays with unit dose strength of 50 mcg per spray.
DRUG	FPNS Placebo	Bottled placebo nasal spray (vehicle for Fluticasone propionate aqueous nasal spray), 16 gm net fill weight for 120 metered sprays.
DRUG	Cetirizine	Over-encapsulated Cetirizine tablet with unit dose strength of 10 mg in High Density Poly Ethylene Bottles (20 count per bottle).
DRUG	Cetirizine Placebo	Over-encapsulated Cetirizine matching tablet High Density Poly Ethylene Bottles (20 count per bottle).

Timeline

• Start date: 2013-08-01
• Primary completion: 2013-10-01
• Completion: 2013-10-17
• First posted: 2013-08-05
• Last updated: 2018-06-20
• Results posted: 2014-08-27

Locations

31 sites across 1 country: United States