A Comparison of Fluticasone Furoate Nasal Spray Versus Oral Fexofenadine in the Treatment of Seasonal Allergic Rhinitis

NCT00502775 Phase 4 COMPLETED Results posted

The primary objective of the study is to compare nighttime symptom relief of fluticasone furoate nasal spray versus oral fexofenadine

Details

Lead sponsor	GlaxoSmithKline
Phase	Phase 4
Status	COMPLETED
Enrolment	680
Start date	2007-08
Completion	2007-11

Conditions

• Rhinitis, Allergic, Seasonal

Interventions

• fluticasone furoate, fexofenadine

Primary outcomes

• Mean Change From Baseline in the Nighttime Symptom Score (NSS) — Baseline and Weeks 1-2
  Questions include: 1. Nasal congestion on awakening (Score: 0=none, 1=mild, 2=moderate, 3=severe); 2. Difficulty going to sleep (Score: 0=not at all, 1=little, 2=moderately, 3=very); 3. Nighttime awakenings (Score: 0=not at all, 1=once, 2=more than once, 3=felt like awake all night). The sum of the ratings for the three items comprises the NSS.

Countries

United States