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A Pilot, Randomised, Double-blind, Placebo-controlled, Parallel-group, Multicentre Study to Evaluate the Efficacy and Safety of Once-daily Intranasal Administration of Fluticasone Furoate Nasal Spray 110 mcg for 4 Weeks in Adults and Adolescents With Irritant (Non-Allergic) Rhinitis
The purpose of this pilot study is to compare the effects (effectiveness and safety)of an intranasal corticosteroid (fluticasone furoate nasal spray \[FFNS\]) with a placebo nasal spray for the treatment of irritant (non-allergic) rhinitis.
Details
| Lead sponsor | GlaxoSmithKline |
|---|---|
| Phase | Phase 2 |
| Status | COMPLETED |
| Enrolment | 102 |
| Start date | 2008-03 |
| Completion | 2009-02 |
Conditions
- Rhinitis, Allergic, Perennial
Interventions
- Fluticasone Furoate Nasal Spray
- Placebo Nasal Spray
Primary outcomes
- Mean Change From Baseline in Daily rTNSS Over the Entire Treatment Period (28 Days) — Baseline through Week 4 (28 days)
The Total Nasal Symptom Score (TNSS) is the sum (scale 0-9) of the individual nasal scores for rhinorrhea, nasal congestion, and post-nasal drip. All symptoms were evaluated using a scale of 0 (None), 1 (Mild), 2 (Moderate), or 3 (Severe). Reflective (r) assessments were performed in the morning (AM) and evening (PM) and assessed the participant's symptoms over the preceding 12 hours. The daily reflective Total Nasal Symptoms Score (daily rTNSS) is the average of the AM and PM rTNSS. Mean change from baseline was calculated as the participant's treatment period mean minus the baseline mean.
Countries
Thailand