An open label, active controlled, multicentric clinical trial to assess the efficacy and safety of fluticasone furoate nasal spray in adult Indian patients suffering from allergic rhinitis.

Background: Allergic rhinitis is a common upper respiratory tract inflammation associated with a significant morbidity in all the age groups. Fluticasone furoate is a new potent topical glucocorticoid for the treatment of allergic rhinitis. Objective: To compare efficacy and safety of fluticasone furoate (FF) nasal spray 110 µg/day with fluticasone propionate (FP) nasal spray 200 µg/day for the relief of symptoms of allergic rhinitis in adult Indian patients. Methods: Clinically symptomatic patients (n=220) with allergic rhinitis received treatment with FF or FP for 2 weeks in this comparative, open label, multicentric, clinical trial. Nasal symptoms (nasal congestion, rhinorrhea, nasal itching, and sneezing) and ocular symptoms (itching/burning eyes, tearing/watering eyes, and eye redness) were recorded on a 4-point categoric scale by the patients. The efficacy was assessed by the change in nasal and ocular symptom scores as their subtotals (Total Nasal Symptom Score and Total Ocular Symptom Score) and grand total (Total Symptom Score). Results: FF produced significantly better improvement in Total Symptom Score (-10.4 ± 3.2 vs. -8.9 ± 3.5, p<0.005) and Total Nasal Symptom Score (-7.3 ± 2.2 vs. -6.2 ± 2.6, p<0.005) as compared to FP. Also a significantly larger percentage of patients achieved complete symptomatic relief with FF (45.3% vs. 31.4%, p<0.05). FF was also better tolerated than FP. Conclusion: FF nasal spray is significantly more effective and better tolerated than FP nasal spray for the treatment of allergic rhinitis in adult Indian patients.