FLONASE Nasal Efficacy

Study designs:

A. Nasal symptoms: SAR

Multicenter, double-blind, randomized, parallel group study evaluated and safety of 227 adult patients with moderate to severe seasonal allergic rhinitis. Patients received the once-daily administration FPANS 200 mcg once daily or 100 mcg twice daily or matching placebo. Patients were evaluated on days 4, 8, and 15 of treatment and day 22 for a follow-up visit. At the end of the study, the clinician assessed the overall effectiveness of treatment on a 7-point scale: significant improvement, moderate improvement, mild improvement, no change, mildly worse, moderately worse, or significantly worse.

B. Nasal symptoms: PAR

Randomized, double-blind, placebo-controlled group study of 365 patients conducted at 13 centers. Patients were >12 years of age with moderate to severe perennial allergic rhinitis. Patients were randomly assigned to receive either FPANS 200 mcg once daily, 100 mcg twice daily, or placebo. At the end of the study, the clinician assessed the overall effectiveness of treatment on a 7-point scale: significant improvement, moderate improvement, mild improvement, no change, mildly worse, moderately worse, or significantly worse. Primary efficacy evaluations were clinician-rated nasal symptom scores and clinician rated overall evaluation.

References

1. Nathan RA, Bronsky EA, Fireman P, et al. Once daily fluticasone propionate aqueous nasal spray is an effective treatment for seasonal allergic rhinitis. Ann Allergy 1991;67:332-338.
2. Banov CH, Woehler TR, LaForce CF, et al. Once daily intranasal fluticasone propionate is effective for perennial allergic rhinitis. Ann Allergy 1994;3:240-246.
3. DeWester J, Philpot EE, Westlund RE, Cook CK, Rickard KA. The Efficacy of Intranasal Fluticasone Propionate In the Relief of Ocular Symptoms Associated with Seasonal Allergic Rhinitis. Allergy Asthma Proc 2003;24(5):331-337