FLONASE Ocular Efficacy

Study design:

A. Ocular symptoms

Retrospective analysis to evaluate the efficacy of fluticasone propionate aqueous nasal spray (FPANS) in the treatment of ocular symptoms in patients with seasonal allergic rhinitis. Efficacy data was pooled from 7 multicenter, randomized, double-blind placebo-controlled studies of similar design. Each study evaluated the efficacy of FPANS 200 mcg once daily (vs placebo) in the treatment of nasal and ocular symptoms associated with seasonal allergic rhinitis. Patients were >12 years of age (N= 1645). At Day 7 and again at Day 14, clinicians rated the severity of 4 individual ocular symptoms (itching, tearing, redness, and puffiness) via visual analog scales of 0 to 100, where O=no symptoms and 1OO=worst symptoms. The primary outcome was the mean change from baseline in clinician-rated TOSS.

Calculations: Clinician-rated TOSS, Day 7 improvement

FLONASE Allergy Relief: 76.0/183.5 x 100=41.4% reduction or improvement in TOSS.

Placebo: 50.9/192.6 x 100=26.4% reduction.

Calculations: Clinician-rated TOSS, Day 14 improvement

FLONASE Allergy Relief: 91.8/183.5 x 100=50.0% reduction or improvement in TOSS.

Placebo: 60.2/192.6 x 100=31.3% reduction.

Calculations: Overall ocular scores, Week 1

FLONASE Allergy Relief: 20.2/64.7 x 10=31.2% reduction.

Placebo: 14.2/66.0 x 100=21.5% reduction.

Calculations: Overall ocular scores, Week 2

FLONASE Allergy Relief: 29.2/64.7 x 100=45.1% reduction.

Placebo: 19.5/66.0 x 100=29.5% reduction.

References

1. 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.