Portal de Periódicos da CAPES

Effect of loteprednol etabonate nasal spray suspension on seasonal allergic rhinitis assessed by allergen challenge in an environmental exposure unit

2005; Wiley; Volume: 60; Issue: 3 Linguagem: Inglês

10.1111/j.1398-9995.2005.00703.x

1398-9995

N. Krug, Jens M. Hohlfeld, H Geldmacher, M. Larbig, R. Heermann, Nicole LaVallee, Dat Tan Nguyen, U. Petzold, Róbert Hermann,

Respiratory and Cough-Related Research

Background: Loteprednol etabonate (LE) is a novel soft steroid that was designed to improve the benefit/risk ratio of topical corticosteroid therapy. This study assesses the clinical efficacy and safety of three different doses of LE nasal spray in seasonal allergic rhinitis (SAR). Methods: In this single‐center, double‐blind, placebo‐controlled, parallel‐group trial 165 subjects with SAR to grass pollen received daily single doses of either 100, 200, 400 μ g LE nasal spray, or placebo for 14 days. The patients underwent three 4‐h allergen challenges with grass pollen in an environmental exposure unit at a screening visit (baseline) and on days 7 and 14 of treatment. Standardized nasal symptom scores were obtained every 20 min. Nasal flow, nasal secretions, and FEV 1 were measured every hour during allergen challenges. Results: After 14 days of treatment, patients who received 400 μ g LE had significantly lower total nasal symptom scores compared with those receiving placebo ( P = 0.007). LE400 reduced rhinorrhea, nasal congestion, nasal itching, the amount of nasal secretions, and improved nasal flow as compared with placebo ( P < 0.05). LE100 and LE200 were not significantly different from placebo. All treatments were well tolerated. Conclusions: Loteprednol 400 μ g once daily is superior to placebo and the only effective dose tested in improving nasal symptoms and objective parameters in patients with SAR.