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Fexofenadine HCl

A Single-Center, Randomized, Double-Blind, Placebo-Controlled, Two-Way Crossover Study Designed to Evaluate the Efficacy of Fexofenadine HCl 180 mg for Preventing and Controlling Cat Allergy Symptoms

Ensayo de Sanofi en Cat Induced Allergic Rhinitis (del registro, en inglés).

Fase

Fase 4

Estado

Completado

Participantes

70

previstos

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, doble ciego. Comenzó en nov 2003.

Qué mide

Determine efficacy of fexofenadine HCl 180 mg versus placebo in preventing and controlling self-reported cat allergy symptoms in subjects who have a known allergy to cats and who are exposed to feline domesticus allergen 1 (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThis is a single-center, prospective, randomized, double-blind, placebo-controlled, two-way crossover study. A live cat challenge model will be used for exposing subjects to Fel d1. Subjects who test positive for cat allergy symptoms during a priming cat exposure challenge will be eligible to enter the treatment phase of the study. Baseline efficacy measures will be obtained prior to the dispensing of study medication during both treatment periods. Cat challenges will be initiated 1.5 hours following treatment with study medication.

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Todos los de SNY, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT00637884), actualizada en ene 2011.