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Sponsored by: |
Sanofi-Aventis |
---|---|
Information provided by: | Sanofi-Aventis |
ClinicalTrials.gov Identifier: | NCT00637884 |
This 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.
Condition | Intervention | Phase |
---|---|---|
Cat Induced Allergic Rhinitis |
Drug: Fexofenadine HCl |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Crossover Assignment, Safety/Efficacy Study |
Official Title: | 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 |
Enrollment: | 70 |
Study Start Date: | November 2003 |
Study Completion Date: | February 2004 |
Ages Eligible for Study: | 12 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | sanofi-aventis ( Study Director ) |
Study ID Numbers: | M016455A/4148 |
Study First Received: | March 10, 2008 |
Last Updated: | March 17, 2008 |
ClinicalTrials.gov Identifier: | NCT00637884 History of Changes |
Health Authority: | United States: Institutional Review Board |
Neurotransmitter Agents Otorhinolaryngologic Diseases Rhinitis Anti-Allergic Agents Histamine Hypersensitivity Terfenadine |
Respiratory Tract Diseases Respiratory Tract Infections Histamine Antagonists Fexofenadine Histamine H1 Antagonists Histamine phosphate |
Neurotransmitter Agents Otorhinolaryngologic Diseases Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Histamine Agents Rhinitis Anti-Allergic Agents Nose Diseases Pharmacologic Actions |
Terfenadine Respiratory Tract Diseases Respiratory Tract Infections Histamine Antagonists Therapeutic Uses Fexofenadine Histamine H1 Antagonists Histamine H1 Antagonists, Non-Sedating |