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

Sanofi0 sites70 target enrollmentNovember 2003

ConditionsCat Induced Allergic Rhinitis

DrugsFexofenadine HCl

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Cat Induced Allergic Rhinitis
Sponsor: Sanofi
Enrollment: 70
Primary Endpoint: 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
Status: Completed
Last Updated: 15 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

November 2003

End Date

February 2004

Last Updated

15 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Sanofi

Eligibility Criteria

Inclusion Criteria

•Male and female subjects, aged 12 years and older, inclusive
•History of cat-induced allergic rhinitis for at least 2 years, requiring the use of allergy medication or resulting in avoidance of cats
•Skin test positive to cat allergen at screening, defined as a wheal greater than one-half the diameter of the histamine control and at least 3 mm larger than the diameter of the glycerin-saline solution control. A skin test performed in the previous 15 months may be used to qualify the subject if it was performed at the investigator's site and recorded in the subject's medical record
•FEV1 greater than or equal to 80% of the predicted value on the screening assessment, and at the baseline assessment prior to the priming cat challenge(s). After the priming cat challenge, FEV1 must not have decreased \>12% from the pre-challenge testing % predicted value
•Reversibility of \<12% in absolute FEV1 following 2 puffs of albuterol at screening
•Minimal baseline allergic symptoms, defined as TSS less than or equal to 4 at the baseline assessments prior to the priming cat challenges
•All females must have a negative urine pregnancy test
•Willing and able to adhere to visit schedules and all study requirements
•Mild to moderate allergic symptoms defined as TSS less than or equal to 8 at screening

Exclusion Criteria

•Asthma that requires treatment with medication other than inhaled, short-acting beta-agonists (not to be taken within 6 hours prior to the priming visit(s) or Visits 3 or 4) or asthma known to be exacerbated by exposure to Fel d
•(Subjects with exercise-induced asthma will be allowed.)
•Requires medication for rhinitis that cannot be withheld
•Has a cat in the home (Subjects who have cats who are exclusively outdoors will be allowed.)
•Upper respiratory infection within 4 weeks of study entry
•History of severe reactions to cat exposure by self-report (severe is defined as being unable to tolerate cat exposure for at least 30 minutes)
•Acute or chronic sinusitis or other nasal diseases that resulted in nasal obstruction (e.g., nasal septum deviation, nasal polyps) within 4 weeks of study entry
•Known hypersensitivity to fexofenadine HCl or to drugs with similar chemical structures
•Clinically significant ECG values that, in the judgment of the investigator, would have clinical implications for the subject's participation in the study
•Clinically significant medical condition (such as cardiovascular, hepatic, neurologic, hematological, renal, gastrointestinal, endocrine, or other major systemic disease), that, in the judgment of the investigator, might interfere with the study, require treatment or make implementation of the protocol or interpretation of the study results difficult

Outcomes

Primary Outcomes

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