Abstract | BACKGROUND: OBJECTIVE: METHODS: This single-center, randomized, double-blind, placebo-controlled, 2-way crossover study consisted of a screening visit, 1 or 2 qualifying visits, and 2 treatment periods separated by a mean +/- SD washout period of 14 +/- 3 days. Patients were randomized to treatment sequence 1 (placebo followed by fexofenadine) or sequence 2 ( fexofenadine followed by placebo). Baseline end points were obtained before study drug administration, and allergen challenges were initiated 1 1/2 hours after dosing. The primary end point was the change from predose baseline in the total symptom score (sum of rhinorrhea, itchy nose/palate/ throat, sneezing, and itchy/watery/red eyes) after 30 minutes of allergen exposure compared with placebo. RESULTS: Of 211 patients screened, 66 were randomized and 63 completed the study. Mean change in the total symptom score from predose baseline was significantly less with fexofenadine compared with placebo 30 minutes after initiation of the cat allergen challenge (2 hours after dosing) (P = .03). The overall incidence of treatment-emergent adverse events was low and comparable for both groups. CONCLUSION:
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Authors | Robert B Berkowitz, Susan Braker, Cheryl Lutz, Pat Jones, Suzanne Meeves, Chunfu Qiu, Santosh T Varghese, George Georges |
Journal | Annals of allergy, asthma & immunology : official publication of the American College of Allergy, Asthma, & Immunology
(Ann Allergy Asthma Immunol)
Vol. 96
Issue 2
Pg. 327-33
(Feb 2006)
ISSN: 1081-1206 [Print] United States |
PMID | 16498855
(Publication Type: Clinical Trial, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Anti-Allergic Agents
- Glycoproteins
- Placebos
- Terfenadine
- fexofenadine
- Fel d 1 protein, Felis domesticus
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Topics |
- Adolescent
- Animals
- Anti-Allergic Agents
(administration & dosage, therapeutic use)
- Cats
- Child
- Cross-Over Studies
- Double-Blind Method
- Environmental Exposure
- Female
- Forced Expiratory Volume
- Glycoproteins
(immunology)
- Humans
- Male
- Placebos
- Rhinitis, Allergic, Perennial
(drug therapy, prevention & control)
- Terfenadine
(administration & dosage, analogs & derivatives, therapeutic use)
- Time Factors
- Treatment Outcome
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