A non-comparative trial of the efficacy and safety of fexofenadine for treatment of perennial allergic rhinitis

An open-label, non-comparative study was performed in three Otolaryngology centers in Bangkok, Thailand, to assess the efficacy, safety and tolerabili ty of fexofenadine in Thai patients with perennial allergic rhinitis. Altog ether 101 perennial allergic rhinitis patients were included, 33 males and 68 females. Mean age was 33 years, average duration of symptoms was 6 years . Ail patients received fexofenadine hydrochloride 120 mg once daily (OD) i n the morning for 2 weeks. Patients recorded their allergy symptoms daily u sing a 5 point rating scales in the diary card. At the end of 2 weeks, pati ents and investigators assessed the overall efficacy of treatment. Adverse events and onset of symptom relief were also recorded by every patient. Blo od test and ECG were performed before and after treatment in one center (Si riraj Hospital). Total symptom scores and nasal scores decreased significan tly from a baseline at I week and 2 weeks after treatment (p < 0.05). The m ean onset of symptom relief was 2 hours and 12 minutes. The global assessme nt of the treatment by patients and investigators showed significant concor dance. There was no significant change in either the vital signs, laborator y tests or EGG. The incidence of treatment related adverse events was 8% bu t all were mild and easily tolerated. Drowsiness was reported from only one patient. This study suggests that fexofenadine 120 mg once daily was an ef fective, safe and well tolerated treatment for perennial allergic rhinitis in Thai patients.