Double-blind, placebo-controlled study comparing the efficacy and safety of fexofenadine hydrochloride (120 and 180 mg once daily) and cetirizine in seasonal allergic rhinitis☆,☆☆
Section snippets
Study design
The study was a multicenter, double-blind, randomized, placebo-controlled, parallel-group design of 2 weeks’ duration, preceded by a single-blind placebo run-in period of 3 to 5 days in symptomatic patients with SAR. To ensure entry at periods of pollen prevalence, the local pollen count was recorded in each region of entry with use of the local pollen count method and the study was conducted in the respective peak grass pollen seasons.
Patient population
Patients were eligible to participate in the study if they
Number of patients studied
A total of 1094 eligible patients were screened for entry to the study. Of these, 842 fulfilled the entry criteria and were randomized to double-blind treatment at 49 investigation sites (33 in Europe, 15 in South Africa, and 1 in Australia). The mean (±SD) number of patients per center was 17 (±25.1), with the number of patients at each center ranging from 1 to 68. There were 8 centers with fewer than 5 patients and 17 centers with 5 to 10 patients; country centers were pooled if they had 6 or
DISCUSSION
This study demonstrates that fexofenadine HCl 120 mg and 180 mg administered QD is an effective and safe treatment for SAR, with efficacy comparable to that of cetirizine for both doses. There were no statistical differences among any of the active treatments in any of the primary or secondary efficacy criteria. All active treatments were still effective at trough drug levels, just before repeat daily dosing, indicating 24-hour symptom relief. Analysis of individual symptoms identified
Acknowledgements
We thank Hoechst Marion Roussel for providing the fexofenadine HCl and sponsoring this project and UCB Pharma for providing the cetirizine used in this study. We thank the following investigators who participated in the trial:
Dr Packermann, Sunnyside, South Africa; Dr Adler, Ludwigshafen, Germany; Dr N. F. Alberts, Heidelberg, South Africa; Dr C. Bachert, Dusseldorf, Germany; Dr Bannert, Weil am Rhein, Germany; Dr Barrage, Lieven, France; Dr B. Bertrand, Goddine, Belgium; Dr Bestajovski,
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2022, Journal of Allergy and Clinical Immunology: In PracticeCitation Excerpt :In wheal and erythema suppression studies, cetirizine was found to be superior to fexofenadine, with loratadine being the least potent.76 Despite having minor difference in pharmacokinetics and pharmacodynamics individually, the second-generation antihistamines may be regarded as equally efficacious for allergic rhinitis based on the results of randomized controlled trials.77-79 They have been recommended over first-generation antihistamines based on being more favorable from a risk/benefit standpoint.80
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Reprint requests: Peter Howarth, MBBS, FRCP, Respiratory Cell and Molecular Biology Division, University Medicine, Level D, Centre Block, Southampton General Hospital, Southampton, SO16 6YD, United Kingdom.
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