Efficacy and Tolerability of Once-Daily 5mg Desloratadine, an H1-Receptor Antagonist, in Patients with Seasonal Allergic Rhinitis
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To evaluate the efficacy and tolerability of desloratadine 5mg once daily, a new, selective, H1-receptor antagonist, for the treatment of patients with seasonal allergic rhinitis (SAR) during the two major pollen seasons in the USA.
Two multicentre, randomised, double-blind, placebo-controlled, parallel-group investigations in patients with SAR are reported, one conducted during the spring (172 and 174 patients in the desloratadine and placebo groups, respectively) and the other during the fall (164 patients each in the desloratadine and placebo groups) allergy season.
Patients 12 years of age or older with clinically symptomatic SAR and a minimum 2-year history of SAR.
Desloratadine 5mg or placebo once daily for 14 days following a 1-week screening period.
Main Outcome Measures
The primary efficacy assessment was the mean change from baseline in the average reflective am/pm total symptom score (TSS) averaged over the 2-week study period.
In both seasons, desloratadine 5mg once daily resulted in a significant improvement in TSS for patients with SAR (p < 0.01 and p = 0.02, respectively) over the 2-week study. Adverse events reported were mild to moderate in severity and similar to placebo. Assessment of sedation and ECG data revealed no clinically significant changes from baseline with desloratadine- or placebo-treated patients.
Desloratadine 5mg once daily was effective and well tolerated in the treatment of symptoms associated with SAR following the first dose of therapy and continuing for the 2-week duration of the study during both the spring and fall allergy seasons.
KeywordsLoratadine Seasonal Allergic Rhinitis Desloratadine Total Symptom Score Allergy Season
Funding was provided by Schering-Plough Research Institute, Kenilworth, New Jersey, USA.
- 1.American Academy of Allergy Asthma & Immunology. The Allergy Report, Volume 1: Overview of Allergic Diseases. 2000. Milwaukee, WI, American Academy of Allergy, Asthma & ImmunologyGoogle Scholar
- 6.Affrime M, Gupta S, Banfield C, et al. A pharmacokinetic profile of desloratadine in healthy adults including elderly subjects. Clin Pharmacokinet. In pressGoogle Scholar
- 7.Gupta S, Padhi D, Banfield C, et al. The oral bioavailability of desloratadine is unaffected by food, [abstract] Allergy 2000; 55 Suppl. 63: 268Google Scholar
- 8.Banfield C, Hunt T, Reyderman L, et al. Lack of interaction between desloratadine and erythromycin. Clin Pharmacokinet. In pressGoogle Scholar
- 9.Banfield C, Herron J, Keung A, et al. Desloratadine has no electrocardiographic or pharmacodynamic interactions with ketoconazole. Clin Pharmacokinet. In pressGoogle Scholar
- 10.Marino M, Glue P, Herron JM, et al. Lack of electrocardiographic effects of multiple high doses of desloratadine. [abstract] Allergy 2000; 55 Suppl. 63: 279Google Scholar