24-hour efficacy of once-daily desloratadine therapy in patients with seasonal allergic rhinitis [ISRCTN32042139].

Abstract

BACKGROUND:

Early studies with desloratadine demonstrated efficacy in treating seasonal allergic rhinitis (SAR). A dose-ranging study was conducted to characterize its 24-hour efficacy in patients with SAR.

METHODS:

Patients (N = 1,026) were randomly assigned once-daily (QD) desloratadine (2.5, 5, 7.5, 10, or 20 mg) for 2 weeks in a placebo-controlled, double-blind study. The end point of 24-hour efficacy was assessed by the mean change from baseline in the average AM instantaneous total symptom score (TSS) over the treatment period. Day 2 data were assessed for efficacy of desloratadine following the first dose. Other efficacy variables included AM/PM previous total nasal and nonnasal symptom scores and individual symptom scores.

RESULTS:

Desloratadine 5-20 mg was significantly (P <.01) more effective than placebo in improving total AM instantaneous TSS and AM/PM previous total nasal and nonnasal symptom scores. This dosing range also was significantly (P <.01) more effective than placebo for reducing AM instantaneous TSS beginning with the first dose; thus, demonstrating the full 24-hour efficacy of desloratadine. AM/PM previous scores for all individual symptoms, including nasal congestion, were also significantly improved versus placebo (P <.05) with desloratadine at 5, 7.5, and 20 mg. All treatments were well tolerated. There were no clinically meaningful changes in electrocardiogram parameters.

CONCLUSION:

Desloratadine 5-20 mg provided significant 24-hour relief of SAR signs and symptoms. There were no statistically significant differences between the 4 largest doses suggesting that desloratadine 5 mg QD offers the best therapeutic profile for patients with SAR.

• Authors: Luis M Salmun, Richard Lorber
• Journal: BMC family practice (BMC Fam Pract) Vol. 3 Pg. 14 (Aug 05 2002) ISSN: 1471-2296 [Electronic] England
• PMID: 12162793 (Publication Type: Clinical Trial, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Histamine H1 Antagonists, Non-Sedating
• Loratadine
• desloratadine

Topics

• Adolescent
• Adult
• Aged
• Aged, 80 and over
• Analysis of Variance
• Child
• Double-Blind Method
• Drug Administration Schedule
• Female
• Histamine H1 Antagonists, Non-Sedating (administration & dosage, adverse effects)
• Humans
• Loratadine (administration & dosage, adverse effects, analogs & derivatives)
• Male
• Middle Aged
• Rhinitis, Allergic, Seasonal (drug therapy)