Efficacy of desloratadine in persistent allergic rhinitis - a GA²LEN study.

Abstract

BACKGROUND:

The ARIA (Allergic Rhinitis and its Impact on Asthma) guidelines proposed a classification for allergic rhinitis based on the duration of symptoms (intermittent or persistent) rather than on the time of allergen exposure (seasonal or perennial). There had been no placebo-controlled, randomized, clinical trial of desloratadine (DL) in patients with persistent allergic rhinitis to date.

OBJECTIVES:

To assess the efficacy and safety of DL in patients with persistent allergic rhinitis based on the ARIA classification.

METHODS:

Patients 12 years of age and older with persistent allergic rhinitis were assessed over 85 days of treatment with DL 5 mg once daily (n = 360) or placebo (n = 356). The primary endpoint was the AM/PM reflective total 5-symptom score (T5SS) averaged over days 1-29. Secondary endpoints included AM/PM instantaneous T5SS and individual symptoms, therapeutic response, symptom severity assessed by a visual analogue scale and quality of life.

RESULTS:

The mean reduction in AM/PM reflective T5SS was significantly greater with DL than placebo over days 1-29 (-3.76 vs. -2.87, p < 0.001) and on each individual day (p < 0.05). The mean AM instantaneous T5SS was significantly reduced with DL compared with placebo as early as day 2 (-1.90 vs. -1.46; p < 0.001). The therapeutic response and improvement in quality of life were significantly greater with DL than placebo (p < 0.001 for each). The frequency of treatment-related adverse events was low and similar between DL (10.0%) and placebo (8.4%).

CONCLUSIONS:

This study showed DL to be effective and safe in the treatment of persistent allergic rhinitis.

• Authors: Jean Bousquet, Claus Bachert, Giorgio W Canonica, Joaquim Mullol, Paul Van Cauwenberge, Carsten Bindslev Jensen, Wystke J Fokkens, Johannes Ring, Paul Keith, Gokul Gopalan, Richard Lorber, Torsten Zuberbier, ACCEPT-2 Study Group
• Journal: International archives of allergy and immunology (Int Arch Allergy Immunol) Vol. 153 Issue 4 Pg. 395-402 ( 2010) ISSN: 1423-0097 [Electronic] Switzerland
• PMID: 20559006 (Publication Type: Clinical Trial, Journal Article, Randomized Controlled Trial)
• Copyright: Copyright © 2010 S. Karger AG, Basel.

Chemical References

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

Topics

• Adult
• Disease Progression
• Female
• Follow-Up Studies
• Histamine H1 Antagonists, Non-Sedating (administration & dosage, adverse effects)
• Humans
• Loratadine (administration & dosage, adverse effects, analogs & derivatives)
• Male
• Middle Aged
• Pain Measurement
• Quality of Life
• Rhinitis, Allergic, Perennial (drug therapy, physiopathology)
• Rhinitis, Allergic, Seasonal (drug therapy, physiopathology)
• Severity of Illness Index