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Efficacy of desloratadine in intermittent allergic rhinitis: a GA(2)LEN study.

AbstractBACKGROUND:
The Allergic Rhinitis and its Impact on Asthma (ARIA) guidelines proposed a classification for allergic rhinitis based on the duration of symptoms (intermittent, persistent) rather than on the time of allergen exposure (seasonal, perennial). There is no placebo-controlled, randomized clinical trial on intermittent allergic rhinitis (IAR) to date. Desloratadine (DL) is recommended for the first-line treatment of seasonal and perennial allergic rhinitis.
OBJECTIVES:
To assess the efficacy and safety of DL in subjects with IAR based on the ARIA classification.
METHODS:
Patients over 12 years of age with IAR were assessed over 15 days of treatment with DL 5 mg once daily (n = 276) or placebo (n = 271). The primary endpoint was the AM/PM reflective total 5 symptom score (T5SS). Secondary endpoints included AM/PM instantaneous T5SS and individual symptoms, therapeutic response, symptom severity by visual analogue scale, and quality-of-life.
RESULTS:
The mean reduction of AM/PM reflective T5SS was significantly greater with DL than with placebo over 15 days (-3.01 vs-2.13, P < 0.001) and on each individual day (P < 0.05). Mean AM instantaneous T5SS was reduced significantly with DL compared to placebo as early as day 2 (-1.84 vs-0.89; P < 0.001). The therapeutic response and improvement in quality-of-life were significantly greater with DL than with placebo (P < 0.001 for each). The frequency of treatment-related adverse events was low and similar between DL (7.2%) and placebo (7.0%).
CONCLUSIONS:
This is the first large trial to show that treatment can be effective in IAR. Desloratadine was effective and safe.
AuthorsJ Bousquet, C Bachert, G W Canonica, J Mullol, P Van Cauwenberge, C Bindslev Jensen, W J Fokkens, J Ring, P Keith, R Lorber, T Zuberbier, ACCEPT-1 study group
JournalAllergy (Allergy) Vol. 64 Issue 10 Pg. 1516-1523 (Oct 2009) ISSN: 1398-9995 [Electronic] Denmark
PMID19624554 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
Chemical References
  • Histamine H1 Antagonists, Non-Sedating
  • Loratadine
  • desloratadine
Topics
  • Adult
  • Double-Blind Method
  • Female
  • Histamine H1 Antagonists, Non-Sedating (administration & dosage, adverse effects, therapeutic use)
  • Humans
  • Loratadine (administration & dosage, adverse effects, analogs & derivatives, therapeutic use)
  • Male
  • Middle Aged
  • Quality of Life
  • Rhinitis, Allergic, Perennial (drug therapy, physiopathology)
  • Rhinitis, Allergic, Seasonal (drug therapy, physiopathology)
  • Severity of Illness Index
  • Time Factors
  • Treatment Outcome
  • Young Adult

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