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Dokumenttyp:
Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't; Article
Autor(en):
Bousquet, J; Bachert, C; Canonica, GW; Mullol, J; van Cauwenberge, P; Bindslev Jensen, C; Fokkens, WJ; Ring, J; Keith, P; Lorber, R; Zuberbier, T
Titel:
Efficacy of desloratadine in intermittent allergic rhinitis: a GA(2)LEN study.
Abstract:
BACKGROUND: 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.
Zeitschriftentitel:
Allergy
Jahr:
2009
Band / Volume:
64
Heft / Issue:
10
Seitenangaben Beitrag:
1516-23
Sprache:
eng
Volltext / DOI:
doi:10.1111/j.1398-9995.2009.02115.x
PubMed:
http://view.ncbi.nlm.nih.gov/pubmed/19624554
Print-ISSN:
0105-4538
TUM Einrichtung:
Klinik und Poliklinik für Dermatologie und Allergologie
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