TY - JOUR
T1 - Efficacy of Desloratadine in Persistent Allergic Rhinitis - A GALEN Study
AU - Bousquet, Jean
AU - Bachert, Claus
AU - Canonica, Giorgio W.
AU - Mullol, Joaquim
AU - van Cauwenberge, Paul
AU - Jensen, Carsten Bindslev
AU - Fokkens, Wytske J.
AU - Ring, Johannes
AU - Keith, Paul
AU - Gopalan, Gokul
AU - Lorber, Richard
AU - Zuberbier, Torsten
PY - 2010
Y1 - 2010
N2 - 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
AB - 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
U2 - https://doi.org/10.1159/000316351
DO - https://doi.org/10.1159/000316351
M3 - Article
C2 - 20559006
SN - 1018-2438
VL - 153
SP - 395
EP - 402
JO - International archives of allergy and immunology
JF - International archives of allergy and immunology
IS - 4
ER -