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


OBJECTIVE
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.
Bousquet
Jean
J
University Hospital, Hôpital Arnaud de Villeneuve, Montpellier, France. jean.bousquet@inserm.fr
Bachert
Claus
C
Canonica
Giorgio W
GW
Mullol
Joaquim
J
Van Cauwenberge
Paul
P
Jensen
Carsten Bindslev
CB
Fokkens
Wystke J
WJ
Ring
Johannes
J
Keith
Paul
P
Gopalan
Gokul
G
Lorber
Richard
R
Zuberbier
Torsten
T
D000328:Adult; D018450:Disease Progression; D005260:Female; D005500:Follow-Up Studies; D039563:Histamine H1 Antagonists, Non-Sedating / Q000008:administration & dosage* / Q000009:adverse effects; D006801:Humans; D017336:Loratadine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D008297:Male; D008875:Middle Aged; D010147:Pain Measurement; D011788:Quality of Life; D012221:Rhinitis, Allergic, Perennial / Q000188:drug therapy* / Q000503:physiopathology; D006255:Rhinitis, Allergic, Seasonal / Q000188:drug therapy* / Q000503:physiopathology; D012720:Severity of Illness Index
D039563:Histamine H1 Antagonists, Non-Sedating; D017336:Loratadine; C121345:desloratadine