title: 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.
  
  
  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.
authors.affiliation: University Hospital, Hôpital Arnaud de Villeneuve, Montpellier, France. jean.bousquet@inserm.fr
authors.forename: Jean
authors.initials: J
authors.lastname: Bousquet
authors.forename: Claus
authors.initials: C
authors.lastname: Bachert
authors.forename: Giorgio W
authors.initials: GW
authors.lastname: Canonica
authors.forename: Joaquim
authors.initials: J
authors.lastname: Mullol
authors.forename: Paul
authors.initials: P
authors.lastname: Van Cauwenberge
authors.forename: Carsten Bindslev
authors.initials: CB
authors.lastname: Jensen
authors.forename: Wystke J
authors.initials: WJ
authors.lastname: Fokkens
authors.forename: Johannes
authors.initials: J
authors.lastname: Ring
authors.forename: Paul
authors.initials: P
authors.lastname: Keith
authors.forename: Gokul
authors.initials: G
authors.lastname: Gopalan
authors.forename: Richard
authors.initials: R
authors.lastname: Lorber
authors.forename: Torsten
authors.initials: T
authors.lastname: Zuberbier
mesh_terms: 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
chemical_list: D039563:Histamine H1 Antagonists, Non-Sedating; D017336:Loratadine; C121345:desloratadine