title: Randomized, double-blind, placebo-controlled trial of standardized ragweed sublingual-liquid immunotherapy for allergic rhinoconjunctivitis.
abstract: BACKGROUND
  Sublingual immunotherapy with liquid extracts provides an appealing alternative to subcutaneous immunotherapy for the treatment of allergic rhinoconjunctivitis (ARC), but a lack of robust evidence has deterred its use in North America.
  
  
  OBJECTIVE
  To determine the efficacy and tolerability of standardized glycerinated short ragweed sublingual allergen immunotherapy liquid (RW-SAIL) extract in subjects with ragweed-related ARC.
  
  
  METHODS
  This phase 3, randomized, placebo-controlled trial was conducted in North America. Subjects (age range, 18-55 years) with or without asthma were selected based on ARC symptom severity and erythema skin prick reaction to short ragweed. Subjects self-administered the maximum tolerated dose of RW-SAIL (n = 218) or placebo (n = 211) daily beginning approximately 8 to 16 weeks before and through the end of the ragweed pollen season. The primary end point was subject-assessed total combined daily rhinoconjunctivitis symptom and medication scores (TCS).
  
  
  RESULTS
  During the entire season, there was a 43% decrease in TCS in subjects treated with RW-SAIL compared with placebo. Similar decreases were observed in TCS between the 2 groups during peak season (42%) and in daily symptom scores during the entire (42%) and peak (41%) seasons. The occurrence of adverse events was similar between the treatment groups; most were mild in severity. Treatment-related oromucosal local application site reactions occurred early and were transient and self-limited. No anaphylaxis occurred.
  
  
  CONCLUSIONS
  This is the first successful North American confirmatory phase 3 clinical trial to demonstrate the safety and efficacy of a sublingual standardized ragweed allergen immunotherapy liquid extract for the treatment of ARC.
authors: Creticos Research Group, Crownsville, and Allergy & Asthma Specialists of Greater Washington, Warrenton, Va. Electronic address: psocrates@comcast.net.
authors: Peter S
authors: PS
authors: Creticos
authors: Greer Laboratories, Lenoir, NC.
authors: Robert E
authors: RE
authors: Esch
authors: Topstone Research, Toronto, Ontario, Canada.
authors: Peter
authors: P
authors: Couroux
authors: Department of Medicine, Division of Allergy, Asthma and Immunology, Allegheny General Hospital, Pittsburgh, Pa.
authors: Deborah
authors: D
authors: Gentile
authors: Novum Pharmaceutical Research Services, Pittsburgh, Pa.
authors: Pina
authors: P
authors: D'Angelo
authors: Greer Laboratories, Lenoir, NC.
authors: Brad
authors: B
authors: Whitlow
authors: Niagara Clinical Research, Niagara Falls, Ontario, Canada.
authors: Michael
authors: M
authors: Alexander
authors: Greer Laboratories, Lenoir, NC.
authors: Terrance C
authors: TC
authors: Coyne
mesh_terms: D000328:Adult; D052179:Antigens, Plant / Q000276:immunology*; D003233:Conjunctivitis, Allergic / Q000276:immunology / Q000628:therapy*; D003888:Desensitization, Immunologic / Q000009:adverse effects / Q000379:methods*; D004311:Double-Blind Method; D023381:Endpoint Determination; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010936:Plant Extracts / Q000276:immunology*; D065631:Rhinitis, Allergic; D012221:Rhinitis, Allergic, Perennial / Q000276:immunology / Q000628:therapy*
chemical_list: D052179:Antigens, Plant; D010936:Plant Extracts; C433085:ragweed pollen
keywords: Allergen-specific IgE; allergen-specific IgG(4); allergy immunotherapy; combined score; ragweed; specific immunotherapy; sublingual immunotherapy