title: Recommendations for appropriate sublingual immunotherapy clinical trials.
abstract: Sublingual immunotherapy is gaining widespread attention as a viable alternative to subcutaneous immunotherapy for the treatment of allergic rhinoconjunctivitis. In addition, sublingual immunotherapy has been studied in other allergic disorders including asthma. However, a review of published studies indicates that there are deficiencies and considerable heterogeneity in both design and data interpretation of sublingual immunotherapy studies. These deficiencies have made it somewhat difficult to assess the appropriate place of sublingual immunotherapy in guidelines for the therapy of allergic diseases. Moreover, several unpublished oral and sublingual immunotherapy studies in the United States failed to meet primary endpoints. This article reviews data from sublingual immunotherapy trials and makes recommendations about appropriate designs of future sublingual immunotherapy studies. It is hoped that these recommendations will result in more adequately designed sublingual immunotherapy trials to facilitate the appropriate placement of this therapy to treat patients with allergic rhinoconjunctivitis and other allergic diseases.
authors.affiliation: Creighton University, Omaha, Neb. 68131, USA. tbcasale@creighton.edu
authors.forename: Thomas B
authors.initials: TB
authors.lastname: Casale
authors.forename: G Walter
authors.initials: GW
authors.lastname: Canonica
authors.forename: Jean
authors.initials: J
authors.lastname: Bousquet
authors.forename: Linda
authors.initials: L
authors.lastname: Cox
authors.forename: Richard
authors.initials: R
authors.lastname: Lockey
authors.forename: Harold S
authors.initials: HS
authors.lastname: Nelson
authors.forename: Giovanni
authors.initials: G
authors.lastname: Passalacqua
mesh_terms: D000286:Administration, Sublingual; D000485:Allergens / Q000276:immunology / Q000627:therapeutic use*; D002986:Clinical Trials as Topic; D006801:Humans; D006967:Hypersensitivity / Q000276:immunology / Q000628:therapy*; D007167:Immunotherapy / Q000009:adverse effects / Q000592:standards*; D017410:Practice Guidelines as Topic; D012307:Risk Factors
chemical_list: D000485:Allergens