title: Standardized quality (SQ) house dust mite sublingual immunotherapy tablet (ALK) reduces inhaled corticosteroid use while maintaining asthma control: a randomized, double-blind, placebo-controlled trial.
abstract: BACKGROUND
  Investigations meeting current standards are limited for the effect of house dust mite (HDM) allergy immunotherapy in asthmatic patients.
  
  
  OBJECTIVE
  This trial investigated the efficacy and safety of a standardized quality (SQ; allergen standardization method proprietary to the trial sponsor) HDM SLIT-tablet (ALK, Hørsholm, Denmark) in adults and adolescents with HDM respiratory allergic disease. This publication reports the results of the endpoints related to asthma.
  
  
  METHODS
  Six hundred four subjects 14 years or older with HDM allergic rhinitis and mild-to-moderate asthma were randomized 1:1:1:1 to double-blind daily treatment with one of 3 active doses (1, 3, or 6 SQ-HDM) or placebo. Their use of inhaled corticosteroid (ICS) was standardized and adjusted at baseline and the end of treatment to the lowest dose providing asthma control. The primary end point was a reduction in ICS dose from the individual subject's baseline dose after 1 year of treatment.
  
  
  RESULTS
  The primary analysis revealed a mean difference between 6 SQ-HDM and placebo in the reduction in daily ICS dose of 81 μg (P = .004). Relative mean and median reductions were 42% and 50% for 6 SQ-HDM and 15% and 25% for placebo, respectively. No statistically significant differences were observed for the other assessed asthma parameters, reflecting the intended controlled status of the trial subjects. The most common adverse events were local reactions in the mouth. The rate and severity of adverse events were higher for 3 and 6 SQ-HDM than for 1 SQ-HDM and placebo.
  
  
  CONCLUSIONS
  Efficacy in mild-to-moderate asthma of 6 SQ-HDM relative to placebo was demonstrated by a moderate statistically significant reduction in the ICS dose required to maintain asthma control. All active doses were well tolerated.
authors.affiliation: Allergy Unit, Copenhagen University Hospital Gentofte, Gentofte, Denmark. Electronic address: hmos0006@geh.regionh.dk.
authors.forename: Holger
authors.initials: H
authors.lastname: Mosbech
authors.affiliation: SALVUS-UG-Centre for Clinical Trials, Leipzig, Germany.
authors.forename: Regina
authors.initials: R
authors.lastname: Deckelmann
authors.affiliation: Chest Diseases Department, Strasbourg University Hospital, Federation of Translational Medicine, University of Strasbourg, Strasbourg, France.
authors.forename: Fréderic
authors.initials: F
authors.lastname: de Blay
authors.affiliation: Ospedale Niguarda Ca' Granda, Milan, Italy.
authors.forename: Elide Anna
authors.initials: EA
authors.lastname: Pastorello
authors.affiliation: Lublin, Poland.
authors.forename: Ewa
authors.initials: E
authors.lastname: Trebas-Pietras
authors.affiliation: Valencia University, Valencia, Spain.
authors.forename: Luis Prieto
authors.initials: LP
authors.lastname: Andres
authors.affiliation: Malmö, Sweden.
authors.forename: Inga
authors.initials: I
authors.lastname: Malcus
authors.affiliation: ALK, Hørsholm, Denmark.
authors.forename: Christian
authors.initials: C
authors.lastname: Ljørring
authors.affiliation: Respiratory Diseases and Allergy, University of Genoa, Genoa, Italy.
authors.forename: Giorgio Walter
authors.initials: GW
authors.lastname: Canonica
mesh_terms: D000280:Administration, Inhalation; D000286:Administration, Sublingual; D000293:Adolescent; D000305:Adrenal Cortex Hormones / Q000627:therapeutic use*; D000328:Adult; D000818:Animals; D039741:Antigens, Dermatophagoides / Q000276:immunology / Q000627:therapeutic use*; D001249:Asthma / Q000276:immunology / Q000628:therapy*; D003888:Desensitization, Immunologic / Q000379:methods* / Q000592:standards; D018450:Disease Progression; D004311:Double-Blind Method; D054796:Drug Dosage Calculations; D005260:Female; D006801:Humans; D008297:Male; D010818:Practice Patterns, Physicians' / Q000592:standards / Q000706:statistics & numerical data; D039981:Pyroglyphidae; D011786:Quality Control; D012015:Reference Standards; D013607:Tablets / Q000008:administration & dosage* / Q000009:adverse effects; D016896:Treatment Outcome
chemical_list: D000305:Adrenal Cortex Hormones; D039741:Antigens, Dermatophagoides; D013607:Tablets
keywords: Allergy; SLIT-tablet; SQ; allergy immunotherapy; asthma; asthma control; house dust mite; immunotherapy; inhaled corticosteroid; respiratory allergic disease