title: Assessment of short-term changes induced by a Dermatophagoides pteronyssinus extract on asthmatic patients. Randomised, double-blind, placebo-controlled trial.
abstract: BACKGROUND
  Once the optimal dose is reached, subcutaneous immunotherapy [SCIT] with mite extract is capable of reducing symptoms and the need for rescue medication.
  
  
  OBJECTIVE
  To assess the capacity of a subcutaneous extract of mites [D. pteronyssinus] to bring about a reduction in concomitant medication as well as in vivo and in vitro changes in just 2-3 months of treatment in patients with allergic asthma.
  
  
  METHODS
  A total of 45 patients with persistent mild-moderate allergic asthma due to sensitisation to D. pteronyssinus were included in a multi-centre, double-blind, placebo-controlled trial. Length of treatment was 4 months. After a period for adjusting medication in order to classify asthma severity appropriately, patients were commenced on treatment of 400 or 800 g/day of budesonide as concomitant medication.
  
  
  RESULTS
  After 4 months of treatment there were no significant changes in the budesonide dose between the active group and the placebo group. In the active group there was a significant difference between active and placebo group in sIgG4 [p=.0003], as well as a significant increase in the cutaneous tolerance index [2.81, CI 95%: 1.29 - 7.48, which was significant with a Confidence Interval of 95%]. These changes were not observed in the placebo group.
  
  
  CONCLUSIONS
  After just 4 months of treatment, SCIT was capable of inducing in vivo and in vitro changes, but these changes were not reflected in improved clinical outcome within the first 4 months of therapy.
authors.affiliation: H. Conxo, Santiago de Compostela, Spain.
authors.forename: Carmen
authors.initials: C
authors.lastname: Vidal
authors.forename: Ana I
authors.initials: AI
authors.lastname: Tabar
authors.forename: Javier
authors.initials: J
authors.lastname: Figueroa
authors.forename: José A
authors.initials: JA
authors.lastname: Navarro
authors.forename: Cesárea
authors.initials: C
authors.lastname: Sánchez
authors.forename: Agustín
authors.initials: A
authors.lastname: Orovitg
authors.forename: Margarita
authors.initials: M
authors.lastname: Armisen
authors.forename: Susana
authors.initials: S
authors.lastname: Echechipía
authors.forename: Alejandro
authors.initials: A
authors.lastname: Joral
authors.forename: Susana
authors.initials: S
authors.lastname: Lizarza
authors.forename: M Teresa
authors.initials: MT
authors.lastname: Lizaso
authors.forename: Virginia
authors.initials: V
authors.lastname: Rodriguez
authors.forename: Fernando
authors.initials: F
authors.lastname: de la Torre
mesh_terms: D000293:Adolescent; D000328:Adult; D000485:Allergens / Q000276:immunology*; D000818:Animals; D018926:Anti-Allergic Agents / Q000008:administration & dosage / Q000627:therapeutic use; D039741:Antigens, Dermatophagoides / Q000276:immunology*; D001249:Asthma / Q000188:drug therapy / Q000276:immunology* / Q000628:therapy*; D019819:Budesonide / Q000008:administration & dosage / Q000627:therapeutic use; D040002:Dermatophagoides pteronyssinus / Q000276:immunology*; D003888:Desensitization, Immunologic / Q000009:adverse effects; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007074:Immunoglobulin G / Q000097:blood; D008297:Male; D015203:Reproducibility of Results; D012720:Severity of Illness Index; D012882:Skin Tests; D014020:Tissue Extracts / Q000276:immunology; D055815:Young Adult
chemical_list: D000485:Allergens; D018926:Anti-Allergic Agents; D039741:Antigens, Dermatophagoides; D007074:Immunoglobulin G; D014020:Tissue Extracts; D019819:Budesonide