title: Double-blind and placebo-controlled study to assess efficacy and safety of a modified allergen extract of Dermatophagoides pteronyssinus in allergic asthma.
abstract: BACKGROUND
  A randomized double-blind, placebo-controlled study was conducted in patients allergic asthma sensitized to Dermatophagoides pteronyssinus.
  
  
  OBJECTIVE
  To evaluate the efficacy and safety after 1-year of immunotherapy with a modified D. pteronyssinus extract compared with placebo.
  
  
  METHODS
  Fifty-five patients were randomly allocated to receive the active treatment (n = 29), or placebo (n = 26). The main outcome was the specific bronchial provocation test (BPT). Other parameters analysed were dose-response skin prick test (SPT), symptom and medication scores and asthma quality of life (AQLQ).
  
  
  RESULTS
  At the end of the study, the active group showed a significant increase in the PD(20)FEV(1) compared with placebo (P = 0.0029). Nineteen patients of the active vs 10 of the placebo group needed more than twice the initial amount of allergen extract to have a positive BPT (P = 0.0293); seven patients in the placebo vs one in the active group needed less than half (P = 0.0137). In SPT, a significant improvement (P = 0.0049) was found in the active group. This group also had a median reduction of 91.5% in symptom scores, whereas the placebo group increased by 86%. Medication scores decreased in both groups (56% in the active and 11.4% in the placebo). In AQLQ, the differences between both groups were significant (P = 0.0234) at the end of the study.
  
  
  CONCLUSIONS
  After 1 year of treatment, the modified extract of D. pteronyssinus demonstrated to be safe and efficacious to treat patients with asthma and allergic rhinoconjunctivitis sensitized to this mite.
authors.affiliation: Allergy Department, Hospital 'Carlos Haya', Málaga, Spain.
authors.forename: A
authors.initials: A
authors.lastname: Ameal
authors.forename: J M
authors.initials: JM
authors.lastname: Vega-Chicote
authors.forename: S
authors.initials: S
authors.lastname: Fernández
authors.forename: A
authors.initials: A
authors.lastname: Miranda
authors.forename: M J
authors.initials: MJ
authors.lastname: Carmona
authors.forename: M C
authors.initials: MC
authors.lastname: Rondón
authors.forename: E
authors.initials: E
authors.lastname: Reina
authors.forename: J J
authors.initials: JJ
authors.lastname: García-González
mesh_terms: D000293:Adolescent; D000328:Adult; D000485:Allergens / Q000276:immunology*; D039741:Antigens, Dermatophagoides / Q000276:immunology*; D001249:Asthma / Q000276:immunology / Q000628:therapy*; D001985:Bronchial Provocation Tests; D003233:Conjunctivitis, Allergic / Q000276:immunology / Q000628:therapy; D003888:Desensitization, Immunologic / Q000379:methods*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D012221:Rhinitis, Allergic, Perennial / Q000276:immunology / Q000628:therapy; D012882:Skin Tests; D016896:Treatment Outcome
chemical_list: D000485:Allergens; D039741:Antigens, Dermatophagoides