Double-blind and placebo-controlled study to assess efficacy and safety of a modified allergen extract of Dermatophagoides pteronyssinus in allergic asthma.
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.
Ameal
A
A
Allergy Department, Hospital 'Carlos Haya', Málaga, Spain.
Vega-Chicote
J M
JM
Fernández
S
S
Miranda
A
A
Carmona
M J
MJ
Rondón
M C
MC
Reina
E
E
García-González
J J
JJ
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
D000485:Allergens; D039741:Antigens, Dermatophagoides