Double-blind and placebo-controlled study to assess efficacy and safety of a modified allergen extract of Dermatophagoides pteronyssinus in allergic asthma
Version of Record online: 2 AUG 2005
Volume 60, Issue 9, pages 1178–1183, September 2005
How to Cite
Ameal, A., Vega-Chicote, J. M., Fernández, S., Miranda, A., Carmona, M. J., Rondón, M. C., Reina, E. and García-González, J. J. (2005), Double-blind and placebo-controlled study to assess efficacy and safety of a modified allergen extract of Dermatophagoides pteronyssinus in allergic asthma. Allergy, 60: 1178–1183. doi: 10.1111/j.1398-9995.2005.00862.x
- Issue online: 2 AUG 2005
- Version of Record online: 2 AUG 2005
- Accepted for publication 20 February 2005
- allergen vaccine;
- bronchial provocation;
- clinical efficacy;
- Dermatophagoides pteronyssinus;
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.
Material and 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 PD20FEV1 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.
Conclusion: 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.