Asthma diagnosis and treatmentSuccessful management of mite-allergic asthma with modified extracts of Dermatophagoides pteronyssinus and Dermatophagoides farinae in a double-blind, placebo-controlled study
Section snippets
Study design and patient assignment
The study was prospective, double-blind, placebo-controlled, and randomized. The active group received a mixture (50%:50%) of modified allergen extracts of D pteronyssinus and D farinae, whereas the control group received placebo. The placebo contained aluminum hydroxide, phenol, and saline solution with the exception of the modified allergen extracts. The duration of the study was 54 weeks. This study was approved by the Ethics Committee of the University Hospital “Virgen de la Candelaria,”
Patients
Fifty-four patients (84.4%) completed the trial; 5 abandoned in each group. Withdrawals were not caused by lack of efficacy, worsening of the disease, or adverse reactions. One patient withdrew because of pregnancy. Each patient who completed the study received 18 injections (5 in the build-up phase and 13 in maintenance).
Safety
There were 4 local reactions (2 in each group). All these reactions were with the maintenance dose (0.5 mL of vial number 2), and all were immediate with a diameter smaller
Discussion
In the current manuscript, we describe the results of a double-blind, placebo-controlled study using a modified therapeutic vaccine containing a mixture of D pteronyssinus and D farinae extracts. The results of the study demonstrate that the treatment was efficacious and well tolerated. The BPT was used as an objective method to document the clinical effect and to calculate the sample size. BPT has good reproducibility when using FEV1 as an objective marker of obstruction42, 43 not affected by
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Disclosure of potential conflict of interest: E. Fernández-Caldas and M. Casanovas are employed by Laboratorios LETI, SL. The rest of the authors have declared that they have no conflict of interest.