Terapeutic effect and safety of therapeutic allergens vaccine Dermatophagoides siboney adjuvanted with proteoliposome of Neisseria meningitidis B in asthmatic patients sensitive to this mite.

ational Center of Bioproducts (BioCen)0 个研究点目标入组 60 人开始时间: 2018年6月14日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

研究类型: Interventional
分配方式: Randomized controlled trial. Masking: Double Blind. Control group: Placebo. Assignment: Parallel. Purpose: Treatment

•1. Allergic asthmatic patients with a positive history of allergic symptoms caused by house dust.
•2. Positive skin test to Dermatophagoides siboney with wheal diameter greater than or equal to 3 mm (VALERGEN-DS 20 000 BU / mL) and negative skin test Blomia tropicalis and Dermatophagoides pteronyssinus, or positive with a diameter lower than for DS.
•3. Patients included in the study are patients diagnosed clinically as extrinsic asthmatics, which are classified as intermittent or persistent mild or moderate according to international guidelines for asthma (GINA, Global Initiative for Asthma)
•4. Any color skin.
•5. Patients express written consent to participate in the trial.

•1. Patients previously treated with immunotherapy with allergenic extracts in previous five years.
•2. Patients classified as severe intermittent and persistent asthmatics according to the guide International Asthma Initiative (GINA).
•3. Diagnosed autoimmune disease of any kind.
•4. Generalized severe eczema.
•5. Patients with a diagnosis of tumor disease.
•6. Patients under treatment with beta-blockers.
•7. Patients where the use of adrenaline is contraindicated (arterial hypertension).
•8. Pregnancy and lactation.
•9. Patients who required treatment at least one year before the study immunostimulant or immunosuppressant (except corticosteroids), including interferons, cyclosporin A and natural immunomodulators (Vimang, Biomodulin, etc.).
•10. Patients who have suffered from bacterial meningitis in the last year.
•11. Patients with a history of psychiatric disorders.
•12. Patients who do not wish to participate in the trial.

发起方

ational Center of Bioproducts (BioCen)