Evaluation of the therapeutic effect and safety of the combination of SC and SL routes in allergen-specific immunotherapy with extracts of house dust mites in asthmatic patients sensitized to these mites. Phase II clinical trial.

ational Center of Bioproducts (BioCen)0 个研究点目标入组 180 人开始时间: 2019年2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: Active. Assignment: Parallel. Purpose: Treatment

•1. Allergic asthmatic patients with a positive history of allergic symptoms caused by house dust.
•2. Positive skin test to one of the three mites greater than or equal to 3 mm (VALERGEN DP, VALERGEN DS or VALERGEN BT, 20 000 UB / mL) and skin test negative to the other two or positive, but with a smaller diameter.
•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. Age between 18 and 50.
•5. Patients express written consent to participate in the trial.

•1. Patients previously treated with immunotherapy with allergenic extracts in the previous five years.
•2. Patients classified as Intermittent or severe persistent asthma.
•3. Diagnosed autoimmune disease of any kind.
•4. Generalized severe eczema.
•5. Patients with tumor disease.
•6. Patients treated with beta-blockers.
•7. Patients where the use of adrenaline is contraindicated (hypertension).
•8. Pregnancy and lactation (pregnancy tests will be performed on females).
•9. Patients at least one year prior to the study required immunostimulant or immunosuppressive treatment (except corticosteroids), including interferons, cyclosporin A and natural immunomodulators (Vimang Biomodulina)
•10. Patients with a history of psychiatric disorders that compromise data collection and adherence to treatment.

发起方

ational Center of Bioproducts (BioCen)