Clinical trial of Blomia tropicalis (VALERGENT-BT) allergenic extract for therapeutic use in asthmatic adults sensitive to this allergen

ational Biopreparations Center (BIOCEN)0 个研究点开始时间: 2010年12月7日最近更新: 2024年8月19日

适应症

试验速览

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

•1) Asthmatic allergic patients with positive responses during the preliminary survey on the following aspects: family and personal history of atopy, clinical symptoms only triggered when exposed to dust at home, mainly indoors, when getting up in the morning or going to bed at night. 2) Skin test positive to B. tropicalis allergenic extract, 20,000 UB/ml VALERGEN-BT. The response to the allergen under study is predominant when compared to that obtained with other mites. 3) Patients included in the study will be patients clinically diagnosed as extrinsic asthmatics who, according to the clinical-therapeutic identification booklet, are classified as mild or moderate persistent patients in keeping with the International Agreement on Asthma Diagnosis and Treatment. 4) Age between 16 and 45 years. 5) Any sex and race. 6) Patients expressing their consent in writing to participate in our trial.

•1) Patients not giving their consent in writing to participate in our trial. 2) Patients on allergenic extract immunotherapy during the two preceding years. 3) Patients classified as intermittent or severe persistent asthmatics after being interviewed. 4) Patients with a diagnosed autoimmune disease of any kind. 5) Generalized severe eczema. 6) Patients with diagnosed tumoral disease. 7) Patients on betablocker treatment. 8) Patients with psychiatric disorders. 9) Patients not cooperating with treatment. 10) Patients who, at least one year before the study, needed immunostimulant or immunosuppressor treatment (no corticosteroids), including interferon and cyclosporine A. 11) Pregnancy and breastfeeding. 12) Adrenalin-contraindicated patients (high blood pressure). 13) Patients who, at least one year before the study, were under non-conventional treatments such as: Vimang, Aloe, ozone, banana capsules.

发起方

ational Biopreparations Center (BIOCEN)