Randomized double-blind placebo-controlled prospective, parallel, single centre clinical trial of bacterial vaccine (BACTEK ®) sublingual (oral mucosa) in patients with repeat bronchospasm for the immunomodulatory eficacy evaluation, security and clinical impact.

Inmunotek S.L.0 个研究点目标入组 121 人开始时间: 2012年6月25日最近更新: 2022年4月19日

适应症

试验速览

暂无简介。

•- Subjects whose parents /legal representative have given written informed consent.
•- Both gender
•- Subject up to 36 months of age.
•- Subjects with recurrent bronchospasms ; 3 or more exacerbations in the last 12 months
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 108
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•- Subjects whose parents/legal representative have not given written informed consent.
•- Subjects out of aged range
•- Subjects with malignancies or chemotherapy treatment
•- Subjects included in another clinical trial in the last 12 months.
•- Subject in immunosuppressive or immunostimulatory treatment
•- Subjects who have received iv gamma globulin in the past 12 months.
•- Subjects with recurrent respiratory infections
•- Subjects diagnosed with candidiasis or fungal recurrent infections.
•- Subjects diagnosed with malabsorption syndrome
•- Subjects with clinical allergy tocommon aeroallergens in the geographical area.
•- Subjects with hepatitis virus infections, HIV and tuberculosis

发起方

Inmunotek S.L.