Multicentre, Randomised, Double Blind, Placebo-controlled Study of the Efficacy and Safety of Broncho-Vaxom (OM 85 BV) in Children Suffering From Atopic Dermatitis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 179
- 主要终点
- Number of Atopic Dermatitis (AD) flares over 9 months of treatment
研究概览
简要总结
The objective of this pilot double-blind study was to evaluate the efficacy and the safety of Broncho-Vaxom 1 capsule (3.5 mg) per day for 9 months compared to placebo on the evolution of the disease in children suffering from Atopic Dermatitis (AD).
详细描述
Children outpatients of both sexes, aged 6 months to 7 years, with AD confirmed by Haniffin-Rajka or Williams et al, and an AD score (SCORAD) between 25 and 70 were included and followed for 9 months. Patients were randomized to receive either Broncho-Vaxom 1 capsule (3.5 mg) per day or the corresponding placebo over 9 months.
Children under general corticotherapy within one month of study start, patients with immunodeficiency, patient's affected body surface area less than 15% or greater than 70% or with known allergy to desonide were excluded.
Outcome measures were a comparisons between the two groups in the number of AD flares during the study after the first month of treatment. Secondary outcome measures were comparisons between the two groups based on SCORAD evolution, area of eczema, amount of corticoids used and parents/investigator assessments.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Months 至 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female children aged 6 months to 7 years (in eighth year of life)
- •Children with Atopic Dermatitis (Hanifin-Rajka or Williams et al criteria) with affected body surface area ≥15% and ≤ 70%
- •25 ≤ SCORAD ≤ 70
- •Written informed consent obtained from the parents/legal Guardian (and the child if applicable)
排除标准
- •Children under general corticotherapy within one month of study start
- •Children with immunodeficiency
- •Children with malignant disease
- •Children with SCORAD<25 or >70
- •Children with affected body surface area < 15% or >70%
- •Children with autoimmune disease
- •Children under immunosuppressive or immunostimulating therapy within 1 month of study start
- •Children whose parents or Guardians are unable to comply with the requirements of the protocol e.g.completion of patient's diary card
- •Children with a known allergy or previous intolerance or known hypersensitivity to the trial drug or any of the corticoids used
- •Participation in another clinical trial and/or treatment with an experimental drug within 3 months of study start and during present trial
研究组 & 干预措施
Broncho-Vaxom
1 capsule (3.5 mg) per day, administered over 9 months
干预措施: Broncho-Vaxom (Drug)
Placebo
Matching placebo capsule
干预措施: Placebo - Cap (Drug)
结局指标
主要结局
Number of Atopic Dermatitis (AD) flares over 9 months of treatment
时间窗: 9 months
Comparison between experimental and Placebo arms in the number of AD flares
次要结局
- SCORAD Evolution over 9 months of treatment(9 months)
- Area of eczema involvement(9 months)
- Amount of corticosteroids used(9 months)