Phase IV Study of Effect of OM-85 BV (Broncho-Vaxom) on Wheezing Related Morbidity in Children With Recurrent Wheezing
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Mean Rate of Wheezing Attacks
研究概览
简要总结
The purpose of this study is to determine whether OM-85 BV (Broncho-Vaxom)has any effect on respiratory infections, infection related wheezing attacks, beta-2 agonist use, duration of attacks and effect on serum cytokine levels.
详细描述
Context: Respiratory infections are the major cause of wheezing attacks in children with recurrent wheezing or asthma in preschool age. OM-85 BV is an bacteria lysate which has been proven to prevent respiratory infections about 40 percent in children.
Objective
To determine if using OM-85 BV diminish the number and duration of the respiratory infections and respiratory infection related wheezing attacks,beta-2 agonist and steroid use, and number and duration of hospitalizations in children with recurrent wheezing and asthma. And also to determine if OM-85 BV has any effect on serum cytokine levels after 6 months.
Study Design/Setting/Participants: A double-blind, randomized, controlled trial of OM-85 BV versus placebo for children 6 months to 6 years of age who have respiratory tract infection related recurrent wheezing attacks.
Intervention: Participants will receive either active Broncho-Vaxom or placebo for 3 months.
Study Measures: They follow up for 1 year for number and duration of wheezing attacks, number, type and duration of respiratory infections, number and duration of beta-2 agonist use, number and duration of steroid use and number and duration of hospitalizations. Serum cytokine levels will measure to determine if Broncho-Vaxom has any effect on serum cytokine levels (at the beginning of the trial and sixth months of the trial).
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Months 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children with recurrent wheezing who had at least 3 wheezing attacks in the last 6 months
- •Children with asthma who had at least 3 wheezing attacks in the last 6 months
排除标准
- •Chronic lung disease
- •Immun deficiency
- •Malabsorption
- •Anatomic abnormalities of the respiratory tract
- •Gastroesophageal reflux disease
研究组 & 干预措施
1 Broncho-Vaxom
The children received one capsule per oral, OM-85 BV (3.5 mg) per day for the first 10 consecutive days of each month for 3 consecutive months.
干预措施: OM-85 BV (Broncho-Vaxom) (Drug)
2 (Placebo OM-85 BV)
The children received one capsule per oral, placebo per day for the first 10 consecutive days of each month for 3 consecutive months.
干预措施: OM-85 BV (placebo) (Drug)
结局指标
主要结局
Mean Rate of Wheezing Attacks
时间窗: 12 months
Acute wheezing attack was defined as episode of progressive increase in shortness of breath, cough, wheezing, retraction of the chest and chest tightness, or combination of these symptoms. When wheezing attack occured it was Over the 12 months of the study mean number (rate) of wheezing attacks/per patient was calculated and compared with placebo. This outcome measure was calculated by dividing cumulative wheezing attacks to number of participants in each group.
次要结局
- Mean Duration (in Day) of Wheezing Attacks Per Patient(12 months)
- Number of Common Cold(12 months)
- Number of Wheezing Attacks That Required Systemic Steroid Therapy(12 months)
- Effect of OM-85 BV on Cytokine Levels(6 months)
- Number of Hospitalizations(12 months)
- Duration of Hospitalization/Per Patient(12 months)
研究者
Cem Hasan Razi
MD
Kecioren Education and Training Hospital