Influence of Polyvalent Mechanical Bacterial Lysate ISMIGEN® on Clinical Course of Asthma and Related Immunological Parameters in Asthmatic Children (EOLIA Study): Randomised Double-blind Placebo-controlled Multicentre Parallel-group Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 8
- 主要终点
- Change in asthma control level (mean ACT or P-ACT) score
研究概览
简要总结
This study evaluate the efficacy of Mechanical Bacterial Lysate (PMBL - Ismigen®) to improve the asthma control level (ACT score) as add-on treatment to routine asthma treatment in children aged 6 to 16 with uncontrolled or partly controlled asthma. Half of the 150 participants will receive Ismigen® and their current asthma therapy while the other half will receive Placebo and their current asthma treatment.
详细描述
Acute and recurrent respiratory infections of the upper and middle respiratory tracts in the paediatric population of asthmatic patients represent a leading clinical burden, particularly during the winter. Respiratory tract infections, mainly viral infection are important factors that exacerbate asthma course in children. Currently no clinical data demonstrated the benefit of oral or sublingual bacterial lysates on asthma clinical course in children apart from one trial with OM-85 BV (Bronchovaxom®) suggesting reduced number and duration of infection-related wheezing attacks in children with asthma wheezing.
Therefore it was hypothesized that PMBL (Ismigen®) used in asthmatic children should significantly improve asthma course and control. A seasonal approach of active prevention, based on full-fledged antibacterial oral vaccination would be useful to show the potential benefit of this type of products.
The Primary objective was to assess the benefit of Ismigen® versus Placebo on the mean ACT score after administration of a Polyvalent Mechanical Bacterial Lysate (PMBL - Ismigen®) as add-on to routine asthma treatment.
Secondary objectives investigated:
- the potential reduction (vs Placebo) of number of asthma exacerbations, time to first event with Ismigen®;
- the potential decrease in number of respiratory tract infections during the observation period (3-month treatment and 6-month follow-up) after treatment;
- the specific changes occurring in a panel of immunological markers as the result of Ismigen® effect (subset of 48 patients).
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 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children of both genders aged 6 to 16 years.
- •Allergic asthma diagnosis with at least one perennial allergen according to the Global Strategy for Asthma Management and Prevention (GINA 2012 guidelines) prior to screening visit.
- •Patient shows clinical characteristics of partly controlled or uncontrolled asthma according to GINA
- •Already treated with SABA prn and ICS or ICS + LABA during the previous 3 months.
- •Patient shows antigen-specific IgE against HDM ≥ class 2 or positive skin prick test or RAST for at least one perennial allergen.
- •Patient who had at least 2 exacerbations of asthma within the 12-mo period before V
- •Patient not treated with Polyvalent Mechanical Bacterial Lysate (Ismigen®) within the previous 6 months prior to Visit 1.
排除标准
- •Patient received mechanical or any other bacterial lysate immunostimulation within the previous 6 months before Visit
- •Patient received oral/subcutaneous allergen-immunotherapy within the previous 6 months before Visit
- •History of near fatal asthma (e.g. brittle asthma, hospitalization for asthma exacerbation in Intensive Care Unit).
- •Pregnant or breastfeeding woman.
结局指标
主要结局
Change in asthma control level (mean ACT or P-ACT) score
时间窗: at 3-months
The main criterion is the improvement in mean ACT/P-ACT score versus baseline (between-groups comparison)
次要结局
- Time-dependent change in asthma control level (mean ACT or P-ACT) score(at 6-months and at 9-months)
- Number of respiratory infections occurring during the 3-mo treatment and the 6-mo follow-up after treatment(at 3-months, at 6-months and at 9-months)
- Time to first mild or severe asthma exacerbation(From baseline)
- Standardized mean daily dose of Inhaled Corticosteroids (ICS) used(From baseline, up to the 9-month time point)
- Frequency of short acting beta-2 agonists use as rescue medication(From baseline, up to the 9-month time point)
- Serum Immunoglobulins(At baseline and at 3-months)
- Serum antibacterial antibodies concentration(At baseline, at 3-weeks and at 3-months)
- Blood Specific markers of Lymphocyte activation(At baseline and at 3-months)
- Activation of CD4 T cells in peripheral blood(At baseline and at 3-months)
- Specific T cells responses in peripheral blood mononuclear cells (PBMC)(At baseline, at 3-weeks and at 3-months)
- PAQLQ (Paediatric Asthma Quality of Life Questionnaire) and PACQLQ (Paediatric Asthma Caregivers Quality of Life Questionnaire)(At baseline and at 9-months)
- Cumulative number of days with respiratory tract infections(From baseline, up to the 9-month time point)
- Number of lost school days due to respiratory infections and to asthma exacerbations(From baseline, up to the 9-month time point)