Efficacy of Allergy Immunotherapy in Preventing Asthma Morbidity in Atopic, Wheezing Children (Age 18 Months - 3 Years)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 58
- 试验地点
- 2
- 主要终点
- Asthma Severity as Measured by the Asthma Severity Score (Averaged up to 36 Months)
研究概览
简要总结
In this clinical study we aim to determine the effect of allergy immunotherapy in decreasing asthma and allergy related disease in children who had multiple episodes of wheezing and who are at high risk for developing persisting asthma. These risks include a history of asthma in the parents, allergies to environmental allergens (such as dust mite, cockroach or mouse) and other allergic diseases such as eczema or food allergies. Allergy Immunotherapy is not new and has been practiced for many years to treat asthma and environmental allergies in older children and adults, but has not yet been systematically studied in young children.
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
- None
入排标准
- 年龄范围
- 18 Months 至 3 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children between 18 months through 3 years who had at least 2 episodes of wheezing prior to enrolment.
- •Positive skin tests or specific Immunoglobulin E (IgE) antibody titers to at least one of common airborne allergens: Dust Mite, cat, cockroach, mouse, dog, pollen (all allergy testing can be done at the screening visit at the study site).
- •The child must also fulfill the criteria for high risk of developing persistent asthma by meeting at least one of the following major conditions OR 2 of the following minor conditions:
- •Major criteria: History of atopic dermatitis and/or parental history of asthma.
- •Minor criteria: MD-diagnosed allergic rhinitis, wheezing unrelated to colds, blood eosinophils above 4%.
排除标准
- •The child has a severe systemic condition (other than allergy or asthma) including (but not limited to) seizures, major congenital anomalies, physical and intellectual delay, cerebral palsy, chest surgery, tuberculosis, primary or secondary immunodeficiency or cardiac disorder (except a hemodynamically insignificant atrial or ventricular septum defect or heart murmur).
- •The child was born following 35 or less weeks of gestation.
- •Parental report that the child received oxygen for more than 5 days in the neonatal period, or required mechanical ventilation at any time since birth.
- •The child fails to thrive, defined as crossing of two major growth percentile lines during the last year.
- •The child has chronic lung disease of prematurity (CLDP), cystic fibrosis or any other chronic lung disease.
- •The child ever received immunotherapy.
- •The child ever received i.v. gammaglobulins or immunosuppressants (other than corticosteroids for asthma).
- •History of a life-threatening asthma exacerbation which required intubation and mechanical ventilation.
研究组 & 干预措施
No immunotherapy, receive standard of care asthma treatment
This group consists of children who do not receive allergy immunotherapy. Both groups - the experimental as well as the control group receive otherwise standard of care asthma and allergy treatment
干预措施: Standard of care (Other)
Allergen immunotherapy
This group receives initially weekly, later biweekly subcutaneous injections of a mixture of allergen extracts, tailored to the individual child's allergy sensitization profile. The maximum number of injections at each visit is 1-3 injections per child. In addition to allergy immunotherapy. this group receives standard of care asthma and allergy treatment
干预措施: Allergen extracts (subcutaneous injections) (Biological)
Allergen immunotherapy
This group receives initially weekly, later biweekly subcutaneous injections of a mixture of allergen extracts, tailored to the individual child's allergy sensitization profile. The maximum number of injections at each visit is 1-3 injections per child. In addition to allergy immunotherapy. this group receives standard of care asthma and allergy treatment
干预措施: Standard of care (Other)
结局指标
主要结局
Asthma Severity as Measured by the Asthma Severity Score (Averaged up to 36 Months)
时间窗: baseline and every two weeks up to end of study (up to 36 months)
The Asthma Severity Score is a customized score created for this study due to the lack of standardized instruments for this age group. It takes into account asthma symptom severity and frequency, as well as asthma medication dosing and potency. Data was collected at baseline and every 2 weeks through interviews conducted over the phone. If the caregiver could not be reached by the phone, the interview was conducted at the next face-to face opportunity (study or injection visit). The minimum score on this scale is 0 (no asthma symptoms and no asthma medicines used during the 14 day interview period). The maximum score is 224 (uncontrolled severe asthma with severe cough, shortness of breath and wheezing on 14 of 14 days, using Albuterol 2 puffs 4x/day, budesonide/formoterol 160ug/4.5ug 2 puffs twice daily and Montelukast 4mg daily on 14 of 14 days). Scores calculated from the collected data were averaged to produce one reported value at baseline and year 1, 2 and 3.
次要结局
- Number of Newly Gained Allergic Sensitizations as Assessed by Serum Specific Immunoglobulin E (IgE) Testing(Baseline and end of treatment (36 months))
- Peripheral Blood T Regulatory Cells as a Percentage of CD4+ (Cluster of Differentiation 4) Cells(Baseline and every 12 months until end of treatment (36 months))
- Incidence Rate of Systemic Corticosteroid Bursts (CSB) Per Child(From baseline through end of study (maximum 36 months))
研究者
Gabriele de Vos
Assistant Professor of Medicine (Allergy and Immunology)
Albert Einstein College of Medicine