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临床试验/NCT03763630
NCT03763630已完成2 期

Primary Prevention of Atopy and Asthma With House Dust Mite Sublingual Immunotherapy: 6-8 Years Follow up

University of Southampton2 个研究点 分布在 1 个国家目标入组 263 人开始时间: 2017年9月15日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
263
试验地点
2
主要终点
Clinical Asthma - parental questionnaire

研究概览

简要总结

This study represents the follow-up, age 6-8 years, of children recruited at birth into two cohorts. The first cohort, the Mite Allergen Prevention Study (MAPS) was a double-blind, randomized controlled trial of the use of house dust-mite immunotherapy in the primary prevention of atopy and asthma. The Immune Tolerance in Early Childhood (ITEC) cohort is a separate observational cohort following up infants at high risk of atopy and correlating atopic disease development with epigenetic markers.

详细描述

There is an epidemic of allergic disease in childhood and current preventative strategies have failed to demonstrate effectiveness outside of isolated trials. In a previous study, the efficacy of sublingual immunotherapy (SLIT) with house dust mite in preventing the development of allergic sensitisation in infants was assessed. The long term objective was to assess the effect of the intervention on the subsequent development of asthma. The hypothesis is that high dose oral immunotherapy will induce immune tolerance and reduce development of allergic sensitisation and later clinical asthma and allergy. A total of 111 infants at high risk of allergy (with ≥2 first degree relatives affected by asthma or allergy) but with no evidence of allergic sensitisation at recruitment were recruited. These infants were randomised at 6 months of age to receive a year of active HDM (House dust-mite) allergen extract delivered as SLIT or placebo intervention. At 18 months of age, there was a significant reduction in cumulative allergic sensitisation in the SLIT intervention group and a trend for reduction in allergic symptoms. They have also been followed up at 3 years of age. The data currently being analysed.

Additionally, an observational cohort (Immune Tolerance in Early Childhood, ITEC) was recruited at birth with the same inclusion criteria as the interventional one and assessed in the same way up to 3 years. This cohort has provided additional control data and samples to utilise in the analyses.

This proposed study is the 6-8 year follow up of these interventional and observational cohorts. The aim of the 6-8 year assessment is to assess the efficacy of prophylactic oral immunotherapy with HDM allergen in preventing the later development of asthma. The hypothesis is that high dose oral immunotherapy will induce immune tolerance and reduce development of allergic sensitisation and later clinical asthma and allergy. Participants will be assessed 6-8 years after finishing the intervention. The assessment will include a questionnaire, skin prick testing to the common aeroallergens and food allergens and lung function. Families and study investigators will both be blinded to participants' original treatment allocations. An additional aim is to investigate the epigenetic and immune mechanisms involved in the development of asthma and allergy and how allergen immunotherapy influence this process.

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
5 Months 至 9 Months(Child)
性别
All
接受健康志愿者

入选标准

  • Inclusion in original study cohorts at birth
  • ≥2 first-degree relatives with allergic disease (food allergy, asthma, eczema, rhinoconjunctivitis)

排除标准

  • Not included in the original study cohorts
  • Skin-prick test positive to any allergen (HDM, cat, grass pollen, peanut, egg and milk) age 5 months

研究组 & 干预措施

Intervention arm

Active Comparator

House dust-mite SLIT

干预措施: House dust-mite SLIT (Drug)

Control arm

Placebo Comparator

Normal saline

干预措施: Normal saline (Drug)

结局指标

主要结局

Clinical Asthma - parental questionnaire

时间窗: Age 6 years

Comparison of clinical asthma, as assessed by parental questionnaire, at age 6 years between control and intervention groups. Clinical asthma will be defined as either doctor diagnosed asthma or presence of wheeze and asthma medication use within the past year.

Clinical Asthma- spirometry with reversibility

时间窗: 6 years

Comparison of clinical asthma, as assessed by lung function testing, at age 6 years between control and intervention groups. Clinical asthma will be defined as in improvement in FEV1 (Forced Expiratory Volume in 1 second) of 12% or more following administration of salbutamol inhaler (bronchodilator).

次要结局

  • Asthma comparison(Age 6 years)
  • Bronchial hyper-responsiveness(Age 6 years)
  • Cumulative sensitization(Age 6 years)
  • Cumulative aeroallergen sensitization(Age 6 years)
  • Clinical atopic disease- parental questionnaire(Age 6 years)
  • Airway inflammation level- exhaled nitric oxide measurement(Age 6 years)
  • House dust-mite sensitization(Age 6 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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