Asthma Clinical Trial
Official title:
Primary Prevention of Atopy and Asthma With House Dust Mite Sublingual Immunotherapy: 6-8 Years Follow up
Verified date | October 2021 |
Source | University of Southampton |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 263 |
Est. completion date | January 15, 2019 |
Est. primary completion date | December 5, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 5 Months to 9 Months |
Eligibility | Inclusion Criteria: •Inclusion in original study cohorts at birth •=2 first-degree relatives with allergic disease (food allergy, asthma, eczema, rhinoconjunctivitis) Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
United Kingdom | David Hyde Asthma and Allergy Centre | Newport | Isle Of White |
United Kingdom | University Hospital Southampton NHS Foundation Trust | Southampton | Hampshire |
Lead Sponsor | Collaborator |
---|---|
University of Southampton | Isle of Wight NHS Trust |
United Kingdom,
Zolkipli Z, Roberts G, Cornelius V, Clayton B, Pearson S, Michaelis L, Djukanovic R, Kurukulaaratchy R, Arshad SH. Randomized controlled trial of primary prevention of atopy using house dust mite allergen oral immunotherapy in early childhood. J Allergy C — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Clinical Asthma - parental questionnaire | 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. | Age 6 years | |
Primary | Clinical Asthma- spirometry with reversibility | 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). | 6 years | |
Secondary | Bronchial hyper-responsiveness | Comparison of bronchial hyperresponsiveness, as determined by methacholine bronchial allergen challenge, at age 6 years. | Age 6 years | |
Secondary | Asthma comparison | Comparison of asthma, as defined by wheeze plus bronchial hyperreactivity | Age 6 years | |
Secondary | Airway inflammation level- exhaled nitric oxide measurement | Comparison of airway inflammation level, as assessed by exhaled nitric oxide, between placebo and intervention group age 6 years | Age 6 years | |
Secondary | Cumulative sensitization | Comparison of cumulative sensitization to one or more of 6 common allergens, as assessed by skin prick test, up to 6-8 years of age between control and interventions groups. | Age 6 years | |
Secondary | Cumulative aeroallergen sensitization | Comparison of cumulative sensitization to one or more of 6 common aeroallergens, as assessed by skin prick test, up to 6-8 years of age between control and interventions groups. | Age 6 years | |
Secondary | House dust-mite sensitization | Comparison of sensitization to house dust mite, as assessed by skin prick test, at 18 months, 3 years and 6-8 years of age between control and intervention groups. | Age 6 years | |
Secondary | Clinical atopic disease- parental questionnaire | Comparison of clinical allergic diseases/symptoms (atopic eczema, wheeze, allergic rhinitis, food allergy) at 18 months, 3 years and 6 years of age between control and intervention groups. Presence of clinical disease evaluated through parental questionnaires | Age 6 years |
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