MAPS & ITEC Cohorts: 6-8 Years Follow-up
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|ClinicalTrials.gov Identifier: NCT03763630|
Recruitment Status : Recruiting
First Posted : December 4, 2018
Last Update Posted : December 4, 2018
|Condition or disease||Intervention/treatment||Phase|
|Immunotherapy Allergy and Immunology Asthma||Drug: House dust-mite SLIT Drug: Normal saline||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||270 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Primary Prevention of Atopy and Asthma With House Dust Mite Sublingual Immunotherapy: 6-8 Years Follow up|
|Actual Study Start Date :||September 15, 2017|
|Estimated Primary Completion Date :||December 5, 2018|
|Estimated Study Completion Date :||January 15, 2019|
Active Comparator: Intervention arm
House dust-mite SLIT
Drug: House dust-mite SLIT
received 2000 standard treatment units of glycerinated HDM allergen extract (ALK-AbellÓ) per day. Normal saline was administered to the placebo group. 11 µg of HDM allergen (equal parts of Dermatophagoides pteronyssinus and Dermatophagoides farinae) administered twice daily as oral drops.
Other Name: glycerinated HDM allergen extract (ALK-AbellÓ)
Placebo Comparator: Control arm
Drug: Normal saline
Normal saline administered in same frequency and manner as intervention
Other Name: Normal saline placebo control
No Intervention: Observation cohort
ITEC observational cohort, no intervention administered
- Clinical Asthma - parental questionnaire [ Time Frame: 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 [ Time Frame: 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).
- Bronchial hyper-responsiveness [ Time Frame: Age 6 years ]Comparison of bronchial hyperresponsiveness, as determined by methacholine bronchial allergen challenge, at age 6 years.
- Asthma comparison [ Time Frame: Age 6 years ]Comparison of asthma, as defined by wheeze plus bronchial hyperreactivity
- Airway inflammation level- exhaled nitric oxide measurement [ Time Frame: Age 6 years ]Comparison of airway inflammation level, as assessed by exhaled nitric oxide, between placebo and intervention group age 6 years
- Cumulative sensitization [ Time Frame: Age 6 years ]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.
- Cumulative aeroallergen sensitization [ Time Frame: Age 6 years ]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.
- House dust-mite sensitization [ Time Frame: Age 6 years ]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.
- Clinical atopic disease- parental questionnaire [ Time Frame: Age 6 years ]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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03763630
|Contact: Hasan Arshad, Prof||02381203366 ext firstname.lastname@example.org|
|University Hospital Southampton NHS Foundation Trust||Recruiting|
|Southampton, Hampshire, United Kingdom, SO16 6YD|
|Contact: Hasan Arshad, Prof 02381203366 email@example.com|
|Contact: Graham Roberts, Prof 02381206160 firstname.lastname@example.org|
|David Hyde Asthma and Allergy Centre||Recruiting|
|Newport, Isle Of White, United Kingdom, PO30 5TG|
|Contact: Hasan Arshad, Prof 02381203366 email@example.com|
|Principal Investigator:||Graham Roberts, Prof||University of Southampton|