NCT03763630

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
263

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Sep 2017

Shorter than P25 for phase_2

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 15, 2017

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

November 22, 2018

Completed
12 days until next milestone

First Posted

Study publicly available on registry

December 4, 2018

Completed
1 day until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 5, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2019

Completed
Last Updated

October 4, 2021

Status Verified

October 1, 2021

Enrollment Period

1.2 years

First QC Date

November 22, 2018

Last Update Submit

October 1, 2021

Conditions

ImmunotherapyAllergy and ImmunologyAsthma

Keywords

AtopyEarly childhoodHouse Dust-miteSublingual immunotherapy

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (7)

  • Bronchial hyper-responsiveness

    Age 6 years

  • Asthma comparison

    Age 6 years

  • Airway inflammation level- exhaled nitric oxide measurement

    Age 6 years

  • Cumulative sensitization

    Age 6 years

  • Cumulative aeroallergen sensitization

    Age 6 years

  • +2 more secondary outcomes

Study Arms (3)

Intervention arm

ACTIVE COMPARATOR

House dust-mite SLIT

Drug: House dust-mite SLIT

Control arm

PLACEBO COMPARATOR

Normal saline

Drug: Normal saline

Observation cohort

NO INTERVENTION

ITEC observational cohort, no intervention administered

Interventions

House dust-mite SLITDRUG

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.

Also known as: glycerinated HDM allergen extract (ALK-AbellÓ)
Intervention arm
Normal salineDRUG

Normal saline administered in same frequency and manner as intervention

Also known as: Normal saline placebo control
Control arm

Eligibility Criteria

Age5 Months - 9 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • ≥2 first-degree relatives with allergic disease (food allergy, asthma, eczema, rhinoconjunctivitis)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University Hospital Southampton NHS Foundation Trust

Southampton, Hampshire, SO16 6YD, United Kingdom

Location

David Hyde Asthma and Allergy Centre

Newport, Isle of White, PO30 5TG, United Kingdom

Location

Related Publications (1)

  • 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 Clin Immunol. 2015 Dec;136(6):1541-1547.e11. doi: 10.1016/j.jaci.2015.04.045. Epub 2015 Jun 12.

    PMID: 26073754RESULT

MeSH Terms

Conditions

HypersensitivityAsthma

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Immune System DiseasesBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, Immediate

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Graham Roberts, Prof

    University of Southampton

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 22, 2018

First Posted

December 4, 2018

Study Start

September 15, 2017

Primary Completion

December 5, 2018

Study Completion

January 15, 2019

Last Updated

October 4, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

Locations

GB(2)