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MAPS & ITEC Cohorts: 6-8 Years Follow-up

NCT03763630 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 263

Last updated 2021-10-04

No results posted yet for this study

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.

Conditions

  • Immunotherapy
  • Allergy and Immunology
  • Asthma

Interventions

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.

DRUG

Normal saline

Normal saline administered in same frequency and manner as intervention

Sponsors & Collaborators

  • Isle of Wight NHS Trust

    collaborator OTHER

  • University of Southampton

    lead OTHER

Principal Investigators

  • Graham Roberts, Prof · University of Southampton

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
5 Months
Max Age
9 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-15
Primary Completion
2018-12-05
Completion
2019-01-15

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03763630 on ClinicalTrials.gov