Preventing Childhood Asthma Using Prophylactic House Dust Mite Allergen Immunotherapy

Phase 2

Withdrawn

• Conditions: Allergy; Asthma
• Interventions: Drug: Placebo; Drug: HDM sublingual Immunotherapy

• Registration Number: NCT05113394
• Lead Sponsor: Boston Children's Hospital

Brief Summary

To establish efficacy and safety of HDM sublingual Immunotherapy (HDM-SLIT) by comparing Odactra and placebo, when given sublingually for 3 years to high risk infants aged between 6 to 12 months at enrollment in preventing the development of asthma, assessed 1.5 years after discontinuation of treatment.

Detailed Description

Aim to prevent the development of asthma in children by intervening at a time when the developing system in still amenable to immune modulation, by using the only therapy that has proven ability to change the natural history of allergic diseases and induce clinical remission. We hypothesize that three years of HDM Immunotherapy in high-risk infants will prevent the development of asthma assessed over a period of 1.5 years after discontinuation of treatment and HDM immunotherapy will result in (a) a significant reduction in the number and pathogenic features of HDM-reactive TH2 cells, and (b) an increase in the numbers of HDM-reactive TH and TREG cells expressing the interferon-response signature. The study is a Randomized (1:1), double blinded, placebo controlled, parallel arms, multi-site, Phase II study with a 3 year treatment phase and further 1.5 year follow-up phase. The study duration for each participant is 4.5 years. Overall study duration is 84 months (7 years); which include 9 months preparation and regulatory approvals, 15 months accrual, 36 months treatment and 18 months follow-up observation period.

Study Timeline

• Study First Submitted: 2021-10-19
• Study First Submitted QC: 2021-10-28
• Study First Posted: 2021-11-09
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-22
• Last Update Posted: 2024-11-26
• Study Start: 2027-02-01
• Primary Completion: 2028-02-01
• Study Completion: 2029-08-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: 270

Inclusion Criteria

1. Aged 6 to 12 months of age
2. history of physician diagnosed atopic dermatitis OR
3. allergen sensitization OR
4. family history of asthma or allergy

Exclusion Criteria

1. Evidence of sensitization to house dust mite (SPT ≥3 mm OR sIgE (> 0.35 kU/L)
2. Prematurity (<37 weeks)
3. Failure to thrive
4. Need for oxygen for more than 5 days in the neonatal period
5. history of intubation or mechanical ventilation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo arm	Placebo	Placebo administered sublingually for 3 years to high-risk infants aged between 6 to 12 months with outcome of asthma development assessed 1.5 years after discontinuation of treatment.
Experimental arm	HDM sublingual Immunotherapy	HDM sublingual Immunotherapy (HDM-SLIT) with Odactra® for 3 years to high-risk infants aged between 6 to 12 months at enrollment in preventing the development of asthma, assessed 1.5 years after discontinuation of treatment.

Primary Outcome Measures

Name	Time	Method
Number of Participants with Asthma	1.5 years after discontinuation of 3 years of treatment	asthma diagnosis