Clinical trial NCT05113394: Preventing Childhood Asthma Using Prophylactic House Dust Mite Allergen Immunotherapy
Official title: Preventing Childhood Asthma Using Prophylactic House Dust Mite Allergen Immunotherapy
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Asthma
Allergy
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
Collaborators: name: Children's Hospital Medical Center, Cincinnati
name: University of North Carolina, Chapel Hill
name: George Washington University
name: Emory University
name: University of Southampton
name: Imperial College London
First posted: 2021-11-09
Enrollment: 0
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized (1:1), double blinded, placebo controlled, parallel arms, multi-site, Phase II study; 3 year treatment phase with further 1.5 year follow-up phase.
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants with Asthma
timeFrame: 1.5 years after discontinuation of 3 years of treatment
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Boston Children's Hospital
name: Wanda Phipatanakul, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: