Preventing Childhood Asthma Using Prophylactic House Dust Mite Allergen Immunotherapy

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.

Conditions

• Asthma
• Allergy

Interventions

DRUG

HDM sublingual Immunotherapy

HDM-SLIT tablet (Odactra®/Acarizax®) is a rapidly dissolving, freeze-dried, oral lyophilizate for oromucosal treatment, which contains a 1:1 mixture of two allergen extracts derived for the cultivated house dust mites, D. pteronyssinus and D. farinae. These species are included in SLIT tablet and subcutaneous immunotherapy administered for the treatment of allergic rhinitis and asthma in the pediatric and adult populations. The tablet dissolves within seconds after contact with a wet surface such as the oral mucosa. Participants will be administered the drug sublingually for 3 years.

DRUG

Placebo

Placebo sublingual therapy

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati

  collaborator OTHER

• University of North Carolina, Chapel Hill

  collaborator OTHER

• George Washington University

  collaborator OTHER

• Emory University

  collaborator OTHER

• University of Southampton

  collaborator OTHER

• Imperial College London

  collaborator OTHER

• Boston Children's Hospital

  lead OTHER

Principal Investigators

• Wanda Phipatanakul, MD, MS · Boston Children's Hospital

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

6 Months

Max Age

12 Months

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2027-02-01

Primary Completion

2028-02-01

Completion

2029-08-01