Preventing Childhood Asthma Using Prophylactic House Dust Mite Allergen Immunotherapy

• Status: Not yet recruiting
• Trial end date: 2029-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Boston Children's Hospital
• Collaborators: Children's Hospital Medical Center, Cincinnati; Emory University; George Washington University; Imperial College London; University of North Carolina, Chapel Hill; University of Southampton
• Treatments: Immunologic Factors

Criteria

Inclusion Criteria:

Parent/guardian must be able to understand and provide informed consent Aged 6 to 12 months of age, of either sex and of any race at randomization

High risk of asthma (two or more of the three criteria);

1. Single OR dual heredity for allergy (at least one biological mother, father or sibling affected by asthma or allergy, assessed through standardized questionnaires)

2. History of physician diagnosed atopic dermatitis

3. Allergen sensitization; defined as positive SPT (≥3 mm wheal diameter) OR sIgE (> 0.35 kU/L) to at least one common allergen on SPT or specific IgE; grass pollen, cat, dog, peanut, milk, and egg)

Exclusion Criteria:

Inability or unwillingness of a participant's parent/guardian to give written informed consent or comply with study protocol Evidence of sensitization to HDM (SPT ≥3 mm OR sIgE (> 0.35 kU/L) Prematurity (<37 weeks) Failure to thrive and or need for oxygen for more than 5 days in the neonatal period or history of intubation or mechanical ventilation Other significant medical conditions including but not limited to eosinophilic esophagitis, seizures, major congenital anomalies, cardiac disorders requiring medical therapy, cystic fibrosis, chronic pulmonary diseases, bronchopulmonary dysplasia, developmental delay, cerebral palsy, immunodeficiency (primary or secondary) (vi) Use of investigational drugs since birth (vii) Expecting to relocate out of area within 4 years of study initiation (viii) Deemed as unable to adhere to study activities (ix) Past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study.

(x) Has any clinically significant abnormal vital sign or laboratory value that in the opinion of the investigator would preclude participation in the trial.