Preventing Childhood Asthma Using Prophylactic House Dust Mite Allergen Immunotherapy
Status: Withdrawn
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 6 months
Maximum Age: 1
Healthy Volunteers: t
View:
• Aged 6 to 12 months of age
• history of physician diagnosed atopic dermatitis OR
• allergen sensitization OR
• family history of asthma or allergy
Time Frame
Start Date: 2027-02-01
Completion Date: 2029-08-01
Treatments
Experimental: Experimental arm
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.
Placebo_comparator: Placebo arm
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.
Related Therapeutic Areas
Sponsors
Collaborators: Emory University, Children's Hospital Medical Center, Cincinnati, Imperial College London, University of Southampton, George Washington University, University of North Carolina, Chapel Hill
Leads: Boston Children's Hospital