WithdrawnPhase 2

Preventing Childhood Asthma Using Prophylactic House Dust Mite Allergen Immunotherapy

Stopped: Awaiting funding

0Started 2027-02-01

Plain-language 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.

Who can participate

Age range6 Months – 12 Months

SexALL

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Inclusion criteria

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

Exclusion criteria

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

What they're measuring

Number of Participants with Asthma

Timeframe: 1.5 years after discontinuation of 3 years of treatment

Trial details

NCT IDNCT05113394

SponsorBoston Children's Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-02-01

View on ClinicalTrials.gov More Asthma trials