| Registry | NCT05113394, acronym PAPA |
|---|---|
| Status | Withdrawn - Awaiting funding |
| Phase | Phase 2 |
| Study type | Interventional; randomized, parallel, masking: single, prevention |
| Sponsor | Boston Children's Hospital (Other); collaborators: Children's Hospital Medical Center, Cincinnati, University of North Carolina, Chapel Hill, George Washington University, Emory University, University of Southampton, Imperial College London |
| Conditions | Asthma, Allergy |
| Interventions | HDM sublingual Immunotherapy, Placebo (Drug) |
| Dates | start 2027-02-01 (estimated), primary completion 2028-02-01 (estimated), completion 2029-08-01 (estimated), first posted 2021-11-09, last updated 2024-11-26 |
Related Papers Related Patents Related Grants Related Experts
All trials for Asthma All trials for Allergy All trials of HDM sublingual Immunotherapy All trials of Placebo
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.
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Experimental arm | Experimental | Drug: HDM sublingual Immunotherapy | 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 arm | Placebo comparator | Drug: Placebo | 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. |
Sex: All, ages: 6 Months to 12 Months, accepts healthy volunteers
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