Preventing Childhood Asthma Using Prophylactic House Dust Mite Allergen Immunotherapy

Asthma Clinical Trial

— PAPA  

Official title:

Preventing Childhood Asthma Using Prophylactic House Dust Mite Allergen Immunotherapy

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05113394
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: February 1, 2024
• Est. completion date: August 1, 2029

Study information

• Verified date: December 2023
• Source: Boston Children's Hospital
• Contact: Amparito Cunningham
• Phone: 857-218-5336
• Email: asthma[@]childrens.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 270
• Est. completion date: August 1, 2029
• Est. primary completion date: February 1, 2028
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Months to 12 Months

Eligibility

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

Related Conditions & MeSH terms

• Allergy
• Asthma

Intervention

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.
• Placebo
Placebo sublingual therapy

Locations

Country	Name	City	State
n/a

Sponsors (7)

Lead Sponsor	Collaborator
Boston Children's Hospital	Children's Hospital Medical Center, Cincinnati, Emory University, George Washington University, Imperial College London, University of North Carolina, Chapel Hill, University of Southampton

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with Asthma	asthma diagnosis	1.5 years after discontinuation of 3 years of treatment