Preventing Childhood Asthma Using Prophylactic House Dust Mite Allergen Immunotherapy

NCT05113394 | Withdrawn Phase 2 DMC

• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Asthma; Allergy

Outcome Measures

Primary Outcomes (1)

• Number of Participants with Asthma

  asthma diagnosis

  1.5 years after discontinuation of 3 years of treatment

Study Arms (2)

Experimental arm

EXPERIMENTAL

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.

Drug: HDM sublingual Immunotherapy

Placebo arm

PLACEBO COMPARATOR

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.

Drug: Placebo

Interventions

HDM sublingual Immunotherapy DRUG

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.

Also known as: dust mite sublingual immunotherapy

Experimental arm

Placebo DRUG

Placebo sublingual therapy

Also known as: placebo dust mite sublingual immunotherapy

Placebo arm

Eligibility Criteria

• Age: 6 Months - 12 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston Children's Hospital: lead
• Children's Hospital Medical Center, Cincinnati: collaborator
• University of North Carolina, Chapel Hill: collaborator
• George Washington University: collaborator
• Emory University: collaborator
• University of Southampton: collaborator
• Imperial College London: collaborator

MeSH Terms

Conditions

Asthma; Hypersensitivity

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Immune System Diseases

Study Officials

• Wanda Phipatanakul, MD, MS

  Boston Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: double blinded
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Pediatrics

Model Details: Randomized (1:1), double blinded, placebo controlled, parallel arms, multi-site, Phase II study; 3 year treatment phase with further 1.5 year follow-up phase.

Study Record Dates

• First Submitted: October 19, 2021
• First Posted: November 9, 2021
• Study Start (Estimated): February 1, 2027
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): August 1, 2029
• Last Updated: November 26, 2024

Record last verified: 2024-11