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Preventing Childhood Asthma Using Prophylactic House Dust Mite Allergen Immunotherapy

Studies

Study First Submitted Date 2021-10-19
Study First Posted Date 2021-11-09
Last Update Posted Date 2022-12-06
Start Month Year February 1, 2024
Primary Completion Month Year February 1, 2028
Verification Month Year December 2022
Verification Date 2022-12-31
Last Update Posted Date 2022-12-06

Detailed Descriptions

Sequence: 20605974
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.

Browse Interventions

Sequence: 95463944 Sequence: 95463945 Sequence: 95463946
Mesh Term Immunomodulating Agents Mesh Term Immunologic Factors Mesh Term Physiological Effects of Drugs
Downcase Mesh Term immunomodulating agents Downcase Mesh Term immunologic factors Downcase Mesh Term physiological effects of drugs
Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-ancestor

Conditions

Sequence: 51875707 Sequence: 51875708
Name Asthma Name Allergy
Downcase Name asthma Downcase Name allergy

Design Groups

Sequence: 55297208 Sequence: 55297209
Group Type Experimental Group Type Placebo Comparator
Title Experimental arm Title Placebo arm
Description 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. Description 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.

Interventions

Sequence: 52194096 Sequence: 52194097
Intervention Type Drug Intervention Type Drug
Name HDM sublingual Immunotherapy Name Placebo
Description 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. Description Placebo sublingual therapy

Design Outcomes

Sequence: 176401078
Outcome Type primary
Measure Number of Participants with Asthma
Time Frame 1.5 years after discontinuation of 3 years of treatment
Description asthma diagnosis

Browse Conditions

Sequence: 192291375 Sequence: 192291376 Sequence: 192291377 Sequence: 192291378 Sequence: 192291379 Sequence: 192291380 Sequence: 192291381 Sequence: 192291382 Sequence: 192291383
Mesh Term Asthma Mesh Term Bronchial Diseases Mesh Term Respiratory Tract Diseases Mesh Term Lung Diseases, Obstructive Mesh Term Lung Diseases Mesh Term Respiratory Hypersensitivity Mesh Term Hypersensitivity, Immediate Mesh Term Hypersensitivity Mesh Term Immune System Diseases
Downcase Mesh Term asthma Downcase Mesh Term bronchial diseases Downcase Mesh Term respiratory tract diseases Downcase Mesh Term lung diseases, obstructive Downcase Mesh Term lung diseases Downcase Mesh Term respiratory hypersensitivity Downcase Mesh Term hypersensitivity, immediate Downcase Mesh Term hypersensitivity Downcase Mesh Term immune system diseases
Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Sponsors

Sequence: 48043141 Sequence: 48043142 Sequence: 48043143 Sequence: 48043144 Sequence: 48043145 Sequence: 48043146 Sequence: 48043147
Agency Class OTHER Agency Class OTHER Agency Class OTHER Agency Class OTHER Agency Class OTHER Agency Class OTHER Agency Class OTHER
Lead Or Collaborator lead Lead Or Collaborator collaborator Lead Or Collaborator collaborator Lead Or Collaborator collaborator Lead Or Collaborator collaborator Lead Or Collaborator collaborator Lead Or Collaborator collaborator
Name Boston Children's Hospital Name Children's Hospital Medical Center, Cincinnati Name University of North Carolina, Chapel Hill Name George Washington University Name Emory University Name University of Southampton Name Imperial College London

Overall Officials

Sequence: 29111888
Role Principal Investigator
Name Wanda Phipatanakul, MD, MS
Affiliation Boston Children's Hospital

Central Contacts

Sequence: 11946883
Contact Type primary
Name Amparito Cunningham
Phone 857-218-5336
Email asthma@childrens.harvard.edu
Role Contact

Design Group Interventions

Sequence: 67790135 Sequence: 67790136
Design Group Id 55297208 Design Group Id 55297209
Intervention Id 52194096 Intervention Id 52194097

Eligibilities

Sequence: 30591131
Gender All
Minimum Age 6 Months
Maximum Age 12 Months
Healthy Volunteers Accepts Healthy Volunteers
Criteria 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
Adult False
Child True
Older Adult False

Calculated Values

Sequence: 253877775
Registered In Calendar Year 2021
Were Results Reported False
Has Single Facility False
Minimum Age Num 6
Maximum Age Num 12
Minimum Age Unit Months
Maximum Age Unit Months
Number Of Primary Outcomes To Measure 1

Designs

Sequence: 30338865
Allocation Randomized
Intervention Model Parallel Assignment
Observational Model
Primary Purpose Prevention
Time Perspective
Masking Single
Masking Description double blinded
Intervention Model Description 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.
Outcomes Assessor Masked True

Intervention Other Names

Sequence: 26534836 Sequence: 26534837
Intervention Id 52194096 Intervention Id 52194097
Name dust mite sublingual immunotherapy Name placebo dust mite sublingual immunotherapy

Responsible Parties

Sequence: 28716034
Responsible Party Type Principal Investigator
Name Wanda Phipatanakul
Title Professor of Pediatrics
Affiliation Boston Children's Hospital