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 |
| 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 |