Ignite Creation Date:
2025-12-25 @ 1:45 AM
Ignite Modification Date:
2025-12-28 @ 12:06 AM
Study NCT ID:
NCT05113394
Status:
WITHDRAWN
Last Update Posted:
2024-11-26
First Post:
2021-10-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Preventing Childhood Asthma Using Prophylactic House Dust Mite Allergen Immunotherapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001249', 'term': 'Asthma'}, {'id': 'D006967', 'term': 'Hypersensitivity'}], 'ancestors': [{'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'double blinded'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Awaiting funding', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2027-02-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2029-08-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-22', 'studyFirstSubmitDate': '2021-10-19', 'studyFirstSubmitQcDate': '2021-10-28', 'lastUpdatePostDateStruct': {'date': '2024-11-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-11-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-02-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants with Asthma', 'timeFrame': '1.5 years after discontinuation of 3 years of treatment', 'description': 'asthma diagnosis'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Asthma', 'Allergy']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Months', 'minimumAge': '6 Months', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Aged 6 to 12 months of age\n2. history of physician diagnosed atopic dermatitis OR\n3. allergen sensitization OR\n4. family history of asthma or allergy\n\nExclusion Criteria:\n\n1. Evidence of sensitization to house dust mite (SPT ≥3 mm OR sIgE (\\> 0.35 kU/L)\n2. Prematurity (\\<37 weeks)\n3. Failure to thrive\n4. Need for oxygen for more than 5 days in the neonatal period\n5. history of intubation or mechanical ventilation'}, 'identificationModule': {'nctId': 'NCT05113394', 'acronym': 'PAPA', 'briefTitle': 'Preventing Childhood Asthma Using Prophylactic House Dust Mite Allergen Immunotherapy', 'organization': {'class': 'OTHER', 'fullName': "Boston Children's Hospital"}, 'officialTitle': 'Preventing Childhood Asthma Using Prophylactic House Dust Mite Allergen Immunotherapy'}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental 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.', 'interventionNames': ['Drug: HDM sublingual Immunotherapy']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo arm', '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.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'HDM sublingual Immunotherapy', 'type': 'DRUG', 'otherNames': ['dust mite sublingual immunotherapy'], '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.', 'armGroupLabels': ['Experimental arm']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['placebo dust mite sublingual immunotherapy'], 'description': 'Placebo sublingual therapy', 'armGroupLabels': ['Placebo arm']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Wanda Phipatanakul, MD, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Boston Children's Hospital"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Boston Children's Hospital", 'class': 'OTHER'}, 'collaborators': [{'name': "Children's Hospital Medical Center, Cincinnati", 'class': 'OTHER'}, {'name': 'University of North Carolina, Chapel Hill', 'class': 'OTHER'}, {'name': 'George Washington University', 'class': 'OTHER'}, {'name': 'Emory University', 'class': 'OTHER'}, {'name': 'University of Southampton', 'class': 'OTHER'}, {'name': 'Imperial College London', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Pediatrics', 'investigatorFullName': 'Wanda Phipatanakul', 'investigatorAffiliation': 'Harvard Medical School (HMS and HSDM)'}}}}