Ignite Creation Date:
2025-12-24 @ 11:53 AM
Ignite Modification Date:
2026-06-02 @ 7:43 PM
Study NCT ID:
NCT03431961
Status:
UNKNOWN
Last Update Posted:
2018-08-02
First Post:
2018-02-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Nasal Allergen Challenge - Reproducibility of Biomarkers and Effect of Topical Steroid Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D014222', 'term': 'Triamcinolone Acetonide'}, {'id': 'D014221', 'term': 'Triamcinolone'}, {'id': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}, {'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-03-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2019-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-08-01', 'studyFirstSubmitDate': '2018-02-07', 'studyFirstSubmitQcDate': '2018-02-07', 'lastUpdatePostDateStruct': {'date': '2018-08-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-02-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cellular inflammation', 'timeFrame': '24 hours after nasal allergen challenge', 'description': 'Nasal eosinophils'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Allergic Asthma']}, 'referencesModule': {'references': [{'pmid': '37794659', 'type': 'DERIVED', 'citation': "Bauer RN, Xie Y, Beaudin S, Wiltshire L, Wattie J, Munoz C, Alsaji N, Oliveria JP, Ju X, MacLean J, Sommer DD, Keith PK, Satia I, Cusack RP, O'Byrne PM, Sperinde G, Hokom M, Li O, Banerjee P, Chen C, Staton T, Sehmi R, Gauvreau GM. Evaluation of the reproducibility of responses to nasal allergen challenge and effects of inhaled nasal corticosteroids. Clin Exp Allergy. 2023 Nov;53(11):1187-1197. doi: 10.1111/cea.14406. Epub 2023 Oct 4."}]}, 'descriptionModule': {'briefSummary': 'Subjects with allergic asthma developing the required nasal symptoms in response to nasal allergen titration during a screening period will be randomized 1:1 to one of 2 cohorts. All subjects will have repeated nasal challenges with allergen. One cohort will have nasal saline challenge as control. One cohort will have intranasal corticosteroid intervention.', 'detailedDescription': 'Eligible subjects will be randomized 1:1 to Cohort A or Cohort B. Each cohort will undergo 3 nasal challenges, each separated by 3 weeks. Cohort A will undergo 2 nasal allergen challenges, and 1 nasal diluent challenge. TNSS, PNIF, spirometry, and samples of blood, urine and nasal secretions will be collected until 24h post-challenge to assess reproducibility. Cohort B will undergo 3 nasal allergen challenges; one of the challenge will be conducted after 14 days treatment with placebo, and one challenge will be conducted after 14 days treatment with triamcinolone acetonide aqueous nasal spray at a dose of 220 mcg administered twice daily for a total daily dose of 440 mcg. TNSS, PNIF, spirometry, and samples of blood, urine, nasal secretions will be collected until 24h post-challenge to determine reproducibility, and nasal tissue will be collected 24h post-challenge to determine effect of steroid treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* allergic rhinitis + mild asthma\n\nExclusion Criteria:\n\n* other respiratory disease\n* any medication for treatment of asthma/allergic rhinitis with the exception of infrequent beta-2 agonist.'}, 'identificationModule': {'nctId': 'NCT03431961', 'acronym': 'NACHO', 'briefTitle': 'Nasal Allergen Challenge - Reproducibility of Biomarkers and Effect of Topical Steroid Treatment', 'organization': {'class': 'OTHER', 'fullName': 'Hamilton Health Sciences Corporation'}, 'officialTitle': 'Nasal Allergen Challenge - Reproducibility of Biomarkers and Effect of Topical Steroid Treatment', 'orgStudyIdInfo': {'id': 'DC002544/HIREB3820'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': '0.9% normal saline administered twice daily for 14 days', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Intranasal Corticosteroid', 'description': 'Triamcinolone acetonide aqueous nasal spray at a dose of 220 mcg administered twice daily (for a total daily dose of 440 mcg) for 14 days', 'interventionNames': ['Drug: Triamcinolone Acetonide']}], 'interventions': [{'name': 'Triamcinolone Acetonide', 'type': 'DRUG', 'otherNames': ['Nasacort'], 'description': '220 mcg administered twice daily for 14 days', 'armGroupLabels': ['Intranasal Corticosteroid']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['0.9% Normal Saline'], 'description': 'twice daily for 14 days', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'L8N 3Z5', 'city': 'Hamilton', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Gail Gauvreau, PhD.', 'role': 'CONTACT', 'email': 'gauvreau@mcmaster.ca', 'phone': '905-525-9140', 'phoneExt': '22791'}, {'name': 'Gail M Gauvreau, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Cardio- Respiratory Research Laboratory, Hamilton Health Sciences', 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}], 'centralContacts': [{'name': 'Gail M Gauvreau, PhD', 'role': 'CONTACT', 'email': 'gauvreau@mcmaster.ca', 'phone': '905-525-9140', 'phoneExt': '22791'}, {'name': "Paul M O'Byrne, MB", 'role': 'CONTACT', 'email': 'obyrnep@mcmaster.ca', 'phone': '905-525-9140', 'phoneExt': '22100'}], 'overallOfficials': [{'name': 'Gail M Gauvreau, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'McMaster University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gail Gauvreau', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Gail Gauvreau', 'investigatorAffiliation': 'Hamilton Health Sciences Corporation'}}}}