Ignite Creation Date:
2025-12-25 @ 3:38 AM
Ignite Modification Date:
2026-01-11 @ 5:01 PM
Study NCT ID:
NCT03825302
Status:
WITHDRAWN
Last Update Posted:
2022-03-17
First Post:
2019-01-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prostaglandin E2 as a Critical Mediator of Sex Disparities in Asthma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001249', 'term': 'Asthma'}], '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': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Sputum, blood, nasal fluid, urine'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'No funding available.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2021-12-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2022-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-03-02', 'studyFirstSubmitDate': '2019-01-30', 'studyFirstSubmitQcDate': '2019-01-30', 'lastUpdatePostDateStruct': {'date': '2022-03-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-01-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Provacative dose of mannitol that elicits a 15% decline in forced expiratory volume in males', 'timeFrame': 'Baseline', 'description': 'Males only'}, {'measure': 'Provacative dose of mannitol that elicits a 15% decline in forced expiratory volume in females', 'timeFrame': 'Baseline', 'description': 'Females only during the luteal phase of the menstrual cycle'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Asthma']}, 'descriptionModule': {'briefSummary': 'This study seeks to understand how biological sex influences airway hyperresponsiveness in adult asthma.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Asthmatics at VUMC', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Subject must be able to understand and provide informed consent\n* Age 18-50\n* A history of physician-diagnosed asthma well controlled as assessed by ACQ-6 \\<1.5 and FEV1\\>70% of predicted and FEV1 \\>1.5 liters.\n* Asthma must be persistent, defined by the requirement of a daily controller agent.\n* Use of a stable dose of daily inhaled corticosteroids for the prior 3 months.\n* Female subjects of childbearing potential must have a negative pregnancy test upon study entry and at each study visit.\n\nExclusion Criteria:\n\n* Inability or unwillingness of a participant to give written informed consent or comply with study protocol.\n* Hypogonadism, irregular menstrual cycles, polycystic ovarian syndrome (PCOS), exogenous hormonal supplements or contraception.\n* Any chronic lung condition outside of asthma including chronic obstructive pulmonary disease (COPD), interstitial lung disease, eosinophilic granulomatosis with polyangiitis, allergic bronchopulmonary aspergillosis.\n* Inability or unwillingness to hold the following medications prior to mannitol and methacholine inhalational challenge(s): Short-Acting Beta 2 Agonists \\>8 hours, Inhaled Corticosteroids and Anticholinergic Bronchodilators \\>12 hours, Phosphodiesterase Inhibitors or Adenosine Receptors \\>24 hours, Long-acting Beta 2 Agonists \\>36 hours, Long-acting Anticholinergics or Short-Acting Antihistamines \\>48 hours, Long-Acting Antihistamines \\>72 hours, and Leukotriene-Receptor Antagonist or 5-Lipooxygenase Inhibitors \\>4 days.\n* For males, a screening morning serum total testosterone level (obtained between 8-10 AM) below the normal reference lab value.\n* Current pregnancy, breast-feeding, or plans to become pregnant during the study period.\n* Oral or systemic corticosteroid use or biologic agent for asthma in the previous 3 months or ED/Hospitalization for asthma within 6 months.\n* Use of investigational drugs within 12 weeks of participation.\n* Known hypersensitivity or allergy to mannitol, gelatin or methacholine.\n* Upper or lower respiratory tract infection within the proceeding 6 weeks.\n* A history of uncontrolled hypertension, coronary artery disease, stroke, epilepsy, urinary tract obstruction, untreated thyroid disease, or a chronic lung disease other than asthma.\n* Daily use of a beta-blocker.\n* Intolerance to anticholinergic medications.\n* Inability to produce an adequate sputum sample.\n* Past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study."}, 'identificationModule': {'nctId': 'NCT03825302', 'briefTitle': 'Prostaglandin E2 as a Critical Mediator of Sex Disparities in Asthma', 'organization': {'class': 'OTHER', 'fullName': 'Vanderbilt University Medical Center'}, 'officialTitle': 'Prostaglandin E2 as a Critical Mediator of Sex Disparities in Asthma', 'orgStudyIdInfo': {'id': 'PGE2 in asthma'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Males with asthma', 'description': 'Induced sputum, methacholine challenge, and mannitol challenge will be performed.', 'interventionNames': ['Diagnostic Test: Methacholine challenge', 'Diagnostic Test: Mannitol challenge']}, {'label': 'Females with asthma', 'description': 'Induced sputum, methacholine challenge, and mannitol challenge will be performed.', 'interventionNames': ['Diagnostic Test: Methacholine challenge', 'Diagnostic Test: Mannitol challenge']}], 'interventions': [{'name': 'Methacholine challenge', 'type': 'DIAGNOSTIC_TEST', 'description': 'Methacholine inhalation challenge will be administered to both male and females with asthma', 'armGroupLabels': ['Females with asthma', 'Males with asthma']}, {'name': 'Mannitol challenge', 'type': 'DIAGNOSTIC_TEST', 'description': 'Mannitol inhalation challenge will be administered to both male and females with asthma', 'armGroupLabels': ['Females with asthma', 'Males with asthma']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37232', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt University Medical Center', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}], 'overallOfficials': [{'name': 'Katherine Cahill, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Vanderbilt University Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vanderbilt University Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Katherine Cahill', 'investigatorAffiliation': 'Vanderbilt University Medical Center'}}}}