Ignite Creation Date:
2025-12-24 @ 8:03 PM
Ignite Modification Date:
2025-12-25 @ 5:35 PM
Study NCT ID:
NCT07228104
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-11-14
First Post:
2025-11-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Use of Steroid Injections to Prevent the Recurrence of Tracheal Stenosis in Idiopathic Subglottic Stenosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'C536283', 'term': 'Idiopathic subglottic tracheal stenosis'}, {'id': 'D003251', 'term': 'Constriction, Pathologic'}], 'ancestors': [{'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 226}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-01-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2032-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-11', 'studyFirstSubmitDate': '2025-11-11', 'studyFirstSubmitQcDate': '2025-11-11', 'lastUpdatePostDateStruct': {'date': '2025-11-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-11-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2031-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Peak Expiratory Flow (Liters/min)', 'timeFrame': '6 Months'}], 'secondaryOutcomes': [{'measure': 'Clinical COPD Questionnaire', 'timeFrame': '6 months', 'description': 'Score range 0-60, Lower score indicates better health'}, {'measure': 'Voice Handicap Index-10', 'timeFrame': '6 Months', 'description': 'Score range 0 to 40, Lower score indicates better voice'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Steroid injection', 'Stenosis'], 'conditions': ['Idiopathic Subglottic Stenosis']}, 'descriptionModule': {'briefSummary': 'This study will examine the ability of steroid injections into the site of stenosis following surgical dilation to delay the need for repeated surgical dilations.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Have a life expectancy of ≥6 months; and,\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 1.\n\nExclusion Criteria:\n\n* History of subglottic stenosis from identifiable cause (not idiopathic), including any of the below clinical criteria:\n* Prolonged endotracheal intubation or tracheostomy (intervention greater than 7 days immediately prior to diagnosis of subglottic stenosis);\n* External physical trauma (including but not limited to blunt, penetration, chemical, or thermal injury) that causes injury to the subglottis;\n* Clinical diagnosis of granulomatosis with polyangiitis (GPA);\n* Radiation exposure to the neck;\n* Current or previous treatment with Serial Intralesional Steroid Injection (SILSI);\n* Use of systemic corticosteroids (oral, intravenous, or intramuscular glucocorticoids), regardless of indication, within 7 days before triamcinolone administration;\n* Local administration of corticosteroids (ophthalmic, intranasal, inhaled) is not prohibited. However, the administration of intraarticular corticosteroids during the treatment phase is not recommended due to potential increased risk of infection.\n* Intralesional administration, in a site other than the subglottis, of corticosteroids should be discussed with the site PI before enrollment\n* Intraarticular corticosteroids during the treatment phase due to potential increased risk of infection;\n* Use of anticoagulants other than aspirin (aspirin dose should not exceed 81mg);\n* Pulmonary disease including interstitial lung disease and Chronic Obstructive Pulmonary Disease (COPD)/emphysema;\n* Systemic infection requiring treatment with antibiotics, antifungal, or antiviral agents within 21 days of enrollment;\n* Poorly controlled diabetes as defined by a HbA1C value greater or equal to 8.0 in the last 180 days);\n* Participants with active cancer or a history of cancer in the last 5 years, except for squamous or basal cell carcinoma of the skin;\n* Participation in any clinical trial involving an investigational drug or device, within four weeks, or 5 half-lives of the investigational agent (whichever time point is longer) prior to enrollment or during this trial participation;\n* Active autoimmune disease requiring systemic treatment;\n* History of solid organ transplant due to use of immunosuppression;\n* Contraindication to any aspect of the index endoscopic dilation procedure.\n* Inability to tolerate in office SILSI procedure;\n* Contraindication, hypersensitivity, or history of intolerance to oral or injectable steroids;\n* Contraindication to intralipid including:\n* Severe lipid metabolism disorders characterized by hypertriglyceridemia;\n* Hypersensitivity to eggs, soybean, peanut protein, or any active ingredient in intralipid;\n* History of intolerance to intralipid;\n* Participants with known, suspected, or plan for becoming pregnant or breastfeeding;\n* New York Heart Association (NYHA) class II-IV heart failure within the past 6 months;\n* History of angioedema;\n* History of subglottic stenosis from other causes, including prolonged intubation (intubation of \\>1 week immediately prior to diagnosis of subglottic stenosis, external physical trauma that causes injury to the subglottis);\n* Lack of capacity to consent;\n* Alcohol or substance abuse or dependence in the past 6 months;\n* Participants who for any reason may not complete the study as judged by the PI;\n* Participants planning to move to another city or state during the duration of the study;\n* Not able to undergo phlebotomy as reported by the participant or determined by the study coordinator or physician.\n* The presence of a medical condition, and/or use of a medication and/or any substance, individually or in aggregate, that in the judgement of the study team could impair study participation.'}, 'identificationModule': {'nctId': 'NCT07228104', 'acronym': 'ASTRO', 'briefTitle': 'Use of Steroid Injections to Prevent the Recurrence of Tracheal Stenosis in Idiopathic Subglottic Stenosis', 'organization': {'class': 'OTHER', 'fullName': 'Johns Hopkins University'}, 'officialTitle': 'Adjuvant STeRoid Outcomes in Idiopathic Subglottic Stenosis', 'orgStudyIdInfo': {'id': 'IRB00507375'}, 'secondaryIdInfos': [{'id': '1UG3HL173394-01A1', 'link': 'https://reporter.nih.gov/quickSearch/1UG3HL173394-01A1', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intralesional steroid injection with Triamcinolone', 'interventionNames': ['Drug: Triamcinolone 0.1%']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Intralesional Placebo injection', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Triamcinolone 0.1%', 'type': 'DRUG', 'description': 'Intralesional Triamcinolone injection 3x at one, two, and three months following surgical dilation', 'armGroupLabels': ['Intralesional steroid injection with Triamcinolone']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Intralesional Placebo injection 3x at one, two, and three months following surgical dilation', 'armGroupLabels': ['Intralesional Placebo injection']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21231', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'contacts': [{'name': 'Samuel Collins, Ph.D.', 'role': 'CONTACT', 'email': 'scollin7@jh.edu', 'phone': '410-702-0421'}], 'facility': 'Johns Hopkins Hospital', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}], 'centralContacts': [{'name': 'Alexander Hillel, M.D.', 'role': 'CONTACT', 'email': 'ahillel@jh.edu', 'phone': '4432876006'}], 'overallOfficials': [{'name': 'Alexander Hillel, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Johns Hopkins University'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'ICF'], 'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johns Hopkins University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Heart, Lung, and Blood Institute (NHLBI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}