[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100610478":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":29,"centralContacts":33,"locations":39,"responsibleParty":59,"collaborators":61,"id":65,"slug":66,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":71,"eligibilityCriteria":72,"healthyVolunteers":67,"sex":73,"minAge":74,"maxAge":75,"enrollmentInfo":76,"targetDuration":11,"studyType":79,"phases":80,"briefSummary":82,"conditions":83,"keywords":85,"overallStatus":42,"whyStopped":11,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},{"fullName":5,"class":6},"Johns Hopkins University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Intralesional steroid injection with Triamcinolone","EXPERIMENTAL",null,[13],"Drug: Triamcinolone 0.1%",{"label":15,"type":16,"description":11,"interventionNames":17},"Intralesional Placebo injection","PLACEBO_COMPARATOR",[18],"Drug: Placebo",[20,25],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":11},"DRUG","Triamcinolone 0.1%","Intralesional Triamcinolone injection 3x at one, two, and three months following surgical dilation",[9],{"type":21,"name":26,"description":27,"armGroupLabels":28,"otherNames":11},"Placebo","Intralesional Placebo injection 3x at one, two, and three months following surgical dilation",[15],[30],{"name":31,"affiliation":5,"role":32},"Alexander Hillel, MD","PRINCIPAL_INVESTIGATOR",[34],{"name":35,"role":36,"phone":37,"phoneExt":11,"email":38},"Alexander Hillel, M.D.","CONTACT","4432876006","ahillel@jh.edu",[40],{"facility":41,"status":42,"city":43,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"Johns Hopkins Hospital","RECRUITING","Baltimore","Maryland","21231","United States","US",{"type":49,"coordinates":50},"Point",[51,52],-76.61219,39.29038,{"lat":52,"lon":51},[55],{"name":56,"role":36,"phone":57,"phoneExt":11,"email":58},"Samuel Collins, Ph.D.","410-702-0421","scollin7@jh.edu",{"type":60,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR",[62],{"name":63,"class":64},"National Heart, Lung, and Blood Institute (NHLBI)","NIH","100610478","phase-3-use-of-steroid-injections-to-prevent-the-recurrence-of-tracheal-stenosis-in-idiopathic-subglottic-stenosis-100610478",false,"NCT07228104","Use of Steroid Injections to Prevent the Recurrence of Tracheal Stenosis in Idiopathic Subglottic Stenosis","Adjuvant STeRoid Outcomes in Idiopathic Subglottic Stenosis","ASTRO","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)\u002Femphysema;\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\u002For use of a medication and\u002For any substance, individually or in aggregate, that in the judgement of the study team could impair study participation.","ALL","18 Years","80 Years",{"count":77,"type":78},226,"ESTIMATED","INTERVENTIONAL",[81],"PHASE3","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.",[84],"Idiopathic Subglottic Stenosis",[86,87],"Steroid injection","Stenosis","2026-06-04",{"date":90,"type":91},"2026-06-08","ACTUAL",{"date":93,"type":91},"2026-05-20",{"date":95,"type":78},"2032-01",{"name":5,"class":6},1]