[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"idiopathic-subglottic-stenosis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:idiopathic-subglottic-stenosis":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,44],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100610478","phase-3-use-of-steroid-injections-to-prevent-the-recurrence-of-tracheal-stenosis-in-idiopathic-subglottic-stenosis-100610478",false,"NCT07228104","Adjuvant Steroid Outcomes in Idiopathic Subglottic Stenosis","ASTRO","Inclusion Criteria:\n\n1. Diagnosis of iSGS following the NoAAC criteria which involves ruling out known causes for airway stenosis. Participants may be newly diagnosed or carry an existing diagnosis of iSGS;\n2. Age Range: 18 years to 80 years old at the time of consent;\n3. Sex distribution: all eligible men and women will be included, and no one will be excluded;\n4. Have a life expectancy of ≥6 months; and,\n5. ECOG performance status of 0 or 1.\n\nExclusion Criteria:\n\n1. History of subglottic stenosis from identifiable cause (not idiopathic), including any of the below clinical criteria:\n\n   1. Prolonged endotracheal intubation or tracheostomy (intervention greater than 7 days immediately prior to diagnosis of subglottic stenosis);\n   2. External physical trauma (including but not limited to blunt, penetration, chemical, or thermal injury) that causes injury to the subglottis;\n   3. Clinical diagnosis of granulomatosis with polyangiitis (GPA);\n   4. Radiation exposure to the neck;\n   5. Complications resulting from the Index Procedure, including needing an endotracheal tube or tracheostomy immediately following surgery or a perforation of the trachea;\n2. Current or previous treatment with SILSI;\n3. Use of systemic corticosteroids (oral, intravenous, or intramuscular glucocorticoids), regardless of indication, within 7 days before triamcinolone administration;\n\n   1. Local administration of corticosteroids (ophthalmic, intranasal, inhaled) is not prohibited. However, the administration of intraarticular corticosteroids during the Study Drug Dosing phase is not recommended due to potential increased risk of infection.\n   2. Intralesional administration, in a site other than the subglottis, of corticosteroids should be discussed with the site PI before enrollment.\n   3. Use of inhaled steroids is permitted during the study if the participant was taking at the time of consent, and no new inhaled steroids can be started while enrolled in the study.\n4. Intraarticular corticosteroids during the Study Drug Dosing phase due to potential increased risk of infection;\n5. Use of anticoagulants other than aspirin (daily aspirin dose should not exceed 81mg);\n6. Pulmonary disease including interstitial lung disease or COPD\u002Femphysema;\n7. Systemic infection requiring treatment with antibiotics, antifungal, or antiviral agents within 21 days of Enrollment;\n8. Poorly controlled diabetes as defined by a HbA1C value greater or equal to 8.0 in the last 180 days;\n9. Participants with active cancer or a history of cancer in the last 5 years prior to enrollment, except for squamous or basal cell carcinoma of the skin;\n10. 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;\n11. Active autoimmune disease requiring systemic treatment;\n12. History of solid organ transplant due to use of immunosuppression;\n13. Contraindication to any aspect of the index procedure;\n14. Inability to tolerate in-office SILSI procedure;\n15. Contraindication, hypersensitivity, or history of intolerance to oral or injectable steroids;\n16. Contraindication to SMOFlipid including any of the below:\n\n    1. Severe lipid metabolism disorders characterized by hypertriglyceridemia (greater than 500 mg\u002FdL);\n    2. Hypersensitivity to eggs, soybean, peanut protein, or any active ingredient in SMOFlipid;\n    3. History of intolerance to SMOFlipid;\n17. Participants with known, suspected, or plan for becoming pregnant in the next 6 months after the index procedure, or participants who are breastfeeding;\n18. NYHA class II-IV heart failure within the past 6 months prior to Enrollment;\n19. History of angioedema;\n20. Lack of capacity to consent;\n21. Alcohol or substance abuse or dependence in the past 6 months prior to Enrollment;\n22. Participants who for any reason may not complete the study as judged by the PI;\n23. Participants planning to move to another city or state for 6 months after the Index Procedure;\n24. Not able to undergo phlebotomy as reported by the participant or determined by the study coordinator or physician.\n25. The presence of a medical condition, lab test result, and\u002For use of a medication and\u002For any substance, individually or in aggregate, that in the judgement of the site investigator could impair study participation.","ALL","18 Years","80 Years",{"count":20,"type":21},226,"ESTIMATED","INTERVENTIONAL",[24],"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.",[27],"Idiopathic Subglottic Stenosis",[29,30],"Steroid injection","Stenosis","RECRUITING","2026-08-20",{"date":34,"type":35},"2026-08-21","ACTUAL",{"date":37,"type":35},"2026-05-20",{"date":39,"type":21},"2032-01",{"name":41,"class":42},"Johns Hopkins University","OTHER",10,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":50,"minAge":17,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":22,"phases":53,"briefSummary":55,"conditions":56,"keywords":58,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":73},"100641406","phase-1-a-phase-i-evaluation-of-the-safety-and-tolerability-of-pirfenidone-in-idiopathic-subglottic-stenosis-100641406","NCT07654517","A Phase I Evaluation of the Safety and Tolerability of Pirfenidone in Idiopathic Subglottic Stenosis","Inclusion Criteria:\n\n* Adults 18-65 years of age\n* Confirmed diagnosis of idiopathic subglottic stenosis (iSGS)\n* History of at least 2 endoscopic dilations within the past 12 months or -Receiving regular intralesional steroid injections as part of iSGS management (every 3 months)\n* Clinically stable at enrollment (no acute infection or active inflammation)\n* Adequate liver and renal function on screening laboratory tests\n* Willing and able to comply with study procedures, visits, and follow-up\n* Ability to provide written informed consent\n* For participants of childbearing potential: negative pregnancy test and agreement to use effective contraception during treatment and for the protocol-specified period after the last dose\n\nExclusion Criteria:\n\n* Subglottic stenosis due to another identifiable cause (e.g., intubation, granulomatosis with polyangiitis, malignancy)\n* Known hypersensitivity or allergic reaction to pirfenidone or any component of its formulation\n* Severe hepatic impairment or active liver disease (AST or ALT above the upper limit of normal)\n* Severe renal impairment or requirement for dialysis\n* Concurrent use of fluvoxamine\n* Use of high-dose ciprofloxacin or other strong CYP1A2 inhibitors where dose adjustment is not feasible\n* Current smoking or unwillingness to abstain from smoking during treatment\n* Pregnant or breastfeeding individuals\n* Clinically significant comorbid illness that could increase risk or confound results (e.g., advanced cardiac, pulmonary, or autoimmune disease)\n* History of photosensitivity disorders or inability to adhere to sun protection precautions\n* Participation in another investigational clinical trial within the previous 30 days\n* Any condition that, in the investigator's judgment, would interfere with safety monitoring, adherence, or study assessments","FEMALE",{"count":52,"type":21},40,[54],"PHASE1","Idiopathic subglottic stenosis (iSGS) is a rare condition where scar tissue forms just below the vocal cords and in the upper windpipe, making the airway narrow. People with iSGS often feel short of breath, hear noisy breathing, and notice changes in their voice. Many need repeated operations and steroid injections to open the airway, but the narrowing usually comes back, so these treatments are not a cure.\n\nRecent research from a Canadian iSGS registry and biobank has shown that this disease is driven by overactive scarring pathways, similar to those seen in idiopathic pulmonary fibrosis (IPF), a serious lung disease. Pirfenidone is an oral medication already approved for IPF that works by slowing down the cells and signals that cause scarring. Because the same scarring pathways appear to be active in iSGS, pirfenidone may be able to slow or reduce the build-up of scar tissue in the airway.\n\nIn this study, adults with iSGS will be randomly assigned (like flipping a coin) to receive either pirfenidone or a placebo (a look-alike pill with no active drug) for 52 weeks, in addition to their usual intralesional steroid injections. The pirfenidone dose will be increased gradually over the first two weeks up to a regular dose taken three times a day with food, which is the same schedule used in patients with IPF. Participants and their doctors will not know which treatment they are getting until the end of the study, unless this needs to be revealed for safety reasons.\n\nThe main goal of this trial is to see how safe pirfenidone is for people with iSGS and how well they can tolerate taking it for one year. The study team will watch closely for side effects such as stomach upset, skin rash or sensitivity to sunlight, tiredness, and changes in liver blood tests. They will also look for early signs that pirfenidone may help, such as longer time until the next airway dilation, better breathing tests, and improvements in breathlessness and voice-related quality of life scores.\n\nParticipants will be followed for a total of up to two years, including one year on study medication and one year of follow-up. This study may not directly help every person who takes part, but the results will provide important information about whether pirfenidone is safe in iSGS and whether it could become the first medication to slow down this scarring airway disease.",[27,57],"Subglottic Stenosis (SGS)",[59,60,61,62],"Subglottic Stenosis","Idiopathic Subglottic stenosis","Airway Fibrosis","Pirfenidone","NOT_YET_RECRUITING","2026-06-12",{"date":66,"type":35},"2026-06-17",{"date":68,"type":21},"2026-12-01",{"date":70,"type":21},"2029-12-01",{"name":72,"class":42},"London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's",1]