[{"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":25},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,45],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":23,"conditions":24,"keywords":27,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100641406","phase-1-a-phase-i-evaluation-of-the-safety-and-tolerability-of-pirfenidone-in-idiopathic-subglottic-stenosis-100641406",false,"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","18 Years",{"count":18,"type":19},40,"ESTIMATED","INTERVENTIONAL",[22],"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.",[25,26],"Idiopathic Subglottic Stenosis","Subglottic Stenosis (SGS)",[28,29,30,31],"Subglottic Stenosis","Idiopathic Subglottic stenosis","Airway Fibrosis","Pirfenidone","NOT_YET_RECRUITING","2026-06-12",{"date":35,"type":36},"2026-06-17","ACTUAL",{"date":38,"type":19},"2026-12-01",{"date":40,"type":19},"2029-12-01",{"name":42,"class":43},"London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's","OTHER",1,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":53,"minAge":16,"maxAge":54,"enrollmentInfo":55,"targetDuration":4,"studyType":20,"phases":57,"briefSummary":59,"conditions":60,"keywords":61,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":44},"100610478","phase-3-use-of-steroid-injections-to-prevent-the-recurrence-of-tracheal-stenosis-in-idiopathic-subglottic-stenosis-100610478","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","80 Years",{"count":56,"type":19},226,[58],"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.",[25],[62,63],"Steroid injection","Stenosis","RECRUITING","2026-06-04",{"date":67,"type":36},"2026-06-08",{"date":69,"type":36},"2026-05-20",{"date":71,"type":19},"2032-01",{"name":73,"class":43},"Johns Hopkins University"]