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New treatment option for Idiopathic Subglottic Stenosis
Official title Use of Steroid Injections to Prevent the Recurrence of Tracheal Stenosis in Idiopathic Subglottic Stenosis
ClinicalTrials.gov ID: NCT07228104
What this study is testing
What is Triamcinolone 0.1%?
Triamcinolone 0.1% is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for idiopathic subglottic stenosis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- Have a life expectancy of ≥6 months; and,
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 1.
You likely can't join if
- History of subglottic stenosis from identifiable cause (not idiopathic), including any of the below clinical criteria:
- Prolonged endotracheal intubation or tracheostomy (intervention greater than 7 days immediately prior to diagnosis of subglottic stenosis);
- External physical trauma (including but not limited to blunt, penetration, chemical, or thermal injury) that causes injury to the subglottis;
- Clinical diagnosis of granulomatosis with polyangiitis (GPA);
- Radiation exposure to the neck;
- Current or previous treatment with Serial Intralesional Steroid Injection (SILSI);
See the full eligibility criteria
- Have a life expectancy of ≥6 months; and,
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 1.
- History of subglottic stenosis from identifiable cause (not idiopathic), including any of the below clinical criteria:
- Prolonged endotracheal intubation or tracheostomy (intervention greater than 7 days immediately prior to diagnosis of subglottic stenosis);
- External physical trauma (including but not limited to blunt, penetration, chemical, or thermal injury) that causes injury to the subglottis;
- Clinical diagnosis of granulomatosis with polyangiitis (GPA);
- Radiation exposure to the neck;
- Current or previous treatment with Serial Intralesional Steroid Injection (SILSI);
- Use of systemic corticosteroids (oral, intravenous, or intramuscular glucocorticoids), regardless of indication, within 7 days before triamcinolone administration;
- 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...
- Intralesional administration, in a site other than the subglottis, of corticosteroids should be discussed with the site PI before enrollment
- Intraarticular corticosteroids during the treatment phase due to potential increased risk of infection;
- Use of anticoagulants other than aspirin (aspirin dose should not exceed 81mg);
- Pulmonary disease including interstitial lung disease and Chronic Obstructive Pulmonary Disease (COPD)/emphysema;
- Systemic infection requiring treatment with antibiotics, antifungal, or antiviral agents within 21 days of enrollment;
- Poorly controlled diabetes as defined by a HbA1C value greater or equal to 8.0 in the last 180 days);
- Participants with active cancer or a history of cancer in the last 5 years, except for squamous or basal cell carcinoma of the skin;
- 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...
- Active autoimmune disease requiring systemic treatment;
- History of solid organ transplant due to use of immunosuppression;
- Contraindication to any aspect of the index endoscopic dilation procedure.
- Inability to tolerate in office SILSI procedure;
- Contraindication, hypersensitivity, or history of intolerance to oral or injectable steroids;
- Contraindication to intralipid including:
- Severe lipid metabolism disorders characterized by hypertriglyceridemia;
- Hypersensitivity to eggs, soybean, peanut protein, or any active ingredient in intralipid;
- History of intolerance to intralipid;
- Participants with known, suspected, or plan for becoming pregnant or breastfeeding;
- New York Heart Association (NYHA) class II-IV heart failure within the past 6 months;
- History of angioedema;
- 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...
- Lack of capacity to consent;
- Alcohol or substance abuse or dependence in the past 6 months;
- Participants who for any reason may not complete the study as judged by the PI;
- Participants planning to move to another city or state during the duration of the study;
- Not able to undergo phlebotomy as reported by the participant or determined by the study coordinator or physician.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Baltimore, Maryland, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Baltimore, Maryland, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.