Could a simple steroid injection keep your airway open longer?
NCT ID NCT07228104
First seen Jun 27, 2026 · Last updated Aug 25, 2026 · Updated 5 times
Summary
This study tests whether injecting steroids into the narrowed part of the windpipe after a dilation procedure can help people with idiopathic subglottic stenosis go longer between surgeries. About 226 adults with this rare condition will receive either steroid injections or a placebo. The goal is to see if the treatment improves breathing and reduces how often repeat procedures are needed.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
-
About 226 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
May 2026
- Expected to finish
-
Jan 2032
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 80 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. 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; 2. Age Range: 18 years to 80 years old at the time of consent; 3. Sex distribution: all eligible men and women will be included, and no one will be excluded; 4. Have a life expectancy of ≥6 months; and, 5. ECOG performance status of 0 or 1. Exclusion Criteria: 1. History of subglottic stenosis from identifiable cause (not idiopathic), including any of the below clinical criteria: 1. Prolonged endotracheal intubation or tracheostomy (intervention greater than 7 days immediately prior to diagnosis of subglottic stenosis); 2. External physical trauma (including but not limited to blunt, penetration, chemical, or thermal injury) that causes injury to the subglottis; 3. Clinical diagnosis of granulomatosis with polyangiitis (GPA); 4. Radiation exposure to the neck; 5. Complications resulting from the Index Procedure, including needing an endotracheal tube or tracheostomy immediately following surgery or a perforation of the trachea; 2. Current or previous treatment with SILSI; 3. Use of systemic corticosteroids (oral, intravenous, or intramuscular glucocorticoids), regardless of indication, within 7 days before triamcinolone administration; 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. 2. Intralesional administration, in a site other than the subglottis, of corticosteroids should be discussed with the site PI before enrollment. 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. 4. Intraarticular corticosteroids during the Study Drug Dosing phase due to potential increased risk of infection; 5. Use of anticoagulants other than aspirin (daily aspirin dose should not exceed 81mg); 6. Pulmonary disease including interstitial lung disease or COPD/emphysema; 7. Systemic infection requiring treatment with antibiotics, antifungal, or antiviral agents within 21 days of Enrollment; 8. Poorly controlled diabetes as defined by a HbA1C value greater or equal to 8.0 in the last 180 days; 9. 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; 10. 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; 11. Active autoimmune disease requiring systemic treatment; 12. History of solid organ transplant due to use of immunosuppression; 13. Contraindication to any aspect of the index procedure; 14. Inability to tolerate in-office SILSI procedure; 15. Contraindication, hypersensitivity, or history of intolerance to oral or injectable steroids; 16. Contraindication to SMOFlipid including any of the below: 1. Severe lipid metabolism disorders characterized by hypertriglyceridemia (greater than 500 mg/dL); 2. Hypersensitivity to eggs, soybean, peanut protein, or any active ingredient in SMOFlipid; 3. History of intolerance to SMOFlipid; 17. Participants with known, suspected, or plan for becoming pregnant in the next 6 months after the index procedure, or participants who are breastfeeding; 18. NYHA class II-IV heart failure within the past 6 months prior to Enrollment; 19. History of angioedema; 20. Lack of capacity to consent; 21. Alcohol or substance abuse or dependence in the past 6 months prior to Enrollment; 22. Participants who for any reason may not complete the study as judged by the PI; 23. Participants planning to move to another city or state for 6 months after the Index Procedure; 24. Not able to undergo phlebotomy as reported by the participant or determined by the study coordinator or physician. 25. The presence of a medical condition, lab test result, and/or use of a medication and/or any substance, individually or in aggregate, that in the judgement of the site investigator could impair study participation.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Idiopathic subglottic stenosis are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
10 sites. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
Johns Hopkins Hospital
RECRUITINGBaltimore, Maryland, 21231, United States
-
University of California - San Diego
NOT_YET_RECRUITINGSan Diego, California, 92121, United States
-
University of California - San Francisco
NOT_YET_RECRUITINGSan Francisco, California, 94115, United States
-
University of Colorado
NOT_YET_RECRUITINGAurora, Colorado, 80045, United States
-
University of Iowa Hospitals and Clinics
NOT_YET_RECRUITINGIowa City, Iowa, 52242, United States
-
University of Rochester Medical Center
NOT_YET_RECRUITINGRochester, New York, 14642, United States
-
University of South Florida
RECRUITINGTampa, Florida, 33612, United States
-
University of Utah
RECRUITINGSalt Lake City, Utah, 84112, United States
-
University of Wisconsin - Madison
NOT_YET_RECRUITINGMadison, Wisconsin, 53792, United States
-
Vanderbilt University Medical Center
RECRUITINGNashville, Tennessee, 37232, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.