Idiopathic Subglottic StenosisPhase 3ASTRONCT07228104
Adjuvant Steroid Outcomes in Idiopathic Subglottic Stenosis
A Phase 3 study testing Triamcinolone 0.1% in people with Idiopathic Subglottic Stenosis, run by Johns Hopkins University at 10 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Idiopathic Subglottic Stenosis
- What is being tested?
- Triamcinolone 0.1%
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 226 participants
- Where
- 10 sitesUnited States
- Study dates
- 20 May 2026to Jan 2032
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
- Age Range: 18 years to 80 years old at the time of consent;
- Sex distribution: all eligible men and women will be included, and no one will be excluded;
- Have a life expectancy of ≥6 months; and,
- ECOG performance status of 0 or 1.
Who cannot join
- 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;
- Complications resulting from the Index Procedure, including needing an endotracheal tube or tracheostomy immediately following surgery or a perforation of the trachea;
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- Current or previous treatment with 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 Study Drug Dosing phase is not recommended due to potential increased risk of infection.
- Intralesional administration, in a site other than the subglottis, of corticosteroids should be discussed with the site PI before enrollment.
- 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.
- Intraarticular corticosteroids during the Study Drug Dosing phase due to potential increased risk of infection;
- Use of anticoagulants other than aspirin (daily aspirin dose should not exceed 81mg);
- Pulmonary disease including interstitial lung disease or 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 prior to enrollment, 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 participation;
- Active autoimmune disease requiring systemic treatment;
- History of solid organ transplant due to use of immunosuppression;
- Contraindication to any aspect of the index procedure;
- Inability to tolerate in-office SILSI procedure;
- Contraindication, hypersensitivity, or history of intolerance to oral or injectable steroids;
- Contraindication to SMOFlipid including any of the below:
- Severe lipid metabolism disorders characterized by hypertriglyceridemia (greater than 500 mg/dL);
- Hypersensitivity to eggs, soybean, peanut protein, or any active ingredient in SMOFlipid;
- History of intolerance to SMOFlipid;
- Participants with known, suspected, or plan for becoming pregnant in the next 6 months after the index procedure, or participants who are breastfeeding;
- NYHA class II-IV heart failure within the past 6 months prior to Enrollment;
- History of angioedema;
- Lack of capacity to consent;
- Alcohol or substance abuse or dependence in the past 6 months prior to Enrollment;
- Participants who for any reason may not complete the study as judged by the PI;
- Participants planning to move to another city or state for 6 months after the Index Procedure;
- Not able to undergo phlebotomy as reported by the participant or determined by the study coordinator or physician.
- 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.
Trial locations and contacts
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
10 sites in 1 country
United States10 sites, 10 recruiting
- Not yet recruiting
University of Colorado
Aurora, Colorado, 80045
Yosr Doghri, yosr.doghri@cuanschutz.edu
Matthew Clary, MD
- Recruiting
Johns Hopkins Hospital
Baltimore, Maryland, 21231
Sarah E Collins, M.S., 434-962-3058, shirsh1@jh.edu
Sam L Collins, Ph.D., 4107020420, scollin7@jhmi.edu
- Recruiting
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
Emma Thayer, emma-thayer@uiowa.edu
Matthew Hoffman, MD, PhD
- Not yet recruiting
University of Wisconsin - Madison
Madison, Wisconsin, 53792
Maddie Baranek, baranek@surgery.wisc.edu
David Francis, MD
- Recruiting
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Samantha Salvi Cruz, samantha.salvicruz@vumc.org
Alexander Gelbard, MD
- Recruiting
University of Rochester Medical Center
Rochester, New York, 14642
Paul Allen, paul_allen@urmc.rochester.edu
G. Todd Schneider, MD, MS
- Recruiting
University of Utah
Salt Lake City, Utah, 84112
Chen Wilson, u0661901@utah.edu
Breanne Schiffer, MD, MPH
- Not yet recruiting
University of California - San Diego
San Diego, California, 92121
Daniel Cates, djcates@health.ucsd.edu
Daniel Cates, MD
- Not yet recruiting
University of California - San Francisco
San Francisco, California, 94115
Meera Kohli, meera.kohli@ucsf.edu
Clark Rosen, MD
- Recruiting
University of South Florida
Tampa, Florida, 33612
Jacquie Persaud, jdpersaud@usf.edu
Yael Bensoussan, MD
About this study
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.
- Conditions
- Idiopathic Subglottic Stenosis
- Being tested
- Triamcinolone 0.1%, Placebo
- Keywords
- Steroid injection, Stenosis
- Medical subject headings
- Idiopathic subglottic tracheal stenosis, Constriction, Pathologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Triamcinolone 0.1%Drug
Intralesional Triamcinolone injection 3x at one, two, and three months following surgical dilation
PlaceboDrug
Intralesional Placebo injection 3x at one, two, and three months following surgical dilation
| Study group | Role | What they receive |
|---|---|---|
| Intralesional steroid injection with Triamcinolone | Experimental | Not described Receives: Drug: Triamcinolone 0.1% |
| Intralesional Placebo injection | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Peak Expiratory Flow (Liters/min)
Measured: 6 Months
Secondary outcomes (2)
Clinical COPD Questionnaire
Score range 0-60, Lower score indicates better health
Measured: 6 months
Voice Handicap Index-10
Score range 0 to 40, Lower score indicates better voice
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2025
- Study start20 May 2026
- Primary completion1 Jan 2031 (estimated)
- Study completionJan 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Subglottic StenosisStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 226 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Alexander Hillel, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07228104
- Sponsor's protocol ID
- IRB00507375
- Other IDs
- 1UG3HL173394-01A1
- Acronym
- ASTRO
- Status last verified
- Oct 2026
- First submitted
- 11 Nov 2025
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes