Adjuvant Steroid Outcomes in Idiopathic Subglottic Stenosis (ASTRO)

August 21, 2026 updated by: Johns Hopkins University
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
226

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Alexander Hillel, M.D.
  • Phone Number: 4432876006
  • Email: ahillel@jh.edu

Study Locations

  • United States
    • California
      • San Diego, California, United States, 92121
        • Not yet recruiting
        • University of California - San Diego
        • Contact:
        • Principal Investigator:
          • Daniel Cates, MD
      • San Francisco, California, United States, 94115
        • Not yet recruiting
        • University of California - San Francisco
        • Principal Investigator:
          • Clark Rosen, MD
        • Contact:
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Not yet recruiting
        • University of Colorado
        • Contact:
        • Principal Investigator:
          • Matthew Clary, MD
    • Florida
      • Tampa, Florida, United States, 33612
        • Recruiting
        • University of South Florida
        • Contact:
        • Principal Investigator:
          • Yael Bensoussan, MD
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Not yet recruiting
        • University of Iowa Hospitals and Clinics
        • Contact:
        • Principal Investigator:
          • Matthew Hoffman, MD, PhD
    • Maryland
      • Baltimore, Maryland, United States, 21231
        • Recruiting
        • Johns Hopkins Hospital
        • Principal Investigator:
          • Alexander Hillel, MD
        • Contact:
          • Sarah E Collins, M.S.
          • Phone Number: 434-962-3058
          • Email: shirsh1@jh.edu
        • Contact:
        • Sub-Investigator:
          • Kevin Motz, MD
    • New York
      • Rochester, New York, United States, 14642
        • Not yet recruiting
        • University of Rochester Medical Center
        • Contact:
        • Principal Investigator:
          • G. Todd Schneider, MD, MS
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Recruiting
        • Vanderbilt University Medical Center
        • Principal Investigator:
          • Alexander Gelbard, MD
        • Contact:
    • Utah
      • Salt Lake City, Utah, United States, 84112
        • Recruiting
        • University of Utah
        • Contact:
        • Principal Investigator:
          • Breanne Schiffer, MD, MPH
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • Not yet recruiting
        • University of Wisconsin - Madison
        • Contact:
        • Principal Investigator:
          • David Francis, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Intralesional steroid injection with Triamcinolone
Drug: Triamcinolone 0.1%
Intralesional Triamcinolone injection 3x at one, two, and three months following surgical dilation
Placebo Comparator: Intralesional Placebo injection
Drug: Placebo
Intralesional Placebo injection 3x at one, two, and three months following surgical dilation

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Change in Peak Expiratory Flow (Liters/min)
Time Frame: 6 Months
6 Months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Clinical COPD Questionnaire
Time Frame: 6 months
Score range 0-60, Lower score indicates better health
6 months
Voice Handicap Index-10
Time Frame: 6 Months
Score range 0 to 40, Lower score indicates better voice
6 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Johns Hopkins University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Heart, Lung, and Blood Institute (NHLBI)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Alexander Hillel, MD, Johns Hopkins University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 20, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2031

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2032

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 11, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 11, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 14, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 24, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 21, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB00507375
  • 1UG3HL173394-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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