Idiopathic Subglottic Tracheal StenosisEarly Phase 1NCT05153668
Everolimus Trial in Laryngotracheal Stenosis
A Early Phase 1 study testing Everolimus Oral Tablet in people with Idiopathic Subglottic Tracheal Stenosis, run by Johns Hopkins University at 1 site in United States.
Trial summary
Subglottic stenosis (obstructing scar in the larynx and trachea) occurs in patients spontaneously (idiopathic), with autoimmune disease, and after long-term breathing tube placement and can result in communication disability and high mortality rates due to the obstructed airway. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Idiopathic Subglottic Tracheal Stenosis
- What is being tested?
- Everolimus Oral Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Sep 2022to 23 Oct 2025
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
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
- Current diagnosis of laryngotracheal stenosis
- Patient age 18 - 80 years old
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 1
- Serum total bilirubin and Serum Glutamic Pyruvic Transaminase (SGPT)/(ALT) < 2.0 times the upper limit of normal;
- Serum creatinine < 2.0 mg/dL;
- The patient must be able to comprehend and have signed the informed consent.
- The patient must have documentation of their date of laryngotracheal stenosis diagnosis and prior medical/surgical history.
- Participants must have also had a prior suspension microlaryngoscopy with endoscopic excision of scar and balloon dilation procedure prior to study entry
Who cannot join
- Use of corticosteroids (glucocorticoids) within 7 days of everolimus administration (except physiologic dose equivalent)
- Infection requiring treatment with antibiotics, antifungal, or antiviral agents within 7 days of registration
- Participation in any clinical trial within 21 days of bone marrow collection involving an investigational drug or device
- History of malignancy within five years of registration, except adequately treated basal or squamous cell skin cancer
- History of an autoimmune disease (e.g., rheumatoid arthritis, multiple sclerosis, systemic lupus erythematosus) requiring active systemic treatment. Hypothyroidism without evidence of Grave's disease or Hashimoto's thyroiditis is permitted.
- Human T-cell Lymphotropic Virus type 1 (HTLV-1) or type 2 (HTLV-2)
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- New York Heart Association (NYHA) class II-IV heart failure within the past 6 months
- History of organ transplant with use of immunosuppression
- Current use of immunosuppression
- Contraindication or documented intolerance to everolimus
- Women of childbearing potential who are not on highly effective contraception or abstinent for at least 30 days. Highly effective contraception includes at least two forms of concurrent contraception (Condoms, oral contraceptives, intrauterine devices, contraceptive implants).
- Women who are pregnant or breastfeeding, or wishing to become pregnant are excluded from this study
- Current use of cytochrome P450 3A inducers (such as some anticonvulsants, rifampin, isoniazid, St. John's wort).
- Current use of cytochrome P450 3A inhibitors (such as azole antifungals, nondihydropyridine calcium channel blockers, some macrolide antibiotics, grapefruit) can result in significant interactions
- Baseline proteinuria as defined by urine dipstick analysis
- History of angioedema
- Baseline/continued use of drugs known to be associated with angioedema including angiotensin converting enzyme inhibitors
- Significant pulmonary disease independent of laryngotracheal stenosis as defined by and forced expiratory volume at one second (FEV1)/forced vital capacity (FVC) < 10% of the expected value for the patient's age.
- Evidence of a COVID-19 infection including anosmia, upper respiratory symptoms or positive test result within the 30 days prior of trial participation.
- Patients who are not fully vaccinated for COVID 19 for at least 4 weeks prior to study entry
- Immunosuppressive therapy within previous 21 days or expected need for immunosuppressive therapy for the duration of the study
- Known immunodeficiency
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins Outpatient Center
Baltimore, Maryland, 21287
About this study
Official title: AERO: Adjuvant EveRolimus Outcomes in Laryngotracheal Stenosis
Subglottic stenosis (obstructing scar in the larynx and trachea) occurs in patients spontaneously (idiopathic), with autoimmune disease, and after long-term breathing tube placement and can result in communication disability and high mortality rates due to the obstructed airway. The proposed Adjuvant EveRolimus Outcomes (AERO) trial is proof-of-concept study using the immunosuppressant drug, everolimus, to reduce the number of surgeries for patients with idiopathic Subglottic Stenosis (iSGS). Success with the AERO trial will allow for everolimus to be used in subsequent larger trials of participants with laryngotracheal stenosis and could lead to everolimus being the first FDA approved medical treatment for iSGS.
- Conditions
- Idiopathic Subglottic Tracheal Stenosis
- Being tested
- Everolimus Oral Tablet
- Keywords
- Tracheal Stenosis, Everolimus, Immunosuppression
- Medical subject headings
- Idiopathic subglottic tracheal stenosis, Tracheal Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Everolimus Oral TabletDrug
Also called Zortress
Everolimus 1.5mg by mouth daily will be given for 42 days after dilation surgery.
| Study group | Role | What they receive |
|---|---|---|
| Adjuvant Everolimus After Surgical Dilation | Experimental | Individuals will take low dose everolimus for 6 weeks after dilation. Receives: Drug: Everolimus Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Peak Expiratory flow in patients with Laryngotracheal Stenosis
Change in Peak Expiratory flow (L/min) in patients with Laryngotracheal Stenosis will be assessed.
Measured: Baseline, 1 month, 2 months, 3 months, 4 months, 5 months, 6 months, 1 year, 2 years
Secondary outcomes (6)
Dilation interval (time between surgery)
Dilation interval (time between surgery) in months will be assessed.
Measured: Up to 2 years
Change in Voice-related Quality of Life Score
Number scale of 0-100
Measured: Baseline, 1 month, 2 months, 3 months, 6 months, 1 year, 2 years
Change in Clinical Chronic Obstructive Pulmonary Disease (COPD) Questionnaire Quality of Life Score
Number scale of 0-6
Measured: Baseline, 1 month, 2 months, 3 months, 6 months, 1 year, 2 years
Change in Eating Assessment Tool (EAT-10) Swallow Quality of Life Score
Number scale of 0-40
Measured: Baseline, 1 month, 2 months, 3 months, 6 months, 1 year, 2 years
Change in 12-Item Short Form (SF-12) Survey Global Quality of Life Score
Number scale of 0-100
Measured: Baseline, 1 month, 2 months, 3 months, 6 months, 1 year, 2 years
Change in lumen surface area
CT Neck will be used to assess change in lumen surface area in millimeters squared (mm^2).
Measured: Baseline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2021
- Study start30 Sep 2022
- Primary completion23 Oct 2025
- Study completion23 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Idiopathic Subglottic Tracheal 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alexander Hillel, MD, Principal investigator, Johns Hopkins School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05153668
- Sponsor's protocol ID
- IRB00284589
- Status last verified
- Mar 2026
- First submitted
- 29 Nov 2021
- Last updated
- 19 Mar 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
So RJ, Collins SL, Collins S, Mafla L, Chan-Li Y, Lina I, Gelbard A, Motz KM, Hillel AT. Oral Everolimus Following Dilation in Idiopathic Subglottic Stenosis: A Phase 1 Nonrandomized Clinical Trial. JAMA Otolaryngol Head Neck Surg. 2024 Nov 1;150(11):1029-1033. doi: 10.1001/jamaoto.2024.2886.
PubMed 39325463
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AERO: Adjuvant EveRolimus Outcomes in Laryngotracheal Stenosis
- ClinicalTrials.gov ID
- NCT05153668
- Acronym / sponsor ID
- IRB00284589
- Conditions
- Idiopathic Subglottic Tracheal Stenosis
- Keywords
- Tracheal Stenosis, Everolimus, Immunosuppression
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- 30 Sep 2022 (actual)
- Primary completion
- 23 Oct 2025 (actual)
- Study completion
- 23 Oct 2025 (actual)
- First posted
- 10 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Subglottic stenosis (obstructing scar in the larynx and trachea) occurs in patients spontaneously (idiopathic), with autoimmune disease, and after long-term breathing tube placement and can result in communication disability and high mortality rates due to the obstructed airway. The proposed Adjuvant EveRolimus Outcomes (AERO) trial is proof-of-concept study using the immunosuppressant drug, everolimus, to reduce the number of surgeries for patients with idiopathic Subglottic Stenosis (iSGS). Success with the AERO trial will allow for everolimus to be used in subsequent larger trials of participants with laryngotracheal stenosis and could lead to everolimus being the first FDA approved medical treatment for iSGS.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adjuvant Everolimus After Surgical Dilation | Experimental | Drug: Everolimus Oral TabletIndividuals will take low dose everolimus for 6 weeks after dilation. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Current diagnosis of laryngotracheal stenosis
- Patient age 18 - 80 years old
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 1
- Serum total bilirubin and Serum Glutamic Pyruvic Transaminase (SGPT)/(ALT) < 2.0 times the upper limit of normal;
- Serum creatinine < 2.0 mg/dL;
Key exclusion criteria (22 listed)
- Use of corticosteroids (glucocorticoids) within 7 days of everolimus administration (except physiologic dose equivalent)
- Infection requiring treatment with antibiotics, antifungal, or antiviral agents within 7 days of registration
- Participation in any clinical trial within 21 days of bone marrow collection involving an investigational drug or device
- History of malignancy within five years of registration, except adequately treated basal or squamous cell skin cancer
- History of an autoimmune disease (e.g., rheumatoid arthritis, multiple sclerosis, systemic lupus erythematosus) requiring active systemic treatment. Hypothyroidism without evidence of Grave's disease or Hashimoto's thyroiditis is permitted.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Everolimus Oral TabletAlso: ZortressEverolimus 1.5mg by mouth daily will be given for 42 days after dilation surgery. | Drug | Adjuvant Everolimus After Surgical Dilation |
Primary outcome
Change in Peak Expiratory flow in patients with Laryngotracheal Stenosis
Time frame: Baseline, 1 month, 2 months, 3 months, 4 months, 5 months, 6 months, 1 year, 2 years
Change in Peak Expiratory flow (L/min) in patients with Laryngotracheal Stenosis will be assessed.
6 secondary outcomes
Dilation interval (time between surgery)
Time frame: Up to 2 years
Change in Voice-related Quality of Life Score
Time frame: Baseline, 1 month, 2 months, 3 months, 6 months, 1 year, 2 years
Change in Clinical Chronic Obstructive Pulmonary Disease (COPD) Questionnaire Quality of Life Score
Time frame: Baseline, 1 month, 2 months, 3 months, 6 months, 1 year, 2 years
Change in Eating Assessment Tool (EAT-10) Swallow Quality of Life Score
Time frame: Baseline, 1 month, 2 months, 3 months, 6 months, 1 year, 2 years
Change in 12-Item Short Form (SF-12) Survey Global Quality of Life Score
Time frame: Baseline, 1 month, 2 months, 3 months, 6 months, 1 year, 2 years
Change in lumen surface area
Time frame: Baseline and 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2026.
- Derived from this study: PubMed 39325463So RJ, Collins SL, Collins S, Mafla L, Chan-Li Y, Lina I, Gelbard A, Motz KM, Hillel AT. Oral Everolimus Following Dilation in Idiopathic Subglottic Stenosis: A Phase 1 Nonrandomized Clinical Trial. JAMA Otolaryngol Head Neck Surg. 2024 Nov 1;150(11):1029-1033. doi: 10.1001/jamaoto.2024.2886.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexander Hillel, MD principal investigator
Johns Hopkins School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Everolimus Oral Tablet in people with Idiopathic Subglottic Tracheal Stenosis, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Peak Expiratory flow in patients with Laryngotracheal Stenosis (time frame: Baseline, 1 month, 2 months, 3 months, 4 months, 5 months, 6 months, 1 year, 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05153668, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2026.