Could a transplant drug keep a rare airway disease at bay?
NCT ID NCT05153668
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-phase trial tested whether the immunosuppressant drug everolimus could help people with idiopathic subglottic stenosis, a rare condition where scarring narrows the airway. Eight participants took everolimus for 42 days after a dilation surgery to open the airway. The goal was to see if the drug could lengthen the time between repeat surgeries, which are often needed to keep the airway open.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Everolimus (an immunosuppressant drug)
- What this could lead to
- If successful, this could lead to the first FDA-approved drug treatment for idiopathic subglottic stenosis, potentially reducing the need for repeat surgeries.
- What could go wrong
- This is a very early, small proof-of-concept study with only 8 participants. The drug is an immunosuppressant, which carries risks like infection, and it may not prove effective in larger trials.
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
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Early phase 1
The earliest testing in people: a first look at safety, in a very small group.
- Participants
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8 people
The number who actually took part.
- Started
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Sep 2022
- Finished
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Oct 2025
- 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
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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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: * 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 Exclusion Criteria: * 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) * 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
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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.
Contacts and locations
Locations
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Johns Hopkins Outpatient Center
Baltimore, Maryland, 21287, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.