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Could a transplant drug keep a rare airway disease at bay?

NCT ID NCT05153668

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Early phase 1

The earliest testing in people: a first look at safety, in a very small group.

Participants

8 people

The number who actually took part.

Started

Sep 2022

Finished

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

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

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.

idiopathic subglottic stenosis Idiopathic subglottic tracheal stenosis tracheal stenosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Johns Hopkins Outpatient Center

    Baltimore, Maryland, 21287, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.