Everolimus Trial in Laryngotracheal Stenosis (NCT05153668) | Clinical Trial Compass
CompletedEarly Phase 1
Everolimus Trial in Laryngotracheal Stenosis
United States8 participantsStarted 2022-09-30
Plain-language 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. 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.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
* Ne…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Peak Expiratory flow in patients with Laryngotracheal Stenosis