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mTOR Inhibitor
Everolimus for Tracheal Stenosis
Baltimore, MD
Phase < 1
Waitlist Available
Led By Alexander Hillel, MD
Research Sponsored by Johns Hopkins University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Current diagnosis of laryngotracheal stenosis
Participants must have also had a prior suspension microlaryngoscopy with endoscopic excision of scar and balloon dilation procedure prior to study entry
Must not have
HTLV 1 or 2 positive
Use of corticosteroids (glucocorticoids) within 7 days of everolimus administration (except physiologic dose equivalent)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing the drug everolimus to see if it can reduce the number of surgeries needed for patients with idiopathic Subglottic Stenosis (iSGS), a condition where scar tissue blocks the airway. Everolimus helps by calming the immune system and reducing scar tissue formation. If successful, this could lead to everolimus becoming an approved treatment for iSGS.
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Who is the study for?
Adults aged 18-80 with laryngotracheal stenosis, who've had a specific throat surgery, can join this trial. They must understand the study and agree to participate. Key health markers like liver function and kidney function need to be within certain limits. Pregnant women, those with severe lung disease unrelated to their stenosis, recent participants in other drug trials, people with active autoimmune diseases or recent cancers (except some skin cancers), organ transplant recipients on immunosuppressants, and individuals not fully vaccinated against COVID-19 are excluded.Check my eligibility
What is being tested?
The AERO trial is testing an oral tablet called everolimus as a potential treatment for patients with idiopathic Subglottic Stenosis—a condition causing scar-induced airway obstruction—to reduce the number of required surgeries. This proof-of-concept study could pave the way for larger trials if successful.See study design
What are the potential side effects?
Everolimus may cause side effects such as increased risk of infections due to its immune-suppressing properties; it might also interact negatively with certain other drugs leading to more complications.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with narrowing of the windpipe.
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I've had a throat surgery involving scar removal and stretching.
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I am fully active or can carry out light work.
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I am between 18 and 80 years old.
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Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have tested positive for HTLV 1 or 2.
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I haven't taken corticosteroids in the last 7 days, except for low doses.
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I have been diagnosed with moderate to severe heart failure in the last 6 months.
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I have not taken antibiotics or antiviral drugs in the last 7 days.
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I cannot take everolimus due to an allergy or bad reaction.
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I am currently taking medication that affects liver enzyme levels.
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I haven't taken immunosuppressive drugs in the last 21 days and don't expect to need them during the study.
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I have a severe lung condition not related to airway narrowing, with very low lung function scores.
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I have had an organ transplant and am on immunosuppressants.
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I am not pregnant, breastfeeding, nor planning to become pregnant.
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I am currently taking medication that affects my liver's ability to process drugs.
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I haven't had any cancer except for skin cancer in the last 5 years.
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I am currently taking medication to suppress my immune system.
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I am taking medication that could cause swelling under the skin.
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Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in Peak Expiratory flow in patients with Laryngotracheal Stenosis
Secondary study objectives
Change in 12-Item Short Form (SF-12) Survey Global Quality of Life Score
Change in Clinical COPD Questionnaire Quality of Life Score
Change in Eating Assessment Tool (EAT-10) Swallow Quality of Life Score
+3 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Adjuvant Everolimus After Surgical DilationExperimental Treatment1 Intervention
Individuals will take low dose everolimus for 6 weeks after dilation.
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Subglottic Tracheal Stenosis (SGTS) treatments focus on reducing scar tissue formation to keep the airway open. Everolimus, an immunosuppressant, is being studied for its ability to inhibit pathways that cause scar formation, potentially decreasing the need for repeated surgeries.
This is important for SGTS patients as it can improve their quality of life by minimizing airway obstruction and reducing the frequency of invasive procedures.
Find a Location
Closest Location:Johns Hopkins Outpatient Center· Baltimore, MD
Who is running the clinical trial?
Johns Hopkins UniversityLead Sponsor
2,339 Previous Clinical Trials
14,881,611 Total Patients Enrolled
Alexander Hillel, MDPrincipal InvestigatorJohns Hopkins School of Medicine
2 Previous Clinical Trials
103 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have records of when my airway narrowing was diagnosed and my past treatments.You have a known weak immune system.I have tested positive for HTLV 1 or 2.I haven't taken corticosteroids in the last 7 days, except for low doses.I am a woman able to have children and not using effective birth control for the past month.You must have received both doses of the COVID-19 vaccine at least 4 weeks before joining the study.I have been diagnosed with moderate to severe heart failure in the last 6 months.I have not taken antibiotics or antiviral drugs in the last 7 days.I cannot take everolimus due to an allergy or bad reaction.I am currently taking medication that affects liver enzyme levels.I haven't taken immunosuppressive drugs in the last 21 days and don't expect to need them during the study.I have been diagnosed with narrowing of the windpipe.I've had a throat surgery involving scar removal and stretching.I have an autoimmune disease but am not on active treatment, except for stable hypothyroidism.I am fully active or can carry out light work.I am not pregnant, breastfeeding, nor planning to become pregnant.I have a severe lung condition not related to airway narrowing, with very low lung function scores.I have had an organ transplant and am on immunosuppressants.The amount of protein in your urine is too high, as measured by a urine dipstick test.I am currently taking medication that affects my liver's ability to process drugs.I am between 18 and 80 years old.Your blood creatinine level is less than 2.0 mg/dL.I haven't had any cancer except for skin cancer in the last 5 years.The levels of bilirubin and SGPT (ALT) in your blood should be less than two times the upper limit of normal.I am currently taking medication to suppress my immune system.You have experienced angioedema in the past.I am taking medication that could cause swelling under the skin.I have had COVID-19 in the last 30 days.
Research Study Groups:
This trial has the following groups:- Group 1: Adjuvant Everolimus After Surgical Dilation
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Subglottic Tracheal Stenosis Patient Testimony for trial: Trial Name: NCT05153668 — Phase < 1