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mTOR Inhibitor
Everolimus for Tracheal Stenosis
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
The patient must have documentation of their date of laryngotracheal stenosis diagnosis and prior medical/surgical history
Current diagnosis of laryngotracheal stenosis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
Study Summary
This trial is a proof-of-concept study to test if the immunosuppressant drug, everolimus, can reduce the number of surgeries for patients with idiopathic Subglottic Stenosis (iSGS).
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 records of when my airway narrowing was diagnosed and my past treatments.
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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.
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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Peak Expiratory flow in patients with Laryngotracheal Stenosis
Secondary outcome measures
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 moreTrial 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.
Find a Location
Who is running the clinical trial?
Johns Hopkins UniversityLead Sponsor
2,259 Previous Clinical Trials
14,820,633 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
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Would I satisfy the requirements to join this trial?
"To qualify as a participant in this clinical trial, patients must have idiopathic subglottic tracheal stenosis and be within the age range of 18 to 80. This study is aiming to recruit 20 individuals."
Answered by AI
Is this medical experiment accommodating participants aged fifty and over?
"This clinical trial is available for humans aged between 18-80 years old. For those outside this age bracket, there are 36 trials specifically tailored to minors and 297 catered towards seniors over 65."
Answered by AI
What maladies is Everolimus Oral Tablet employed to address?
"Rejection of kidneys during a transplant can be managed with Everolimus Oral Tablets. Additionally, this medication has proven to help patients suffering from Waldenstrom macroglobulinemia, lung cancer and advanced carcinoid tumours."
Answered by AI
Is recruitment for this trial still ongoing?
"Affirmative. Data on clinicaltrials.gov demonstrates that this experiment is currently in recruitment mode and was initially posted on September 30th 2022 with the latest update being October 6th 2022. The trial requires 20 patients at one location to be enrolled."
Answered by AI
What is the aggregate size of the current cohort for this clinical experiment?
"Affirmative. According to information on clinicaltrials.gov, this medical study is actively recruiting patients and was initially posted on September 30th 2022. It seeks 20 participants from a single location for the trial's course of operation."
Answered by AI
Who else is applying?
What state do they live in?
Florida
What site did they apply to?
Johns Hopkins Outpatient Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
3+
What questions have other patients asked about this trial?
How often would I be required to come to Baltimore? What type of screening is done? What are the side effects of the drug treatment proposed in the study?
PatientReceived 2+ prior treatments
Why did patients apply to this trial?
Hoping for treatment that stops scar tissue growth. Keep having to have surgery and want a better quality of life.
PatientReceived 1 prior treatment
If there is a way to have a better quality of life, I want it. I am interested in advancing the research for this rare medical condition.
PatientReceived no prior treatments
I have idiopathic subglottic stenosis and had multiple dilations, and would like to find a treatment that does not require surgery.
PatientReceived no prior treatments
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