Everolimus for Tracheal Stenosis

Recruiting in Palo Alto (17 mi)

Overseen by Alexander Hillel, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase < 1

Waitlist Available

Sponsor: Johns Hopkins University

Stay on Your Current Meds

No Placebo Group

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

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.

Inclusion Criteria

I have records of when my airway narrowing was diagnosed and my past treatments.

I have been diagnosed with narrowing of the windpipe.

I've had a throat surgery involving scar removal and stretching.

Exclusion Criteria

Participation in any clinical trial within 21 days of bone marrow collection involving an investigational drug or device

You have a known weak immune system.

I have tested positive for HTLV 1 or 2.

Participant Groups

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.

Group I: Adjuvant Everolimus After Surgical Dilation Experimental Treatment 1 Intervention

Individuals will take low dose everolimus for 6 weeks after dilation.

Everolimus is already approved in United States, European Union, United States for the following indications:

🇺🇸 Approved in United States as Afinitor for:

• Advanced renal cell carcinoma
• Subependymal giant cell astrocytoma
• Progressive neuroendocrine tumors of pancreatic origin
• Advanced hormone receptor-positive, HER2-negative breast cancer
• Tuberous sclerosis complex-associated partial-onset seizures

🇪🇺 Approved in European Union as Votubia for:

• Subependymal giant cell astrocytoma
• Renal angiomyolipoma
• Tuberous sclerosis complex-associated partial-onset seizures

🇺🇸 Approved in United States as Zortress for:

• Prevention of organ rejection in kidney transplant patients

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Johns Hopkins Outpatient Center Baltimore, MD

Who Is Running the Clinical Trial?

Johns Hopkins University Lead Sponsor

References