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Everolimus Trial in Laryngotracheal Stenosis

NCT05153668 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2026-03-19

No results posted yet for this study

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.

Conditions

  • Idiopathic Subglottic Tracheal Stenosis

Interventions

DRUG

Everolimus Oral Tablet

Everolimus 1.5mg by mouth daily will be given for 42 days after dilation surgery.

Sponsors & Collaborators

Principal Investigators

  • Alexander Hillel, MD · Johns Hopkins School of Medicine

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-30
Primary Completion
2025-10-23
Completion
2025-10-23
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05153668 on ClinicalTrials.gov