NCT05153668

Everolimus Trial in Laryngotracheal Stenosis

AERO: Adjuvant EveRolimus Outcomes in Laryngotracheal Stenosis

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Johns Hopkins University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
DRUG	Everolimus Oral Tablet	Everolimus 1.5mg by mouth daily will be given for 42 days after dilation surgery.

Timeline

• Start date: 2022-09-30
• Primary completion: 2025-10-23
• Completion: 2025-10-23
• First posted: 2021-12-10
• Last updated: 2026-03-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study