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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Everolimus 1.5mg by mouth daily will be given for 42 days after dilation surgery.
Johns Hopkins Outpatient Center
Baltimore, Maryland, United States
Change in Peak Expiratory flow in patients with Laryngotracheal Stenosis
Change in Peak Expiratory flow (L/min) in patients with Laryngotracheal Stenosis will be assessed.
Time frame: Baseline, 1 month, 2 months, 3 months, 4 months, 5 months, 6 months, 1 year, 2 years
Dilation interval (time between surgery)
Dilation interval (time between surgery) in months will be assessed.
Time frame: Up to 2 years
Change in Voice-related Quality of Life Score
Number scale of 0-100
Time frame: Baseline, 1 month, 2 months, 3 months, 6 months, 1 year, 2 years
Change in Clinical Chronic Obstructive Pulmonary Disease (COPD) Questionnaire Quality of Life Score
Number scale of 0-6
Time frame: Baseline, 1 month, 2 months, 3 months, 6 months, 1 year, 2 years
Change in Eating Assessment Tool (EAT-10) Swallow Quality of Life Score
Number scale of 0-40
Time frame: Baseline, 1 month, 2 months, 3 months, 6 months, 1 year, 2 years
Change in 12-Item Short Form (SF-12) Survey Global Quality of Life Score
Number scale of 0-100
Time frame: Baseline, 1 month, 2 months, 3 months, 6 months, 1 year, 2 years
Change in lumen surface area
CT Neck will be used to assess change in lumen surface area in millimeters squared (mm\^2).
Time frame: Baseline and 6 months
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