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NCT05153668 · ClinicalTrials.gov registry record · Early Phase 1
Everolimus Trial in Laryngotracheal Stenosis
A Early Phase 1 study of Idiopathic Subglottic Tracheal Stenosis, sponsored by Johns Hopkins University.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 8
- Enrollment target
- 1
- Study location
NCT05153668: Completed Early Phase 1 study of Idiopathic Subglottic Tracheal Stenosis, sponsored by Johns Hopkins University.
NCT05153668 is a Early Phase 1 study of Idiopathic Subglottic Tracheal Stenosis that has completed, run by Johns Hopkins University. The registered enrollment target is 8 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (85% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05153668, a Early Phase 1 study of Idiopathic Subglottic Tracheal Stenosis, has completed, sponsored by Johns Hopkins University.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 8 participants
- Enrollment target
- 1
- Study location
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.
Primary Outcome
Change in Peak Expiratory flow (L/min) in patients with Laryngotracheal Stenosis will be assessed.
Conditions Studied
Interventions
- DRUG Everolimus Oral Tablet
Study Locations (1)
Maryland
- Johns Hopkins Outpatient Center - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2022-09-30 |
| Est. Completion | 2025-10-23 |
| Phase | Early Phase 1 |
What the finished NCT05153668 record still lists
NCT05153668 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 8 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (85% lower).
The record links to 1 condition, with Idiopathic Subglottic Tracheal Stenosis appearing as the primary indexed condition, and to 1 intervention - of which Everolimus Oral Tablet is the first listed.
NCT05153668 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT05153668 about?
NCT05153668 is a clinical study titled "Everolimus Trial in Laryngotracheal Stenosis". 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 Adjuvan...
What is the current status of trial NCT05153668?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 8 participants. The study started on 2022-09-30. Estimated completion is 2025-10-23.
What conditions does trial NCT05153668 study?
This clinical trial studies the following conditions: Idiopathic Subglottic Tracheal Stenosis.
What interventions are being tested in trial NCT05153668?
The interventions under investigation include: Everolimus Oral Tablet (DRUG).
Who is sponsoring clinical trial NCT05153668?
This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05153668 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05153668's enrollment target sits among peer trials
8 1783rd of 2000 higher than 176 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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