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Adjuvant Steroid Outcomes in Idiopathic Subglottic Stenosis

Study acronym: ASTRO
StatusRecruiting
PhasePhase 3
Started2026-05-20
View on ClinicalTrials.gov ↗

Amendment history

2026-08-21
minor
Study Status, Contacts/Locations v7
Trial sites expanded: 1 → 10 locations
Study sitesdetails revised at 1 of 10 sites
2026-08-20
minor
Study Identification, Study Status, Eligibility, Contacts/Locations v6
Study sites1→10
Eligibility criteria+513 characters
Inclusion Criteria: Diagnosis of iSGS following the NoAAC criteria which involves ruling out known causes for airway stenosis. Participants may be newly diagnosed or carry an existing diagnosis of iSGS; Age Range: 18 years to 80 years old at the time of consent; Sex distribution: all eligible men and women will be incl [...] Have a life expectancy of ≥6 months; and, Eastern Cooperative Oncology Group (ECOG) performance status of 0 -or 1. Exclusion Criteria: History of subglottic stenosis from [...] is with polyangiitis (GPA); Radiation exposure to the neck; Complications resulting from the Index Procedure, [...] [...]
Study title-47 characters
Use ofAdjuvant Steroid Injections to Prevent the Recurrence of Tracheal StenosisOutcomes in Idiopathic Subglottic Stenosis
2026-07-13
minor
Study Status, Contacts/Locations v5
Study sitescontacts updated at 1 of 1 site
2026-06-04
notable
Study Status, Oversight, Contacts/Locations v4
Recruitment opened
Start dateestimated 2026-06-01→confirmed 2026-05-20
Study sitesdetails revised at 1 of 1 site
2026-05-18
minor
Study Status v3
Start date2026-05-01→2026-06-01
Show 2 earlier versions
2026-03-12
minor
Study Status v2
Start date2026-03-01→2026-05-01
2026-01-08
minor
Study Status v1
Start date2026-01-01→2026-03-01
2025-11-11
minor
Original filing
This study will examine the ability of steroid injections into the site of stenosis following surgical dilation to delay the need for repeated surgical dilations.
Trial Details
NCT Number NCT07228104
Lead Sponsor Johns Hopkins University
Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
Conditions Idiopathic Subglottic Stenosis
Enrollment 226 participants
Start Date 2026-05-20
Primary Completion 2031-01-01 (estimated)
Study Completion 2032-01 (estimated)
Updated on ClinicalTrials.gov 2026-09-23