Use of Steroid Injections to Prevent the Recurrence of Tracheal Stenosis in Idiopathic Subglottic Stenosis

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Johns Hopkins University
Study ID
NCT07228104
Phase
PHASE3
Status
Recruiting
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Conditions

  • Idiopathic Subglottic Stenosis

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Triamcinolone 0.1% — DRUG
    Intralesional Triamcinolone injection 3x at one, two, and three months following surgical dilation
  • Placebo — DRUG
    Intralesional Placebo injection 3x at one, two, and three months following surgical dilation

Study Details

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.

Key Dates

Start date
May 20, 2026
Status verified
Jun 2026
Primary completion
Jan 1, 2031
Completion
Jan 31, 2032

Study Design

Enrollment
226 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Intralesional steroid injection with Triamcinolone
  • Placebo Comparator: Intralesional Placebo injection

Primary Outcome Measure

Change in Peak Expiratory Flow (Liters/min) [ Time Frame: 6 Months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Johns Hopkins HospitalBaltimoreMaryland21231
Samuel Collins, Ph.D.
[email protected]
410-702-0421

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By research site
Johns Hopkins Hospital· Baltimore, MD