Adjuvant Steroid Outcomes in Idiopathic Subglottic Stenosis

Part of paid clinical trials in San Diego, California.

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

First listed
Nov 14, 2025
Start date
May 20, 2026
Status verified
Aug 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 (10)

FacilityCityStateZIPSite coordinators
University of California - San DiegoSan DiegoCalifornia92121
Daniel Cates
[email protected]
Daniel Cates, MD (PRINCIPAL_INVESTIGATOR)
University of California - San FranciscoSan FranciscoCalifornia94115
Clark Rosen, MD (PRINCIPAL_INVESTIGATOR)
University of ColoradoAuroraColorado80045
Matthew Clary, MD (PRINCIPAL_INVESTIGATOR)
University of South FloridaTampaFlorida33612
Jacquie Persaud
[email protected]
Yael Bensoussan, MD (PRINCIPAL_INVESTIGATOR)
University of Iowa Hospitals and ClinicsIowa CityIowa52242
Matthew Hoffman, MD, PhD (PRINCIPAL_INVESTIGATOR)
Johns Hopkins HospitalBaltimoreMaryland21231
Sarah E Collins, M.S.
[email protected]
434-962-3058
Sam L Collins, Ph.D.
[email protected]
4107020420
Kevin Motz, MD (SUB_INVESTIGATOR)
Alexander Hillel, MD (PRINCIPAL_INVESTIGATOR)
University of Rochester Medical CenterRochesterNew York14642
G. Todd Schneider, MD, MS (PRINCIPAL_INVESTIGATOR)
Vanderbilt University Medical CenterNashvilleTennessee37232
Samantha Salvi Cruz
[email protected]
Alexander Gelbard, MD (PRINCIPAL_INVESTIGATOR)
University of UtahSalt Lake CityUtah84112
Breanne Schiffer, MD, MPH (PRINCIPAL_INVESTIGATOR)
University of Wisconsin - MadisonMadisonWisconsin53792
Maddie Baranek
[email protected]
David Francis, MD (PRINCIPAL_INVESTIGATOR)

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University of California - San Diego· San Diego, CAUniversity of California - San Francisco· San Francisco, CAUniversity of Colorado· Aurora, COUniversity of South Florida· Tampa, FLUniversity of Iowa Hospitals and Clinics· Iowa City, IAJohns Hopkins Hospital· Baltimore, MD