NCT07228104

Brief Summary

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 Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
226

participants targeted

Target at P25-P50 for phase_3

Timeline
67mo left

Started May 2026

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress1%
May 2026Jan 2032

First Submitted

Initial submission to the registry

November 11, 2025

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 14, 2025

Completed
6 months until next milestone

Study Start

First participant enrolled

May 20, 2026

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2031

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2032

Last Updated

June 8, 2026

Status Verified

June 1, 2026

Enrollment Period

4.6 years

First QC Date

November 11, 2025

Last Update Submit

June 4, 2026

Conditions

Idiopathic Subglottic Stenosis

Keywords

Steroid injectionStenosis

Outcome Measures

Primary Outcomes (1)

  • Change in Peak Expiratory Flow (Liters/min)

    6 Months

Secondary Outcomes (2)

  • Clinical COPD Questionnaire

    6 months

  • Voice Handicap Index-10

    6 Months

Study Arms (2)

Intralesional steroid injection with Triamcinolone

EXPERIMENTAL
Drug: Triamcinolone 0.1%

Intralesional Placebo injection

PLACEBO COMPARATOR
Drug: Placebo

Interventions

PlaceboDRUG

Intralesional Placebo injection 3x at one, two, and three months following surgical dilation

Intralesional Placebo injection
Triamcinolone 0.1%DRUG

Intralesional Triamcinolone injection 3x at one, two, and three months following surgical dilation

Intralesional steroid injection with Triamcinolone

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Have a life expectancy of ≥6 months; and,
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 1.

You may not qualify if:

  • History of subglottic stenosis from identifiable cause (not idiopathic), including any of the below clinical criteria:
  • Prolonged endotracheal intubation or tracheostomy (intervention greater than 7 days immediately prior to diagnosis of subglottic stenosis);
  • External physical trauma (including but not limited to blunt, penetration, chemical, or thermal injury) that causes injury to the subglottis;
  • Clinical diagnosis of granulomatosis with polyangiitis (GPA);
  • Radiation exposure to the neck;
  • Current or previous treatment with Serial Intralesional Steroid Injection (SILSI);
  • Use of systemic corticosteroids (oral, intravenous, or intramuscular glucocorticoids), regardless of indication, within 7 days before triamcinolone administration;
  • Local administration of corticosteroids (ophthalmic, intranasal, inhaled) is not prohibited. However, the administration of intraarticular corticosteroids during the treatment phase is not recommended due to potential increased risk of infection.
  • Intralesional administration, in a site other than the subglottis, of corticosteroids should be discussed with the site PI before enrollment
  • Intraarticular corticosteroids during the treatment phase due to potential increased risk of infection;
  • Use of anticoagulants other than aspirin (aspirin dose should not exceed 81mg);
  • Pulmonary disease including interstitial lung disease and Chronic Obstructive Pulmonary Disease (COPD)/emphysema;
  • Systemic infection requiring treatment with antibiotics, antifungal, or antiviral agents within 21 days of enrollment;
  • Poorly controlled diabetes as defined by a HbA1C value greater or equal to 8.0 in the last 180 days);
  • Participants with active cancer or a history of cancer in the last 5 years, except for squamous or basal cell carcinoma of the skin;
  • +20 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins Hospital

Baltimore, Maryland, 21231, United States

RECRUITING

MeSH Terms

Conditions

Idiopathic subglottic tracheal stenosisConstriction, Pathologic

Condition Hierarchy (Ancestors)

Pathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Alexander Hillel, MD

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexander Hillel, M.D.

CONTACT

4432876006ahillel@jh.edu

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 11, 2025

First Posted

November 14, 2025

Study Start

May 20, 2026

Primary Completion (Estimated)

January 1, 2031

Study Completion (Estimated)

January 1, 2032

Last Updated

June 8, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, ICF

Locations

US(1)