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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-80
SponsorJohns Hopkins University

About this trial

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.

Eligibility criteria

Qualifiers

Have a life expectancy of ≥6 months; and,

Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 1.

Disqualifiers

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;

Trial design

Treatments tested in this trial

  • Triamcinolone 0.1%
  • Placebo

Treatment groups

226 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Johns Hopkins University

Lead sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator