Adjuvant Steroid Outcomes in Idiopathic Subglottic Stenosis
ConditionIdiopathic 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
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 included, and no one will be excluded;
Have a life expectancy of ≥6 months; and,
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 groupsSponsors and collaborators
Johns Hopkins University
Lead sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
Source ClinicalTrials.gov