Health TrialsbyHealthPanel

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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

226 Participants
are divided into 2 treatment groups
Group A: Intralesional steroid injection with TriamcinoloneExperimental treatment 1 intervention
Group B: Intralesional Placebo injectionPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in Peak Expiratory Flow (Liters/min)

Time frame
6 Months

Secondary outcomes

1

Clinical COPD Questionnaire

Score range 0-60, Lower score indicates better health

Time frame
6 months
2

Voice Handicap Index-10

Score range 0 to 40, Lower score indicates better voice

Time frame
6 Months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Johns Hopkins University

Lead sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Source ClinicalTrials.gov
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