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

Official title

Adjuvant STeRoid Outcomes in Idiopathic Subglottic Stenosis

Overview

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.

Interventions

• Drug Triamcinolone 0.1%
  Intralesional Triamcinolone injection 3x at one, two, and three months following surgical dilation
• Drug Placebo
  Intralesional Placebo injection 3x at one, two, and three months following surgical dilation

Primary outcome measures

• Change in Peak Expiratory Flow (Liters/min) [Time frame: 6 Months]

Secondary outcome measures (2)

• Clinical COPD Questionnaire [Time frame: 6 months]
• Voice Handicap Index-10 [Time frame: 6 Months]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

• 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;
• Participation in any clinical trial involving an investigational drug or device, within four weeks, or 5 half-lives of the investigational agent (whichever time point is longer) prior to enrollment or during this trial participation;
• Active autoimmune disease requiring systemic treatment;
• History of solid organ transplant due to use of immunosuppression;
• Contraindication to any aspect of the index endoscopic dilation procedure.
• Inability to tolerate in office SILSI procedure;
• Contraindication, hypersensitivity, or history of intolerance to oral or injectable steroids;
• Contraindication to intralipid including:
• Severe lipid metabolism disorders characterized by hypertriglyceridemia;
• Hypersensitivity to eggs, soybean, peanut protein, or any active ingredient in intralipid;
• History of intolerance to intralipid;
• Participants with known, suspected, or plan for becoming pregnant or breastfeeding;
• New York Heart Association (NYHA) class II-IV heart failure within the past 6 months;
• History of angioedema;
• History of subglottic stenosis from other causes, including prolonged intubation (intubation of >1 week immediately prior to diagnosis of subglottic stenosis, external physical trauma that causes injury to the subglottis);
• Lack of capacity to consent;
• Alcohol or substance abuse or dependence in the past 6 months;
• Participants who for any reason may not complete the study as judged by the PI;
• Participants planning to move to another city or state during the duration of the study;
• Not able to undergo phlebotomy as reported by the participant or determined by the study coordinator or physician.
• The presence of a medical condition, and/or use of a medication and/or any substance, individually or in aggregate, that in the judgement of the study team could impair study participation.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

United States · 1 center

• Johns Hopkins Hospital — Baltimore

Identifiers

NCT: NCT07228104 · IRB00507375 · 1UG3HL173394-01A1

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗