Steroid Injections for Subglottic Tracheal Stenosis

(ASTRO Trial)

Overseen By Alexander Hillel, M.D.

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Johns Hopkins University

Must not be taking: Systemic corticosteroids, Anticoagulants

Disqualifiers: Pulmonary disease, Active cancer, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if Triamcinolone steroid injections can help individuals with subglottic tracheal stenosis delay the need for additional surgeries. Participants will receive either the steroid injection or a placebo (a harmless substance) following a procedure to widen their windpipe. The trial seeks individuals with unexplained subglottic stenosis and no recent history of steroid treatments or certain lung diseases. As a Phase 3 trial, this study represents the final step before FDA approval, providing participants an opportunity to contribute to potentially groundbreaking treatment advancements.

Do I have to stop taking my current medications for the trial?

You may need to stop taking certain medications, like systemic corticosteroids and anticoagulants other than low-dose aspirin, before joining the trial. It's best to discuss your current medications with the study team to see if any changes are needed.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that triamcinolone injections are generally safe for treating various conditions. In studies on airway problems, patients did not experience serious side effects after receiving these injections, indicating the treatment is well-tolerated. Another study on triamcinolone for skin issues found that doses up to 120 mg per month were safe when injected into the skin. These findings suggest that triamcinolone is likely safe for treating tracheal stenosis, a narrowing of the windpipe. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for subglottic tracheal stenosis, which typically involve surgical procedures or dilation techniques, the investigational treatment with Triamcinolone offers a non-surgical approach. Triamcinolone, a corticosteroid, is administered directly into the lesion, potentially reducing inflammation and scarring more effectively than systemic treatments. Researchers are excited about this method because it targets the affected area directly, which might lead to quicker relief and less need for invasive surgeries, making the management of this condition more comfortable for patients.

What evidence suggests that Triamcinolone might be an effective treatment for subglottic tracheal stenosis?

This trial will compare the effects of intralesional steroid injections with Triamcinolone to a placebo injection for managing subglottic stenosis, a narrowing of the airway just below the vocal cords. Research has shown that triamcinolone injections can help manage this condition. Studies have found that patients experience easier breathing and better voice quality after these injections. Specifically, one study noted a significant decrease in scar tissue just three weeks after the first injection. Another study suggested that combining these injections with a procedure to widen the airway effectively treats this condition. Overall, strong evidence indicates that triamcinolone can improve symptoms and reduce the need for additional surgeries. ^{1 2 3 6 7}

Who Is on the Research Team?

Alexander Hillel, MD

Principal Investigator

Johns Hopkins University

Are You a Good Fit for This Trial?

This trial is for individuals with a narrowing of the windpipe just below the vocal cords, known as idiopathic subglottic stenosis. Participants should have had surgery to widen their windpipe and are now at risk of it narrowing again.

Inclusion Criteria

Have a life expectancy of ≥6 months

I am fully active or can carry out light work.

Exclusion Criteria

History of subglottic stenosis from identifiable cause (not idiopathic) including: prolonged endotracheal intubation or tracheostomy, external physical trauma, 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 within 7 days before triamcinolone administration, use of anticoagulants other than aspirin, pulmonary disease including interstitial lung disease and COPD/emphysema, systemic infection requiring treatment with antibiotics, antifungal, or antiviral agents within 21 days of enrollment, poorly controlled diabetes, active cancer or 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 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, hypersensitivity to eggs, soybean, peanut protein, or any active ingredient in intralipid, history of intolerance to intralipid, known, suspected, or planned pregnancy 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, lack of capacity to consent, alcohol or substance abuse or dependence in the past 6 months, inability to complete the study as judged by the PI, planning to move to another city or state during the study, not able to undergo phlebotomy, presence of a medical condition, medication, or substance that could impair study participation

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive intralesional steroid or placebo injections following surgical dilation

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Triamcinolone

Trial Overview

The study is testing if injecting steroids (Triamcinolone) into the previously narrowed area can prevent or delay its recurrence compared to using a placebo (no active medication).

How Is the Trial Designed?

Group I: Intralesional steroid injection with Triamcinolone Experimental Treatment 1 Intervention

Group II: Intralesional Placebo injection Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8558814/

Serial Intralesional Steroid Injection for Subglottic Stenosis

Patients indicate less dyspnea, decreased vocal handicap, and improved voice-related quality of life. While SILSIs have been rapidly and widely ...

2.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S1043181023000313

Office based steroid injections for subglottic stenosis

At 3 weeks after the first injection, there was a dramatic reduction in scar and in the number of fibroblasts in the idiopathic subglottic stenosis scar seen ...

3.

onlinelibrary.wiley.com

onlinelibrary.wiley.com/doi/full/10.1002/lary.30449

Impact of Serial Intralesional Steroid Injections on ...

Serial intralesional steroid injection (SILSI) has been increasingly used to treat idiopathic subglottic stenosis (iSGS).

4.

jamanetwork.com

jamanetwork.com/journals/OTOL/articlepdf/2667846/jamaotolaryngology_bertelsen_2018_oi_170084.pdf

Serial In-Office Intralesional Steroid Injections in Airway ...

Intralesional corticosteroid injection and dilatation provides effective management of subglottic stenosis in. Wegener's granulomatosis.

5.

mednexus.org

mednexus.org/doi/full/10.1002/wjo2.159

In-office serial intralesional steroid injection for subglottic ...

This study is a retrospective case series of 14 patients with subglottic stenosis treated with in-office serial intralesional steroid injections ...

6.

smw.ch

smw.ch/index.php/smw/article/view/3363/5950

Endoscopic treatment of benign tracheal stenosis

We recommend local administration of triamcinolone into the mucosa as an additional treatment to decrease the risk of recurrence.

7.

emedicine.medscape.com

emedicine.medscape.com/article/865437-treatment

Subglottic Stenosis in Adults Treatment & Management

The endoscopic approach was found to be successful in 57-90% of cases. Intraluminal stents were found to be successful in 80% of cases.