Could a lung scarring drug ease rare windpipe narrowing?
NCT ID NCT07654517
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests if pirfenidone, a drug used for lung scarring, can safely slow scar buildup in the windpipe of people with idiopathic subglottic stenosis (iSGS). About 40 adults will receive either pirfenidone or a placebo for one year, alongside their usual steroid injections. The main goal is to check safety and tolerability, while also looking for signs that the drug may delay the need for airway dilation procedures.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
About 40 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
-
Dec 2026
An estimate. Start dates often move.
- Expected to finish
-
Dec 2029
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Female participants only
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Adults 18-65 years of age * Confirmed diagnosis of idiopathic subglottic stenosis (iSGS) * History of at least 2 endoscopic dilations within the past 12 months or -Receiving regular intralesional steroid injections as part of iSGS management (every 3 months) * Clinically stable at enrollment (no acute infection or active inflammation) * Adequate liver and renal function on screening laboratory tests * Willing and able to comply with study procedures, visits, and follow-up * Ability to provide written informed consent * For participants of childbearing potential: negative pregnancy test and agreement to use effective contraception during treatment and for the protocol-specified period after the last dose Exclusion Criteria: * Subglottic stenosis due to another identifiable cause (e.g., intubation, granulomatosis with polyangiitis, malignancy) * Known hypersensitivity or allergic reaction to pirfenidone or any component of its formulation * Severe hepatic impairment or active liver disease (AST or ALT above the upper limit of normal) * Severe renal impairment or requirement for dialysis * Concurrent use of fluvoxamine * Use of high-dose ciprofloxacin or other strong CYP1A2 inhibitors where dose adjustment is not feasible * Current smoking or unwillingness to abstain from smoking during treatment * Pregnant or breastfeeding individuals * Clinically significant comorbid illness that could increase risk or confound results (e.g., advanced cardiac, pulmonary, or autoimmune disease) * History of photosensitivity disorders or inability to adhere to sun protection precautions * Participation in another investigational clinical trial within the previous 30 days * Any condition that, in the investigator's judgment, would interfere with safety monitoring, adherence, or study assessments
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Idiopathic subglottic stenosis are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
Schulich School of Medicine and Dentistry
London, Ontario, N6A 4L6, Canada
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Virtual reality could replace pills for pain during ENT procedures
- New study aims to predict breathing emergencies in throat surgery
- Scientists probe healing after windpipe surgery
- Could a biologic drug spare patients from repeat throat surgeries?
- Windpipe surgery showdown: which technique helps patients breathe easier?
- Could a simple steroid injection keep your airway open longer?