Idiopathic Subglottic StenosisPhase 1NCT07654517
Pirfenidone for Idiopathic Subglottic Stenosis: A Pilot Trial of Tolerability and Feasibility
A Phase 1 study testing Pirfenidone in people with Idiopathic Subglottic Stenosis and Subglottic Stenosis (SGS), run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 2 sites in Canada.
Trial summary
Idiopathic subglottic stenosis (iSGS) is a rare condition where scar tissue forms just below the vocal cords and in the upper windpipe, making the airway narrow. People with iSGS often feel short of breath, hear noisy breathing, and notice changes in their voice. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Idiopathic Subglottic Stenosis, Subglottic Stenosis (SGS)
- What is being tested?
- Pirfenidone
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 2 sitesCanada
- Study dates
- 1 Apr 2027to 31 Mar 2030
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults 18-65 years of age
- Confirmed diagnosis of idiopathic subglottic stenosis (iSGS)
- At least 1 endoscopic dilation within the past 12 months, or receiving intralesional steroid injections every 3 months as part of iSGS management
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Canada2 sites
Schulich School of Medicine and Dentistry / LHSCRI
London, Ontario, N6A 4L6
Halema Khan, PhD, 2267002100, halema.khan@lhsc.on.ca
Anthony C Nichols, MD
St. Michael's Hospital, Unity Health Toronto
Toronto, Ontario, M5B 1W8
R. Jun Lin, MD, MSc
About this study
Official title: Pirfenidone for Idiopathic Subglottic Stenosis: A Randomized, Placebo Controlled Pilot Trial of Tolerability and Feasibility
Idiopathic subglottic stenosis (iSGS) is a rare condition where scar tissue forms just below the vocal cords and in the upper windpipe, making the airway narrow. People with iSGS often feel short of breath, hear noisy breathing, and notice changes in their voice. Many need repeated operations and steroid injections to open the airway, but the narrowing usually comes back, so these treatments are not a cure.
Recent research from a Canadian iSGS registry and biobank has shown that this disease is driven by overactive scarring pathways, similar to those seen in idiopathic pulmonary fibrosis (IPF), a serious lung disease. Pirfenidone is an oral medication already approved for IPF that works by slowing down the cells and signals that cause scarring. Because the same scarring pathways appear to be active in iSGS, pirfenidone may be able to slow or reduce the build-up of scar tissue in the airway.
Read more
In this study, adults with iSGS will be randomly assigned (like flipping a coin) to receive either pirfenidone or a placebo (a look-alike pill with no active drug) for 52 weeks, in addition to their usual intralesional steroid injections. The pirfenidone dose will be increased gradually over the first two weeks up to a regular dose taken three times a day with food, which is the same schedule used in patients with IPF. Participants and their doctors will not know which treatment they are getting until the end of the study, unless this needs to be revealed for safety reasons.
The main goal of this trial is to find out whether people with iSGS can stay on pirfenidone for one year, and how often they have moderate or more serious side effects compared with placebo. The study team will watch closely for side effects such as stomach upset, skin rash or sensitivity to sunlight, tiredness, and changes in liver blood tests. The study will also show whether a larger trial is possible, by measuring how many eligible patients agree to take part and how many complete the year of treatment. The team will also look for early signs that pirfenidone may help, such as a longer time until the next airway surgery, better breathing (peak flow) measurements, and improvements in breathlessness and voice related quality of life scores.
Forty four participants will take part at two hospitals, one in London and one in Toronto, Ontario. Each participant will be followed for up to two years: one year on study medication and one year of follow up after treatment. This study may not directly help every person who takes part, but the results will show whether pirfenidone is tolerable in iSGS and will provide the information needed to plan a larger trial testing whether it could become the first medication to slow this scarring airway disease.
Read the detailed description
Idiopathic subglottic stenosis (iSGS) is a progressive fibro-inflammatory airway disease characterized by recurrent scarring and narrowing of the subglottic and upper tracheal airway in otherwise healthy adults, predominantly women. Current management relies on repeated endoscopic dilations and serial intralesional steroid injections, which temporarily restore airway patency but are not curative and are associated with high rates of restenosis and substantial symptom burden. Molecular and single-cell transcriptomic studies from the Canadian Airways Research (CARE) Group biobank have demonstrated a fibrotic gene expression signature in iSGS, with transforming growth factor (TGF)-mediated fibroblast activation and extracellular matrix deposition that closely parallels idiopathic pulmonary fibrosis (IPF).
Pirfenidone is an oral antifibrotic agent approved for IPF that inhibits TGF-driven fibroblast proliferation, collagen synthesis, and profibrotic cytokine release and has an established long-term safety profile in chronic fibrotic lung disease. On this mechanistic basis, pirfenidone is being repurposed as a potential disease-modifying therapy for iSGS. This multicentre, randomized (1:1), double blinded, placebo controlled pilot trial will determine the tolerability of pirfenidone over 52 weeks and the feasibility of a placebo controlled trial in adults with iSGS receiving standardized intralesional steroid injections.
Hypothesis: Pirfenidone will be tolerable in iSGS, with no excess of adverse events beyond its established profile and at least 80% of participants still taking study drug at 52 weeks.
Forty four participants (22 per site) aged 18-65 years with a diagnosis of iSGS will be enrolled across two tertiary airway centres (London Health Sciences Centre - Victoria Hospital and St. Michael's Hospital, Unity Health Toronto). Participants will be randomized in a 1:1 ratio to receive oral pirfenidone or matching placebo for 52 weeks, in addition to protocolized intralesional steroid injections. Pirfenidone will be titrated from 801 mg/day in Week 1 to 1,602 mg/day in Week 2 and 2,403 mg/day (801 mg three times daily) from Week 3 onward, as tolerated. Study drug and placebo will be identical in appearance, and participants, investigators, and study staff will remain blinded to treatment allocation unless unblinding is required for safety.
The primary objective is to determine the tolerability of 52 weeks of pirfenidone treatment in iSGS. The primary endpoint is the proportion of participants who experience a moderate or worse (Grade ≥2, CTCAE v5.0) adverse event during 52 weeks of treatment. Tolerability is further described by the proportion still taking study drug at 52 weeks, rates of dose reduction, interruption and discontinuation, and protocol-defined laboratory abnormalities, particularly elevations in liver enzymes. Safety monitoring will include regular clinical assessments, vital signs, complete blood counts, renal function, and liver function tests at baseline, early after initiation, and at 3-month intervals. An independent Data Safety Monitoring Board will periodically review unblinded safety data under a signed charter and provide recommendations regarding trial continuation or modification.
Secondary and exploratory outcomes will characterize preliminary efficacy signals. These include time from randomization to first endoscopic dilation, total number of dilations during the 52-week treatment period, changes in peak expiratory flow, and patient-reported outcomes assessed using the Dyspnea Index and Voice Handicap Index-10 (VHI-10). Endoscopic laryngoscopic assessments will document airway patency and subglottic mucosal appearance over time, and may be correlated with clinical and functional outcomes.
Sample size: The primary endpoint is the proportion of participants who experience a moderate or worse (Grade ≥2) adverse event during 52 weeks of treatment. Assuming this occurs in 10% of placebo and 50% of pirfenidone recipients, 19 participants per arm provide 80% power to detect the difference (Fisher's exact test, one sided α = 0.05). A one sided test is used because the question is directional: whether pirfenidone increases moderate or worse adverse events relative to placebo. The primary analysis includes every participant who receives at least one dose of study drug, so later withdrawals do not reduce the analysis population, and enrolment of 22 per arm (N = 44) already exceeds the 19 per arm required. The 10% placebo assumption reflects events attributed to study drug rather than to the dilations and steroid injections that both arms receive. With 22 per arm, the proportion still taking study drug at 52 weeks will be estimated with a 95% confidence interval of approximately ±20 percentage points.
Statistical analysis: Reporting will follow the CONSORT extension for randomized pilot and feasibility trials. Tolerability and feasibility outcomes will be summarized by arm with exact (Clopper-Pearson) 95% confidence intervals and between arm risk differences. Consistent with pilot trial methodology, the trial is not powered for efficacy; clinical outcomes are exploratory and reported as estimates. Time to first dilation will be described using Kaplan-Meier estimates and a Cox proportional hazards model, reported as a hazard ratio with 95% confidence interval for planning a Phase III trial. Peak expiratory flow and patient reported outcomes will be analyzed with linear mixed effects models. Analyses of adverse events and dose maintenance will include all participants receiving at least one dose; clinical outcomes will be analyzed by intention to treat, including all randomized participants. Participants who withdraw are counted as no longer taking study drug, and missing repeated measures are handled within the mixed effects models under a missing at random assumption.
Concomitant medications will be managed to minimize interactions with pirfenidone, with exclusion of strong CYP1A2 inhibitors, CYP1A2 inducers such as smoking, and other antifibrotic agents. Participants will receive education on dosing with food, sun protection to reduce photosensitivity risk, adherence strategies, and timely reporting of side effects. Compliance will be assessed via pill counts, medication diaries, and scheduled visits every 3 months, supplemented with interim contact as needed.
This trial is designed to establish the tolerability of systemic antifibrotic therapy in iSGS and the feasibility of a placebo controlled trial, while generating early evidence on its potential to reduce procedure frequency and improve respiratory and voice-related quality of life. If tolerability is established, the results will inform the design of a large Phase III efficacy trial across the CARE network and may represent a critical step toward introducing the first disease-modifying pharmacologic therapy for this rare airway disorder.
- Being tested
- Pirfenidone, Placebo
- Keywords
- Subglottic Stenosis, Idiopathic Subglottic stenosis, Airway Fibrosis, Pirfenidone
- Medical subject headings
- Idiopathic subglottic tracheal stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PirfenidoneDrug
Oral pirfenidone (267 mg units) given as systemic antifibrotic therapy for idiopathic subglottic stenosis. Participants assigned to the experimental arm will follow a standard titration regimen: 801 mg/day (267 mg three times daily) during Week 1, 1,602 mg/day (534 mg three times daily) during Week 2, and 2,403 mg/day (801 mg three times daily) from Week 3 through Week 52, as tolerated. Doses are taken with food to reduce gastrointestinal side effects. Pirfenidone is given in addition to standardized intralesional steroid injections as part of protocolized airway management.
PlaceboDrug
Oral placebo identical to pirfenidone in appearance, packaging and dosing schedule. Participants assigned to the placebo comparator arm will receive placebo using the same titration and maintenance schedule as the pirfenidone arm (three times daily with food for 52 weeks). Placebo is given in addition to standardized intralesional steroid injections as part of protocolized airway management, to allow blinded comparison with active pirfenidone treatment.
| Study group | Role | What they receive |
|---|---|---|
| Pirfenidone plus standardized intralesional steroid therapy | Experimental | Participants in this arm will receive oral pirfenidone in addition to standardized intralesional steroid injections for idiopathic subglottic stenosis. Pirfenidone will be titrated from 801 mg/day in Week 1 to 1,602 mg/day in Week 2, then to a maintenance dose of 2,403 mg/day (801 mg three times daily) from Week 3 through Week 52, as tolerated. Study drug will be taken with food to reduce gastrointestinal side effects. All participants will continue to receive protocolized intralesional steroid injections as part of their usual airway management. Participants will be followed during treatment and for an additional post-treatment follow-up period to assess safety, tolerability, and preliminary efficacy. Receives: Drug: Pirfenidone |
| Placebo plus standardized intralesional steroid therapy | Placebo comparator | Participants in this arm will receive an oral placebo in addition to standardized intralesional steroid injections for idiopathic subglottic stenosis. Placebo will be identical to pirfenidone in appearance, packaging and dosing schedule, including titration over the first 2 weeks and maintenance dosing three times daily with food through Week 52. All participants will continue to receive protocolized intralesional steroid injections as part of their usual airway management. Participants will be followed during treatment and for an additional post-treatment follow-up period to assess safety, tolerability, and to compare outcomes with the pirfenidone arm. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants with a moderate or worse (Grade ≥2) adverse event
Proportion of participants in each arm who experience at least one moderate or worse (Grade ≥2) adverse event during 52 weeks of treatment, graded using CTCAE v5.0 at every study visit. The analysis includes all participants who receive at least one dose of study drug, and results are reported by arm with exact 95% confidence intervals and the between arm risk difference.
Measured: From first dose of study drug through Week 52 of treatment
Secondary outcomes (7)
Time to first dilation
Time from randomization to first endoscopic airway dilation performed for clinically significant recurrent subglottic stenosis, comparing pirfenidone with placebo.
Measured: From randomization through end of study follow-up, up to 24 months.
Change in peak expiratory flow
Change from baseline in peak expiratory flow (L/min), measured in clinic at scheduled study visits, comparing pirfenidone with placebo.
Measured: Baseline; Months 1, 3, 6, 9 and 12 of treatment
Change in Dyspnea Index (DI) total score
Change from baseline in the Dyspnea Index (DI), a 10 item patient reported measure of upper airway related breathlessness. Each item is scored 0 to 4, giving a total score from 0 to 40; higher scores indicate worse dyspnea. Compared between pirfenidone and placebo.
Measured: Baseline; Months 1, 3, 6, 9 and 12 of treatment; and Months 15, 18, 21 and 24 of follow up
Change in Voice Handicap Index-10 (VHI-10) total score
Change from baseline in the Voice Handicap Index-10 (VHI-10), a 10 item patient reported measure of voice related quality of life. Each item is scored 0 to 4, giving a total score from 0 to 40; higher scores indicate a greater voice handicap (worse outcome). Compared between pirfenidone and placebo.
Measured: Baseline; Months 1, 3, 6, 9 and 12 of treatment; and Months 15, 18, 21 and 24 of follow up
Proportion of participants still taking study drug at Week 52
Proportion of randomized participants in each arm still taking study drug at Week 52 (target ≥80% in the pirfenidone arm), with mean dose intensity and rates of dose reduction, interruption and discontinuation reported alongside. Participants who withdraw are counted as no longer taking study drug.
Measured: Week 52 of treatment
Number of endoscopic dilations and intralesional steroid injections
Total number of endoscopic airway dilations and intralesional steroid injections per participant during the 52 week treatment period, comparing pirfenidone with placebo.
Measured: From randomization through Week 52 of treatment
Recruitment and retention
Feasibility of a larger Phase III trial, measured by the number of participants randomized (target 44 by Month 11 of enrolment, from screening logs of eligible, approached, consented and randomized patients) and the proportion completing the Week 52 visit (target ≥85%).
Measured: Recruitment through Month 11 of enrolment; retention at Week 52 of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2026
- Study start1 Apr 2027 (estimated)
- Primary completion31 Mar 2029 (estimated)
- Study completion31 Mar 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for Idiopathic Subglottic StenosisStudies of the same condition, open and under way.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a multicentre, randomized (1:1), double blinded, placebo controlled pilot trial using a parallel group design. Adults with idiopathic subglottic stenosis will be assigned to oral pirfenidone or matching placebo for 52 weeks, with both arms receiving standardized intralesional steroid injections every 3 months. Randomization is through a central, concealed REDCap allocation module stratified by site. Participants remain in their assigned arm for the full treatment period, followed by off treatment follow up to 24 months.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Collaborators
- Unity Health Toronto
- Responsible party
- Principal investigator, Anthony Nichols, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Investigators
- Anthony C Nichols, MD, Principal investigator, London Health Sciences Centre Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07654517
- Sponsor's protocol ID
- 129042
- Status last verified
- Nov 2026
- First submitted
- 12 Jun 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) underlying the main trial publications will be shared with qualified researchers upon reasonable request after completion of the study and publication of primary results. All datasets will be stripped of direct identifiers and prepared in accordance with applicable privacy regulations and institutional policies before sharing. Access will be granted only under a data use agreement that outlines the proposed research question, limits on data reuse and linkage, and requirements for data security and confidentiality.
Publications
Ying S, Zeng PYF, Fung K, Khan H, Cecchini MJ, MacInnis P, Anderson J, Karimi AH, Al Jawhri M, Pan H, Le N, Joris K, Mymryk JS, Dumeaux V, Barrett JW, Nichols AC, Lin RJ; Canadian Airways Research Group of the Canadian Society of Otolaryngology Collaborative Research Initiative. Effect of Serial Intralesional Steroid Injections on Risk of Recurrence in Idiopathic Subglottic Stenosis. Laryngoscope. 2025 Sep;135(9):3265-3272. doi: 10.1002/lary.32179. Epub 2025 Apr 16.
PubMed 40237535Ying S, Zeng PYF, Fung K, Khan H, Cecchini MJ, Woo E, Anderson J, MacInnis P, Karimi AH, Al Jawhri M, Pan H, Le N, Joris K, Wen R, Mymryk JS, Inculet R, Dumeaux V, Barrett JW, Nichols AC, Lin RJ; Canadian Airways Research Group of the Canadian Society of Otolaryngology Collaborative Research Initiative. Transcriptomic Features of Recurrence Rates in Idiopathic Subglottic Stenosis. Laryngoscope. 2025 Sep;135(9):3273-3279. doi: 10.1002/lary.32214. Epub 2025 May 6.
PubMed 40326273Lin RJ, Zeng PYF, Fung K, Khan H, Cecchini MJ, Woo E, Hu A, Anderson J, MacInnis P, Karimi A, Ying S, Al Jawhri M, Lin S, Jarycki L, Shaikh MH, Pan H, Coburn B, Mymryk JS, Inculet R, Barrett JW, Nichols AC; Canadian Airways Research Group of the Canadian Society of Otolaryngology Collaborative Research Initiative. Cohort-level clinical trajectory and molecular landscape of idiopathic subglottic stenosis for precision laryngology-a study of the Canadian Airways Research (CARE) group. EBioMedicine. 2025 Apr;114:105629. doi: 10.1016/j.ebiom.2025.105629. Epub 2025 Mar 5.
PubMed 40048847Zeng PYF, Lin RJ, Fung K, Khan H, Cecchini MJ, Woo E, Hu A, Anderson J, MacInnis P, Jarycki L, Karimi A, Ying S, Al Jawhri M, Lin S, Shaikh M, Pan H, Coburn B, Mymryk JS, Inculet R, Barrett JW, Nichols AC; Canadian Airways Research Group of the Canadian Society of Otolaryngology Collaborative Research Initiative. Cellular blueprint of healthy and diseased human epiglottis and subglottis-a study of the Canadian Airways Research (CARE) group. EBioMedicine. 2025 Apr;114:105631. doi: 10.1016/j.ebiom.2025.105631. Epub 2025 Mar 5.
PubMed 40048848Brandenburg JH. Idiopathic subglottic stenosis. Trans Am Acad Ophthalmol Otolaryngol. 1972 Sep-Oct;76(5):1402-6. No abstract available.
PubMed 4666597Valdez TA, Shapshay SM. Idiopathic subglottic stenosis revisited. Ann Otol Rhinol Laryngol. 2002 Aug;111(8):690-5. doi: 10.1177/000348940211100806.
PubMed 12184589Aravena C, Almeida FA, Mukhopadhyay S, Ghosh S, Lorenz RR, Murthy SC, Mehta AC. Idiopathic subglottic stenosis: a review. J Thorac Dis. 2020 Mar;12(3):1100-1111. doi: 10.21037/jtd.2019.11.43.
PubMed 32274178Gelbard A, Donovan DT, Ongkasuwan J, Nouraei SA, Sandhu G, Benninger MS, Bryson PC, Lorenz RR, Tierney WS, Hillel AT, Gadkaree SK, Lott DG, Edell ES, Ekbom DC, Kasperbauer JL, Maldonado F, Schindler JS, Smith ME, Daniero JJ, Garrett CG, Netterville JL, Rickman OB, Sinard RJ, Wootten CT, Francis DO. Disease homogeneity and treatment heterogeneity in idiopathic subglottic stenosis. Laryngoscope. 2016 Jun;126(6):1390-6. doi: 10.1002/lary.25708. Epub 2015 Nov 4.
PubMed 26536285Maldonado F, Loiselle A, Depew ZS, Edell ES, Ekbom DC, Malinchoc M, Hagen CE, Alon E, Kasperbauer JL. Idiopathic subglottic stenosis: an evolving therapeutic algorithm. Laryngoscope. 2014 Feb;124(2):498-503. doi: 10.1002/lary.24287. Epub 2013 Aug 8.
PubMed 23818139Gelbard A, Anderson C, Berry LD, Amin MR, Benninger MS, Blumin JH, Bock JM, Bryson PC, Castellanos PF, Chen SC, Clary MS, Cohen SM, Crawley BK, Dailey SH, Daniero JJ, de Alarcon A, Donovan DT, Edell ES, Ekbom DC, Fernandes-Taylor S, Fink DS, Franco RA, Garrett CG, Guardiani EA, Hillel AT, Hoffman HT, Hogikyan ND, Howell RJ, Huang LC, Hussain LK, Johns MM 3rd, Kasperbauer JL, Khosla SM, Kinnard C, Kupfer RA, Langerman AJ, Lentz RJ, Lorenz RR, Lott DG, Lowery AS, Makani SS, Maldonado F, Mannion K, Matrka L, McWhorter AJ, Merati AL, Mori MC, Netterville JL, O'Dell K, Ongkasuwan J, Postma GN, Reder LS, Rohde SL, Richardson BE, Rickman OB, Rosen CA, Rutter MJ, Sandhu GS, Schindler JS, Schneider GT, Shah RN, Sikora AG, Sinard RJ, Smith ME, Smith LJ, Soliman AMS, Sveinsdottir S, Van Daele DJ, Veivers D, Verma SP, Weinberger PM, Weissbrod PA, Wootten CT, Shyr Y, Francis DO. Comparative Treatment Outcomes for Patients With Idiopathic Subglottic Stenosis. JAMA Otolaryngol Head Neck Surg. 2020 Jan 1;146(1):20-29. doi: 10.1001/jamaoto.2019.3022.
PubMed 31670805King TE Jr, Bradford WZ, Castro-Bernardini S, Fagan EA, Glaspole I, Glassberg MK, Gorina E, Hopkins PM, Kardatzke D, Lancaster L, Lederer DJ, Nathan SD, Pereira CA, Sahn SA, Sussman R, Swigris JJ, Noble PW; ASCEND Study Group. A phase 3 trial of pirfenidone in patients with idiopathic pulmonary fibrosis. N Engl J Med. 2014 May 29;370(22):2083-92. doi: 10.1056/NEJMoa1402582. Epub 2014 May 18.
PubMed 24836312Costabel U, Albera C, Lancaster LH, Lin CY, Hormel P, Hulter HN, Noble PW. An Open-Label Study of the Long-Term Safety of Pirfenidone in Patients with Idiopathic Pulmonary Fibrosis (RECAP). Respiration. 2017;94(5):408-415. doi: 10.1159/000479976. Epub 2017 Sep 13.
PubMed 28898890Noble PW, Albera C, Bradford WZ, Costabel U, Glassberg MK, Kardatzke D, King TE Jr, Lancaster L, Sahn SA, Szwarcberg J, Valeyre D, du Bois RM; CAPACITY Study Group. Pirfenidone in patients with idiopathic pulmonary fibrosis (CAPACITY): two randomised trials. Lancet. 2011 May 21;377(9779):1760-9. doi: 10.1016/S0140-6736(11)60405-4. Epub 2011 May 13.
PubMed 21571362Lewis GA, Dodd S, Clayton D, Bedson E, Eccleson H, Schelbert EB, Naish JH, Jimenez BD, Williams SG, Cunnington C, Ahmed FZ, Cooper A, Rajavarma Viswesvaraiah, Russell S, McDonagh T, Williamson PR, Miller CA. Pirfenidone in heart failure with preserved ejection fraction: a randomized phase 2 trial. Nat Med. 2021 Aug;27(8):1477-1482. doi: 10.1038/s41591-021-01452-0. Epub 2021 Aug 12.
PubMed 34385704Stahnke T, Kowtharapu BS, Stachs O, Schmitz KP, Wurm J, Wree A, Guthoff RF, Hovakimyan M. Suppression of TGF-beta pathway by pirfenidone decreases extracellular matrix deposition in ocular fibroblasts in vitro. PLoS One. 2017 Feb 23;12(2):e0172592. doi: 10.1371/journal.pone.0172592. eCollection 2017.
PubMed 28231275
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pirfenidone for Idiopathic Subglottic Stenosis: A Randomized, Placebo Controlled Pilot Trial of Tolerability and Feasibility
- ClinicalTrials.gov ID
- NCT07654517
- Acronym / sponsor ID
- 129042
- Keywords
- Subglottic Stenosis, Idiopathic Subglottic stenosis, Airway Fibrosis, Pirfenidone
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Collaborators
- Unity Health Toronto
- Study start
- 1 Apr 2027 (estimated)
- Primary completion
- 31 Mar 2029 (estimated)
- Study completion
- 31 Mar 2030 (estimated)
- First posted
- 17 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Idiopathic subglottic stenosis (iSGS) is a rare condition where scar tissue forms just below the vocal cords and in the upper windpipe, making the airway narrow. People with iSGS often feel short of breath, hear noisy breathing, and notice changes in their voice. Many need repeated operations and steroid injections to open the airway, but the narrowing usually comes back, so these treatments are not a cure.
Recent research from a Canadian iSGS registry and biobank has shown that this disease is driven by overactive scarring pathways, similar to those seen in idiopathic pulmonary fibrosis (IPF), a serious lung disease. Pirfenidone is an oral medication already approved for IPF that works by slowing down the cells and signals that cause scarring. Because the same scarring pathways appear to be active in iSGS, pirfenidone may be able to slow or reduce the build-up of scar tissue in the airway.
In this study, adults with iSGS will be randomly assigned (like flipping a coin) to receive either pirfenidone or a placebo (a look-alike pill with no active drug) for 52 weeks, in addition to their usual intralesional steroid injections. The pirfenidone dose will be increased gradually over the first two weeks up to a regular dose taken three times a day with food, which is the same schedule used in patients with IPF. Participants and their doctors will not know which treatment they are getting until the end of the study, unless this needs to be revealed for safety reasons.
The main goal of this trial is to find out whether people with iSGS can stay on pirfenidone for one year, and how often they have moderate or more serious side effects compared with placebo. The study team will watch closely for side effects such as stomach upset, skin rash or sensitivity to sunlight, tiredness, and changes in liver blood tests. The study will also show whether a larger trial is possible, by measuring how many eligible patients agree to take part and how many complete the year of treatment. The team will also look for early signs that pirfenidone may help, such as a longer time until the next airway surgery, better breathing (peak flow) measurements, and improvements in breathlessness and voice related quality of life scores.
Forty four participants will take part at two hospitals, one in London and one in Toronto, Ontario. Each participant will be followed for up to two years: one year on study medication and one year of follow up after treatment. This study may not directly help every person who takes part, but the results will show whether pirfenidone is tolerable in iSGS and will provide the information needed to plan a larger trial testing whether it could become the first medication to slow this scarring airway disease.
Detailed description
Idiopathic subglottic stenosis (iSGS) is a progressive fibro-inflammatory airway disease characterized by recurrent scarring and narrowing of the subglottic and upper tracheal airway in otherwise healthy adults, predominantly women. Current management relies on repeated endoscopic dilations and serial intralesional steroid injections, which temporarily restore airway patency but are not curative and are associated with high rates of restenosis and substantial symptom burden. Molecular and single-cell transcriptomic studies from the Canadian Airways Research (CARE) Group biobank have demonstrated a fibrotic gene expression signature in iSGS, with transforming growth factor (TGF)-mediated fibroblast activation and extracellular matrix deposition that closely parallels idiopathic pulmonary fibrosis (IPF).
Pirfenidone is an oral antifibrotic agent approved for IPF that inhibits TGF-driven fibroblast proliferation, collagen synthesis, and profibrotic cytokine release and has an established long-term safety profile in chronic fibrotic lung disease. On this mechanistic basis, pirfenidone is being repurposed as a potential disease-modifying therapy for iSGS. This multicentre, randomized (1:1), double blinded, placebo controlled pilot trial will determine the tolerability of pirfenidone over 52 weeks and the feasibility of a placebo controlled trial in adults with iSGS receiving standardized intralesional steroid injections.
Hypothesis: Pirfenidone will be tolerable in iSGS, with no excess of adverse events beyond its established profile and at least 80% of participants still taking study drug at 52 weeks.
Forty four participants (22 per site) aged 18-65 years with a diagnosis of iSGS will be enrolled across two tertiary airway centres (London Health Sciences Centre - Victoria Hospital and St. Michael's Hospital, Unity Health Toronto). Participants will be randomized in a 1:1 ratio to receive oral pirfenidone or matching placebo for 52 weeks, in addition to protocolized intralesional steroid injections. Pirfenidone will be titrated from 801 mg/day in Week 1 to 1,602 mg/day in Week 2 and 2,403 mg/day (801 mg three times daily) from Week 3 onward, as tolerated. Study drug and placebo will be identical in appearance, and participants, investigators, and study staff will remain blinded to treatment allocation unless unblinding is required for safety.
The primary objective is to determine the tolerability of 52 weeks of pirfenidone treatment in iSGS. The primary endpoint is the proportion of participants who experience a moderate or worse (Grade ≥2, CTCAE v5.0) adverse event during 52 weeks of treatment. Tolerability is further described by the proportion still taking study drug at 52 weeks, rates of dose reduction, interruption and discontinuation, and protocol-defined laboratory abnormalities, particularly elevations in liver enzymes. Safety monitoring will include regular clinical assessments, vital signs, complete blood counts, renal function, and liver function tests at baseline, early after initiation, and at 3-month intervals. An independent Data Safety Monitoring Board will periodically review unblinded safety data under a signed charter and provide recommendations regarding trial continuation or modification.
Secondary and exploratory outcomes will characterize preliminary efficacy signals. These include time from randomization to first endoscopic dilation, total number of dilations during the 52-week treatment period, changes in peak expiratory flow, and patient-reported outcomes assessed using the Dyspnea Index and Voice Handicap Index-10 (VHI-10). Endoscopic laryngoscopic assessments will document airway patency and subglottic mucosal appearance over time, and may be correlated with clinical and functional outcomes.
Sample size: The primary endpoint is the proportion of participants who experience a moderate or worse (Grade ≥2) adverse event during 52 weeks of treatment. Assuming this occurs in 10% of placebo and 50% of pirfenidone recipients, 19 participants per arm provide 80% power to detect the difference (Fisher's exact test, one sided α = 0.05). A one sided test is used because the question is directional: whether pirfenidone increases moderate or worse adverse events relative to placebo. The primary analysis includes every participant who receives at least one dose of study drug, so later withdrawals do not reduce the analysis population, and enrolment of 22 per arm (N = 44) already exceeds the 19 per arm required. The 10% placebo assumption reflects events attributed to study drug rather than to the dilations and steroid injections that both arms receive. With 22 per arm, the proportion still taking study drug at 52 weeks will be estimated with a 95% confidence interval of approximately ±20 percentage points.
Statistical analysis: Reporting will follow the CONSORT extension for randomized pilot and feasibility trials. Tolerability and feasibility outcomes will be summarized by arm with exact (Clopper-Pearson) 95% confidence intervals and between arm risk differences. Consistent with pilot trial methodology, the trial is not powered for efficacy; clinical outcomes are exploratory and reported as estimates. Time to first dilation will be described using Kaplan-Meier estimates and a Cox proportional hazards model, reported as a hazard ratio with 95% confidence interval for planning a Phase III trial. Peak expiratory flow and patient reported outcomes will be analyzed with linear mixed effects models. Analyses of adverse events and dose maintenance will include all participants receiving at least one dose; clinical outcomes will be analyzed by intention to treat, including all randomized participants. Participants who withdraw are counted as no longer taking study drug, and missing repeated measures are handled within the mixed effects models under a missing at random assumption.
Concomitant medications will be managed to minimize interactions with pirfenidone, with exclusion of strong CYP1A2 inhibitors, CYP1A2 inducers such as smoking, and other antifibrotic agents. Participants will receive education on dosing with food, sun protection to reduce photosensitivity risk, adherence strategies, and timely reporting of side effects. Compliance will be assessed via pill counts, medication diaries, and scheduled visits every 3 months, supplemented with interim contact as needed.
This trial is designed to establish the tolerability of systemic antifibrotic therapy in iSGS and the feasibility of a placebo controlled trial, while generating early evidence on its potential to reduce procedure frequency and improve respiratory and voice-related quality of life. If tolerability is established, the results will inform the design of a large Phase III efficacy trial across the CARE network and may represent a critical step toward introducing the first disease-modifying pharmacologic therapy for this rare airway disorder.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a multicentre, randomized (1:1), double blinded, placebo controlled pilot trial using a parallel group design. Adults with idiopathic subglottic stenosis will be assigned to oral pirfenidone or matching placebo for 52 weeks, with both arms receiving standardized intralesional steroid injections every 3 months. Randomization is through a central, concealed REDCap allocation module stratified by site. Participants remain in their assigned arm for the full treatment period, followed by off treatment follow up to 24 months.
| Arm | Type | Receives |
|---|---|---|
| Pirfenidone plus standardized intralesional steroid therapy | Experimental | Drug: PirfenidoneParticipants in this arm will receive oral pirfenidone in addition to standardized intralesional steroid injections for idiopathic subglottic stenosis. Pirfenidone will be titrated from 801 mg/day in Week 1 to 1,602 mg/day in Week 2, then to a maintenance dose of 2,403 mg/day (801 mg three times daily) from Week 3 through Week 52, as tolerated. Study drug will be taken with food to reduce gastrointestinal side effects. All participants will continue to receive protocolized intralesional steroid injections as part of their usual airway management. Participants will be followed during treatment and for an additional post-treatment follow-up period to assess safety, tolerability, and preliminary efficacy. |
| Placebo plus standardized intralesional steroid therapy | Placebo comparator | Drug: PlaceboParticipants in this arm will receive an oral placebo in addition to standardized intralesional steroid injections for idiopathic subglottic stenosis. Placebo will be identical to pirfenidone in appearance, packaging and dosing schedule, including titration over the first 2 weeks and maintenance dosing three times daily with food through Week 52. All participants will continue to receive protocolized intralesional steroid injections as part of their usual airway management. Participants will be followed during treatment and for an additional post-treatment follow-up period to assess safety, tolerability, and to compare outcomes with the pirfenidone arm. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Adults 18-65 years of age
- Confirmed diagnosis of idiopathic subglottic stenosis (iSGS)
- At least 1 endoscopic dilation within the past 12 months, or receiving intralesional steroid injections every 3 months as part of iSGS management
- Clinically stable at enrollment (no acute infection or active inflammation)
- Adequate liver and renal function on screening laboratory tests
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PirfenidoneOral pirfenidone (267 mg units) given as systemic antifibrotic therapy for idiopathic subglottic stenosis. Participants assigned to the experimental arm will follow a standard titration regimen: 801 mg/day (267 mg three times daily) during Week 1, 1,602 mg/day (534 mg three times daily) during Week 2, and 2,403 mg/day (801 mg three times daily) from Week 3 through Week 52, as tolerated. Doses are taken with food to reduce gastrointestinal side effects. Pirfenidone is given in addition to standardized intralesional steroid injections as part of protocolized airway management. | Drug | Pirfenidone plus standardized intralesional steroid therapy |
| PlaceboOral placebo identical to pirfenidone in appearance, packaging and dosing schedule. Participants assigned to the placebo comparator arm will receive placebo using the same titration and maintenance schedule as the pirfenidone arm (three times daily with food for 52 weeks). Placebo is given in addition to standardized intralesional steroid injections as part of protocolized airway management, to allow blinded comparison with active pirfenidone treatment. | Drug | Placebo plus standardized intralesional steroid therapy |
Primary outcome
Proportion of participants with a moderate or worse (Grade ≥2) adverse event
Time frame: From first dose of study drug through Week 52 of treatment
Proportion of participants in each arm who experience at least one moderate or worse (Grade ≥2) adverse event during 52 weeks of treatment, graded using CTCAE v5.0 at every study visit. The analysis includes all participants who receive at least one dose of study drug, and results are reported by arm with exact 95% confidence intervals and the between arm risk difference.
7 secondary outcomes
Time to first dilation
Time frame: From randomization through end of study follow-up, up to 24 months.
Change in peak expiratory flow
Time frame: Baseline; Months 1, 3, 6, 9 and 12 of treatment
Change in Dyspnea Index (DI) total score
Time frame: Baseline; Months 1, 3, 6, 9 and 12 of treatment; and Months 15, 18, 21 and 24 of follow up
Change in Voice Handicap Index-10 (VHI-10) total score
Time frame: Baseline; Months 1, 3, 6, 9 and 12 of treatment; and Months 15, 18, 21 and 24 of follow up
Proportion of participants still taking study drug at Week 52
Time frame: Week 52 of treatment
Number of endoscopic dilations and intralesional steroid injections
Time frame: From randomization through Week 52 of treatment
Recruitment and retention
Time frame: Recruitment through Month 11 of enrolment; retention at Week 52 of treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Background: PubMed 40237535Ying S, Zeng PYF, Fung K, Khan H, Cecchini MJ, MacInnis P, Anderson J, Karimi AH, Al Jawhri M, Pan H, Le N, Joris K, Mymryk JS, Dumeaux V, Barrett JW, Nichols AC, Lin RJ; Canadian Airways Research Group of the Canadian Society of Otolaryngology Collaborative Research Initiative. Effect of Serial Intralesional Steroid Injections on Risk of Recurrence in Idiopathic Subglottic Stenosis. Laryngoscope. 2025 Sep;135(9):3265-3272. doi: 10.1002/lary.32179. Epub 2025 Apr 16.
- Background: PubMed 40326273Ying S, Zeng PYF, Fung K, Khan H, Cecchini MJ, Woo E, Anderson J, MacInnis P, Karimi AH, Al Jawhri M, Pan H, Le N, Joris K, Wen R, Mymryk JS, Inculet R, Dumeaux V, Barrett JW, Nichols AC, Lin RJ; Canadian Airways Research Group of the Canadian Society of Otolaryngology Collaborative Research Initiative. Transcriptomic Features of Recurrence Rates in Idiopathic Subglottic Stenosis. Laryngoscope. 2025 Sep;135(9):3273-3279. doi: 10.1002/lary.32214. Epub 2025 May 6.
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- Background: PubMed 40048848Zeng PYF, Lin RJ, Fung K, Khan H, Cecchini MJ, Woo E, Hu A, Anderson J, MacInnis P, Jarycki L, Karimi A, Ying S, Al Jawhri M, Lin S, Shaikh M, Pan H, Coburn B, Mymryk JS, Inculet R, Barrett JW, Nichols AC; Canadian Airways Research Group of the Canadian Society of Otolaryngology Collaborative Research Initiative. Cellular blueprint of healthy and diseased human epiglottis and subglottis-a study of the Canadian Airways Research (CARE) group. EBioMedicine. 2025 Apr;114:105631. doi: 10.1016/j.ebiom.2025.105631. Epub 2025 Mar 5.
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- Background: PubMed 26536285Gelbard A, Donovan DT, Ongkasuwan J, Nouraei SA, Sandhu G, Benninger MS, Bryson PC, Lorenz RR, Tierney WS, Hillel AT, Gadkaree SK, Lott DG, Edell ES, Ekbom DC, Kasperbauer JL, Maldonado F, Schindler JS, Smith ME, Daniero JJ, Garrett CG, Netterville JL, Rickman OB, Sinard RJ, Wootten CT, Francis DO. Disease homogeneity and treatment heterogeneity in idiopathic subglottic stenosis. Laryngoscope. 2016 Jun;126(6):1390-6. doi: 10.1002/lary.25708. Epub 2015 Nov 4.
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- Background: PubMed 24836312King TE Jr, Bradford WZ, Castro-Bernardini S, Fagan EA, Glaspole I, Glassberg MK, Gorina E, Hopkins PM, Kardatzke D, Lancaster L, Lederer DJ, Nathan SD, Pereira CA, Sahn SA, Sussman R, Swigris JJ, Noble PW; ASCEND Study Group. A phase 3 trial of pirfenidone in patients with idiopathic pulmonary fibrosis. N Engl J Med. 2014 May 29;370(22):2083-92. doi: 10.1056/NEJMoa1402582. Epub 2014 May 18.
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- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) underlying the main trial publications will be shared with qualified researchers upon reasonable request after completion of the study and publication of primary results. All datasets will be stripped of direct identifiers and prepared in accordance with applicable privacy regulations and institutional policies before sharing. Access will be granted only under a data use agreement that outlines the proposed research question, limits on data reuse and linkage, and requirements for data security and confidentiality.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Anthony C Nichols, MD principal investigator
London Health Sciences Centre Research Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Pirfenidone in people with Idiopathic Subglottic Stenosis and Subglottic Stenosis (SGS), run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Halema Khan, PhD (519-685-8500, halema.khan@lhsc.on.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants with a moderate or worse (Grade ≥2) adverse event (time frame: From first dose of study drug through Week 52 of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07654517, which also lists 21 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.