New balloon coated with drug could keep airways open longer
NCT ID NCT07191860
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a special balloon coated with the drug paclitaxel to treat benign (non-cancerous) narrowing of the windpipe or main breathing tubes. The balloon is inflated to open the airway, and the drug may help keep it open longer. About 200 adults with this condition will be randomly assigned to get either the drug-coated balloon or a standard uncoated balloon. The goal is to see if the drug-coated balloon reduces the need for repeat procedures.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- paclitaxel-coated balloon
- What this could lead to
- If it works, this could reduce how often patients need repeat procedures to open a narrowed airway, improving their quality of life.
- What could go wrong
- This is a relatively early-stage trial with 200 participants. The drug-coated balloon may not work better than standard treatment, and there are risks like bleeding, airway injury, or breathing problems.
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
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 200 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2026
- Expected to finish
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Nov 2030
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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22 years and older
- Sex
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Anyone
- Healthy volunteers
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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: 1. Age ≥ 22 years. 2. Symptomatic de-novo or restenotic benign central airway stenosis in the subglottis, trachea, or mainstem bronchi with at least 50% narrowing, as determined by CT or bronchoscopy. 3. In the opinion of the investigator, subject can undergo laryngoscopy/bronchoscopy under general anesthesia and has a central airway stenosis amenable to balloon dilation. 4. For idiopathic subglottic stenoses, either de-novo or a dilation interval equal to or less than 18 months. 5. Target benign stenosis etiologies including: 1. Post-intubation stenosis, 2. Idiopathic subglottic stenosis, 3. Post-transplantation stenosis, 4. Non-malignant trachea-bronchial stenosis 6. Willing and able to complete protocol required follow-up visits. 7. Willing and able to provide written informed consent. Exclusion Criteria:1. Two or more clinically significant (e.g. non-traversable) stenoses with total length \>5cm or unable to be treated with a single balloon 2. Female subjects who are pregnant or breastfeeding or plan to become pregnant in next 12 months 3. Subject currently has a stent at target stenosis location or has had a stent at the target location within the past 90 days. 4\. Subject has existing tracheostomy or had a tracheostomy within past 90 days 5. Contraindication to laryngoscopy/bronchoscopy, anesthesia, or deep sedation 6. Planned tracheal resection in the next 90 days. 7. Dynamic etiology of benign stenosis such as excessive dynamic airway collapse, tracheobronchomalacia, or stenosis due to external compression, or past tracheostomy which requires stent placement or surgical referral 8. Inclusion of vocal cord in target stenosis 9. Known medically significant unresolved lower respiratory tract infection, such as pneumonia, fungus, tuberculosis, etc.unrelated to stenosis 10. Target stenosis is beyond the mainstem bronchi 11. Signs or suspicion of a malignant airway obstruction NOTE: If obstruction is suspicious for malignancy based on clinical or laryngoscopic/bronchoscopic presentation, malignancy must be excluded by biopsy prior to randomization 12. Severe coagulation disorders or current use of anticoagulant or antiplatelet medication that cannot be safely managed per recommended guidelines prior to the index procedure 13. Chronic steroid use exceeding more than 10 mg per day for any medical condition including immunosuppression post-lung transplant or autoimmune associated airway suppression. 14\. Received local steroid or chemotherapeutic treatments into target stenosis in the last 12 weeks or planned treatment during index or staged study procedure. 15\. Planned serial intralesional steroid injections (SILSIs) post index procedure. 16\. Stenosis not amenable to laryngoscopic/bronchoscopic dilation in the opinion of the investigator 17. Acute condition that requires emergent procedure prior to screening assessment 18. Concurrent medical condition that would affect the investigator's ability to evaluate the patient's condition or could compromise patient safety, such as recent myocardial infarction, severe pulmonary disease, bleeding diathesis, large thoracic aneurysm, pharyngeal or cervical deformity, ongoing infection, etc 19. Subject has known fistula between tracheobronchial tree and esophagus, mediastinum to pleural space. 20\. Subject has vasculitis that is not well controlled in the opinion of the investigator. 21\. Diagnosed with a disease requiring chemotherapy (e.g. cancer). 22. Allergy to paclitaxel or structurally related compounds 23. Target stenosis is within a transplanted lung or transplant anastomosis, or a tracheal resection anastomosis, which has been transplanted or resected within the last 60 days. 24\. Target stenosis is related to radiation therapy 25. Subject has a life expectancy of less than 2 years. 26. Current participation in another pre-market drug or medical device clinical study that has not reached its primary endpoint. \-
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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.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Johns Hopkins University
RECRUITINGBaltimore, Maryland, 21218, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can 3D-printed stents solve complex airway blockages?
- Custom 3D stents aim to make breathing easier and safer
- Laser vs. balloon: which works best for narrowed windpipe?
- Microwave probe aims to clear cancer-blocked airways, but study halted early
- Scientists probe healing after windpipe surgery
- New balloon could keep blocked airways open longer