Adult Subjects With Symptomatic Benign Airway ObstructionOXYGEN-RCTNCT07191860
Paclitaxel-Coated Pulmonary Balloon for the Treatment of Benign Central Airway Stenosis
A study testing The Airiver Pulmonary drug-coated balloon (DCB) dilation and Commercial airway balloon dilation in people with Adult Subjects With Symptomatic Benign Airway Obstruction and Adult Benign Central Airway Stenosis, run by Airiver Medical, Inc. at 1 site in United States.
Trial summary
The OXYGEN-RCT trial is a randomized, controlled, double blinded, prospective, multi-center trial to demonstrate the safety and efficacy in adult benign central airway stenosis. Participates will be in a 1:1 allocation to treatment with the Airiver Pulmonary DCB or standard of care laryngoscopic/bronchoscopic balloon… Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Adult Subjects With Symptomatic Benign Airway Obstruction, Adult Benign Central Airway Stenosis, Adult Tracheobronchial Stenosis
- What is being tested?
- The Airiver Pulmonary drug-coated balloon (DCB) dilation and Commercial airway balloon dilation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Feb 2026to 1 Nov 2030
- Phase
- Interventional
- 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 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 22 years.
- 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.
- In the opinion of the investigator, subject can undergo laryngoscopy/bronchoscopy under general anesthesia and has a central airway stenosis amenable to balloon dilation.
- For idiopathic subglottic stenoses, either de-novo or a dilation interval equal to or less than 18 months.
- Target benign stenosis etiologies including:
- Post-intubation stenosis,
Show all 20Show fewer
- Idiopathic subglottic stenosis,
- Post-transplantation stenosis,
- Non-malignant trachea-bronchial stenosis
- Willing and able to complete protocol required follow-up visits.
- 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.
- -
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Johns Hopkins University
Baltimore, Maryland, 21218
Clinical Operation Director, 6123108755, schachererr@airiver.com
About this study
Official title: A Randomized, Controlled, Multi-Center, Prospective Trial of Paclitaxel-Coated Pulmonary Balloon for the Treatment of Benign Airway Stenosis (OXYGEN-RCT Trial)
The OXYGEN-RCT trial is a randomized, controlled, double blinded, prospective, multi-center trial to demonstrate the safety and efficacy in adult benign central airway stenosis. Participates will be in a 1:1 allocation to treatment with the Airiver Pulmonary DCB or standard of care laryngoscopic/bronchoscopic balloon dilation, respectively.
Read the detailed description
Subjects will complete follow-up post-treatment at 30 days, 3 months, 6 months, 12 months, and every 6 months after through the primary endpoint, with a minimum of 2 years at study end.
- Conditions
- Adult Subjects With Symptomatic Benign Airway Obstruction, Adult Benign Central Airway Stenosis, Adult Tracheobronchial Stenosis, Tracheal Stenosis, Central Airway Stenosis, Central Airway Obstruction
- Being tested
- The Airiver Pulmonary drug-coated balloon (DCB) dilation, Commercial airway balloon dilation
- Medical subject headings
- Tracheal Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Airiver Pulmonary drug-coated balloon (DCB) dilationCombination product
drug coated balloon dilation
Commercial airway balloon dilationDevice
uncoated airway balloon dilation
| Study group | Role | What they receive |
|---|---|---|
| treatment with the Airiver Pulmonary DCB | Experimental | dilate benign stenoses of the airway tree. Receives: Combination Product: The Airiver Pulmonary drug-coated balloon (DCB) dilation |
| treatment of Commercial airway dilation balloon | Active comparator | dilate benign stenoses of the airway tree. Receives: Device: Commercial airway balloon dilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Safety: defined as Incidence of device- and/or procedure-related Major Adverse Events(MAEs)
including:
- Pneumothorax
- Pneumomediastinum
- Tracheal or bronchial laceration requiring intervention
- Airway perforation or rupture
- Required tracheostomy
- Bleeding from treatment site consistent with massive hemoptysis defined as > 100mL of blood expectorated in 24 hours or requiring transfusion
- Mediastinitis requiring the need for IV antibiotics and / or hospitalization
- Respiratory distress or asphyxia requiring intubation or reintervention
- Death
Measured: 30 days post index procedure
Primary Efficacy: freedom from clinically indicated target lesion re-intervention over time
defined as a therapeutic reintervention/dilation that occurs due to either a recurrence of patient symptoms due to the stenosis and/or a recurrence seen through imaging of the stenosis (≥ 50%) or is an emergent condition related to the stenosis and treatment is required.
Measured: Through the study completion, an average of 1 year
Secondary outcomes (18)
Time to first reintervention, defined as duration in days between the index/staged procedure and the first, subsequent procedure for treatment of the target stenosis.
Hypothesis-test
Measured: From Day 1 until the date of first documented reintervention, assessed through the study completion, an average of 1 year.
Percent change in airway lumen area at 6 months by CT
Hypothesis-test. The percent change expressed as the airway lumen volume within the treated segment at 6 months (Area 6mo), compared to the personal baseline airway lumen volume (AreaBL) on CT scan. Percent change in airway luminal area = (Area6mo - AreaBL) / AreaBL ×100%
Measured: Baseline, 6 months
Change in Peak Expiratory Flow (PEF) from 30 days to 6 months
Hypothesis-test. PEF in L/min
Measured: 1 month, 6 months
Index procedure success, defined as the ability to deliver study device to the targeted stenosis, inflate, deflate, and remove and with a < 25% residual stenosis.
Non-hypothesis test. NO device malfunction issues. Use visual estimation under bronchoscopy at the end of index procedure, compare post-treated airway diameter (TD, mm) versus airway native diameter (ND, mm), residual stenosis = (ND- TD)/NDx100%
Measured: On index procedure day 0
Change in airway lumen volume by CT at follow-up visit
Non-hypothesis test. Change in lumen volume in percentage (%). The percent change expressed as the airway lumen volume within the treated segment at follow-up (AreaFU) compared to the personal baseline airway lumen volume (AreaBL) on CT scan. Percent change in airway luminal area = (AreaFU - AreaBL) / AreaBL ×100%
Measured: Baseline, 30 days, 6 months, 12 months, then every 6 months until the date of the study complete (assessed up to 2 years)
Freedom from reintervention, defined as any reintervention on the target stenosis, whether clinically indicated or not
Non-hypothesis test
Measured: 30 days, 3 months, 6 months, 12 months, then every 6 months until the date of study complete (assessed up to 2 years)
Annualized rate, of reinterventions
Non-hypothesis test
Measured: Assessed annually through the date of the study complete, an average of 1 year.
Secondary patency, defined as freedom from reintervention after a first reintervention, at each follow-up
Non-hypothesis test
Measured: From the date of the first reintervention to the next follow-up visit through the study completion, an average of 1 year.
Change in forced expiratory volume in 1 second (FEV1) at follow-up visit
Non-hypothesis test. FEV1 in liters
Measured: Baseline, 30 days, 3 months, 6 months, 12 months, then every 6 months until the date for the study complete (assessed up to 2 years)
Change in forced vital capacity (FVC) at follow-up visit
Non-hypnoses test. FVC in liters
Measured: Baseline, 30 day, 3 months, 6 months, 12 months, then every 6 months until the date of the study complete (assessed up to 2 years)
Changes in the ratio of FVE1 and FVC at follow-up visit
Non-hypnoses test. The Ratio =(FVE1/FVC) x100%
Measured: Baseline, 30 days, 3 months, 6 months, 12 months, then every 6 months until the date of the study complete (assessed up to 2 years)
Change in peak expiratory flow (PEF)
Non-hypnoses test. PEF in liters per minute (L/min)
Measured: Baseline, 3 months, 12 months, then every 6 months until the date of the study complete (assessed up to 2 years).
Change in expiratory disproportion index (EDI)
Non-hypnoses test. EDI= (FEV1/PEF) x100%
Measured: Baseline, 30 days, 3 months, 6 months, 12 months, then every 6month until the date of the study complete (assessed up to 2 years)
Rate of cannulation, stent, or open surgery due to target lesion stenosis
Non-hypothesis test
Measured: 30 days, 3 months, 6 months, 12 months, then every 6 months until the date of study complete (assessed up to 2 years)
Change in modified Medical Research Council (mMRC) Dyspnea Scale
Non-hypothesis test. mMRC is a self-assessment tool and rated on a scale from 0 to 4, where a higher score means a worse outcome.
Measured: Baseline, 30 days, 3 months, 6 months, 12 months, then every 6 months until the date of study completion (assessed up to 2 years)
Change in Chronic Obstructive Pulmonary Disease (COPD) Questionnaire
Non-hypnoses test. The questionnaire is rated on 0-6 scale, a higher score indicating a worse health status.
Measured: Baseline, 30 days, 3 months, 6 months, 12 months, then every 6 months until the date of study completion (assessed up to 2 years)
Change in 12-Item Short Form (SF-12) Survey Global Quality of Life Score
Non-hypnosis test. SF-12 is a self-reported outcome and rated on a 0-5 scale, where a higher score indicates better health.
Measured: Baseline, 30 days, 3 months, 6 months, 12 months, then every 6 months until the date of the study completion (assessed up to 2 years)
Change in Voice Handicap Index (VHI-10) questionnaire
Non-hypnosis test. VHI-10 is a self-administered questionnaire and scored from 0 to 4, where a higher score indicates a greater voice -related handicap.
Measured: Baseline, 30 days, 3 months, 6 months, 12 months, then every 6 months until the study completion (assessed up to 2 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2025
- Study start24 Feb 2026
- Primary completion1 Nov 2027 (estimated)
- Study completion1 Nov 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adult Subjects With Symptomatic Benign Airway ObstructionStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Airiver Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alexander Hillel, MD, Principal investigator, Johns Hopkins UniversityRyan M Kern, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07191860
- Sponsor's protocol ID
- Protocol Number: PR3050
- Acronym
- OXYGEN-RCT
- Status last verified
- Dec 2025
- First submitted
- 11 Aug 2025
- Last updated
- 18 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled, Multi-Center, Prospective Trial of Paclitaxel-Coated Pulmonary Balloon for the Treatment of Benign Airway Stenosis (OXYGEN-RCT Trial)
- ClinicalTrials.gov ID
- NCT07191860
- Acronym / sponsor ID
- OXYGEN-RCT / Protocol Number: PR3050
- Conditions
- Adult Subjects With Symptomatic Benign Airway Obstruction, Adult Benign Central Airway Stenosis, Adult Tracheobronchial Stenosis, Tracheal Stenosis, Central Airway Stenosis, Central Airway Obstruction
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Airiver Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- 24 Feb 2026 (actual)
- Primary completion
- 1 Nov 2027 (estimated)
- Study completion
- 1 Nov 2030 (estimated)
- First posted
- 25 Sep 2025 (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.
The OXYGEN-RCT trial is a randomized, controlled, double blinded, prospective, multi-center trial to demonstrate the safety and efficacy in adult benign central airway stenosis. Participates will be in a 1:1 allocation to treatment with the Airiver Pulmonary DCB or standard of care laryngoscopic/bronchoscopic balloon dilation, respectively.
Detailed description
Subjects will complete follow-up post-treatment at 30 days, 3 months, 6 months, 12 months, and every 6 months after through the primary endpoint, with a minimum of 2 years at study end.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| treatment with the Airiver Pulmonary DCB | Experimental | Combination Product: The Airiver Pulmonary drug-coated balloon (DCB) dilationdilate benign stenoses of the airway tree. |
| treatment of Commercial airway dilation balloon | Active comparator | Device: Commercial airway balloon dilationdilate benign stenoses of the airway tree. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Age ≥ 22 years.
- 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.
- In the opinion of the investigator, subject can undergo laryngoscopy/bronchoscopy under general anesthesia and has a central airway stenosis amenable to balloon dilation.
- For idiopathic subglottic stenoses, either de-novo or a dilation interval equal to or less than 18 months.
- Target benign stenosis etiologies including:
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| The Airiver Pulmonary drug-coated balloon (DCB) dilationdrug coated balloon dilation | Combination product | treatment with the Airiver Pulmonary DCB |
| Commercial airway balloon dilationuncoated airway balloon dilation | Device | treatment of Commercial airway dilation balloon |
Primary outcome
Primary Safety: defined as Incidence of device- and/or procedure-related Major Adverse Events(MAEs)
Time frame: 30 days post index procedure
including: * Pneumothorax * Pneumomediastinum * Tracheal or bronchial laceration requiring intervention * Airway perforation or rupture * Required tracheostomy * Bleeding from treatment site consistent with massive hemoptysis defined as > 100mL of blood expectorated in 24 hours or requiring transfusion * Mediastinitis requiring the need for IV antibiotics and / or hospitalization * Respiratory distress or asphyxia requiring intubation or reintervention * Death
Primary Efficacy: freedom from clinically indicated target lesion re-intervention over time
Time frame: Through the study completion, an average of 1 year
defined as a therapeutic reintervention/dilation that occurs due to either a recurrence of patient symptoms due to the stenosis and/or a recurrence seen through imaging of the stenosis (≥ 50%) or is an emergent condition related to the stenosis and treatment is required.
18 secondary outcomes
Time to first reintervention, defined as duration in days between the index/staged procedure and the first, subsequent procedure for treatment of the target stenosis.
Time frame: From Day 1 until the date of first documented reintervention, assessed through the study completion, an average of 1 year.
Percent change in airway lumen area at 6 months by CT
Time frame: Baseline, 6 months
Change in Peak Expiratory Flow (PEF) from 30 days to 6 months
Time frame: 1 month, 6 months
Index procedure success, defined as the ability to deliver study device to the targeted stenosis, inflate, deflate, and remove and with a < 25% residual stenosis.
Time frame: On index procedure day 0
Change in airway lumen volume by CT at follow-up visit
Time frame: Baseline, 30 days, 6 months, 12 months, then every 6 months until the date of the study complete (assessed up to 2 years)
Freedom from reintervention, defined as any reintervention on the target stenosis, whether clinically indicated or not
Time frame: 30 days, 3 months, 6 months, 12 months, then every 6 months until the date of study complete (assessed up to 2 years)
Annualized rate, of reinterventions
Time frame: Assessed annually through the date of the study complete, an average of 1 year.
Secondary patency, defined as freedom from reintervention after a first reintervention, at each follow-up
Time frame: From the date of the first reintervention to the next follow-up visit through the study completion, an average of 1 year.
Change in forced expiratory volume in 1 second (FEV1) at follow-up visit
Time frame: Baseline, 30 days, 3 months, 6 months, 12 months, then every 6 months until the date for the study complete (assessed up to 2 years)
Change in forced vital capacity (FVC) at follow-up visit
Time frame: Baseline, 30 day, 3 months, 6 months, 12 months, then every 6 months until the date of the study complete (assessed up to 2 years)
Changes in the ratio of FVE1 and FVC at follow-up visit
Time frame: Baseline, 30 days, 3 months, 6 months, 12 months, then every 6 months until the date of the study complete (assessed up to 2 years)
Change in peak expiratory flow (PEF)
Time frame: Baseline, 3 months, 12 months, then every 6 months until the date of the study complete (assessed up to 2 years).
Change in expiratory disproportion index (EDI)
Time frame: Baseline, 30 days, 3 months, 6 months, 12 months, then every 6month until the date of the study complete (assessed up to 2 years)
Rate of cannulation, stent, or open surgery due to target lesion stenosis
Time frame: 30 days, 3 months, 6 months, 12 months, then every 6 months until the date of study complete (assessed up to 2 years)
Change in modified Medical Research Council (mMRC) Dyspnea Scale
Time frame: Baseline, 30 days, 3 months, 6 months, 12 months, then every 6 months until the date of study completion (assessed up to 2 years)
Change in Chronic Obstructive Pulmonary Disease (COPD) Questionnaire
Time frame: Baseline, 30 days, 3 months, 6 months, 12 months, then every 6 months until the date of study completion (assessed up to 2 years)
Change in 12-Item Short Form (SF-12) Survey Global Quality of Life Score
Time frame: Baseline, 30 days, 3 months, 6 months, 12 months, then every 6 months until the date of the study completion (assessed up to 2 years)
Change in Voice Handicap Index (VHI-10) questionnaire
Time frame: Baseline, 30 days, 3 months, 6 months, 12 months, then every 6 months until the study completion (assessed up to 2 years)
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 18 Jun 2026.
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.
Alexander Hillel, MD principal investigator
Johns Hopkins University
Ryan M Kern, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The Airiver Pulmonary drug-coated balloon (DCB) dilation and Commercial airway balloon dilation in people with Adult Subjects With Symptomatic Benign Airway Obstruction and Adult Benign Central Airway Stenosis, run by Airiver Medical, Inc. at 1 site in United States.
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 20 inclusion and 0 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: looking for participants now, as of the sponsor's last update on 18 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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 Robyn Schacherer, RN (6123108755, schachererr@airiver.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Safety: defined as Incidence of device- and/or procedure-related Major Adverse Events(MAEs) (time frame: 30 days post index procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Jun 2026.