Central Airway ObstructionEarly Phase 1NCT05895305
Paclitaxel-Coated Pulmonary Balloon for the Treatment of Benign Airway Stenosis
A Early Phase 1 study testing Paclitaxel-Coated Pulmonary Balloon Catheter in people with Central Airway Obstruction, run by Airiver Medical, Inc. at 1 site in Georgia.
Trial summary
The goal of this Prospective Trial of Paclitaxel-Coated Pulmonary Balloon for the Treatment of Benign Airway Obstruction (OXYGEN-1) is to evaluate clinical safety and potential efficacy of the Airiver Pulmonary DCB in the treatment of benign central airway stenosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Central Airway Obstruction
- What is being tested?
- Paclitaxel-Coated Pulmonary Balloon Catheter
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteGeorgia
- Study dates
- 16 May 2023to 4 Oct 2029
- Phase
- Early 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male or female, aged ≥18 old
- Symptomatic, severe (> 50%) benign CAO (by CT or bronchoscopy)
- Stenosis is distal to cricoid and proximal to segmental bronchi
- Indicated for balloon dilation only or as an adjunct to standard of care
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- Includes, but not limited to :
- Post intubation tracheal stenosis (PITS)
- Post tracheostomy tracheal stenosis (PTTS)
- Post lung transplantation stenosis
- Stenosis related to airway stent
- Subglottic stenosis (SGS)
- Stenosis due to tuberculosis
Who cannot join
- Malignant CAO
- Dynamic etiology of benign stenosis such as excessive dynamic airway collapse, tracheobronchomalacia, or stenosis due to external compression
- Presence of a known perforation at the site of proposed dilation
- Presence of a known fistula between the tracheobronchial tree and esophagus, mediastinum to pleural space
- Obstruction not amenable to bronchoscopic dilation in the opinion of the investigator
- Allergy to paclitaxel or structurally related compounds
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- Severe coagulation disorders or current use of anticoagulant or antiplatelet medication that cannot be safely managed per recommended guidelines prior to the index procedure
- Acute stricture condition that requires emergent procedure (e.g., immediate dilation)
- Vasculitis that is not well controlled
- Inability to tolerate bronchoscopy or contraindication to bronchoscopy, anesthesia, or deep sedation
- Any anatomical limitation of the head and neck, oral cavity or laryngopharynx that may preclude bronchoscopic evaluation or treatment
- Patient with active pulmonary infection, including but not limited to: COVID-19, influenza, etc.
- Any disease or condition that interferes with safe completion of the study, such as severe COPD or severe asthma or pulmonary fibrosis.
- Patients actively being treated with immunosuppressive therapy or with an active immunosuppressed state due to other treatment or underlying disease.
- Pregnancy or planning on pregnant during the first 12 months of enrollment in the study
- Life expectancy <1 year
- Patient is currently enrolled in other investigational studies. Participation in studies for products approved in the US are not considered investigational
Trial locations and contacts
1 site in 1 country.
Georgia1 site
Israeli-Georgian Medical Research Clinic Helsicore
Tbilisi, 0112
About this study
Official title: Prospective Trial of Paclitaxel-Coated Pulmonary Balloon for the Treatment of Benign Airway Obstruction (OXYGEN-1 Trial)
The goal of this Prospective Trial of Paclitaxel-Coated Pulmonary Balloon for the Treatment of Benign Airway Obstruction (OXYGEN-1) is to evaluate clinical safety and potential efficacy of the Airiver Pulmonary DCB in the treatment of benign central airway stenosis.
Read the detailed description
Benign central airway stenosis/obstruction, including stenosis of the subglottic area, trachea, and bronchi, is related to significant morbidity due to dyspnea and impaired quality of life. It is hypothesized that Airiver pulmonary drug-coated balloon (DCB) will improve patient outcome in the bronchoscopic treatment of benign airway obstruction, and, as an adjunct to standard of care, will prolong airway patency compared to the standard of care alone. This is a prospective, multi-center, single-arm, open-label, safety \& feasibility, OUS first in human study for safety and potential efficacy.
- Conditions
- Central Airway Obstruction
- Being tested
- Paclitaxel-Coated Pulmonary Balloon Catheter
- Keywords
- benign, central airway obstruction, drug coated balloon
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paclitaxel-Coated Pulmonary Balloon CatheterCombination product
Also called DCB
Subjects with benign airway stenosis will be treated by Airiver pulmonary DCB at index procedure
| Study group | Role | What they receive |
|---|---|---|
| Single arm treated by Airiver Pulmonary DCB | Experimental | subject will be treated by Airiver Pulmonary Drug Coated Balloon (DCB) catheter. The balloon is coated with a paclitaxel drug (3.5ug/mm2). Receives: Combination Product: Paclitaxel-Coated Pulmonary Balloon Catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary safety: Freedom from major adverse device events (MADE) post index procedure through 30 days.
MADE is defined as:
- Airway perforation (Pneumothorax)
- Pneumomediastinum
- Massive bleeding
- Mediastinitis requiring the need for IV antibiotics and / or hospitalization
- Respiratory distress or asphyxia requiring intubation or reintervention
- Evidence of negative local tissue reaction to paclitaxel Subjects failing any component of the primary safety endpoint will be considered a safety failure, and subjects who remain event free through 30 days will be considered safety successes. Primary safety will be assessed as the proportion of subjects free from the primary safety event.
Measured: 30 days
Primary efficacy: Freedom from symptom-driven target lesion reintervention (TLR) due to recurrence of stenosis through 6 months
The incidence of subjects free from symptom-driven TLR will be assessed via Kaplan-Meier survival analysis.
Measured: 6 months
Secondary outcomes (6)
Incidence of, and time to, symptom-driven target lesion reintervention through 12 months.
assessed via Kaplan-Meier survival analysis.
Measured: 12 months
Bronchoscopic target lesion patency (Myer-Cotton airway grading system) change through 12 months.
Grade 1 - 0-50% obstruction Grade 2 - 51-70% obstruction Grade 3 - 71-99% obstruction Grade 4 - No detectable lumen.
Measured: 12 months
Spirometry (FEV1) change through 12 months
A spirometry will be compared at baseline vs follow-ups. Lower readings indicate more significant obstruction.
Measured: 12 months
mMRC (Modified Medical Research Council) dyspnea scale change through 12 months
The grade range is from 0-4. Higher grades indicate worse respiratory disability.
Measured: 12 months.
Quality of life (QOL) change: Patient report outcomes (SF-12) through 12 months
Converting SF-12 Item Responses to Physical and Mental Standardized Values. Higher scores indicate better health
Measured: 12 months
Clinical pharmacokinetics of paclitaxel by 10 days
plasma paclitaxel concentration will be assessed per predesignated time points.
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2023
- Study start16 May 2023
- Primary completion4 Oct 2025
- Study completion4 Oct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Central 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Airiver Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Libra Medical
- Responsible party
- Sponsor
- Investigators
- Kakha Vacharadze, MD, Principal investigator, National Center for Tuberculosis and Lung Diseases, Tbilisi State Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05895305
- Sponsor's protocol ID
- Oxygen-1
- Status last verified
- Dec 2025
- First submitted
- 31 May 2023
- Last updated
- 15 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Trial of Paclitaxel-Coated Pulmonary Balloon for the Treatment of Benign Airway Obstruction (OXYGEN-1 Trial)
- ClinicalTrials.gov ID
- NCT05895305
- Acronym / sponsor ID
- Oxygen-1
- Conditions
- Central Airway Obstruction
- Keywords
- benign, central airway obstruction, drug coated balloon
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Airiver Medical, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Libra Medical
- Study start
- 16 May 2023 (actual)
- Primary completion
- 4 Oct 2025 (actual)
- Study completion
- 4 Oct 2029 (estimated)
- First posted
- 8 Jun 2023 (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 goal of this Prospective Trial of Paclitaxel-Coated Pulmonary Balloon for the Treatment of Benign Airway Obstruction (OXYGEN-1) is to evaluate clinical safety and potential efficacy of the Airiver Pulmonary DCB in the treatment of benign central airway stenosis.
Detailed description
Benign central airway stenosis/obstruction, including stenosis of the subglottic area, trachea, and bronchi, is related to significant morbidity due to dyspnea and impaired quality of life. It is hypothesized that Airiver pulmonary drug-coated balloon (DCB) will improve patient outcome in the bronchoscopic treatment of benign airway obstruction, and, as an adjunct to standard of care, will prolong airway patency compared to the standard of care alone. This is a prospective, multi-center, single-arm, open-label, safety \& feasibility, OUS first in human study for safety and potential efficacy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single arm treated by Airiver Pulmonary DCB | Experimental | Combination Product: Paclitaxel-Coated Pulmonary Balloon Cathetersubject will be treated by Airiver Pulmonary Drug Coated Balloon (DCB) catheter. The balloon is coated with a paclitaxel drug (3.5ug/mm2). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male or female, aged ≥18 old
- Symptomatic, severe (> 50%) benign CAO (by CT or bronchoscopy)
Key exclusion criteria (17 listed)
- Malignant CAO
- Dynamic etiology of benign stenosis such as excessive dynamic airway collapse, tracheobronchomalacia, or stenosis due to external compression
- Presence of a known perforation at the site of proposed dilation
- Presence of a known fistula between the tracheobronchial tree and esophagus, mediastinum to pleural space
- Obstruction not amenable to bronchoscopic dilation in the opinion of the investigator
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 |
|---|---|---|
| Paclitaxel-Coated Pulmonary Balloon CatheterAlso: DCBSubjects with benign airway stenosis will be treated by Airiver pulmonary DCB at index procedure | Combination product | Single arm treated by Airiver Pulmonary DCB |
Primary outcome
Primary safety: Freedom from major adverse device events (MADE) post index procedure through 30 days.
Time frame: 30 days
MADE is defined as: * Airway perforation (Pneumothorax) * Pneumomediastinum * Massive bleeding * Mediastinitis requiring the need for IV antibiotics and / or hospitalization * Respiratory distress or asphyxia requiring intubation or reintervention * Evidence of negative local tissue reaction to paclitaxel Subjects failing any component of the primary safety endpoint will be considered a safety failure, and subjects who remain event free through 30 days will be considered safety successes. Primary safety will be assessed as the proportion of subjects free from the primary safety event.
Primary efficacy: Freedom from symptom-driven target lesion reintervention (TLR) due to recurrence of stenosis through 6 months
Time frame: 6 months
The incidence of subjects free from symptom-driven TLR will be assessed via Kaplan-Meier survival analysis.
6 secondary outcomes
Incidence of, and time to, symptom-driven target lesion reintervention through 12 months.
Time frame: 12 months
Bronchoscopic target lesion patency (Myer-Cotton airway grading system) change through 12 months.
Time frame: 12 months
Spirometry (FEV1) change through 12 months
Time frame: 12 months
mMRC (Modified Medical Research Council) dyspnea scale change through 12 months
Time frame: 12 months.
Quality of life (QOL) change: Patient report outcomes (SF-12) through 12 months
Time frame: 12 months
Clinical pharmacokinetics of paclitaxel by 10 days
Time frame: 10 days
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 15 Dec 2025.
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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. This study is not recruiting at the moment.
Kakha Vacharadze, MD principal investigator
National Center for Tuberculosis and Lung Diseases, Tbilisi State Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Paclitaxel-Coated Pulmonary Balloon Catheter in people with Central Airway Obstruction, run by Airiver Medical, Inc. at 1 site in Georgia.
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 13 inclusion and 17 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: under way, not looking for participants, as of the sponsor's last update on 15 Dec 2025. 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 Georgia. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary safety: Freedom from major adverse device events (MADE) post index procedure through 30 days. (time frame: 30 days). 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 15 Dec 2025.