Using a Paclitaxel-Coated Balloon to Treat Benign Airway Stenosis

Prospective Trial of Paclitaxel-Coated Pulmonary Balloon for the Treatment of Benign Airway Obstruction (OXYGEN-1 Trial)

This study is testing a special balloon coated with medication to see if it can help people with blocked airways breathe better when used with regular treatments.

Quick facts

• Phase: Early Phase 1
• Study type: Interventional
• Enrollment: 45 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Airiver Medical, Inc. (Industry-sponsored)
• Locations: 1 site (Tbilisi)
• Trial ID: NCT05895305 on ClinicalTrials.gov

What this trial studies

This trial evaluates the safety and potential effectiveness of the Airiver pulmonary drug-coated balloon (DCB) for treating benign central airway obstruction. It focuses on patients with significant airway stenosis, aiming to improve outcomes and prolong airway patency when used alongside standard care. The study is prospective, multi-center, single-arm, and open-label, marking it as a first-in-human investigation outside the United States.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with symptomatic, severe benign central airway obstruction.

Not a fit: Patients with malignant central airway obstruction or dynamic etiologies of stenosis may not benefit from this treatment.

Why it matters

Potential benefit: If successful, this treatment could significantly improve breathing and quality of life for patients with benign airway stenosis.

How similar studies have performed: While this approach is novel, similar studies using drug-coated balloons in other contexts have shown promising results.

Eligibility criteria

Inclusion Criteria:

1. Provision of signed and dated informed consent form
2. Stated willingness to comply with all study procedures and availability for the duration of the study
3. Male or female, aged ≥18 old
4. Symptomatic, severe (\> 50%) benign CAO (by CT or bronchoscopy)

   1. Stenosis is distal to cricoid and proximal to segmental bronchi
   2. Indicated for balloon dilation only or as an adjunct to standard of care
   3. 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

Exclusion Criteria:

1. Malignant CAO
2. Dynamic etiology of benign stenosis such as excessive dynamic airway collapse, tracheobronchomalacia, or stenosis due to external compression
3. Presence of a known perforation at the site of proposed dilation
4. Presence of a known fistula between the tracheobronchial tree and esophagus, mediastinum to pleural space
5. Obstruction not amenable to bronchoscopic dilation in the opinion of the investigator
6. Allergy to paclitaxel or structurally related compounds
7. Severe coagulation disorders or current use of anticoagulant or antiplatelet medication that cannot be safely managed per recommended guidelines prior to the index procedure
8. Acute stricture condition that requires emergent procedure (e.g., immediate dilation)
9. Vasculitis that is not well controlled
10. Inability to tolerate bronchoscopy or contraindication to bronchoscopy, anesthesia, or deep sedation
11. Any anatomical limitation of the head and neck, oral cavity or laryngopharynx that may preclude bronchoscopic evaluation or treatment
12. Patient with active pulmonary infection, including but not limited to: COVID-19, influenza, etc.
13. Any disease or condition that interferes with safe completion of the study, such as severe COPD or severe asthma or pulmonary fibrosis.
14. Patients actively being treated with immunosuppressive therapy or with an active immunosuppressed state due to other treatment or underlying disease.
15. Pregnancy or planning on pregnant during the first 12 months of enrollment in the study
16. Life expectancy \<1 year
17. Patient is currently enrolled in other investigational studies. Participation in studies for products approved in the US are not considered investigational

Where this trial is running

Tbilisi

• Tbilisi State Medical University — Tbilisi, Georgia (Recruiting)

Study contacts

• Principal investigator: Kakha Vacharadze, MD — National Center for Tuberculosis and Lung Diseases, Tbilisi State Medical University
• Study coordinator: Yan Li, MD

Conditions Central Airway Obstruction; benign, central airway obstruction