Clinical trial NCT05895305: Paclitaxel-Coated Pulmonary Balloon for the Treatment of Benign Airway Stenosis
Official title: Prospective Trial of Paclitaxel-Coated Pulmonary Balloon for the Treatment of Benign Airway Obstruction (OXYGEN-1 Trial)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Central Airway Obstruction
Keywords: benign, central airway obstruction
Lead sponsor: Airiver Medical, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Libra Medical
First posted: 2023-06-08
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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.

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

Primary outcomes:
measure: Primary safety: Freedom from major adverse device events (MADE) post index procedure through 30 days.
timeFrame: 30 days
measure: Primary efficacy: Freedom from symptom-driven target lesion reintervention (TLR) due to recurrence of stenosis through 6 months
timeFrame: 6 months
Secondary outcomes:
measure: Incidence of, and time to, symptom-driven target lesion reintervention through 12 months.
timeFrame: 12 months
measure: Bronchoscopic target lesion patency (Myer-Cotton airway grading system) change through 12 months.
timeFrame: 12 months
measure: Spirometry (FEV1) change through 12 months
timeFrame: 12 months
measure: mMRC (Modified Medical Research Council) dyspnea scale change through 12 months
timeFrame: 12 months.
measure: Quality of life (QOL) change: Patient report outcomes (SF-12) through 12 months
timeFrame: 12 months
measure: Clinical pharmacokinetics of paclitaxel by 10 days
timeFrame: 10 days
Other outcomes:
Locations:
city: Tbilisi
country: Georgia
facility: Tbilisi State Medical University
Study officials:
affiliation: National Center for Tuberculosis and Lung Diseases, Tbilisi State Medical University
name: Kakha Vacharadze, MD
role: PRINCIPAL_INVESTIGATOR
References: