Paclitaxel-Coated Balloon for Narrowing of the Airway

(OXYGEN-RCT Trial)

This trial explores a new treatment for benign central airway stenosis (narrowing of the airway) using a special balloon coated with paclitaxel, a medication that helps keep the airway open. Participants will receive either the paclitaxel-coated pulmonary balloon treatment or the standard procedure, which uses a regular balloon. The trial aims to determine if the new treatment is safer and more effective than the current standard. Individuals who have experienced airway narrowing, whether from past intubation or unknown causes, and who can undergo the procedure under general anesthesia, may be suitable candidates for this trial. As an unphased trial, this study provides a unique opportunity to explore innovative treatment options for airway stenosis.

The trial does not specify if you need to stop taking your current medications. However, if you are on anticoagulant or antiplatelet medication, it must be safely managed before the procedure. Chronic steroid use over 10 mg per day is also not allowed.

Research has shown that paclitaxel-coated balloons have been safely used in various treatments, including those for blood vessels. These balloons help open narrowed areas in the body, such as blood vessels or airways. The FDA has recognized the Airiver Pulmonary Drug-Coated Balloon as a Breakthrough Device, indicating its potential to improve treatment for central airway stenosis (narrowing of the airway). This recognition is often given to devices that might outperform current options.

Unlike the standard airway dilation balloons, the paclitaxel-coated pulmonary balloon uses the drug paclitaxel, which is typically used in cancer treatments, to help keep airways open longer by preventing tissue growth that can narrow them again. This unique feature could mean fewer procedures for patients, as it targets the underlying cause of airway narrowing more effectively. Researchers are excited about this approach because it combines mechanical dilation with a drug that specifically inhibits cell proliferation, potentially offering a longer-lasting solution than traditional treatments.

Research has shown that paclitaxel-coated balloons effectively treat airway stenosis, a narrowing of the airway. Studies have found that these balloons help keep airways open, making breathing easier. In this trial, participants will receive either the Airiver Pulmonary Drug-Coated Balloon, recognized by the FDA as a Breakthrough Device, or a commercial airway dilation balloon. Patients using similar devices experienced improved airway function and easier breathing. This suggests that the paclitaxel-coated balloon could be a promising option for treating non-cancerous airway narrowing.¹²⁴⁵⁶