RecruitingPhase 2NCT07037836

Inhaled Treprostinil (Tyvaso Nebulizer) For COPD Patients With Hypoxemia

Sponsor

Bastiaan Driehuys

Enrollment

10 participants

Start Date

Sep 29, 2025

Study Type

INTERVENTIONAL

Conditions

COPD, Chronic Obstructive Pulmonary Disease Hypoxemia

Summary

The goal of this clinical trial is to evaluate whether inhaled Treprostinil (Tyvaso) can improve oxygen delivery and blood flow in the lungs in adults (age ≥40) with chronic obstructive pulmonary disease (COPD) and hypoxemia who have less severe reduction in lung blood volume (diffusing capacity of the lungs for carbon monoxide \[DLCO\] ≥45%). The main questions it aims to answer are: 1. Does inhaled Treprostinil increase pulmonary capillary blood volume in ventilated lung regions, as measured by hyperpolarized xenon-129 magnetic resonance imaging (HP129Xe MRI)? 2. Does inhaled Treprostinil improve oxygen delivery (measured as red blood cell \[RBC\] chemical shift) and maintain or only slightly change pulmonary vascular resistance (measured by RBC oscillation amplitude)? 3. Can pre-treatment MRI parameters (RBC transfer and RBC oscillation amplitude) predict who will respond to inhaled Treprostinil? Participants will: * Use the Tyvaso nebulizer (inhaled Treprostinil) 4 times daily for 4 weeks, starting at 3 breaths per session and increasing to a maximum of 6 breaths per session as tolerated. * Undergo HP129Xe MRI before and after treatment to assess regional lung function and oxygen exchange. * Complete pulmonary function tests (PFTs), 6-minute walk tests (6MWT), and echocardiograms at the beginning and end of the study. * Be monitored for adverse events, with a phone check-in midway through and after the treatment period.

Eligibility

Min Age: 40 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether inhaled treprostinil (brand name Tyvaso), a medication approved for pulmonary hypertension, also helps COPD patients who have low oxygen levels (hypoxemia) by improving breathing and exercise capacity. **You may be eligible if...** - You are 40 years old or older - You have been diagnosed with COPD (chronic obstructive pulmonary disease) - You have chronic bronchitis (a productive cough for more than 3 months per year) - You are a current or former smoker with at least a 20 pack-year history - You have low oxygen levels **You may NOT be eligible if...** - You have severe unstable heart disease - You are already using treprostinil or similar medications - You have had a recent lung infection or hospitalization Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGInhaled Treprostinil (Tyvaso Nebulizer)

Participants will receive inhaled Treprostinil (Tyvaso nebulizer), 6 µg per breath, administered four times daily for 4 weeks. The starting dose will be 3 breaths per session. The dose will increase by 1 breath per session each week, as tolerated, to a target of 6 breaths per session by week 4. If adverse effects occur, participants will remain at the highest tolerated dose. The drug will be administered using the Tyvaso inhalation system provided by United Therapeutics. No changes to baseline COPD maintenance medications are allowed during the treatment period. Participants will be monitored for safety throughout the study.