Inhaled Treprostinil (Tyvaso Nebulizer) For COPD Patients With Hypoxemia

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 40
Healthy Volunteers: f
View:

• Outpatients of either gender, age ≥ 40.

• Clinical evidence of chronic bronchitis (a productive cough lasting more than 3 months within a 2-year period).

• Current or former cigarette smokers with a smoking history of 20 or more pack-years.

• Clinical diagnosis of chronic obstructive pulmonary disease (COPD) confirmed by spirometry demonstrating forced expiratory volume in 1 second (FEV1) to forced vital capacity (FVC) ratio \< 0.70, pre-bronchodilator FEV1 ≥ 30% predicted, and diffusing capacity of the lungs for carbon monoxide (DLCO) ≥ 45% predicted.

• On stable maintenance COPD medications including inhaled corticosteroids (ICS), long-acting beta agonists (LABA), long-acting muscarinic antagonists (LAMA), combination inhalers, azithromycin, or roflumilast (with no changes over the past 3 months).

• Patients with hypoxemia, evidenced by the use of supplemental oxygen at rest or during exercise (≤ 4 liters/minute).

• Willing and able to give informed consent and adhere to visit and protocol schedules (consent must be obtained prior to any study procedures).

• Women of childbearing potential must have a negative serum pregnancy test, confirmed prior to participation in this investigational protocol.

Locations
United States
North Carolina
Duke Asthma Allergy and Airway Center
RECRUITING
Durham
Contact Information
Primary
Yuh-Chin Huang, M.D., M.H.S., MD
yuhchin.huang@duke.edu
919-684-3069
Backup
Savannah Barbieri
savannah.barbieri@duke.edu
919-613-0740
Time Frame
Start Date: 2025-09-29
Estimated Completion Date: 2027-07-01
Participants
Target number of participants: 10
Treatments
Experimental: Inhaled Treprostinil in COPD Patients With Hypoxemia and Preserved DLCO
Sponsors
Leads: Bastiaan Driehuys
Collaborators: United Therapeutics

This content was sourced from clinicaltrials.gov