Actively Recruiting
Inhaled Treprostinil (Tyvaso Nebulizer) For COPD Patients With Hypoxemia
Led by Bastiaan Driehuys · Updated on 2025-10-30
10
Participants Needed
1
Research Sites
91 weeks
Total Duration
On this page
Sponsors
B
Bastiaan Driehuys
Lead Sponsor
U
United Therapeutics
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Inhaled Treprostinil (Tyvaso Nebulizer) For COPD Patients With Hypoxemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Outpatients of any gender aged 40 years or older
- Clinical evidence of chronic bronchitis with productive cough lasting more than 3 months within a 2-year period
- Current or former smokers with at least 20 pack-years smoking history
- Confirmed COPD diagnosis with FEV1/FVC ratio below 0.70, pre-bronchodilator FEV1 of 30% predicted or higher, and DLCO of 45% predicted or higher
- On stable COPD maintenance medications for at least 3 months without changes
- Presence of hypoxemia requiring supplemental oxygen at rest or during exercise at 4 liters per minute or less
- Able and willing to provide informed consent and follow study schedules
- Women of childbearing potential must have a negative serum pregnancy test before participation
You will not qualify if you...
- Upper respiratory tract infection within 6 weeks prior to screening
- History of lung resection surgery or pleural decortication
- Previous pneumothorax
- Imaging showing interstitial lung disease, occupational lung disease, or chronic infectious lung disease
- History of asthma
- Exposure history to occupational or environmental hazards causing lung disease
- Positive pregnancy test for women of childbearing potential
- Major chronic illness that may interfere with study participation
- Contraindications to MRI including pregnancy or lactation
- Respiratory illness of bacterial or viral origin within 6 weeks prior to MRI
- Known cardiac arrhythmia
- Inability to fit into the hyperpolarized xenon-129 MRI vest coil
- Inability to hold breath for 10 seconds during imaging
- Unlikely to comply with instructions during MRI imaging
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Duke Asthma Allergy and Airway Center
Durham, North Carolina, United States, 27705
Actively Recruiting
Research Team
Y
Yuh-Chin Huang, M.D., M.H.S., MD
CONTACT
S
Savannah Barbieri
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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