Inhaled Treprostinil (Tyvaso Nebulizer) For COPD Patients With Hypoxemia

Part of paid clinical trials in Durham, North Carolina.

Sponsor
Bastiaan Driehuys
Study ID
NCT07037836
Phase
PHASE2
Status
Recruiting
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Conditions

  • COPD (Chronic Obstructive Pulmonary Disease)
  • Hypoxemia

Eligibility Criteria

Sex
ALL
Age
40 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Inhaled Treprostinil (Tyvaso Nebulizer) — DRUG
    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.

Study Details

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.

Key Dates

Start date
Sep 29, 2025
Status verified
Jun 2025
Primary completion
Jul 1, 2027
Completion
Jul 1, 2027

Study Design

Enrollment
10 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Inhaled Treprostinil in COPD Patients With Hypoxemia and Preserved DLCO

Primary Outcome Measure

Ventilation Defect Percentage (VDP) on HP129XeMRI [ Time Frame: Baseline and 4 weeks post-Tyvaso ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Duke Asthma Allergy and Airway CenterDurhamNorth Carolina27705
Savannah Barbieri
[email protected]
919613740
Jessica Shier
[email protected]
Yuh-Chin Huang, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Duke Asthma Allergy and Airway Center· Durham, NC

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