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Inhaled Treprostinil (Tyvaso Nebulizer) For COPD Patients With Hypoxemia

NCT07037836 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2025-10-30

No results posted yet for this study

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.

Conditions

  • COPD (Chronic Obstructive Pulmonary Disease)
  • Hypoxemia

Interventions

DRUG

Inhaled 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.

Sponsors & Collaborators

  • United Therapeutics

    collaborator INDUSTRY

  • Bastiaan Driehuys

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-29
Primary Completion
2027-07-01
Completion
2027-07-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07037836 on ClinicalTrials.gov