Inhaled Treprostinil (Tyvaso Nebulizer) For COPD Patients With Hypoxemia

NCT07037836 | Recruiting Phase 2 FDA Drug

• 1 other identifier: PRO00118083
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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:

• 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

Keywords

Tyvaso; COPD; Hypoxemia

Outcome Measures

Primary Outcomes (7)

• Ventilation Defect Percentage (VDP) on HP129XeMRI

  Defined as the region with ventilation signals \< mean - 2SD, measured by HP129XeMRI and expressed as a percentage of total lung volume.

  Baseline and 4 weeks post-Tyvaso

• Membrane Defect Percentage on HP129XeMRI

  Defined as the region with membrane signals \< mean - 2SD, measured by HP129XeMRI and expressed as a percentage of total lung volume.

  Baseline and 4 weeks post-Tyvaso

• Low Membrane Region Percentage on HP129XeMRI

  Defined as the region with membrane signals between 1SD and 2SD below the mean, measured by HP129XeMRI and expressed as a percentage of total lung volume.

  Baseline and 4 weeks post-Tyvaso

• RBC Transfer Defect Percentage on HP129XeMRI

  Defined as the region with RBC transfer signals \< mean - 2SD, measured by HP129XeMRI and expressed as a percentage of total lung volume.

  Baseline and 4 weeks post-Tyvaso

• Low RBC Transfer Region Percentage on HP129XeMRI

  Defined as the region with RBC transfer signals between 1SD and 2SD below the mean, measured by HP129XeMRI and expressed as a percentage of total lung volume.

  Baseline and 4 weeks post-Tyvaso

• RBC Oscillation Amplitude Normalized for RBC Transfer Defect

  Measured using HP129XeMRI spectroscopy as a surrogate for pulmonary vascular resistance, normalized to RBC transfer signal intensity.

  Baseline and 4 weeks post-Tyvaso

• RBC Chemical Shift on HP129XeMRI Spectroscopy

  Frequency shift in RBC signal reflecting capillary blood oxygenation, measured using HP129XeMRI spectroscopy.

  Baseline and 4 weeks post-Tyvaso

Secondary Outcomes (11)

• Nadir SpO₂ During 6MWT

  Baseline and 4 weeks post-Tyvaso treatment

• Supplemental Oxygen Flow During 6MWT

  Baseline and 4 weeks post-Tyvaso treatment

• 6-Minute Walk Distance (6MWD)

  Baseline and 4 weeks post-Tyvaso treatment

• Dyspnea Score During 6MWT

  Baseline and 4 weeks post-Tyvaso treatment

• Peak Heart Rate (% Predicted) During 6MWT

  Baseline and 4 weeks post-Tyvaso treatment

Study Arms (1)

Inhaled Treprostinil in COPD Patients With Hypoxemia and Preserved DLCO

EXPERIMENTAL

Drug: Inhaled Treprostinil (Tyvaso Nebulizer)

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.

Inhaled Treprostinil in COPD Patients With Hypoxemia and Preserved DLCO

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Upper respiratory tract infection within 6 weeks (participants may be rescreened after this period).
• History of lung resection surgery or pleural decortication.
• Previous history of pneumothorax.
• Imaging evidence of interstitial lung disease, occupational lung disease, or chronic infectious lung disease.
• History of asthma.
• History of exposure to occupational or environmental hazards known to cause lung disease.
• Positive pregnancy test for women of childbearing potential.
• Major chronic illness that, in the judgment of the study physician, would interfere with participation in the study.
• For Magnetic Resonance Imaging (MRI):
• Contraindications to MRI based on screening questionnaire responses.
• Participant is pregnant or lactating.
• Respiratory illness of bacterial or viral etiology within 6 weeks prior to MRI.
• Known cardiac arrhythmia.
• Participant does not fit into the hyperpolarized xenon-129 (\^129Xe) vest coil used for MRI.
• Participant cannot hold their breath for 10 seconds.

Sponsors & Collaborators

• Bastiaan Driehuys: lead
• United Therapeutics: collaborator

Study Sites (1)

Duke Asthma Allergy and Airway Center

Durham, North Carolina, 27705, United States

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Hypoxia

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Respiratory; Signs and Symptoms

Central Study Contacts

Yuh-Chin Huang, M.D., M.H.S., MD

CONTACT

919-684-3069; yuhchin.huang@duke.edu

Savannah Barbieri

CONTACT

919-613-0740; savannah.barbieri@duke.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Radiology

Study Record Dates

• First Submitted: May 9, 2025
• First Posted: June 26, 2025
• Study Start: September 29, 2025
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: October 30, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)