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RECRUITING

NCT07037836

PHASE2

Inhaled Treprostinil (Tyvaso Nebulizer) For COPD Patients With Hypoxemia

Sponsor: Bastiaan Driehuys

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

40 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2025-09-29

Completion Date

2027-07-01

Last Updated

2025-10-30

Healthy Volunteers

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.

Inclusion Criteria * 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. Exclusion Criteria * 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. * Participant is unlikely to comply with instructions during imaging.

Locations (1)

Duke Asthma Allergy and Airway Center

Durham, North Carolina, United States