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RecruitingPhase 2

Inhaled Treprostinil (Tyvaso Nebulizer) For COPD Patients With Hypoxemia

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
40 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: MRI scans

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Does inhaled Treprostinil increase pulmonary capillary blood volume in ventilated lung regions, as measured by hyperpolarized xenon-129 magnetic resonance imaging (HP129Xe MRI)? 2."
  • "Can pre-treatment MRI parameters (RBC transfer and RBC oscillation amplitude) predict who will respond to inhaled Treprostinil?"
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether inhaled treprostinil (Tyvaso) improves oxygen delivery and blood flow in the lungs. It is for adults age 40 or older with COPD, a long-term lung disease, and low blood oxygen who meet lung test requirements. Participants will use Tyvaso 4 times a day for 4 weeks and have lung scans and other tests.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Age 40 or older and not staying in a hospital.
  • Have chronic bronchitis, with a cough that brings up mucus for more than 3 months within a 2-year period.
  • Currently smoke or used to smoke cigarettes, with at least 20 pack-years of smoking, such as 1 pack a day for 20 years.
  • Have COPD confirmed by breathing tests: FEV1/FVC below 0.70, FEV1 at least 30% of expected before airway-opening medicine, and DLCO at least 45% of expected. These tests measure airflow and how well gas passes from the lungs into the blood.
  • Have taken regular COPD medicines with no changes in the past 3 months.
  • Use extra oxygen at rest or during exercise, at no more than 4 liters per minute.
  • Can agree to join before any study tests and follow the study visit and treatment schedule.
  • If able to become pregnant, have a negative blood pregnancy test before joining.

Who can't join

  • Had an upper airway infection in the past 6 weeks, or a bacterial or viral breathing illness within 6 weeks before MRI. People with a recent upper airway infection may be checked again later.
  • Have had a collapsed lung, surgery to remove part of a lung, or surgery to remove thickened tissue around a lung.
  • Have asthma, or scans show lung scarring, work-related lung disease, or a long-term lung infection.
  • Have been exposed to hazards at work or in the environment known to cause lung disease.
  • Are pregnant, have a positive pregnancy test, or are breastfeeding.
  • Have a major long-term illness that the study doctor thinks would prevent participation, or a known irregular heartbeat.
  • Cannot safely have an MRI based on the screening questions, or cannot fit in the special MRI vest.
  • Cannot hold your breath for 10 seconds or are unlikely to follow instructions during the scan.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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.

Study sites (1)

NC