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New treatment option for COPD (Chronic Obstructive Pulmonary Disease)
Official title Inhaled Treprostinil (Tyvaso Nebulizer) For COPD Patients With Hypoxemia
ClinicalTrials.gov ID: NCT07037836
What this study is testing
What is Inhaled Treprostinil (Tyvaso Nebulizer)?
Inhaled Treprostinil (Tyvaso Nebulizer) is an investigational medicine, given as an once-daily inhaled treatment, being studied as a potential treatment for copd (chronic obstructive pulmonary disease).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 and older
You may be able to join 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)...
- On stable maintenance COPD medications including inhaled corticosteroids (ICS), long-acting beta agonists (LABA), long-acting muscarinic antagonists...
You likely can't join 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.
See the full eligibility 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...
- 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...
- 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Durham, North Carolina, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 40 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Durham, North Carolina, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.