NCT07037836Toboroz2. fázis
Inhaled Treprostinil (Tyvaso Nebulizer) For COPD Patients With Hypoxemia
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. aug. 27.
Rövid összefoglaló (regiszter, angolul)
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.
- Állapot (regiszter)
- Toboroz
- Fázis (regiszter)
- 2. fázis
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 10 (tervezett)
- Első benyújtás
- 2025. máj. 9.
- Kezdés
- 2025. szept. 29.
- Elsődleges befejezés
- 2027. júl. 1.
- Fő szponzor
- Bastiaan Driehuys
- Betegségek
- Krónikus obstruktív tüdőbetegség (COPD)
- NCT-szám
- NCT07037836
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó · 2. fázis
- Tervezett résztvevők: 10
- 2025. szept. 29. és az elsődleges befejezés (2027. júl. 1.) között
- 1 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.
Ki nem vehet részt
Szó szerint a(z) ClinicalTrials.gov forrásból, témák szerint csoportosítva. Hogy ki vehet részt, azt csak a vizsgálat csapata dönti el.
Korábbi kezelés
- Previous history of pneumothorax.
- Respiratory illness of bacterial or viral etiology within 6 weeks prior to MRI.
Más betegség
- Upper respiratory tract infection within 6 weeks (participants may be rescreened after this period).
- History of lung resection surgery or pleural decortication.
- 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.
- Major chronic illness that, in the judgment of the study physician, would interfere with participation in the study.
- For Magnetic Resonance Imaging (MRI):
- Known cardiac arrhythmia.
Egyéb
- Positive pregnancy test for women of childbearing potential.
- Contraindications to MRI based on screening questionnaire responses.
- Participant is pregnant or lactating.
- 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.
Kiket keres a vizsgálat
- 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.
Életkor a regiszterben: 40 év – - · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (1)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| Duke Asthma Allergy and Airway Center | Durham | Egyesült Államok | Toboroz |
Ez az oldal tájékoztatás, nem orvosi tanács. Bármely vizsgálatról az orvosoddal beszélj.