Inhaled Treprostinil (Tyvaso Nebulizer) For COPD Patients With Hypoxemia
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age40+
SponsorBastiaan Driehuys
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Inhaled Treprostinil (Tyvaso Nebulizer)
DrugParticipants 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.
Treatment groups
10 Participants
are divided into 1 treatment groupGroup A: Inhaled Treprostinil in COPD Patients With Hypoxemia and Preserved DLCOExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline and 4 weeks post-Tyvaso2
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.
Time frame
Baseline and 4 weeks post-Tyvaso3
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.
Time frame
Baseline and 4 weeks post-Tyvaso4
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.
Time frame
Baseline and 4 weeks post-TyvasoSecondary outcomes
1
Nadir SpO₂ During 6MWT
Lowest oxygen saturation (SpO₂) recorded during the 6-minute walk test, measured by pulse oximetry. The test is performed on room air unless SpO₂ drops below 89%, at which point supplemental oxygen is administered to maintain SpO₂ ≥89%.
Time frame
Baseline and 4 weeks post-Tyvaso treatment2
Supplemental Oxygen Flow During 6MWT
Oxygen flow rate in liters per minute required to maintain SpO₂ ≥89% during the 6-minute walk test if room air is insufficient.
Time frame
Baseline and 4 weeks post-Tyvaso treatment3
6-Minute Walk Distance (6MWD)
Total distance walked in meters during the 6-minute walk test, following ATS guidelines.
Time frame
Baseline and 4 weeks post-Tyvaso treatment4
Dyspnea Score During 6MWT
Subjective rating of dyspnea severity on a 1-10 scale reported by participants at the end of the 6-minute walk test.
Time frame
Baseline and 4 weeks post-Tyvaso treatmentSponsors and contacts
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Source ClinicalTrials.gov