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A Study of Treprostinil to Treat Interstitial Lung Disease Pulmonary Hypertension

NCT05564637 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2025-12-03

Study results available
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Summary

The purpose of this research study is to find out more about the drug treprostinil via inhaler and the mechanisms of why patients with pulmonary arterial hypertension related to Interstitial Lung disease (PAH-ILD) have limitations during exercise. The investigator is studying treprostinil's effect on patients with PAH-ILD during exercise and its effect on their quality of life after using it for 3 months.

Conditions

Interventions

DRUG

Treprostinil

30mcg (5 breaths) of inhaled treprostinil will be administered during the RHC procedure and patients will be initiated on outpatient inhaled treprostinil therapy for 3-months with gradual up titration to target dose as per standard clinical practice.

DIAGNOSTIC_TEST

Right Heart Catheterization (RHC) while exercising

A procedure to measure how well or poorly your heart is pumping and to measure the pressures in the heart and lungs. A catheter will be inserted into a vein and artery in order to take the measurements and this will be conducted while exercising on a supine cycle ergometer. Various measurements will be taken during periods of rest and exercise.

DIAGNOSTIC_TEST

Optional Muscle Biopsy

A sample of muscle tissue will be collected and analyzed for the ability of the cells to utilize oxygen.

Sponsors & Collaborators

  • United Therapeutics

    collaborator INDUSTRY

  • Mayo Clinic

    lead OTHER

Principal Investigators

  • Yogesh N Reddy, M.B.B.S · Mayo Clinic

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-03-13
Primary Completion
2024-10-30
Completion
2024-10-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05564637 on ClinicalTrials.gov