A Multicenter Randomized Double-Blinded Placebo-Controlled Trial to Evaluate the Safety and Efficacy of Inhaled Treprostinil in Subjects with Pulmonary Hypertension due to Parenchymal Lung Disease

W
William Harvey, MD

Primary Investigator

Overview

The purpose of this research study is to investigate the safety and how well inhaled treprostinil works in subjects with pulmonary hypertension (PH) associated with interstitial lung disease (ILD) or combined pulmonary fibrosis and emphysema (CPFE).

Description

The purpose of this study is to investigate the safety and how well inhaled treprostinil works in subjects with WHO Group 3 PH.

Eligibility

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    lung disease,pulmonary hypertension,1602009422
  • Age: Between 18 Years - 79 Years
  • Gender: All

Inclusion Criteria
Females of reproductive potential must be non-pregnant and non-lactating
Confirmed diagnosis of World Health Organization Group 3 PH associated with idiopathic interstitial pneumonia or chronic hypersensitivity pneumonitis
Exclusion Criteria
Has a diagnosis of pulmonary arterial hypertension or PH for reasons other than ILD
Has shown intolerance or significant lack of efficacy to a prostacyclin or prostacyclin analogue that resulted in discontinuation or inability to effectively titrate that therapy
Has received any prostacyclin therapy within 30 days of informed consent, except for acute vasoreactivity testing
Has evidence of clinically significant left-sided heart disease
Use of any inhaled tobacco products or significant history of drug abuse within six months prior to first dose of study drug
Exacerbation of underlying lung disease or active pulmonary or upper respiratory infection within 30 days of the first dose of study drug
Initiation of pulmonary rehabilitation within 12 weeks prior to the first dose of study drug
Has uncontrolled systemic hypertension
Has any form of congenital heart disease or congenital hear defect
Has anemia
Has any musculoskeletal disorder, is using a device to assist walking, or has any other condition that would limit ambulation
Use of any investigational drug/device, or participation in any investigational study within 30 days prior to the first dose of study drug

Additional Information:
Participants will be paid for their participation.

Updated on 20 Nov 2022. Study ID: 1602009422

Interested in the study?

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