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An Open-Label ProSpective MultiCENTer Study to Evaluate Safety and Tolerability of Dry Powder Inhaled Treprostinil in PH | Clinical Trials | Clareo Health

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An Open-Label ProSpective MultiCENTer Study to Evaluate Safety and Tolerability of Dry Powder Inhaled Treprostinil in PH

An Open-Label ProSpective MultiCENTer Study to Evaluate Safety and Tolerability of Dry Powder Inhaled Treprostinil in Pulmonary Hypertension

NCT06129240•Liquidia Technologies, Inc.

View on ClinicalTrials.gov

Summary

Study LTI-401 is an open-label, multicenter study which will evaluate the safety and tolerability of LIQ861 in subjects who have WHO Group 1 \& 3 PH.

Detailed Description

Open-label, multicenter study which will evaluate the safety and tolerability of LIQ861 in subjects who have WHO Group 1 \& 3 PH. Cohort A will include approximately 60 subjects who have WHO Group 3 Pulmonary Hypertension associated with interstitial lung disease (PH-ILD) Cohort B will include approximately 20 subjects who have WHO Group 3 PH-ILD, have been on protocol specified dosing of inhaled treprostinil QID, not at treatment goal, and able to transition to LIQ861. The primary objective of this study is to evaluate the safety and tolerability of LIQ861 in subjects with WHO Group 1 \& 3 Pulmonary Hypertension (PH).

Eligibility

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Males or Females between 18 years to 80 years of age.
•2. Has a confirmed diagnosis of WHO Group 3 PH-ILD based on CT chest imaging performed, which demonstrates evidence of diffuse parenchymal lung disease and FEV1/FVC (absolute values) ≥ 70% and are required to have evidence of pulmonary hypertension (PH) as demonstrated from right heart catheterization (RHC) with the following hemodynamic parameters.
•1. i) Pulmonary vascular resistance (PVR) ≥ 3 Wood Units (WU) and ii) Pulmonary capillary wedge pressure (PCWP) of ≤ 15 mmHg and iii) A mean pulmonary arterial pressure (mPAP) of ≥ 30 mmHg.
•OR
•2. An exploratory subset of subjects with ILD: i) Pulmonary vascular resistance (PVR) ≥ 3 Wood Units (WU) and ii) Pulmonary capillary wedge pressure (PCWP) of ≤ 15 mmHg and iii) A mean pulmonary arterial pressure (mPAP) of ≥ 21 mmHg.
•3. 6-minute walk distance of ≥ 125 meters
•1. Male or Females between 18 years to 75 years of age at Screening.
•2. Has a diagnosis of WHO Group 3 PH-ILD confirmed with CT chest imaging performed at the screening visit, which demonstrates evidence of diffuse parenchymal lung disease and FEV1/FVC (absolute values) ≥70%. Subjects are required to have evidence of pulmonary hypertension (PH) as demonstrated from right heart catheterization (RHC) with the following documented parameters:
•1. Pulmonary vascular resistance (PVR) ≥3 Wood Units (WU) and
•2. Pulmonary capillary wedge pressure (PCWP) of ≤ 15 mmHg and
+3 more criteria

Exclusion Criteria

•1. PH in the Updated WHO Classification Groups 1, 2, 4, or 5.
•2. History of hemodynamically significant left-sided heart disease.
•3. Exacerbation of underlying lung disease or active pulmonary or upper respiratory infections.
•4. Initiation of pulmonary rehabilitation.
•1. PH in the Updated WHO Classification Groups 1, 2, 4, or 5.
•2. Inability to titrate inhaled treprostinil above 5 breaths (Tyvaso®) or above 16 mcg Tyvaso DPI®.
•3. History of Bronchospasm with Tyvaso or Tyvaso DPI.
•4. History of persistent moderate asthma or severe asthma.
•5. History of hemodynamically significant left-sided heart disease.
•6. Exacerbation of underlying lung disease or active pulmonary or upper respiratory infections.

Locations (18)

Arizona Pulmonary Specialists

Phoenix, Arizona, United States

The Medical Research Group, Inc.

Fresno, California, United States

UCLA Westwood

Los Angeles, California, United States

UC Davis

Sacramento, California, United States

UCSF

San Francisco, California, United States

National Jewish Health

Denver, Colorado, United States

Advent Health

Orlando, Florida, United States

Tampa General Hospital Center of Research Excellence

Tampa, Florida, United States

Vincent Medical Group

Indianapolis, Indiana, United States

University of Michigan

Ann Arbor, Michigan, United States

Key Dates

Start Date

December 28, 2023

Primary Completion Date

July 31, 2027

Completion Date

February 8, 2028

Last Updated

February 9, 2026

Enrollment

ESTIMATED participants

Conditions

Pulmonary HypertensionInterstitial Lung Disease

Interventions

LIQ861

DRUG

Clinical Cohort Construction and Therapeutic Effect Evaluation of Integrated Traditional Chinese and Western Medicine in the Treatment of Rheumatoid Arthritis

NCT07484243

Rheumatoid Arthritis (RA)Rheumatoid Arthritis-Associated Interstitial Lung Disease+1 more

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RECRUITINGPHASE2

A Study to Learn About the Study Medicine (Called PF-07868489) in People With Pulmonary Arterial Hypertension Who Have Previously Participated in a Clinical Study With PF-07868489

NCT07073820

Pulmonary Hypertension

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 9, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

An Open-Label ProSpective MultiCENTer Study to Evaluate Safety and Tolerability of Dry Powder Inhaled Treprostinil in PH

Inclusion Criteria

Exclusion Criteria

Clinical Cohort Construction and Therapeutic Effect Evaluation of Integrated Traditional Chinese and Western Medicine in the Treatment of Rheumatoid Arthritis

A Study to Learn About the Study Medicine (Called PF-07868489) in People With Pulmonary Arterial Hypertension Who Have Previously Participated in a Clinical Study With PF-07868489

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