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

NCT ID: NCT06129240

Last Updated: 2026-02-09

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 80 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-12-28
• Study Completion Date: 2028-02-08

Brief 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).

Conditions

Pulmonary Hypertension; Interstitial Lung Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Cohort A

PH-ILD

LIQ861

Intervention Type: DRUG

trepostinil inhalation powder in combination with inhaler

Cohort B

PH-ILD

LIQ861

Intervention Type: DRUG

trepostinil inhalation powder in combination with inhaler

Interventions

LIQ861

trepostinil inhalation powder in combination with inhaler

Intervention Type: DRUG

Eligibility Criteria

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. A mean pulmonary arterial pressure (mPAP) of ≥ 25 mmHg

3. Subjects must be on protocol specified dose of inhaled treprostinil QID not at treatment goal, and able to transition from their prescribed dose of inhaled Treprostinil therapy to LIQ861.

4. 6-minute walk distance of ≥ 200 meters

Exclusion Criteria

A Subject is not eligible for inclusion in the study if any of the following criteria apply:

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Liquidia Technologies, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

University of Minnesota

Minneapolis, Minnesota, United States

NYU Langone Medical Center

New York, New York, United States

University of Rochester

Rochester, New York, United States

University of Cincinnati Health

Cincinnati, Ohio, United States

Summit Health

Bend, Oregon, United States

Medical University of South Carolina

Charleston, South Carolina, United States

Houston Methodist

Houston, Texas, United States

University of Utah

Salt Lake City, Utah, United States

Countries

United States

Other Identifiers

LTI-401

Identifier Type: -

Identifier Source: org_study_id