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

NCT06129240 | Active Not Recruiting FDA Drug

• 1 other identifier: LTI-401
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 18

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.

Conditions

Pulmonary Hypertension; Interstitial Lung Disease

Outcome Measures

Primary Outcomes (2)

• Cohort A: Incident of treatment-emergent drug/device-related adverse events and Serious Adverse Events (SAEs)

  Treatment-emergent AEs and SAEs will be grouped by MedDRA System Organ Class, dose level at onset, time on drug at onset, and relationship to dose titration. Device-related AEs and SAEs will be grouped by MedDRA System Organ Class, dose level at onset, time on drug at onset, and relationship to dose titration.

  Baseline until the end of the study.

• Cohort B: Number of participants with treatment-emergent drug/device-related adverse events and Serious Adverse Events (SAEs)

  Treatment-emergent AEs and SAEs will be grouped by MedDRA System Organ Class, dose level at onset, time on drug at onset, and relationship to dose titration. Device-related AEs and SAEs will be grouped by MedDRA System Organ Class, dose level at onset, time on drug at onset, and relationship to dose titration.

  16 weeks

Study Arms (2)

Cohort A

PH-ILD

Drug: LIQ861

Cohort B

PH-ILD

Drug: LIQ861

Interventions

LIQ861 DRUG

trepostinil inhalation powder in combination with inhaler

Cohort A; Cohort B

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subject with PH-ILD

You may qualify if:

• Males or Females between 18 years to 80 years of age.
• 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.
• 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.
• 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.
• minute walk distance of ≥ 125 meters

You may not qualify if:

• PH in the Updated WHO Classification Groups 1, 2, 4, or 5.
• History of hemodynamically significant left-sided heart disease.
• Exacerbation of underlying lung disease or active pulmonary or upper respiratory infections.
• Initiation of pulmonary rehabilitation.
• Male or Females between 18 years to 75 years of age at Screening.
• 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:
• Pulmonary vascular resistance (PVR) ≥3 Wood Units (WU) and
• Pulmonary capillary wedge pressure (PCWP) of ≤ 15 mmHg and
• A mean pulmonary arterial pressure (mPAP) of ≥ 25 mmHg
• 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.
• minute walk distance of ≥ 200 meters
• PH in the Updated WHO Classification Groups 1, 2, 4, or 5.
• Inability to titrate inhaled treprostinil above 5 breaths (Tyvaso®) or above 16 mcg Tyvaso DPI®.
• History of Bronchospasm with Tyvaso or Tyvaso DPI.
• History of persistent moderate asthma or severe asthma.

Sponsors & Collaborators

• Liquidia Technologies, Inc.: lead

Study Sites (18)

Arizona Pulmonary Specialists

Phoenix, Arizona, 85012, United States

Location

The Medical Research Group, Inc.

Fresno, California, 93720, United States

Location

UCLA Westwood

Los Angeles, California, 90095, United States

Location

UC Davis

Sacramento, California, 95817, United States

Location

UCSF

San Francisco, California, 94143, United States

Location

National Jewish Health

Denver, Colorado, 80206, United States

Location

Advent Health

Orlando, Florida, 32803, United States

Location

Tampa General Hospital Center of Research Excellence

Tampa, Florida, 33606, United States

Location

Vincent Medical Group

Indianapolis, Indiana, 46260, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

NYU Langone Medical Center

New York, New York, 10016, United States

Location

University of Rochester

Rochester, New York, 14627, United States

Location

University of Cincinnati Health

Cincinnati, Ohio, 45219, United States

Location

Summit Health

Bend, Oregon, 97701, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Houston Methodist

Houston, Texas, 77030, United States

Location

University of Utah

Salt Lake City, Utah, 84112, United States

Location

MeSH Terms

Conditions

Hypertension, Pulmonary; Lung Diseases, Interstitial

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 52 Weeks
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 6, 2023
• First Posted: November 13, 2023
• Study Start: December 28, 2023
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): February 8, 2028
• Last Updated: February 9, 2026

Record last verified: 2026-02

Locations

US (18)