LIQ861: trepostinil inhalation powder in combination with inhaler
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
Cohort A Key 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
Cohort A Key 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.
Cohort B Key Inclusion Criteria
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
Cohort B Key Exclusion Criteria
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.
Primary outcome measure(s)
Cohort A: Incident of treatment-emergent drug/device-related adverse events and Serious Adverse Events (SAEs) — Baseline until the end of the study. 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.
Cohort B: Number of participants with treatment-emergent drug/device-related adverse events and Serious Adverse Events (SAEs) — 16 weeks 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.
Trial sites (23)
Facility
City
Region
Status
Arizona Pulmonary Specialists
Phoenix
Arizona
Recruiting
The Medical Research Group, Inc.
Fresno
California
Recruiting
University of California San Diego
La Jolla
California
Withdrawn
UCLA Westwood
Los Angeles
California
Active Not Recruiting
UC Davis
Sacremento
California
Active Not Recruiting
UCSF
San Francisco
California
Active Not Recruiting
National Jewish Health
Denver
Colorado
Recruiting
Hartford Hospital
Hartford
Connecticut
Withdrawn
Advent Health
Orlando
Florida
Recruiting
Tampa General Hospital Center of Research Excellence
Tampa
Florida
Recruiting
Vincent Medical Group
Indianapolis
Indiana
Recruiting
Norton Pulmonary Specialists
Louisville
Kentucky
Withdrawn
Tufts Medical Center
Boston
Massachusetts
Withdrawn
University of Michigan
Ann Arbor
Michigan
Active Not Recruiting
University of Minnesota
Minneapolis
Minnesota
Active Not Recruiting
NYU Langone Medical Center
New York
New York
Active Not Recruiting
University of Rochester
Rochester
New York
Active Not Recruiting
University of North Carolina at Chapel Hill
Chapel Hill
North Carolina
Withdrawn
University of Cincinnati Health
Cincinnati
Ohio
Active Not Recruiting
Summit Health
Bend
Oregon
Recruiting
Medical University of South Carolina
Charleston
South Carolina
Recruiting
Houston Methodist
Houston
Texas
Active Not Recruiting
University of Utah
Salt Lake City
Utah
Active Not Recruiting
More Liquidia Technologies, Inc. trials in the USA
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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