Investigation of the Safety and Pharmacology of Dry Powder Inhalation of Treprostinil



Status:Recruiting
Conditions:High Blood Pressure (Hypertension), High Blood Pressure (Hypertension)
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:1/27/2019
Start Date:January 2, 2018
End Date:July 31, 2020
Contact:Executive Director, Clinical Operations
Email:ClinicalTrials@Liquidia.com
Phone:(919) 328-4368

Use our guide to learn which trials are right for you!

A Phase 3 Open-label, Multicenter Study to Evaluate the Long-term Safety and Tolerability of Inhaled LIQ861(Treprostinil) in Pulmonary Arterial Hypertension (WHO Group 1) Patients

The primary objective of this study is to evaluate the long-term safety and tolerability of
LIQ861, a dry powder formulation of treprostinil, in patients with Pulmonary Arterial
Hypertension (PAH). A secondary objective of this study is to evaluate the comparative
bioavailability of treprostinil between two formulations of inhaled therapy.

One of the greatest impediments to patient treatment satisfaction with current inhaled
treprostinil therapy is inconvenience. Currently, PAH patients using inhaled treprostinil may
require more than 36 breaths per day using a nebulizer requiring daily set up and cleaning.
The use of a discrete, hand-held dry powder inhaler to deliver treprostinil to the lungs
could represent a major improvement in convenience and patient satisfaction, thereby
improving the quality of life for PAH patients. Liquidia is pursuing approval of LIQ861, an
inhalation dry powder formulation of treprostinil that is produced using Liquidia's PRINT®
Technology (Particle Replication in Nonwetting Templates), as an alternative to current
inhaled treprostinil therapy for the treatment of patients with PAH (WHO Group 1).

Inclusion Criteria:

- signed informed consent by patient prior to study enrollment

- 18 years of age or older

- If female of childbearing potential, a negative pregnancy test at the Baseline Visit
and agrees to practice adequate birth control throughout the duration of the study. If
the patient is postmenopausal or has documented surgical sterilization, a pregnancy
test and birth control is not necessary.

- The patient has been diagnosed with PAH belonging to the following subgroups of the
updated Nice Clinical Classification Group 1 (Simonneau, Gatzoulis et al. 2013), which
include:

1. Idiopathic PAH (1.1), or

2. Heritable PAH (1.2), or

3. Drug and toxin induced PAH (1.3), or

4. PAH associated with connective tissue disease (1.4.1), HIV infection (1.4.2), or
congenital heart disease (1.4.4) with simple systemic-to-pulmonary shunt at least
1 year after surgical repair

- The patient has been diagnosed with PAH and is NYHA Functional Class II - IV at
Screening.

1. has documented stable doses of approved inhaled therapy for at least 3 months
prior to screening and is willing and able to transition from their prescribed
dose of inhaled therapy to study drug, or

2. has documented stable doses of no more than two approved oral therapies for at
least 3 months prior to screening and is willing and able to add LIQ861 to their
treatment regimen.

- The patient can complete a baseline six-minute walk distance (6MWD) ≥ 150 m.

- The patient has had evidence of FEV1 ≥ 60% and FEV1/FVC ratio ≥ 60% during the 6-month
period prior to enrollment.

Exclusion Criteria:

- The patient's clinical condition is such that, in the opinion of the Investigator,
they are not expected to remain clinically stable for the duration of the study.

- Patients with PH in the Updated Nice Classification Groups 2-5, or PAH Group 1
subgroups not covered by the inclusion criteria (e.g., associated with portal
hypertension [1.4.3] or with schistosomiasis [1.4.5]).

- The patient is currently taking oral prostacyclin analogues or agonists, including
treprostinil and selexipag.

- The patient has had any PAH medication (except for anticoagulants) discontinued within
14 days of Baseline.

- The patient has had a new type of chronic therapy (including but not limited to
oxygen, a different class of vasodilator, diuretic, digoxin, and digitalis) for
pulmonary hypertension added within 30 days of Baseline.

- The patient has uncontrolled systemic hypertension as evidenced by persistent systolic
blood pressure greater than 160 mmHg or diastolic blood pressure greater than 100
mmHg.

- The patient has a history of hemodynamically significant left-sided heart disease
including, but not limited to: aortic or mitral valve disease, pericardial
constriction, restrictive or congestive cardiomyopathy, or coronary artery disease
(CAD).

- The patient has had an atrial septostomy.

- The patient has any serious or life-threatening disease other than conditions
associated with PAH (e.g. malignancy requiring aggressive chemotherapy, end stage
renal disease, etc.).

- The patient is taking any excluded medications listed in the Investigator's Brochure,
namely inhibitors and inducers of CYP2C8

- The patient has a hypersensitivity or allergy to any of the ingredients of LIQ861 or
other clinically relevant allergies (clinical relevance per Investigator judgment).

- The patient has had a pulmonary infarction (defined as infarction in more than one
lung segment documented by V/Q scan or pulmonary angiography) within two weeks of
Screening.

- The patient has had a stroke or transient ischemic attack (TIA) within six months of
Screening.

- The patient has evidence of an active uncontrolled sepsis or systemic infection during
Screening.

- The patient is pregnant or lactating.

- The patient has any musculoskeletal disease or any other disease that would limit
ambulation.

- The patient has participated in an investigational product or device study within the
30 days prior to Screening.

- The patient has current evidence of drug abuse in the opinion of the Investigator.

- The patient has severe hepatic impairment as evidenced by any history of ascites AND
encephalopathy.

- The patient has severe renal impairment (eGFR < 35).

- The patient is taking inhaled treprostinil doses of greater than 90 μg (more than 15
breaths).

Additional Exclusion Criteria for PK Sub-Study:

- The patient meets any of Primary Exclusion Criteria #1 - 19.

- The patient has moderate or severe renal impairment (eGFR < 60).

- The patient is taking inhaled treprostinil doses of greater than 72 μg (more than 12
breaths).
We found this trial at
38
sites
462 1st Avenue
New York, New York 10010
?
mi
from
New York, NY
Click here to add this to my saved trials
1648 Pierce Dr NE
Atlanta, Georgia 30322
(404) 727-5640
Emory University School of Medicine Emory University School of Medicine has 2,359 full- and part-time...
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
800 Washington St
Boston, Massachusetts 02111
(617) 636-5000
Tufts Medical Center Tufts Medical Center is an internationally-respected academic medical center – a teaching...
?
mi
from
Boston, MA
Click here to add this to my saved trials
333 South Columbia Street
Chapel Hill, North Carolina 27599
?
mi
from
Chapel Hill, NC
Click here to add this to my saved trials
234 Goodman Dr
Cincinnati, Ohio 45229
(513) 584-1000
University of Cincinnati Medical Center Opening in 1823 as the country
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
?
mi
from
Cleveland, OH
Click here to add this to my saved trials
Gainesville, Florida 32610
(352) 392-3261
University of Florida The University of Florida (UF) is a major, public, comprehensive, land-grant, research...
?
mi
from
Gainesville, FL
Click here to add this to my saved trials
Minneapolis, Minnesota 55455
(612) 625-5000
Univ of Minnesota With a flagship campus in the heart of the Twin Cities, and...
?
mi
from
Minneapolis, MN
Click here to add this to my saved trials
Sacramento, California 95814
?
mi
from
Sacramento, CA
Click here to add this to my saved trials
4502 Medical Drive
San Antonio, Texas 78284
(210) 567-7000
University of Texas Health Science Center at San Antonio The University of Texas Health Science...
?
mi
from
San Antonio, TX
Click here to add this to my saved trials
Albuquerque, New Mexico 87131
?
mi
from
Albuquerque, NM
Click here to add this to my saved trials
13001 E 17th Pl
Aurora, Colorado 80045
(303) 724-5000
University of Colorado Anschutz Medical Campus Located in the Denver metro area near the Rocky...
?
mi
from
Aurora, CO
Click here to add this to my saved trials
?
mi
from
Chicago, IL
Click here to add this to my saved trials
Chicago, Illinois 60637
?
mi
from
Chicago, IL
Click here to add this to my saved trials
?
mi
from
Cleveland, OH
Click here to add this to my saved trials
410 W 10th Ave
Columbus, Ohio 43210
(614) 293-8652
The Ohio State University, Wexner Medical Center Located in Columbus, The Ohio State University Wexner...
?
mi
from
Columbus, OH
Click here to add this to my saved trials
2201 Inwood Rd
Dallas, Texas 75235
(214) 645-8300
U.T. Southwestern Medical Center The story of UT Southwestern Medical Center is one of commitment...
?
mi
from
Dallas, TX
Click here to add this to my saved trials
Falls Church, Virginia 22042
?
mi
from
Falls Church, VA
Click here to add this to my saved trials
Houston, Texas 77030
?
mi
from
Houston, TX
Click here to add this to my saved trials
?
mi
from
Houston, TX
Click here to add this to my saved trials
Jacksonville, Florida 32216
?
mi
from
Jacksonville, FL
Click here to add this to my saved trials
3901 Rainbow Blvd
Kansas City, Kansas 66160
(913) 588-5000
University of Kansas Medical Center The University of Kansas Medical Center serves Kansas through excellence...
?
mi
from
Kansas City, KS
Click here to add this to my saved trials
Los Angeles, California 90073
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
100 West Market Street
Louisville, Kentucky 40202
?
mi
from
Louisville, KY
Click here to add this to my saved trials
Marietta, Georgia 30060
?
mi
from
Marietta, GA
Click here to add this to my saved trials
?
mi
from
Milwaukee, WI
Click here to add this to my saved trials
Mineola, New York 11501
?
mi
from
Mineola, NY
Click here to add this to my saved trials
1514 Jefferson Hwy.
New Orleans, Louisiana 70121
504-842-3000
Ochsner Medical Center Ochsner Medical Center is located near uptown New Orleans and includes acute...
?
mi
from
New Orleans, LA
Click here to add this to my saved trials
?
mi
from
Orlando, FL
Click here to add this to my saved trials
Philadelphia, Pennsylvania 19104
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
Phoenix, Arizona 85013
?
mi
from
Phoenix, AZ
Click here to add this to my saved trials
Phoenix, Arizona 85006
?
mi
from
Phoenix, AZ
Click here to add this to my saved trials
Pittsburgh, Pennsylvania 15212
?
mi
from
Pittsburgh, PA
Click here to add this to my saved trials
Pittsburgh, Pennsylvania 15213
?
mi
from
Pittsburgh, PA
Click here to add this to my saved trials
Portland, Oregon 97239
?
mi
from
Portland, OR
Click here to add this to my saved trials
200 First Street SW
Rochester, Minnesota 55905
507-284-2511
Mayo Clinic Rochester Mayo Clinic is a nonprofit worldwide leader in medical care, research and...
?
mi
from
Rochester, MN
Click here to add this to my saved trials
660 S Euclid Ave
Saint Louis, Missouri 63110
(314) 362-5000
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
?
mi
from
Saint Louis, MO
Click here to add this to my saved trials
Torrance, California 90502
?
mi
from
Torrance, CA
Click here to add this to my saved trials