Researchers are looking for ways to treat pulmonary hypertension (PH) caused by chronic obstructive pulmonary disease (COPD). The goal of the study is to learn if people who take frespaciguat can walk farther in 6 minutes at Week 24 compared to people who take placebo.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
120
Frespaciguat 380 µg administered as dry powder inhalation once daily.
Placebo administered as dry powder inhalation once daily.
Mean Change From Baseline in 6-minute Walk Distance (6MWD) at Week 24
6MWD is assessed using the 6-minute walk test (6MWT).
Time frame: Baseline and Week 24
Mean Change From Baseline in 6MWD at Week 12
6MWD is assessed using the 6-minute walk test (6MWT).
Time frame: Baseline and Week 12
Mean Change From Baseline in N-Terminal Pro B-Type Natriuretic Peptide (NT-proBNP) at Week 12
NT-proBNP was measured at baseline and Week 12.
Time frame: Baseline and Week 12
Mean Change From Baseline in NT-ProBNP at Week 24
NT-proBNP was measured at baseline and Week 24
Time frame: Baseline and Week 24
Percentage of Participants Whose World Health Organization-Functional Class (WHO-FC) Does not Worsen Relative to Baseline at Week 12
Participants are assigned one of four WHO-FC, dependent on limits of physical activity. As WHO-FC increases from I to IV, limits of physical activity increase.
Time frame: Baseline and Week 12
Percentage of Participants Whose WHO-FC Does not Worsen Relative to Baseline at Week 24
Participants are assigned one of four WHO-FC, dependent on limits of physical activity. As WHO-FC increases from I to IV, limits of physical activity increase.
Time frame: Baseline and Week 24
Percentage of Participants With One or More Adverse Events (AEs)
An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.
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UCSF Helen Diller Medical Center at Parnassus Heights ( Site 0110)
San Francisco, California, United States
University of Colorado Anschutz Medical Campus-University of Colorado Hospital Cardiac and Vascular ( Site 0101)
Aurora, Colorado, United States
Clinovation Intl. Corp. ( Site 0108)
Sebring, Florida, United States
Alexian Brothers Medical Center-Pulmonary ( Site 0109)
Elk Grove Village, Illinois, United States
University of Iowa ( Site 0103)
Iowa City, Iowa, United States
University of Kansas Medical Center-IM-Pulmonary and Critical Care Medicine ( Site 0102)
Kansas City, Kansas, United States
Lexington VA Medical Center - Cooper Division ( Site 0137)
Lexington, Kentucky, United States
Corewell Health ( Site 0133)
Grand Rapids, Michigan, United States
Mayo Clinic in Rochester, Minnesota ( Site 0131)
Rochester, Minnesota, United States
Creighton University Clinical Research Office ( Site 0123)
Omaha, Nebraska, United States
...and 74 more locations
Time frame: Up to Week 206
Percentage of Participants who Discontinued Study Treatment due to an AE
An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The percentage of participants who discontinue study treatment due to an AE will be presented.
Time frame: Up to Week 204