Chronic Obstructive Pulmonary Disease, Pulmonary Hypertension
Conditions
Brief summary
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.
Interventions
DRUGFrespaciguat
Frespaciguat 380 µg administered as dry powder inhalation once daily.
DRUGPlacebo
Placebo administered as dry powder inhalation once daily.
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
Double-blind
Eligibility
Sex/Gender
ALL
Age
40 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
The key inclusion and
Exclusion criteria
include but are not limited to the following: Inclusion Criteria: * Has Group 3.1 pulmonary hypertension chronic obstructive pulmonary disease (PH-COPD) as defined by the Clinical Classification of Pulmonary Hypertension. * Has a right heart catheterization (RHC) at screening or historical RHC within 12 months before screening that meets hemodynamic criteria. * Has a physician diagnosis of obstructive lung disease on pulmonary function testing (PFT) performed at screening. * Has a WHO Functional Class assessment of Class II to IV. * If on supplemental oxygen, the regimen must be stable. * Has stable and optimized chronic, baseline COPD-specific therapy. * If on PDE5 inhibitor, has stable concomitant use (initiated at least 3 months prior to randomization and no change in drug or dosage for at least 3 months prior to randomization) and changes to PDE5 inhibitor dosing is not anticipated during the 24 week Base Period. * If on antihypertensives and/or a diuretic regimen has stable concomitant use. * If on anticoagulants has stable concomitant use. * Is of any sex/gender from 40 to 85 years of age inclusive. * Female is not pregnant or breastfeeding, and is not of childbearing potential or uses acceptable contraceptive method or abstains from sexual intercourse, or has a negative highly sensitive pregnancy test within 24 hours before the first dose of study intervention, or whose history and sexual activity has been reviewed by the investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline in 6-minute Walk Distance (6MWD) at Week 24 | Baseline and Week 24 | 6MWD is assessed using the 6-minute walk test (6MWT). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline in 6MWD at Week 12 | Baseline and Week 12 | 6MWD is assessed using the 6-minute walk test (6MWT). |
| Mean Change From Baseline in N-Terminal Pro B-Type Natriuretic Peptide (NT-proBNP) at Week 12 | Baseline and Week 12 | NT-proBNP was measured at baseline and Week 12. |
| Mean Change From Baseline in NT-ProBNP at Week 24 | Baseline and Week 24 | NT-proBNP was measured at baseline and Week 24 |
| Percentage of Participants Whose World Health Organization-Functional Class (WHO-FC) Does not Worsen Relative to Baseline at Week 12 | Baseline and 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. |
| Percentage of Participants Whose WHO-FC Does not Worsen Relative to Baseline at Week 24 | Baseline and 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. |
| Percentage of Participants With One or More Adverse Events (AEs) | Up to Week 206 | 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. |
| Percentage of Participants who Discontinued Study Treatment due to an AE | Up to Week 204 | 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. |
Countries
Argentina, Australia, Austria, Belgium, Colombia, France, Germany, Guatemala, Israel, Italy, Mexico, Peru, South Africa, South Korea, Spain, Switzerland, Turkey (Türkiye), United Kingdom, United States
Contacts
STUDY_DIRECTORMedical Director
Merck Sharp & Dohme LLC
Outcome results
None listed