What is the PALM-PAH Study?
Thank you for your interest in the PALM-PAH Study. This is a clinical study being done to evaluate an inhaled investigational drug in adults with pulmonary arterial hypertension (PAH). This clinical study is being sponsored by Insmed Incorporated. The drug being studied is investigational and has not been approved for use in any country for any indication.
PAH is a type of high blood pressure that affects the arteries that carry blood from your heart to your lungs. These blood vessels become narrow or blocked, so the heart must work harder to pump blood through them. This extra effort can cause the heart to become weak and fail.
Researchers want to see if the study drug can improve symptoms and functioning.
Who can participate?
You may be able to participate if you meet these and other criteria:
Age
Are 18 to 75 years of age
Diagnosis
Have had a confirmed diagnosis of PAH for at least 3 months
Medicine
Are on a stable (consistent) dose of certain medicines for PAH
What happens during the study?
Before any study procedures can begin, you need to understand the study and sign an Informed Consent Form, which contains all the details of the study including potential safety information. Throughout the study, you will have visits to check on your health. The study lasts up to 32 weeks and has 3 periods.
Have questions? See our FAQs pageScreening Period
Up to 30 days
The study team will collect information about your health and run tests to see if you qualify for the study.
Study Treatment Period
24 weeks
You will receive the study treatment and have 8 clinic visits for health checks and tests.
Optional Long-Term Extension Study
If you choose, you may continue in the study to receive the active study drug (no placebo) and have clinic visits.
Follow-up Period
4 weeks
If you choose not to continue into the optional Long-Term Extension Study and no longer take the study drug, you will have 1 more visit or phone call to check on your health.
What is the study treatment?
The study treatment is a dry powder that you will inhale through your mouth once a day. The study treatment is investigational and has not been approved for use in any country for any indication. During the Study Treatment Period, you will receive either the active study drug or the placebo. The placebo looks just like the study drug but contains no active ingredients. Neither you nor the study doctor will know if you are receiving the active study drug or the placebo.
After completing the 24-week Study Treatment Period, you may choose to continue into an optional Long-Term Extension Study where all participants will receive the active study drug (no placebo).
What kind of study-related health checks and tests can you expect?
During the study, you will visit the clinic for health checks and tests. You will not have every test at each visit.
Physical exam
Height/Weight
Vital signs
Heart activity (ECG)
Blood tests
Pregnancy test (if needed)
Breathing tests
Walking tests
Heart imaging
Right heart catheterization
Questionnaires
Side effects check
ECG = electrocardiogram.
Find a study site
Below is a list of sites that are participating in this study that can be used to identify a location near you.
Study site locations are being confirmed. Please check back soon.
Interested in learning more?
To learn more about the PALM-PAH Study, speak with your doctor or contact Insmed Medical Information at 1-844-446-7633 or medicalinformation@insmed.com.
Visit our FAQs