Active not recruitingPHASE2INTERVENTIONAL

Frespaciguat (MK-5475) INSIGNIA-PH-COPD: A Study of the Efficacy and Safety of Frespaciguat (an Inhaled sGC Stimulator) in Adults With PH-COPD

Doctors are studying a new treatment called frespaciguat for people who have both Chronic Obstructive Pulmonary Disease (COPD) and high blood pressure in their lungs, known as pulmonary hypertension (PH). This medicine is given through an inhaler. The main goal of the study is to find out if frespaciguat is safe and if it can help people walk further in a set amount of time after 24 weeks, compared to a dummy medicine (placebo). We hope this research will lead to better ways to manage these conditions and improve daily life for those affected. This is a Phase 2 study, meaning it's still in the earlier stages of testing.

At a glance

Status

Active not recruiting

Phase

PHASE2

Sponsor

Merck Sharp & Dohme LLC

Enrolment target

129

Start

16 Mar 2023

Estimated completion

08 Oct 2029

Pulmonary Hypertension Chronic Obstructive Pulmonary Disease

What is this study about?

This study is looking into a new inhaled medicine called frespaciguat. It's for people who have two-part breathing problems: Chronic Obstructive Pulmonary Disease (COPD), which makes it hard to breathe, and pulmonary hypertension (PH), which is high blood pressure in the arteries that go from your heart to your lungs. PH can make you feel breathless and tired.

The research aims to see if frespaciguat can make a real difference for people struggling with both conditions. Specifically, doctors want to know if taking this medicine regularly allows people to walk further in six minutes compared to those who receive a 'dummy' treatment called a placebo. This walking test helps researchers understand how the medicine might improve your day-to-day ability to do activities.

Finding new ways to treat PH in people with COPD is important because current treatments can be limited. If frespaciguat proves to be helpful and safe, it could offer a new option to improve the quality of life for many people.

Key takeaways

This study is testing a new inhaled medicine, frespaciguat.
It's for people with both COPD and high blood pressure in their lungs.
The main goal is to see if it helps people walk further.
Participants will receive either the new medicine or a placebo.
Regular clinic visits and tests will be part of the study.
You can withdraw from the study at any time.

Who may be eligible?

To join this study, you would typically need to be between 40 and 85 years old. You should have a specific type of high blood pressure in your lungs (pulmonary hypertension) that's linked to your COPD. Doctors will confirm this with special tests. You'll also need to have COPD that has been diagnosed by a doctor and is being managed with stable treatments.

Some things might mean you can't join. For example, if you have other types of pulmonary hypertension that are not related to COPD, or if you have serious heart problems on your left side. You also can't participate if you have severe sleep apnoea that hasn't been treated, or if your oxygen levels are too low at rest. If you've recently had a serious flare-up of your COPD, you might need to wait before joining.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you between 40 and 85 years old?
Do you have a diagnosis of COPD and high blood pressure in your lungs?
Are your regular COPD medicines stable?
Do you not have severe, untreated sleep apnoea?
Are you able to attend regular clinic visits for 6 months?

Answer every question to see your result.

What does participation involve?

If you join this study, you'll either receive the new medicine, frespaciguat, or a dummy medicine called a placebo – you won't know which one. Both are given through an inhaler. You'll have regular visits to the clinic over 24 weeks (about 6 months) to monitor your health and how you're responding to the treatment. These visits will include tests like the 6-minute walk test, which measures how far you can walk in that time, and other check-ups.

If you're already taking other medicines for your COPD, high blood pressure (antihypertensives), diuretics (water pills), or blood thinners (anticoagulants), it's important that your dosage of these has been stable. If you take a specific type of heart medicine called a PDE5 inhibitor, that also needs to have been stable for at least 3 months without any changes. You'll be asked to continue all your usual stable medicines during the study. If you're a woman who can have children, you'll need to use reliable contraception or agree not to have sex during the study.

Potential risks and benefits

Taking part in a study like this might offer a chance to try a new medicine that could potentially help your condition, which is a possible benefit. However, there's no guarantee the medicine will work, and you might receive the placebo instead. All medicines have potential side effects, and frespaciguat will be carefully monitored for any risks. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (85)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

UCSF Helen Diller Medical Center at Parnassus Heights ( Site 0110)
Verified postcode
San Francisco, United States
University of Colorado Anschutz Medical Campus-University of Colorado Hospital Cardiac and Vascular ( Site 0101)
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Aurora, United States
Clinovation Intl. Corp. ( Site 0108)
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Sebring, United States
Alexian Brothers Medical Center-Pulmonary ( Site 0109)
Verified postcode
Elk Grove Village, United States
University of Iowa ( Site 0103)
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Iowa City, United States
University of Kansas Medical Center-IM-Pulmonary and Critical Care Medicine ( Site 0102)
Verified postcode
Kansas City, United States
Lexington VA Medical Center - Cooper Division ( Site 0137)
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Lexington, United States
Corewell Health ( Site 0133)
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Grand Rapids, United States
Mayo Clinic in Rochester, Minnesota ( Site 0131)
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Rochester, United States
Creighton University Clinical Research Office ( Site 0123)
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Omaha, United States
University of New Mexico Hospital ( Site 0146)
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Albuquerque, United States
UNC Health - Eastowne Medical Office-Clinical Trials Unit ( Site 0147)
Verified postcode
Chapel Hill, United States

Common questions

What is frespaciguat?

Frespaciguat is a new medicine given through an inhaler that doctors are studying to see if it helps people with COPD and high blood pressure in their lungs.

What is a placebo?

A placebo is a 'dummy' medicine that looks just like the real medicine but contains no active drug. This helps researchers fairly compare the new medicine's effects.

How long does the study last?

The main part of the study where you take the medicine and have regular check-ups lasts for 24 weeks, which is about 6 months.

What is a 6-minute walk test?

This is a simple test where you walk as far as you can in 6 minutes. It helps doctors measure how well your body performs physical activity.

Can I stop the study if I want to?

Yes, you are always free to leave the study at any time, for any reason, and it won't affect your regular medical care.