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Study on the Safety and Effectiveness of MK-5475 for Adults with Pulmonary Hypertension and COPD

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What is this study about?

This clinical trial is focused on studying a condition called Pulmonary Hypertension associated with Chronic Obstructive Pulmonary Disease (PH-COPD). Pulmonary Hypertension is a type of high blood pressure that affects the arteries in the lungs and the right side of the heart. Chronic Obstructive Pulmonary Disease is a chronic inflammatory lung disease that causes obstructed airflow from the lungs. The study is testing a new treatment called MK-5475, which is an inhalation powder, to see if it can help improve the condition of people with PH-COPD. Some participants will receive MK-5475, while others will receive a placebo, which looks like the treatment but does not contain the active substance.

The purpose of the study is to evaluate the effect of MK-5475 on the distance participants can walk in six minutes, known as the 6-minute walk distance, after 24 weeks. Participants will be randomly assigned to receive either MK-5475 or a placebo. The study will last for several months, during which participants will have regular check-ups to monitor their health and the effects of the treatment. The study aims to see if MK-5475 can help improve the ability to walk longer distances and assess its safety for people with PH-COPD.

Throughout the study, participants will be closely monitored for any changes in their condition and any side effects they might experience. The study will also look at other health indicators, such as levels of a substance called N-terminal pro B-type natriuretic peptide (NT-proBNP), which can be a marker of heart stress, and the overall health status of participants as classified by the World Health Organization (WHO). The goal is to gather information that could lead to better treatment options for people living with PH-COPD.

1 beginning of the trial

Upon joining the study, you will be randomly assigned to receive either the study medication, MK-5475, or a placebo. A placebo is a substance with no active medication, used to compare effects.

The medication is administered as an inhalation powder. You will be instructed on how to use the inhalation device properly.

2 medication schedule

You will take the assigned medication through inhalation. The specific dosage and frequency will be provided by the study team.

The duration of the medication administration is planned for up to 24 weeks, with regular monitoring and assessments throughout this period.

3 regular assessments

Throughout the trial, you will undergo regular assessments to monitor your health and the effects of the medication. This includes measuring your ability to walk for six minutes, known as the 6-minute walk distance (6MWD).

Additional tests may include blood tests to measure specific markers related to your condition.

4 mid-trial evaluation

At approximately 12 weeks into the trial, there will be a mid-trial evaluation. This will include a review of your 6-minute walk distance and other health markers.

The study team will assess any changes in your condition and any side effects you may be experiencing.

5 end of trial evaluation

At the end of the 24-week period, a final evaluation will be conducted. This will include a comprehensive review of your health, the 6-minute walk distance, and other relevant health markers.

The study team will discuss the overall findings with you and provide guidance on any next steps.

Who Can Join the Study?

  • The patient must have pulmonary hypertension associated with chronic obstructive pulmonary disease (PH-COPD). This means they have high blood pressure in the lungs related to a long-term lung disease that makes it hard to breathe.
  • The patient can be of any sex/gender and must be between 40 to 85 years old.
  • If the patient is a female, she must not be pregnant or breastfeeding. She should either not be able to have children, use an acceptable method of birth control, abstain from sexual intercourse, or have a negative pregnancy test within 24 hours before the first dose of the study medication. The doctor will review her medical history and sexual activity.
  • The patient must have had a right heart catheterization (RHC), which is a test to check the pressure in the heart and lungs, either at the start of the study or within the last 12 months, and it must meet certain criteria.
  • The patient must show signs of obstructive lung disease on a pulmonary function test (PFT) done at the start of the study. This test measures how well the lungs are working.
  • The patient must have a WHO Functional Class of Class II to IV, which is a way to describe how much the disease affects their daily life and activities.
  • If the patient uses supplemental oxygen, the amount and schedule must be stable.
  • The patient must have a stable and optimized treatment plan for their chronic COPD.
  • If the patient is taking a PDE5 inhibitor, which is a type of medication, its use must be stable.
  • If the patient is taking antihypertensives (medications to lower blood pressure) and/or a diuretic regimen (medications to help remove excess fluid from the body), their use must be stable.
  • If the patient is taking anticoagulants (medications to prevent blood clots), their use must be stable.

Who Cannot Join the Study?

  • Patients with any other type of pulmonary hypertension (high blood pressure in the lungs) not associated with chronic obstructive pulmonary disease (COPD) cannot participate.
  • Patients who have had a heart attack or stroke in the last 6 months are excluded.
  • Patients with uncontrolled high blood pressure (hypertension) are not eligible.
  • Patients with severe liver disease cannot take part in the study.
  • Patients with kidney disease requiring dialysis are excluded.
  • Patients who are pregnant or breastfeeding cannot participate.
  • Patients who have participated in another clinical trial within the last 30 days are not eligible.
  • Patients with a history of drug or alcohol abuse in the past year are excluded.
  • Patients with cancer that is not in remission are not eligible.
  • Patients with severe mental health disorders that are not well controlled cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Technische Universitaet Dresden Dresden Germany
Katholieke Universiteit te Leuven Leuven Belgium
Medizinische Hochschule Hannover Hanover Germany
Université Libre de Bruxelles – Hôpital Erasme Brussels Belgium

Other Sites

Site Name City Country Status
Hospital Del Mar Barcelona Spain
Virgen del Rocío University Hospital Sevilla Spain
Justus-Liebig-Universitaet Giessen Giessen Germany
Thoraxklinik Heidelberg gGmbH Heidelberg Germany
Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer Barcelona Spain
Centre Hospitalier Universitaire De Poitiers Poitiers France
Fondazione IRCCS San Gerardo Dei Tintori Monza Italy
Ayfeghqzgb Pjysoxev Hlbwjbrc Di Pszfh Le Kremlin-Bicetre France
Cvhoue Hapwuphyfwi Rasswiky Duftyxqyyrjhsh Angers France
Ivydewjk Myczqenfayrz Pqp I Tlkjezbgs E Twpklim Af Afkg Sjuroswzyxqxrxgx Swsrtf Palermo Italy
Cxhucaasi Htuppzkk Trieste Italy
Avnljxkslr Prnxruly Hhttlciy Dn Mtlmfynhe Marseille France
Mawhzsq Uqrwbeupos Oi Grhx Graz Austria
Cfop Dw Ndgmh Vandoeuvre Les Nancy France
Hzlbxthk Uiqtwzphrcjtq Mejoiza Du Vakijrxlnn Santander Spain
Hovanmxy Vfxh dkplsqbg Barcelona Spain

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Austria Austria
Not recruiting
29.12.2022
Belgium Belgium
Not recruiting
29.12.2022
France France
Not recruiting
29.12.2022
Germany Germany
Not recruiting
29.12.2022
Italy Italy
Not recruiting
29.12.2022
Spain Spain
Not recruiting
29.12.2022

Trial locations

Investigated drugs:

MK-5475 is a medication being studied for its potential to help people with pulmonary hypertension, which is high blood pressure in the lungs, associated with chronic obstructive pulmonary disease (COPD). This medication is being tested to see if it can improve how far a person can walk in six minutes, which is a common way to measure how well someone with lung problems can function in daily life. The goal is to see if this medication can help improve breathing and overall physical activity in people with this condition.

Pulmonary hypertension associated with chronic obstructive pulmonary disease (PH-COPD) – This condition involves high blood pressure in the arteries of the lungs, which is linked to chronic obstructive pulmonary disease. It occurs when the small blood vessels in the lungs become narrowed, blocked, or destroyed, leading to increased resistance to blood flow. As a result, the heart must work harder to pump blood through the lungs, which can lead to heart strain. Over time, this increased pressure can cause the right side of the heart to enlarge and weaken. Symptoms may include shortness of breath, fatigue, dizziness, and swelling in the ankles or legs. The progression of the disease can vary, with symptoms potentially worsening over time.

Trial ID:
2022-501201-13-00
Protocol code:
MK-5475-013
Trial Phase:
Therapeutic exploratory (Phase II)

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