A randomized, placebo-controlled, phase 2a clinical study to assess the safety and efficacy of MK-5475 in pulmonary hypertension (PH) associated with chronic obstructive pulmonary disease (COPD).

Zusammenfassung der Studie

This study investigates the safety and efficacy of MK-5475 in patients with currently treated pulmonary hypertension associated with COPD. It will test whether the additional administration of MK-5475 to standard treatment has an additional positive effect compared to treatment with the standard drug and placebo. A placebo visually resembles the drug under investigation but contains no active ingredient. Additionally, it will be tested whether the new drug MK-5475 is safe. To participate in the study, several relevant tests and clinical parameters will be collected beforehand, providing insights into the current health status of the participants. The investigational product MK-5475 has been developed in the form of a dry powder for inhalation (inhalation using an inhaler). The chemical structure and mode of action may lead to vasodilation and thus improved blood flow to the lungs, aiming to achieve increased oxygen uptake in the lungs. Throughout the study duration, participants will continue their previous treatment. The effect of MK-5475 compared to placebo will be assessed, among other things, using a 6-minute walk test. This is a clinical exercise test in which the distance covered by a patient within 6 minutes is measured. Approximately 120 patients aged between 40 and 85 years will participate in the study worldwide. The total duration of the study is expected to be 43 months.

(BASEC)

Untersuchte Intervention

The study consists of a 6-week screening phase, a 24-week baseline phase, and an optional 18-month extension phase.

Screening and baseline phase:

After careful eligibility assessment, collection of medical history, and detailed information, the patient will be included in the study. Subsequently, participants will be randomly assigned in a 2:1 ratio to one of the following two groups:

• Group A: receives the drug MK-5475

• Group B: receives the placebo

Neither the study physician nor the participants know which group they are assigned to and thus whether MK-5475 or placebo is being taken (the study is termed "double-blind" at this stage).

All participants will inhale the dry powder MK-5475 or placebo once daily at home after being assigned to the MK-5475 or placebo treatment group. Study personnel will train participants in the use of the inhaler. They will also demonstrate how to keep a diary to document the intake of the medication.

As part of eight study visits during the baseline phase, various measures and examinations may be conducted, e.g.: 6-minute walk tests, assessment of general health status, discussions with medical personnel, blood draws, blood pressure measurements, urine samples, weight measurements, and various tests to examine the heart and lungs.

The study team may also contact participants between visits and after the completion of the study drug intake to inquire about their health status.

Optional extension phase:

Following the baseline phase, participants, regardless of whether they were previously treated with MK-5475 or placebo, may potentially participate in the extension phase. From this point on, all will receive MK-5475, which they should inhale once daily in the morning for an additional 18 months. Study control visits will occur approximately every four weeks.

Two weeks after the last visit at the study center in the optional extension phase, a closing phone call will take place with the study physician.

(BASEC)

Untersuchte Krankheit(en)

Chronic obstructive pulmonary disease (COPD) is a progressive disease, meaning it worsens over time. In COPD, less air flows in and out of the airways, making breathing difficult. The main symptoms include shortness of breath and cough. As COPD progressively worsens, everyday activities such as walking or dressing become more difficult. Pulmonary hypertension (PH) is a common complication of COPD and is associated with worsening clinical symptoms and disease progression. Pulmonary hypertension is high blood pressure that affects the arteries in the lungs and the right side of the heart. Pulmonary hypertension is dangerous because it disrupts blood flow through the heart and lungs. High blood pressure in the pulmonary arteries leads to narrowing of these arteries. As a result, the heart has to work harder to pump oxygen-poor blood into the lungs. Over time, pulmonary hypertension damages the heart and causes problems throughout the body. Currently, there is no effective medication for treating patients with pulmonary hypertension related to COPD (PH-COPD), but long-term oxygen therapy is often used to bring more oxygen into the lungs. PH-COPD has a significant impact on quality of life and leads to life-threatening problems.

(BASEC)

Sponsor

MSD Merck Sharp & Dohme AG, Luzern

(BASEC)

Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)

Ethikkommission Zürich

(BASEC)

Datum der Bewilligung durch die Ethikkommission

20.01.2023

(BASEC)

Ergebnisse der Studie