Pulmonary hypertension associated with chronic obstructive pulmonary disease
Pulmonary arterial hypertension (PAH) is a serious, often fatal condition which involves high blood pressure in the arteries that provide blood to the lungs. Existing treatments have undesirable effects on lung function which make them unsuitable for patients who also have Chronic Obstructive Pulmonary Disease (COPD).
This clinical trial is being conducted to evaluate a new drug, MK-5475, which was developed to overcome these limitations to provide an effective treatment for patients with PAH and COPD. Study participants will be assigned, at random, to receive the study drug or placebo, administered as a dry powder with an inhaler. Twice as many participants will be assigned to receive study drug as placebo. The study aims to determine whether taking the study drug improves cardiovascular function as measured by a 6 minute walk test. The study doctors will also monitor participants closely to determine if there are any unwanted side effects or safety risks.
What you need to know
Who can take part?
You may participate in this study if you:
- Have been diagnosed with pulmonary arterial hypertension and you have COPD
- Are between 40 and 80 years old
- Are willing to avoid pregnancy during the study, if you are female
Certain pre-existing health conditions and medications may make you unable to participate in the study. The study doctor will discuss these with you if you are interested in participating in the study.
What is involved for you?
Participants in the study will undertake the following assessments, tests and procedures:
- Medical history and collection of demographic information
- Training in use of a dry powder inhaler
- Take the study medication using a dry powder inhaler once daily for 42 weeks
- Keep a medication diary
- 6-minute walk test
- Blood tests
- Health questionnaires
- Physical exam
- Height, weight and vital sign measurements
- Lung function tests
- Electrocardiogram
- Urine tests
- Pregnancy tests (women who can have children only)
- CT Scan of the chest, if one has not been performed in the past 12 months
- Echocardiogram, if one has not been performed in the past 6 months
- Right heart catheterisation, if not performed in the past 12 months
Trial Dates
April 2023 to August 2024