Is chronic cough interrupting your life?

If you have a persistent cough, also known as chronic cough, you may be eligible for a clinical trial.

If you experience chronic cough, activites you once took for granted can become challenges. The MK‑7264‑043 clinical research study is evaluating an investigational drug to see if it may be a safe and effective treatment for chronic cough.

Answer a few questions to see if you may qualify for the MK‑7264‑043 study.

Answer Questions

What is chronic cough?

Chronic cough is a cough that persists for at least 8 weeks. Chronic cough is the most common single reason for primary care physician visits and is a common source of referrals to specialists such as pulmonologists, otolaryngologists, and allergists. In many cases, there may be more than one cause for chronic cough.

What factors may contribute to chronic cough?

The following factors may put you at increased risk:

  • Smoking
  • Asthma
  • Acid reflux
  • Allergies
  • Postnasal drip

How is chronic cough diagnosed?

Your doctor may ask you questions, such as how bad your cough is and how frequently your cough persists. Other tests or activities that could be important in diagnosing chronic cough include:

  • Physical examination
  • Imaging tests
  • Lung tests
  • Lab tests

How is chronic cough treated?

Treatment for chronic cough depends on what may be causing the cough. Often, more than one underlying health condition can contribute to a chronic cough. Treatments may include behavioral changes (such as quitting smoking) or medications that may address underlying conditions. Prescription cough suppressants may help relieve symptoms while the doctor determines how best to treat your chronic cough.

doctor with patient

Who can participate?

You may be eligible to participate in the MK‑7264‑043 clinical research study if you:

  • You are at least 18 years of age
  • You have had chronic cough for less than 1 year
  • You meet other requirements, as determined by a screening process

There may be reasons why you cannot be in this study. The study doctor or staff will discuss this with you.

What should I expect?

Before joining the MK‑7264‑043 study, you will be screened to find out if you are eligible. If you are eligible and choose to enroll, your participation will last approximately 16 weeks. It will include 4 scheduled visits to the study clinic and 3 phone calls with the study doctor or staff.

What are my responsibilities in the study?

Clinical studies rely on the cooperation of volunteer participants. While you are taking part in this study, you will need to:

  • Follow instructions from the study doctor and staff
  • Ask questions if you have concerns or need clarification
  • Take your study drug as directed
  • Attend all study visits
  • Complete your study diary entries
  • Tell the study doctor or staff about any changes to your health

All study medication and study-related tests will be provided at no cost.

Where do I begin?

The first step involves answering a few questions in an online prescreening questionnaire to see if you are a potential candidate for the study. Depending on your answers, you may be referred to a study clinic for screening.

Answer Questions
Clinical studies, also called clinical trials, help determine if investigational drugs, medical devices, and procedures are safe and effective for treating or preventing diseases and other health conditions.
Clinical studies follow a specific set of standards and are closely regulated to help protect study participants. An independent Ethics Committee or Institutional Review Board reviews and monitors each study closely to safeguard the rights and welfare of participants. Nevertheless, all clinical studies and investigational products have risks, including the potential to make participants sick or uncomfortable. Although safety precautions are put in place to protect people who participate in clinical studies, your condition or health could remain the same, improve, or get worse. Any known risks and side effects will be discussed during the informed consent process, but there may be unknown risks.
The investigational drug is called gefapixant and is also known as MK-7264. This drug is considered investigational because it is not currently approved for uses other than research.
If you qualify and choose to participate, you will be put into a group by chance, like flipping a coin, to determine what type of study drug you will get:

  • Gefapixant - 1 tablet two times a day
    OR
  • Placebo - 1 tablet two times a day

You will have a 50/50 chance of getting either gefapixant or placebo.

The placebo looks like the investigational drug but contains no active ingredients. Placebos are often used in clinical research studies to help evaluate the investigational drug by comparing effects seen in study participants who take the investigational drug to effects seen in those who take placebo.

Placebos have been used in clinical research for many years. During this time study doctors have observed that some patients may start to feel better even if they just believe they are receiving the investigational treatment. This is called the placebo effect and can happen to anyone participating in a clinical trial.

Placebos help study physicians see how much of the effect patients have when they take the study drug is not just due to the placebo effect but actually due to the investigational treatment.

The use of placebos in clinical trials is important in determining if the investigational medication is both safe and effective. All data that is collected in a clinical trial, even from those patients that are on placebo, is important.

Although MK-7264-043 study participants who take the placebo will not receive any active drug, they will receive the same care from the study doctor and staff as participants taking the investigational drug. Study activities, including diary entries, study visits, and phone calls will help the study doctor monitor your health and assess your chronic cough throughout the study.

You can stop taking part in this study at any time. If you choose not to take part or you agree to take part but then withdraw, medical care you receive outside the study will not be affected. The study doctor will discuss other treatment options with you.
You will need to stop taking certain medications during the study. The study doctor or staff will discuss this with you in detail.
You can visit any doctor to meet your health needs during a study. You should tell other medical professionals you see that you are participating in a clinical study and always communicate openly with the study doctor regarding other care you receive.
At study visits, you will talk with the study doctor or staff about how you are feeling and about other medications you may be taking. You will review your study diary entries with the study doctor or staff and complete questionnaires about your cough and how it affects your daily life. At some visits, medical procedures, such as measurement of your vital signs, blood and urine tests, and physical examinations, may be required. You will also be provided with your study drug at visits.
If you choose to participate in a study, we encourage you to communicate freely with the study doctor and staff throughout the study. If you have questions or concerns about any aspect of the study, you should feel comfortable discussing them with the study doctor at any time.