Do You Have a Chronic Cough?
You May Be Eligible for a Clinical Study
A clinical research study is currently evaluating an investigational drug for its safety and effectiveness in the treatment of chronic cough.
About Chronic Cough
Many patients are familiar with the idea of a short-lived cough due to an infection such as the common cold, bronchitis, or pneumonia. This type of cough usually resolves when the infection goes away.
However, some patients cough for a long time, and if they cough for more than eight weeks, they have chronic cough. Most patients with chronic cough have an associated medical condition, such as reflux, asthma, or allergies that could play a role in their cough. Many patients respond to treatment for these types of conditions and their cough improves. However, some patients do not fully respond to treatment for these associated conditions and develop refractory chronic cough. Also, some patients may never be diagnosed with a medical condition that could play a role in their chronic cough. These types of patients have an unexplained chronic cough.
For patients with refractory or unexplained chronic cough, the trigger that is causing the cough may not be known. Patients with refractory or unexplained chronic cough have a cough that is extremely sensitive, causing the person to cough in response to things that usually should not cause a cough, like smells, changes in temperature, certain types of food, or activities like talking or singing. Patients with this type of cough can suffer for weeks, months or even years. In addition to a cough, symptoms also can include feeling like you have a lump in your throat, hoarseness, and trouble swallowing.
To be diagnosed with refractory cough for the purposes of the study, a patient must have a cough for at least 1 year that has not fully responded to any treatment for associated causes such as asthma, gastrointestinal reflux, or allergies. To be diagnosed with unexplained chronic cough for the purposes of the study, a patient must have symptoms for 1 year and have had an appropriate evaluation for associated conditions that did not reveal a potential cause for cough.
What is A Clinical Study?
Before a drug can be approved for people to use thorough research must be completed. Clinical research studies are used to evaluate these new investigational drugs for both safety and effectiveness. Without clinical studies, many of the medications we use every day would not be available.
There are many different types of clinical studies. Clinical studies are closely regulated by government and regulatory agencies, and are designed to help protect the safety of the patients. The study follows a protocol, which is a study plan that details what researchers will do in the study.
Clinical study participants work closely with a team of doctors, nurses, and other health professionals to follow specific instructions for using the investigational treatment, medication or device throughout the study. This team monitors the participant as the study progresses and stays in touch after it is complete. A participant can leave a clinical study at any time.
About the Study
If you are eligible and interested in participating, you will go through a series of screening assessments to see if you are eligible. This process will take at least a week.
After the screening phase, you will participate in the study for about 52 weeks (one year). There also will be a follow up two weeks after the end of treatment.
In this study, you will be randomly assigned (like the flip of a coin) to receive either the investigational study drug or a placebo. A placebo looks like a study drug but has no active ingredients in it. The placebo is used to determine how it compares to the study drug being tested. You will not know if you are receiving the study drug or the placebo.
Your participation in this study may or may not help in the treatment of your cough. However, the knowledge gained from this study may help researchers learn more about the investigational medication. The clinical research team will discuss with you the possible risks and potential benefits of study participation and answer any questions you may have.
You may be eligible to participate in this clinical study if you are:
- Are at least 18 years old
- Have chronic cough for more than one year with a diagnosis for unexplained or refractory chronic cough
- Are currently a non-smoker
- Are not pregnant and are willing to use contraceptives to prevent pregnancy during the study
Note: These are not the only eligibility requirements for this clinical research study. A clinical research team member will help determine if you meet all necessary criteria to participate.