What is the CALM-2 Study?
The CALM-2 Study is evaluating an investigational drug to treat refractory chronic cough (RCC), including unexplained chronic cough. A persistent cough is more than an annoyance. It can seriously impact your quality of life and social interactions, cause urine leaks, nausea or headaches, prevent you from being able to fall asleep or talk over the phone, and may cause you to feel isolated or anxious. Symptoms often include:
- an irritated cough
- often feeling the urge to cough
- sensation of having a lump in the throat
- voice disorders
We are looking for participants 18–80 years of age who have had a cough for at least 1 year that did not improve or only partially improved following medical evaluation and prescription or over-the-counter treatments.
Participants will receive 1 of 2 doses of the active investigational drug, and a placebo during the study. A placebo looks like the investigational drug but contains no active ingredients. The investigational drug or the placebo together may be referred to as the 'study drug'. You will take the study drug tablets by mouth, twice a day, every day.
Approximately 675 people from sites worldwide will be invited to take part.
What to expect
If you are eligible to take part, you will be in the study for approximately 1.5 years and will be asked to attend up to 20 visits at the study centre to complete study assessments. You will also have 2 phone calls from the study team to check on your health.
Several tests and assessments will be performed to monitor the health of study participants during the study. These will include, but are not limited to:
- Questions about your health and any medications you are taking
- Physical examinations
- Blood tests
You will have to wear a cough monitor for 24 hours on different days during the study. The cough monitor will record how many times you cough during the day and night. You will also complete an electronic diary (eDiary) and record answers to questions on how much you cough and how severe your cough is during the day.
The study periods
CALM-2 Study periods
The CALM-2 Study is split into 3 periods and you will be in the study for approximately 1.5 years:
1
Screening period
To see if the study is right for you
- 1 visit
- Up to 4 weeks
2
Study treatment period
Continue taking the study drug if you continue to be eligible
- 17 visits
- About 55 weeks
- 2 phone calls to check on your health
3
Follow-up period
Visit the study centre for follow-up visits
- 2 visits
- About 12 weeks
Why is diversity important?
Diversity matters in clinical trials.
We plan to enrol a wide variety of participants because chronic cough and medications may affect people differently based on their age, sex, gender, and race/ethnicity.
A lack of diversity can affect how we understand the potential effectiveness of new medicines and treatments in different groups of people. The more diversity in a study, the more we may learn about how the medicine works. Diversity also helps us understand if an investigational drug may be better suited for some people over others.