Study Details
Testing the Study Drug BLU-5937 for Adults with Refractory Chronic Cough (RRC) Including Unexplained Cough
(IRB#: IRB_00160784)
Refractory Chronic Cough (RCC) is a cough lasting more than 8 weeks that has not improved after treatment for possible causes (such as acid reflux, asthma, or nasal congestion). An unexplained cough is a cough lasting more than 8 weeks that does not have a known cause, even after a thorough medical evaluation and testing. This study will test a drug called BLU-5937 in adults with these conditions. The study wants to see if the drug will help people with RCC or unexplained cough and is safe. People in this study will be randomly chosen to be treated with doses of BLU-5937 and placebo. The drug and placebo are taken as a swallowed pill. A placebo is a pill that does not have the study drug. Participation in the study will last up to 1.5 years. The study will consist of a 4-week screening period, a 79-week study drug treatment period, and a 2-week follow-up period. Participants will be asked to attend up to 19 visits at the study center to complete the study assessments and procedures. Participants will also have 6 phone calls from the study team, to check on participants health. Study procedures include a chest x-ray or CT scan, physical exams, blood tests, breathing tests, questionnaires, wearing a cough monitor, and taking the study drug. Participants will be compensated at time points throughout the study.
- All genders
- Over 18 years old
- Volunteers with special conditions
- In Person
- Paid
Who can participate?
Gender: All genders
Age: Over 18 years old
Volunteers: Volunteers with special conditions
Location: In Person
Inclusion Criteria
- Ages 18 and 80 years old
- Have a diagnosis of refractory chronic cough including unexplained cough
- A persistent cough for more than 1 year
- People of childbearing age willing to use birth control
- Able to use a cough monitor correctly
Exclusion Criteria
- Pregnant, trying to become pregnant or breastfeeding
- Chronic smoker or currently use tobacco smoke, cannabis smoke, or nicotine vapors
- Diagnosis of specific diseases or conditions that may impact a cough based on doctors assessment
- Uncontrolled asthma
- COVID-19 within last 3 months, history of long COVID, or known exposure to someone with COVID within the past 10 days
Will I be paid for my time?
Yes
IRB#: IRB_00160784
PI: Krishna Sundar
Department: PULMONARY
Approval Date: 2023-12-07 07:00:00
Specialties: Pulmonary