About this trial
This study is testing new ways to help people who have chronic cough that has not improved with typical treatments. One approach is called behavioral cough suppression (BCS) therapy, which teaches people techniques to stop themselves from coughing. Another approach uses a natural substance thought to help reduce the body's sensitivity to cough triggers.
In this study, we will test two treatments and include one no-treatment control group. The control group will undergo baseline testing, cough monitoring, and an fMRI brain scan and will be offered BCS at end of study participation.
The two treatments include:
* BCS therapy with active inhaled treatment (BCS+active), * BCS therapy with inactive inhaled treatment (BCS+inactive),
The investigators will enroll 135 adults with refractory chronic cough (RCC). 100 participants who qualify and are willing and able to complete 14 study visits in the clinic and two online study visits will be randomly assigned to one of the two treatments. The no-treatment control group (n=35) will be recruited from adults with RCC who are willing to complete baseline testing and fMRI but are not able or willing to attend 14 study clinic visits. These participants will not be randomized.
The investigators want to find out how these treatments affect:
* How sensitive someone is to things that make them cough, * How well they can hold back a cough when they try, * How their brain responds to things that cause an urge-to-cough, * And how much their coughing affects their quality of life.
The investigators believe both treatments will reduce sensitivity to cough stimulants, reduce cough severity, and improve quality of life, but BCS+active inhaled treatment will work better than BCS+inactive inhaled treatment.
Eligibility criteria
Qualifiers
18 - 99 years of age
Diagnosis of refractory or unexplained chronic cough
Normal chest imaging (x-ray or CT scan) within past 2 years, without change in cough symptoms
Asthma diagnosed by a pulmonary provider
Disqualifiers
Currently a smoker of any substance or has a positive history of smoking any substance within the last 6 months
Currently suffering from any signs of an upper respiratory infection (other than cough)
Hemoptysis (coughing up blood) within the last 6 months
Pulmonary diagnosis other than asthma
Trial design
Treatments tested in this trial
- BCS+inactive
- BCS+active
Treatment groups
Sponsors and collaborators
University of Montana
Lead sponsor
University of Colorado, Denver
Collaborator
Emory University
Collaborator
University of Melbourne
Collaborator