Mechanisms of Change in Behavioral Cough Suppression Therapy for Refractory Chronic Cough
University of Montana
Summary
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 found in chili peppers (capsaicin) 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 capsaicin (BCS+CAP), * BCS therapy with a placebo (BCS+Sham), 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+CAP treatment will work better than. BCS+Sham.
Description
Refractory chronic cough (RCC) is a persistent and costly condition that is difficult to treat, often persisting despite appropriate treatment of underlying causes. While behavioral cough suppression (BCS) therapy has shown effectiveness in reducing cough frequency and improving quality of life in controlled studies, it remains underutilized, and the mechanisms by which it works are not well understood. This multi-site randomized controlled trial will investigate the effects and mechanisms of BCS therapy with and without the addition of capsaicin. Capsaicin, a known cough stimulant, has demon…
Eligibility
- Age range
- 18–99 years
- Sex
- All
- Healthy volunteers
- No
INCLUSION CRITERIA To be eligible to participate, participants must meet the following criteria: * 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 * If you a potential participant has asthma, the following criteria must be met: * Asthma diagnosed by a pulmonary provider * Documentation from a pulmonary provider that asthma is well-controlled * Agree to carry prescribed rescue inhaler to each study visit * Can tolerate, and agree to, avoid rescue inhaler use for…
Interventions
- BehavioralBehavioral cough suppression therapy combined with inactive inhaled drug (BCS+Sham)
Behavioral cough suppression therapy plus inactive inhaled drug. Treatment given twice per week for 12 sessions.
- Combination ProductBehavioral cough suppression therapy combined with capsaicin inhalation (BCS+CAP)
Behavioral cough suppression therapy combined with inhaled capsaicin (cough stimulant). Treatment given twice per week for 12 sessions.
Locations (3)
- University of Colorado Anschutz Medical CampusAurora, Colorado
- Emory UniversityAtlanta, Georgia
- University of MontanaMissoula, Montana