Mechanisms of Change in Behavioral Cough Suppression Therapy for Refractory Chronic Cough

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.

Conditions

• Chronic Cough (CC)
• Refractory Chronic Cough
• Unexplained Chronic Cough

Interventions

BEHAVIORAL

Behavioral 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_PRODUCT

Behavioral 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.

Sponsors & Collaborators

• University of Colorado, Denver

  collaborator OTHER

• Emory University

  collaborator OTHER

• University of Melbourne

  collaborator OTHER

• University of Montana

  lead OTHER

Principal Investigators

• Laurie J Slovarp, PhD · University of Montana

• Marie Jetté, PhD · University of Colorado, Denver

• Amanda Gillespie, PhD · Emory University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

99 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-05-15

Primary Completion

2029-06-30

Completion

2030-03-31

FDA Drug

Yes

Countries

• United States

Study Locations