Behavioral Cough Suppression Therapy for Refractory Chronic Cough
Behavioral cough suppression therapy combined with inactive inhaled drug (BCS+Sham)
+ Behavioral cough suppression therapy combined with capsaicin inhalation (BCS+CAP)
+ Inhaled capsaicin (CAP)
Chronic Cough+4
+ Cough
+ Respiration Disorders
Treatment Study
Summary
Study start date: August 1, 2025
Actual date on which the first participant was enrolled.Refractory chronic cough (RCC) is a condition where coughing persists despite treatment of the underlying causes, making it challenging and costly to manage. This study focuses on a therapy called behavioral cough suppression (BCS) which has been effective in reducing cough frequency and improving quality of life, although it's not widely used and its working mechanism is not well understood. The trial aims to explore how BCS works and whether combining it with capsaicin, a cough stimulant, improves its effectiveness. This research is important as it could lead to better treatments for people with RCC who struggle to find relief with current options. Participants in this study will be randomly assigned to one of three groups: BCS with capsaicin stimulation, BCS with a sham stimulation, or capsaicin stimulation alone. Over several weeks, participants will attend 12 treatment sessions. The study will measure how well participants can suppress their cough, the sensitivity of their cough reflex, and changes in brain activity related to coughing. These will be evaluated using different methods including questionnaires, cough frequency monitoring, and brain scans. By comparing the outcomes, researchers hope to determine which treatment combination is most effective and understand the mechanisms behind BCS therapy.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.150 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 99 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: * Diagnosis of refractory or unexplained chronic cough * Normal chest x-ray within past 2 years, without change in cough symptoms * If diagnosed with asthma, is it well controlled * Normal spirometry (or FEV1/FVC of at least 70% if diagnosed with asthma) within two years, without change in symptoms since * Laryngoscopy or stroboscopy within 2 years without evidence of structural pathology and no change in vocal quality since exam * Proficient reader/speaker of English * Willing to take a pregnancy test before enrollment (if applicable) * Willing to use contraception during the study (if applicable) * Demonstrates understanding in study procedures and risks in order to consent Exclusion Criteria: * Currently a smoker of any substance * Currently suffering from any signs of an upper respiratory infection (other than cough) * Hemoptysis (coughing up blood) * Pulmonary diagnosis other than asthma * Used an ACE-inhibitor in the past 60 days * Pregnant or trying to become pregnant * Any complaints or clinical symptoms of dysphagia * Live with or work with anyone with chronic cough The following additional exclusion criteria will apply to participants at University of Colorado: * Presence of metal implants, devices or fragments in the body * Claustrophobia
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.3 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
Active ComparatorGroup II
ExperimentalGroup III
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 3 locations
University of Colorado Anschutz Medical Campus
Aurora, United StatesOpen University of Colorado Anschutz Medical Campus in Google MapsEmory University
Atlanta, United StatesUniversity of Montana
Missoula, United States