Chronic Cough Clinical Trials

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

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Combination product, Behavioral
Study Type: Interventional
Study Phase: Phase 2
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 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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 99
Healthy Volunteers: f
View:

∙ 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 4 hours prior to each study visit. If rescue inhaler use is unavoidable within 4 hours of a study visit, agree to inform researchers in advance so that the session can be rescheduled.

• Normal pulmonary function testing with spirometry (FEV1/FVC of at least 70% if diagnosed with asthma) within 2 years (6 months for those with a diagnosis of asthma), without change in symptoms since (NOTE: spirometry is included as part of cough threshold testing and can serve as this criteria if the participant has not had spirometry within the designated time.)

• 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)

• Access to reliable internet, working email address (for surveys) and a smart phone (for use with CoughMonitor Watch)

• Demonstrates understanding in study procedures and risks in order to consent

• Available, and willing, to comply to all study procedures and clinic visits.

Locations
United States
Colorado
University of Colorado Anschutz Medical Campus
NOT_YET_RECRUITING
Aurora
Georgia
Emory University
RECRUITING
Atlanta
Montana
University of Montana
RECRUITING
Missoula
Contact Information
Primary
Laurie J Slovarp, PhD
laurie.slovarp@umontana.edu
406-243-2107
Backup
Marie Jetté, PhD
marie.jette@cuanschutz.edu
Time Frame
Start Date: 2026-08-13
Estimated Completion Date: 2030-03-31
Participants
Target number of participants: 135
Treatments
Active_comparator: Behavioral treatment plus inactive drug
Participants receive behavioral cough suppression therapy (BCST) combined with an inactive inhaled substance.
Experimental: Behavioral treatment plus inhaled drug
Participants receive behavioral cough suppression (BCS) therapy combined with inhaled drug designed to enhance BCS therapy
No_intervention: fMRI Control
Participants will undergo assessments without treatment
Related Therapeutic Areas
Sponsors
Collaborators: Emory University, University of Colorado, Denver, University of Melbourne
Leads: University of Montana

This content was sourced from clinicaltrials.gov