Mechanisms of Change in Behavioral Cough Suppression Therapy for Refractory Chronic Cough
NCT ID: NCT06960759
Last Updated: 2025-05-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE2
150 participants
INTERVENTIONAL
2025-08-01
2030-03-31
Brief Summary
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In this study, we will test three treatments:
* BCS therapy with capsaicin (BCS+CAP),
* BCS therapy with a placebo (BCS+Sham),
* Capsaicin stimulation alone (CAP).
The investigators will enroll 150 adults with chronic cough and randomly assign them to one of the three treatments. Each person will attend 12 treatment sessions.
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 all treatments may reduce sensitivity to cough stimulants, but BCS treatments will also improve how people sense and control the urge to cough. The investigators think combining BCS with capsaicin will work the best overall.
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Detailed Description
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This multi-site randomized controlled trial will investigate the effects and mechanisms of BCS therapy with and without the addition of capsaicin desensitization, compared to capsaicin stimulation alone. Capsaicin, a known cough stimulant, has demonstrated desensitization effects on sensory pathways in conditions such as chronic rhinitis and pain syndromes, suggesting potential utility in modulating cough-related neural pathways.
The investigators will recruit 150 participants diagnosed with RCC and randomize them into one of three treatment arms:
* BCS combined with capsaicin stimulation (BCS+CAP),
* BCS combined with sham stimulation (BCS+Sham),
* Capsaicin stimulation alone (CAP).
Participants will undergo 12 treatment sessions over several weeks. The study will evaluate both behavioral and neural markers of treatment response. Primary outcome measures will include:
* Cough sensory threshold (C5): the lowest concentration of citric acid causing five or more coughs,
* Cough suppression ability: the ability to suppress cough when instructed (the difference between the dose of capsaicin causing five or more coughs when trying to suppress cough (CS5) and C5,
* Urge-to-cough (UTC) sensory-motor threshold difference: a measure of how perception of the need to cough relates to actual coughing behavior,
* Blood oxygen level dependent (BOLD) neural responses using whole-brain functional MRI (fMRI) during UTC stimulation.
Secondary outcomes will include patient-reported measures such as the Leicester Cough Questionnaire (LCQ) and objective ambulatory cough frequency monitoring.
The investigators hypothesize that all three treatments will lead to desensitization of cough sensitivity (i.e., increase in C5), but only the BCS-based interventions will alter UTC thresholds, suppression ability, and brain network activity. We further hypothesize that the combination of BCS and capsaicin (BCS+CAP) will provide the greatest therapeutic benefit due to simultaneous peripheral desensitization and central sensory-motor modulation.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Behavioral treatment plus inactive drug
Participants receive behavioral cough suppression therapy (BCST) combined with an inactive inhaled substance.
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.
Behavioral treatment plus inhaled drug
Participants receive behavioral cough suppression therapy (BCST) combined with inhaled vaporized drug designed to enhance BCST
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.
Inhaled drug
Participants inhale a drug designed to desensitize the cough reflex.
Inhaled capsaicin (CAP)
Repeated inhalation of diluted capsaicin in increasing concentrations. Treatment given twice per week for 12 sessions.
Interventions
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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.
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.
Inhaled capsaicin (CAP)
Repeated inhalation of diluted capsaicin in increasing concentrations. Treatment given twice per week for 12 sessions.
Eligibility Criteria
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Inclusion Criteria
* 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 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
* Presence of metal implants, devices or fragments in the body
* Claustrophobia
18 Years
99 Years
ALL
No
Sponsors
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University of Colorado, Denver
OTHER
Emory University
OTHER
University of Melbourne
OTHER
University of Montana
OTHER
Responsible Party
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Laurie Slovarp
Professor
Principal Investigators
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Laurie J Slovarp, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Montana
Marie Jetté, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Colorado, Denver
Locations
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University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States
Emory University
Atlanta, Georgia, United States
University of Montana
Missoula, Montana, United States
Countries
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Central Contacts
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Facility Contacts
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References
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Losche D, Furst W, Falk M, Weickert H. [Preparation of a cytostatic-containing bone cement]. Pharmazie. 1987 Feb;42(2):97-9. German.
Moe AAK, Singh N, Dimmock M, Cox K, McGarvey L, Chung KF, McGovern AE, McMahon M, Richards AL, Farrell MJ, Mazzone SB. Brainstem processing of cough sensory inputs in chronic cough hypersensitivity. EBioMedicine. 2024 Feb;100:104976. doi: 10.1016/j.ebiom.2024.104976. Epub 2024 Jan 19.
Slovarp LJ, Reynolds JE, Tolbert S, Campbell S, Welby S, Morkrid P. Cough desensitization treatment for patients with refractory chronic cough: results of a second pilot randomized control trial. BMC Pulm Med. 2023 Apr 28;23(1):148. doi: 10.1186/s12890-023-02423-6.
Slovarp L, Reynolds JE, Bozarth-Dailey E, Popp S, Campbell S, Morkrid P. Cough desensitization treatment: A randomized, sham-controlled pilot trial for patients with refractory chronic cough. Respir Med. 2022 Mar;193:106739. doi: 10.1016/j.rmed.2022.106739. Epub 2022 Jan 15.
Chamberlain SA, Garrod R, Douiri A, Masefield S, Powell P, Bucher C, Pandyan A, Morice AH, Birring SS. The impact of chronic cough: a cross-sectional European survey. Lung. 2015 Jun;193(3):401-8. doi: 10.1007/s00408-015-9701-2. Epub 2015 Mar 19.
Other Identifiers
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25-0206
Identifier Type: -
Identifier Source: org_study_id
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