Behavioral Cough Suppression Therapy with or without an inhaled aid for refractory chronic cough
Official title: Mechanisms of Change in Behavioral Cough Suppression Therapy for Refractory Chronic Cough
Run by University of Montana · NCT06960759 · Data updated 2026-11-12
This study tests whether adding an inhaled substance to behavioral cough suppression helps people with persistent chronic cough see if it works better than behavior therapy alone.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Enrollment | 135 (estimated) |
| Sponsor | University of Montana Academic / other |
| Locations | 3 sites (Aurora, Colorado and 2 other locations) |
| Status | Recruiting |
| Started | August 13, 2026 |
| Main results expected | June 30, 2029 |
| Study ends | March 31, 2030 |
| Registry record updated | August 18, 2026 |
| Trial ID | NCT06960759 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 18–99 with refractory or unexplained chronic cough, with normal chest imaging within the past 2 years, and (if asthma is present) well-controlled asthma and ability to withhold rescue inhaler for study visits.
✕Probably not a fit
Patients whose cough is driven by non-neural factors beyond the study's scope or who do not respond to behavioral therapy may not experience benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This multicenter randomized trial enrolls adults with refractory or unexplained chronic cough to compare two active approaches: behavioral cough suppression (BCS) therapy combined with an active inhaled substance, and BCS therapy with an inactive inhaled substance. A non-randomized control group will receive no treatment but will have baseline testing, cough monitoring, and an fMRI to provide comparative data. Participants complete 12 treatment sessions over several weeks and undergo assessments of cough frequency, quality of life, and neural markers to explore both clinical and mechanistic outcomes. The study aims to understand how BCS works and whether the inhaled agent enhances its effects, using neural imaging to probe brain pathways related to cough.
Why it matters
Potential benefit: If successful, participants may experience reduced coughing and improved quality of life, with clearer understanding of brain mechanisms involved.
How similar studies have gone: Prior studies show that behavioral cough suppression can reduce cough frequency and improve quality of life, but mechanisms and additive effects of an inhaled agent are less established.
Who can join: the full rules
Show full inclusion / exclusion criteria
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 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. EXCLUSION CRITERIA Any of the following will be grounds for exclusion from the study: * Currently a smoker of any substance or has a positive history of smoking any substance within the last 6 months * Currently suffering from any signs of an upper respiratory infection (other than cough) * Hemoptysis (coughing up blood) within the last 6 months * Pulmonary diagnosis other than asthma * Asthma criteria - participant is deemed ineligible if screened for one or more of the following: * Use of rescue inhaler in response to active asthma symptoms ≥ 2 times per week * Respiratory related emergency department visit within the past 4 weeks * Respiratory related ICU admission within the past 12 months * Asthma exacerbation requiring systemic corticosteroid use within the past 4 weeks * Pregnant or trying to become pregnant * Any complaints or clinical symptoms of dysphagia * Live with someone with chronic cough or work with someone with chronic cough who is in close proximity (e.g., within 25 feet) on a daily or nearly daily basis * Known allergy to peppers * Currently receiving or has received BCS therapy for management of refractory chronic cough * Excluded concomitant medications: * Inhaled pulmonary medications (inhaled corticosteroids, short-acting beta agonists, long-acting beta-agonist, short-acting muscarinic antagonists), unless prescribed for asthma by pulmonary provider: 30 days prior to Visit 1 through completion of study participation * ACE inhibitor (benazepril, captopril, enalapril, fosiniopril, lisinopril, perindopril, quinapril, ramipril, trandolapril): 30 days prior to Visit 1 through completion of study participation. * Narcotic antitussive (hydrocodone, oxycodone, morphine, codeine, tramadol): 7 days prior to Visit 1 through completion of study participation * Non-narcotic antitussive (benzonatate/Tessalon, dextromethorphan/Delsym, carbetapentane/Solotuss): 7 days prior to Visit 1 through completion of study * P2X3 receptor antagonist (gefapixant/Lyfnua): 14 days prior to Visit 1 through completion of study * Any off-label prescription medication prescribed for cough (pregabalin/Lyrica, gabapentin/Neurontin, amitriptyline/Elavil): 14 days prior to Visit 1 through completion of study \*if a neuromodulator is prescribed for something other than cough, participant must be on a stable dose for a minimum of 7 days The following additional exclusion criteria will apply to participants who will undergo fMRI: * Presence of metal implants, devices or fragments (e.g., shrapnel) in the body * Claustrophobia
Where it's running
-
Emory University
Atlanta, Georgia, United States Recruiting -
University of Montana
Missoula, Montana, United States Recruiting -
University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States Not yet recruiting
Study contacts
- Principal investigator: Laurie J Slovarp, PhD — University of Montana
- Study coordinator: Laurie J Slovarp, PhD
- Email: laurie.slovarp@umontana.edu
- Phone: 406-243-2107
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.