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

RecruitingPhase 2Ages 18 Years - 99 YearsAllUniversity of Montana
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In plain words

What the trial is, and whether it could suit you

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

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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 โ‰ฅ 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
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What it tests

  • BCS+inactive
  • BCS+active
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Where

3 sites
University of Colorado Anschutz Medical Campus
Aurora, United States
Emory University
Atlanta, United States
University of Montana
Missoula, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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