[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"unexplained-chronic-cough\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:unexplained-chronic-cough":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,50,81],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":30,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":5},"100589926","phase-2-mechanisms-of-change-in-behavioral-cough-suppression-therapy-for-refractory-chronic-cough-100589926",false,"NCT06960759","Mechanisms of Change in Behavioral Cough Suppression Therapy for Refractory Chronic Cough","CoughLESS","INCLUSION CRITERIA\n\nTo be eligible to participate, participants must meet the following criteria:\n\n* 18 - 99 years of age\n* Diagnosis of refractory or unexplained chronic cough\n* Normal chest imaging (x-ray or CT scan) within past 2 years, without change in cough symptoms\n* If you a potential participant has asthma, the following criteria must be met:\n\n  * Asthma diagnosed by a pulmonary provider\n  * Documentation from a pulmonary provider that asthma is well-controlled\n  * Agree to carry prescribed rescue inhaler to each study visit\n  * 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.\n* Normal pulmonary function testing with spirometry (FEV1\u002FFVC 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.)\n* Laryngoscopy or stroboscopy within 2 years without evidence of structural pathology and no change in vocal quality since exam\n* Proficient reader\u002Fspeaker of English\n* Willing to take a pregnancy test before enrollment (if applicable)\n* Willing to use contraception during the study (if applicable)\n* Access to reliable internet, working email address (for surveys) and a smart phone (for use with CoughMonitor Watch)\n* Demonstrates understanding in study procedures and risks in order to consent\n* Available, and willing, to comply to all study procedures and clinic visits.\n\nEXCLUSION CRITERIA\n\nAny of the following will be grounds for exclusion from the study:\n\n* Currently a smoker of any substance or has a positive history of smoking any substance within the last 6 months\n* Currently suffering from any signs of an upper respiratory infection (other than cough)\n* Hemoptysis (coughing up blood) within the last 6 months\n* Pulmonary diagnosis other than asthma\n* Asthma criteria - participant is deemed ineligible if screened for one or more of the following:\n\n  * Use of rescue inhaler in response to active asthma symptoms ≥ 2 times per week\n  * Respiratory related emergency department visit within the past 4 weeks\n  * Respiratory related ICU admission within the past 12 months\n  * Asthma exacerbation requiring systemic corticosteroid use within the past 4 weeks\n* Pregnant or trying to become pregnant\n* Any complaints or clinical symptoms of dysphagia\n* 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\n* Known allergy to peppers\n* Currently receiving or has received BCS therapy for management of refractory chronic cough\n* Excluded concomitant medications:\n\n  * 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\n  * ACE inhibitor (benazepril, captopril, enalapril, fosiniopril, lisinopril, perindopril, quinapril, ramipril, trandolapril): 30 days prior to Visit 1 through completion of study participation.\n  * Narcotic antitussive (hydrocodone, oxycodone, morphine, codeine, tramadol): 7 days prior to Visit 1 through completion of study participation\n  * Non-narcotic antitussive (benzonatate\u002FTessalon, dextromethorphan\u002FDelsym, carbetapentane\u002FSolotuss): 7 days prior to Visit 1 through completion of study\n  * P2X3 receptor antagonist (gefapixant\u002FLyfnua): 14 days prior to Visit 1 through completion of study\n  * Any off-label prescription medication prescribed for cough (pregabalin\u002FLyrica, gabapentin\u002FNeurontin, amitriptyline\u002FElavil): 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\n\nThe following additional exclusion criteria will apply to participants who will undergo fMRI:\n\n* Presence of metal implants, devices or fragments (e.g., shrapnel) in the body\n* Claustrophobia","ALL","18 Years","99 Years",{"count":20,"type":21},135,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","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.\n\nIn 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.\n\nThe two treatments include:\n\n* BCS therapy with active inhaled treatment (BCS+active),\n* BCS therapy with inactive inhaled treatment (BCS+inactive),\n\nThe 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.\n\nThe investigators want to find out how these treatments affect:\n\n* How sensitive someone is to things that make them cough,\n* How well they can hold back a cough when they try,\n* How their brain responds to things that cause an urge-to-cough,\n* And how much their coughing affects their quality of life.\n\nThe 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.",[27,28,29],"Chronic Cough (CC)","Refractory Chronic Cough","Unexplained Chronic Cough",[31,32,33,34,35,36,37],"cough hypersensitivity syndrome","randomized control trial","neurogenic cough","refractory chronic cough","unexplained chronic cough","chronic cough","behavioral cough suppression therapy","NOT_YET_RECRUITING","2026-06-01",{"date":41,"type":42},"2026-06-03","ACTUAL",{"date":44,"type":21},"2026-06-29",{"date":46,"type":21},"2030-03-31",{"name":48,"class":49},"University of Montana","OTHER",{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":56,"eligibilityCriteria":57,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":58,"targetDuration":4,"studyType":22,"phases":60,"briefSummary":62,"conditions":63,"keywords":67,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":80},"100615124","phase-4-a-2x2-factorial-randomized-open-label-trial-to-evaluate-neuromodulators-and-cough-control-therapy-in-patients-with-refractory-or-unexplained-chronic-cough-100615124","NCT07288528","A 2x2 Factorial, Randomized, Open-label Trial to Evaluate Neuromodulators and Cough Control Therapy in Patients With Refractory or Unexplained Chronic Cough","A 2x2 Factorial, Randomized, Open-label Trial to Evaluate Neuromodulators and Cough Control Therapy in Patients With Refractory or Unexplained Chronic Cough (FORTITUDE)","FORTITUDE","Inclusion Criteria:\n\n1. Adults (≥18 years old) with either:\n2. Refractory chronic cough (RCC), defined as having one or more identifiable causes of cough (asthma, allergic rhinitis, and\u002For GERD), but with previous trials of treatment targeting the underlying condition leading to no cough resolution; OR\n3. Unexplained chronic cough (UCC), defined as having a cough lasting \\>8 weeks with (i) a normal chest X-ray\u002FCT in the last 5 years and since the onset of chronic cough; (ii) FEV1 and FVC ≥80% predicted or \\>lower limit of normal (LLN); (iii) FEV1\u002FFVC ≥0.7 or \\>LLN; (iv) no evidence of asthma; and (vi) no regular symptoms of nasal\u002Freflux disease.\n\nExclusion Criteria:\n\n1. Those who, in the opinion of the investigator, have previously tried low-dose morphine, pregabalin, and\u002For CCT with full intervention fidelity for the treatment of RCC\u002FUCC;\n2. Are currently taking morphine or pregabalin for the treatment of any indication (i.e., RCC\u002FUCC or chronic pain);\\*\n3. Are currently taking other centrally-acting medication (i.e., gabapentin, amitriptyline, dextromethorphan) for the treatment of any indication (i.e., RCC\u002FUCC, seizures, or depression);\\*\n4. Have a history of opioid or substance abuse that, in the opinion of the investigator, may interfere with the conduct of the study;\n5. Are a current smoker, or ex-smoker with a \\>20 pack-year history who have abstained from smoking for \\\u003C6 months;\n6. Have cough due to angiotensin-converting enzyme inhibitor use;\n7. Have symptoms of an upper respiratory infection within the last month that have not resolved;\n8. Had an asthma exacerbation within the last month that requires an increase or start of an oral corticosteroid;\n9. Have other primary pulmonary disorders, including pulmonary embolism, pulmonary hypertension, lung cancer, cystic fibrosis, radiologically-proven emphysema, interstitial lung disease, or severe bronchiectasis;\n10. Have language, memory, cognitive, or psychiatric issues that may prevent optimal participation;\n11. Have creatinine clearance \\\u003C15 mL\u002Fmin, including individuals with end-stage renal disease who require hemodialysis or peritoneal dialysis;\n12. Have any other condition that, in the opinion of the qualified investigator, may adversely affect the participant's ability to complete the study or its measures or pose significant risk to the participant;\n13. Have participated in another clinical trial of an investigational medicinal product within 30 days;\n14. Pregnant or breastfeeding; or\n15. Females of child-bearing potential who:\n\n    1. Do not agree to use a medically approved method of birth control for the duration of the study. All hormonal birth control must have been in use for a minimum of 3 months.\n    2. Acceptable methods of birth control include oral contraceptives, hormone birth control patch, vaginal contraceptive ring, injectable contraceptives, or hormone implant, double-barrier method, intrauterine devices, non-heterosexual lifestyle or agrees to use contraception if planning on changing to heterosexual partner(s), vasectomy of partner at least 6 months prior to screening.\n    3. Females who are not of child-bearing potential will be defined as females who have undergone a sterilization procedure (e.g., hysterectomy, bilateral oophorectomy, bilateral tubal ligation, complete endometrial ablation) or have been post-menopausal for at least 1 year prior to screening.\n\n       * Participants taking any of the above medications at baseline will only be eligible if they are willing and medically able to safely discontinue them at least 2 weeks prior to the first study visit. Eligibility will be confirmed by the local study investigator prior to enrolment.",{"count":59,"type":21},124,[61],"PHASE4","The FORTITUDE trial will provide head-to-head evidence on the benefits and harms of two commonly prescribed neuromodulators (low-dose morphine and pregabalin), the effectiveness of a virtual cough control therapy, exploratory assessment of potential synergy in combining these interventions, and the long-term outcomes of these treatments in patients with refractory or unexplained chronic cough.",[64,28,29,65,66],"Cough","Cough Hypersensitivity Syndrome","Chronic Cough",[64,66,68,69,70,28,29],"Morphine","Pregabalin","Non-Pharmacologic Therapy","2025-12-04",{"date":73,"type":42},"2025-12-17",{"date":75,"type":21},"2026-04-01",{"date":77,"type":21},"2029-07-01",{"name":79,"class":49},"McMaster University",5,{"id":82,"slug":83,"hasResults":11,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":4,"eligibilityCriteria":87,"healthyVolunteers":11,"sex":16,"minAge":88,"maxAge":4,"enrollmentInfo":89,"targetDuration":4,"studyType":22,"phases":91,"briefSummary":93,"conditions":94,"keywords":96,"overallStatus":116,"whyStopped":4,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":118,"startDateStruct":120,"completionDateStruct":122,"leadSponsor":124,"locationsCount":126},"100598392","cough-management-wellness-app-for-refractory-or-unexplained-chronic-cough-100598392","NCT07070895","Cough Management Wellness App for Refractory or Unexplained Chronic Cough","A Prospective Decentralized Investigation of the Effect of a Cough Management Feature Inside a Wellness Application (CoughPro) in Refractory or Unexplained Chronic Cough (RCC\u002FUCC)","Inclusion Criteria:\n\n* Age 21 or older.\n* Currently suffering from a cough that started at least 8 weeks ago that is largely unproductive (i.e., at least 50% of the time the cough produces zero mucus that needs to be spit out or swallowed).\n* Normal chest X-ray or chest CT scan at some point that was prescribed specifically for their cough.\n* At least one physician visit for cough with standard-of-care therapy but inadequate symptom relief.\n* Stability of treatment: willing to avoid new cough treatments during study or report changes if they occur.\n* Ability to comply: willing\u002Fable to wear the watch daily for the required duration of study and to complete all required questionnaires.\n* Informed consent: understanding of the study procedures and agreement to comply with protocol.\n\nExclusion Criteria:\n\n* Recent upper respiratory infection (past 4 weeks).\n* History of hemoptysis (coughing up blood) since onset of the current cough.\n* Current smoker (incl. vaping) of any substance.\n* ≥10 consecutive pack-years smoking history within \\\u003C10 years prior to screening.\n* Diagnosed with a chronic lung condition (COPD, emphysema, lung cancer, IPF, chronic bronchitis, asthma). Note: Suspected asthma without confirmed diagnosis or benefit from asthma therapy is not an exclusion.\n* Current or past head\u002Fneck cancer.\n* Difficulty swallowing.\n* On ACE inhibitors, such as Benzapril (Lotensin), Captopril (Capoten), Enalapril\u002FEnalaprilat (Vasotec oral and injectable), Fosinopril (Monopril), Lisinopril (Zestril and Prinivil), Moexipril (Univasc), Perindopril (Aceon), Quinapril (Accupril), Ramipril (Altace), and Trandolapril (Mavik)\n* Prior treatment for cough by a speech-language pathologist.\n* Living with another individual with a frequent cough that would interfere with monitoring.\n* Participation in any cough intervention study within 30 days or 5 half-lives of the intervention.\n* Major scheduled surgery during the study period.","21 Years",{"count":90,"type":21},20,[92],"NA","The goal of this single-cohort clinical trial is to learn whether a smartphone-based Cough Management (CM) program can reduce cough frequency and burden in adults (21-80 years) who have refractory or unexplained chronic cough. \n\nThe main questions it aims to answer are:\n\n* Does four weeks of using the CM feature in the CoughPro app lower objective cough rate (coughs per hour) compared with each participant's one-week baseline? \n* Does the program also lessen cough intensity (bout metrics) and improve patient-reported quality-of-life scores on the Leicester Cough Questionnaire and PGI-S?\n\nParticipants will:\n\n* Wear a Hyfe CoughMonitor smartwatch continuously for 6 weeks (1-week baseline, 4-week intervention, 1-week follow-up), charging it nightly. \n* Complete science-based in-app CM lessons based on behavioral cough-suppression therapy and practice the techniques during the 4-week intervention.\n* Fill out online questionnaires (LCQ and PGI-S) at baseline and at the end of Week 4.\n* Join a brief exit interview, then return the smartwatch and receive a compensation voucher.",[28,29,95],"Cough Hypersensitivity",[36,97,98,99,34,35,100,101,102,103,104,105,106,107,108,109,110,111,112,113,114,115],"hyfe","cough monitoring","coughpro","digital therapeutic","DTx","software enhanced treatment","cough management","behavioural cough suppression techniques","BCST","digital health","CoughMonitor Suite","cough tracking","cough recording","cough bouts","coughing","cough hypersensitivity","urge to cough","cough-free time","Leicester Cough Questionnaire (LCQ)","RECRUITING","2025-09-10",{"date":119,"type":42},"2025-09-11",{"date":121,"type":42},"2025-03-27",{"date":123,"type":21},"2025-09",{"name":125,"class":49},"Hyfe Inc",1]