[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100615124":3},{"organization":4,"armGroups":7,"interventions":29,"overallOfficials":41,"centralContacts":50,"locations":56,"responsibleParty":138,"collaborators":33,"id":140,"slug":141,"hasResults":142,"nctId":143,"briefTitle":144,"officialTitle":145,"acronym":146,"eligibilityCriteria":147,"healthyVolunteers":142,"sex":148,"minAge":149,"maxAge":33,"enrollmentInfo":150,"targetDuration":33,"studyType":153,"phases":154,"briefSummary":156,"conditions":157,"keywords":163,"overallStatus":166,"whyStopped":33,"lastUpdateSubmitDate":167,"lastUpdatePostDateStruct":168,"startDateStruct":171,"completionDateStruct":173,"leadSponsor":175,"locationsCount":176},{"fullName":5,"class":6},"McMaster University","OTHER",[8,14,19,24],{"label":9,"type":10,"description":11,"interventionNames":12},"Morphine Sulphate","EXPERIMENTAL","Oral morphine sulphate given up to 5 mg twice daily.",[13],"Drug: Morphine Sulphate",{"label":15,"type":10,"description":16,"interventionNames":17},"Morphine Sulphate + Cough Control Therapy","Oral morphine sulphate given up to 5 mg twice daily and cough control therapy (5 virtual sessions delivered over 6 weeks by a trained physiotherapist and speech-language pathologist).",[18],"Combination Product: Morphine Sulphate + Cough Control Therapy",{"label":20,"type":10,"description":21,"interventionNames":22},"Pregabalin","Oral pregabalin given up to a maximum tolerated dose of 150 mg twice daily.",[23],"Drug: Pregabalin",{"label":25,"type":10,"description":26,"interventionNames":27},"Pregabalin + Cough Control Therapy","Oral pregabalin given up to a maximum tolerated dose of 150 mg twice daily and cough control therapy (5 virtual sessions delivered over 6 weeks by a trained physiotherapist and speech-language pathologist).",[28],"Combination Product: Pregabalin + Cough Control Therapy",[30,34,37,39],{"type":31,"name":9,"description":11,"armGroupLabels":32,"otherNames":33},"DRUG",[9],null,{"type":35,"name":15,"description":16,"armGroupLabels":36,"otherNames":33},"COMBINATION_PRODUCT",[15],{"type":31,"name":20,"description":21,"armGroupLabels":38,"otherNames":33},[20],{"type":35,"name":25,"description":26,"armGroupLabels":40,"otherNames":33},[25],[42,45,48],{"name":43,"affiliation":5,"role":44},"Imran Satia, MD PhD","PRINCIPAL_INVESTIGATOR",{"name":46,"affiliation":5,"role":47},"Wafa Hassan, MD","STUDY_CHAIR",{"name":49,"affiliation":5,"role":47},"Elena Kum",[51],{"name":43,"role":52,"phone":53,"phoneExt":54,"email":55},"CONTACT","905-521-2100","76228","satiai@mcmaster.ca",[57,78,93,108,123],{"facility":58,"status":33,"city":59,"state":60,"zip":61,"country":62,"countryCode":63,"cosmosGeoPoint":64,"geoPoint":69,"contacts":70},"Respiratory Clinical Trials Centre, University of Calgary","Calgary","Alberta","T2N 4Z6","Canada","CA",{"type":65,"coordinates":66},"Point",[67,68],-114.08529,51.05011,{"lat":68,"lon":67},[71,75,76],{"name":72,"role":52,"phone":73,"phoneExt":33,"email":74},"Stephen Field, MD","403-220-8722","sfield@ucalgary.ca",{"name":72,"role":44,"phone":33,"phoneExt":33,"email":33},{"name":77,"role":44,"phone":33,"phoneExt":33,"email":33},"Danica Brister, MD",{"facility":79,"status":33,"city":80,"state":81,"zip":82,"country":62,"countryCode":63,"cosmosGeoPoint":83,"geoPoint":87,"contacts":88},"Respiratory Research Lab, McMaster University","Hamilton","Ontario","L8N 3Z5",{"type":65,"coordinates":84},[85,86],-79.84963,43.25011,{"lat":86,"lon":85},[89,91,92],{"name":43,"role":52,"phone":53,"phoneExt":54,"email":90},"satai@mcmaster.ca",{"name":49,"role":44,"phone":33,"phoneExt":33,"email":33},{"name":46,"role":44,"phone":33,"phoneExt":33,"email":33},{"facility":94,"status":33,"city":95,"state":81,"zip":96,"country":62,"countryCode":63,"cosmosGeoPoint":97,"geoPoint":101,"contacts":102},"St Joseph's Health Care London","London","N6A 4V2",{"type":65,"coordinates":98},[99,100],-81.23304,42.98339,{"lat":100,"lon":99},[103],{"name":104,"role":52,"phone":105,"phoneExt":106,"email":107},"Anurag Bhalla, MD","519-646-6100","61352","anurag.bhalla@sjhc.london.on.ca",{"facility":109,"status":33,"city":110,"state":111,"zip":112,"country":62,"countryCode":63,"cosmosGeoPoint":113,"geoPoint":117,"contacts":118},"Institut universitaire de cardiologie et de pneumologie de Quebec - University Laval","Québec","Quebec","G1V 4G5",{"type":65,"coordinates":114},[115,116],-71.21454,46.81228,{"lat":116,"lon":115},[119],{"name":120,"role":52,"phone":121,"phoneExt":33,"email":122},"Andreanne Cote, MD MA","418-656-4747","andreanne.cote@criucpq.ulaval.ca",{"facility":124,"status":33,"city":125,"state":111,"zip":126,"country":62,"countryCode":63,"cosmosGeoPoint":127,"geoPoint":131,"contacts":132},"Centre de recherche du Centre Hospitalier Universitaire de Sherbrooke","Sherbrooke","J1H 5N4",{"type":65,"coordinates":128},[129,130],-71.89908,45.40008,{"lat":130,"lon":129},[133],{"name":134,"role":52,"phone":135,"phoneExt":136,"email":137},"Simon Couillard, MD MSc","819-436-1110","15037","simon.couillard2@usherbrooke.ca",{"type":139,"investigatorFullName":33,"investigatorTitle":33,"investigatorAffiliation":33,"oldNameTitle":33,"oldOrganization":33},"SPONSOR","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",false,"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.","ALL","18 Years",{"count":151,"type":152},124,"ESTIMATED","INTERVENTIONAL",[155],"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.",[158,159,160,161,162],"Cough","Refractory Chronic Cough","Unexplained Chronic Cough","Cough Hypersensitivity Syndrome","Chronic Cough",[158,162,164,20,165,159,160],"Morphine","Non-Pharmacologic Therapy","NOT_YET_RECRUITING","2025-12-04",{"date":169,"type":170},"2025-12-17","ACTUAL",{"date":172,"type":152},"2026-04-01",{"date":174,"type":152},"2029-07-01",{"name":5,"class":6},5]