A 2x2 Factorial, Randomized, Open-label Trial to Evaluate Neuromodulators and Cough Control Thera… (NCT07288528) | Clinical Trial Compass
Not Yet RecruitingPhase 4
A 2x2 Factorial, Randomized, Open-label Trial to Evaluate Neuromodulators and Cough Control Therapy in Patients With Refractory or Unexplained Chronic Cough
Canada124 participantsStarted 2026-04-01
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Adults (≥18 years old) with either:
✓. Refractory chronic cough (RCC), defined as having one or more identifiable causes of cough (asthma, allergic rhinitis, and/or GERD), but with previous trials of treatment targeting the underlying condition leading to no cough resolution; OR
✓. Unexplained chronic cough (UCC), defined as having a cough lasting \>8 weeks with (i) a normal chest X-ray/CT 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/FVC ≥0.7 or \>LLN; (iv) no evidence of asthma; and (vi) no regular symptoms of nasal/reflux disease.
Exclusion criteria
✕. Those who, in the opinion of the investigator, have previously tried low-dose morphine, pregabalin, and/or CCT with full intervention fidelity for the treatment of RCC/UCC;
✕. Are currently taking morphine or pregabalin for the treatment of any indication (i.e., RCC/UCC or chronic pain);\*
✕. Are currently taking other centrally-acting medication (i.e., gabapentin, amitriptyline, dextromethorphan) for the treatment of any indication (i.e., RCC/UCC, seizures, or depression);\*
✕. Have a history of opioid or substance abuse that, in the opinion of the investigator, may interfere with the conduct of the study;
✕. Are a current smoker, or ex-smoker with a \>20 pack-year history who have abstained from smoking for \<6 months;
✕. Have cough due to angiotensin-converting enzyme inhibitor use;
What they're measuring
1
Change from baseline in 24-hour cough frequency (coughs/hour) measured by the VitaloJAK ambulatory cough monitor at 6 weeks