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.
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.
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;
Factorial
Morphine Sulphate
DrugOral morphine sulphate given up to 5 mg twice daily.
Morphine Sulphate + Cough Control Therapy
Combination productOral 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).
Pregabalin
DrugOral pregabalin given up to a maximum tolerated dose of 150 mg twice daily.
Pregabalin + Cough Control Therapy
Combination productOral 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).
Change from baseline in 24-hour cough frequency (coughs/hour) measured by the VitaloJAK ambulatory cough monitor at 6 weeks
Change from baseline in awake cough frequency (coughs/hour) measured by the VitaloJAK ambulatory cough monitor at 6 weeks
Change from baseline in sleep cough frequency (coughs/hour) measured by the VitaloJAK ambulatory cough monitor at 6 weeks
Change from baseline in cough bouts (defined by inter-cough intervals) measured by the VitaloJAK ambulatory cough monitor at 6 weeks
Change from baseline in cough severity on the McMaster Cough Severity Questionnaire at 6 weeks
Proportion of patients with any adverse event for each intervention at 6 weeks, 6 months, and 12 months
Proportion of patients with treatment-related adverse events for each intervention at 6 weeks, 6 months, and 12 months
Proportion of patients with serious adverse events for each intervention at 6 weeks, 6 months, and 12 months
Proportion of patients with adverse events leading to treatment discontinuation for each intervention at 6 weeks, 6 months, and 12 months
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