A 2x2 factorial, randomized, open-label trial to evaluate neuromodulators and cough control therapy in patients with refractory or unexplained chronic cough: the FORTITUDE trial protocol

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Introduction: While clinicians commonly prescribe neuromodulators for the treatment of refractory or unexplained chronic cough (RUCC), no trials have directly compared these treatments. Furthermore, although guidelines recommend non-pharmacologic cough control therapy (CCT), few trials have evaluated its long-term effectiveness. Methods: FORTITUDE is a 6-week, 2x2 factorial, randomized, open-label trial with an observational extension up to 1 year ( NCT07288528 ). The trial will include Canadian hospital sites enrolling 124 patients. Patients ≥18 years old with RUCC will undergo 1:1:1:1 randomization to either low-dose morphine (up to 5 mg twice daily) or pregabalin (up to 150 mg twice daily) with or without virtual CCT delivered across 5 sessions by a trained physiotherapist and speech-language pathologist. Analysis: Change from baseline in 24-hour cough frequency at 6 weeks represents the primary outcome. Secondary outcomes include change from baseline in awake, sleep, and cough bout frequencies; cough severity on the McMaster Cough Severity Questionnaire and the 100-mm visual analogue scale; and cough quality of life on the Leicester Cough Questionnaire at 6 weeks. We will analyze safety and tolerability at 6 weeks and explore potential interactions between neuromodulators and CCT. Follow-up in an observational extension up to 1-year post-randomization will assess long-term treatment patterns, adherence, and safety. Conclusions: FORTITUDE will provide head-to-head evidence on the benefits and harms of commonly prescribed neuromodulators and the effectiveness of virtual CCT in patients with RUCC.

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