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 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.

NCT Number	NCT07288528
Lead Sponsor	McMaster University
Conditions	Cough, Refractory Chronic Cough, Unexplained Chronic Cough, Cough Hypersensitivity Syndrome, Chronic Cough
Enrollment	124 participants
Start Date	2026-04-01
Primary Completion	2029-04-01 (estimated)
Study Completion	2029-07-01 (estimated)
Updated on ClinicalTrials.gov	2025-12-17