drugset / Trial / NCT07288528

A 2x2 Factorial, Randomized, Open-label Trial to Evaluate Neuromodulators and Cough Control Therapy in Patients With Refractory or Unexplained Chronic Cough

NCT07288528

Phase 4 Not yet recruiting 124 enrolled McMaster University
RandomizedFactorialOpen-labelTreatment

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.

Timeline

Start
2026-04-01
Primary completion
2029-04-01
Completion
2029-07-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Morphine Other / unclassified 5 mg Oral
Subject Pregabalin Small molecule 150 mg Oral