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A 2x2 Factorial, Randomized, Open-label Trial to Evaluate Neuromodulators and Cough Control Therapy in Patients With Refractory or Unexplained Chronic Cough
Sponsor: McMaster University
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.
Official title: A 2x2 Factorial, Randomized, Open-label Trial to Evaluate Neuromodulators and Cough Control Therapy in Patients With Refractory or Unexplained Chronic Cough (FORTITUDE)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
124
Start Date
2026-04-01
Completion Date
2029-07-01
Last Updated
2025-12-17
Healthy Volunteers
No
Conditions
Interventions
Morphine Sulphate
Oral morphine sulphate given up to 5 mg twice daily.
Morphine Sulphate + Cough Control Therapy
Oral 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
Oral pregabalin given up to a maximum tolerated dose of 150 mg twice daily.
Pregabalin + Cough Control Therapy
Oral 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).
Locations (5)
Respiratory Clinical Trials Centre, University of Calgary
Calgary, Alberta, Canada
Respiratory Research Lab, McMaster University
Hamilton, Ontario, Canada
St Joseph's Health Care London
London, Ontario, Canada
Institut universitaire de cardiologie et de pneumologie de Quebec - University Laval
Québec, Quebec, Canada
Centre de recherche du Centre Hospitalier Universitaire de Sherbrooke
Sherbrooke, Quebec, Canada