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NOT YET RECRUITING
NCT07288528
PHASE4

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

View on ClinicalTrials.gov

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

Interventions

DRUG

Morphine Sulphate

Oral morphine sulphate given up to 5 mg twice daily.

COMBINATION_PRODUCT

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).

DRUG

Pregabalin

Oral pregabalin given up to a maximum tolerated dose of 150 mg twice daily.

COMBINATION_PRODUCT

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