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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

NCT07288528 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 124

Last updated 2025-12-17

No results posted yet for this study

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.

Conditions

  • Cough
  • Refractory Chronic Cough
  • Unexplained Chronic Cough
  • Cough Hypersensitivity Syndrome
  • Chronic Cough

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).

Sponsors & Collaborators

Principal Investigators

  • Imran Satia, MD PhD · McMaster University

  • Wafa Hassan, MD · McMaster University

  • Elena Kum · McMaster University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • Canada

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07288528 on ClinicalTrials.gov