Neuromodulators and Cough Control Therapy for Chronic Cough

(FORTITUDE Trial)

Not yet recruiting at 4 trial locations

Overseen By Imran Satia, MD PhD

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: McMaster University

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

Wafa Hassan, MD

Principal Investigator

McMaster University

Imran Satia, MD PhD

Principal Investigator

McMaster University

Elena Kum

Principal Investigator

McMaster University

Are You a Good Fit for This Trial?

This trial is for patients with a persistent cough that hasn't improved despite trying other treatments. Participants should be adults who can safely take morphine or pregabalin and are willing to try cough control therapy. Specific eligibility details, including any required health conditions or exclusions, were not provided.

Inclusion Criteria

I have a cough lasting more than 8 weeks and meet specific health criteria.

I am an adult with a chronic cough that hasn't improved with treatment.

I have a cough that treatments haven't helped.

Exclusion Criteria

Participation in another clinical trial within 30 days

Pregnant or breastfeeding

History of opioid or substance abuse

What Are the Treatments Tested in This Trial?

Interventions

• Cough Control Therapy
• Morphine Sulphate
• Pregabalin

Trial Overview

The FORTITUDE trial is testing the effectiveness of two drugs—low-dose morphine and pregabalin—alone or combined with a virtual cough control therapy in managing chronic coughs that haven't responded to usual care.

How Is the Trial Designed?

Group I: Pregabalin + Cough Control Therapy Experimental Treatment 1 Intervention

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).

Group II: Pregabalin Experimental Treatment 1 Intervention

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

Group III: Morphine Sulphate + Cough Control Therapy Experimental Treatment 1 Intervention

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).

Group IV: Morphine Sulphate Experimental Treatment 1 Intervention

Oral morphine sulphate given up to 5 mg twice daily.

Who Is Running the Clinical Trial?

McMaster University

Lead Sponsor

Trials

936

Recruited

2,630,000+