Neuromodulators and Cough Control Therapy for Chronic Cough
(FORTITUDE Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests treatments for people with a chronic cough that persists despite other treatments. It examines two medications—low-dose morphine, a pain reliever, and pregabalin, often used for nerve pain—alongside a virtual cough therapy program. Researchers aim to assess how these treatments work individually and in combination, as well as their benefits and any side effects over time. This trial suits adults with an unexplained or treatment-resistant cough lasting more than 8 weeks. As a Phase 4 trial, the treatments are already FDA-approved and proven effective, providing an opportunity to understand their benefits for more patients.
Will I have to stop taking my current medications?
If you are currently taking morphine, pregabalin, or other centrally-acting medications like gabapentin, amitriptyline, or dextromethorphan, you will need to stop them at least 2 weeks before the study starts. This is to ensure you can safely participate in the trial.
What is the safety track record for these treatments?
Previous studies have shown that low-dose morphine effectively reduces cough in patients with chronic cough. Patients taking 5-10 mg of morphine sulfate twice daily reported a significant decrease in cough severity. However, more research is needed to understand the long-term safety of using morphine for this purpose.
Research suggests pregabalin could be a good alternative for chronic cough because it is generally safe. However, some reports indicate serious breathing problems, especially when combined with other drugs affecting the nervous system.
Cough control therapy, which involves learning techniques to manage coughing, is considered safe. It helps improve cough symptoms for most patients and usually requires only a few sessions with a therapist.
Overall, both morphine and pregabalin have shown potential in treating chronic cough, but they come with some risks. Cough control therapy offers a safer option with fewer side effects.12345Why are researchers enthusiastic about this study treatment?
Researchers are excited about these treatments for chronic cough because they combine traditional medication with innovative therapy. Unlike standard care options that typically focus solely on medications like codeine or dextromethorphan, these treatments include neuromodulators such as morphine sulphate and pregabalin, which have different mechanisms of action. Pregabalin, for example, is known for its ability to calm overactive nerves, potentially reducing cough frequency and intensity. Additionally, the integration of cough control therapy, delivered virtually, offers a holistic approach by addressing behavioral aspects of coughing, which is a novel addition that could enhance overall treatment effectiveness. This combination of pharmacological and therapeutic strategies is what sets these treatments apart and fuels researchers' enthusiasm.
What evidence suggests that this trial's treatments could be effective for chronic cough?
Research has shown that low-dose morphine, one of the treatments in this trial, can effectively reduce chronic cough. Studies have found it can lower cough frequency by up to 71.8% over a day and reduce daytime coughs by an average of 39.4%.
Pregabalin, another treatment option in this trial, has produced mixed results, with some patients experiencing relief from chronic cough symptoms. In one study, about 56% of participants reported a significant improvement in their cough-related quality of life.
Cough control therapy, included in some treatment arms of this trial, involves guided sessions and has helped up to 87% of patients improve their cough. It is considered a safe and effective treatment option. Together, these treatments offer promising ways to manage chronic cough in this trial.16789Who 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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either low-dose morphine or pregabalin, with or without cough control therapy over 6 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
Extension Observational Phase
Long-term outcomes of treatments are observed up to 1 year
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?
4
Treatment groups
Experimental Treatment
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).
Oral pregabalin given up to a maximum tolerated dose of 150 mg twice daily.
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).
Oral morphine sulphate given up to 5 mg twice daily.
Find a Clinic Near You
Who Is Running the Clinical Trial?
McMaster University
Lead Sponsor
Citations
PMC - PubMed Central
BCST is safe, improves cough outcomes in up to 87% of patients, is inexpensive and efficient (i.e., patients typically need no more than four treatment sessions) ...
Prospective Study of Long‐Term Outcomes and the Patient ...
One hundredtwenty-two patients were injected for cough, representing 249 injections. At 2 weeks after injection, 63.1% endorsed improvement on ...
Results from a national survey | PLOS One - Research journals
Cough suppressants (18%) were the most frequent current treatment. Respondents were moderately satisfied with their HCPs, but more than half ...
Management of non-pharmacologic therapy for chronic ...
Cough-specific quality of life improved significantly after treatment. Both the cough frequency score and the sleep disturbance scores decreased significantly.
Preliminary Data From a Randomized Clinical Trial
The purpose of this study is to analyze the effectiveness of the Therapy Program for Management of Chronic Cough (TMCC) in laryngeal sensations and symptoms ...
Efficacy and safety of pharmacotherapy for refractory or ...
In this network meta-analysis, P2X3 antagonist showing advantages in terms of efficacy is currently the most promising medication for treatment of RCC.
Study Details | NCT05392192 | A Clinical Trial to Evaluate ...
A Clinical Trial to Evaluate the Safety and Efficacy in Subjects With Chronic Cough · Study Overview · Contacts and Locations · Participation Criteria · Study Plan.
Chronic cough: Investigations, management, current and ...
Chronic cough, defined as cough lasting 8 weeks or longer, is a condition for which there is currently no licensed treatment.
Chronic Cough
This systematic review and meta-analysis investigates the effects of speech-language therapy compared to other interventions on self-assessment of cough.
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