Mepolizumab for Chronic Cough
(MUCOSA Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests whether mepolizumab, a medication, can reduce chronic cough in people with eosinophilic asthma or non-asthmatic eosinophilic bronchitis. Researchers aim to determine if the drug can decrease cough frequency and improve quality of life for those with this condition. Participants will receive either mepolizumab or a placebo (a harmless substance with no effect) to compare results. This trial suits individuals who have experienced a persistent cough for over 8 weeks and have been diagnosed with eosinophilic (a type of white blood cell) airway issues. As a Phase 4 trial, this research seeks to understand how the already FDA-approved and effective treatment benefits more patients.
Do I need to stop my current medications to join the trial?
Yes, you may need to stop certain medications. Specifically, you cannot use regular maintenance oral corticosteroids, long-acting muscarinic antagonists, angiotensin-converting-enzyme inhibitors, immunosuppressive medications, or any centrally acting medications like amitriptyline, dextromethorphan, pregabalin, gabapentin, or opioids. If you are taking these, you must be willing and able to stop them for the study.
What is the safety track record for mepolizumab?
Research has shown that mepolizumab is generally safe for use. Long-term studies, some lasting up to 10 years, have not identified any major safety issues. Most individuals taking mepolizumab find the benefits outweigh the risks. In everyday use, patients with bronchial asthma in Japan found it effective and easy to tolerate.
In a study involving patients with severe eosinophilic asthma (a type of asthma characterized by high levels of a certain white blood cell), mepolizumab reduced the frequency of asthma attacks. Overall, the safety profile of mepolizumab appears strong, offering reassurance for those considering it for chronic cough related to eosinophilic conditions.12345Why are researchers enthusiastic about this study treatment?
Mepolizumab is unique for treating chronic cough because it specifically targets and blocks interleukin-5 (IL-5), a protein that plays a key role in inflammation and immune response. Unlike standard treatments such as cough suppressants and antihistamines, which only manage symptoms, Mepolizumab addresses the underlying cause of inflammation. Researchers are excited because this approach could offer more effective and longer-lasting relief for patients by reducing the inflammation that contributes to chronic cough.
What evidence suggests that mepolizumab might be an effective treatment for chronic cough?
Research has shown that mepolizumab effectively treats conditions related to eosinophils, a type of white blood cell that causes inflammation. In people with eosinophilic asthma, mepolizumab greatly reduces flare-ups, helping to control symptoms. Long-term studies have found a 61% decrease in flare-up rates over several years. Mepolizumab also improves quality of life by lessening symptom severity in patients with similar breathing problems. In this trial, participants will receive either mepolizumab or a placebo to evaluate its potential in reducing chronic cough by targeting inflammation in the airways.23467
Who Is on the Research Team?
Imran Satia, MD, PhD
Principal Investigator
McMaster University
Are You a Good Fit for This Trial?
Adults over 18 with chronic cough and eosinophilic airway diseases (like certain types of bronchitis or asthma) can join this trial. They must have a history of cough lasting more than 8 weeks, signs of airway inflammation, normal lung function tests, and an up-to-date chest x-ray. Participants need to be vaccinated against COVID-19 at least two weeks before joining.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Mepolizumab or placebo over a 12-week period with 4 doses administered at days 0, 28, 56, and 84
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Mepolizumab
Trial Overview
The study is testing if Mepolizumab reduces the frequency of coughing in patients with eosinophilic asthma and non-asthmatic eosinophilic bronchitis compared to a saline placebo. It's a single-center trial that also looks at quality of life improvements and changes in airway sensitivity and inflammation.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
Mepolizumab Dosage form: 1ml pre-filled syringe Dosage: 100mg Frequency: 4 doses at days 0, 28, 56 and 84 Duration: 12 weeks
Normal Saline (0.09% normal saline) Dosage form: 1ml pre-filled syringe Dosage: n/a Frequency: 4 doses at days 0, 28, 56 and 84 Duration: 12 weeks
Find a Clinic Near You
Who Is Running the Clinical Trial?
McMaster University
Lead Sponsor
GlaxoSmithKline
Industry Sponsor
Dame Emma Walmsley
GlaxoSmithKline
Chief Executive Officer since 2017
MA in Classics and Modern Languages from Oxford University
Dr. Hal Barron
GlaxoSmithKline
Chief Medical Officer since 2018
MD from Harvard Medical School
University of Manchester
Collaborator
Citations
Mepolizumab for the Treatment of Chronic Cough With ...
The purpose of this study is to evaluate the effectiveness of mepolizumab for the treatment of refractory chronic cough in patients with eosinophilic airway ...
Long-term safety and effectiveness of mepolizumab for ...
This analysis of real-world data demonstrates that mepolizumab was well tolerated and effective in patients with bronchial asthma in Japan.
Real-life effectiveness of mepolizumab in patients with ...
After 1 year of MEPO treatment, we observed a significant difference in the number of exacerbations/year (6, IQR 4–12 vs. 0, IQR 0–1; p < ...
long-term data in 4.5-year open-label study
4.5-year open-label study (N=347): 61% reduction in mean rate of exacerbations/year* at 4.5 years vs period between Trial 1† and open-label study. Secondary ...
Evaluation of real‐world efficacy of mepolizumab on SNOT ...
Our results confirmed that mepolizumab significantly reduces symptom severity and improves overall QoL, particularly in patients with UAD, ...
Long-term safety of mepolizumab for up to ∼10 years in ...
This long-term safety analysis of mepolizumab was consistent with previous reports, with no emerging safety concerns; most patients had a favorable benefit:risk ...
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drugsincontext.com
drugsincontext.com/effectiveness-and-safety-of-mepolizumab-in-severe-refractory-eosinophilic-asthma-results-in-clinical-practice/Effectiveness and safety of mepolizumab in severe ...
Conclusion: Mepolizumab has been shown to be effective based on the high decrease in the exacerbation frequency and reduced use of OCS. Reported ...
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