Mepolizumab for Chronic Cough

(MUCOSA Trial)

Overseen By Paul O'Byrne, MD

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: McMaster University

Must not be taking: Corticosteroids, Immunosuppressants, ACE inhibitors, others

Disqualifiers: Cardiovascular disease, Neurologic disease, Pulmonary disorders, others

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

Compensation: Varies

Number of Visits: 11

Duration: 12 weeks

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. ^{1 2 3 4 5}

Why 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. ^{2 3 4 6 7}

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

You can breathe out at least 70% of the air you are expected to.

Test results show high levels of a certain type of white blood cells in your airways.

I received at least one COVID-19 vaccine dose over 2 weeks ago.

Exclusion Criteria

I haven't taken any immunosuppressive drugs in the last 3 months.

I have not had a lung infection or pneumonia in the past month.

History of psychiatric illness, drug or alcohol abuse which may interfere in the participation of the trial

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive Mepolizumab or placebo over a 12-week period with 4 doses administered at days 0, 28, 56, and 84

12 weeks

9 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

1 visit (in-person)

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?

Group I: Mepolizumab arm Experimental Treatment 1 Intervention

Mepolizumab Dosage form: 1ml pre-filled syringe Dosage: 100mg Frequency: 4 doses at days 0, 28, 56 and 84 Duration: 12 weeks

Group II: Placebo arm Placebo Group 1 Intervention

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

Who Is Running the Clinical Trial?

McMaster University

Lead Sponsor

Trials

936

Recruited

2,630,000+

GlaxoSmithKline

Industry Sponsor

Trials

4,834

Recruited

8,389,000+

Headquarters

London, UK

Known For

Vaccines & Medicines

Top Products

**Advair (salmeterol, fluticasone propionate)**, **Shingrix (shingles vaccine)**, **Augmentin (amoxicillin/clavulanate potassium)**, **Ventolin (salbutamol sulfate)

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

Trials

370

Recruited

621,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04765722

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 ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S221253452500067X

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.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7508691/

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 < ...

4. nucalahcp.com nucalahcp.com/severe-eosinophilic-asthma/efficacy-safety/long-term-data-safety/

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 ...

5. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1002/clt2.70006

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, ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11520089/

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 ...

7. 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 ...