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30 Participants Needed

Mepolizumab for Chronic Cough
(MUCOSA Trial)

Overseen ByPaul 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 DataThis treatment has passed at least one previous human trial

Trial Summary

What is the purpose of this trial?

Cough is the most common presenting symptom to family physician. Chronic Cough affects approximately 10-12% of the general population and is one of the commonest reasons for referral to secondary care. Unfortunately, there are no licensed treatments for this debilitating condition, which is associated with a poor quality of life, affecting the social, physical and psychological well-being of patients. The aim of this single-centre proof-of-concept study is to investigate whether mepolizumab reduces objective cough frequency in patients with eosinophilic asthma and non-asthmatic eosinophilic bronchitis presenting with chronic cough. Secondary outcomes including the effects on quality of life, the intensity of irritant sensations, airway hyper-reactivity and inflammatory cells and their progenitors will also be evaluated. The investigators hypothesize that in patients with asthma and non-asthmatic eosinophilic bronchitis, eosinophils are involved in sensitizing airway nerves and thereby increasing spontaneous objective coughs. The investigators predict that treatment with mepolizumab will reduce airway eosinophilia in patients with chronic cough due to eosinophilic asthma and non-asthmatic eosinophilic bronchitis, thereby causing a reduction in objective cough frequency.

Research Team

Imran Satia, MD, PhD

Principal Investigator

McMaster University

Eligibility Criteria

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.

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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

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Treatment Details

Interventions

Mepolizumab

Trial OverviewThe 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.

Participant Groups

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Mepolizumab armExperimental Treatment1 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 armPlacebo Group1 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

Find a Clinic Near You

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

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Mepolizumab for Chronic Cough (MUCOSA Trial)