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Monoclonal Antibodies

Mepolizumab for Chronic Cough (MUCOSA Trial)

Phase 4
Waitlist Available
Led By Imran Satia, MD, PhD
Research Sponsored by McMaster University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Aged ≥18
Subjects with a history of chronic cough (cough lasting for >8 weeks)
Must not have
Use of immunosuppressive medication (including but not limited to: methotrexate, cyclosporine, azathioprine, intramuscular long-acting depot corticosteroid, oral corticosteroid, or any experimental anti-inflammatory therapy) within 3 months prior to the date informed consent is obtained
A previous asthma exacerbation requiring Intensive Care Unit admission
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 14 weeks
Awards & highlights
Pivotal Trial
Drug Has Already Been Approved

Summary

This trial is testing whether mepolizumab can help people with chronic cough due to eosinophilic asthma or bronchitis. Mepolizumab is given by injection and the investigators will test whether it can help reduce the number of objective coughs in patients with chronic cough.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Mepolizumab may cause side effects like headache, injection site reactions (pain, redness), fatigue, back pain, allergic reactions including rash or swelling. Some people might experience respiratory problems such as shortness of breath.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I have had a cough for more than 8 weeks.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I haven't taken any immunosuppressive drugs in the last 3 months.
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I was admitted to the ICU for a severe asthma attack.
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My asthma is not well-controlled, as shown by my medication use or recent exacerbation.
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I haven't taken any biological treatments for 4 months or longer.
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My diabetes is not under control.
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I have smoked for 10 or more years and quit less than 6 months ago, or I currently smoke.
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I do not have major lung conditions like pulmonary embolism or cystic fibrosis.
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I have a history of significant neurological issues like stroke or seizures.
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I am a male and will use contraception during the study.
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I have a history of significant autoimmune disease.
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I have had symptoms of a cold or similar illness in the last month that haven't gone away.
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I have severe kidney or liver disease.
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I have a history or symptoms of heart disease.
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My asthma worsens with seasonal allergies.
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I have a history of immune system disorders or tested positive for HIV.
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I have had Guillain-Barre Syndrome in the past.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~14 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 14 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Cough frequency
Secondary study objectives
Awake cough frequency at 14 weeks
Awake cough frequency at 8 weeks
Blood eosinophils at 14 weeks
+13 more
Other study objectives
Methacholine provocative concentration20 at 14 weeks
Total and activated mature eosinophils at 14 weeks

Side effects data

From 2016 Phase 3 trial • 136 Patients • NCT02020889
32%
Headache
22%
Arthralgia
21%
Sinusitis
21%
Upper respiratory tract infection
18%
Nasopharyngitis
18%
Diarrhoea
16%
Vomiting
16%
Nausea
15%
Asthma
15%
Fatigue
13%
Rash
13%
Injection site reaction
12%
Back pain
12%
Neck pain
12%
Oropharyngeal pain
10%
Influenza
10%
Bronchitis
10%
Pyrexia
9%
Musculoskeletal pain
9%
Productive cough
9%
Acute sinusitis
9%
Myalgia
9%
Sinus congestion
9%
Pruritus
7%
Respiratory tract infection
7%
Vertigo
7%
Wheezing
7%
Gastroenteritis
7%
Pain in extremity
7%
Asthenia
7%
Cough
7%
Abdominal pain upper
7%
Alanine aminotransferase increased
7%
Urinary tract infection
7%
Rhinitis
6%
Fungal skin infection
6%
Oral herpes
6%
Paraesthesia
6%
Conjunctivitis
6%
Nasal congestion
6%
Urticaria
6%
Vision blurred
6%
Weight increased
6%
Ligament sprain
4%
Epistaxis
4%
Gamma-glutamyltransferase increased
4%
Oedema peripheral
4%
Sneezing
4%
Cataract
4%
Viral infection
4%
Laceration
4%
Influenza like illness
4%
Dizziness
4%
Migraine
4%
Skin lesion
4%
Eye pruritus
4%
Aspartate aminotransferase increased
4%
Muscle spasms
4%
Contusion
4%
Otitis media
4%
Adrenal insufficiency
4%
Hot flush
3%
Joint swelling
3%
Abdominal pain
3%
Sinus headache
3%
Upper-airway cough syndrome
3%
Insomnia
3%
Injection site pain
1%
Cardiac arrest
1%
Nystagmus
1%
Gastrooesophageal reflux disease
1%
Enterococcal infection
1%
Ear infection
1%
Chest pain
1%
Lacunar infarction
1%
Cerebellar ischaemia
1%
Dyspnoea
1%
Ear discomfort
1%
Hernia
1%
Pachymeningitis
1%
Perirectal abscess
1%
Facial paresis
1%
Hypersensitivity
1%
Dyspepsia
1%
Parainfluenzae virus infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
Mepolizumab 300mg
Placebo

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Mepolizumab armExperimental Treatment1 Intervention
Mepolizumab Dosage form: 1ml pre-filled syringe Dosage: 100mg Frequency: 3 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: 3 doses at days 0, 28, 56 and 84 Duration: 12 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Mepolizumab
2020
Completed Phase 4
~5010

Find a Location

Who is running the clinical trial?

McMaster UniversityLead Sponsor
917 Previous Clinical Trials
2,615,303 Total Patients Enrolled
20 Trials studying Asthma
901 Patients Enrolled for Asthma
GlaxoSmithKlineIndustry Sponsor
4,807 Previous Clinical Trials
8,381,288 Total Patients Enrolled
301 Trials studying Asthma
500,482 Patients Enrolled for Asthma
University of ManchesterOTHER
358 Previous Clinical Trials
618,446 Total Patients Enrolled
4 Trials studying Asthma
442 Patients Enrolled for Asthma

Media Library

Mepolizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04765722 — Phase 4
Asthma Research Study Groups: Mepolizumab arm, Placebo arm
Asthma Clinical Trial 2023: Mepolizumab Highlights & Side Effects. Trial Name: NCT04765722 — Phase 4
Mepolizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04765722 — Phase 4
~0 spots leftby Nov 2024
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