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Monoclonal Antibodies
Mepolizumab for Chronic Cough (MUCOSA Trial)
Phase 4
Recruiting
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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 14 weeks
Awards & highlights
MUCOSA Trial 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.Check my eligibility
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.See study design
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.
MUCOSA Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
I have had a cough for more than 8 weeks.
MUCOSA Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 14 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~14 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Cough frequency
Secondary outcome measures
Awake cough frequency at 14 weeks
Awake cough frequency at 8 weeks
Blood eosinophils at 14 weeks
+13 moreOther outcome measures
Methacholine provocative concentration20 at 14 weeks
Total and activated mature eosinophils at 14 weeks
Side effects data
From 2016 Phase 3 trial • 136 Patients • NCT0202088932%
Headache
22%
Arthralgia
21%
Sinusitis
21%
Upper respiratory tract infection
18%
Diarrhoea
18%
Nasopharyngitis
16%
Nausea
16%
Vomiting
15%
Fatigue
15%
Asthma
13%
Injection site reaction
13%
Rash
12%
Back pain
12%
Oropharyngeal pain
12%
Neck pain
10%
Influenza
10%
Bronchitis
10%
Pyrexia
9%
Pruritus
9%
Acute sinusitis
9%
Myalgia
9%
Musculoskeletal pain
9%
Productive cough
9%
Sinus congestion
7%
Wheezing
7%
Alanine aminotransferase increased
7%
Vertigo
7%
Respiratory tract infection
7%
Gastroenteritis
7%
Rhinitis
7%
Abdominal pain upper
7%
Cough
7%
Urinary tract infection
7%
Asthenia
7%
Pain in extremity
6%
Weight increased
6%
Nasal congestion
6%
Fungal skin infection
6%
Oral herpes
6%
Conjunctivitis
6%
Paraesthesia
6%
Urticaria
6%
Vision blurred
6%
Ligament sprain
4%
Aspartate aminotransferase increased
4%
Muscle spasms
4%
Skin lesion
4%
Adrenal insufficiency
4%
Hot flush
4%
Otitis media
4%
Viral infection
4%
Epistaxis
4%
Sneezing
4%
Dizziness
4%
Migraine
4%
Oedema peripheral
4%
Influenza like illness
4%
Cataract
4%
Eye pruritus
4%
Laceration
4%
Contusion
4%
Gamma-glutamyltransferase increased
3%
Insomnia
3%
Abdominal pain
3%
Upper-airway cough syndrome
3%
Injection site pain
3%
Sinus headache
3%
Joint swelling
1%
Nystagmus
1%
Ear discomfort
1%
Hernia
1%
Lacunar infarction
1%
Cerebellar ischaemia
1%
Cardiac arrest
1%
Pachymeningitis
1%
Facial paresis
1%
Dyspepsia
1%
Hypersensitivity
1%
Gastrooesophageal reflux disease
1%
Dyspnoea
1%
Enterococcal infection
1%
Parainfluenzae virus infection
1%
Perirectal abscess
1%
Chest pain
1%
Ear infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Mepolizumab 300mg
MUCOSA 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 3
~4800
Find a Location
Who is running the clinical trial?
McMaster UniversityLead Sponsor
885 Previous Clinical Trials
2,598,313 Total Patients Enrolled
GlaxoSmithKlineIndustry Sponsor
4,758 Previous Clinical Trials
8,104,100 Total Patients Enrolled
3 Trials studying Chronic Bronchitis
170 Patients Enrolled for Chronic Bronchitis
University of ManchesterOTHER
340 Previous Clinical Trials
614,152 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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.I was admitted to the ICU for a severe asthma attack.My asthma is not well-controlled, as shown by my medication use or recent exacerbation.I haven't taken any biological treatments for 4 months or longer.My diabetes is not under control.I haven't taken any medication in the last 2 weeks that affects coughing.I have smoked for 10 or more years and quit less than 6 months ago, or I currently smoke.I was diagnosed with a worm infection in the last 24 weeks and standard treatments didn't work or weren't used.You tested positive for COVID-19 within 2 weeks before the screening.I am using or willing to use approved birth control methods if of childbearing potential.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 do not have major lung conditions like pulmonary embolism or cystic fibrosis.I received at least one COVID-19 vaccine dose over 2 weeks ago.You had a chest x-ray in the last 6 months and it looked normal.You have had a severe allergic reaction to any biologic therapy or vaccine in the past.I have a history of significant neurological issues like stroke or seizures.Your recent blood tests show important health issues, unless the doctor says they are not important.I am taking medication for high blood pressure.I am a male and will use contraception during the study.I have a history of significant autoimmune disease.I have had symptoms of a cold or similar illness in the last month that haven't gone away.I have tested positive for hepatitis B or C, or have a history of these conditions.I have severe kidney or liver disease.I haven't taken long-term steroids or certain lung medications in the last 4 weeks.I am 18 years old or older.I have a history or symptoms of heart disease.I have had a cough for more than 8 weeks.My asthma worsens with seasonal allergies.I have a history of immune system disorders or tested positive for HIV.I have had Guillain-Barre Syndrome in the past.
Research Study Groups:
This trial has the following groups:- Group 1: Mepolizumab arm
- Group 2: Placebo arm
Awards:
This trial has 2 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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