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Mepolizumab for Chronic Obstructive Pulmonary Disease (MATINEE Trial)
Phase 3
Waitlist Available
Research Sponsored by GlaxoSmithKline
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Participant must be at least 40 years of age at Screening Visit 1.
Participants with a clinically documented history of COPD for at least 1 year in accordance with the definition by the American Thoracic Society or European Respiratory Society.
Must not have
Participants with specific underlying causes of COPD or other active pulmonary diseases.
Participants with specific recent medical history including pneumonia, COPD exacerbation, or lower respiratory tract infection within the 4 weeks prior to Screening Visit 1.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to week 104
Awards & highlights
Pivotal Trial
Summary
This trial is testing mepolizumab as a possible treatment for COPD. 800 people will be randomly assigned to either the treatment group or the placebo group. The treatment group will receive mepolizumab and the placebo group will not receive the treatment. The trial will last for up to 104 weeks.
Who is the study for?
Adults over 40 with frequent COPD exacerbations and certain levels of blood eosinophils, who are current or former smokers. They must have used specific inhaled medications for the past year and not be pregnant or breastfeeding. Excluded are those with other lung diseases, asthma, recent lung infections or surgeries, drug abuse history, and certain medical conditions.
What is being tested?
The trial is testing Mepolizumab as an additional treatment for COPD against a placebo. Participants will receive either the actual drug or a placebo every four weeks for up to two years while continuing their usual COPD treatments.
What are the potential side effects?
Mepolizumab may cause side effects such as headache, injection site reactions (pain, redness), back pain, fatigue, allergic reactions including rash and swelling under the skin (angioedema), and potentially more serious ones like systemic inflammation.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am at least 40 years old.
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I have been diagnosed with COPD for at least a year.
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My lung function tests confirm I have COPD with specific FEV1/FVC ratios.
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I have had at least 2 moderate or 1 severe COPD flare-ups in the last year.
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I am not pregnant or breastfeeding, and if I can have children, I use effective birth control.
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I am at least 40 years old.
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I have been diagnosed with COPD for at least a year.
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I have had at least 2 moderate or 1 severe COPD flare-up in the last year.
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I have been on a specific COPD treatment with 3 medications for the past year.
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I have smoked at least 10 pack-years.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have COPD or another lung condition due to a specific cause.
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I haven't had pneumonia, COPD flare-ups, or lung infections in the last 4 weeks.
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I am currently on oxygen therapy or have certain heart conditions.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to week 104
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to week 104
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Heart rate
Secondary study objectives
Annualized rate of exacerbations requiring Emergency Department (ED) visit or hospitalization
Number of COPD assessment test (CAT) responders
Number of Evaluating Respiratory Symptoms in COPD (E-RS: COPD) responders
+2 moreSide effects data
From 2016 Phase 3 trial • 136 Patients • NCT0202088932%
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%
Upper-airway cough syndrome
3%
Joint swelling
3%
Abdominal pain
3%
Sinus headache
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.
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: MepolizumabExperimental Treatment1 Intervention
Participants will receive mepolizumab subcutaneously once every 4 weeks over a treatment period of at least 52 weeks up to a maximum of 104 weeks.
Group II: PlaceboPlacebo Group1 Intervention
Participants will receive placebo subcutaneously once every 4 weeks over a treatment period of at least 52 weeks up to a maximum of 104 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?
PPD DEVELOPMENT, LPIndustry Sponsor
158 Previous Clinical Trials
35,243 Total Patients Enrolled
GlaxoSmithKlineLead Sponsor
4,807 Previous Clinical Trials
8,380,588 Total Patients Enrolled
PPDIndustry Sponsor
161 Previous Clinical Trials
35,585 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I've been on a specific COPD treatment plan for the last 12 months.I had lung surgery in the last year and joined a lung rehab program within the last month.I have had at least 2 moderate or 1 severe COPD flare-up in the last year.You have conditions that could cause high levels of eosinophils, or you have a pre-existing parasitic infection or weakened immune system.Your blood test shows high levels of a type of white blood cell called eosinophils.Women of childbearing potential (WOCBP) must take a pregnancy test before starting the study. If the test is positive, they can't participate. If the urine test is unclear, a blood test will be done.I am not pregnant or breastfeeding and follow specific birth control guidelines.I have smoked at least 10 pack-years.My blood tests show high eosinophil levels now and in the past year.I have had at least 2 moderate or 1 severe COPD flare-ups in the last year.I am not pregnant or breastfeeding, and if I can have children, I use effective birth control.I am at least 40 years old.Female participants must use birth control methods that follow local regulations for clinical study participation.I have been diagnosed with COPD for at least a year.I have not recently used certain drugs or have allergies to study treatments.I have COPD or another lung condition due to a specific cause.You have had asthma in the past or have been diagnosed with asthma at the same time as the study.I am currently on oxygen therapy or have certain heart conditions.I have a specific health condition affecting my nerves, mental health, kidneys, liver, immune system, hormones, blood, or other parts of my body.I am at least 40 years old.I have been diagnosed with COPD for at least a year.You have a history of alcohol or drug abuse, or you currently have a COVID-19 infection or have been in contact with someone who has it.You need to have specific lung function measurements before and after using salbutamol.I have been on a specific COPD treatment with 3 medications for the past year.I haven't had pneumonia, COPD flare-ups, or lung infections in the last 4 weeks.My lung function tests confirm I have COPD with specific FEV1/FVC ratios.
Research Study Groups:
This trial has the following groups:- Group 1: Mepolizumab
- Group 2: Placebo
Awards:
This trial has 1 awards, including:- 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.
Chronic Obstructive Pulmonary Disease Patient Testimony for trial: Trial Name: NCT04133909 — Phase 3
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