← Back to Search

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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to week 104
Awards & highlights

MATINEE 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.Check my eligibility
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.See study design
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.

MATINEE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am at least 40 years old.
Select...
I have been diagnosed with COPD for at least a year.
Select...
My lung function tests confirm I have COPD with specific FEV1/FVC ratios.
Select...
I have had at least 2 moderate or 1 severe COPD flare-ups in the last year.
Select...
I am not pregnant or breastfeeding, and if I can have children, I use effective birth control.
Select...
I am at least 40 years old.
Select...
I have been diagnosed with COPD for at least a year.
Select...
I have had at least 2 moderate or 1 severe COPD flare-up in the last year.
Select...
I have been on a specific COPD treatment with 3 medications for the past year.
Select...
I have smoked at least 10 pack-years.

MATINEE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to week 104
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to week 104 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Heart rate
Secondary outcome measures
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 more

Side effects data

From 2016 Phase 3 trial • 136 Patients • NCT02020889
32%
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%
Vertigo
7%
Wheezing
7%
Alanine aminotransferase increased
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%
Skin lesion
4%
Muscle spasms
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%
Ear discomfort
1%
Hernia
1%
Lacunar infarction
1%
Nystagmus
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

MATINEE 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 3
~4800

Find a Location

Who is running the clinical trial?

GlaxoSmithKlineLead Sponsor
4,750 Previous Clinical Trials
8,066,646 Total Patients Enrolled
PPDIndustry Sponsor
159 Previous Clinical Trials
36,109 Total Patients Enrolled
GSK Clinical TrialsStudy DirectorGlaxoSmithKline
3,595 Previous Clinical Trials
6,143,124 Total Patients Enrolled

Media Library

Mepolizumab Clinical Trial Eligibility Overview. Trial Name: NCT04133909 — Phase 3
Chronic Obstructive Pulmonary Disease Research Study Groups: Mepolizumab, Placebo
Chronic Obstructive Pulmonary Disease Clinical Trial 2023: Mepolizumab Highlights & Side Effects. Trial Name: NCT04133909 — Phase 3
Mepolizumab 2023 Treatment Timeline for Medical Study. Trial Name: NCT04133909 — Phase 3
Chronic Obstructive Pulmonary Disease Patient Testimony for trial: Trial Name: NCT04133909 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research the first to explore this topic?

"Mepolizumab has undergone 17 clinical trials in 327 cities and 32 countries since the initial study in 2015. The first trial, sponsored by GlaxoSmithKline, completed Phase 3 in 2015 with 104 participants. Since then, 18265 additional studies have been completed."

Answered by AI

How many people fit the bill to participate in this experiment?

"Yes, the online clinicaltrials.gov registry reflects that this study is currently looking for patients. The trial was posted on October 30th, 2019 and was last updated on August 1st, 2020. There is a total of 800 spots open for enrolment at 69 different sites."

Answered by AI

Is this trial offered at more than one location in the city?

"At the moment, this trial is being conducted in 69 different hospitals, clinics, and medical centres. Some of the notable locations include Melbourne, Sheffield, and Torrance. If you are considering participating in this trial, know that you can choose a location that is close to minimize travel."

Answered by AI

What are some of the dangers that patients face when taking Mepolizumab?

"Mepolizumab is estimated to be a safe medication because it is in Phase 3 of clinical trials. This suggests that not only is there some evidence that the drug is effective, but also that it has undergone several rounds of testing for safety."

Answered by AI

Are there any other ongoing research projects that are similar to this one?

"Mepolizumab was first trialed in 2015 at GSK Investigational Site. So far, there have been 18265 completed trials. Currently, there are 17 live studies, with many of these based in Melbourne, Florida."

Answered by AI

What conditions does Mepolizumab help alleviate?

"Mepolizumab is an effective treatment for hypereosinophilic syndrome (HES), polyangiitis, and other conditions that require corticosteroid therapy."

Answered by AI

Who else is applying?

What state do they live in?
New York
North Carolina
Florida
Other
How old are they?
65+
18 - 65
What site did they apply to?
GSK Investigational Site
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
2
3+
0

Why did patients apply to this trial?

Im on 3 pumps and 1 pill. To hopefully help myself and others. I use an inhaler since I lost Wei light n stopped cigarettes it’s gotten better then before.
PatientReceived no prior treatments

How responsive is this trial?

Typically responds via
Phone Call
Email
Most responsive sites:
  1. GSK Investigational Site: < 48 hours
Average response time
  • < 2 Days
Recent research and studies
clinicaltrials.govStudy
Mepolizumab as Add-on Treatment IN Participants With COPD Characterized by Frequent Exacerbations and Eosinophil Level
2019. "Mepolizumab as Add-on Treatment IN Participants With COPD Characterized by Frequent Exacerbations and Eosinophil Level". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04133909.
~42 spots leftby Aug 2024
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top