AzTrials
AzTrials

Pulmonary Disease, Chronic ObstructivePhase 3MATINEENCT04133909

Mepolizumab as Add-on Treatment IN Participants With COPD Characterized by Frequent Exacerbations and Eosinophil Level

A Phase 3 study testing Mepolizumab in people with Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline at 339 sites in 26 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

This is a multi-center, randomized, placebo-controlled, double-blind, parallel group study designed to confirm the benefits of mepolizumab treatment on moderate or severe exacerbations in chronic obstructive pulmonary disease (COPD) participants given as an add on to their optimized maintenance COPD therapy. Read more about this study

Who is it for?
Ages 40 years and older
Conditions the study is for
Pulmonary Disease, Chronic Obstructive
What is being tested?
Mepolizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
806 participants
Where
339 sitesin 26 countries
Study dates
30 Oct 2019to 8 Aug 2024
Phase
Phase 3

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participant must be at least 40 years of age at Screening Visit 1.
  • Participants with a peripheral blood eosinophil count of >=300 cells per microliter (μL) from the hematology sample collected at Screening Visit 0 AND a documented historical blood eosinophil count of >=150 cells per μL in the 12 months prior to Screening Visit 0 that meets the following: It must have been measured between 12 months and 1 month prior to Screening Visit 0, and it must not have been measured within 14 days of a COPD exacerbation. Participants with no documented historical blood eosinophil count of >=150 cells per µL must meet this threshold at the Screening Visit 1 assessment.
  • 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.
  • Participants must present with a measured pre- and post-salbutamol Forced expiratory volume in one second (FEV1)/Forced vital capacity (FVC) ratio of <0.70 at Screening Visit 1 to confirm the diagnosis of COPD and with a measured post-salbutamol FEV1>20% and <=80% of predicted normal values calculated using NHANES III reference equations at Screening Visit 1.
  • Participants must have a well-documented history (for example, medical record verification) in the 12 months prior to Screening Visit 1 of two or more moderate COPD exacerbations that were treated with systemic corticosteroids (intramuscular [IM], intravenous, or oral) with or without antibiotics or at least one severe COPD exacerbation requiring hospitalization.
  • Participants must have a well-documented requirement for optimized standard of care background therapy that includes inhaled corticosteroids (ICS) plus 2 additional COPD medications (ICS-based triple therapy) for the 12 months prior to Screening Visit 1 and meets the following criteria: immediately prior to Screening Visit 1, minimum of 3 months of use of an 1) inhaled corticosteroid at a dose >=500 microgram (mcg) per day fluticasone propionate dose equivalent plus 2) Long acting beta2-agonist (LABA) and 3) Long acting muscarinic antagonist (LAMA) unless documentation of safety or intolerance issues related to LABA or LAMA. For participants who are not continually maintained on ICS plus LABA plus LAMA for the entire 12 months prior to Visit 1 use of the following is allowed (but not in the 3 months immediately prior to Visit 1); inhaled corticosteroid at a dose >=500 mcg per day fluticasone propionate dose equivalent plus inhaled LABA or inhaled LAMA and Phosphodiesterase-4-inhibitors, methylxanthines, or scheduled daily use of short acting beta2-agonist (SABA) and/or short acting muscarinic antagonist (SAMA).
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  • Current or former cigarette smokers with a history of cigarette smoking of >=10 pack-years at Screening (Visit 1) calculated as (number of pack years = [number of cigarettes per day/20] multiplied by number of years smoked [For example, 20 cigarettes per day for 10 years or 10 cigarettes per day for 20 years]).
  • Contraceptive use for female participant should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
  • A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies: She is not a woman of childbearing potential (WOCBP) or she is a WOCBP and using a contraceptive method that is highly effective, with a failure rate of <1%, during the intervention period and for at least 16 weeks after the last dose of study intervention. The principal investigator (PI) should evaluate the effectiveness of the contraceptive method in relation to the first dose of study intervention.
  • A WOCBP must have a negative highly sensitive pregnancy urine test within 24 hours before the first dose of study intervention. If a urine test cannot be confirmed as negative (For example, an ambiguous result), a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive.
  • Participants capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
  • Participants must meet following randomization inclusion criteria at Visit 2 to be randomized and commence the study intervention period: a) Participants that do not have documented historical blood eosinophil count of ≥150 cells/μL prior to Screening Visit must meet this threshold based on the Screening Visit 1 assessment, b) Participants must have eosinophil count of ≥300 cells/μL from the hematology sample collected at Screening Visit 0, c) Compliance with completion of the e-diary defined as completion of all questions on 5 or more days out of the 7 days immediately preceding Visit 2.

Who cannot join

  • Participants with a past history or concurrent diagnosis of asthma are excluded regardless of whether they have active or inactive disease.
  • The Investigator must judge that COPD is the primary diagnosis accounting for the clinical manifestations of the lung disease. Participants with alpha1-antitrypsin deficiency as the underlying cause of COPD are excluded. Also, excluded are participants with active tuberculosis, lung cancer, bronchiectasis, sarcoidosis, lung fibrosis, primary pulmonary hypertension, interstitial lung diseases or other active pulmonary diseases.
  • Participants with pneumonia, COPD exacerbation, or lower respiratory tract infection within the 4 weeks prior to Screening Visit 1.
  • Participants with lung volume reduction surgery within the 12 months prior to Screening Visit 1.
  • Participation in the acute phase of a pulmonary rehabilitation program within 4 weeks prior to Screening Visit 1. Participants who are in the maintenance phase of a pulmonary rehabilitation program are not excluded.
  • Participants receiving treatment with oxygen more than 2 liter (L) per minute at rest over 24 hours. For participants receiving oxygen treatment, participants should demonstrate an oxyhemoglobin saturation greater than or equal to 89% while breathing supplemental oxygen.
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  • Participants with a QT interval, from the electrocardiogram (ECG) conducted at Screening Visit 1, corrected with Fridericia's formula (QTcF) >450 millisecond (msec) (or QTcF >480 msec in participants with bundle branch block). Fridericia's formula must be used to determine eligibility and discontinuation for an individual participant. Participants are excluded if an abnormal ECG finding from the 12-lead ECG conducted at Screening Visit 1 is considered to be clinically significant and would impact the participant's participation during the study, based on the evaluation of the Investigator.
  • Participants with any of the following would be excluded: myocardial infarction or unstable angina in the 6 months prior to Screening Visit 1; unstable or life threatening cardiac arrhythmia requiring intervention in the 3 months prior to Screening Visit 1; New York Heart Association (NYHA) Class IV Heart failure.
  • Participants with (historical or) current evidence of clinically significant, neurological, psychiatric, renal, hepatic, immunological, endocrine (including uncontrolled diabetes or thyroid disease) or hematological abnormalities that are uncontrolled. Significant is defined as any disease that, in the opinion of the Investigator, would put the safety of the participant at risk through participation, or which could affect the efficacy or safety analysis if the disease/condition exacerbated during the study.
  • Participants with other conditions that could lead to elevated eosinophils such as Hypereosinophilic syndromes including Eosinophilic Granulomatosis with Polyangiitis (EGPA), also known as Churg-Strauss Syndrome, or Eosinophilic Esophagitis.
  • Participants with a known, pre-existing parasitic infestation within 6 months prior to Screening Visit 1.
  • A current malignancy or previous history of cancer in remission for less than 12 months prior to Screening Visit 1 (participants that had localized carcinoma of the skin or cervix which was resected for cure will not be excluded).
  • Participants with a known immunodeficiency (For example, human immunodeficiency virus [HIV]), other than that explained by the use of corticosteroids taken for COPD.
  • Participants with cirrhosis or current unstable liver disease per investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, or persistent jaundice. Stable non-cirrhotic chronic liver disease (including Gilbert's syndrome, asymptomatic gallstones, and chronic stable hepatitis B or C -e.g., presence of hepatitis B surface antigen [HbsAg] or positive hepatitis C antibody test result) is acceptable if the participant otherwise meets entry criteria.
  • Participants who have received interventional product in previous mepolizumab studies are excluded.
  • Participants who have received any monoclonal antibody within 5 half-lives of Screening Visit 1.
  • Participants who have received an investigational drug within 30 days of Visit 1, or within 5 drug half-lives of the investigational drug, whichever is longer (this also includes investigational formulations of a marketed product).
  • Participants who have received short term use of oral corticosteroids within 30 days of Visit 1.
  • Participants with a known allergy or sensitivity to any of the study interventions, or components thereof, or drug or other allergy that, in the opinion of the Investigator or Medical Monitor, contraindicates participation in the study or intolerance to another monoclonal antibody or biologic including history of anaphylaxis to another biologic.
  • Participants at risk of non-compliance, or unable to comply with the study procedures. Any infirmity, disability, or geographic location that would limit compliance for scheduled visits.
  • Participants with conditions that will limit the validity of informed consent to participate in the study, for example, uncontrolled psychiatric disease or intellectual deficiency.
  • Participants with a known or suspected history of alcohol or drug abuse within 2 years prior to Visit 1.
  • Participant is an Investigator, sub-Investigator, study coordinator, employee of a participating Investigator or study site, or immediate family member of the aforementioned that is involved in this study.
  • Participants with a current active COVID-19 infection, either laboratory confirmed or according to the investigator's medical judgement and who are known to be in contact with active COVID-19 positive individuals within the past 14 days.
  • Participant will not be randomized if they meet any of the following randomization exclusion criteria at Visit 2: a) Participants who have pneumonia, exacerbation, lower respiratory infection during the Run-in period. b) Evidence of clinically significant abnormality in the hematological or biochemical screen at Visit 1, as judged by the Investigator. c) Participants who meet the following based on results from sample taken at Screening Visit 1: Alanine aminotransferase (ALT) >2x upper limit of normal (ULN), bilirubin >1.5 x ULN (isolated bilirubin >1.5 x ULN is acceptable if bilirubin is fractionated and direct bilirubin <35%), cirrhosis or current unstable liver or biliary disease per Investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminaemia, oesophageal or gastric varices, or persistent jaundice. d) Participants who are pregnant or breastfeeding. Participants should not be randomized if they plan to become pregnant during the time of study participation. e) Participants that had an active COVID-19 infection during the Run-in period, either laboratory confirmed or according to the investigator's medical judgment or known to be in contact with active COVID-19 positive individuals within the past 14 days. f) Participants with a QT interval, from the ECG conducted at Visit 2, corrected with Fridericia's formula (QTcF) >450 msec (or QTcF >480 msec in participants with bundle branch block).

Trial locations and contacts

339 sites in 26 countries.

339 sites in 26 countries

United States88 sites

  • GSK Investigational Site

    Adairsville, Georgia, 30103

  • GSK Investigational Site

    Alpine, California, 92262

  • GSK Investigational Site

    Altoona, Pennsylvania, 15801

  • GSK Investigational Site

    Anderson, South Carolina, 29621

  • GSK Investigational Site

    Baltimore, Maryland, 21224-2141

  • GSK Investigational Site

    Birmingham, Alabama, 35211

  • GSK Investigational Site

    Boynton Beach, Florida, 33472-2952

  • GSK Investigational Site

    Cerritos, California, 90703

  • GSK Investigational Site

    Chandler, Arizona, 29720-1709

  • GSK Investigational Site

    Chandler, Arizona, 85224

  • GSK Investigational Site

    Charleston, South Carolina, 29406-7108

  • GSK Investigational Site

    Charlotte, North Carolina, 28054

  • GSK Investigational Site

    Chicago, Illinois, 60602

  • GSK Investigational Site

    Cincinnati, Ohio, 45236

  • GSK Investigational Site

    Clearwater, Florida, 33765

  • GSK Investigational Site

    Clinton, South Carolina, 29325

  • GSK Investigational Site

    Colorado Springs, Colorado, 80907

  • GSK Investigational Site

    Columbia, Maryland, 21044

  • GSK Investigational Site

    Columbus, Ohio, 43016

  • GSK Investigational Site

    Columbus, Ohio, 43215

  • GSK Investigational Site

    Conway, Arkansas, 72032

  • GSK Investigational Site

    Corsicana, Texas, 75110

  • GSK Investigational Site

    Daytona Beach, Florida, 32117

  • GSK Investigational Site

    Doral, Florida, 33172-1604

  • GSK Investigational Site

    Dothan, Alabama, 36305

  • GSK Investigational Site

    Evansville, Indiana, 47714

  • GSK Investigational Site

    Fort Mill, South Carolina, 29707

  • GSK Investigational Site

    Gastonia, North Carolina, 28054

  • GSK Investigational Site

    Gilbert, Arizona, 85296

  • GSK Investigational Site

    Greenville, North Carolina, 29340

  • GSK Investigational Site

    Greenville, South Carolina, 29615

  • GSK Investigational Site

    Hialeah, Florida, 33016

  • GSK Investigational Site

    Hickory, North Carolina, 28601

  • GSK Investigational Site

    Homestead, Florida, 33032

  • GSK Investigational Site

    Houston, Texas, 77042-4643

  • GSK Investigational Site

    Houston, Texas, 77479

  • GSK Investigational Site

    Huntsville, Alabama, 77340

  • GSK Investigational Site

    Jasper, Alabama, 35501

  • GSK Investigational Site

    Johns Creek, Georgia, 30022-7484

  • GSK Investigational Site

    Kettering, Ohio, 45439-2201

  • GSK Investigational Site

    Knoxville, Tennessee, 37909

  • GSK Investigational Site

    Las Vegas, Nevada, 89106

  • GSK Investigational Site

    Lathrup Village, Michigan, 48076

  • GSK Investigational Site

    Lawrenceville, Georgia, 30046

  • GSK Investigational Site

    Lexington, Kentucky, 40503

  • GSK Investigational Site

    McKinney, Texas, 75069

  • GSK Investigational Site

    Mesa, Arizona, 85206

  • GSK Investigational Site

    Miami, Florida, 33126

  • GSK Investigational Site

    Miami, Florida, 33144-257

  • GSK Investigational Site

    Miami, Florida, 33144

  • GSK Investigational Site

    Miami, Florida, 33155

  • GSK Investigational Site

    Miami, Florida, 33173-3259

  • GSK Investigational Site

    Miami, Florida, 33174

  • GSK Investigational Site

    Miami, Florida, 33186-6597

  • GSK Investigational Site

    Miami Lakes, Florida, 33014-2473

  • GSK Investigational Site

    Miami Lakes, Florida, 33016

  • GSK Investigational Site

    Newport Beach, California, 92663

  • GSK Investigational Site

    Norman, Oklahoma, 73072

  • GSK Investigational Site

    Oklahoma City, Oklahoma, 73111

  • GSK Investigational Site

    Oregon City, Oregon, 97220

  • GSK Investigational Site

    Orlando, Florida, 32825

  • GSK Investigational Site

    Philadelphia, Pennsylvania, 19140

  • GSK Investigational Site

    Phoenix, Arizona, 85020

  • GSK Investigational Site

    Phoenix, Arizona, 85050

  • GSK Investigational Site

    Phoenix, Arizona, 89014

  • GSK Investigational Site

    Pinellas Park, Florida, 33781

  • GSK Investigational Site

    Plantation, Florida, 33324

  • GSK Investigational Site

    Port Orange, Florida, 32127

  • GSK Investigational Site

    Rock Hill, South Carolina, 29732

  • GSK Investigational Site

    Rutland, Vermont, 05701

  • GSK Investigational Site

    San Antonio, Texas, 78229

  • GSK Investigational Site

    San Antonio, Texas, 78258

  • GSK Investigational Site

    San Diego, California, 92120

  • GSK Investigational Site

    Shelby, North Carolina, 28150

  • GSK Investigational Site

    Sherman, Texas, 75092

  • GSK Investigational Site

    Spartanburg, South Carolina, 29303

  • GSK Investigational Site

    St Louis, Missouri, 63141

  • GSK Investigational Site

    St. Petersburg, Florida, 33704

  • GSK Investigational Site

    The Bronx, New York, 10455

  • GSK Investigational Site

    Toms River, New Jersey, 08755

  • GSK Investigational Site

    Torrance, California, 90503-4818

  • GSK Investigational Site

    Tucson, Arizona, 85741

  • GSK Investigational Site

    Valparaiso, Indiana, 46383

  • GSK Investigational Site

    Vista, California, 92083

  • GSK Investigational Site

    Webster, Texas, 77598

  • GSK Investigational Site

    Wilmington, North Carolina, 28401

  • GSK Investigational Site

    Winston-Salem, North Carolina, 27103

  • GSK Investigational Site

    Woodstock, Georgia, 30189

Other trials in United States

China40 sites

  • GSK Investigational Site

    Baotou, 014010

  • GSK Investigational Site

    Beijing, 100020

  • GSK Investigational Site

    Beijing, 100034

  • GSK Investigational Site

    Beijing, 100730

  • GSK Investigational Site

    Changchun, 130021

  • GSK Investigational Site

    Changchun, 130041

  • GSK Investigational Site

    Changsha, 410004

  • GSK Investigational Site

    Changsha, 410005

  • GSK Investigational Site

    Changsha, 410008

  • GSK Investigational Site

    Changsha, 410013

  • GSK Investigational Site

    Guangzhou, 510080

  • GSK Investigational Site

    Guangzhou, 510150

  • GSK Investigational Site

    Guangzhou, 51080

  • GSK Investigational Site

    Haikou, 570311

  • GSK Investigational Site

    Hangzhou, 310006

  • GSK Investigational Site

    Hangzhou, 310009

  • GSK Investigational Site

    Hohehot, 010050

  • GSK Investigational Site

    Jiaxing, 314001

  • GSK Investigational Site

    Jinan, 250013

  • GSK Investigational Site

    Nanchang, 330006

  • GSK Investigational Site

    Nanchang, 330038

  • GSK Investigational Site

    Nanchang, 330200

  • GSK Investigational Site

    Nanjing, 210009

  • GSK Investigational Site

    Nanjing, 210029

  • GSK Investigational Site

    Nanning, 530021

  • GSK Investigational Site

    Qingdao, 266071

  • GSK Investigational Site

    Shanghai, 200032

  • GSK Investigational Site

    Shanghai, 200040

  • GSK Investigational Site

    Shanghai, 200120

  • GSK Investigational Site

    Shanghai, 201100

  • GSK Investigational Site

    Taiyuan, 30000

  • GSK Investigational Site

    Taizhou, 318000

  • GSK Investigational Site

    Ürümqi, 830054

  • GSK Investigational Site

    Wuhan, 430024

  • GSK Investigational Site

    Wuxi, 214023

  • GSK Investigational Site

    Xiamen, 361004

  • GSK Investigational Site

    Xining, 810007

  • GSK Investigational Site

    Xinxiang, 453000

  • GSK Investigational Site

    Zhuhai, 519001

  • GSK Investigational Site

    Zigong, 643036

Other trials in China

Germany28 sites

  • GSK Investigational Site

    Berlin, 10119

  • GSK Investigational Site

    Berlin, 10367

  • GSK Investigational Site

    Berlin, 10717

  • GSK Investigational Site

    Berlin, 10787

  • GSK Investigational Site

    Berlin, 12157

  • GSK Investigational Site

    Berlin, 12203

  • GSK Investigational Site

    Berlin, 12627

  • GSK Investigational Site

    Cottbus, 03050

  • GSK Investigational Site

    Frankfurt, 60313

  • GSK Investigational Site

    Frankfurt, 60389

  • GSK Investigational Site

    Frankfurt, 60596

  • GSK Investigational Site

    Geesthacht, 21502

  • GSK Investigational Site

    Gelsenkirchen, 45879

  • GSK Investigational Site

    Halle, 06108

  • GSK Investigational Site

    Immenhausen, 34376

  • GSK Investigational Site

    Koblenz, 56068

  • GSK Investigational Site

    Leipzig, 04103

  • GSK Investigational Site

    Leipzig, 04207

  • GSK Investigational Site

    Leipzig, 04275

  • GSK Investigational Site

    Leipzig, 04357

  • GSK Investigational Site

    Lübeck, 23552

  • GSK Investigational Site

    Mainz, 55131

  • GSK Investigational Site

    Neu-Isenburg, 63263

  • GSK Investigational Site

    Peine, 31224

  • GSK Investigational Site

    Rheine, 48431

  • GSK Investigational Site

    Rodgau, 63110

  • GSK Investigational Site

    Schleswig, 24837

  • GSK Investigational Site

    Stuttgart, 70378

Other trials in Germany

Poland24 sites

  • GSK Investigational Site

    Bialystok, 15-044

  • GSK Investigational Site

    Bydgoszcz, 85-796

  • GSK Investigational Site

    Częstochowa, 42202

  • GSK Investigational Site

    Elblag, 82-300

  • GSK Investigational Site

    Gdansk, 80-382

  • GSK Investigational Site

    Gdynia, 81-537

  • GSK Investigational Site

    Katowice, 40-040

  • GSK Investigational Site

    Katowice, 40-081

  • GSK Investigational Site

    Kielce, 25-751

  • GSK Investigational Site

    Krakow, 30-033

  • GSK Investigational Site

    Krakow, 31-209

  • GSK Investigational Site

    Lodz, 90-127

  • GSK Investigational Site

    Lodz, 90-141

  • GSK Investigational Site

    Ostrowiec Świętokrzyski, 27-400

  • GSK Investigational Site

    Poznan, 60-214

  • GSK Investigational Site

    Poznan, 60-702

  • GSK Investigational Site

    Rzeszów, 35-051

  • GSK Investigational Site

    Rzeszów, 35-205

  • GSK Investigational Site

    Sopot, 81-741

  • GSK Investigational Site

    Sosnowiec, 41-200

  • GSK Investigational Site

    Warsaw, 01-192

  • GSK Investigational Site

    Warsaw, 02-777

  • GSK Investigational Site

    Wroclaw, 53-301

  • GSK Investigational Site

    Zamość, 22-400

Other trials in Poland

Argentina20 sites

  • GSK Investigational Site

    Berazategui Buenos Aires, B1884AAC

  • GSK Investigational Site

    Buenos Aires, 1646

  • GSK Investigational Site

    Buenos Aires, C1426ABP

  • GSK Investigational Site

    Ciudad Autonoma de Bueno, C1122AAK

  • GSK Investigational Site

    Ciudad Autonoma de Bueno, C1414AIF

  • GSK Investigational Site

    Ciudad AutOnoma de Buenos Aire, C1425AZE

  • GSK Investigational Site

    Córdoba, X5003DCE

  • GSK Investigational Site

    La Plata, B1902COS

  • GSK Investigational Site

    Lobos, 7240

  • GSK Investigational Site

    Mar del Plata, 7600

  • GSK Investigational Site

    Mar del Plata, B7600DHK

  • GSK Investigational Site

    Mendoza, 5500

  • GSK Investigational Site

    Mendoza, M5500CCG

  • GSK Investigational Site

    Quilmes, B1878FNR

  • GSK Investigational Site

    Rosario, 2000

  • GSK Investigational Site

    Rosario, S2002OJN

  • GSK Investigational Site

    Rosario Provincia de Santa FE, C1121ABE

  • GSK Investigational Site

    San Miguel de Tucumán, 4000

  • GSK Investigational Site

    San Miguel de Tucumán, T4000IHE

  • GSK Investigational Site

    San Rafael, 5600

Other trials in Argentina

Spain18 sites

  • GSK Investigational Site

    Alzira, 46600

  • GSK Investigational Site

    Barcelona, 08003

  • GSK Investigational Site

    Barcelona, 08017

  • GSK Investigational Site

    Barcelona, 08036

  • GSK Investigational Site

    Barcelona, 08907

  • GSK Investigational Site

    Benalmádena, 29630

  • GSK Investigational Site

    Cáceres, 10003

  • GSK Investigational Site

    Cadiz, 10009

  • GSK Investigational Site

    Galdakano, 48960

  • GSK Investigational Site

    Granada, 18014

  • GSK Investigational Site

    Granada, 18300

  • GSK Investigational Site

    HebrOn, 08035

  • GSK Investigational Site

    Madrid, 28007

  • GSK Investigational Site

    Marbella, 29603

  • GSK Investigational Site

    Pozuelo de AlarcOn Madr, 28223

  • GSK Investigational Site

    Santiago de Compostela, 15706

  • GSK Investigational Site

    Valencia, 46520

  • GSK Investigational Site

    Zaragoza, 50009

Other trials in Spain

United Kingdom12 sites

  • GSK Investigational Site

    Birmingham, B15 2SQ

  • GSK Investigational Site

    Cardiff, CF159SS

  • GSK Investigational Site

    Glasgow, G20 0SP

  • GSK Investigational Site

    Hardwick, TS19 8PE

  • GSK Investigational Site

    Hexham, NE46 1QJ

  • GSK Investigational Site

    Lancashire, PR7 7NA

  • GSK Investigational Site

    Liverpool, CF15 9SS

  • GSK Investigational Site

    London, W1G 8HU

  • GSK Investigational Site

    Manchester, M15 6SE

  • GSK Investigational Site

    Norwich, NR4 7UY

  • GSK Investigational Site

    Reading, B15 2SQ

  • GSK Investigational Site

    Wishaw, ML2 0DP

Other trials in United Kingdom

Hungary11 sites

  • GSK Investigational Site

    Budapest, 1036

  • GSK Investigational Site

    Budapest, 1125

  • GSK Investigational Site

    Debrecen, 4025

  • GSK Investigational Site

    Debrecen, 4032

  • GSK Investigational Site

    Gyula, 5700

  • GSK Investigational Site

    Hajdúnánás, 4080

  • GSK Investigational Site

    Hatvan, 3000

  • GSK Investigational Site

    Pécs, 7635

  • GSK Investigational Site

    Siófok, 8600

  • GSK Investigational Site

    Törökbálint, 2045

  • GSK Investigational Site

    Zalaegerszeg, 8900

Other trials in Hungary

Israel10 sites

  • GSK Investigational Site

    Ashkelon, 78278

  • GSK Investigational Site

    Beer-Yaakov, 703000

  • GSK Investigational Site

    Haifa, 34362

  • GSK Investigational Site

    Holon, 58100

  • GSK Investigational Site

    Jerusalem, 91031

  • GSK Investigational Site

    Jerusalem, 91120

  • GSK Investigational Site

    Kfar Saba, 44281

  • GSK Investigational Site

    Petah Tikva, 49100

  • GSK Investigational Site

    Ramat Gan, 52621

  • GSK Investigational Site

    Rehovot, 76100

Other trials in Israel

India9 sites

  • GSK Investigational Site

    Ahmedabad, 380052

  • GSK Investigational Site

    Hyderabad, 500003

  • GSK Investigational Site

    Hyderabad, 500018

  • GSK Investigational Site

    Jaipur, 302023

  • GSK Investigational Site

    Kanpur, 208001

  • GSK Investigational Site

    Lucknow, 226003

  • GSK Investigational Site

    Nagpur, 440012

  • GSK Investigational Site

    Nagpur, 44009

  • GSK Investigational Site

    New Delhi, 110060

Other trials in India

South Korea9 sites

  • GSK Investigational Site

    Daegu, 42415

  • GSK Investigational Site

    Incheon, 21431

  • GSK Investigational Site

    Incheon, 21565

  • GSK Investigational Site

    Jeonju, 54907

  • GSK Investigational Site

    Seoul, 02447

  • GSK Investigational Site

    Seoul, 02559

  • GSK Investigational Site

    Seoul, 02841

  • GSK Investigational Site

    Seoul, 06591

  • GSK Investigational Site

    Seoul, 143-729

Other trials in South Korea

Denmark7 sites

  • GSK Investigational Site

    Aalborg, 9100

  • GSK Investigational Site

    Hvidovre, DK-2650

  • GSK Investigational Site

    Kbenhavn N, 2100

  • GSK Investigational Site

    Koebenhavn NV, 2400

  • GSK Investigational Site

    Odense C, DK-5000

  • GSK Investigational Site

    Roskilde, 4000

  • GSK Investigational Site

    Vejle, 7100

Other trials in Denmark

France7 sites

  • GSK Investigational Site

    Brest, 29609

  • GSK Investigational Site

    Cholet, 49300

  • GSK Investigational Site

    Epagny Metz-Tessy, 74374

  • GSK Investigational Site

    Le Mans, 72000

  • GSK Investigational Site

    Lyon, 69004

  • GSK Investigational Site

    Montpellier, 34295

  • GSK Investigational Site

    Mulhouse, 68100

Other trials in France

Canada6 sites

  • GSK Investigational Site

    Ajax, Ontario, L1S 2J5

  • GSK Investigational Site

    Saint-Charles-Borromée, Quebec, J6E 2B4

  • GSK Investigational Site

    Sarnia, Ontario, N7T 4X3

  • GSK Investigational Site

    Truro, Nova Scotia, B2N 1L2

  • GSK Investigational Site

    Vancouver, British Columbia, V5Z 4E1

  • GSK Investigational Site

    Windsor, Ontario, N8X 1T3

Other trials in Canada

Greece6 sites

  • GSK Investigational Site

    Alexandroupoli, 68100

  • GSK Investigational Site

    Athens, 106 76

  • GSK Investigational Site

    Athens, 11527

  • GSK Investigational Site

    Ioannina, 455 00

  • GSK Investigational Site

    Rio Patras, 26054

  • GSK Investigational Site

    Thessaloniki, 57010

Other trials in Greece

Netherlands6 sites

  • GSK Investigational Site

    Breda, 4818 CK

  • GSK Investigational Site

    Groningen, 9728 NT

  • GSK Investigational Site

    Heerlen, 6419 PC

  • GSK Investigational Site

    Rotterdam, 3045 PM

  • GSK Investigational Site

    The Hague, 2545 AA

  • GSK Investigational Site

    Zutphen, 7207 AE

Other trials in Netherlands

Australia5 sites

  • GSK Investigational Site

    Coffs Harbour, New South Wales, 2450

  • GSK Investigational Site

    Frankston, Victoria, 3199

  • GSK Investigational Site

    Kent Town, South Australia, 5067

  • GSK Investigational Site

    New Lambton, New South Wales, 2305

  • GSK Investigational Site

    Sydney, New South Wales, 2010

Other trials in Australia

Ireland5 sites

  • GSK Investigational Site

    Drogheda, A92 VW28

  • GSK Investigational Site

    Dublin, D15 X40D

  • GSK Investigational Site

    Dublin, DO4T6F4

  • GSK Investigational Site

    Galway, H53 T971

  • GSK Investigational Site

    Limerick, V94 F858

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Italy5 sites

  • GSK Investigational Site

    Bari, 70020

  • GSK Investigational Site

    Ferrara, 44123

  • GSK Investigational Site

    Roma, 00128

  • GSK Investigational Site

    Telese Terme BN, 82037

  • GSK Investigational Site

    Verona, 37134

Other trials in Italy

Mexico5 sites

  • GSK Investigational Site

    Guadalajara, 44100

  • GSK Investigational Site

    Guadalajara, 44160

  • GSK Investigational Site

    Jalisco, 44130

  • GSK Investigational Site

    Monterrey, 64020

  • GSK Investigational Site

    Monterrey, 64460

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New Zealand5 sites

  • GSK Investigational Site

    Auckland, 1051

  • GSK Investigational Site

    Hamilton, 3240

  • GSK Investigational Site

    Havelock North, Hawke's Bay Region, 3410

  • GSK Investigational Site

    Rotorua, 3010

  • GSK Investigational Site

    Wellington, 6021

Other trials in New Zealand

Brazil4 sites

  • GSK Investigational Site

    Porto Alegre, 90035-074

  • GSK Investigational Site

    Porto Alegre, 90430-000

  • GSK Investigational Site

    Porto Alegre, 90610000

  • GSK Investigational Site

    São Paulo, 05403-000

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Belgium3 sites

  • GSK Investigational Site

    Jambes, 5100

  • GSK Investigational Site

    Liège, 4000

  • GSK Investigational Site

    Yvoir, 5530

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Sweden3 sites

  • GSK Investigational Site

    Härnösand, SE-871 31

  • GSK Investigational Site

    Malmö, SE-211 52

  • GSK Investigational Site

    Uppsala, SE-752 37

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Taiwan2 sites

  • GSK Investigational Site

    Taichung, 40705

  • GSK Investigational Site

    Taipei, 11490

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Estonia1 site

  • GSK Investigational Site

    Tallinn, 50-088

Other trials in Estonia

About this study

Official title: A Multi-center, Randomized, Double-blind, Parallel-group, Placebo-controlled Study of Mepolizumab 100 mg SC as add-on Treatment in Participants With COPD Experiencing Frequent Exacerbations and Characterized by Eosinophil Levels (Study 208657)

This is a multi-center, randomized, placebo-controlled, double-blind, parallel group study designed to confirm the benefits of mepolizumab treatment on moderate or severe exacerbations in chronic obstructive pulmonary disease (COPD) participants given as an add on to their optimized maintenance COPD therapy. The maximum duration of participant participation is approximately 109 weeks, consisting of 2 screening visits (up to 3 weeks), a run-in period (up to 2 weeks), and an intervention period of at least 52 weeks and up to 104 weeks. 800 participants will be randomized in a 1:1 ratio to receive mepolizumab 100 milligrams (mg) or placebo every 4 weeks for at least 13 doses (52 weeks treatment period) up to a maximum of 26 doses (104 weeks treatment period). The number of randomized participants may increase up to approximately 1400.

Being tested
Mepolizumab, Placebo
Keywords
COPD, Mepolizumab, Exacerbations, MATINEE
Medical subject headings
Pulmonary Disease, Chronic Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MepolizumabBiological

    Mepolizumab was a sterile liquid formulation. It was administered as a subcutaneous injection (100 milligrams per milliliter [mg/mL]) delivered once every 4 weeks using a pre-filled safety syringe.

  • PlaceboDrug

    Placebo was a 0.9% sodium chloride solution. It was administered as a subcutaneous injection delivered once every 4 weeks using a pre-filled safety syringe.

Study groups in NCT04133909
Study groupRoleWhat they receive
Mepolizumab 100 mgExperimentalParticipants with Chronic Obstructive Pulmonary Disease (COPD) received a 100 milligrams (mg) dose of mepolizumab as a subcutaneous injection every 4 weeks. Participants remained in the study for an assessment period of minimum of 52 weeks and a maximum of 104 weeks.
Receives: Biological: Mepolizumab
PlaceboExperimentalParticipants with COPD received matching placebo as a subcutaneous injection every 4 weeks. Participants remained in the study for an assessment period of minimum of 52 weeks and a maximum of 104 weeks.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Annualized Rate of Moderate or Severe Exacerbations

    Annualized rate of moderate or severe exacerbations were assessed. Moderate exacerbations are defined as clinically significant exacerbations that require treatment with oral or systemic corticosteroids and/or antibiotics. Severe exacerbations are defined per protocol as clinically significant exacerbations that require in-patient hospitalization (that is greater than or equal to [>=] 24 hours) or result in death.

    Measured: Up to Week 104

Secondary outcomes (5)

  1. Time to First Moderate or Severe Exacerbation

    The time to first moderate or severe exacerbation was determined as the number of days from the date of first dose to the date of the first moderate or severe exacerbation. Kaplan-Meier estimate of the cumulative percentage of participants with a moderate or severe exacerbation within each treatment arm over time were produced.

    Measured: At week 8,16, 24, 32, 40, 48, 52, 56, 64, 72, 80, 88, 96, 104

  2. Percentage of COPD Assessment Test (CAT) Responders With >=2 Point Reduction From Baseline at Week 52

    The CAT is an 8-item questionnaire used to measure the health status of participants with COPD. Participants rated their experience on a 6-point scale, ranging from 0 (no impairment) to 5 (maximum impairment), with a scoring range of 0 (no impact)-40 (maximum impact). Higher scores indicate greater disease impact, and lower score indicates lesser disease impact. Participants were considered responders if they had a 2-point or more improvement (reduction) in CAT Score from baseline. Participants who withdrew from the study prior to Week 52 were included in the analysis as non-responders. The baseline value was the last measurement collected prior to the first dose of investigational product.

    Measured: Baseline and Week 52

  3. Percentage of St. George's Respiratory Questionnaire for COPD (SGRQ) Total Score Responders With >=4 Point Reduction From Baseline at Week 52

    The St George's Respiratory Questionnaire for COPD (SGRQ-C) is a 40-item questionnaire. The total SGRQ score is calculated by summing up the weights of all positively answered items across the entire questionnaire, dividing by the total possible weight for all questionnaire items. The total score was expressed as a percentage of overall impairment, with 0 (best possible health status) and 100 (the worst possible health status). Higher scores indicated greater impairment of health, and lower scores indicate a lesser impairment on health. A participant was considered a responder if they had a 4-point or more improvement (reduction) in the SGRQ-C total score from baseline. Participants who withdrew from the study prior to Week 52 were included in the analysis as non- responders.

    Measured: Baseline and Week 52

  4. Percentage of Evaluating Respiratory Symptoms in COPD (E-RS: COPD) Responders With >=2 Point Reduction From Baseline

    The E-RS: COPD consists of 11 items from the 14 item Exacerbations of Chronic Pulmonary Disease Tool (EXACT) instrument (completed each evening using an eDiary). E-RS: COPD is intended to capture information related to the respiratory symptoms of COPD, that is, breathlessness, cough, sputum production, chest congestion, and chest tightness. The E-RS: COPD has a scoring range of 0 (no symptoms)-40 (most severe symptoms), higher scores indicate more severe symptoms. A participant is considered a responder if they have a 2-unit or more improvement (reduction) in their average E-RS: COPD total score during a 4-week period prior to Week 52 (Weeks 49-52) compared to baseline. The average of daily scores in 4-weekly intervals were calculated and data is presented for Weeks 49-52. Participants who withdrew from study prior to the start of the Weeks 49-52 time-period were included in the analysis as a non-responder.

    Measured: Baseline and 4-weeks prior to Week 52

  5. Annualized Rate of Exacerbations Requiring Emergency Department (ED) Visit and/or Hospitalization

    Annualized rate of exacerbations requiring ED visit or hospitalization were evaluated. This included moderate exacerbations which led to a visit to the ED and severe exacerbations, were defined as clinically significant exacerbations that require in-patient hospitalization (>= 24 hours) or result in death.

    Measured: Up to Week 104

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Oct 2019
  2. Study start30 Oct 2019
  3. Primary completion8 Aug 2024
  4. Study completion8 Aug 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
806 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04133909
Sponsor's protocol ID
208657
Acronym
MATINEE
Status last verified
Jul 2026
First submitted
18 Oct 2019
Last updated
21 Aug 2026
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Study Sponsor will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.gsk-studyregister.com/gsk-patient-level-data-sharing-july2025.pdf
Expanded access
Available

Publications

  • Sciurba FC, Criner GJ, Christenson SA, Martinez FJ, Papi A, Roche N, Bourbeau J, Korn S, Bafadhel M, Han MK, Kolterer S, Miller K, Mouneimne D, Fletcher J, Mayer B, Min J, Pavord ID; MATINEE Study Investigators. Mepolizumab to Prevent Exacerbations of COPD with an Eosinophilic Phenotype. N Engl J Med. 2025 May 1;392(17):1710-1720. doi: 10.1056/NEJMoa2413181.

    PubMed 40305712

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