Mepolizumab as Add-on Treatment IN Participants With COPD Characterized by Frequent Exacerbations and Eosinophil Level
MATINEE
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)
1 other identifier
interventional
806
25 countries
360
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Oct 2019
Longer than P75 for phase_3
360 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 18, 2019
CompletedFirst Posted
Study publicly available on registry
October 21, 2019
CompletedStudy Start
First participant enrolled
October 30, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 8, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
August 8, 2024
CompletedResults Posted
Study results publicly available
August 15, 2025
CompletedAugust 15, 2025
July 1, 2025
4.8 years
October 18, 2019
July 30, 2025
July 30, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (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.
Up to Week 104
Secondary Outcomes (5)
Time to First Moderate or Severe Exacerbation
At week 8,16, 24, 32, 40, 48, 52, 56, 64, 72, 80, 88, 96, 104
Percentage of COPD Assessment Test (CAT) Responders With >=2 Point Reduction From Baseline at Week 52
Baseline and Week 52
Percentage of St. George's Respiratory Questionnaire for COPD (SGRQ) Total Score Responders With >=4 Point Reduction From Baseline at Week 52
Baseline and Week 52
Percentage of Evaluating Respiratory Symptoms in COPD (E-RS: COPD) Responders With >=2 Point Reduction From Baseline
Baseline and 4-weeks prior to Week 52
Annualized Rate of Exacerbations Requiring Emergency Department (ED) Visit and/or Hospitalization
Up to Week 104
Study Arms (2)
Mepolizumab 100 mg
EXPERIMENTALParticipants 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.
Placebo
EXPERIMENTALParticipants 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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).
- 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.
You may not qualify if:
- 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.
- 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.
- +9 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
- PPD Development, LPcollaborator
Study Sites (361)
GSK Investigational Site
Birmingham, Alabama, 35211, United States
GSK Investigational Site
Dothan, Alabama, 36305, United States
GSK Investigational Site
Huntsville, Alabama, 77340, United States
GSK Investigational Site
Jasper, Alabama, 35501, United States
GSK Investigational Site
Sheffield, Alabama, 35660, United States
GSK Investigational Site
Chandler, Arizona, 29720-1709, United States
GSK Investigational Site
Chandler, Arizona, 85224, United States
GSK Investigational Site
Gilbert, Arizona, 85296, United States
GSK Investigational Site
Mesa, Arizona, 85206, United States
GSK Investigational Site
Phoenix, Arizona, 85018, United States
GSK Investigational Site
Phoenix, Arizona, 85020, United States
GSK Investigational Site
Phoenix, Arizona, 85050, United States
GSK Investigational Site
Phoenix, Arizona, 89014, United States
GSK Investigational Site
Tucson, Arizona, 85741, United States
GSK Investigational Site
Conway, Arkansas, 72032, United States
GSK Investigational Site
Alpine, California, 92262, United States
GSK Investigational Site
Cerritos, California, 90703, United States
GSK Investigational Site
Newport Beach, California, 92663, United States
GSK Investigational Site
Riverside, California, 92506, United States
GSK Investigational Site
San Diego, California, 92120, United States
GSK Investigational Site
Torrance, California, 90503-4818, United States
GSK Investigational Site
Vista, California, 92083, United States
GSK Investigational Site
Colorado Springs, Colorado, 80907, United States
GSK Investigational Site
Boynton Beach, Florida, 33472-2952, United States
GSK Investigational Site
Clearwater, Florida, 33765, United States
GSK Investigational Site
Daytona Beach, Florida, 32117, United States
GSK Investigational Site
Doral, Florida, 33172-1604, United States
GSK Investigational Site
Ft. Pierce, Florida, 34950-4832, United States
GSK Investigational Site
Gainesville, Florida, 32608, United States
GSK Investigational Site
Hialeah, Florida, 33016, United States
GSK Investigational Site
Homestead, Florida, 33032, United States
GSK Investigational Site
Miami, Florida, 33126, United States
GSK Investigational Site
Miami, Florida, 33144-257, United States
GSK Investigational Site
Miami, Florida, 33144, United States
GSK Investigational Site
Miami, Florida, 33155, United States
GSK Investigational Site
Miami, Florida, 33173-3259, United States
GSK Investigational Site
Miami, Florida, 33174, United States
GSK Investigational Site
Miami, Florida, 33186-6597, United States
GSK Investigational Site
Miami, Florida, 33186, United States
GSK Investigational Site
Miami Lakes, Florida, 33014-2473, United States
GSK Investigational Site
Miami Lakes, Florida, 33016, United States
GSK Investigational Site
New Port Richey, Florida, 34653, United States
GSK Investigational Site
Orlando, Florida, 32825, United States
GSK Investigational Site
Pinellas Park, Florida, 33781, United States
GSK Investigational Site
Plantation, Florida, 33324, United States
GSK Investigational Site
Port Orange, Florida, 32127, United States
GSK Investigational Site
St. Petersburg, Florida, 33704, United States
GSK Investigational Site
Tampa, Florida, 33615-3219, United States
GSK Investigational Site
Adairsville, Georgia, 30103, United States
GSK Investigational Site
Johns Creek, Georgia, 30022-7484, United States
GSK Investigational Site
Lawrenceville, Georgia, 30046, United States
GSK Investigational Site
Woodstock, Georgia, 30189, United States
GSK Investigational Site
Chicago, Illinois, 60602, United States
GSK Investigational Site
Evansville, Indiana, 47714, United States
GSK Investigational Site
Valparaiso, Indiana, 46383, United States
GSK Investigational Site
Iowa City, Iowa, 52246-2209, United States
GSK Investigational Site
Lexington, Kentucky, 40503, United States
GSK Investigational Site
Natchitoches, Louisiana, 71457-6215, United States
GSK Investigational Site
Baltimore, Maryland, 21224-2141, United States
GSK Investigational Site
Columbia, Maryland, 21044, United States
GSK Investigational Site
Lathrup Village, Michigan, 48076, United States
GSK Investigational Site
St Louis, Missouri, 63141, United States
GSK Investigational Site
Las Vegas, Nevada, 89106, United States
GSK Investigational Site
Toms River, New Jersey, 08755, United States
GSK Investigational Site
Albuquerque, New Mexico, 87108, United States
GSK Investigational Site
The Bronx, New York, 10455, United States
GSK Investigational Site
Charlotte, North Carolina, 28054, United States
GSK Investigational Site
Gastonia, North Carolina, 28054, United States
GSK Investigational Site
Greenville, North Carolina, 29340, United States
GSK Investigational Site
Hickory, North Carolina, 28601, United States
GSK Investigational Site
Shelby, North Carolina, 28150, United States
GSK Investigational Site
Wilmington, North Carolina, 28401, United States
GSK Investigational Site
Winston-Salem, North Carolina, 27103, United States
GSK Investigational Site
Cincinnati, Ohio, 45236, United States
GSK Investigational Site
Columbus, Ohio, 43016, United States
GSK Investigational Site
Columbus, Ohio, 43215, United States
GSK Investigational Site
Hilliard, Ohio, 43026, United States
GSK Investigational Site
Kettering, Ohio, 45439-2201, United States
GSK Investigational Site
Norman, Oklahoma, 73072, United States
GSK Investigational Site
Oklahoma City, Oklahoma, 73111, United States
GSK Investigational Site
Portland, Oregon, 97220, United States
GSK Investigational Site
Altoona, Pennsylvania, 15801, United States
GSK Investigational Site
Philadelphia, Pennsylvania, 19140, United States
GSK Investigational Site
Anderson, South Carolina, 29621, United States
GSK Investigational Site
Charleston, South Carolina, 29406-7108, United States
GSK Investigational Site
Clinton, South Carolina, 29325, United States
GSK Investigational Site
Fort Mill, South Carolina, 29707, United States
GSK Investigational Site
Greenville, South Carolina, 29615, United States
GSK Investigational Site
Rock Hill, South Carolina, 29732, United States
GSK Investigational Site
Spartanburg, South Carolina, 29303, United States
GSK Investigational Site
Knoxville, Tennessee, 37909, United States
GSK Investigational Site
Corsicana, Texas, 75110, United States
GSK Investigational Site
Dallas, Texas, 75225-6301, United States
GSK Investigational Site
Houston, Texas, 77042-4643, United States
GSK Investigational Site
Houston, Texas, 77479, United States
GSK Investigational Site
Lampasas, Texas, 76550, United States
GSK Investigational Site
McAllen, Texas, 78503, United States
GSK Investigational Site
McKinney, Texas, 75069, United States
GSK Investigational Site
San Antonio, Texas, 78229, United States
GSK Investigational Site
San Antonio, Texas, 78258, United States
GSK Investigational Site
Sherman, Texas, 75092, United States
GSK Investigational Site
Webster, Texas, 77598, United States
GSK Investigational Site
Rutland, Vermont, 05701, United States
GSK Investigational Site
Berazategui Buenos Aires, B1884AAC, Argentina
GSK Investigational Site
Buenos Aires, 1646, Argentina
GSK Investigational Site
Buenos Aires, C1426ABP, Argentina
GSK Investigational Site
Ciudad AutOnoma de Buenos Aire, C1425AZE, Argentina
GSK Investigational Site
Ciudad Autonoma de Bueno, C1122AAK, Argentina
GSK Investigational Site
Ciudad Autonoma de Bueno, C1414AIF, Argentina
GSK Investigational Site
Córdoba, X5003DCE, Argentina
GSK Investigational Site
La Plata, B1902COS, Argentina
GSK Investigational Site
Lobos, 7240, Argentina
GSK Investigational Site
Mar del Plata, 7600, Argentina
GSK Investigational Site
Mar del Plata, B7600DHK, Argentina
GSK Investigational Site
Mendoza, 5500, Argentina
GSK Investigational Site
Mendoza, M5500CCG, Argentina
GSK Investigational Site
Quilmes, B1878FNR, Argentina
GSK Investigational Site
Rosario, 2000, Argentina
GSK Investigational Site
Rosario, S2002OJN, Argentina
GSK Investigational Site
Rosario Provincia de Santa FE, C1121ABE, Argentina
GSK Investigational Site
San Miguel de Tucumán, 4000, Argentina
GSK Investigational Site
San Rafael, 5600, Argentina
GSK Investigational Site
Coffs Harbour, New South Wales, 2450, Australia
GSK Investigational Site
New Lambton, New South Wales, 2305, Australia
GSK Investigational Site
Sydney, New South Wales, 2010, Australia
GSK Investigational Site
Westmead, New South Wales, 2145, Australia
GSK Investigational Site
Kent Town, South Australia, 5067, Australia
GSK Investigational Site
Frankston, Victoria, 3199, Australia
GSK Investigational Site
Jambes, 5100, Belgium
GSK Investigational Site
Liège, 4000, Belgium
GSK Investigational Site
Yvoir, 5530, Belgium
GSK Investigational Site
Porto Alegre, 90035-074, Brazil
GSK Investigational Site
Porto Alegre, 90430-000, Brazil
GSK Investigational Site
Porto Alegre, 90610000, Brazil
GSK Investigational Site
São Paulo, 05403-000, Brazil
GSK Investigational Site
Vancouver, British Columbia, V5Z 4E1, Canada
GSK Investigational Site
Truro, Nova Scotia, B2N 1L2, Canada
GSK Investigational Site
Ajax, Ontario, L1S 2J5, Canada
GSK Investigational Site
Newmarket, Ontario, L3Y 5G8, Canada
GSK Investigational Site
Sarnia, Ontario, N7T 4X3, Canada
GSK Investigational Site
Windsor, Ontario, N8X 1T3, Canada
GSK Investigational Site
Saint-Charles-Borromée, Quebec, J6E 2B4, Canada
GSK Investigational Site
Baotou, 014010, China
GSK Investigational Site
Beijing, 100020, China
GSK Investigational Site
Beijing, 100029, China
GSK Investigational Site
Beijing, 100034, China
GSK Investigational Site
Beijing, 100730, China
GSK Investigational Site
Changchun, 130021, China
GSK Investigational Site
Changchun, 130041, China
GSK Investigational Site
Changsha, 410004, China
GSK Investigational Site
Changsha, 410005, China
GSK Investigational Site
Changsha, 410008, China
GSK Investigational Site
Changsha, 410013, China
GSK Investigational Site
Guangzhou, 510080, China
GSK Investigational Site
Guangzhou, 510150, China
GSK Investigational Site
Guangzhou, 51080, China
GSK Investigational Site
Hangzhou, 310006, China
GSK Investigational Site
Hangzhou, 310009, China
GSK Investigational Site
Hohehot, 010050, China
GSK Investigational Site
Jiaxing, 314001, China
GSK Investigational Site
Jinan, 250013, China
GSK Investigational Site
Nanchang, 330006, China
GSK Investigational Site
Nanchang, 330038, China
GSK Investigational Site
Nanchang, 330200, China
GSK Investigational Site
Nanjing, 210009, China
GSK Investigational Site
Nanjing, 210029, China
GSK Investigational Site
Nanning, 530021, China
GSK Investigational Site
Qingdao, 266071, China
GSK Investigational Site
Sanya, 570311, China
GSK Investigational Site
Shanghai, 200032, China
GSK Investigational Site
Shanghai, 200040, China
GSK Investigational Site
Shanghai, 200120, China
GSK Investigational Site
Shanghai, 201100, China
GSK Investigational Site
Taiyuan, 30000, China
GSK Investigational Site
Taizhou, 318000, China
GSK Investigational Site
Ürümqi, 830054, China
GSK Investigational Site
Wuhan, 430024, China
GSK Investigational Site
Wuxi, 214023, China
GSK Investigational Site
Xiamen, 361004, China
GSK Investigational Site
Xining, 810007, China
GSK Investigational Site
Xinxiang, 453000, China
GSK Investigational Site
Zhuhai, 519001, China
GSK Investigational Site
Zigong, 643036, China
GSK Investigational Site
Aalborg, 9100, Denmark
GSK Investigational Site
Hvidovre, DK-2650, Denmark
GSK Investigational Site
Kbenhavn N, 2100, Denmark
GSK Investigational Site
Koebenhavn NV, 2400, Denmark
GSK Investigational Site
Odense C, DK-5000, Denmark
GSK Investigational Site
Roskilde, 4000, Denmark
GSK Investigational Site
Vejle, 7100, Denmark
GSK Investigational Site
Tallinn, 50-088, Estonia
GSK Investigational Site
Brest, 29609, France
GSK Investigational Site
Cholet, 49300, France
GSK Investigational Site
Clermont-Ferrand, 63000, France
GSK Investigational Site
Epagny Metz-Tessy, 74374, France
GSK Investigational Site
Le Mans, 72000, France
GSK Investigational Site
Lyon, 69004, France
GSK Investigational Site
Montpellier, 34295, France
GSK Investigational Site
Mulhouse, 68100, France
GSK Investigational Site
Berlin, 10119, Germany
GSK Investigational Site
Berlin, 10367, Germany
GSK Investigational Site
Berlin, 10717, Germany
GSK Investigational Site
Berlin, 10787, Germany
GSK Investigational Site
Berlin, 12157, Germany
GSK Investigational Site
Berlin, 12203, Germany
GSK Investigational Site
Berlin, 12627, Germany
GSK Investigational Site
Cottbus, 03050, Germany
GSK Investigational Site
Frankfurt, 60313, Germany
GSK Investigational Site
Frankfurt, 60389, Germany
GSK Investigational Site
Frankfurt, 60596, Germany
GSK Investigational Site
Fürstenwalde, 15517, Germany
GSK Investigational Site
Geesthacht, 21502, Germany
GSK Investigational Site
Gelsenkirchen, 45879, Germany
GSK Investigational Site
Halle, 06108, Germany
GSK Investigational Site
Immenhausen, 34376, Germany
GSK Investigational Site
Koblenz, 56068, Germany
GSK Investigational Site
Leipzig, 04103, Germany
GSK Investigational Site
Leipzig, 04207, Germany
GSK Investigational Site
Leipzig, 04275, Germany
GSK Investigational Site
Leipzig, 04357, Germany
GSK Investigational Site
Lübeck, 23552, Germany
GSK Investigational Site
Mainz, 55131, Germany
GSK Investigational Site
Neu-Isenburg, 63263, Germany
GSK Investigational Site
Peine, 31224, Germany
GSK Investigational Site
Rheine, 48431, Germany
GSK Investigational Site
Rodgau, 63110, Germany
GSK Investigational Site
Schleswig, 24837, Germany
GSK Investigational Site
Stuttgart, 70378, Germany
GSK Investigational Site
Alexandroupoli, 68100, Greece
GSK Investigational Site
Athens, 106 76, Greece
GSK Investigational Site
Athens, 11527, Greece
GSK Investigational Site
Ioannina, 455 00, Greece
GSK Investigational Site
Rio Patras, 26054, Greece
GSK Investigational Site
Thessaloniki, 57010, Greece
GSK Investigational Site
Budapest, 1036, Hungary
GSK Investigational Site
Budapest, 1125, Hungary
GSK Investigational Site
Debrecen, 4025, Hungary
GSK Investigational Site
Debrecen, 4032, Hungary
GSK Investigational Site
Gyula, 5700, Hungary
GSK Investigational Site
Hajdúnánás, 4080, Hungary
GSK Investigational Site
Hatvan, 3000, Hungary
GSK Investigational Site
Pécs, 7635, Hungary
GSK Investigational Site
Siófok, 8600, Hungary
GSK Investigational Site
Törökbálint, 2045, Hungary
GSK Investigational Site
Zalaegerszeg, 8900, Hungary
GSK Investigational Site
Ahmedabad, 380052, India
GSK Investigational Site
Hyderabad, 500003, India
GSK Investigational Site
Hyderabad, 500018, India
GSK Investigational Site
Jaipur, 302023, India
GSK Investigational Site
Kanpur, 208001, India
GSK Investigational Site
Lucknow, 226003, India
GSK Investigational Site
Nagpur, 440012, India
GSK Investigational Site
Nagpur, 44009, India
GSK Investigational Site
New Delhi, 110005, India
GSK Investigational Site
New Delhi, 110060, India
GSK Investigational Site
Puducherry, 202002, India
GSK Investigational Site
Drogheda, A92 VW28, Ireland
GSK Investigational Site
Dublin, D15 X40D, Ireland
GSK Investigational Site
Dublin, D24 NR0A, Ireland
GSK Investigational Site
Dublin, DO4T6F4, Ireland
GSK Investigational Site
Galway, H53 T971, Ireland
GSK Investigational Site
Limerick, V94 F858, Ireland
GSK Investigational Site
Ashkelon, 78278, Israel
GSK Investigational Site
Beer-Yaakov, 703000, Israel
GSK Investigational Site
Haifa, 34362, Israel
GSK Investigational Site
Holon, 58100, Israel
GSK Investigational Site
Jerusalem, 91031, Israel
GSK Investigational Site
Jerusalem, 91120, Israel
GSK Investigational Site
Kfar Saba, 44281, Israel
GSK Investigational Site
Petah Tikva, 49100, Israel
GSK Investigational Site
Ramat Gan, 52621, Israel
GSK Investigational Site
Rehovot, 76100, Israel
GSK Investigational Site
Bari, 70020, Italy
GSK Investigational Site
Ferrara, 44123, Italy
GSK Investigational Site
Roma, 00128, Italy
GSK Investigational Site
Telese Terme BN, 82037, Italy
GSK Investigational Site
Verona, 37134, Italy
GSK Investigational Site
Guadalajara, 44100, Mexico
GSK Investigational Site
Guadalajara, 44160, Mexico
GSK Investigational Site
Jalisco, 44130, Mexico
GSK Investigational Site
Monterrey, 64020, Mexico
GSK Investigational Site
Monterrey, 64460, Mexico
GSK Investigational Site
Breda, 4818 CK, Netherlands
GSK Investigational Site
Groningen, 9728 NT, Netherlands
GSK Investigational Site
Heerlen, 6419 PC, Netherlands
GSK Investigational Site
Rotterdam, 3045 PM, Netherlands
GSK Investigational Site
The Hague, 2545 AA, Netherlands
GSK Investigational Site
Zutphen, 7207 AE, Netherlands
GSK Investigational Site
Auckland, 1051, New Zealand
GSK Investigational Site
Hamilton, 3240, New Zealand
GSK Investigational Site
Havelock North, 4130, New Zealand
GSK Investigational Site
Rotorua, 3010, New Zealand
GSK Investigational Site
Wellington, 6021, New Zealand
GSK Investigational Site
Bialystok, 15-044, Poland
GSK Investigational Site
Bydgoszcz, 85-796, Poland
GSK Investigational Site
Częstochowa, 42202, Poland
GSK Investigational Site
Elblag, 82-300, Poland
GSK Investigational Site
Gdansk, 80-382, Poland
GSK Investigational Site
Gdynia, 81-537, Poland
GSK Investigational Site
Katowice, 40-040, Poland
GSK Investigational Site
Katowice, 40-081, Poland
GSK Investigational Site
Kielce, 25-751, Poland
GSK Investigational Site
Krakow, 30-033, Poland
GSK Investigational Site
Krakow, 31-209, Poland
GSK Investigational Site
Lodz, 90-127, Poland
GSK Investigational Site
Lodz, 90-141, Poland
GSK Investigational Site
Ostrowiec Świętokrzyski, 27-400, Poland
GSK Investigational Site
Poznan, 60-214, Poland
GSK Investigational Site
Poznan, 60-702, Poland
GSK Investigational Site
Rzeszów, 35-051, Poland
GSK Investigational Site
Rzeszów, 35-205, Poland
GSK Investigational Site
Sopot, 81-741, Poland
GSK Investigational Site
Sosnowiec, 41-200, Poland
GSK Investigational Site
Warsaw, 01-192, Poland
GSK Investigational Site
Warsaw, 02-777, Poland
GSK Investigational Site
Wroclaw, 53-301, Poland
GSK Investigational Site
Zamość, 22-400, Poland
GSK Investigational Site
Daegu, 42415, South Korea
GSK Investigational Site
Incheon, 21431, South Korea
GSK Investigational Site
Incheon, 21565, South Korea
GSK Investigational Site
Jeonju, 54907, South Korea
GSK Investigational Site
Seoul, 02447, South Korea
GSK Investigational Site
Seoul, 02559, South Korea
GSK Investigational Site
Seoul, 02841, South Korea
GSK Investigational Site
Seoul, 06591, South Korea
GSK Investigational Site
Seoul, 143-729, South Korea
GSK Investigational Site
Alzira, 46600, Spain
GSK Investigational Site
Barcelona, 08003, Spain
GSK Investigational Site
Barcelona, 08017, Spain
GSK Investigational Site
Barcelona, 08036, Spain
GSK Investigational Site
Barcelona, 08907, Spain
GSK Investigational Site
Benalmádena, 29630, Spain
GSK Investigational Site
Cadiz, 10009, Spain
GSK Investigational Site
Cáceres, 10003, Spain
GSK Investigational Site
Galdakano, 48960, Spain
GSK Investigational Site
Granada, 18014, Spain
GSK Investigational Site
Granada, 18300, Spain
GSK Investigational Site
HebrOn, 08035, Spain
GSK Investigational Site
Madrid, 28007, Spain
GSK Investigational Site
Marbella, 29603, Spain
GSK Investigational Site
Pozuelo de AlarcOn Madr, 28223, Spain
GSK Investigational Site
Santiago de Compostela, 15706, Spain
GSK Investigational Site
Valencia, 46520, Spain
GSK Investigational Site
Zaragoza, 50009, Spain
GSK Investigational Site
Härnösand, SE-871 31, Sweden
GSK Investigational Site
Malmo, SE-211 52, Sweden
GSK Investigational Site
Uppsala, SE-752 37, Sweden
GSK Investigational Site
Taichung, 40705, Taiwan
GSK Investigational Site
Taipei, 11490, Taiwan
GSK Investigational Site
Birmingham, B15 2SQ, United Kingdom
GSK Investigational Site
Cardiff, CF159SS, United Kingdom
GSK Investigational Site
Glasgow, G20 0SP, United Kingdom
GSK Investigational Site
Hardwick, TS19 8PE, United Kingdom
GSK Investigational Site
Hexham, NE46 1QJ, United Kingdom
GSK Investigational Site
Lancashire, PR7 7NA, United Kingdom
GSK Investigational Site
Liverpool, CF15 9SS, United Kingdom
GSK Investigational Site
London, W1G 8HU, United Kingdom
GSK Investigational Site
Manchester, M15 6SE, United Kingdom
GSK Investigational Site
Norwich, NR4 7UY, United Kingdom
GSK Investigational Site
Reading, B15 2SQ, United Kingdom
GSK Investigational Site
Wishaw, ML2 0DP, United Kingdom
Related Publications (1)
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.
PMID: 40305712BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- GSK Response Center
- Organization
- GlaxoSmithKline
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
- Expanded Access
- Yes
Study Record Dates
First Submitted
October 18, 2019
First Posted
October 21, 2019
Study Start
October 30, 2019
Primary Completion
August 8, 2024
Study Completion
August 8, 2024
Last Updated
August 15, 2025
Results First Posted
August 15, 2025
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Time Frame
- IPD will be made available within 6 months of publishing the results of the primary endpoints of the study.
- Access Criteria
- Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
IPD for this study will be made available via the Clinical Study Data Request site.