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)

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.

Study Overview

• Status: Completed
• Conditions: Pulmonary Disease, Chronic Obstructive
• Intervention / Treatment: Biological: Mepolizumab; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 806
• Phase: Phase 3

Expanded Access

No longer available outside the clinical trial. See expanded access record.

Contacts and Locations

Study Locations

• Argentina
  • Berazategui Buenos Aires, Argentina, B1884AAC
    • GSK Investigational Site
  • Buenos Aires, Argentina, C1426ABP
    • GSK Investigational Site
  • Buenos Aires, Argentina, 1646
    • GSK Investigational Site
  • Ciudad AutOnoma de Buenos Aire, Argentina, C1425AZE
    • GSK Investigational Site
  • Ciudad Autonoma De Bueno, Argentina, C1122AAK
    • GSK Investigational Site
  • Ciudad Autonoma De Bueno, Argentina, C1414AIF
    • GSK Investigational Site
  • Cordoba, Argentina, X5003DCE
    • GSK Investigational Site
  • La Plata, Argentina, B1902COS
    • GSK Investigational Site
  • Lobos, Argentina, 7240
    • GSK Investigational Site
  • Mar Del Plata, Argentina, B7600DHK
    • GSK Investigational Site
  • Mar del Plata, Argentina, 7600
    • GSK Investigational Site
  • Mendoza, Argentina, M5500CCG
    • GSK Investigational Site
  • Mendoza, Argentina, 5500
    • GSK Investigational Site
  • Quilmes, Argentina, B1878FNR
    • GSK Investigational Site
  • Rosario, Argentina, 2000
    • GSK Investigational Site
  • Rosario, Argentina, S2002OJN
    • GSK Investigational Site
  • Rosario Provincia De Santa FE, Argentina, C1121ABE
    • GSK Investigational Site
  • San Rafael, Argentina, 5600
    • GSK Investigational Site
  • Tucuman, Argentina, 4000
    • GSK Investigational Site
• Australia
  • New South Wales
    • Coffs Harbour, New South Wales, Australia, 2450
      • GSK Investigational Site
    • New Lambton, New South Wales, Australia, 2305
      • GSK Investigational Site
    • Sydney, New South Wales, Australia, 2010
      • GSK Investigational Site
    • Westmead, New South Wales, Australia, 2145
      • GSK Investigational Site
  • South Australia
    • Kent Town, South Australia, Australia, 5067
      • GSK Investigational Site
  • Victoria
    • Frankston, Victoria, Australia, 3199
      • GSK Investigational Site
• Belgium
  • Jambes, Belgium, 5100
    • GSK Investigational Site
  • LiEge, Belgium, 4000
    • GSK Investigational Site
  • Yvoir, Belgium, 5530
    • GSK Investigational Site
• Brazil
  • Porto Alegre, Brazil, 90610000
    • GSK Investigational Site
  • Porto Alegre, Brazil, 90035-074
    • GSK Investigational Site
  • Porto Alegre, Brazil, 90430-000
    • GSK Investigational Site
  • SAo Paulo, Brazil, 05403-000
    • GSK Investigational Site
• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z 4E1
      • GSK Investigational Site
  • Nova Scotia
    • Truro, Nova Scotia, Canada, B2N 1L2
      • GSK Investigational Site
  • Ontario
    • Ajax, Ontario, Canada, L1S 2J5
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    • Newmarket, Ontario, Canada, L3Y 5G8
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    • Sarnia, Ontario, Canada, N7T 4X3
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    • Windsor, Ontario, Canada, N8X 1T3
      • GSK Investigational Site
  • Quebec
    • St-Charles-Borromee, Quebec, Canada, J6E 2B4
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• China
  • Baotou, China, 014010
    • GSK Investigational Site
  • Beijing, China, 100034
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  • Beijing, China, 100029
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  • Beijing, China, 100730
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  • Beijing, China, 100020
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  • Changchun, China, 130021
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  • Changchun, China, 130041
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  • Changsha, China, 410013
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  • Changsha, China, 410008
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  • Changsha, China, 410005
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  • Changsha, China, 410004
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  • Guangzhou, China, 510080
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  • Guangzhou, China, 510150
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  • Guangzhou, China, 51080
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  • Hangzhou, China, 310009
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  • Hangzhou, China, 310006
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  • Hohehot, China, 010050
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  • Jiaxing, China, 314001
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  • Jinan, China, 250013
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  • Nanchang, China, 330006
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  • Nanchang, China, 330038
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  • Nanchang, China, 330200
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  • Nanjing, China, 210009
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  • Nanjing, China, 210029
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  • Nanning, China, 530021
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  • Qingdao, China, 266071
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  • Sanya, China, 570311
    • GSK Investigational Site
  • Shanghai, China, 200040
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  • Shanghai, China, 200032
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  • Shanghai, China, 200120
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  • Shanghai, China, 201100
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  • Taiyuan, China, 30000
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  • Taizhou, China, 318000
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  • Urumqi, China, 830054
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  • Wuhan, China, 430024
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  • Wuxi, China, 214023
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  • Xiamen, China, 361004
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  • Xining, China, 810007
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  • Xinxiang, China, 453000
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  • Zhuhai, China, 519001
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  • Zigong, China, 643036
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• Denmark
  • Aalborg, Denmark, 9100
    • GSK Investigational Site
  • Hvidovre, Denmark, DK-2650
    • GSK Investigational Site
  • Kbenhavn N, Denmark, 2100
    • GSK Investigational Site
  • Koebenhavn NV, Denmark, 2400
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  • Odense C, Denmark, DK-5000
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  • Roskilde, Denmark, 4000
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  • Vejle, Denmark, 7100
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• Estonia
  • Tallinn, Estonia, 50-088
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• France
  • Brest, France, 29609
    • GSK Investigational Site
  • Cholet, France, 49300
    • GSK Investigational Site
  • Clermont Ferrand, France, 63000
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  • Epagny Metz-Tessy, France, 74374
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  • Le Mans, France, 72000
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  • Lyon, France, 69004
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  • Montpellier cedex, France, 34295
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  • Mulhouse, France, 68100
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• Germany
  • Berlin, Germany, 10367
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  • Berlin, Germany, 10717
    • GSK Investigational Site
  • Berlin, Germany, 10119
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  • Berlin, Germany, 10787
    • GSK Investigational Site
  • Berlin, Germany, 12627
    • GSK Investigational Site
  • Berlin, Germany, 12203
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  • Berlin, Germany, 12157
    • GSK Investigational Site
  • Cottbus, Germany, 03050
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  • Frankfurt, Germany, 60313
    • GSK Investigational Site
  • Frankfurt, Germany, 60596
    • GSK Investigational Site
  • Frankfurt, Germany, 60389
    • GSK Investigational Site
  • Fuerstenwalde, Germany, 15517
    • GSK Investigational Site
  • Geesthacht, Germany, 21502
    • GSK Investigational Site
  • Gelsenkirchen, Germany, 45879
    • GSK Investigational Site
  • Halle, Germany, 06108
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  • Immenhausen, Germany, 34376
    • GSK Investigational Site
  • Koblenz, Germany, 56068
    • GSK Investigational Site
  • Leipzig, Germany, 04207
    • GSK Investigational Site
  • Leipzig, Germany, 04103
    • GSK Investigational Site
  • Leipzig, Germany, 04275
    • GSK Investigational Site
  • Leipzig, Germany, 04357
    • GSK Investigational Site
  • Luebeck, Germany, 23552
    • GSK Investigational Site
  • Mainz, Germany, 55131
    • GSK Investigational Site
  • Neu-Isenburg, Germany, 63263
    • GSK Investigational Site
  • Peine, Germany, 31224
    • GSK Investigational Site
  • Rheine, Germany, 48431
    • GSK Investigational Site
  • Rodgau, Germany, 63110
    • GSK Investigational Site
  • Schleswig, Germany, 24837
    • GSK Investigational Site
  • Stuttgart, Germany, 70378
    • GSK Investigational Site
• Greece
  • Alexandroupolis, Greece, 68100
    • GSK Investigational Site
  • Athens, Greece, 106 76
    • GSK Investigational Site
  • Athina, Greece, 11527
    • GSK Investigational Site
  • Ioannina, Greece, 455 00
    • GSK Investigational Site
  • Rio Patras, Greece, 26054
    • GSK Investigational Site
  • Thessaloniki, Greece, 57010
    • GSK Investigational Site
• Hungary
  • Budapest, Hungary, 1036
    • GSK Investigational Site
  • Budapest, Hungary, 1125
    • GSK Investigational Site
  • Debrecen, Hungary, 4025
    • GSK Investigational Site
  • Debrecen, Hungary, 4032
    • GSK Investigational Site
  • Gyula, Hungary, 5700
    • GSK Investigational Site
  • Hajdunanas, Hungary, 4080
    • GSK Investigational Site
  • Hatvan, Hungary, 3000
    • GSK Investigational Site
  • Pecs, Hungary, 7635
    • GSK Investigational Site
  • Siofok, Hungary, 8600
    • GSK Investigational Site
  • TOrOkbAlint, Hungary, 2045
    • GSK Investigational Site
  • Zalaegerszeg, Hungary, 8900
    • GSK Investigational Site
• India
  • Ahmedabad, India, 380052
    • GSK Investigational Site
  • Hyderabad, India, 500018
    • GSK Investigational Site
  • Hyderabad, India, 500003
    • GSK Investigational Site
  • Jaipur, India, 302023
    • GSK Investigational Site
  • Kanpur, India, 208001
    • GSK Investigational Site
  • Lucknow, India, 226003
    • GSK Investigational Site
  • Nagpur, India, 440012
    • GSK Investigational Site
  • Nagpur, India, 44009
    • GSK Investigational Site
  • New Delhi, India, 110060
    • GSK Investigational Site
  • New Delhi, India, 110005
    • GSK Investigational Site
  • Pondichery, India, 202002
    • GSK Investigational Site
• Ireland
  • Drogheda, Ireland, A92 VW28
    • GSK Investigational Site
  • Dublin, Ireland, D24 NR0A
    • GSK Investigational Site
  • Dublin, Ireland, DO4T6F4
    • GSK Investigational Site
  • Dublin 15, Ireland, D15 X40D
    • GSK Investigational Site
  • Galway, Ireland, H53 T971
    • GSK Investigational Site
  • Limerick, Ireland, V94 F858
    • GSK Investigational Site
• Israel
  • Ashkelon, Israel, 78278
    • GSK Investigational Site
  • Beer-Yaakov, Israel, 703000
    • GSK Investigational Site
  • Haifa, Israel, 34362
    • GSK Investigational Site
  • Holon, Israel, 58100
    • GSK Investigational Site
  • Jerusalem, Israel, 91031
    • GSK Investigational Site
  • Jerusalem, Israel, 91120
    • GSK Investigational Site
  • Kfar Saba, Israel, 44281
    • GSK Investigational Site
  • Petach Tikva, Israel, 49100
    • GSK Investigational Site
  • Ramat Gan, Israel, 52621
    • GSK Investigational Site
  • Rehovot, Israel, 76100
    • GSK Investigational Site
• Italy
  • Bari, Italy, 70020
    • GSK Investigational Site
  • Ferrara, Italy, 44123
    • GSK Investigational Site
  • Roma, Italy, 00128
    • GSK Investigational Site
  • Telese Terme BN, Italy, 82037
    • GSK Investigational Site
  • Verona, Italy, 37134
    • GSK Investigational Site
• Korea, Republic of
  • Daegu, Korea, Republic of, 42415
    • GSK Investigational Site
  • Incheon, Korea, Republic of, 21565
    • GSK Investigational Site
  • Incheon, Korea, Republic of, 21431
    • GSK Investigational Site
  • Jeonju, Korea, Republic of, 54907
    • GSK Investigational Site
  • Seoul, Korea, Republic of, 143-729
    • GSK Investigational Site
  • Seoul, Korea, Republic of, 06591
    • GSK Investigational Site
  • Seoul, Korea, Republic of, 02559
    • GSK Investigational Site
  • Seoul, Korea, Republic of, 02447
    • GSK Investigational Site
  • Seoul, Korea, Republic of, 02841
    • GSK Investigational Site
• Mexico
  • Guadalajara, Mexico, 44160
    • GSK Investigational Site
  • Guadalajara, Mexico, 44100
    • GSK Investigational Site
  • Jalisco, Mexico, 44130
    • GSK Investigational Site
  • Monterrey, Mexico, 64460
    • GSK Investigational Site
  • Monterrey, Mexico, 64020
    • GSK Investigational Site
• Netherlands
  • Breda, Netherlands, 4818 CK
    • GSK Investigational Site
  • Den Haag, Netherlands, 2545 AA
    • GSK Investigational Site
  • Groningen, Netherlands, 9728 NT
    • GSK Investigational Site
  • Heerlen, Netherlands, 6419 PC
    • GSK Investigational Site
  • Rotterdam, Netherlands, 3045 PM
    • GSK Investigational Site
  • Zutphen, Netherlands, 7207 AE
    • GSK Investigational Site
• New Zealand
  • Auckland, New Zealand, 1051
    • GSK Investigational Site
  • Hamilton, New Zealand, 3240
    • GSK Investigational Site
  • Havelock North, New Zealand, 4130
    • GSK Investigational Site
  • Rotorua, New Zealand, 3010
    • GSK Investigational Site
  • Wellington, New Zealand, 6021
    • GSK Investigational Site
• Poland
  • Bialystok, Poland, 15-044
    • GSK Investigational Site
  • Bydgoszcz, Poland, 85-796
    • GSK Investigational Site
  • Czestochowa, Poland, 42202
    • GSK Investigational Site
  • Elblag, Poland, 82-300
    • GSK Investigational Site
  • Gdansk, Poland, 80-382
    • GSK Investigational Site
  • Gdynia, Poland, 81-537
    • GSK Investigational Site
  • Katowice, Poland, 40-040
    • GSK Investigational Site
  • Katowice, Poland, 40-081
    • GSK Investigational Site
  • Kielce, Poland, 25-751
    • GSK Investigational Site
  • Krakow, Poland, 30-033
    • GSK Investigational Site
  • Krakow, Poland, 31-209
    • GSK Investigational Site
  • Lodz, Poland, 90-127
    • GSK Investigational Site
  • Lodz, Poland, 90-141
    • GSK Investigational Site
  • Ostrowiec Swietokrzyski, Poland, 27-400
    • GSK Investigational Site
  • Poznan, Poland, 60-214
    • GSK Investigational Site
  • Poznan, Poland, 60-702
    • GSK Investigational Site
  • Rzeszow, Poland, 35-051
    • GSK Investigational Site
  • Rzeszow, Poland, 35-205
    • GSK Investigational Site
  • Sopot, Poland, 81-741
    • GSK Investigational Site
  • Sosnowiec, Poland, 41-200
    • GSK Investigational Site
  • Warszawa, Poland, 01-192
    • GSK Investigational Site
  • Warszawa, Poland, 02-777
    • GSK Investigational Site
  • Wroclaw, Poland, 53-301
    • GSK Investigational Site
  • Zamosc, Poland, 22-400
    • GSK Investigational Site
• Spain
  • Alzira, Spain, 46600
    • GSK Investigational Site
  • Barcelona, Spain, 08036
    • GSK Investigational Site
  • Barcelona, Spain, 08003
    • GSK Investigational Site
  • Barcelona, Spain, 08907
    • GSK Investigational Site
  • Barcelona, Spain, 08017
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  • BenalmAdena, Spain, 29630
    • GSK Investigational Site
  • Caceres, Spain, 10003
    • GSK Investigational Site
  • Cadiz, Spain, 10009
    • GSK Investigational Site
  • Galdakano, Spain, 48960
    • GSK Investigational Site
  • Granada, Spain, 18014
    • GSK Investigational Site
  • Granada, Spain, 18300
    • GSK Investigational Site
  • HebrOn, Spain, 08035
    • GSK Investigational Site
  • Madrid, Spain, 28007
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  • Marbella, Spain, 29603
    • GSK Investigational Site
  • Pozuelo De AlarcOn Madr, Spain, 28223
    • GSK Investigational Site
  • Santiago de Compostela, Spain, 15706
    • GSK Investigational Site
  • Valencia, Spain, 46520
    • GSK Investigational Site
  • Zaragoza, Spain, 50009
    • GSK Investigational Site
• Sweden
  • Harnosand, Sweden, SE-871 31
    • GSK Investigational Site
  • Malmo, Sweden, SE-211 52
    • GSK Investigational Site
  • Uppsala, Sweden, SE-752 37
    • GSK Investigational Site
• Taiwan
  • Taichung, Taiwan, 40705
    • GSK Investigational Site
  • Taipei, Taiwan, 11490
    • GSK Investigational Site
• United Kingdom
  • Birmingham, United Kingdom, B15 2SQ
    • GSK Investigational Site
  • Cardiff, United Kingdom, CF159SS
    • GSK Investigational Site
  • Glasgow, United Kingdom, G20 0SP
    • GSK Investigational Site
  • Hardwick, United Kingdom, TS19 8PE
    • GSK Investigational Site
  • Hexham, United Kingdom, NE46 1QJ
    • GSK Investigational Site
  • Lancashire, United Kingdom, PR7 7NA
    • GSK Investigational Site
  • Liverpool, United Kingdom, CF15 9SS
    • GSK Investigational Site
  • London, United Kingdom, W1G 8HU
    • GSK Investigational Site
  • Manchester, United Kingdom, M15 6SE
    • GSK Investigational Site
  • Norwich, United Kingdom, NR4 7UY
    • GSK Investigational Site
  • Reading, United Kingdom, B15 2SQ
    • GSK Investigational Site
  • Wishaw, United Kingdom, ML2 0DP
    • GSK Investigational Site
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35211
      • GSK Investigational Site
    • Dothan, Alabama, United States, 36305
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    • Huntsville, Alabama, United States, 77340
      • GSK Investigational Site
    • Jasper, Alabama, United States, 35501
      • GSK Investigational Site
    • Sheffield, Alabama, United States, 35660
      • GSK Investigational Site
  • Arizona
    • Chandler, Arizona, United States, 85224
      • GSK Investigational Site
    • Chandler, Arizona, United States, 29720-1709
      • GSK Investigational Site
    • Gilbert, Arizona, United States, 85296
      • GSK Investigational Site
    • Mesa, Arizona, United States, 85206
      • GSK Investigational Site
    • Phoenix, Arizona, United States, 85020
      • GSK Investigational Site
    • Phoenix, Arizona, United States, 85050
      • GSK Investigational Site
    • Phoenix, Arizona, United States, 85018
      • GSK Investigational Site
    • Phoenix, Arizona, United States, 89014
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    • Tucson, Arizona, United States, 85741
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  • Arkansas
    • Conway, Arkansas, United States, 72032
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  • California
    • Alpine, California, United States, 92262
      • GSK Investigational Site
    • Cerritos, California, United States, 90703
      • GSK Investigational Site
    • Newport Beach, California, United States, 92663
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    • Riverside, California, United States, 92506
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    • San Diego, California, United States, 92120
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    • Torrance, California, United States, 90503-4818
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    • Vista, California, United States, 92083
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  • Colorado
    • Colorado Springs, Colorado, United States, 80907
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  • Florida
    • Boynton Beach, Florida, United States, 33472-2952
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    • Clearwater, Florida, United States, 33765
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    • Daytona Beach, Florida, United States, 32117
      • GSK Investigational Site
    • Doral, Florida, United States, 33172-1604
      • GSK Investigational Site
    • Fort Pierce, Florida, United States, 34950-4832
      • GSK Investigational Site
    • Gainesville, Florida, United States, 32608
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    • Hialeah, Florida, United States, 33016
      • GSK Investigational Site
    • Homestead, Florida, United States, 33032
      • GSK Investigational Site
    • Miami, Florida, United States, 33126
      • GSK Investigational Site
    • Miami, Florida, United States, 33144
      • GSK Investigational Site
    • Miami, Florida, United States, 33174
      • GSK Investigational Site
    • Miami, Florida, United States, 33186
      • GSK Investigational Site
    • Miami, Florida, United States, 33155
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    • Miami, Florida, United States, 33144-257
      • GSK Investigational Site
    • Miami, Florida, United States, 33173-3259
      • GSK Investigational Site
    • Miami, Florida, United States, 33186-6597
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    • Miami Lakes, Florida, United States, 33016
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    • Miami Lakes, Florida, United States, 33014-2473
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    • New Port Richey, Florida, United States, 34653
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    • Orlando, Florida, United States, 32825
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    • Pinellas Park, Florida, United States, 33781
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    • Plantation, Florida, United States, 33324
      • GSK Investigational Site
    • Port Orange, Florida, United States, 32127
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    • Saint Petersburg, Florida, United States, 33704
      • GSK Investigational Site
    • Tampa, Florida, United States, 33615-3219
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  • Georgia
    • Adairsville, Georgia, United States, 30103
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    • Johns Creek, Georgia, United States, 30022-7484
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    • Lawrenceville, Georgia, United States, 30046
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    • Woodstock, Georgia, United States, 30189
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  • Illinois
    • Chicago, Illinois, United States, 60602
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  • Indiana
    • Evansville, Indiana, United States, 47714
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    • Valparaiso, Indiana, United States, 46383
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  • Iowa
    • Iowa City, Iowa, United States, 52246-2209
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  • Kentucky
    • Lexington, Kentucky, United States, 40503
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  • Louisiana
    • Natchitoches, Louisiana, United States, 71457-6215
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  • Maryland
    • Baltimore, Maryland, United States, 21224-2141
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    • Columbia, Maryland, United States, 21044
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  • Michigan
    • Lathrup Village, Michigan, United States, 48076
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  • Missouri
    • Saint Louis, Missouri, United States, 63141
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  • Nevada
    • Las Vegas, Nevada, United States, 89106
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  • New Jersey
    • Toms River, New Jersey, United States, 08755
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  • New Mexico
    • Albuquerque, New Mexico, United States, 87108
      • GSK Investigational Site
  • New York
    • Bronx, New York, United States, 10455
      • GSK Investigational Site
  • North Carolina
    • Charlotte, North Carolina, United States, 28054
      • GSK Investigational Site
    • Gastonia, North Carolina, United States, 28054
      • GSK Investigational Site
    • Greenville, North Carolina, United States, 29340
      • GSK Investigational Site
    • Hickory, North Carolina, United States, 28601
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    • Shelby, North Carolina, United States, 28150
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    • Wilmington, North Carolina, United States, 28401
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    • Winston-Salem, North Carolina, United States, 27103
      • GSK Investigational Site
  • Ohio
    • Cincinnati, Ohio, United States, 45236
      • GSK Investigational Site
    • Columbus, Ohio, United States, 43215
      • GSK Investigational Site
    • Columbus, Ohio, United States, 43016
      • GSK Investigational Site
    • Hilliard, Ohio, United States, 43026
      • GSK Investigational Site
    • Kettering, Ohio, United States, 45439-2201
      • GSK Investigational Site
  • Oklahoma
    • Norman, Oklahoma, United States, 73072
      • GSK Investigational Site
    • Oklahoma City, Oklahoma, United States, 73111
      • GSK Investigational Site
  • Oregon
    • Portland, Oregon, United States, 97220
      • GSK Investigational Site
  • Pennsylvania
    • Altoona, Pennsylvania, United States, 15801
      • GSK Investigational Site
    • Philadelphia, Pennsylvania, United States, 19140
      • GSK Investigational Site
  • South Carolina
    • Anderson, South Carolina, United States, 29621
      • GSK Investigational Site
    • Charleston, South Carolina, United States, 29406-7108
      • GSK Investigational Site
    • Clinton, South Carolina, United States, 29325
      • GSK Investigational Site
    • Fort Mill, South Carolina, United States, 29707
      • GSK Investigational Site
    • Greenville, South Carolina, United States, 29615
      • GSK Investigational Site
    • Rock Hill, South Carolina, United States, 29732
      • GSK Investigational Site
    • Spartanburg, South Carolina, United States, 29303
      • GSK Investigational Site
  • Tennessee
    • Knoxville, Tennessee, United States, 37909
      • GSK Investigational Site
  • Texas
    • Corsicana, Texas, United States, 75110
      • GSK Investigational Site
    • Dallas, Texas, United States, 75225-6301
      • GSK Investigational Site
    • Houston, Texas, United States, 77042-4643
      • GSK Investigational Site
    • Houston, Texas, United States, 77479
      • GSK Investigational Site
    • Lampasas, Texas, United States, 76550
      • GSK Investigational Site
    • McAllen, Texas, United States, 78503
      • GSK Investigational Site
    • McKinney, Texas, United States, 75069
      • GSK Investigational Site
    • San Antonio, Texas, United States, 78229
      • GSK Investigational Site
    • San Antonio, Texas, United States, 78258
      • GSK Investigational Site
    • Sherman, Texas, United States, 75092
      • GSK Investigational Site
    • Webster, Texas, United States, 77598
      • GSK Investigational Site
  • Vermont
    • Rutland, Vermont, United States, 05701
      • GSK Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.
• 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.

Exclusion Criteria:

• 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.
• 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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mepolizumab 100 mg; Participants 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.	Biological: Mepolizumab; 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.
Experimental: Placebo; Participants 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.	Drug: Placebo; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	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.	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	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.	Baseline and Week 52
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.	Baseline and 4-weeks prior to Week 52
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.	Up to Week 104

Collaborators and Investigators

• Sponsor: GlaxoSmithKline
• Collaborators: PPD Development, LP
• Investigators: Study Director: GSK Clinical Trials, GlaxoSmithKline

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 30, 2019
• Primary Completion (Actual): August 8, 2024
• Study Completion (Actual): August 8, 2024

Study Registration Dates

• First Submitted: October 18, 2019
• First Submitted That Met QC Criteria: October 18, 2019
• First Posted (Actual): October 21, 2019

Study Record Updates

• Last Update Posted (Estimated): August 15, 2025
• Last Update Submitted That Met QC Criteria: July 30, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: COPD; Mepolizumab; Exacerbations; MATINEE
• Additional Relevant MeSH Terms: Pathologic Processes; Chronic Disease; Disease Attributes; Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: 208657

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: IPD for this study will be made available via the Clinical Study Data Request site.
• IPD Sharing Time Frame: IPD will be made available within 6 months of publishing the results of the primary endpoints of the study.
• IPD Sharing 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 Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No