Study
Covariates
HZC112206 (NCT01053988)13 and HZC112207 (NCT01054885)15
Trough FEV1 and trough FEV1 responders, WM FEV1 04 hours post-dose: study, treatment, smoking status at screening, baseline FEV1, day, geographical region, age subgroup, day by baseline interaction, day by treatment interaction, age subgroup by treatment interaction, and age subgroup by day by treatment interactions
Trough FVC: study, treatment, smoking status at screening, baseline FVC, day, geographical region, age subgroup, day by baseline interaction, day by treatment interaction
FEV1 ratio: study, treatment, log baseline FEV1, geographical region, smoking status, day, age subgroup, day by log baseline, day by treatment, age subgroup by treatment and age subgroup by day by treatment interactions
Study with UMEC
DB2113373
(NCT01313650)17
Trough FEV1, WM FEV1 06 hours post-dose, trough FEV1 responders and trough FVC: treatment, baseline, smoking status, center group, day, day by baseline and day by treatment interactions. Analysis was performed on each subgroup level separately
FEV1 ratio: treatment, smoking status at screening, log baseline FEV1, day, center group, day by log baseline and day by treatment interactions. Analysis was performed on each subgroup level separately
Studies with UMEC + FF/VI
Pooled data from studies
200110 (NCT02119286)18
Trough FEV1, WM FEV1 06 hours post-dose, trough FEV1 responders and trough FVC: study, treatment, baseline FEV1 or FVC, smoking status, day, age subgroup, day by baseline, day by treatment, age subgroup by treatment and age subgroup by day by treatment interactions
FEV1 ratio: study, treatment, log baseline FEV1, smoking status, day, age subgroup, day by log baseline, day by treatment, age subgroup by treatment and age subgroup by day by treatment interactions
FEV1, forced expiratory volume in 1 second; FF, fluticasone furoate; FVC, forced vital capacity; UMEC, umeclidinium; VI, vilanterol; WM, weighted mean.
Supplementary Table 2. IEC/IRB committees that approved the clinical trials analyzed in this study
Study: 113373
Ethics Committee for Multicentre Trials, 8, Damyan Gruev, Sofia, 1303, Bulgaria
Institutional Review Board Services, Suite 300, 372 Hollandview Trail, Aurora, L4G 0A5, Canada
Conjoint Health Research Ethics Board, Office of Medical Bioethics, Room 93, Heritage Medical Research Building, 3330 Hospital Drive NW, Calgary, T2N 4N1, Canada
Concordia Hospital, 1095 Concordia Avenue, Winnipeg, Manitoba, R2K 3S8, Canada
Comite d'ethique de la Recherche de l'hopital, 2725 Chemin Sainte-Foy, Quebec, G1V 4G5, Canada
Comité d'éthique à la Recherche du CSSSNL- Centre Hospitalier Regional de Lanaudiére, 1000, Boulevard Ste-Anne, St-Charles- Borromée, Québec, J6E 6J2, Canada
Comité de Evaluación Ético Científico, Quinto Piso, Avenida Brasil No 1435, Valparaíso, Chile
Comité de Ética Hospital Regional de Rancagua, Avenida Libertador Bernardo O'Higgins No 611, Rancagua, Reg Del Libert Bern O’Higgins, 2841959, Chile
Comite Etico Cientifico Servicio de Salud Metropolitano Central, Santa Rosa 1234, Santiago, Región Metro De Santiago, 8360160, Chile
Comité de Etica Científica del Servicio de Salud Viña del Mar- Quillota, Calle Limache1307 2 Piso Esquina Peñablanca, Viña del Mar, 2570017, Chile
Comité de Evaluación Ético Científico SSMSO, Avenida Concha y Toro No 3459 - Puente Alto, Santiago, Región Metro De Santiago, 8207257, Chile
Comité Ético Científico, Secretaría Ministerial de Salud Región del Bío Bío, Caupolicán 518, 4° Piso, Of. 417, Concepción, Región Del Biobio, 4030576, Chile
Comité Ético Científico, Servicio de Salud Metropolitano Sur, Santa Rosa 3453, San Miguel, Santiago, Región Metro De Santiago, 8900390, Chile
IKEM a FTN, Eticka Komise, Videnska 800, Praha 4, 140 59, Czech Republic
Nemocnice Kyjov, Eticka Komise, Strazovska 976, Kyjov, 697 01, Czech Republic
Eticka Komise pri Nemocnici s Poliklinikou v Novem Jicine, K Nemocnici 76, Novy Jicin, 74101, Czech Republic
National Ethics Committee, 284, Messogion Avenue, Athens, 15562, Greece
Mito Medical Center, Institutional Review Board, 280, Sakuranosato, Ibaraki-Cho, Higashi-Ibaraki-GunIbaraki, 311–3193, Japan
Dokkyo Medical University Koshigaya Hospital, Institutional Review Board, 2-1-50, Minamikoshigaya, Koshigaya City, Saitama, 343-8555, Japan
Southern Tohoku Medical Clinic, 7–161, Yatsuyamada, Koriyama-Shi, Fukushima, 963–8052, Japan
Nihon University Itabashi Hospital, Institutional Review Board, 30-1, Ohyaguchi, Kami- Cho, Itabashi-Ku, Tokyo, 173– 8610, Japan
Medical Corporation Shinkenkai Suzuki Internal Medicine Cardiovascular Medicine, 202, Maison de Statue, 1-39-5, Sangenjaya, Setagaya-Ku, Tokyo, 154–0024, Japan
AMC Nishi-Umeda Clinic, Institutional Review Board, 3-3- 45, Umeda, Kita-Ku, Osaka-City, Osaka, 530–0001, Japan
Tokyo-Eki Center-building Clinic, Institutional Review Board, Tokyo-Eki Center-Building, 3-3-14, Nihombashi, Chuo-Ku, Tokyo, 103–0027, Japan
Kumamoto Saishunso National Hospital, Institutional Review Board, 2659, Suya, Koushi-City, Kumamoto, 861–1196, Japan
Kumamoto Saishunso National Hospital, 2659, Suya, Koushi- city, Kumamoto, 861–1196, Japan
Nakatani Hospital, Institutional Review Board, 458-1, Hosoe, Shikama-Ku, Himeji-City, Hyogo, 672–8064, Japan
Osaka General Medical Center, Institutional Review Board, 3–1– 56, Bandaihigashi, Sumiyoshi- Ku, Osaka-City, Osaka, 558–8558, Japan
Hitachi, Ltd., Hitachinaka General, Hospital, Institutional Review Board, 20–1, Ishikawa- Cho, Hitachinaka-City, Ibaraki, 312–0057, Japan
Matsue Red Cross Hospital, Institutional Review Board, 200, Horomachi, Matsue-city, Shimane, 690–8506, Japan
Matsue Medical Center, Institutional Review Board, 5-8- 31, Agenogi, Matsue, Shimane, 690–8556, Japan
Hiratsuka Kyosai Hospital, Institutional Review Board, 9-11, Oiwake, Hiratsuka-City, Kanagawa, 254–8502, Japan
Comite de Bioetica del Hospital Christus Muguerza, Poniente No.715 Col. Centro, Puebla, 72000, Mexico
Instituto Jalisciense de Investigación Clínica, S.A. de C.V., Penitenciaria 20, Guadalajara, Jalisco, 44100, Mexico
Comite de Ensenanza Investigacion y Etica del Hospital Real San Jose, Avenida Lázaro Cárdenas No 4135 Colonia Jardines de San Ignacio, Zapopan, Jalisco, 45040, Mexico
Komisja Bioetyczna przy OIL w Warszawie, ul. Pulawska 18, Warszawa, 02–512, Poland
Saratov State Medical University, 112, Bolshaya Kazachaya, Saratov, 410012, Russian Federation
Northen Medical Clinical Center N.A. Semashko, Troitskiy prospect, 115, Arkhangelsk, 163000, Russian Federation
Local Ethics Committee of Krasnoyarsk State Medical University, Partizana Zheleznyaka Street 3a, Krasnoyarsk, 660022, Russian Federation
Local Ethics Committee of St. Petersburg State Healthcare Institution, Prosp. Veteranov, 89 St. Petersburg, 198260, Russian Federation
Russian Medical Academy of Postgraduate Education Barrikadnaya Street, 2/1, Moscow 123995, Russian Federation
St. George The Martyr City Hospital, Severny pr., 1 St.Petersburg, 194354, Russian Federation
Local Ethics Committee of The State Educational Institution of Additional Professional Education of Russian Medical Academy of Post-Graduate Education, 2/1, Barrikadnaya Street, Moscow, 123995, Russian Federation
Yaroslavl Regional Clinical Hospital, Yakovlevskaya Street, 7, Yaroslavl, 150062, Russian Federation
Ethics Committee of City Hospital 6, Admiralskogo Street, Pyatigorsk, 357538, Russian Federation
Local Ethics Committee of The Novosibirsk State Regional Clinical Hospital, Novosibirsk Nemirovicha- Danchenko, Russian Federation
Siberian State Medical University 2, Moskovsky Trakt, Tomsk, 634 050, Russian Federation
Nizhniy Novgorod Region Clinical Hospital Endocrinology and Diabetology Department 190, Rodionova Street, Nizhniy Novgorod, 603126, Russian Federation
Far Easte Scientific Centre Phisiology End Pathology Respiration, Kalinina Street 22 Blagovetchensk, 675000, Russian Federation
Local Ethics Committee of Saint Petersburg State Medical University, Rentgena Street 10, Saint Petersburg, 197101 Russian Federation
Local Ethics Committee of The Clinical Medical Unit 1, Gagarina Bulvar, 68, Perm, 614077, Russian Federation
Local Ethics Committee of the State, Educational Institution of the Highest Professional Education, Bashkirsky State Medical University of Roszdrav, 3 Lenina Street, Ufa, 450000, Russian Federation
City Hospital 17, Volynskaya Street 7, Building 1, 2, 5, Moscow 119620, Russian Federation
Pharma Ethics, 123 Amcor Road, Lyttelton Manor, 157, South Africa
University of Cape Town, Human Research Ethics Committee, Room E52.24, Old Main Building, Groote Schuur Hospital, Main Road, Observatory, 7925, South Africa
University of Stellenbosch, Human Research Ethics Committee 2, Suite 5006 Faculty of Health Sciences, Fransie van Zijl Drive, Tygerberg, 7505, South Africa
Pharma Ethics, 123 Amcor Road, Lyttelton Manor, 157, South Africa
CEIC de Cantabria Fundación Marqués de Valdecilla, Escuela de Enfermeria Planta 5ª, Avda. de, Valdecilla, s/n Santander, 39008, Spain
Hospital Germans Trias i Pujol Comité de Investigación Clínica, Ctra. Canyet s/n 08916, Badalona, Spain
Clínica Mediterránea de Neurociencias Camino Viejo Alicante-Elche, s/n 03114 Alicante, Spain
Comité Etico de Investigación, Trias I Pujol, Ctra. Canyet, s/n, Badalona, 08915, Spain
Hospital la Paz, Planta 8, Paseo de la Castellana 261, Madrid, 28047, Spain
CEIC de las Islas Baleares Camino de Jesús, 8 Palma de Mallorca, 07011, Spain
Comite Etico de Inv. Clinica de Navarra, Patellon de Docencia, Recinto Hospital de Navarra, Irunlarrea, 3, Pamptona (Navarra), 31000, Spain
Hospital Germans Trias i Pujol Comité de Investigación Clínica Ctra. Canyet s/n, Badalona, 08916, Spain
Imma Guasch Fundació Unió Catalana d'Hospitals, C/ Bruc 72 1a, Barcelona, 08009, Spain
Instituto de Asistencia Sanitaria, Doctor Castany, s/n, Gerona, 17190, Spain
Lleida "Arnau de Vilanova" Avda. Alcalde Rovira Roure, 80, 1ª Planta del Edificio Antiguo, Lerida, 25198, SpainSERGAS, C/San Lazaro, Santingo, 15703, Spain
Institutional Review Board, Faculty of Medicine, Khonkaen University, Dean Office 6th Floor, Mitraphap Road, Khonkaen, 40002, Thailand
Institutional Review Board, Royal Thai Army Medical Department, 317 Rajavithi Road, Bangkok, 10400, Thailand
Prince of Songkla University, Institutional Review Board of Faculty ofMedicine, Punnakan Road, Hatyai, Songkhla, 90110 Thailand
Institutional Review Board, Faculty of Medicine, Chulalongkorn University, 1873 Rama 4 Road, Patumwan, Bangkok, 10330, Thailand
Research Ethics Committee, Faculty of Medicine, ChiangMai University, 110 Intravaroros Road, Ampur Muang, ChiangMai, 50200, Thailand
Institute for the Development of Human Research Protections (IHRP), Building 8, Floor 7, Room 702, Department of Medical Sciences Ministry of Public Health, Nonthaburi, 11000, Thailand
Chesapeake Research Review, Inc., Suite 110, 7063 Columbia Gateway Drive, Columbia, Maryland, 21046-3431, United States
McGuire Institutional Review Board, McGuire VA Medical Center, 1201 Broad Rock, Boulevard 151, Richmond, Virginia, 23249, United States
University of Arizona, Human Subjects Protection Program, PO Box 245137, 1618 E Helen Street, Tucson, Arizona, 85724 5137, United States
Institutional Review Board for Human Subject Research For Baylor College of Medicine and Affiliated Hospitals, One Baylor Plaza, Room 600D, Houston, Texas, 77030, United States
Study: HZC112207 [NCT01054885]
Comite de Etica lndependiente en lnvestigacion Cllnica Dr. Carlos A. Barclay, Larrea 1381 3º A, C1117ABK Ciudad Autonoma de Buenos Aires Argentina
Comite de Docencia e lnvestigacion INSARES, M5500CCG Mendoza, Argentina
Comite de Etica en lnvestigacion lnstituto de lnvestigaciones Clinicas Av. Colon 3364 PB, Mar del Plata, Buenos Aires, Argentina
Multicentricka eticka komise IKEM a FTNsP, Fakultni Thomayerova nemocnice s poliklinikou, Videnska 800, 140 59 Praha 4, Czech Republic
Eticka komise, Nemocnice Tabor, Kpt. Jarose 2000, 390 19 Tabor, Czech Republic
Eticka Komise, Vitkpvicke nemocnice a.s., Zaluzanskeho 1192/15, 703 84 OstravaVitkovice Czech Republic
Eticka komise FN Brno, Jihlavska 20, 625 00 Brno, Czech Republic
Ethik-Kommission der Aerztekammer Schleswig-Holstein, Bismarckallee 8–12 23795 Bad Segeberg Germany
Asamoto Naika lin Institutional Review Board, Haimuwisutaria Bldg. 1F, 1, Fukakusahottacho, Fushimi-ku, Kyoto-city, Kyoto, 612–0026, Japan
Institutional Review Board of Japanese Red Cross Kyoto Diani Hospital, 355–5, Haruobicho, Kamanzadori, Marutamachi, Agaru, Kamigyoku, Kyoto city, Kyoto 602–8026 Japan
National Hospital Organization Central Review Board 2–5–21 Higashigaoka, Meguro-ku, 1520021, Japan
Keiaikai Nakagami Hospital, Institutional Review Board 625-5, Chibana, Okinawa-City, Okinawa, 904-2195, Japan
Social Medical Corporation Institutional Review Board of Kameda General Hospital, 929 Higashicho, Kamogawa-city, Chiba
Medicaline Corporation Shinkenkai Suzuki Internal medicine Cardiovascular Medicine, Institutional Review Board 202, Maison de Statue 1-39-5-, Sangenjaya, SetagayaKu, Tokyo, 154-0024, Japan
AMC Nishi-umeda Clinic Institutional Review Board, 3-345, Umeda, Kita-ku, Osakacity, Osaka 530-0001, Japan
Social Medical Corporation Keiaikai Nakagami Hospital, Institutional Review Board, 625–5, Chibana, Okinawa-City, Okinawa, 904-2195, Japan
Hospital, 2190, Sakai-cho, Sashima-gun, Ibaraki, 3060433 Japan National Hospital Organization Central Review Board 2-5-21, Higashigaoka, Meguroku, Tokyo, 152–0021, Japan
Komisja Bioetyczna przy Instytucie Gruzlicy I Chorob Pluc ul. Plocka 26, 01-138 Warszawa, Polska
National Drug Agency, 48 Aviator Sanatescu Street, District 1, postal code 011478, Bucharest, Romania
National Ethics Committee, 48 Aviator Sanatescu Street, District 1, postal code 011478, Bucharest, Romania
Ethics Committee under Federal Service on Surveillance in Healthcare and Social Development, Petrovskiy bulvar, 8, str. 2, Moscow, 127051, Russian Federation
Ethics Committee attached to FGU Scientific Research Institute of Pulmonology, 32/61, 11-Parkovaya Street, Moscow, 105077, Russian Federation
Ethics Committee attached to State Educational Institution of the Highest Professional Education "Krasnoyarsk State Medical University named after Prof. V.F.Vojno-Jasenetskiy of Minzdravsocrazvitya of Russia", 1, Partizana Zheleznyaka str., Krasnoyarsk, 660022, Russian Federation
Ethics Committee attached to City Polyclinic #94, 24, Tovarishcheskiy prospect, Saint-Petersburg 193231 Russian Federation
Komarov Local Ethics Committee attached to Kazan Research Institute of Epidemiology and Microbiology, 67, Bolshaya Krasnaya ul. Kazan. 420015, Russian Federation
Local Independent Ethics Committee attached to State Educational Institution of the Postgraduate Professional Education "Ural state medical academy of postgraduate education", 51 Molodogvardeycev Str., Chelyabinsk, 454136, Russian Federation
Ethics Committee attached to State Educational Institution of the Highest Professional Education "Moscow Medical Academy named after I.M Sechenov of Roszdrav", 8, Trubetskaya str., Building 2. 119991, Moscow, Russian Federation
Komarov Ethics Committee attached to Clinical Hospital #2, d. 24, Ul. Popova. Yaroslavl, 150010, Russian Federation
Ethics Committee attached to St. George the Martyr City Hospital, 1, Sevemy pr., SaintPetersburg, 194354 Russian Federation
Ethics Committee attached to City Clinical Hospital #3, 22, Ostrovskogo str., Kemerovo, 650099 Russian Federation
Ethics Committee attached to City Consultative Diagnostic Center #1, 10, Sikeyrosa street, Saint-Petersburg, 194354 Russian Federation
Komarov Ethics Committee attached to City Clinical Hospital # 11, 6, Dvintsev str., Moscow, 127018, Russian Federation
Central Ethics Committee, Ministry of Health of Ukraine 5, Narodnogo Opolchennya str. 03151 Kyiv, Ukraine
Local Ethics Committee, Kharkiv City Hospital #13, 137 Gagarina Str, 61035, Kharkiv Ukraine
Local Ethics Committee Institute of Phthisiatry and Pulmonology, 10, Amosova Str 03680 Kiev Ukraine
Local Ethics Committee Research lnstitute of Gerontology 67, Vyshgorodskaya str., 01114, Kyiv, Ukraine
Local Ethics Committee Kyiv city tuberculosis hospital # 1, 121/3, Kharkivske shosse, 02091, Kyiv, Ukraine
Local Ethics Committee Vinnytsia City Clinical Hospital # 1, 96, Khmelnytske shosse, 21029, Vinnytsia, Ukraine
Local Ethics Committee, City Clinical Hospital #6, 13, Batumska str. 49051, Dnipropetrovsk, Ukraine
Local Ethics Committee Odesa Regional Clinical Hospital, 26, Zabolotnogo str, 65117 Odesa Ukraine
Local Ethics Committee, Research Center of Radiation Medicine, 119/121 Peremogy avenue, Kyiv 04050 Ukraine
Local Ethics Committee Simferopol Railroad Hospital, 142, Kyivska str., 95043, Simferopol, Ukraine
Schulman Associates IRB, Inc. 4290 Glendale-Milford Road, Cincinnati, Ohio, 45242, United States
Palmetto Health Institutional Review Boards, Research Administration, 5 Medical Patk, Columbia, South Carolina, 29203, United States
Birmingham VA Institutional Review Board, Department of Veterans Affairs Medical Center, 700 South 19’ th streets, Birmingham, Alabama, 35233, United States
Human Studies SubCommittee, Bay Pines VA Healthcare System, Research and Development Service (151), 10000 Bay pines Blvd., Bay Pines, Florida, 33744, United States
Scott & White Institutional Review Board, 2401 South 31st Street, Temple, Texas 76508, United States
Study: HZC112206 [NCT01053988]
Comite Etico Cientifico Servicio de salud Valparaiso-San Antonio, Av. Brasil 1435 Valparaiso Chile, 2362731
Comité de Ética Científico Servicio Salud Araucanía Sur. Andrés Bello 636 Temuco, Chile
Comite Etico Cientifico Servicio de salud Metropolitano Oriente, Av. Salvador 364 - Providencia, Santiago, Chile 7500922
Comite de Etica, Hospital Dipreca, Vital Apoquindo 1200 - Las Condes, Santiago, Chile 7601003
Comite Etico Cientifico Servicio de salud Metropolitano Sur Oriente, Av. Concha y Toro 3459, Puente Alto - Santiago, Chile, Post Code 8207257
Comite Etico Cientifico Servicio de Salud Metropolitano Norte, San Jose 1053 Independencia, Santiago, Chile, Post code 8380755
Comite de etica de Investigacion en seres humanos, Universidad de Chile, Facultad de Medicina, Independencia 1027, Santiago, Chile, Post Code 8380453
Tallinn Medical Research Ethics Committee, National Institute for Health Development, Hiiu 42, Talliinn 11619, Estonia
Ethik-Kommission der, Aerztekammer Schleswig-Holstein, Bismarckallee 8–12, 23795 Bad Segeberg, Germany
Institutional Review Board, Kishiwada City Hospital 1001, Gakuhara-cho, Kishiwadacity, Osaka, 596–8501, Japan
Institutional Review Board, Medical Corporation Shintoukai Yokohama minoru Clinic, 1-1-3- 8, Besyo, Minami-ku, Yokohama-shi, Kanagawa, 232-0064, Japan
Nagata Hospital Institutional Review Board, 523-1, Shimormiyanaga-machi, Yanagawashi, Fukuoka, 832-0059, Japan
Arima Kondou Kinen Medical Foundation Tomisaka Hospital Institutional Review Board, 5F, Sasaki Building, 2-5-7, Kishikawa, Bunkyo-ku, Tokyo, 112-0002, Japan
Institutional Review Board, Kyushu Central Hospital of the Mutual Aid Association of Public School Teachers, 3-23-1, Shiobaru, Minami-ku, Fukuoka-shi, Fukuoka, 81 58588, Japan
Institutional Review Board, Sakaide City Hospital, 6-43, Bunkyo-cho 1-chome, Sakaide-city, Kagawa, 762-0031, Japan
Institutional Review Board, National Hospital Organization Ibarakihigashi National Hospital, 825 Terunuma, Tokai-mura, Nakagun, Ibaraki, 319-1113, Japan
Institutional Review Board, Medical Corporation-Junkokai Koto Hospital, 6-8-5, Ojima, Koto-ku, Tokyo, 136-0072, Japan
Institutional Review Board, Nagano Prefectural Suzaka Hospital, 1332, Suzaka, Suzaka-city, Nagano, 382-0091, Japan
Institutional Review Board, Iwata City, Hospital, 512-3, Okubo, Iwata-City Shizuoka 438-8550, Japan
Institutional Review Board of Gachon Medical Center, 1198 Guwol-dong, Namdong-gu, Incheon, Korea, 405-760
Hallym University Sacred Heart Hospital, 896, Pyeongchon-dong, Dongan-Gu, Anyang-Si, Gyeonggi-do, Korea, 431-070
Institutional Review Board of The Catholic University of Korea, Uijeongbu St.Mary’s Hospital, 65-1, Kumoh-dong, Uijeongbu-si, Kyonggi-do, Korea, 480-130
Institutional Review Board of Korea University Anam Hospital, 126-1, AnamDong 5-ga, 136-705 Sungbuk-Ku, Seoul, Korea, 136-705
Yeungnam University Medical Center IRB, 317-1 Daemyung-dong, Nam-gu Daegu, Korea, 705-717
Institutional Review Board, St. Paul's Hospital, 620-56 Jeonnong-2dong, Dongdaemun-gu, Seoul, Korea, 130-848
Institutional Review Board, Soonchunhyang University Bucheon Hospital, 1174 Jungdong, Wonmi-gu, Bucheon-si, Korea, 420-767
Korea University Guro Hospital IRB, 80 Guro-dong, Guro-gu, Seoul, Korea, 152-703
Wonju Christian Hospital, 162 Insan-dong Wonju-si, Kangwon-do, Korea, 220-701 IRB of Konkuk University Hospital, 4-12, Hwayang-dong, Gwangjin-gu, Seoul, Korea, 143-729
Comite de Etica Cardiolink Clin Trials, Avenida Hidalgo 1813 A Poniente. Coloinia Obispado, Monterrey, Nuevo Leon, C.P, Mexico, 64060
Comite de Etica del Instituto Jalisciense de Investigacion Clinica, S.A. de C.V., Penitenciaria 20 Colonia Centro, Guadalajara, Jalisco, C.P, Mexico, 44100
Comite Bioetico para la Investigacion Clinica, S.C., Puebla 422-4, Col. Roma, Mexico D. F, C.P, Mexico, 06700
Comite de Etica de la Facultad de Medicina de la UANL y Hospital Universitario "Dr Jose Eleuterio Gonzalez". Edificio de la Biblloteca Central de la Facultad de Medicina de la UANL Planta Baja, Av. Madero Poniente s/n y Dr. E. Aguirre Pequeno, Colonia Mitras Centro, Monterrey, Nuevo León, Mexico, 64460
Comite de Ethica e Investigacion de la Unidad de Investigacion clinica en medicina S. C, Av. La Clínica 2520 Int. 520, 522 y 524. Col. Sertoma, Monterrey, Nuevo León, Mexico, 64718
Research and Ethics Committee, Veterans Memorial Medical Center, North Avenue, Quezon City, Philippines, 1101
Institutional Ethics Committee, Mary Mediatrix Medical Center, J.P. Laurel Highway, Lipa City, Batangas, Philippines, 421
Ethics Committee, St Paul's Hospital, General Luna Street, Iloilo City, Philippines, 5000
Institutional Review Board, The Medical City, Ortigas Avenue, Pasig City, Philippines, 1600
Ethics Committee, Lung Center of the Philippines, Quezon Avenue, Quezon City, Philippines, 1100
Komisja Bloetyki Uniwersytetu Medycznego w Lodzi, Al. Kosciuszki 4, 90–419 Lodz, Polska
Board of Ethic under Minzdravsocrazvitiya of RF, 8 Petrovsky boulevards, Moscow 127051, Russian Federation
Ethics Committee under GOU VPO "Russian State Medical University of Roszdrav", 1, Ostrovltianova Street, Moscow, 117997, Russian Federation
Ethics Commettee under GOU DPO "State Educational Institution of Additional Professional Education Irkutsk State Institution of Postgraduate Physician Education of Roszdrav», 100, microregion Yubileyniy, Irkutsk, 664079, Russia
Ethics Commettee under GUZ “Center of Restorative Medicine and Rehabilitation #2”, 4 Dubinina Str., Shakhty, Rostovskaya Region, 346510, Russia
Ethics Commettee under Yaroslavl Clinical Hospital #2, 7, Yakovlevskaya str., Yaroslavl, 150062, Russia
Ethics Commettee under MUZ "City Hospital #2", 6, Admiralskogo, Pyatigorsk, 357538, Russia
Local Ethics Committee under State Educational institution of the Highest Professional Education, Ural State Medical Academy of Roszdrav 3 Repina street, Ekaterinburg, 620219, Russian Federation
Local Ethics Commettee under MUZ "City Hospital #5", 75, Zmeinogorsky Track, Barnaul, 656045, Russia
Ethics Commeetee under GOU VPO, Sibirsky State Medical University of Roszdrav, 2, Moskovsky Tract, Tomsk, 634050, Russia
Ethics Committee attached to State Educational Institution of the Highest Professional Education, Tumen State Medical Academy Roszdrav 54, Odesskaya street, Tumen, 625023, Russian Federation
Board of Ethic under Minzdravsocrazvitiya of RF, 8 Petrovsky boulevard, Moscow 127051, Russian Federation
Expert Board for Biomedical Ethics for Clinical Disciplines under GOU VPO "Bashkirsky State Medical University of Roszdrav", 3, Lesnaya str., Ufa, 450077, Russia
Ethics Committee of City Hospital #17 GUZ ZAO of Moscow", 7, build. 1, Volynskaya str., 119620, Moscow, Russia
Local Ethics Committee under State Educational Institution of the Highest Professional Education "Samara State Medical University Roszdrav", 89 Chapayevskaya Street, Samara 443099, Russia
Schulman Associates Institutional Review Board, Inc, 4290 Glendale-Milford Road, Cincinnati, Ohio 45242, United States
Western Institutional Review Board, 3535 7th Avenue SW, Olympia, Washington, 98502 Miami VAHCS 2B199, 1201 NW 16th Street, Miami, Florida 33125, United States
Johns Hopkins Medicine Institutional Review Board, Office of Human Research, 1620 McEldarry Street, Reed Hall, Suite B-130, Baltimore, Maryland, 21205, United States
Research and Development Human Studies Subcommittee, 16111 Plummer Street (151), Sepulveda, California, 91343, United States
Study: 200110
Fakultni nemocnice Kralovske Vinohrady, Eticka komise, Budova Q - 1 Patro, Srobarova 1150/50, Praha 10, 100 34, Czech Republic
Nemocnice Tábor, Eticka komise, Kapitána Jaroše 2000/10, Tábor, 390 03, Czech Republic
Vítkovická Nemocnice, a.s., Eticka komise, Zaluanského 1192/15, Ostrava – Vítkovice, 703 84, Czech Republic
Ethikkommission Schleswig-Holstein, Bismarckallee 8–12, Bad Segeberg, 23795, Germany
SMG- Seoul National University Boramae Medical Center Institutional Review Board, #425, Sindaebang-2-dong, Dongjak-gu, Seoul, 156–707, Korea
The Catholic University of Korea Seoul St. Mary’s Hospital, Department of Internal Medicine, 222 Banpo-Daero, Seocho-gu, Seoul, 137-701, Korea
Yeungnam University Medical Center, 317-1 Daemyung-dong, Nam-gu, Daegu, 705-717, Korea
Catholic University of Korea – St. Paul's Hospital, 180, Wangsan-ro, Dongdaemun-gu, Seoul, 130-709, Korea
Kyung Hee University Medical Centre, 23, Kyungheedae-ro, Dongdaemun-gu, Seoul, 130-872, Korea
Hallym University Kangdong Sacred Heart Hospital, 150 Sungnaegil Gangdong-gu, Seoul, 134-701, Korea
University Guro Hospital, 148, Gurodong gil, Guro-gu, Seoul, 152-703, Korea
Wonju Severance Christian Hospital, # 162 Ilsan-dong, Wonju-si, Kangwon-do, 220-701, Korea
Chesapeake Research Review, Inc., 6940 Columbia Gateway Drive, Suite 110, Columbia, Maryland, 21046-3431, United States
Study: 200109
Instituto InAER - Instituto de Investigaciones en Alergia y Enfermedades Respiratorias, Arenales 3146, 1° piso, depto B, Ciudad Autonoma de Buenos Aires, C1425BEN, Argentina
Institutional Review Board Services, Suite 300, 372 Hollandview Trail, Aurora, Ontario, L4G 0A5, Canada
Concordia Hospital, 1095 Concordia Avenue, Winnipeg, Manitoba, R2K 3S8, Canada
Comite d'ethique de la recherche de l'hopital, 2725 Chemin Sainte-Foy, Québec, Québec, G1V 4G5, Canada
Comité de Etica Cientifico del Servicio de Salud Metropolitano Oriente, Avenida Salvador 364, Providencia / Santiago, 7500922, Chile
Comité de Etica Científica del Servicio de Salud Viña del MarQuillota, Calle Limache1307, 2 Piso Esquina Peñablanca, Viña del Mar, 2570017, Chile
Comité Ético Científico Servicio Salud Concepción, San Martín 1436, Concepción, Región Del Biobio, 4070038, Chile
Comité Ético Científico, Servicio de Salud Metropolitano Sur, Santa Rosa 3453, San Miguel, Santiago, Región Metro De Santiago, 8900390, Chile
Comité de Etica Científica del Servicio de Salud Viña del MarQuillota, Calle Limache1307, 2 Piso Esquina Peñablanca, Viña del Mar, 2570017, Chile
Comité de Evaluación Ético Científico SSMSO, Avenida Concha y Toro #3459, Puente Alto, Santiago, Región Metro De Santiago, 8207257, Chile
Comité de Etica de la Investigación Servicio de Salud Metropolitano Norte, San José 1053, Independencia / Santiago, Región Metro De Santiago, 8380755, Chile
Comisia Nationala de Bioetica a medicamentelor si a Dispozitivelor Medicale, Pavilion K, Spitalul Clinic Colentina, Sos. Stefan cel Mare nr. 19-21, Bucureti, 020125, Romania
Chesapeake Research Review Inc., 7063 Columbia Gateway Drive, Suite 110, Columbia, Maryland, 21046, United States
Supplementary Figure 1: Change from baseline in weighted mean FEV1 over the course of the studies comparing FF/VI versus placebo (A, B), UMEC versus placebo (C, D), and UMEC + FF/VI versus placebo + FF/VI (E, F)
n=number of patients with data available for at least 1 time point; **p<0.01; ***p≤0.001 vs placebo.
FEV1, forced expiratory volume in 1 second; FF, fluticasone furoate; LS, least squares; SE, standard error; UMEC, umeclidinium; VI, vilanterol; WM, weighted mean.
Supplementary Figure 2: Change from baseline in trough FVC over the course of the studies comparing FF/VI versus placebo (A, B), UMEC versus placebo (C, D), and UMEC + FF/VI versus placebo + FF/VI (E, F)
n=number of patients with data available for at least 1 time point; ***p≤0.001 vs placebo.