Pragmatic Open - Label Randomized Clinical Trial of FF/UMEC/VI vs Non-ellipta Usual Care ICS-LABA for Adult Participants With Uncontrolled Asthma

Last updated: March 20, 2026
Sponsor: GlaxoSmithKline
Overall Status: Active - Not Recruiting

Phase

4

Condition

Asthma

Treatment

Inhaled corticosteroids/long-acting beta-2 agonists

Fluticasone furoate/umeclidinium bromide/vilanterol trifenatate

Clinical Study ID

NCT06372496
219912
  • Ages 18-75
  • All Genders

Study Summary

The goal of this study is to assess and compare the effectiveness of fluticasone furoate/umeclidinium bromide/vilanterol trifenatate (FF/UMEC/VI) with inhaled corticosteroids/long-acting beta-2 agonists (ICS/LABA) in adult participants with uncontrolled asthma

Eligibility Criteria

Inclusion

Inclusion Criteria:

Participants are eligible to be included in the study only if all of the following criteria apply:

  1. Has a diagnosis of asthma as defined by Global Initiative for Asthma (GINA) 2023guidelines for at least 3 months prior to randomization.

  2. Participants who are either:

  • Currently untreated

  • Treated with daily maintenance ICS or ICS/LABA

  1. ACQ-6 score ≥1.5 at randomization.

  2. Participants able to perform technically acceptable and repeatable FEV1 maneuvers (i.e., a minimum of 2 acceptable and 1 repeatable effort) at visit 2 (V2)

  3. Participants must be able to complete the study questionnaires.

Exclusion

Exclusion Criteria:

Participants are excluded from the study if any of the following criteria apply:

  1. Recent history of life-threatening asthma

  2. History of >1 severe exacerbation of asthma within 12 months prior to randomization.

  3. Women of childbearing potential that are not following at least one highly effectivemethod of contraception. This includes women who are pregnant or lactating or areplanning on becoming pregnant during the study.

  4. A WOCBP must have a negative pregnancy test ≤7 days prior to randomization.

  5. Exposure to inhaler triple therapy [ICS + Long-acting muscarinic antagonist (LAMA) +LABA as Single inhaler triple therapy (SITT) or Multiple inhaler tripletherapy(MITT)] and/or any LAMA-containing therapy within 12 months prior torandomization.

  6. Ongoing need for biologic therapy or recent use of a biologic therapy

  7. Participants with the diagnosis of chronic obstructive pulmonary disease, as perGlobal Initiative for Chronic Obstructive Lung Disease (GOLD 2024) guidelines.

  8. Participants whose current medications include RELVAR ELLIPTA and ARNUITY ELLIPTAare not eligible to enter the study.

  9. Participants who are medically unable to withhold their albuterol/salbutamol for 6hours prior to spirometry testing

  10. Changes in asthma medication (e.g., maintenance ICS/LABA) within 3 months prior torandomization.

  11. Participants with a history of hypersensitivity to any of the study medications

Study Design

Total Participants: 1366
Treatment Group(s): 2
Primary Treatment: Inhaled corticosteroids/long-acting beta-2 agonists
Phase: 4
Study Start date:
April 16, 2024
Estimated Completion Date:
March 31, 2027

Connect with a study center

  • GSK Investigational Site

    Ciudad Autónoma de Buenos Aires, Buenos Aires C1192AAW
    Argentina

    Site Not Available

  • GSK Investigational Site

    Florencio Varela, Buenos Aires 1888
    Argentina

    Site Not Available

  • GSK Investigational Site

    Florencio Varela, Buenos Aires 1888
    Argentina

    Site Not Available

  • GSK Investigational Site

    Cordoba, Córdova X5003DCE
    Argentina

    Site Not Available

  • GSK Investigational Site

    Buenos Aires, FVH1425
    Argentina

    Site Not Available

  • GSK Investigational Site

    Buenos Aires 3435910, C1192AAW
    Argentina

    Site Not Available

  • GSK Investigational Site

    Ciudad AutOnoma de Buenos Aires, C1192AAW
    Argentina

    Site Not Available

  • GSK Investigational Site

    Ciudad Autonoma de Buenos Aire, 1012
    Argentina

    Site Not Available

  • GSK Investigational Site

    Ciudad Autonoma de Buenos Aires, FVH1425
    Argentina

    Site Not Available

  • GSK Investigational Site

    Concepcion del Uruguay, 3260
    Argentina

    Site Not Available

  • GSK Investigational Site

    Concepción del Uruguay, 3260
    Argentina

    Site Not Available

  • GSK Investigational Site

    Concepción del Uruguay 3435264, 3260
    Argentina

    Site Not Available

  • GSK Investigational Site

    Córdoba, X5003DCE
    Argentina

    Site Not Available

  • GSK Investigational Site

    Formosa, 3600
    Argentina

    Site Not Available

  • GSK Investigational Site

    Luján, 6700
    Argentina

    Site Not Available

  • GSK Investigational Site

    Luján de Cuyo, 5509
    Argentina

    Site Not Available

  • GSK Investigational Site

    Mar del Plata, 7600
    Argentina

    Site Not Available

  • GSK Investigational Site

    Mendoza, M5500
    Argentina

    Site Not Available

  • GSK Investigational Site

    Mendoza 3844421, 5577
    Argentina

    Site Not Available

  • GSK Investigational Site

    Quilmes, 1878
    Argentina

    Site Not Available

  • GSK Investigational Site

    Quilmes 3429652, 1878
    Argentina

    Site Not Available

  • GSK Investigational Site

    Rosario, S2000 DEJ
    Argentina

    Site Not Available

  • GSK Investigational Site

    Rosario 3838583, S2000DBS
    Argentina

    Site Not Available

  • GSK Investigational Site

    San Juan Bautista, 1888
    Argentina

    Site Not Available

  • GSK Investigational Site

    San Miguel de Tucumán, T4000AXL
    Argentina

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    Santa Fe, 3000
    Argentina

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    Bruce, Australian Capital Territory 2617
    Australia

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  • GSK Investigational Site

    Bruce 8349301, Australian Capital Territory 2177478 2617
    Australia

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  • GSK Investigational Site

    Blacktown, New South Wales 2148
    Australia

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  • GSK Investigational Site

    Campbelltown, New South Wales 2560
    Australia

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    Coffs Harbour, New South Wales 2450
    Australia

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    Kanwal, New South Wales 2259
    Australia

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  • GSK Investigational Site

    Sydney, New South Wales 2035
    Australia

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  • GSK Investigational Site

    Blacktown 2175411, New South Wales 2155400 2148
    Australia

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  • GSK Investigational Site

    Coffs Harbour 2171085, New South Wales 2155400 2450
    Australia

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  • GSK Investigational Site

    Kanwal 2161863, New South Wales 2155400 2259
    Australia

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    Sydney 2147714, New South Wales 2155400 2035
    Australia

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    Brisbane, Queensland 4006
    Australia

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    Brisbane 2174003, Queensland 2152274 4006
    Australia

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    Murdoch, Western Australia 6163
    Australia

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    Osborne Park, Western Australia 6017
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    Spearwood, Western Australia 6163
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    Osborne Park 6621354, Western Australia 2058645 6017
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    Spearwood 2061224, Western Australia 2058645 6163
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    Brampton, Ontario L6T 0G1
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    Windsor, Ontario N8X 1T3
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    Windsor 6182962, Ontario 6093943 N8X 1T3
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    Trois RiviEres, Quebec G9A 4P3
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    Trois-Rivieres, Quebec G9A 4P3
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    Trois-Rivières, Quebec G9A 4P3
    Canada

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    Trois-Rivières 6169141, Quebec 6115047 G9A 4P3
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    Saskatoon, Saskatchewan S7N OW8
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    Chancheng District, Foshan City 528031
    China

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    Liwan District, Guangzhou 510160
    China

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    North Street, Jiangmen City 52900
    China

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    Nanshan District, 518067
    China

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    Zhuhai, 519099
    China

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    Fukuoka, 832-0059
    Japan

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  • GSK Investigational Site

    Fukuoka 1863967, 802-0083
    Japan

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  • GSK Investigational Site

    Gifu, 509-6134
    Japan

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    Gifu 1863641, 509-6134
    Japan

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    Hiroshima, 730-0013
    Japan

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  • GSK Investigational Site

    Hiroshima 1862415, 730-0853
    Japan

    Site Not Available

  • GSK Investigational Site

    Hyogo, 651-0053
    Japan

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  • GSK Investigational Site

    Hyōgo, 651-0053
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  • GSK Investigational Site

    Hyōgo 2129969, 651-0053
    Japan

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    Kagawa, 761-8073
    Japan

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    Kagawa 1860837, 761-8073
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    Kagoshima, 890-0053
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    Kagoshima 1860827, 890-0053
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    Kanagawa, 252-0143
    Japan

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    Kanagawa 1860292, 252-0143
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    Kumamoto, 860-8556
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    Kumamoto 1858421, 860-8556
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    Kumamoto-shi, 862-0965
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    Matsuyama, 790-0925
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    Matsuyama 1926099, 790-0925
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    Matsuyama-shi, 790-0925
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    Miyagi, 980-0871
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  • GSK Investigational Site

    Miyazaki, 880-2112
    Japan

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  • GSK Investigational Site

    Miyazaki 1856717, 880-2112
    Japan

    Site Not Available

  • GSK Investigational Site

    Nagaoka-Shi, 940-0087
    Japan

    Site Not Available

  • GSK Investigational Site

    Niigata, 950-0088
    Japan

    Site Not Available

  • GSK Investigational Site

    Niigata 1855431, 950-0088
    Japan

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  • GSK Investigational Site

    Oita,
    Japan

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  • GSK Investigational Site

    Okawa-shi, 831-0016
    Japan

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  • GSK Investigational Site

    Shinjuku-kuTokyo, 160-0021
    Japan

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  • GSK Investigational Site

    Tokyo, 157-0066
    Japan

    Site Not Available

  • GSK Investigational Site

    Tokyo 1850147, 145-0063
    Japan

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  • GSK Investigational Site

    Yokohama, 223-0053
    Japan

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  • GSK Investigational Site

    Yokohama 1848354, 223-0053
    Japan

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  • GSK Investigational Site

    Yokohama-shi, 223-0053
    Japan

    Site Not Available

  • GSK Investigational Site

    Ōita,
    Japan

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  • GSK Investigational Site

    Ōita 1854487,
    Japan

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  • GSK Investigational Site

    Daegu, 41404
    Korea, Republic of

    Site Not Available

  • GSK Investigational Site

    Seoul, 158-710
    Korea, Republic of

    Site Not Available

  • GSK Investigational Site

    Busan, 602 702
    South Korea

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  • GSK Investigational Site

    Daegu, 41404
    South Korea

    Site Not Available

  • GSK Investigational Site

    Seongnam-si Gyeonggi-do, 13620
    South Korea

    Site Not Available

  • GSK Investigational Site

    Seoul, 07061
    South Korea

    Site Not Available

  • GSK Investigational Site

    Seoul 1835848, 03080
    South Korea

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  • GSK Investigational Site

    Suwon Kyunggi-do, 16499
    South Korea

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  • GSK Investigational Site

    Kaohsiung, 807
    Taiwan

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  • GSK Investigational Site

    Kaohsiung City, 807
    Taiwan

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  • GSK Investigational Site

    Kaohsiung City 1673820, 807
    Taiwan

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  • GSK Investigational Site

    Taichung, 407219
    Taiwan

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  • GSK Investigational Site

    Taichung 1668399, 40447
    Taiwan

    Site Not Available

  • GSK Investigational Site

    Taipei, 10002
    Taiwan

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  • GSK Investigational Site

    Centreville, Alabama 35042
    United States

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    Little Rock, Arkansas 72205
    United States

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    Little Rock 4119403, Arkansas 4099753 72205
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    Newport Beach, California 92663
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    Newport Beach 5376890, California 5332921 92663
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  • GSK Investigational Site

    Newark, Delaware 08901
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    Clearwater, Florida 33765-2150
    United States

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  • GSK Investigational Site

    Florida City, Florida 32819
    United States

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  • GSK Investigational Site

    Miami, Florida 33126
    United States

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  • GSK Investigational Site

    North Miami Beach, Florida 33169
    United States

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  • GSK Investigational Site

    Orlando, Florida 32819
    United States

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  • GSK Investigational Site

    Palm Springs, Florida 33406
    United States

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  • GSK Investigational Site

    Port Charlotte, Florida 33952
    United States

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  • GSK Investigational Site

    Tallahassee, Florida 32308
    United States

    Site Not Available

  • GSK Investigational Site

    Miami 4164138, Florida 4155751 33126
    United States

    Site Not Available

  • GSK Investigational Site

    North Miami Beach 4166233, Florida 4155751 33169
    United States

    Site Not Available

  • GSK Investigational Site

    Orlando 4167147, Florida 4155751 32819
    United States

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  • GSK Investigational Site

    Palm Springs 4167583, Florida 4155751 33406
    United States

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  • GSK Investigational Site

    Port Charlotte 4169130, Florida 4155751 33952
    United States

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  • GSK Investigational Site

    Tallahassee 4174715, Florida 4155751 32308
    United States

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  • GSK Investigational Site

    Columbus, Georgia 31904
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  • GSK Investigational Site

    Normal, Illinois 61761
    United States

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  • GSK Investigational Site

    Normal 4903780, Illinois 4896861 61761
    United States

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  • GSK Investigational Site

    New Orleans, Louisiana 20852
    United States

    Site Not Available

  • GSK Investigational Site

    New Orleans 4335045, Louisiana 4331987 20852
    United States

    Site Not Available

  • GSK Investigational Site

    Bangor, Maine 04401
    United States

    Site Not Available

  • GSK Investigational Site

    Bangor 4957280, Maine 4971068 04401
    United States

    Site Not Available

  • GSK Investigational Site

    Columbia, Maryland 21044
    United States

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  • GSK Investigational Site

    Detroit, Michigan 48202
    United States

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  • GSK Investigational Site

    Warren, Michigan 48088
    United States

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  • GSK Investigational Site

    Warren 5014051, Michigan 5001836 48088
    United States

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  • GSK Investigational Site

    Missoula, Montana 59804
    United States

    Site Not Available

  • GSK Investigational Site

    Missoula 5666639, Montana 5667009 59804
    United States

    Site Not Available

  • GSK Investigational Site

    Papillion, Nebraska 68046
    United States

    Site Not Available

  • GSK Investigational Site

    Papillion 5074792, Nebraska 5073708 68046
    United States

    Site Not Available

  • GSK Investigational Site

    Brick, New Jersey 08724
    United States

    Site Not Available

  • GSK Investigational Site

    Linwood, New Jersey 08221
    United States

    Site Not Available

  • GSK Investigational Site

    Linwood 4502690, New Jersey 5101760 08221
    United States

    Site Not Available

  • GSK Investigational Site

    New Windsor, New York 12553
    United States

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  • GSK Investigational Site

    New Windsor 5128577, New York 5128638 12553
    United States

    Site Not Available

  • GSK Investigational Site

    Asheville, North Carolina 28801
    United States

    Site Not Available

  • GSK Investigational Site

    Charlotte, North Carolina 28273
    United States

    Site Not Available

  • GSK Investigational Site

    Greenville, North Carolina 27834
    United States

    Site Not Available

  • GSK Investigational Site

    Raleigh, North Carolina 27607
    United States

    Site Not Available

  • GSK Investigational Site

    Winston-Salem, North Carolina 27104
    United States

    Site Not Available

  • GSK Investigational Site

    Asheville 4453066, North Carolina 4482348 28801
    United States

    Site Not Available

  • GSK Investigational Site

    Charlotte 4460243, North Carolina 4482348 28273
    United States

    Site Not Available

  • GSK Investigational Site

    Cincinnati, Ohio 45231
    United States

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  • GSK Investigational Site

    Cincinnati 4508722, Ohio 5165418 45231
    United States

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    Philadelphia, Pennsylvania 19140
    United States

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  • GSK Investigational Site

    Pittsburgh, Pennsylvania 15241
    United States

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  • GSK Investigational Site

    Philadelphia 4560349, Pennsylvania 6254927 19140
    United States

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  • GSK Investigational Site

    Pittsburgh 5206379, Pennsylvania 6254927 15241
    United States

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    Rock Hill, South Carolina 29732
    United States

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  • GSK Investigational Site

    Spartanburg, South Carolina 29303
    United States

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  • GSK Investigational Site

    Rock Hill 4593142, South Carolina 4597040 29732
    United States

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  • GSK Investigational Site

    Spartanburg 4597200, South Carolina 4597040 29303
    United States

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  • GSK Investigational Site

    Beaumont, Texas 77701
    United States

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  • GSK Investigational Site

    Dallas, Texas 75225
    United States

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  • GSK Investigational Site

    Kerrville, Texas 78028
    United States

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  • GSK Investigational Site

    Waco, Texas 76712
    United States

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  • GSK Investigational Site

    Beaumont 4672989, Texas 4736286 77701
    United States

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  • GSK Investigational Site

    Dallas 4684888, Texas 4736286 75225
    United States

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  • GSK Investigational Site

    Bellingham, Washington 98225
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