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Прагматическое открытое рандомизированное клиническое исследование FF/UMEC/VI в сравнении с Non-ellipta ICS-LABA для лечения взрослых участников с неконтролируемой астмой (PERFORM)

11 сентября 2026 г. обновлено: GlaxoSmithKline

Фаза 4, 52 недели (первичный анализ через 24 недели), рандомизированное, стратифицированное, открытое, активно-контролируемое, в параллельных группах, исследование эффективности, сравнение FF/UMEC/VI с неэллиптическим обычным уходом (ICS/ LABA) у взрослых участников с неконтролируемой астмой

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

Обзор исследования

Статус

Активный, не рекрутирующий

Условия

Вмешательство/лечение

Тип исследования

Интервенционный

Регистрация (Действительный)

1358

Фаза

  • Фаза 4

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Места учебы

  • Австралия
    • Australian Capital Territory
      • Bruce, Australian Capital Territory, Австралия, 2617
        • GSK Investigational Site
    • New South Wales
      • Blacktown, New South Wales, Австралия, 2148
        • GSK Investigational Site
      • Coffs Harbour, New South Wales, Австралия, 2450
        • GSK Investigational Site
      • Kanwal, New South Wales, Австралия, 2259
        • GSK Investigational Site
      • Sydney, New South Wales, Австралия, 2035
        • GSK Investigational Site
    • Queensland
      • Brisbane, Queensland, Австралия, 4006
        • GSK Investigational Site
    • Western Australia
      • Osborne Park, Western Australia, Австралия, 6017
        • GSK Investigational Site
      • Spearwood, Western Australia, Австралия, 6163
        • GSK Investigational Site
  • Аргентина
      • Buenos Aires, Аргентина, C1425BEN
        • GSK Investigational Site
      • Buenos Aires, Аргентина, C1128AAF
        • GSK Investigational Site
      • Buenos Aires, Аргентина, C1192AAW
        • GSK Investigational Site
      • Buenos Aires, Аргентина, FVH1425
        • GSK Investigational Site
      • Ciudad Autonoma de Buenos Aire, Аргентина, 1012
        • GSK Investigational Site
      • Concepción del Uruguay, Аргентина, 3260
        • GSK Investigational Site
      • Córdoba, Аргентина, X5003DCE
        • GSK Investigational Site
      • Formosa, Аргентина, 3600
        • GSK Investigational Site
      • Lujan de Cuyo, Аргентина, 5509
        • GSK Investigational Site
      • Luján, Аргентина, 6700
        • GSK Investigational Site
      • Mar del Plata, Аргентина, 7600
        • GSK Investigational Site
      • Mendoza, Аргентина, 5500
        • GSK Investigational Site
      • Mendoza, Аргентина, 5577
        • GSK Investigational Site
      • Mendoza, Аргентина, M5500
        • GSK Investigational Site
      • Quilmes, Аргентина, 1878
        • GSK Investigational Site
      • Rosario, Аргентина, 2000
        • GSK Investigational Site
      • Rosario, Аргентина, S2000DBS
        • GSK Investigational Site
      • Rosario, Аргентина, S2000 DEJ
        • GSK Investigational Site
      • San Juan Bautista, Аргентина, 1888
        • GSK Investigational Site
      • San Miguel de Tucumán, Аргентина, T4000AXL
        • GSK Investigational Site
      • Santa Fe, Аргентина, 3000
        • GSK Investigational Site
  • Канада
    • Ontario
      • Windsor, Ontario, Канада, N8X 1T3
        • GSK Investigational Site
    • Quebec
      • Trois-Rivières, Quebec, Канада, G9A 4P3
        • GSK Investigational Site
  • Китай
      • Nanshan District, Китай, 518067
        • GSK Investigational Site
      • Zhuhai, Китай, 519099
        • GSK Investigational Site
    • Foshan City
      • Chancheng District, Foshan City, Китай, 528031
        • GSK Investigational Site
    • Guangzhou
      • Liwan District, Guangzhou, Китай, 510160
        • GSK Investigational Site
    • Jiangmen City
      • North Street, Jiangmen City, Китай, 52900
        • GSK Investigational Site
  • Соединенные Штаты
    • Alabama
      • Centreville, Alabama, Соединенные Штаты, 35042
        • GSK Investigational Site
    • Arkansas
      • Little Rock, Arkansas, Соединенные Штаты, 72205
        • GSK Investigational Site
    • California
      • Newport Beach, California, Соединенные Штаты, 92663
        • GSK Investigational Site
    • Delaware
      • Newark, Delaware, Соединенные Штаты, 08901
        • GSK Investigational Site
    • Florida
      • Clearwater, Florida, Соединенные Штаты, 33765-2150
        • GSK Investigational Site
      • Miami, Florida, Соединенные Штаты, 33126
        • GSK Investigational Site
      • Miami, Florida, Соединенные Штаты, 33135
        • GSK Investigational Site
      • Miami, Florida, Соединенные Штаты, 33173-3484
        • GSK Investigational Site
      • North Miami Beach, Florida, Соединенные Штаты, 33169
        • GSK Investigational Site
      • Orlando, Florida, Соединенные Штаты, 32819
        • GSK Investigational Site
      • Palm Springs, Florida, Соединенные Штаты, 33406
        • GSK Investigational Site
      • Port Charlotte, Florida, Соединенные Штаты, 33952
        • GSK Investigational Site
      • Tallahassee, Florida, Соединенные Штаты, 32308
        • GSK Investigational Site
    • Illinois
      • Normal, Illinois, Соединенные Штаты, 61761
        • GSK Investigational Site
    • Louisiana
      • New Orleans, Louisiana, Соединенные Штаты, 20852
        • GSK Investigational Site
    • Maine
      • Bangor, Maine, Соединенные Штаты, 04401
        • GSK Investigational Site
    • Michigan
      • Detroit, Michigan, Соединенные Штаты, 48202
        • GSK Investigational Site
      • Warren, Michigan, Соединенные Штаты, 48088
        • GSK Investigational Site
    • Montana
      • Missoula, Montana, Соединенные Штаты, 59804
        • GSK Investigational Site
    • Nebraska
      • Papillion, Nebraska, Соединенные Штаты, 68046
        • GSK Investigational Site
    • New Jersey
      • Brick, New Jersey, Соединенные Штаты, 08724
        • GSK Investigational Site
      • Linwood, New Jersey, Соединенные Штаты, 08221
        • GSK Investigational Site
    • New York
      • New Windsor, New York, Соединенные Штаты, 12553-7754
        • GSK Investigational Site
    • North Carolina
      • Asheville, North Carolina, Соединенные Штаты, 28801
        • GSK Investigational Site
      • Charlotte, North Carolina, Соединенные Штаты, 28273
        • GSK Investigational Site
      • Greenville, North Carolina, Соединенные Штаты, 27834
        • GSK Investigational Site
      • Winston-Salem, North Carolina, Соединенные Штаты, 27104
        • GSK Investigational Site
    • Ohio
      • Cincinnati, Ohio, Соединенные Штаты, 45231
        • GSK Investigational Site
    • Pennsylvania
      • DuBois, Pennsylvania, Соединенные Штаты, 15801-2277
        • GSK Investigational Site
      • Philadelphia, Pennsylvania, Соединенные Штаты, 19140
        • GSK Investigational Site
      • Pittsburgh, Pennsylvania, Соединенные Штаты, 15241
        • GSK Investigational Site
    • South Carolina
      • Rock Hill, South Carolina, Соединенные Штаты, 29732
        • GSK Investigational Site
      • Spartanburg, South Carolina, Соединенные Штаты, 29303-4225
        • GSK Investigational Site
    • Texas
      • Beaumont, Texas, Соединенные Штаты, 77701
        • GSK Investigational Site
      • Dallas, Texas, Соединенные Штаты, 75225
        • GSK Investigational Site
    • Washington
      • Bellingham, Washington, Соединенные Штаты, 98225
        • GSK Investigational Site
  • Тайвань
      • Kaohsiung City, Тайвань, 807
        • GSK Investigational Site
      • Taichung, Тайвань, 40447
        • GSK Investigational Site
      • Taichung, Тайвань, 407219
        • GSK Investigational Site
      • Taipei, Тайвань, 10002
        • GSK Investigational Site
  • Южная Корея
      • Busan, Южная Корея, 602 702
        • GSK Investigational Site
      • Daegu, Южная Корея, 41404
        • GSK Investigational Site
      • Seongnam-si Gyeonggi-do, Южная Корея, 13620
        • GSK Investigational Site
      • Seoul, Южная Корея, 03080
        • GSK Investigational Site
      • Seoul, Южная Корея, 02841
        • GSK Investigational Site
      • Seoul, Южная Корея, 133-792
        • GSK Investigational Site
      • Seoul, Южная Корея, 158-710
        • GSK Investigational Site
      • Seoul, Южная Корея, 07061
        • GSK Investigational Site
      • Seoul, Южная Корея, 5030
        • GSK Investigational Site
      • Suwon Kyunggi-do, Южная Корея, 16499
        • GSK Investigational Site
  • Япония
      • Fukuoka, Япония, 807-8555
        • GSK Investigational Site
      • Fukuoka, Япония, 820-8505
        • GSK Investigational Site
      • Fukuoka, Япония, 816-0813
        • GSK Investigational Site
      • Fukuoka, Япония, 832-0059
        • GSK Investigational Site
      • Fukuoka, Япония, 802-0083
        • GSK Investigational Site
      • Gifu, Япония, 509-6134
        • GSK Investigational Site
      • Hiroshima, Япония, 730-0853
        • GSK Investigational Site
      • Hiroshima, Япония, 730-0013
        • GSK Investigational Site
      • Hiroshima, Япония, 733-0002
        • GSK Investigational Site
      • Hyōgo, Япония, 651-0053
        • GSK Investigational Site
      • Kagawa, Япония, 761-8073
        • GSK Investigational Site
      • Kagoshima, Япония, 890-0053
        • GSK Investigational Site
      • Kanagawa, Япония, 252-0143
        • GSK Investigational Site
      • Kumamoto, Япония, 860-8556
        • GSK Investigational Site
      • Kumamoto, Япония, 862-0965
        • GSK Investigational Site
      • Matsuyama, Япония, 790-0925
        • GSK Investigational Site
      • Miyagi, Япония, 980-0871
        • GSK Investigational Site
      • Miyazaki, Япония, 880-2112
        • GSK Investigational Site
      • Miyazaki, Япония, 889-4304
        • GSK Investigational Site
      • Nagaoka-Shi, Япония, 940-0087
        • GSK Investigational Site
      • Niigata, Япония, 950-0088
        • GSK Investigational Site
      • Okawa-shi, Япония, 831-0016
        • GSK Investigational Site
      • Shinjuku-kuTokyo, Япония, 160-0021
        • GSK Investigational Site
      • Tokyo, Япония, 160-0017
        • GSK Investigational Site
      • Tokyo, Япония, 142-8666
        • GSK Investigational Site
      • Tokyo, Япония, 157-0066
        • GSK Investigational Site
      • Tokyo, Япония, 173-8606
        • GSK Investigational Site
      • Tokyo, Япония, 145-0063
        • GSK Investigational Site
      • Tokyo, Япония, 105-0001
        • GSK Investigational Site
      • Yokohama, Япония, 223-0053
        • GSK Investigational Site
      • Ōita, Япония
        • GSK Investigational Site

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

От 18 лет до 75 лет (Взрослый, Пожилой взрослый)

Принимает здоровых добровольцев

Нет

Полы, имеющие право на обучение

Все

Описание

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) 2023 guidelines for at least 3 months prior to randomization.

  2. Participants who are either:

    • Currently untreated
    • Treated with daily maintenance ICS or ICS/LABA

  3. ACQ-6 score ≥1.5 at randomization.

  4. 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)

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

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 effective method of contraception. This includes women who are pregnant or lactating or are planning 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 triple therapy(MITT)] and/or any LAMA-containing therapy within 12 months prior to randomization.
  6. Ongoing need for biologic therapy or recent use of a biologic therapy
  7. Participants with the diagnosis of chronic obstructive pulmonary disease, as per Global Initiative for Chronic Obstructive Lung Disease (GOLD 2024) guidelines.
  8. Participants whose current medications include RELVAR ELLIPTA and ARNUITY ELLIPTA are not eligible to enter the study.
  9. Participants who are medically unable to withhold their albuterol/salbutamol for 6 hours prior to spirometry testing
  10. Changes in asthma medication (e.g., maintenance ICS/LABA) within 3 months prior to randomization.
  11. Participants with a history of hypersensitivity to any of the study medications

Учебный план

В этом разделе представлена ​​подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

  • Основная цель: Уход
  • Распределение: Рандомизированный
  • Интервенционная модель: Параллельное назначение
  • Маскировка: Нет (открытая этикетка)

Оружие и интервенции

Группа участников / Армия
Вмешательство/лечение
Экспериментальный: Fluticasone Furoate [FF]/ Umeclidinium [UMEC]/ Vilanterol [VI]

Participants with uncontrolled asthma were randomized to receive a once-daily (QD) fixed-dose combination of 100 microgram (mcg) fluticasone furoate (FF), 62.5 mcg umeclidinium (UMEC), and 25 mcg vilanterol (VI) via the Ellipta dry powder inhaler (DPI) for up to 24 weeks. At the discretion of the investigator, a subset of participants received the high-dose ICS-containing therapy, FF/UMEC/VI 200/62.5/25 instead. At any time during the study (post-randomization), participants were escalated to receive FF/UMEC/VI 200/62.5/25 mcg if their asthma control worsened significantly, defined as an increase in Asthma Control Questionnaire (ACQ-7) total score of >0.5 from baseline and the physician determines increased Inhaled Corticosteroid [ICS] is ethically necessary.
Лекарство: Fluticasone furoate/umeclidinium bromide/vilanterol trifenatate

Participants will receive FF/UMEC/VI
Активный компаратор: Inhaled Corticosteroid [ICS]/Long-acting beta-2 agonist [LABA]

Participants with uncontrolled asthma were randomized to receive Inhaled Corticosteroid [ICS]/Long-acting beta-2 agonist [LABA] based on usual care as per the country specific regulatory labels up to 24 weeks. At the discretion of the investigator, a subset of participants received high-dose ICS/LABA. At any time during the study (post-randomization), participants were escalated to receive high dose ICS/LABA if their asthma control worsened significantly, defined as an increase in ACQ-7 total score of >0.5 from baseline and the physician determines increased ICS is ethically necessary.
Лекарство: Inhaled corticosteroids/long-acting beta-2 agonists

Participants will receive ICS/LABA

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Change From Baseline (CFB) in Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 24
Временное ограничение: Baseline (Day 1) and at Week 24

FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 on treatment is defined as the last FEV1 value obtained prior to the morning dose of investigational product. Spirometry was performed to assess FEV1. Baseline is defined as the last acceptable/borderline acceptable pre-dose FEV1 obtained at the Randomization Visit (Visit 2/Day 1). Change from Baseline was calculated by subtracting Baseline value from the post-dose visit (Week 24) value
Baseline (Day 1) and at Week 24

Вторичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Percentage of Participants Achieving Greater Than Equal to (>=) 0.5 Point Improvement (Decrease) From Baseline for the Asthma Control Questionnaire-7 (ACQ-7) at Week 24
Временное ограничение: Baseline (Day 1) and at Week 24

The ACQ-7 measures 7 attributes of asthma control and consists of 5 symptom related questions (nocturnal awakening, symptoms on waking in the morning, activity limitation, shortness of breath, and wheeze) with response options ranging from 0 (no impairment/limitation) to 6 (total impairment/ limitation).ACQ-7 total score is the mean of the responses of the 7 items, ranges from 0 to 6. Higher score indicates poor control. A score of less than equal to (<=)0.75 indicates well-controlled asthma, a score of between 0.75 and 1.5 indicates partially controlled asthma, and a score >=1.5 indicates poorly controlled asthma. Greater than or equal to 0.5 point decrease from baseline suggests a clinically important change in asthma control. Baseline is defined as the last non-missing value prior to or on the prescription date of study intervention. Percentage values are rounded off.
Baseline (Day 1) and at Week 24
Percentage of Participants Achieving the Composite Endpoint (Optimized) at Week 52
Временное ограничение: Baseline (Day 1) and at Week 52

The 4-point composite endpoint is defined as meeting the following criteria: Change from baseline in trough FEV1 >= 100 milliliter (mL) at Week 52, Controlled asthma based on ACQ-5 total score <= 1.5 at Week 52, No severe asthma exacerbations over 52 weeks and oral corticosteroids (OCS)-free over 52 weeks
Baseline (Day 1) and at Week 52
Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 52
Временное ограничение: Baseline (Day 1) and at Week 52

FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 on treatment is defined as the last FEV1 value obtained prior to the morning dose of investigational product. Spirometry was performed to assess FEV1. Baseline is defined as the last acceptable/borderline acceptable pre-dose FEV1 obtained at the Randomization Visit (Visit 2/Day 1).
Baseline (Day 1) and at Week 52
Percentage of Participants With Change From Baseline in Trough FEV1 >= 100 mL at Week 24
Временное ограничение: Baseline (Day 1) and at Week 24

FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 on treatment is defined as the last FEV1 value obtained prior to the morning dose of investigational product. Spirometry was performed to assess FEV1. Baseline is defined as the last acceptable/borderline acceptable pre-dose FEV1 obtained at the Randomization Visit (Visit 2/Day 1). Change from Baseline was calculated by subtracting Baseline value from the post-dose visit (Week 24) value. Percentage values are rounded-off.
Baseline (Day 1) and at Week 24
Percentage of Participants With Change From Baseline in Trough FEV1 >= 100 mL at Week 52
Временное ограничение: Baseline (Day 1) and at Week 52

FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 on treatment is defined as the last FEV1 value obtained prior to the morning dose of investigational product. Spirometry was performed to assess FEV1. Baseline is defined as the last acceptable/borderline acceptable pre-dose FEV1 obtained at the Randomization Visit (Visit 2/Day 1).
Baseline (Day 1) and at Week 52
Percentage of Participants With Change From Baseline in Trough FEV1 >= 0 mL at Week 24
Временное ограничение: Baseline (Day 1) and at Week 24

FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 on treatment is defined as the last FEV1 value obtained prior to the morning dose of investigational product. Spirometry was performed to assess FEV1. Baseline is defined as the last acceptable/borderline acceptable pre-dose FEV1 obtained at the Randomization Visit (Visit 2/Day 1). Change from Baseline was calculated by subtracting Baseline value from the post-dose visit (Week 24) value. Percentage values are rounded-off.
Baseline (Day 1) and at Week 24
Percentage of Participants With Change From Baseline in Trough FEV1 >= 0 mL at Week 52
Временное ограничение: Baseline (Day 1) and at Week 52

FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 on treatment is defined as the last FEV1 value obtained prior to the morning dose of investigational product. Spirometry was performed to assess FEV1. Baseline is defined as the last acceptable/borderline acceptable pre-dose FEV1 obtained at the Randomization Visit (Visit 2/Day 1).
Baseline (Day 1) and at Week 52
Percentage of Participants Achieving >= 0.5 Point Improvement (Decrease) From Baseline for the ACQ-7 Score at Week 52
Временное ограничение: Baseline (Day 1) and at Week 52

The ACQ-7 measures 7 attributes of asthma control and consists of 5 symptom related questions (nocturnal awakening, symptoms on waking in the morning, activity limitation, shortness of breath and wheeze) with response options ranging from zero (no impairment/limitation) to 6 (total impairment/ limitation). ACQ-7 total score is the mean of the responses of the 7 items, ranges from 0 to 6. Higher score indicates poor control. A score of less than equal to (<=) 0.75 indicates well-controlled asthma, a score of between 0.75 and 1.5 indicates partially controlled asthma, and a score >= 1.5 indicates poorly controlled asthma. Greater than or equal to 0.5 point decrease from baseline suggests a clinically important change in asthma control. Baseline is defined as the last non-missing value prior to or on the prescription date of study intervention.
Baseline (Day 1) and at Week 52
Percentage of Participants Achieving >=0.5 Point Improvement (Decrease) From Baseline for the ACQ-6 Score at Week 24
Временное ограничение: Baseline (Day 1) and at Week 24

The ACQ-6 is a shortened version of the ACQ-7 derived by removing one element (lung function element) from the original version. ACQ-6 consists of 6 questions scored from zero (no impairment/limitation) to six (total impairment/ limitation). Higher scores indicate greater impairment. Mean scores of <=0.75 indicate well-controlled asthma, scores between 0.75 and 1.5 indicate partially controlled asthma, and scores >=1.5 indicate poorly controlled asthma. A decrease in ACQ-6 score from Baseline indicates an improvement in asthma control, and individual changes of at least 0.5 are considered clinically meaningful. Baseline is defined as the last non-missing value prior to or on the prescription date of study intervention. Percentage values are rounded off.
Baseline (Day 1) and at Week 24
Percentage of Participants Achieving >=0.5 Point Improvement (Decrease) From Baseline for the ACQ-6 Score at Week 52
Временное ограничение: Baseline (Day 1) and at Week 52

The ACQ-6 is a shortened version of the ACQ-7 derived by removing one element (lung function element) from the original version. ACQ-6 consists of 6 questions scored from zero (no impairment/limitation) to six (total impairment/ limitation). Higher scores indicate greater impairment. Mean scores of <=0.75 indicate well-controlled asthma, scores between 0.75 and 1.5 indicate partially controlled asthma, and scores >=1.5 indicate poorly controlled asthma. A decrease in ACQ-6 score from Baseline indicates an improvement in asthma control, and individual changes of at least 0.5 are considered clinically meaningful. Baseline is defined as the last non-missing value prior to or on the prescription date of study intervention.
Baseline (Day 1) and at Week 52
Percentage of Participants Achieving >=0.5 Point Improvement (Decrease) From Baseline for the ACQ-5 Score at Week 24
Временное ограничение: Baseline (Day 1) and at Week 24

The ACQ-5 is a five-item questionnaire designed to be self-completed by the participants to assess the most common asthma symptoms. The 5 questions enquired to recall how their asthma had been during the previous week and to respond about the frequency and/or severity of symptoms (nocturnal awakening, symptoms on waking in the morning, activity limitation, shortness of breath and wheeze). The overall ACQ-5 response option is the mean score of all 5 questions representing 0=no impairment/limitation and 6=total impairment/ limitation. Higher scores indicated more limitations and lower scores indicated better asthma control. Higher score indicates worse symptoms. Greater than or equal to 0.5 point decrease from baseline suggests a clinically important change in asthma control. Baseline is defined as the last non-missing value prior to or on the prescription date of study intervention. Percentage values are rounded-off.
Baseline (Day 1) and at Week 24
Percentage of Participants Achieving >=0.5 Point Improvement (Decrease) From Baseline for the ACQ-5 at Week 52
Временное ограничение: Baseline (Day 1) and at Week 52

The ACQ-5 is a five-item questionnaire designed to be self-completed by the participants to assess the most common asthma symptoms. The 5 questions enquired to recall how their asthma had been during the previous week and to respond about the frequency and/or severity of symptoms (nocturnal awakening, symptoms on waking in the morning, activity limitation, shortness of breath and wheeze). The overall ACQ-5 response option is the mean score of all 5 questions representing 0=no impairment/limitation and 6=total impairment/ limitation. Higher scores indicated more limitations and lower scores with better asthma control. Higher score indicates worse symptoms. Greater than or equal to 0.5 point decrease from Baseline suggests a clinically important change in asthma control. Baseline is defined as the last non-missing value prior to or on the prescription date of study intervention.
Baseline (Day 1) and at Week 52
Change From Baseline (CFB) in the ACQ-7 Total Score at Week 24
Временное ограничение: Baseline (Day 1) and at Week 24

The ACQ-7 measures 7 attributes of asthma control and consists of 5 symptom related questions (nocturnal awakening, symptoms on waking in the morning, activity limitation, shortness of breath, and wheeze) with response options ranging from 0 (no impairment/limitation) to 6 (total impairment/ limitation). ACQ-7 total score is the mean of the responses of the 7 items, ranges from 0 to 6. Higher score indicates poor control. A score of less than equal to 0.75 indicates well-controlled asthma, a score of between 0.75 and 1.5 indicates partially controlled asthma, and a score >=1.5 indicates poorly controlled asthma. Baseline is defined as the last non-missing value prior to or on the prescription date of study intervention. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit (Week 24) value
Baseline (Day 1) and at Week 24
Change From Baseline (CFB) in the ACQ-7 Total Score at Week 52
Временное ограничение: Baseline (Day 1) and at Week 52

The ACQ-7 measures 7 attributes of asthma control and consists of 5 symptom related questions (nocturnal awakening, symptoms on waking in the morning, activity limitation, shortness of breath, and wheeze) with response options ranging from 0 (no impairment/limitation) to 6 (total impairment/ limitation). ACQ-7 total score is the mean of the responses of the 7 items, ranges from 0 to 6. Higher score indicates poor control. A score of less than equal to 0.75 indicates well-controlled asthma, a score of between 0.75 and 1.5 indicates partially controlled asthma, and a score >=1.5 indicates poorly controlled asthma. Baseline is defined as the last non-missing value prior to or on the prescription date of study intervention.
Baseline (Day 1) and at Week 52
Change From Baseline (CFB) in the ACQ-6 Total Score at Week 24
Временное ограничение: Baseline (Day 1) and at Week 24

The ACQ-6 is a shortened version of the ACQ-7 derived by removing one element (lung function element) from the original version. ACQ-6 consists of 6 questions scored from zero (no impairment/limitation) to six (total impairment/ limitation). Higher scores indicate greater impairment. Mean scores of <=0.75 indicate well-controlled asthma, scores between 0.75 and 1.5 indicate partially controlled asthma, and scores >=1.5 indicate poorly controlled asthma. Baseline is defined as the last non-missing value prior to or on the prescription date of study intervention. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit (Week 24) value.
Baseline (Day 1) and at Week 24
Change From Baseline (CFB) in the ACQ-6 Total Score at Week 52
Временное ограничение: Baseline (Day 1) and at Week 52

The ACQ-6 is a shortened version of the ACQ-7 derived by removing one element (lung function element) from the original version. ACQ-6 consists of 6 questions scored from zero (no impairment/limitation) to six (total impairment/ limitation). Higher scores indicate greater impairment. Mean scores of <=0.75 indicate well-controlled asthma, scores between 0.75 and 1.5 indicate partially controlled asthma, and scores >=1.5 indicate poorly controlled asthma. Baseline is defined as the last non-missing value prior to or on the prescription date of study intervention.
Baseline (Day 1) and at Week 52
Change From Baseline (CFB) in the ACQ-5 Total Score at Week 24
Временное ограничение: Baseline (Day 1) and at Week 24

The ACQ-5 is a five-item questionnaire designed to be self-completed by the participants to assess the most common asthma symptoms. The 5 questions enquired to recall how their asthma had been during the previous week and to respond about the frequency and/or severity of symptoms (nocturnal awakening, symptoms on waking in the morning, activity limitation, shortness of breath and wheeze). The overall ACQ-5 response option is the mean score of all 5 questions representing 0=no impairment/limitation and 6=total impairment/limitation. Higher scores indicated more limitations and lower scores indicated better asthma control. Higher score indicates worse symptoms. Baseline is defined as the last non-missing value prior to or on the prescription date of study intervention. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit (Week 24) value.
Baseline (Day 1) and at Week 24
Change From Baseline (CFB) in the ACQ-5 Total Score at Week 52
Временное ограничение: Baseline (Day 1) and at Week 52

The ACQ-5 is a five-item questionnaire designed to be self-completed by the participants to assess the most common asthma symptoms. The 5 questions enquired to recall how their asthma had been during the previous week and to respond about the frequency and/or severity of symptoms (nocturnal awakening, symptoms on waking in the morning, activity limitation, shortness of breath and wheeze). The overall ACQ-5 response option is the mean score of all 5 questions representing 0=no impairment/limitation and 6=total impairment/limitation. Higher scores indicated more limitations and lower scores indicated better asthma control. Higher score indicates worse symptoms. Baseline is defined as the last non-missing value prior to or on the prescription date of study intervention.
Baseline (Day 1) and at Week 52
Change From Baseline (CFB) in the Asthma Control Test (ACT) Score at Week 24
Временное ограничение: Baseline (Day 1) and at Week 24

The ACT is a validated self-completed questionnaire utilizing 5 questions to assess asthma control on a 5-point categorical scale ranging from 1 (not controlled at all) to 5 (completely controlled) with higher scores indicating better control. Total ACT score is calculated as the sum of the scores from the 5 questions and can range from 5 to 25, with higher scores indicating better control. An ACT total score of 5 to 15 suggests that the participant's asthma is poorly controlled, a score of 16 to 19 suggests that the participant's asthma is somewhat controlled, and a score of 20 to 25 suggests that the participant's asthma is well controlled. Baseline is defined as the last non-missing value prior to or on the prescription date of study intervention. CFB was calculated by subtracting Baseline value from the post-dose visit (Week 24) value.
Baseline (Day 1) and at Week 24
Change From Baseline (CFB) in the Asthma Control Test (ACT) Score at Week 52
Временное ограничение: Baseline (Day 1) and at Week 52

The ACT is a validated self-completed questionnaire utilizing 5 questions to assess asthma control on a 5-point categorical scale ranging from 1 (not controlled at all) to 5 (completely controlled) with higher scores indicating better control. Total ACT score is calculated as the sum of the scores from the 5 questions and can range from 5 to 25, with higher scores indicating better control. An ACT total score of 5 to 15 suggests that the participant's asthma is poorly controlled, a score of 16-to 19 suggests that the participant's asthma is somewhat controlled, and a score of 20 to 25 suggests that the participant's asthma is well controlled. Baseline is defined as the last non-missing value prior to or on the prescription date of study intervention.
Baseline (Day 1) and at Week 52
Percentage of Participants Achieving the Composite Endpoint (Optimized) Subset on Participants Receiving ICS/LABA Prior to Randomization at Week 52
Временное ограничение: Baseline (Day 1) and at Week 52

The 4-point composite endpoint is defined as meeting the following criteria: 1. Change from baseline in trough FEV1 ≥ 100 mL at Week 52; 2. Controlled asthma based on ACQ-5 total score <= 1.5 at Week 52; 3. No severe asthma exacerbations over 52 weeks; 4. OCS-free over 52 weeks. Subset on participants receiving ICS/LABA prior to randomization.
Baseline (Day 1) and at Week 52
Percentage of Participants Achieving the Composite Endpoint (Optimized) Subset on Participants Receiving no Treatment Prior to Randomization at Week 52
Временное ограничение: Baseline (Day 1) and at Week 52

The 4-point composite endpoint is defined as meeting the following criteria: 1. Change from baseline in trough FEV1 ≥ 100 mL at Week 52; 2. Controlled asthma based on ACQ-5 total score <= 1.5 at Week 52; 3. No severe asthma exacerbations over 52 weeks; 4. OCS-free over 52 weeks. Subset on participants receiving no treatment prior to randomization (no ICS-containing therapy within the 3 months prior to randomization).
Baseline (Day 1) and at Week 52
Change From Baseline (CFB) in the Asthma Quality of Life Questionnaire (AQLQ-12) Total Score at Week 24
Временное ограничение: Baseline (Day 1) and at Week 24

AQLQ-12 is a disease-specific, self-administered quality of life questionnaire used to evaluate impact of asthma treatments on quality of life of asthma sufferers. AQLQ-12 has 32 items in 4 domains: activity limitation (11 items), symptoms (12 items), emotional function (5 items), environmental stimuli (4 items). For 32 items on questionnaire, response format consists of a 7-point scale, where 1 indicates "total impairment" and 7 indicates "no impairment." AQLQ-12 total score is defined as average of scores from all 32 questions; thus, total score ranges from 1="total impairment" to 7=indicates "no impairment". Higher score is better asthma-related health-related quality of life. Baseline is last non-missing value prior to or on prescription date of study intervention. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit (Week 24) value.
Baseline (Day 1) and at Week 24
Change From Baseline (CFB) in the Asthma Quality of Life Questionnaire (AQLQ-12) Total Score at Week 52
Временное ограничение: Baseline (Day 1) and at Week 52

AQLQ-12 is a disease-specific, self-administered quality of life questionnaire to evaluate impact of asthma treatments on quality of life of asthma sufferers. AQLQ-12 has 32 items in 4 domains: activity limitation (11 items), symptoms (12 items), emotional function (5 items), environmental stimuli (4 items). For 32 items on questionnaire, response format consists of a 7-point scale, where a value of 1 indicates "total impairment" and a value of 7 indicates "no impairment." AQLQ-12 total score is defined as average of scores from all 32 questions; thus, total score ranges from 1="total impairment" to 7="no impairment". Higher score is better asthma-related health-related quality of life. Baseline is last non-missing value prior to or on prescription date of study intervention.
Baseline (Day 1) and at Week 52
Change From Baseline (CFB) in the Asthma Quality of Life Questionnaire (AQLQ-12) Domain Score at Week 24
Временное ограничение: Baseline (Day 1) and at Week 24

AQLQ-12 is a disease-specific, self-administered quality of life questionnaire used to evaluate impact of asthma treatments on quality of life of asthma sufferers. AQLQ-12 has 32 items in 4 domains: symptoms (12 items), environmental stimuli (4 items), activity limitation (11 items), emotional function (5 items). For 32 items on questionnaire, response format consists of a 7-point scale, where 1 indicates "total impairment" and 7 indicates "no impairment." AQLQ-12 each domain score total score is defined as average of scores from all the 32 questions from the respective domain; thus, each domain total score ranges from 1="total impairment" to 7=indicates "no impairment". Higher score is better asthma-related health-related quality of life. Each domain score is the mean of item scores within that domain. Baseline is last non-missing value prior to or on prescription date of study intervention. CFB was calculated by subtracting Baseline value from the post-dose visit (Week 24) value.
Baseline (Day 1) and at Week 24
Change From Baseline (CFB) in the Asthma Quality of Life Questionnaire (AQLQ-12) Domain Score at Week 52
Временное ограничение: Baseline (Day 1) and at Week 52

AQLQ-12 is a disease-specific, self-administered quality of life questionnaire used to evaluate impact of asthma treatments on quality of life of asthma sufferers. AQLQ-12 has 32 items in 4 domains: symptoms (12 items), environmental stimuli (4 items), activity limitation (11 items), emotional function (5 items). For 32 items on questionnaire, response format consists of a 7-point scale, where 1 indicates "total impairment" and 7 indicates "no impairment." AQLQ-12 each domain score total score is defined as average of scores from all the 32 questions from the respective domain; thus, each domain total score ranges from 1="total impairment" to 7=indicates "no impairment". Higher score is better asthma-related health-related quality of life. Each domain score is the mean of item scores within that domain. Baseline is last non-missing value prior to or on prescription date of study intervention.
Baseline (Day 1) and at Week 52
Change From Baseline (CFB) in the Four Domains of the Asthma-specific Adaptation of the Work Productivity and Activity Impairment (WPAI) Questionnaire at Week 24
Временное ограничение: Baseline (Day 1) and at Week 24

WPAI questionnaire measures impact due to poor health due to asthma on work and regular activities, yielding 4 percentage-based impairment scores, each ranges from 0 to 100%. Higher values=greater impairment and less productivity. Calculation of these 4 scores are as follows: 1. Work time missed due to health (Absenteeism)=hours missed due to health divided by (hours missed due to health+hours missed for other reasons+hours actually worked) *100. 2. Impairment while working due to health (Presenteeism) =Question (Q)5 score (from 0 to 10) divided by 10*100. 3. Overall work impairment due to health =Absenteeism+(1-Absenteeism fraction)*Presenteeism. 4. Activity impairment due to health =Q6 score (from 0 to 10) divided by 10*100. Baseline is last non-missing value prior to or on prescription date of study intervention. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit (Week 24) value.
Baseline (Day 1) and at Week 24
Change From Baseline in the Four Domains of the Asthma-specific Adaptation of the Work Productivity and Activity Impairment Questionnaire at Week 52
Временное ограничение: Baseline (Day 1) and at Week 52

WPAI questionnaire measures impact due to poor health due to asthma on work and regular activities, yielding 4 percentage-based impairment scores, each ranges from 0 to 100%. Higher value=greater impairment and less productivity. Calculation of these 4 scores are as follows: 1. Work time missed due to health (Absenteeism) =hours missed due to health divided by (hours missed due to health+hours missed for other reasons+hours actually worked) *100. 2. Impairment while working due to health (Presenteeism) =Question (Q)5 score (from 0 to 10) divided by 10*100. 3. Overall work impairment due to health =Absenteeism+(1-Absenteeism fraction)*Presenteeism. 4. Activity impairment due to health =Q6 score (from 0 to 10) divided by 10*100. Baseline is last non-missing value prior to or on prescription date of study intervention.
Baseline (Day 1) and at Week 52
Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 24 Among Participants on ICS/LABA Prior to Randomization
Временное ограничение: Baseline (Day 1) and Week 24

FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 on treatment is defined as the last FEV1 value obtained prior to the morning dose of investigational product. Spirometry was performed to assess FEV1. Baseline is defined as the last acceptable/borderline acceptable pre-dose FEV1 obtained at the Randomization Visit (Visit 2/Day 1). Per Protocol the study's subgroup analysis design, the analysis for this endpoint at Week 24 will be performed based on results from the composite (optimized) endpoint's Week 52 analysis. The pending results are expected to be available within 12 months of End of Study (EOS) date.
Baseline (Day 1) and Week 24
Percentage of Participants Achieving >=0.5 Points Improvement (Decrease) From Baseline for ACQ-7 at Week 24 Among Participants on ICS/LABA Prior to Randomization
Временное ограничение: Baseline (Day 1) and at Week 24

The ACQ-7 measures 7 attributes of asthma control & includes 5 symptom questions (nocturnal awakening,symptoms on waking in morning,activity limitation,shortness of breath & wheeze). Responses ranges from 0 (no impairment/limitation) to 6 (total impairment/ limitation). ACQ-7 total score is mean of the responses of 7 items, ranges from 0 to 6. Higher score = poor control. A score of <= 0.75 is well-controlled asthma; a score between 0.75 and 1.5 is partially controlled asthma & a score >= 1.5 is poorly controlled asthma. >= 0.5 point decrease from baseline is clinically important change in asthma control. Baseline is last non-missing value prior to or on the prescription date of study intervention. Per Protocol study's subgroup analysis design, analysis for this endpoint at Week 24 will be performed based on results from composite (optimized) endpoint's Week 52 analysis. The pending results are expected to be available within 12 months of EOS date.
Baseline (Day 1) and at Week 24
Percentage of Participants Achieving >=0.5 Points Improvement (Decrease) From Baseline for ACQ-7 at Week 52 Among Participants on ICS/LABA Prior to Randomization
Временное ограничение: Baseline (Day 1) and at Week 52

The ACQ-7 measures 7 attributes of asthma control & includes 5 symptom questions (nocturnal awakening,symptoms on waking in the morning,activity limitation,shortness of breath & wheeze). Responses ranges from 0 (no impairment/limitation) to 6 (total impairment/ limitation). ACQ-7 total score is mean of the responses of the 7 items, ranges from 0 to 6. Higher score = poor control. A score of <= 0.75 is well-controlled asthma; a score between 0.75 and 1.5 is partially controlled asthma & a score >= 1.5 is poorly controlled asthma. >= 0.5 point decrease from baseline is clinically important change in asthma control. Baseline is last non-missing value prior to or on the prescription date of study intervention.
Baseline (Day 1) and at Week 52
Change From Baseline in the ACQ-7 Total Score at Week 24 Among Participants on ICS/LABA Prior to Randomization
Временное ограничение: Baseline (Day 1) and at Week 24

The ACQ-7 measures 7 attributes of asthma control and consists of 5 symptom related questions with response options ranging from 0 (no impairment/limitation) to 6 (total impairment/ limitation). ACQ-7 total score is mean of responses of the 7 items, ranges from 0 to 6. Higher score indicates poor control. A score of less than equal to 0.75 indicates well-controlled asthma, a score between 0.75 and 1.5 indicates partially controlled asthma, and a score >=1.5 indicates poorly controlled asthma. Baseline is defined as last non-missing value prior to or on prescription date of study intervention. Per Protocol the study's subgroup analysis design, the analysis for this endpoint at Week 24 will be performed based on results from the composite (optimized) endpoint's Week 52 analysis. The pending results are expected to be available within 12 months of End of Study date.
Baseline (Day 1) and at Week 24
Change From Baseline (CFB) in the ACQ-7 Total Score at Week 52 Among Participants on ICS/LABA Prior to Randomization
Временное ограничение: Baseline (Day 1) and at Week 52

The ACQ-7 measures 7 attributes of asthma control and consists of 5 symptom related questions (nocturnal awakening, symptoms on waking in the morning, activity limitation, shortness of breath, and wheeze) with response options ranging from 0 (no impairment/limitation) to 6 (total impairment/ limitation). ACQ-7 total score is the mean of the responses of the 7 items, ranges from 0 to 6. Higher score indicates poor control. A score of less than equal to 0.75 indicates well-controlled asthma, a score between 0.75 and 1.5 indicates partially controlled asthma, and a score >=1.5 indicates poorly controlled asthma. Baseline is defined as the last non-missing value prior to or on the prescription date of study intervention.
Baseline (Day 1) and at Week 52
Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 24 for Participants With no Treatment Prior to Randomization
Временное ограничение: Baseline (Day 1) and Week 24

FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 on treatment is defined as the last FEV1 value obtained prior to the morning dose of investigational product. Spirometry was performed to assess FEV1. Baseline is defined as the last acceptable/borderline acceptable pre-dose FEV1 obtained at the Randomization Visit (Visit 2/Day 1). Per Protocol the study's subgroup analysis design, the analysis for this endpoint at Week 24 will be performed based on results from the composite (optimized) endpoint's Week 52 analysis. The pending results are expected to be available within 12 months of End of Study date.
Baseline (Day 1) and Week 24
Percentage of Participants Achieving >=0.5 Points Improvement (Decrease) From Baseline for ACQ-7 at Week 24 for Participants With no Treatment Prior to Randomization.
Временное ограничение: Baseline (Day 1) and at Week 24

The ACQ-7 measures 7 attributes of asthma control and consists of 5 symptom related questions (nocturnal awakening, symptoms on waking in the morning, activity limitation, shortness of breath and wheeze) with response options ranging from zero (no impairment/limitation) to 6 (total impairment/ limitation). A score of <=0.75 indicates well-controlled asthma and a score >=1.5 indicates poorly controlled asthma. >= 0.5 point decrease from baseline is clinically important change in asthma control. Baseline is defined as the last non-missing value prior to or on the prescription date of study intervention. Per Protocol the study's subgroup analysis design, the analysis for this endpoint at Week 24 will be performed based on results from the composite (optimized) endpoint's Week 52 analysis. The pending results are expected to be available within 12 months of End of Study date.
Baseline (Day 1) and at Week 24
Percentage of Participants Achieving >=0.5 Points Improvement (Decrease) From Baseline for ACQ-7 at Week 52 for Participants With no Treatment Prior to Randomization
Временное ограничение: Baseline (Day 1) and at Week 52

The ACQ-7 measures 7 attributes of asthma control and consists of 5 symptom related questions (nocturnal awakening, symptoms on waking in the morning, activity limitation, shortness of breath and wheeze). Response ranges from 0 (no impairment/limitation) to 6 (total impairment/ limitation). ACQ-7 total score is mean of the responses of 7 items, ranges from 0 to 6. Higher score = poor control. A score of <=0.75 indicates is well-controlled asthma; and a score >=1.5 indicates poorly controlled asthma. Baseline is defined as the last non-missing value prior to or on the prescription date of study intervention.
Baseline (Day 1) and at Week 52
Change From Baseline (CFB) in the ACQ-7 Total Score at Week 24 for Participants With no Treatment Prior to Randomization
Временное ограничение: Baseline (Day 1) and at Week 24

The ACQ-7 measures 7 attributes of asthma control and consists of 5 symptom related questions (nocturnal awakening, symptoms on waking in the morning, activity limitation, shortness of breath and wheeze) with response options ranging from zero (no impairment/limitation) to 6 (total impairment/ limitation). A score of less than equal to 0.75 indicates well-controlled asthma, a score between 0.75 and 1.5 indicates partially controlled asthma, and a score >=1.5 indicates poorly controlled asthma. A change of 0.5 in score suggests a clinically important change in asthma control. Baseline is defined as the last non-missing value prior to or on the prescription date of study intervention. Per Protocol the study's subgroup analysis design, the analysis for this endpoint at Week 24 will be performed based on results from the composite (optimized) endpoint's Week 52 analysis. The pending results are expected to be available within 12 months of End of Study date.
Baseline (Day 1) and at Week 24
Change From Baseline (CFB) in the ACQ-7 Total Score at Week 52 for Participants With no Treatment Prior to Randomization
Временное ограничение: Baseline (Day 1) and at Week 52

The ACQ-7 measures 7 attributes of asthma control and consists of 5 symptom related questions (nocturnal awakening, symptoms on waking in the morning, activity limitation, shortness of breath and wheeze) with response options ranging from zero (no impairment/limitation) to 6 (total impairment/ limitation). A score of less than equal to 0.75 indicates well-controlled asthma, a score of between 0.75 and 1.5 indicates partially controlled asthma, and a score >=1.5 indicates poorly controlled asthma. Baseline is defined as the last non-missing value prior to or on the prescription date of study intervention.
Baseline (Day 1) and at Week 52

Соавторы и исследователи

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Спонсор

GlaxoSmithKline

Публикации и полезные ссылки

Лицо, ответственное за внесение сведений об исследовании, добровольно предоставляет эти публикации. Это может быть что угодно, связанное с исследованием.

Общие публикации

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования (Действительный)

16 апреля 2024 г.

Первичное завершение (Действительный)

28 июля 2025 г.

Завершение исследования (Оцененный)

14 июня 2027 г.

Даты регистрации исследования

Первый отправленный

15 апреля 2024 г.

Впервые представлено, что соответствует критериям контроля качества

15 апреля 2024 г.

Первый опубликованный (Действительный)

18 апреля 2024 г.

Обновления учебных записей

Последнее опубликованное обновление (Действительный)

6 октября 2026 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

11 сентября 2026 г.

Последняя проверка

1 сентября 2026 г.

Дополнительная информация

Термины, связанные с этим исследованием

Ключевые слова

Дополнительные соответствующие термины MeSH

Другие идентификационные номера исследования

  • 219912

Планирование данных отдельных участников (IPD)

Планируете делиться данными об отдельных участниках (IPD)?

ДА

Описание плана IPD

Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/

Сроки обмена IPD

Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.

Критерии совместного доступа к IPD

Anonymized IPD is shared with researchers whose proposals are approved by an 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 may be granted, when justified, for up to 6 months.

Совместное использование IPD Поддерживающий тип информации

  • STUDY_PROTOCOL
  • САП
  • МКФ
  • КСО

Информация о лекарствах и устройствах, исследовательские документы

Изучает лекарственный продукт, регулируемый FDA США.

Да

Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.

Нет

продукт, произведенный в США и экспортированный из США.

Нет

Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .

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