Studie k porovnání účinnosti, bezpečnosti a snášenlivosti FF/UMEC/VI s FF/VI u 12-17letých s astmatem
Fáze 3, 24týdenní, randomizovaná, dvojitě zaslepená bayesovská dynamická výpůjční studie paralelní skupiny srovnávající účinnost, bezpečnost, snášenlivost a farmakokinetiku FF/UMEC/VI s FF/VI u 12-17letých účastníků s Nedostatečně kontrolované astma při stabilní udržovací terapii s IKS/LABA
The primary purpose of this study is to evaluate the effects of Fluticasone Furoate (FF)/ Umeclidinium (UMEC)/ Vilanterol (VI) on lung function compared with FF/VI after 24 weeks of treatment.
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Typ studie
Zápis (Odhadovaný)
Fáze
- Fáze 3
Kontakty a umístění
Studijní místa
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Buenos Aires, Argentina, C1425BEN
- GSK Investigational Site
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Buenos Aires, Argentina, C1202
- GSK Investigational Site
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Buenos Aires, Argentina, 1888
- GSK Investigational Site
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Buenos Aires, Argentina, 1122
- GSK Investigational Site
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Buenos Aires, Argentina, C1023AAB
- GSK Investigational Site
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Córdoba, Argentina, X5000DCE
- GSK Investigational Site
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Córdoba, Argentina, X5014AKM
- GSK Investigational Site
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Lanus, Argentina, B1824KAJ
- GSK Investigational Site
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Lobos, Argentina, 7240
- GSK Investigational Site
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Lujan de Cuyo, Argentina, 5509
- GSK Investigational Site
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Mar del Plata, Argentina, 7600
- GSK Investigational Site
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Rosario, Argentina, 2000
- GSK Investigational Site
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Rosario Provincia de Santa FE, Argentina, 2000
- GSK Investigational Site
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San Miguel de Tucumán, Argentina, T4000IHE
- GSK Investigational Site
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Santa Fe, Argentina, 3000
- GSK Investigational Site
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Queensland
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South Brisbane, Queensland, Austrálie, 4101
- GSK Investigational Site
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South Australia
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North Adelaide, South Australia, Austrálie, 5006
- GSK Investigational Site
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Western Australia
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Joondalup WA, Western Australia, Austrálie, 6027
- GSK Investigational Site
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Lo Barnechea, Chile, 7691236
- GSK Investigational Site
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Santiago, Chile, 7630000
- GSK Investigational Site
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Santiago, Chile, 8320000
- GSK Investigational Site
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Ashkelon, Izrael, 7830604
- GSK Investigational Site
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Haifa, Izrael, 3436212
- GSK Investigational Site
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Haifa, Izrael, 3109600
- GSK Investigational Site
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Petah Tikva, Izrael, 49202
- GSK Investigational Site
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Cheongju Chungcheongbuk-do, Jižní Korea, 28644
- GSK Investigational Site
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Gwangju, Jižní Korea, 501-757
- GSK Investigational Site
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Seoul, Jižní Korea, 05505
- GSK Investigational Site
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Seoul, Jižní Korea, 03722
- GSK Investigational Site
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Seoul, Jižní Korea, 1757
- GSK Investigational Site
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Seoul, Jižní Korea, 2447
- GSK Investigational Site
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Guadalajara, Mexiko, 44100
- GSK Investigational Site
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Monterrey, Mexiko, 64460
- GSK Investigational Site
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San Juan del Río, Mexiko, 76800
- GSK Investigational Site
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Upper Hutt
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Ebdentown, Upper Hutt, Nový Zéland, 5018
- GSK Investigational Site
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Alabama
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Birmingham, Alabama, Spojené státy, 35244
- GSK Investigational Site
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Mobile, Alabama, Spojené státy, 36608
- GSK Investigational Site
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Arizona
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Paradise Valley, Arizona, Spojené státy, 85253
- GSK Investigational Site
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California
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Bakersfield, California, Spojené státy, 93301-4205
- GSK Investigational Site
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Huntington Beach, California, Spojené státy, 92647
- GSK Investigational Site
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Mission Viejo, California, Spojené státy, 92691
- GSK Investigational Site
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Rolling Hills Estates, California, Spojené státy, 90274
- GSK Investigational Site
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Colorado
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Colorado Springs, Colorado, Spojené státy, 80909
- GSK Investigational Site
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Florida
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Aventura, Florida, Spojené státy, 33180
- GSK Investigational Site
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Miami, Florida, Spojené státy, 33173
- GSK Investigational Site
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Miami, Florida, Spojené státy, 33165
- GSK Investigational Site
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Miami, Florida, Spojené státy, 33174
- GSK Investigational Site
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Georgia
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Savannah, Georgia, Spojené státy, 31406
- GSK Investigational Site
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Illinois
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Normal, Illinois, Spojené státy, 61761
- GSK Investigational Site
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Kentucky
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Owensboro, Kentucky, Spojené státy, 42301
- GSK Investigational Site
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Missouri
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Columbia, Missouri, Spojené státy, 65203
- GSK Investigational Site
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Montana
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Missoula, Montana, Spojené státy, 59808
- GSK Investigational Site
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New York
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The Bronx, New York, Spojené státy, 10461-1119
- GSK Investigational Site
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Ohio
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Cincinnati, Ohio, Spojené státy, 45229
- GSK Investigational Site
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Cleveland, Ohio, Spojené státy, 44106
- GSK Investigational Site
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Dayton, Ohio, Spojené státy, 45404
- GSK Investigational Site
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Oklahoma
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Oklahoma City, Oklahoma, Spojené státy, 73120-9350
- GSK Investigational Site
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South Carolina
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Charleston, South Carolina, Spojené státy, 29420
- GSK Investigational Site
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Texas
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Dallas, Texas, Spojené státy, 75225-6301
- GSK Investigational Site
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Kerrville, Texas, Spojené státy, 78028
- GSK Investigational Site
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Plano, Texas, Spojené státy, 75034
- GSK Investigational Site
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Waco, Texas, Spojené státy, 76712
- GSK Investigational Site
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Wisconsin
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Milwaukee, Wisconsin, Spojené státy, 53226
- GSK Investigational Site
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Adana, Turecko (Türkiye), 1173
- GSK Investigational Site
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Antalya, Turecko (Türkiye), 07070
- GSK Investigational Site
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Istanbul, Turecko (Türkiye), 34010
- GSK Investigational Site
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Istanbul, Turecko (Türkiye), 34899
- GSK Investigational Site
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Inclusion Criteria:
- Participant must be 12 to 17 years of age (inclusive), at the time of signing the informed consent/assent.
- Participants who have a diagnosis of asthma as defined by the National Institutes of Health [NIH, 2020] at least 1 year prior to Visit 0.
- Participants who have required daily Inhaled corticosteroids (ICS)/ Long-Acting Beta2-Agonist (LABA) treatment for at least 12 weeks prior to Visit 0 with no changes to maintenance asthma medications during the 6 weeks immediately prior to Visit 0 (including no changes to a stable total ICS dose of >250 to <=500 microgram (mcg)/day fluticasone propionate, or equivalent).
- In the 1 year prior to Visit 1: A documented healthcare contact for acute asthma symptoms; OR A documented temporary change in asthma therapy for acute asthma symptoms, according to a prespecified asthma action plan (or equivalent).
- Participants with inadequately controlled asthma (ACQ-6 score ≥1.5) at Visit 1, despite ICS/LABA maintenance therapy.
- A best pre-bronchodilator FEV1 >40% to <=90% of the predicted normal value and a ≥12% increase in FEV1 with albuterol/salbutamol at Visit 1. Predicted values will be based on the European Respiratory Society (ERS) Global Lung Function Initiative.
Exclusion Criteria:
- Chest X-ray documented pneumonia in the 6 weeks prior to Visit 1.
- Any asthma exacerbation requiring a change in maintenance asthma therapy and/or the use of systemic corticosteroids for at least 3 days in the 6 weeks prior to Visit 1. (Participants requiring a temporary change in asthma therapy (e.g., oral corticosteroids or increased dose of ICS) to treat an exacerbation in the 6 weeks prior to Visit 1 are not explicitly excluded at Visit 1 provided that, at the Investigator's discretion, the participant's condition is stable after they have resumed their pre-exacerbation maintenance asthma therapy (without modification), returned to their baseline asthma status and they are considered appropriate for enrollment into this study of up to 6 months duration)
- History of Life-threatening Asthma
- Participants with current evidence of active pulmonary diseases or abnormalities other than asthma (e.g., pneumonia, active tuberculosis, significant bronchiectasis, etc.).
- Current smokers and users of other inhaled products for recreation with or without nicotine (defined as participants who use cigarettes, e-cigarettes, other/vaping-related devices, cigars or pipe tobacco]) within 12 months prior to Visit 1.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Dvojnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Experimentální: Účastníci obdrží FF/UMEC/VI
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FF/UMEC/VI will be administered. FF/UMEC/VI and FF/VI will be administered via ELLIPTA inhaler |
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Aktivní komparátor: Účastníci obdrží FF/VI
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FF/UMEC/VI and FF/VI will be administered via ELLIPTA inhaler FF/VI will be administered. |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Change from baseline in trough forced expiratory volume in 1 second (FEV1) (Liters) at Week 24
Časové okno: Baseline (Week 0) and Week 24
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FEV1 will be measured using spirometry. |
Baseline (Week 0) and Week 24
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Change from Baseline in Asthma Control Questionnaire (7 items) (ACQ-7) (Scores on a scale)
Časové okno: Baseline (Week 0) and Week 24
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ACQ-7 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 question on rescue use and an additional item relating to lung function which is calculated based on FEV1. A score of less than or equal to (<=) 0.75 indicates well-controlled asthma and a score greater than or equal to (>=)1.5 indicates poorly controlled asthma. |
Baseline (Week 0) and Week 24
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Change from Baseline in Asthma Control Questionnaire (6 items) (ACQ-6) (Scores on a scale)
Časové okno: Baseline (Week 0) and Week 24
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ACQ-6 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)) and a question on rescue bronchodilator use. A score of less than or equal to (<=) 0.75 indicates well-controlled asthma and a score greater than or equal to (>=)1.5 indicates poorly controlled asthma. |
Baseline (Week 0) and Week 24
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Change from Baseline in Asthma Control Questionnaire (5 items) (ACQ-5) (Scores on a scale)
Časové okno: Baseline (Week 0) and Week 24
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ACQ-5 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 or equal to (<=) 0.75 indicates well-controlled asthma and a score greater than or equal to (>=)1.5 indicates poorly controlled asthma. |
Baseline (Week 0) and Week 24
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Number of Participants with a clinically important change from baseline in ACQ-7 Score
Časové okno: Week 24
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ACQ-7 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 question on rescue use and an additional item relating to lung function which is calculated based on FEV1. A score of less than or equal to (<=) 0.75 indicates well-controlled asthma and a score greater than or equal to (>=)1.5 indicates poorly controlled asthma. A change of 0.5 in score suggests a clinically important change in score. |
Week 24
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Number of Participants with a clinically important change from baseline in ACQ-6 Score
Časové okno: Week 24
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ACQ-6 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)) and a question on rescue bronchodilator use. A score of less than or equal to (<=) 0.75 indicates well-controlled asthma and a score greater than or equal to (>=)1.5 indicates poorly controlled asthma. A change of 0.5 in score suggests a clinically important change in score. |
Week 24
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Number of Participants with a clinically important change from baseline in ACQ-5 Score
Časové okno: Week 24
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ACQ-5 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 or equal to (<=) 0.75 indicates well-controlled asthma and a score greater than or equal to (>=)1.5 indicates poorly controlled asthma. A change of 0.5 in score suggests a clinically important change in score. |
Week 24
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Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Ředitel studie: GSK Clinical Trials, GlaxoSmithKline
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 206867
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu 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/
Časový rámec sdílení 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.
Kritéria přístupu pro sdílení 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.
Typ podpůrných informací pro sdílení IPD
- PROTOKOL STUDY
- MÍZA
- ICF
- CSR
Informace o lécích a zařízeních, studijní dokumenty
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