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En studie för att jämföra effektiviteten, säkerheten och tolerabiliteten av FF/UMEC/VI med FF/VI hos 12-17-åringar med astma

3 november 2026 uppdaterad av: GlaxoSmithKline

En fas 3, 24-veckors, randomiserad, dubbelblind, parallellgrupps Bayesiansk dynamisk upplåningsstudie som jämför effektiviteten, säkerheten, tolerabiliteten och farmakokinetiken för FF/UMEC/VI med FF/VI hos 12-17-åriga deltagare med Otillräckligt kontrollerad astma på stabil underhållsterapi med ICS/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.

Studieöversikt

Status

Aktiv, inte rekryterande

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Beräknad)

138

Fas

  • Fas 3

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Argentina
      • Buenos Aires, Argentina, C1425BEN
        • GSK Investigational Site
      • Buenos Aires, Argentina, C1202
        • GSK Investigational Site
      • Buenos Aires, Argentina, 1888
        • GSK Investigational Site
      • Buenos Aires, Argentina, 1122
        • GSK Investigational Site
      • Buenos Aires, Argentina, C1023AAB
        • GSK Investigational Site
      • Córdoba, Argentina, X5000DCE
        • GSK Investigational Site
      • Córdoba, Argentina, X5014AKM
        • GSK Investigational Site
      • Lanus, Argentina, B1824KAJ
        • GSK Investigational Site
      • Lobos, Argentina, 7240
        • GSK Investigational Site
      • Lujan de Cuyo, Argentina, 5509
        • GSK Investigational Site
      • Mar del Plata, Argentina, 7600
        • GSK Investigational Site
      • Rosario, Argentina, 2000
        • GSK Investigational Site
      • Rosario Provincia de Santa FE, Argentina, 2000
        • GSK Investigational Site
      • San Miguel de Tucumán, Argentina, T4000IHE
        • GSK Investigational Site
      • Santa Fe, Argentina, 3000
        • GSK Investigational Site
  • Australien
    • Queensland
      • South Brisbane, Queensland, Australien, 4101
        • GSK Investigational Site
    • South Australia
      • North Adelaide, South Australia, Australien, 5006
        • GSK Investigational Site
    • Western Australia
      • Joondalup WA, Western Australia, Australien, 6027
        • GSK Investigational Site
  • Chile
      • Lo Barnechea, Chile, 7691236
        • GSK Investigational Site
      • Santiago, Chile, 7630000
        • GSK Investigational Site
      • Santiago, Chile, 8320000
        • GSK Investigational Site
  • Förenta staterna
    • Alabama
      • Birmingham, Alabama, Förenta staterna, 35244
        • GSK Investigational Site
      • Mobile, Alabama, Förenta staterna, 36608
        • GSK Investigational Site
    • Arizona
      • Paradise Valley, Arizona, Förenta staterna, 85253
        • GSK Investigational Site
    • California
      • Bakersfield, California, Förenta staterna, 93301-4205
        • GSK Investigational Site
      • Huntington Beach, California, Förenta staterna, 92647
        • GSK Investigational Site
      • Mission Viejo, California, Förenta staterna, 92691
        • GSK Investigational Site
      • Rolling Hills Estates, California, Förenta staterna, 90274
        • GSK Investigational Site
    • Colorado
      • Colorado Springs, Colorado, Förenta staterna, 80909
        • GSK Investigational Site
    • Florida
      • Aventura, Florida, Förenta staterna, 33180
        • GSK Investigational Site
      • Miami, Florida, Förenta staterna, 33173
        • GSK Investigational Site
      • Miami, Florida, Förenta staterna, 33165
        • GSK Investigational Site
      • Miami, Florida, Förenta staterna, 33174
        • GSK Investigational Site
    • Georgia
      • Savannah, Georgia, Förenta staterna, 31406
        • GSK Investigational Site
    • Illinois
      • Normal, Illinois, Förenta staterna, 61761
        • GSK Investigational Site
    • Kentucky
      • Owensboro, Kentucky, Förenta staterna, 42301
        • GSK Investigational Site
    • Missouri
      • Columbia, Missouri, Förenta staterna, 65203
        • GSK Investigational Site
    • Montana
      • Missoula, Montana, Förenta staterna, 59808
        • GSK Investigational Site
    • New York
      • The Bronx, New York, Förenta staterna, 10461-1119
        • GSK Investigational Site
    • Ohio
      • Cincinnati, Ohio, Förenta staterna, 45229
        • GSK Investigational Site
      • Cleveland, Ohio, Förenta staterna, 44106
        • GSK Investigational Site
      • Dayton, Ohio, Förenta staterna, 45404
        • GSK Investigational Site
    • Oklahoma
      • Oklahoma City, Oklahoma, Förenta staterna, 73120-9350
        • GSK Investigational Site
    • South Carolina
      • Charleston, South Carolina, Förenta staterna, 29420
        • GSK Investigational Site
    • Texas
      • Dallas, Texas, Förenta staterna, 75225-6301
        • GSK Investigational Site
      • Kerrville, Texas, Förenta staterna, 78028
        • GSK Investigational Site
      • Plano, Texas, Förenta staterna, 75034
        • GSK Investigational Site
      • Waco, Texas, Förenta staterna, 76712
        • GSK Investigational Site
    • Wisconsin
      • Milwaukee, Wisconsin, Förenta staterna, 53226
        • GSK Investigational Site
  • Israel
      • Ashkelon, Israel, 7830604
        • GSK Investigational Site
      • Haifa, Israel, 3436212
        • GSK Investigational Site
      • Haifa, Israel, 3109600
        • GSK Investigational Site
      • Petah Tikva, Israel, 49202
        • GSK Investigational Site
  • Mexiko
      • Guadalajara, Mexiko, 44100
        • GSK Investigational Site
      • Monterrey, Mexiko, 64460
        • GSK Investigational Site
      • San Juan del Río, Mexiko, 76800
        • GSK Investigational Site
  • Nya Zeeland
    • Upper Hutt
      • Ebdentown, Upper Hutt, Nya Zeeland, 5018
        • GSK Investigational Site
  • Sydkorea
      • Cheongju Chungcheongbuk-do, Sydkorea, 28644
        • GSK Investigational Site
      • Gwangju, Sydkorea, 501-757
        • GSK Investigational Site
      • Seoul, Sydkorea, 05505
        • GSK Investigational Site
      • Seoul, Sydkorea, 03722
        • GSK Investigational Site
      • Seoul, Sydkorea, 1757
        • GSK Investigational Site
      • Seoul, Sydkorea, 2447
        • GSK Investigational Site
  • Turkiet (Türkiye)
      • Adana, Turkiet (Türkiye), 1173
        • GSK Investigational Site
      • Antalya, Turkiet (Türkiye), 07070
        • GSK Investigational Site
      • Istanbul, Turkiet (Türkiye), 34010
        • GSK Investigational Site
      • Istanbul, Turkiet (Türkiye), 34899
        • GSK Investigational Site

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

12 år till 17 år (Barn)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Dubbel

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Deltagare som får FF/UMEC/VI
Läkemedel: FF/UMEC/VI

FF/UMEC/VI will be administered.

Enhet: ELLIPTA

FF/UMEC/VI and FF/VI will be administered via ELLIPTA inhaler
Aktiv komparator: Deltagare som får FF/VI
Enhet: ELLIPTA

FF/UMEC/VI and FF/VI will be administered via ELLIPTA inhaler

Läkemedel: FF/VI

FF/VI will be administered.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change from baseline in trough forced expiratory volume in 1 second (FEV1) (Liters) at Week 24
Tidsram: Baseline (Week 0) and Week 24

FEV1 will be measured using spirometry.
Baseline (Week 0) and Week 24

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change from Baseline in Asthma Control Questionnaire (7 items) (ACQ-7) (Scores on a scale)
Tidsram: Baseline (Week 0) and Week 24

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
Change from Baseline in Asthma Control Questionnaire (6 items) (ACQ-6) (Scores on a scale)
Tidsram: Baseline (Week 0) and Week 24

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
Change from Baseline in Asthma Control Questionnaire (5 items) (ACQ-5) (Scores on a scale)
Tidsram: Baseline (Week 0) and Week 24

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
Number of Participants with a clinically important change from baseline in ACQ-7 Score
Tidsram: Week 24

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
Number of Participants with a clinically important change from baseline in ACQ-6 Score
Tidsram: Week 24

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
Number of Participants with a clinically important change from baseline in ACQ-5 Score
Tidsram: Week 24

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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

GlaxoSmithKline

Utredare

  • Studierektor: GSK Clinical Trials, GlaxoSmithKline

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

24 april 2023

Primärt slutförande (Beräknad)

26 januari 2027

Avslutad studie (Beräknad)

28 januari 2027

Studieregistreringsdatum

Först inskickad

24 februari 2023

Först inskickad som uppfyllde QC-kriterierna

24 februari 2023

Första postat (Faktisk)

7 mars 2023

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

4 november 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

3 november 2026

Senast verifierad

1 november 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 206867

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

JA

IPD-planbeskrivning

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/

Tidsram för IPD-delning

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.

Kriterier för IPD Sharing Access

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.

IPD-delning som stöder informationstyp

  • STUDY_PROTOCOL
  • SAV
  • ICF
  • CSR

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Ja

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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