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En studie for å sammenligne effektiviteten, sikkerheten og toleransen til FF/UMEC/VI med FF/VI hos 12-17-åringer med astma

3. november 2026 oppdatert av: GlaxoSmithKline

En fase 3, 24-ukers, randomisert, dobbeltblind, parallellgruppe Bayesiansk dynamisk lånestudie som sammenligner effektiviteten, sikkerheten, toleransen og farmakokinetikken til FF/UMEC/VI med FF/VI hos 12-17 år gamle deltakere med Utilstrekkelig kontrollert astma på stabil vedlikeholdsterapi 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.

Studieoversikt

Status

Aktiv, ikke rekrutterende

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

138

Fase

  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • 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
  • Australia
    • Queensland
      • South Brisbane, Queensland, Australia, 4101
        • GSK Investigational Site
    • South Australia
      • North Adelaide, South Australia, Australia, 5006
        • GSK Investigational Site
    • Western Australia
      • Joondalup WA, Western Australia, Australia, 6027
        • GSK Investigational Site
  • Chile
      • Lo Barnechea, Chile, 7691236
        • GSK Investigational Site
      • Santiago, Chile, 7630000
        • GSK Investigational Site
      • Santiago, Chile, 8320000
        • GSK Investigational Site
  • Forente stater
    • Alabama
      • Birmingham, Alabama, Forente stater, 35244
        • GSK Investigational Site
      • Mobile, Alabama, Forente stater, 36608
        • GSK Investigational Site
    • Arizona
      • Paradise Valley, Arizona, Forente stater, 85253
        • GSK Investigational Site
    • California
      • Bakersfield, California, Forente stater, 93301-4205
        • GSK Investigational Site
      • Huntington Beach, California, Forente stater, 92647
        • GSK Investigational Site
      • Mission Viejo, California, Forente stater, 92691
        • GSK Investigational Site
      • Rolling Hills Estates, California, Forente stater, 90274
        • GSK Investigational Site
    • Colorado
      • Colorado Springs, Colorado, Forente stater, 80909
        • GSK Investigational Site
    • Florida
      • Aventura, Florida, Forente stater, 33180
        • GSK Investigational Site
      • Miami, Florida, Forente stater, 33173
        • GSK Investigational Site
      • Miami, Florida, Forente stater, 33165
        • GSK Investigational Site
      • Miami, Florida, Forente stater, 33174
        • GSK Investigational Site
    • Georgia
      • Savannah, Georgia, Forente stater, 31406
        • GSK Investigational Site
    • Illinois
      • Normal, Illinois, Forente stater, 61761
        • GSK Investigational Site
    • Kentucky
      • Owensboro, Kentucky, Forente stater, 42301
        • GSK Investigational Site
    • Missouri
      • Columbia, Missouri, Forente stater, 65203
        • GSK Investigational Site
    • Montana
      • Missoula, Montana, Forente stater, 59808
        • GSK Investigational Site
    • New York
      • The Bronx, New York, Forente stater, 10461-1119
        • GSK Investigational Site
    • Ohio
      • Cincinnati, Ohio, Forente stater, 45229
        • GSK Investigational Site
      • Cleveland, Ohio, Forente stater, 44106
        • GSK Investigational Site
      • Dayton, Ohio, Forente stater, 45404
        • GSK Investigational Site
    • Oklahoma
      • Oklahoma City, Oklahoma, Forente stater, 73120-9350
        • GSK Investigational Site
    • South Carolina
      • Charleston, South Carolina, Forente stater, 29420
        • GSK Investigational Site
    • Texas
      • Dallas, Texas, Forente stater, 75225-6301
        • GSK Investigational Site
      • Kerrville, Texas, Forente stater, 78028
        • GSK Investigational Site
      • Plano, Texas, Forente stater, 75034
        • GSK Investigational Site
      • Waco, Texas, Forente stater, 76712
        • GSK Investigational Site
    • Wisconsin
      • Milwaukee, Wisconsin, Forente stater, 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
  • Mexico
      • Guadalajara, Mexico, 44100
        • GSK Investigational Site
      • Monterrey, Mexico, 64460
        • GSK Investigational Site
      • San Juan del Río, Mexico, 76800
        • GSK Investigational Site
  • New Zealand
    • Upper Hutt
      • Ebdentown, Upper Hutt, New Zealand, 5018
        • GSK Investigational Site
  • Sør -Korea
      • Cheongju Chungcheongbuk-do, Sør -Korea, 28644
        • GSK Investigational Site
      • Gwangju, Sør -Korea, 501-757
        • GSK Investigational Site
      • Seoul, Sør -Korea, 05505
        • GSK Investigational Site
      • Seoul, Sør -Korea, 03722
        • GSK Investigational Site
      • Seoul, Sør -Korea, 1757
        • GSK Investigational Site
      • Seoul, Sør -Korea, 2447
        • GSK Investigational Site
  • Tyrkia (Türkiye)
      • Adana, Tyrkia (Türkiye), 1173
        • GSK Investigational Site
      • Antalya, Tyrkia (Türkiye), 07070
        • GSK Investigational Site
      • Istanbul, Tyrkia (Türkiye), 34010
        • GSK Investigational Site
      • Istanbul, Tyrkia (Türkiye), 34899
        • GSK Investigational Site

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

12 år til 17 år (Barn)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Dobbelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Deltakere som mottar FF/UMEC/VI
Legemiddel: 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: Deltakere som mottar FF/VI
Enhet: ELLIPTA

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

Legemiddel: FF/VI

FF/VI will be administered.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change from baseline in trough forced expiratory volume in 1 second (FEV1) (Liters) at Week 24
Tidsramme: Baseline (Week 0) and Week 24

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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change from Baseline in Asthma Control Questionnaire (7 items) (ACQ-7) (Scores on a scale)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

GlaxoSmithKline

Etterforskere

  • Studieleder: GSK Clinical Trials, GlaxoSmithKline

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

24. april 2023

Primær fullføring (Antatt)

26. januar 2027

Studiet fullført (Antatt)

28. januar 2027

Datoer for studieregistrering

Først innsendt

24. februar 2023

Først innsendt som oppfylte QC-kriteriene

24. februar 2023

Først lagt ut (Faktiske)

7. mars 2023

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

4. november 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

3. november 2026

Sist bekreftet

1. november 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 206867

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

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/

IPD-delingstidsramme

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.

Tilgangskriterier for IPD-deling

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-deling Støtteinformasjonstype

  • STUDY_PROTOCOL
  • SEVJE
  • ICF
  • CSR

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere