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Uno studio per confrontare l'efficacia, la sicurezza e la tollerabilità di FF/UMEC/VI con FF/VI in ragazzi di 12-17 anni con asma

3 novembre 2026 aggiornato da: GlaxoSmithKline

Uno studio di prestito dinamico bayesiano di fase 3, di 24 settimane, randomizzato, in doppio cieco, a gruppi paralleli che confronta l'efficacia, la sicurezza, la tollerabilità e la farmacocinetica di FF/UMEC/VI con FF/VI in partecipanti di 12-17 anni con Asma non adeguatamente controllato con terapia di mantenimento stabile con 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.

Panoramica dello studio

Stato

Attivo, non reclutante

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Stimato)

138

Fase

  • Fase 3

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • 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
  • Corea del Sud
      • Cheongju Chungcheongbuk-do, Corea del Sud, 28644
        • GSK Investigational Site
      • Gwangju, Corea del Sud, 501-757
        • GSK Investigational Site
      • Seoul, Corea del Sud, 05505
        • GSK Investigational Site
      • Seoul, Corea del Sud, 03722
        • GSK Investigational Site
      • Seoul, Corea del Sud, 1757
        • GSK Investigational Site
      • Seoul, Corea del Sud, 2447
        • GSK Investigational Site
  • Israele
      • Ashkelon, Israele, 7830604
        • GSK Investigational Site
      • Haifa, Israele, 3436212
        • GSK Investigational Site
      • Haifa, Israele, 3109600
        • GSK Investigational Site
      • Petah Tikva, Israele, 49202
        • GSK Investigational Site
  • Messico
      • Guadalajara, Messico, 44100
        • GSK Investigational Site
      • Monterrey, Messico, 64460
        • GSK Investigational Site
      • San Juan del Río, Messico, 76800
        • GSK Investigational Site
  • Nuova Zelanda
    • Upper Hutt
      • Ebdentown, Upper Hutt, Nuova Zelanda, 5018
        • GSK Investigational Site
  • Stati Uniti
    • Alabama
      • Birmingham, Alabama, Stati Uniti, 35244
        • GSK Investigational Site
      • Mobile, Alabama, Stati Uniti, 36608
        • GSK Investigational Site
    • Arizona
      • Paradise Valley, Arizona, Stati Uniti, 85253
        • GSK Investigational Site
    • California
      • Bakersfield, California, Stati Uniti, 93301-4205
        • GSK Investigational Site
      • Huntington Beach, California, Stati Uniti, 92647
        • GSK Investigational Site
      • Mission Viejo, California, Stati Uniti, 92691
        • GSK Investigational Site
      • Rolling Hills Estates, California, Stati Uniti, 90274
        • GSK Investigational Site
    • Colorado
      • Colorado Springs, Colorado, Stati Uniti, 80909
        • GSK Investigational Site
    • Florida
      • Aventura, Florida, Stati Uniti, 33180
        • GSK Investigational Site
      • Miami, Florida, Stati Uniti, 33173
        • GSK Investigational Site
      • Miami, Florida, Stati Uniti, 33165
        • GSK Investigational Site
      • Miami, Florida, Stati Uniti, 33174
        • GSK Investigational Site
    • Georgia
      • Savannah, Georgia, Stati Uniti, 31406
        • GSK Investigational Site
    • Illinois
      • Normal, Illinois, Stati Uniti, 61761
        • GSK Investigational Site
    • Kentucky
      • Owensboro, Kentucky, Stati Uniti, 42301
        • GSK Investigational Site
    • Missouri
      • Columbia, Missouri, Stati Uniti, 65203
        • GSK Investigational Site
    • Montana
      • Missoula, Montana, Stati Uniti, 59808
        • GSK Investigational Site
    • New York
      • The Bronx, New York, Stati Uniti, 10461-1119
        • GSK Investigational Site
    • Ohio
      • Cincinnati, Ohio, Stati Uniti, 45229
        • GSK Investigational Site
      • Cleveland, Ohio, Stati Uniti, 44106
        • GSK Investigational Site
      • Dayton, Ohio, Stati Uniti, 45404
        • GSK Investigational Site
    • Oklahoma
      • Oklahoma City, Oklahoma, Stati Uniti, 73120-9350
        • GSK Investigational Site
    • South Carolina
      • Charleston, South Carolina, Stati Uniti, 29420
        • GSK Investigational Site
    • Texas
      • Dallas, Texas, Stati Uniti, 75225-6301
        • GSK Investigational Site
      • Kerrville, Texas, Stati Uniti, 78028
        • GSK Investigational Site
      • Plano, Texas, Stati Uniti, 75034
        • GSK Investigational Site
      • Waco, Texas, Stati Uniti, 76712
        • GSK Investigational Site
    • Wisconsin
      • Milwaukee, Wisconsin, Stati Uniti, 53226
        • GSK Investigational Site
  • Turchia (Türkiye)
      • Adana, Turchia (Türkiye), 1173
        • GSK Investigational Site
      • Antalya, Turchia (Türkiye), 07070
        • GSK Investigational Site
      • Istanbul, Turchia (Türkiye), 34010
        • GSK Investigational Site
      • Istanbul, Turchia (Türkiye), 34899
        • GSK Investigational Site

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 12 anni a 17 anni (Bambino)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Doppio

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Partecipanti che ricevono FF/UMEC/VI
Droga: FF/UMEC/VI

FF/UMEC/VI will be administered.

Dispositivo: ELLIPTA

FF/UMEC/VI and FF/VI will be administered via ELLIPTA inhaler
Comparatore attivo: Partecipanti che ricevono FF/VI
Dispositivo: ELLIPTA

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

Droga: FF/VI

FF/VI will be administered.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change from baseline in trough forced expiratory volume in 1 second (FEV1) (Liters) at Week 24
Lasso di tempo: Baseline (Week 0) and Week 24

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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change from Baseline in Asthma Control Questionnaire (7 items) (ACQ-7) (Scores on a scale)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

GlaxoSmithKline

Investigatori

  • Direttore dello studio: GSK Clinical Trials, GlaxoSmithKline

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

24 aprile 2023

Completamento primario (Stimato)

26 gennaio 2027

Completamento dello studio (Stimato)

28 gennaio 2027

Date di iscrizione allo studio

Primo inviato

24 febbraio 2023

Primo inviato che soddisfa i criteri di controllo qualità

24 febbraio 2023

Primo Inserito (Effettivo)

7 marzo 2023

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

4 novembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

3 novembre 2026

Ultimo verificato

1 novembre 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 206867

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano 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/

Periodo di condivisione 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.

Criteri di accesso alla condivisione 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.

Tipo di informazioni di supporto alla condivisione IPD

  • STUDIO_PROTOCOLLO
  • LINFA
  • ICF
  • RSI

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

Sì

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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