Une étude pour comparer l'efficacité, l'innocuité et la tolérabilité de FF/UMEC/VI avec FF/VI chez les 12-17 ans souffrant d'asthme
Une étude d'emprunt dynamique bayésienne de phase 3, de 24 semaines, randomisée, en double aveugle et en groupes parallèles comparant l'efficacité, l'innocuité, la tolérabilité et la pharmacocinétique de FF/UMEC/VI avec FF/VI chez des participants âgés de 12 à 17 ans avec Asthme insuffisamment contrôlé sous traitement d'entretien stable avec CSI/BALA
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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Estimé)
Phase
- Phase 3
Contacts et emplacements
Lieux d'étude
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Buenos Aires, Argentine, C1425BEN
- GSK Investigational Site
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Buenos Aires, Argentine, C1202
- GSK Investigational Site
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Buenos Aires, Argentine, 1888
- GSK Investigational Site
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Buenos Aires, Argentine, 1122
- GSK Investigational Site
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Buenos Aires, Argentine, C1023AAB
- GSK Investigational Site
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Córdoba, Argentine, X5000DCE
- GSK Investigational Site
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Córdoba, Argentine, X5014AKM
- GSK Investigational Site
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Lanus, Argentine, B1824KAJ
- GSK Investigational Site
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Lobos, Argentine, 7240
- GSK Investigational Site
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Lujan de Cuyo, Argentine, 5509
- GSK Investigational Site
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Mar del Plata, Argentine, 7600
- GSK Investigational Site
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Rosario, Argentine, 2000
- GSK Investigational Site
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Rosario Provincia de Santa FE, Argentine, 2000
- GSK Investigational Site
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San Miguel de Tucumán, Argentine, T4000IHE
- GSK Investigational Site
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Santa Fe, Argentine, 3000
- GSK Investigational Site
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Queensland
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South Brisbane, Queensland, Australie, 4101
- GSK Investigational Site
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South Australia
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North Adelaide, South Australia, Australie, 5006
- GSK Investigational Site
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Western Australia
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Joondalup WA, Western Australia, Australie, 6027
- GSK Investigational Site
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Lo Barnechea, Chili, 7691236
- GSK Investigational Site
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Santiago, Chili, 7630000
- GSK Investigational Site
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Santiago, Chili, 8320000
- GSK Investigational Site
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Cheongju Chungcheongbuk-do, Corée du Sud, 28644
- GSK Investigational Site
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Gwangju, Corée du Sud, 501-757
- GSK Investigational Site
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Seoul, Corée du Sud, 05505
- GSK Investigational Site
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Seoul, Corée du Sud, 03722
- GSK Investigational Site
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Seoul, Corée du Sud, 1757
- GSK Investigational Site
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Seoul, Corée du Sud, 2447
- GSK Investigational Site
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Ashkelon, Israël, 7830604
- GSK Investigational Site
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Haifa, Israël, 3436212
- GSK Investigational Site
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Haifa, Israël, 3109600
- GSK Investigational Site
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Petah Tikva, Israël, 49202
- GSK Investigational Site
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Guadalajara, Mexique, 44100
- GSK Investigational Site
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Monterrey, Mexique, 64460
- GSK Investigational Site
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San Juan del Río, Mexique, 76800
- GSK Investigational Site
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Upper Hutt
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Ebdentown, Upper Hutt, Nouvelle-Zélande, 5018
- GSK Investigational Site
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Adana, Turquie (Türkiye), 1173
- GSK Investigational Site
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Antalya, Turquie (Türkiye), 07070
- GSK Investigational Site
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Istanbul, Turquie (Türkiye), 34010
- GSK Investigational Site
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Istanbul, Turquie (Türkiye), 34899
- GSK Investigational Site
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Alabama
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Birmingham, Alabama, États-Unis, 35244
- GSK Investigational Site
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Mobile, Alabama, États-Unis, 36608
- GSK Investigational Site
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Arizona
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Paradise Valley, Arizona, États-Unis, 85253
- GSK Investigational Site
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California
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Bakersfield, California, États-Unis, 93301-4205
- GSK Investigational Site
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Huntington Beach, California, États-Unis, 92647
- GSK Investigational Site
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Mission Viejo, California, États-Unis, 92691
- GSK Investigational Site
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Rolling Hills Estates, California, États-Unis, 90274
- GSK Investigational Site
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Colorado
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Colorado Springs, Colorado, États-Unis, 80909
- GSK Investigational Site
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Florida
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Aventura, Florida, États-Unis, 33180
- GSK Investigational Site
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Miami, Florida, États-Unis, 33173
- GSK Investigational Site
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Miami, Florida, États-Unis, 33165
- GSK Investigational Site
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Miami, Florida, États-Unis, 33174
- GSK Investigational Site
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Georgia
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Savannah, Georgia, États-Unis, 31406
- GSK Investigational Site
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Illinois
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Normal, Illinois, États-Unis, 61761
- GSK Investigational Site
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Kentucky
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Owensboro, Kentucky, États-Unis, 42301
- GSK Investigational Site
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Missouri
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Columbia, Missouri, États-Unis, 65203
- GSK Investigational Site
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Montana
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Missoula, Montana, États-Unis, 59808
- GSK Investigational Site
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New York
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The Bronx, New York, États-Unis, 10461-1119
- GSK Investigational Site
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Ohio
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Cincinnati, Ohio, États-Unis, 45229
- GSK Investigational Site
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Cleveland, Ohio, États-Unis, 44106
- GSK Investigational Site
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Dayton, Ohio, États-Unis, 45404
- GSK Investigational Site
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Oklahoma
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Oklahoma City, Oklahoma, États-Unis, 73120-9350
- GSK Investigational Site
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South Carolina
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Charleston, South Carolina, États-Unis, 29420
- GSK Investigational Site
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Texas
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Dallas, Texas, États-Unis, 75225-6301
- GSK Investigational Site
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Kerrville, Texas, États-Unis, 78028
- GSK Investigational Site
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Plano, Texas, États-Unis, 75034
- GSK Investigational Site
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Waco, Texas, États-Unis, 76712
- GSK Investigational Site
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Wisconsin
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Milwaukee, Wisconsin, États-Unis, 53226
- GSK Investigational Site
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Expérimental: Participants recevant 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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Comparateur actif: Participants recevant FF/VI
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FF/UMEC/VI and FF/VI will be administered via ELLIPTA inhaler FF/VI will be administered. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Change from baseline in trough forced expiratory volume in 1 second (FEV1) (Liters) at Week 24
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
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Change from Baseline in Asthma Control Questionnaire (7 items) (ACQ-7) (Scores on a scale)
Délai: 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)
Délai: 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)
Délai: 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
Délai: 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
Délai: 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
Délai: 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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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Directeur d'études: GSK Clinical Trials, GlaxoSmithKline
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 206867
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