Ignite Creation Date:
2025-12-25 @ 3:52 AM
Ignite Modification Date:
2025-12-26 @ 2:41 AM
Study NCT ID:
NCT05757102
Status:
RECRUITING
Last Update Posted:
2025-10-07
First Post:
2023-02-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study to Compare the Efficacy, Safety and Tolerability of FF/UMEC/VI With FF/VI in 12-17-year-olds With Asthma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Mexico', 'Turkey (Türkiye)']}, 'conditionBrowseModule': {'meshes': [{'id': 'D001249', 'term': 'Asthma'}], 'ancestors': [{'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 292}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-04-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2027-01-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-06', 'studyFirstSubmitDate': '2023-02-24', 'studyFirstSubmitQcDate': '2023-02-24', 'lastUpdatePostDateStruct': {'date': '2025-10-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-03-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-01-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in trough forced expiratory volume in 1 second (FEV1) (Liters) at Week 24', 'timeFrame': 'Baseline (Week 0) and Week 24', 'description': 'FEV1 will be measured using spirometry.'}], 'secondaryOutcomes': [{'measure': 'Change from Baseline in Asthma Control Questionnaire (7 items) (ACQ-7) (Scores on a scale)', 'timeFrame': 'Baseline (Week 0) and Week 24', 'description': '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.'}, {'measure': 'Change from Baseline in Asthma Control Questionnaire (6 items) (ACQ-6) (Scores on a scale)', 'timeFrame': 'Baseline (Week 0) and Week 24', 'description': '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.'}, {'measure': 'Change from Baseline in Asthma Control Questionnaire (5 items) (ACQ-5) (Scores on a scale)', 'timeFrame': 'Baseline (Week 0) and Week 24', 'description': '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.'}, {'measure': 'Number of Participants with a clinically important change from baseline in ACQ-7 Score', 'timeFrame': 'Week 24', 'description': '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.'}, {'measure': 'Number of Participants with a clinically important change from baseline in ACQ-6 Score', 'timeFrame': 'Week 24', 'description': '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.'}, {'measure': 'Number of Participants with a clinically important change from baseline in ACQ-5 Score', 'timeFrame': 'Week 24', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Fluticasone Furoate', 'GW685698', 'Umeclidinium', 'GSK573719', 'Vilanterol', 'GW642444', 'Trelegy', 'Relvar', 'Breo'], 'conditions': ['Asthma']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Participant must be 12 to 17 years of age (inclusive), at the time of signing the informed consent/assent.\n* 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.\n* 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).\n* 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).\n* Participants with inadequately controlled asthma (ACQ-6 score ≥1.5) at Visit 1, despite ICS/LABA maintenance therapy.\n* 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.\n\nExclusion Criteria:\n\n* Chest X-ray documented pneumonia in the 6 weeks prior to Visit 1.\n* 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)\n* History of Life-threatening Asthma\n* Participants with current evidence of active pulmonary diseases or abnormalities other than asthma (e.g., pneumonia, active tuberculosis, significant bronchiectasis, etc.).\n* 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."}, 'identificationModule': {'nctId': 'NCT05757102', 'briefTitle': 'A Study to Compare the Efficacy, Safety and Tolerability of FF/UMEC/VI With FF/VI in 12-17-year-olds With Asthma', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': 'A Phase 3, 24-week, Randomized, Double-blind, Parallel-group Bayesian Dynamic Borrowing Study Comparing the Efficacy, Safety, Tolerability and Pharmacokinetics of FF/UMEC/VI With FF/VI in 12-17-year-old Participants With Inadequately Controlled Asthma on Stable Maintenance Therapy With ICS/LABA', 'orgStudyIdInfo': {'id': '206867'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Participants receiving FF/UMEC/VI', 'interventionNames': ['Drug: FF/UMEC/VI', 'Device: ELLIPTA']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Participants receiving FF/VI', 'interventionNames': ['Device: ELLIPTA', 'Drug: FF/VI']}], 'interventions': [{'name': 'FF/UMEC/VI', 'type': 'DRUG', 'description': 'FF/UMEC/VI will be administered.', 'armGroupLabels': ['Participants receiving FF/UMEC/VI']}, {'name': 'ELLIPTA', 'type': 'DEVICE', 'description': 'FF/UMEC/VI and FF/VI will be administered via ELLIPTA inhaler', 'armGroupLabels': ['Participants receiving FF/UMEC/VI', 'Participants receiving FF/VI']}, {'name': 'FF/VI', 'type': 'DRUG', 'description': 'FF/VI will be administered.', 'armGroupLabels': ['Participants receiving FF/VI']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35209', 'city': 'Birmingham', 'state': 'Alabama', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'US GSK Clinical Trials Call Center', 'role': 'CONTACT', 'email': 'GSKClinicalSupportHD@gsk.com', 'phone': '877-379-3718'}, {'name': 'EU GSK Clinical Trials Call Centre', 'role': 'CONTACT', 'email': 'GSKClinicalSupportHD@gsk.com', 'phone': '+44 (0) 20 8990 4466'}, {'name': 'Weily Soong', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 33.52066, 'lon': 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'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 33.53115, 'lon': -111.94265}}, {'zip': '93301', 'city': 'Bakersfield', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'US GSK Clinical Trials Call Center', 'role': 'CONTACT', 'email': 'GSKClinicalSupportHD@gsk.com', 'phone': '877-379-3718'}, {'name': 'EU GSK Clinical Trials Call Centre', 'role': 'CONTACT', 'email': 'GSKClinicalSupportHD@gsk.com', 'phone': '+44 (0) 20 8990 4466'}, {'name': 'Eric Boren', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 35.37329, 'lon': -119.01871}}, {'zip': '92647', 'city': 'Huntington Beach', 'state': 'California', 'status': 'WITHDRAWN', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 33.6603, 'lon': -117.99923}}, {'zip': '92691', 'city': 'Mission Viejo', 'state': 'California', 'status': 'RECRUITING', 'country': 'United 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'PRINCIPAL_INVESTIGATOR'}], 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 38.83388, 'lon': -104.82136}}, {'zip': '33180', 'city': 'Aventura', 'state': 'Florida', 'status': 'COMPLETED', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 25.95648, 'lon': -80.13921}}, {'zip': '33165', 'city': 'Miami', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'US GSK Clinical Trials Call Center', 'role': 'CONTACT', 'email': 'GSKClinicalSupportHD@gsk.com', 'phone': '877-379-3718'}, {'name': 'EU GSK Clinical Trials Call Centre', 'role': 'CONTACT', 'email': 'GSKClinicalSupportHD@gsk.com', 'phone': '+44 (0) 20 8990 4466'}, {'name': 'Adalberto Aguilera', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33173', 'city': 'Miami', 'state': 'Florida', 'status': 'COMPLETED', 'country': 'United States', 'facility': 'GSK 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Investigational Site', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '29420', 'city': 'Charleston', 'state': 'South Carolina', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'US GSK Clinical Trials Call Center', 'role': 'CONTACT', 'email': 'GSKClinicalSupportHD@gsk.com', 'phone': '877-379-3718'}, {'name': 'EU GSK Clinical Trials Call Centre', 'role': 'CONTACT', 'email': 'GSKClinicalSupportHD@gsk.com', 'phone': '+44 (0) 20 8990 4466'}, {'name': 'Patricia S. 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