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The goal of this study is to assess and compare the effectiveness of fluticasone furoate/umeclidinium bromide/vilanterol trifenatate (FF/UMEC/VI) with inhaled corticosteroids/long-acting beta-2 agonists (ICS/LABA) in adult participants with uncontrolled asthma
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fluticasone furoate/umeclidinium bromide/vilanterol trifenatate (FF/UMEC/VI) | Experimental |
| |
| Inhaled corticosteroids/long-acting beta-2 agonists (ICS/LABA) | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluticasone furoate/umeclidinium bromide/vilanterol trifenatate | Drug | Participants will receive FF/UMEC/VI |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in trough forced expiratory volume in 1 second (FEV1) | Baseline (Day 1), and at Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants achieving ≥0.5 point improvement from baseline for the Asthma Control Questionnaire-7 (ACQ-7) after 24 weeks of treatment | The ACQ-7 consists of 7 questions scored between zero (no impairment/ limitation) to 6 (total impairment/ limitation).Higher scores indicate greater impairment. ACQ-7 is the responder analysis based on a 0.5 point change. | Baseline (Day 1), and Week 24 |
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Inclusion Criteria:
Participants are eligible to be included in the study only if all of the following criteria apply:
Has a diagnosis of asthma as defined by Global Initiative for Asthma (GINA) 2023 guidelines for at least 3 months prior to randomization.
Participants who are either:
ACQ-6 score ≥1.5 at randomization.
Participants able to perform technically acceptable and repeatable FEV1 maneuvers (i.e., a minimum of 2 acceptable and 1 repeatable effort) at visit 2 (V2)
Participants must be able to complete the study questionnaires.
Exclusion Criteria:
Participants are excluded from the study if any of the following criteria apply:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Centreville | Alabama | 35042 | United States | ||
| GSK Investigational Site |
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/
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.
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.
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| Inhaled corticosteroids/long-acting beta-2 agonists | Drug | Participants will receive ICS/LABA |
|
| Number of participants achieving the composite endpoint (optimized) after 52 weeks of treatment | The 4-point composite endpoint is defined as meeting the following criteria:
| Up to 52 weeks |
| Change from baseline in trough forced expiratory volume in 1 second (FEV1) after 52 weeks of treatment | Baseline (Day 1), and Week 52 |
| Change from baseline in trough FEV1 ≥ 100mL after 24 and 52 weeks of treatment | Baseline (Day 1), Week 24 and Week 52 |
| Change from baseline in through FEV1 ≥ 0mL after 24 and 52 weeks of treatment | Baseline (Day 1), Week 24 and Week 52 |
| Number of participants achieving ≥0.5 point improvement from baseline for the ACQ-7 after 52 weeks of treatment | The ACQ-7 consists of 7 questions scored between zero (no impairment/ limitation) to 6 (total impairment/ limitation). Higher scores indicate greater impairment. ACQ-7 is the responder analysis based on a 0.5 point change. | Week 52 |
| Number of participants achieving ≥0.5 point improvement from baseline for the Asthma Control Questionnaire-6 (ACQ-6) after 24 and 52 weeks of treatment | The ACQ-6 is a shortened version of the ACQ-7 derived by removing one element (lung function element) from the original version. The scoring ranges from 0 (no impairment/ limitation) to 6 (total impairment/ limitation), higher scores indicate greater impairment. ACQ-6 is the responder analysis based on a 0.5 point change. | Baseline (Day 1), Week 24 and Week 52 |
| Number of participants achieving ≥0.5 point improvement from baseline for the ACQ-5 after 24 and 52 weeks of treatment | The ACQ-5 consists of 5 questions scored from zero (no impairment/limitation) to six (total impairment/ limitation). Higher scores indicate greater impairment. It is a shorter version of ACQ-7 derived by removal of two elements (lung function and rescue use elements) from original version (ACQ-7). ACQ-5 is the responder analysis based on a 0.5 point change. | Baseline (Day 1), Week 24 and Week 52 |
| Change from baseline in the ACQ-7 total score after 24 and 52 weeks of treatment | The ACQ-7 total consists of 7 questions scored between zero (no impairment/ limitation) to 6 (total impairment/ limitation). Higher scores indicate greater impairment. | Baseline (Day 1), Week 24 and Week 52 |
| Change from baseline in the ACQ-5 total score after 24 and 52 weeks of treatment | The ACQ-5 total consists of 5 questions scored from zero (no impairment/limitation) to six (total impairment/ limitation). Higher scores indicate greater impairment. It is a shorter version of ACQ-7 derived by removal of two elements (lung function and rescue use elements) from original version (ACQ-7). | Baseline (Day 1), Week 24 and Week 52 |
| Change from baseline in the ACQ-6 total score after 24 and 52 weeks of treatment | The ACQ-6 total is a shortened version of the ACQ-7 derived by removing one element (lung function element) from the original version. The scoring ranges from 0 (no impairment/limitation) to 6 (total impairment/ limitation), higher scores indicate greater impairment. | Baseline (Day 1), Week 24 and Week 52 |
| Change from baseline in the Asthma Control Test (ACT) score after 24 and 52 weeks of treatment | The ACT is a 5-question health survey used to measure asthma control in participants aged ≥12 years. Each question is scored from 1 to 5 for a total score ranging from 5 to 25; with higher scores indicating better asthma control. | Baseline (Day 1), Week 24 and Week 52 |
| Number of participants achieving the composite endpoint among those on ICS/LABA prior to randomization | The 4-point composite endpoint is defined as meeting the following criteria:
| Week 52 |
| Number of participants achieving the composite endpoint among those on no treatment prior to randomization | The 4-point composite endpoint is defined as meeting the following criteria:
| Up to 52 weeks |
| Change from baseline in the Asthma Quality of Life Questionnaire (AQLQ-12) total scores after 24 and 52 weeks of treatment | The AQLQ (+12), is a modified version of the original AQLQ with standardized activities. The response scale ranges from 1 (totally impaired) to 7 (not at all impaired). The total score is the score from all 32 questions. | Baseline (Day 1), Week 24 and Week 52 |
| Change from baseline in the Asthma Quality of Life Questionnaire (AQLQ-12) domain scores after 24 and 52 weeks of treatment | The AQLQ (+12), is a modified version of the original AQLQ with standardized activities. The response scale ranges from 1 (totally impaired) to 7 (not at all impaired). The domain score looks at each domain individually - symptoms, activity limitation, emotional function and environmental stimuli. | Baseline (Day 1), Week 24 and Week 52 |
| Change from baseline in the four domains of the asthma-specific adaptation of the Work Productivity and Activity Impairment Questionnaire (WPAI:Asthma) after 24 and 52 weeks of treatment | WPAI is a self-administered tool to determine the degree to which asthma affected work productivity while at work and affected activities outside of work in the last 7 days. The WPAI questionnaire score represents the percentage of impairment, from 0 to 100%. Higher WPAI scores indicate greater activity impairment. | Baseline (Day 1), Week 24 and Week 52 |
| Change from baseline in trough forced expiratory volume in 1 second (FEV1) among participants on budesonide/formoterol prior to randomization | Baseline (Day 1), and Week 24 |
| Number of participants achieving ≥0.5 points improvement from baseline for ACQ-7 among participants on ICS/LABA prior to randomization | The ACQ-7 consists of 7 questions scored between zero (no impairment/ limitation) to 6 (total impairment/ limitation). Higher scores indicate greater impairment. ACQ-7 is the responder analysis based on a 0.5 point change. | Baseline (Day 1), Week 24 and Week 52 |
| Change from baseline in the ACQ-7 total score among participants on ICS/LABA prior to randomization | The ACQ-7 total consists of 7 questions scored between zero (no impairment/ limitation) to 6 (total impairment/ limitation). Higher scores indicate greater impairment. | Baseline (Day 1), Week 24 and Week 52 |
| Change from baseline in trough forced expiratory volume in 1 second (FEV1) for participants with no treatment prior to randomization. | Baseline (Day 1), and Week 24 |
| Number of participants achieving ≥0.5 points improvement from baseline for ACQ-7 for participants with no treatment prior to randomization. | The ACQ-7 consists of 7 questions scored between zero (no impairment/ limitation) to 6 (total impairment/ limitation). Higher scores indicate greater impairment. ACQ-7 is the responder analysis based on a 0.5 point change. | Baseline (Day 1), Week 24 and Week 52 |
| Change from baseline in the ACQ-7 total score for participants with no treatment prior to randomization. | The ACQ-7 total consists of 7 questions scored between zero (no impairment/ limitation) to 6 (total impairment/ limitation). Higher scores indicate greater impairment. s | Baseline (Day 1), Week 24 and Week 52 |
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| Arkansas |
| 72205 |
| United States |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C523187 | fluticasone furoate |
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