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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT06372496
Registration number
NCT06372496
Ethics application status
Date submitted
15/04/2024
Date registered
18/04/2024
Titles & IDs
Public title
Pragmatic Open - Label Randomized Clinical Trial of FF/UMEC/VI vs Non-ellipta Usual Care ICS-LABA for Adult Participants With Uncontrolled Asthma
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Scientific title
A Phase 4, 52-week (Primary Analysis at 24-weeks), Randomized, Stratified, Open-label, Active-controlled, Parallel-group, Effectiveness Study, Comparing FF/UMEC/VI With Non-ellipta Usual Care (ICS/LABA) in Adult Participants With Uncontrolled Asthma
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Secondary ID [1]
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219912
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Asthma
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Condition category
Condition code
Respiratory
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Asthma
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Fluticasone furoate/umeclidinium bromide/vilanterol trifenatate
Treatment: Drugs - Inhaled corticosteroids/long-acting beta-2 agonists
Experimental: Fluticasone furoate/umeclidinium bromide/vilanterol trifenatate (FF/UMEC/VI) -
Active comparator: Inhaled corticosteroids/long-acting beta-2 agonists (ICS/LABA) -
Treatment: Drugs: Fluticasone furoate/umeclidinium bromide/vilanterol trifenatate
Participants will receive FF/UMEC/VI
Treatment: Drugs: Inhaled corticosteroids/long-acting beta-2 agonists
Participants will receive ICS/LABA
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Change from baseline in trough forced expiratory volume in 1 second (FEV1)
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Assessment method [1]
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Timepoint [1]
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Baseline (Day 1), and at Week 24
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Secondary outcome [1]
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Number of participants achieving =0.5 point improvement from baseline for the Asthma Control Questionnaire-7 (ACQ-7) after 24 weeks of treatment
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Assessment method [1]
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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.
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Timepoint [1]
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Baseline (Day 1), and Week 24
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Secondary outcome [2]
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Number of participants achieving the composite endpoint at Week in participants after 52 weeks of treatment
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Assessment method [2]
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The 4-point composite endpoint is defined as meeting the following criteria:
* Change from baseline in trough FEV1 = 100 mL at Week 52.
* Controlled asthma based on ACQ-5 total score = 1.5 at Week 52.
* No severe asthma exacerbations over 52 weeks.
* OCS-free over 52 weeks
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Timepoint [2]
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Up to 52 weeks
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Secondary outcome [3]
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0
Change from baseline in trough forced expiratory volume in 1 second (FEV1) after 52 weeks of treatment
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Assessment method [3]
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0
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Timepoint [3]
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Baseline (Day 1), and Week 52
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Secondary outcome [4]
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Number of participants achieving =0.5 point improvement from baseline for the ACQ-7 after 52 weeks of treatment
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Assessment method [4]
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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.
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Timepoint [4]
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Week 52
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Secondary outcome [5]
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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
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Assessment method [5]
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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.
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Timepoint [5]
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Baseline (Day 1), Week 24 and Week 52
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Secondary outcome [6]
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Number of participants achieving =0.5 point improvement from baseline for the ACQ-5 after 24 and 52 weeks of treatment
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Assessment method [6]
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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.
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Timepoint [6]
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Baseline (Day 1), Week 24 and Week 52
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Secondary outcome [7]
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Change from baseline in the ACQ-7 total score after 24 and 52 weeks of treatment
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Assessment method [7]
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The ACQ-7 total consists of 7 questions scored between zero (no impairment/ limitation) to 6 (total impairment/ limitation). Higher scores indicate greater impairment.
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Timepoint [7]
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Baseline (Day 1), Week 24 and Week 52
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Secondary outcome [8]
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0
Change from baseline in the ACQ-5 total score after 24 and 52 weeks of treatment
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Assessment method [8]
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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).
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Timepoint [8]
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Baseline (Day 1), Week 24 and Week 52
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Secondary outcome [9]
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Change from baseline in the ACQ-6 total score after 24 and 52 weeks of treatment
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Assessment method [9]
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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.
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Timepoint [9]
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0
Baseline (Day 1), Week 24 and Week 52
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Secondary outcome [10]
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Change from baseline in the Asthma Control Test (ACT) score after 24 and 52 weeks of treatment
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Assessment method [10]
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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.
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Timepoint [10]
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Baseline (Day 1), Week 24 and Week 52
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Secondary outcome [11]
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Number of participants achieving the composite endpoint among those on budesonide/formoterol prior to randomization
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Assessment method [11]
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The 4-point composite endpoint is defined as meeting the following criteria:
* Change from baseline in trough FEV1 = 100 mL at Week 52.
* Controlled asthma based on ACQ-5 total score = 1.5 at Week 52.
* No severe asthma exacerbations over 52 weeks.
* OCS-free over 52 weeks
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Timepoint [11]
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Up to 52 weeks
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Secondary outcome [12]
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Change from baseline in the Asthma Quality of Life Questionnaire (AQLQ-12) total scores after 24 and 52 weeks of treatment
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Assessment method [12]
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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.
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Timepoint [12]
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Baseline (Day 1), Week 24 and Week 52
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Secondary outcome [13]
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Change from baseline in the Asthma Quality of Life Questionnaire (AQLQ-12) domain scores after 24 and 52 weeks of treatment
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Assessment method [13]
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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.
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Timepoint [13]
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Baseline (Day 1), Week 24 and Week 52
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Secondary outcome [14]
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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
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Assessment method [14]
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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.
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Timepoint [14]
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Baseline (Day 1), Week 24 and Week 52
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Secondary outcome [15]
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Change from baseline in trough forced expiratory volume in 1 second (FEV1) among participants on budesonide/formoterol prior to randomization
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Assessment method [15]
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Timepoint [15]
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Baseline (Day 1), and Week 24
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Secondary outcome [16]
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Number of participants achieving =0.5 points improvement from baseline for ACQ-7 among participants on budesonide/formoterol prior to randomization
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Assessment method [16]
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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.
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Timepoint [16]
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Baseline (Day 1), Week 24 and Week 52
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Secondary outcome [17]
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0
Change from baseline in the ACQ-7 total score among participants on budesonide/formoterol prior to randomization
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Assessment method [17]
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The ACQ-7 total consists of 7 questions scored between zero (no impairment/ limitation) to 6 (total impairment/ limitation). Higher scores indicate greater impairment.
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Timepoint [17]
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Baseline (Day 1), Week 24 and Week 52
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Secondary outcome [18]
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Change from baseline in trough forced expiratory volume in 1 second (FEV1) for participants with no treatment prior to randomization.
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Assessment method [18]
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0
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Timepoint [18]
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Baseline (Day 1), and Week 24
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Secondary outcome [19]
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0
Number of participants achieving =0.5 points improvement from baseline for ACQ-7 for participants with no treatment prior to randomization.
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Assessment method [19]
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0
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.
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Timepoint [19]
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0
Baseline (Day 1), Week 24 and Week 52
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Secondary outcome [20]
0
0
Change from baseline in the ACQ-7 total score for participants with no treatment prior to randomization.
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Assessment method [20]
0
0
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
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Timepoint [20]
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Baseline (Day 1), Week 24 and Week 52
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Eligibility
Key inclusion criteria
Participants are eligible to be included in the study only if all of the following criteria apply:
1. Has a diagnosis of asthma as defined by Global Initiative for Asthma (GINA) 2022 guidelines for at least 3 months prior to randomization.
2. Participants who are either:
* Currently untreated
* Treated with daily maintenance ICS or ICS/LABA
3. ACQ-6 score =1.5 at randomization.
4. Participants must be able to complete the study questionnaires.
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Minimum age
18
Years
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Maximum age
75
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Participants are excluded from the study if any of the following criteria apply:
1. Recent history of life-threatening asthma
2. History of >1 severe exacerbation of asthma within 12 months prior to randomization.
3. Women of childbearing potential that are not following at least one highly effective method of contraception. This includes women who are pregnant or lactating or are planning on becoming pregnant during the study.
4. A WOCBP must have a negative pregnancy test =7 days prior to randomization.
5. Exposure to inhaler triple therapy [ICS + Long-acting muscarinic antagonist (LAMA) + LABA as Single inhaler triple therapy (SITT) or Multiple inhaler triple therapy(MITT)] and/or any LAMA-containing therapy within 12 months prior to randomization.
6. Ongoing need for biologic therapy or recent use of a biologic therapy
7. Participants with the diagnosis of chronic obstructive pulmonary disease, as per Global Initiative for Chronic Obstructive Lung Disease (GOLD 2024) guidelines.
8. Participants whose current medications include RELVAR ELLIPTA and ARNUITY ELLIPTA are not eligible to enter the study.
9. Participants who are medically unable to withhold their albuterol/salbutamol for 6 hours prior to spirometry testing
10. Changes in asthma medication (e.g., maintenance ICS/LABA) within 3 months prior to randomization.
11. Participants with a history of hypersensitivity to any of the study medications
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 4
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
16/04/2024
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
11/03/2026
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Actual
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Sample size
Target
1136
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,WA
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Recruitment hospital [1]
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GSK Investigational Site - Bruce
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Recruitment hospital [2]
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GSK Investigational Site - Blacktown
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Recruitment hospital [3]
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GSK Investigational Site - Campbelltown
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Recruitment hospital [4]
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GSK Investigational Site - Coffs Harbour
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Recruitment hospital [5]
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GSK Investigational Site - Kanwal
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Recruitment hospital [6]
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GSK Investigational Site - Brisbane
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Recruitment hospital [7]
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GSK Investigational Site - Spearwood
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Recruitment postcode(s) [1]
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2617 - Bruce
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Recruitment postcode(s) [2]
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2148 - Blacktown
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Recruitment postcode(s) [3]
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2560 - Campbelltown
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Recruitment postcode(s) [4]
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2450 - Coffs Harbour
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Recruitment postcode(s) [5]
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2259 - Kanwal
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Recruitment postcode(s) [6]
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4006 - Brisbane
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Recruitment postcode(s) [7]
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6163 - Spearwood
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Arkansas
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United States of America
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California
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United States of America
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Florida
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United States of America
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Georgia
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United States of America
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Illinois
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United States of America
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Maine
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United States of America
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Maryland
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New Jersey
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United States of America
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New York
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United States of America
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North Carolina
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Ohio
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United States of America
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Pennsylvania
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South Carolina
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State/province [14]
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Texas
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Country [15]
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Argentina
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State/province [15]
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Buenos Aires
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Argentina
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State/province [16]
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Córdova
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0
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Argentina
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State/province [17]
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Santa Fe
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Country [18]
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Argentina
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State/province [18]
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Ciudad Autonoma de Buenos Aires
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Country [19]
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Argentina
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Mendoza
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Argentina
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Rosario
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Canada
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Ontario
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Canada
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Quebec
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Canada
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Saskatchewan
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Japan
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Fukuoka
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Japan
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Gifu
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Japan
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Hiroshima
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Japan
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Hyogo
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Japan
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Kagawa
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Japan
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State/province [29]
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Miyazaki
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Japan
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Niigata
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Japan
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Tokyo
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Korea, Republic of
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Daegu
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Korea, Republic of
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Seoul
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Taiwan
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Kaohsiung
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Taiwan
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Taichung
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
GlaxoSmithKline
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
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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Trial website
https://clinicaltrials.gov/study/NCT06372496
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Phone
0
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Fax
0
0
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Email
0
0
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Contact person for public queries
Name
0
0
US GSK Clinical Trials Call Center
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Address
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0
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Country
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Phone
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877-379-3718
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
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/
Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF), Clinical study report (CSR)
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When will data be available (start and end dates)?
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.
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Available to whom?
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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Available for what types of analyses?
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How or where can data be obtained?
IPD available at link: https://www.gsk.com/en-gb/innovation/trials/data-transparency/
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT06372496