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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
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
Secondary ID [1] 0 0
219912
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Asthma 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Asthma

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change from baseline in trough forced expiratory volume in 1 second (FEV1)
Timepoint [1] 0 0
Baseline (Day 1), and at Week 24
Secondary outcome [1] 0 0
Number of participants achieving =0.5 point improvement from baseline for the Asthma Control Questionnaire-7 (ACQ-7) after 24 weeks of treatment
Timepoint [1] 0 0
Baseline (Day 1), and Week 24
Secondary outcome [2] 0 0
Number of participants achieving the composite endpoint at Week in participants after 52 weeks of treatment
Timepoint [2] 0 0
Up to 52 weeks
Secondary outcome [3] 0 0
Change from baseline in trough forced expiratory volume in 1 second (FEV1) after 52 weeks of treatment
Timepoint [3] 0 0
Baseline (Day 1), and Week 52
Secondary outcome [4] 0 0
Number of participants achieving =0.5 point improvement from baseline for the ACQ-7 after 52 weeks of treatment
Timepoint [4] 0 0
Week 52
Secondary outcome [5] 0 0
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
Timepoint [5] 0 0
Baseline (Day 1), Week 24 and Week 52
Secondary outcome [6] 0 0
Number of participants achieving =0.5 point improvement from baseline for the ACQ-5 after 24 and 52 weeks of treatment
Timepoint [6] 0 0
Baseline (Day 1), Week 24 and Week 52
Secondary outcome [7] 0 0
Change from baseline in the ACQ-7 total score after 24 and 52 weeks of treatment
Timepoint [7] 0 0
Baseline (Day 1), Week 24 and Week 52
Secondary outcome [8] 0 0
Change from baseline in the ACQ-5 total score after 24 and 52 weeks of treatment
Timepoint [8] 0 0
Baseline (Day 1), Week 24 and Week 52
Secondary outcome [9] 0 0
Change from baseline in the ACQ-6 total score after 24 and 52 weeks of treatment
Timepoint [9] 0 0
Baseline (Day 1), Week 24 and Week 52
Secondary outcome [10] 0 0
Change from baseline in the Asthma Control Test (ACT) score after 24 and 52 weeks of treatment
Timepoint [10] 0 0
Baseline (Day 1), Week 24 and Week 52
Secondary outcome [11] 0 0
Number of participants achieving the composite endpoint among those on budesonide/formoterol prior to randomization
Timepoint [11] 0 0
Up to 52 weeks
Secondary outcome [12] 0 0
Change from baseline in the Asthma Quality of Life Questionnaire (AQLQ-12) total scores after 24 and 52 weeks of treatment
Timepoint [12] 0 0
Baseline (Day 1), Week 24 and Week 52
Secondary outcome [13] 0 0
Change from baseline in the Asthma Quality of Life Questionnaire (AQLQ-12) domain scores after 24 and 52 weeks of treatment
Timepoint [13] 0 0
Baseline (Day 1), Week 24 and Week 52
Secondary outcome [14] 0 0
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
Timepoint [14] 0 0
Baseline (Day 1), Week 24 and Week 52
Secondary outcome [15] 0 0
Change from baseline in trough forced expiratory volume in 1 second (FEV1) among participants on budesonide/formoterol prior to randomization
Timepoint [15] 0 0
Baseline (Day 1), and Week 24
Secondary outcome [16] 0 0
Number of participants achieving =0.5 points improvement from baseline for ACQ-7 among participants on budesonide/formoterol prior to randomization
Timepoint [16] 0 0
Baseline (Day 1), Week 24 and Week 52
Secondary outcome [17] 0 0
Change from baseline in the ACQ-7 total score among participants on budesonide/formoterol prior to randomization
Timepoint [17] 0 0
Baseline (Day 1), Week 24 and Week 52
Secondary outcome [18] 0 0
Change from baseline in trough forced expiratory volume in 1 second (FEV1) for participants with no treatment prior to randomization.
Timepoint [18] 0 0
Baseline (Day 1), and Week 24
Secondary outcome [19] 0 0
Number of participants achieving =0.5 points improvement from baseline for ACQ-7 for participants with no treatment prior to randomization.
Timepoint [19] 0 0
Baseline (Day 1), Week 24 and Week 52
Secondary outcome [20] 0 0
Change from baseline in the ACQ-7 total score for participants with no treatment prior to randomization.
Timepoint [20] 0 0
Baseline (Day 1), Week 24 and Week 52

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.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
16/04/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
11/03/2026
Actual
Sample size
Target
1136
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,WA
Recruitment hospital [1] 0 0
GSK Investigational Site - Bruce
Recruitment hospital [2] 0 0
GSK Investigational Site - Blacktown
Recruitment hospital [3] 0 0
GSK Investigational Site - Campbelltown
Recruitment hospital [4] 0 0
GSK Investigational Site - Coffs Harbour
Recruitment hospital [5] 0 0
GSK Investigational Site - Kanwal
Recruitment hospital [6] 0 0
GSK Investigational Site - Brisbane
Recruitment hospital [7] 0 0
GSK Investigational Site - Spearwood
Recruitment postcode(s) [1] 0 0
2617 - Bruce
Recruitment postcode(s) [2] 0 0
2148 - Blacktown
Recruitment postcode(s) [3] 0 0
2560 - Campbelltown
Recruitment postcode(s) [4] 0 0
2450 - Coffs Harbour
Recruitment postcode(s) [5] 0 0
2259 - Kanwal
Recruitment postcode(s) [6] 0 0
4006 - Brisbane
Recruitment postcode(s) [7] 0 0
6163 - Spearwood
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arkansas
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Georgia
Country [5] 0 0
United States of America
State/province [5] 0 0
Illinois
Country [6] 0 0
United States of America
State/province [6] 0 0
Maine
Country [7] 0 0
United States of America
State/province [7] 0 0
Maryland
Country [8] 0 0
United States of America
State/province [8] 0 0
New Jersey
Country [9] 0 0
United States of America
State/province [9] 0 0
New York
Country [10] 0 0
United States of America
State/province [10] 0 0
North Carolina
Country [11] 0 0
United States of America
State/province [11] 0 0
Ohio
Country [12] 0 0
United States of America
State/province [12] 0 0
Pennsylvania
Country [13] 0 0
United States of America
State/province [13] 0 0
South Carolina
Country [14] 0 0
United States of America
State/province [14] 0 0
Texas
Country [15] 0 0
Argentina
State/province [15] 0 0
Buenos Aires
Country [16] 0 0
Argentina
State/province [16] 0 0
Córdova
Country [17] 0 0
Argentina
State/province [17] 0 0
Santa Fe
Country [18] 0 0
Argentina
State/province [18] 0 0
Ciudad Autonoma de Buenos Aires
Country [19] 0 0
Argentina
State/province [19] 0 0
Mendoza
Country [20] 0 0
Argentina
State/province [20] 0 0
Rosario
Country [21] 0 0
Canada
State/province [21] 0 0
Ontario
Country [22] 0 0
Canada
State/province [22] 0 0
Quebec
Country [23] 0 0
Canada
State/province [23] 0 0
Saskatchewan
Country [24] 0 0
Japan
State/province [24] 0 0
Fukuoka
Country [25] 0 0
Japan
State/province [25] 0 0
Gifu
Country [26] 0 0
Japan
State/province [26] 0 0
Hiroshima
Country [27] 0 0
Japan
State/province [27] 0 0
Hyogo
Country [28] 0 0
Japan
State/province [28] 0 0
Kagawa
Country [29] 0 0
Japan
State/province [29] 0 0
Miyazaki
Country [30] 0 0
Japan
State/province [30] 0 0
Niigata
Country [31] 0 0
Japan
State/province [31] 0 0
Tokyo
Country [32] 0 0
Korea, Republic of
State/province [32] 0 0
Daegu
Country [33] 0 0
Korea, Republic of
State/province [33] 0 0
Seoul
Country [34] 0 0
Taiwan
State/province [34] 0 0
Kaohsiung
Country [35] 0 0
Taiwan
State/province [35] 0 0
Taichung

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
GlaxoSmithKline
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
US GSK Clinical Trials Call Center
Address 0 0
Country 0 0
Phone 0 0
877-379-3718
Fax 0 0
Email 0 0
GSKClinicalSupportHD@gsk.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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)
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.
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.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.gsk.com/en-gb/innovation/trials/data-transparency/


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