Pragmatic Open - Label Randomized Clinical Trial of FF/UMEC/VI vs Non-ellipta Usual Care ICS-LABA for Adult Participants With Uncontrolled Asthma

Asthma Clinical Trial

Official 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06372496
• Other study ID #: 219912
• Status: Recruiting
• Phase: Phase 4
• Start date: April 16, 2024
• Est. completion date: March 11, 2026

Study information

• Verified date: May 2024
• Source: GlaxoSmithKline
• Contact: US GSK Clinical Trials Call Center
• Phone: 877-379-3718
• Email: GSKClinicalSupportHD[@]gsk.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1136
• Est. completion date: March 11, 2026
• Est. primary completion date: March 11, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

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

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• Fluticasone furoate/umeclidinium bromide/vilanterol trifenatate
Participants will receive FF/UMEC/VI
• Inhaled corticosteroids/long-acting beta-2 agonists
Participants will receive ICS/LABA

Locations

Country	Name	City	State
Argentina	GSK Investigational Site	Ciudad Autonoma de Buenos Aires
Argentina	GSK Investigational Site	Ciudad Autónoma de Buenos Aires	Buenos Aires
Argentina	GSK Investigational Site	Cordoba	Córdova
Argentina	GSK Investigational Site	Florencio Varela	Buenos Aires
Argentina	GSK Investigational Site	Mar del Plata	Buenos Aires
Argentina	GSK Investigational Site	Mendoza
Argentina	GSK Investigational Site	Rosario
Argentina	GSK Investigational Site	Rosario	Santa Fe
Argentina	GSK Investigational Site	Rosario	Santa Fe
Australia	GSK Investigational Site	Blacktown	New South Wales
Australia	GSK Investigational Site	Brisbane	Queensland
Australia	GSK Investigational Site	Bruce	Australian Capital Territory
Australia	GSK Investigational Site	Campbelltown	New South Wales
Australia	GSK Investigational Site	Coffs Harbour	New South Wales
Australia	GSK Investigational Site	Kanwal	New South Wales
Australia	GSK Investigational Site	Spearwood	Western Australia
Canada	GSK Investigational Site	Brampton	Ontario
Canada	GSK Investigational Site	Saskatoon	Saskatchewan
Canada	GSK Investigational Site	Trois-Rivieres	Quebec
Canada	GSK Investigational Site	Windsor	Ontario
Japan	GSK Investigational Site	Fukuoka
Japan	GSK Investigational Site	Fukuoka
Japan	GSK Investigational Site	Gifu
Japan	GSK Investigational Site	Hiroshima
Japan	GSK Investigational Site	Hyogo
Japan	GSK Investigational Site	Kagawa
Japan	GSK Investigational Site	Miyazaki
Japan	GSK Investigational Site	Miyazaki
Japan	GSK Investigational Site	Niigata
Japan	GSK Investigational Site	Tokyo
Japan	GSK Investigational Site	Tokyo
Japan	GSK Investigational Site	Tokyo
Korea, Republic of	GSK Investigational Site	Daegu
Korea, Republic of	GSK Investigational Site	Seoul
Korea, Republic of	GSK Investigational Site	Seoul
Korea, Republic of	GSK Investigational Site	Seoul
Korea, Republic of	GSK Investigational Site	Seoul
Taiwan	GSK Investigational Site	Kaohsiung
Taiwan	GSK Investigational Site	Taichung
Taiwan	GSK Investigational Site	Taichung
United States	GSK Investigational Site	Asheville	North Carolina
United States	GSK Investigational Site	Bangor	Maine
United States	GSK Investigational Site	Brick	New Jersey
United States	GSK Investigational Site	Charlotte	North Carolina
United States	GSK Investigational Site	Cincinnati	Ohio
United States	GSK Investigational Site	Columbia	Maryland
United States	GSK Investigational Site	Columbus	Georgia
United States	GSK Investigational Site	Dallas	Texas
United States	GSK Investigational Site	Greenville	North Carolina
United States	GSK Investigational Site	Kerrville	Texas
United States	GSK Investigational Site	Linwood	New Jersey
United States	GSK Investigational Site	Little Rock	Arkansas
United States	GSK Investigational Site	Miami	Florida
United States	GSK Investigational Site	Miami	Florida
United States	GSK Investigational Site	Miami	Florida
United States	GSK Investigational Site	New Windsor	New York
United States	GSK Investigational Site	Newport Beach	California
United States	GSK Investigational Site	Normal	Illinois
United States	GSK Investigational Site	Orlando	Florida
United States	GSK Investigational Site	Philadelphia	Pennsylvania
United States	GSK Investigational Site	Philadelphia	Pennsylvania
United States	GSK Investigational Site	Pittsburgh	Pennsylvania
United States	GSK Investigational Site	Port Charlotte	Florida
United States	GSK Investigational Site	Raleigh	North Carolina
United States	GSK Investigational Site	Rock Hill	South Carolina
United States	GSK Investigational Site	Spartanburg	South Carolina
United States	GSK Investigational Site	Tallahassee	Florida
United States	GSK Investigational Site	Waco	Texas
United States	GSK Investigational Site	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Canada,  Japan,  Korea, Republic of,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in trough forced expiratory volume in 1 second (FEV1)		Baseline (Day 1), and at Week 24
Secondary	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
Secondary	Number of participants achieving the composite endpoint at Week in participants after 52 weeks of treatment	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	Up to 52 weeks
Secondary	Change from baseline in trough forced expiratory volume in 1 second (FEV1) after 52 weeks of treatment		Baseline (Day 1), and Week 52
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Number of participants achieving the composite endpoint among those on budesonide/formoterol prior to randomization	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	Up to 52 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Number of participants achieving =0.5 points improvement from baseline for ACQ-7 among participants on budesonide/formoterol 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
Secondary	Change from baseline in the ACQ-7 total score among participants on budesonide/formoterol 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
Secondary	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
Secondary	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
Secondary	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