Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06372496
Other study ID # 219912
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Terminated NCT04410523 - Study of Efficacy and Safety of CSJ117 in Patients With Severe Uncontrolled Asthma Phase 2
Completed NCT04624425 - Additional Effects of Segmental Breathing In Asthma N/A
Active, not recruiting NCT03927820 - A Pharmacist-Led Intervention to Increase Inhaler Access and Reduce Hospital Readmissions (PILLAR) N/A
Completed NCT04617015 - Defining and Treating Depression-related Asthma Early Phase 1
Recruiting NCT03694158 - Investigating Dupilumab's Effect in Asthma by Genotype Phase 4
Terminated NCT04946318 - Study of Safety of CSJ117 in Participants With Moderate to Severe Uncontrolled Asthma Phase 2
Completed NCT04450108 - Vivatmo Pro™ for Fractional Exhaled Nitric Oxide (FeNO) Monitoring in U.S. Asthmatic Patients N/A
Completed NCT03086460 - A Dose Ranging Study With CHF 1531 in Subjects With Asthma (FLASH) Phase 2
Completed NCT01160224 - Oral GW766944 (Oral CCR3 Antagonist) Phase 2
Completed NCT03186209 - Efficacy and Safety Study of Benralizumab in Patients With Uncontrolled Asthma on Medium to High Dose Inhaled Corticosteroid Plus LABA (MIRACLE) Phase 3
Completed NCT02502734 - Effect of Inhaled Fluticasone Furoate on Short-term Growth in Paediatric Subjects With Asthma Phase 3
Completed NCT01715844 - L-Citrulline Supplementation Pilot Study for Overweight Late Onset Asthmatics Phase 1
Terminated NCT04993443 - First-In-Human Study to Evaluate the Safety, Tolerability, Immunogenicity, and Pharmacokinetics of LQ036 Phase 1
Completed NCT02787863 - Clinical and Immunological Efficiency of Bacterial Vaccines at Adult Patients With Bronchopulmonary Pathology Phase 4
Recruiting NCT06033833 - Long-term Safety and Efficacy Evaluation of Subcutaneous Amlitelimab in Adult Participants With Moderate-to-severe Asthma Who Completed Treatment Period of Previous Amlitelimab Asthma Clinical Study Phase 2
Completed NCT03257995 - Pharmacodynamics, Safety, Tolerability, and Pharmacokinetics of Two Orally Inhaled Indacaterol Salts in Adult Subjects With Asthma. Phase 2
Completed NCT02212483 - Clinical Effectiveness and Economical Impact of Medical Indoor Environment Counselors Visiting Homes of Asthma Patients N/A
Recruiting NCT04872309 - MUlti-nuclear MR Imaging Investigation of Respiratory Disease-associated CHanges in Lung Physiology
Withdrawn NCT01468805 - Childhood Asthma Reduction Study N/A
Recruiting NCT05145894 - Differentiation of Asthma/COPD Exacerbation and Stable State Using Automated Lung Sound Analysis With LungPass Device