Trial Outcomes & Findings for A Study to Evaluate the Safety and Efficacy of Fluticasone Furoate (FF)/Umeclidinium(UMEC)/Vilanterol (VI) in Participants With Chronic Obstructive Pulmonary Disease (COPD) (NCT NCT04923347)

Results Overview

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. SAE is any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect or any other important medical event according to medical or scientific judgement. Protocol defined AESIs were included. SAEs are subset of AEs. AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA dictionary).

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

229 participants

Primary outcome timeframe

Up to approximately 40 weeks

Results posted on

2025-03-24

Participant Flow

Participant milestones

Participant milestones
Measure	FF/UMEC/VI ELLIPTA Participants with symptomatic chronic obstructive pulmonary disease (COPD) received a single dose of fluticasone furoate \[FF\] 100 microgram \[ug\] / umeclidinium \[UMEC\] 62.5 ug / vilanterol \[VI\] 25 ug as a fixed dose combination in a single inhaler (TRELEGY ELLIPTA) via inhalation for 12 weeks.
Overall Study STARTED	229
Overall Study COMPLETED	215
Overall Study NOT COMPLETED	14

Reasons for withdrawal

Reasons for withdrawal
Measure	FF/UMEC/VI ELLIPTA Participants with symptomatic chronic obstructive pulmonary disease (COPD) received a single dose of fluticasone furoate \[FF\] 100 microgram \[ug\] / umeclidinium \[UMEC\] 62.5 ug / vilanterol \[VI\] 25 ug as a fixed dose combination in a single inhaler (TRELEGY ELLIPTA) via inhalation for 12 weeks.
Overall Study Withdrawal by Subject	14

Baseline Characteristics

A Study to Evaluate the Safety and Efficacy of Fluticasone Furoate (FF)/Umeclidinium(UMEC)/Vilanterol (VI) in Participants With Chronic Obstructive Pulmonary Disease (COPD)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	FF/UMEC/VI ELLIPTA n=229 Participants Participants with symptomatic chronic obstructive pulmonary disease (COPD) received a single dose of fluticasone furoate \[FF\] 100 microgram \[ug\] / umeclidinium \[UMEC\] 62.5 ug / vilanterol \[VI\] 25 ug as a fixed dose combination in a single inhaler (TRELEGY ELLIPTA) via inhalation for 12 weeks.
Age, Continuous	60.4 YEARS STANDARD_DEVIATION 10.09 • n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants
Sex: Female, Male Male	220 Participants n=5 Participants
Race/Ethnicity, Customized Asian	229 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to approximately 40 weeks

Population: Intent-to-Treat (ITT) population included participants who received at least one dose of study treatment.

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. SAE is any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect or any other important medical event according to medical or scientific judgement. Protocol defined AESIs were included. SAEs are subset of AEs. AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA dictionary).

Outcome measures

Outcome measures
Measure	FF/UMEC/VI ELLIPTA n=229 Participants Participants with symptomatic chronic obstructive pulmonary disease (COPD) received a single dose of fluticasone furoate \[FF\] 100 microgram \[ug\] / umeclidinium \[UMEC\] 62.5 ug / vilanterol \[VI\] 25 ug as a fixed dose combination in a single inhaler (TRELEGY ELLIPTA) via inhalation for 12 weeks.
Number of Participants With Adverse Events (AE), Serious Adverse Events (SAE) and Adverse Events of Special Interest (AESIs) AEs	35 Participants
Number of Participants With Adverse Events (AE), Serious Adverse Events (SAE) and Adverse Events of Special Interest (AESIs) SAEs	1 Participants
Number of Participants With Adverse Events (AE), Serious Adverse Events (SAE) and Adverse Events of Special Interest (AESIs) AESIs	0 Participants

SECONDARY outcome

Timeframe: Baseline (Day 1), Day 28 and Day 85

Population: ITT Population. Only those participants with data available at the specified time points were analyzed.

FEV1 is a measure of lung function defined as the maximal amount of air that can be forcefully exhaled in one second. It was measured using spirometry. Baseline is defined as the last non-missing observation made prior to the first administration of study treatment including those from unscheduled visits. Trough FEV1 on Day 28 was defined as the mean of the FEV1 values obtained prior to dosing on Day 28. Trough FEV1 on Day 85 was defined as the mean of the FEV1 values obtained 24 hours after morning dosing on Day 84.

Outcome measures

Outcome measures
Measure	FF/UMEC/VI ELLIPTA n=218 Participants Participants with symptomatic chronic obstructive pulmonary disease (COPD) received a single dose of fluticasone furoate \[FF\] 100 microgram \[ug\] / umeclidinium \[UMEC\] 62.5 ug / vilanterol \[VI\] 25 ug as a fixed dose combination in a single inhaler (TRELEGY ELLIPTA) via inhalation for 12 weeks.
Change From Baseline (CFB) in Trough Forced Expiratory Volume in 1 Second (FEV1) on Day 28 and Day 85 Baseline	1.3645 Liters Standard Deviation 0.58677
Change From Baseline (CFB) in Trough Forced Expiratory Volume in 1 Second (FEV1) on Day 28 and Day 85 CFB to Day 28	0.0542 Liters Standard Deviation 0.21577
Change From Baseline (CFB) in Trough Forced Expiratory Volume in 1 Second (FEV1) on Day 28 and Day 85 CFB to Day 85	0.0317 Liters Standard Deviation 0.25852

Adverse Events

FF/UMEC/VI ELLIPTA

Serious events: 1 serious events

Other events: 19 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	FF/UMEC/VI ELLIPTA n=229 participants at risk Participants with symptomatic chronic obstructive pulmonary disease (COPD) received a single dose of fluticasone furoate \[FF\] 100 microgram \[ug\] / umeclidinium \[UMEC\] 62.5 ug / vilanterol \[VI\] 25 ug as a fixed dose combination in a single inhaler (TRELEGY ELLIPTA) via inhalation for 12 weeks.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.44% 1/229 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 40 weeks. Intent-to-Treat (ITT) population included participants who received at least one dose of study treatment.

Other adverse events

Other adverse events
Measure	FF/UMEC/VI ELLIPTA n=229 participants at risk Participants with symptomatic chronic obstructive pulmonary disease (COPD) received a single dose of fluticasone furoate \[FF\] 100 microgram \[ug\] / umeclidinium \[UMEC\] 62.5 ug / vilanterol \[VI\] 25 ug as a fixed dose combination in a single inhaler (TRELEGY ELLIPTA) via inhalation for 12 weeks.
General disorders Pyrexia	4.4% 10/229 • Number of events 10 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 40 weeks. Intent-to-Treat (ITT) population included participants who received at least one dose of study treatment.
Nervous system disorders Headache	3.9% 9/229 • Number of events 9 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 40 weeks. Intent-to-Treat (ITT) population included participants who received at least one dose of study treatment.

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single site data not precede the primary publication of the entire clinical trial.
Publication restrictions are in place

Restriction type: OTHER