Trial Outcomes & Findings for Efficacy and Safety of Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI) in Chinese Participants With Inadequately Controlled Asthma (NCT NCT04937387)

Results Overview

FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 on treatment is defined as the highest FEV1 value obtained prior to the morning dose of investigational product. Baseline value is the latest acceptable assessment with non-missing value at the randomization visit (Visit 2).

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

359 participants

Primary outcome timeframe

Baseline (pre-dose at Day 1) and Week 12

Results posted on

2025-08-11

Participant Flow

A total of 359 participants were randomized, however 1 participant was randomized in error and did not receive any study intervention. Therefore, 358 participants were included in 'Intent to Treat (ITT)' Population.

Participant milestones

Participant milestones
Measure	Fluticasone Furoate [FF] 100 Microgram[ug] / Vilanterol [VI] 25 ug Participants with inadequately controlled asthma received a single dose of 100 ug fluticasone furoate \[FF\] and 25 ug vilanterol \[VI\] as a dual dose combination in a single inhaler (ELLIPTA) via inhalation for 12 weeks.	Fluticasone Furoate [FF] 100 ug/ Umeclidinium [UMEC] 62.5 ug/ Vilanterol [VI] 25 ug Participants with inadequately controlled asthma received a single dose of 100 ug fluticasone furoate \[FF\] /62.5 ug umeclidinium \[UMEC\] /25 ug vilanterol \[VI\] as a fixed dose combination in a single inhaler (ELLIPTA) via inhalation for 12 weeks.	Fluticasone Furoate [FF] 200 ug / Vilanterol [VI] 25 ug Participants with inadequately controlled asthma received a single dose of 200 ug Fluticasone Furoate \[FF\] and 25 ug Vilanterol \[VI\] as a dual dose combination in a single inhaler (ELLIPTA) via inhalation for 12 weeks.	Fluticasone Furoate [FF] 200 ug/ Umeclidinium [UMEC] 62.5 ug/Vilanterol [VI] 25 ug Participants with inadequately controlled asthma received a single dose of 200 ug Fluticasone Furoate \[FF\]/ 62.5 ug umeclidinium \[UMEC\] / 25 ug Vilanterol \[VI\] as a fixed dose combination in a single inhaler (ELLIPTA) via inhalation for 12 weeks.
Overall Study STARTED	91	90	89	89
Overall Study Safety	90	90	89	88
Overall Study Intent to Treat (ITT) Population	91	90	89	88
Overall Study COMPLETED	88	90	86	86
Overall Study NOT COMPLETED	3	0	3	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Fluticasone Furoate [FF] 100 Microgram[ug] / Vilanterol [VI] 25 ug Participants with inadequately controlled asthma received a single dose of 100 ug fluticasone furoate \[FF\] and 25 ug vilanterol \[VI\] as a dual dose combination in a single inhaler (ELLIPTA) via inhalation for 12 weeks.	Fluticasone Furoate [FF] 200 ug / Vilanterol [VI] 25 ug Participants with inadequately controlled asthma received a single dose of 200 ug Fluticasone Furoate \[FF\] and 25 ug Vilanterol \[VI\] as a dual dose combination in a single inhaler (ELLIPTA) via inhalation for 12 weeks.	Fluticasone Furoate [FF] 200 ug/ Umeclidinium [UMEC] 62.5 ug/Vilanterol [VI] 25 ug Participants with inadequately controlled asthma received a single dose of 200 ug Fluticasone Furoate \[FF\]/ 62.5 ug umeclidinium \[UMEC\] / 25 ug Vilanterol \[VI\] as a fixed dose combination in a single inhaler (ELLIPTA) via inhalation for 12 weeks.
Overall Study Adverse Event	1	2	0
Overall Study Lack of Efficacy	1	0	1
Overall Study Withdrawal by Subject	1	1	1
Overall Study Randomized in error	0	0	1

Baseline Characteristics

Efficacy and Safety of Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI) in Chinese Participants With Inadequately Controlled Asthma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Fluticasone Furoate [FF] 100 Microgram[ug] / Vilanterol [VI] 25 ug n=91 Participants Participants with inadequately controlled asthma received a single dose of 100 ug fluticasone furoate \[FF\] and 25 ug vilanterol \[VI\] as a dual dose combination in a single inhaler (ELLIPTA) via inhalation for 12 weeks.	Fluticasone Furoate [FF] 100 ug/ Umeclidinium [UMEC] 62.5 ug/ Vilanterol [VI] 25 ug n=90 Participants Participants with inadequately controlled asthma received a single dose of 100 ug fluticasone furoate \[FF\] /62.5 ug umeclidinium \[UMEC\] /25 ug vilanterol \[VI\] as a fixed dose combination in a single inhaler (ELLIPTA) via inhalation for 12 weeks.	Fluticasone Furoate [FF] 200 ug / Vilanterol [VI] 25 ug n=89 Participants Participants with inadequately controlled asthma received a single dose of 200 ug Fluticasone Furoate \[FF\] and 25 ug Vilanterol \[VI\] as a dual dose combination in a single inhaler (ELLIPTA) via inhalation for 12 weeks.	Fluticasone Furoate [FF] 200 ug/ Umeclidinium [UMEC] 62.5 ug/Vilanterol [VI] 25 ug n=88 Participants Participants with inadequately controlled asthma received a single dose of 200 ug Fluticasone Furoate \[FF\]/ 62.5 ug umeclidinium \[UMEC\] / 25 ug Vilanterol \[VI\] as a fixed dose combination in a single inhaler (ELLIPTA) via inhalation for 12 weeks.	Total n=358 Participants Total of all reporting groups
Age, Continuous	53.1 Years STANDARD_DEVIATION 11.5 • n=5 Participants	52.6 Years STANDARD_DEVIATION 11.22 • n=7 Participants	50.7 Years STANDARD_DEVIATION 12.23 • n=5 Participants	49.9 Years STANDARD_DEVIATION 12.19 • n=4 Participants	51.6 Years STANDARD_DEVIATION 11.81 • n=21 Participants
Sex: Female, Male Female	51 Participants n=5 Participants	48 Participants n=7 Participants	52 Participants n=5 Participants	58 Participants n=4 Participants	209 Participants n=21 Participants
Sex: Female, Male Male	40 Participants n=5 Participants	42 Participants n=7 Participants	37 Participants n=5 Participants	30 Participants n=4 Participants	149 Participants n=21 Participants
Race/Ethnicity, Customized Asian- East Asian Heritage	91 Participants n=5 Participants	90 Participants n=7 Participants	89 Participants n=5 Participants	88 Participants n=4 Participants	358 Participants n=21 Participants

PRIMARY outcome

Timeframe: Baseline (pre-dose at Day 1) and Week 12

Population: Intent-to-Treat (ITT) Population comprised of all randomized participants who received 100ug FF, excluding those who were randomized in error and did not receive the study drug. Only those participants with data available at specified time points have been analyzed.

FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 on treatment is defined as the highest FEV1 value obtained prior to the morning dose of investigational product. Baseline value is the latest acceptable assessment with non-missing value at the randomization visit (Visit 2).

Outcome measures

Outcome measures
Measure	Fluticasone Furoate [FF] 100 Microgram[ug] / Vilanterol [VI] 25 ug n=83 Participants Participants with inadequately controlled asthma received a single dose of 100 ug fluticasone furoate \[FF\] and 25 ug vilanterol \[VI\] as a dual dose combination in a single inhaler (ELLIPTA) via inhalation for 12 weeks.	Fluticasone Furoate [FF] 100 ug/ Umeclidinium [UMEC] 62.5 ug/ Vilanterol [VI] 25 ug n=87 Participants Participants with inadequately controlled asthma received a single dose of 100 ug fluticasone furoate \[FF\] /62.5 ug umeclidinium \[UMEC\] /25 ug vilanterol \[VI\] as a fixed dose combination in a single inhaler (ELLIPTA) via inhalation for 12 weeks.	Fluticasone Furoate [FF] 200 ug / Vilanterol [VI] 25 ug Participants with inadequately controlled asthma received a single dose of 200 ug Fluticasone Furoate \[FF\] and 25 ug Vilanterol \[VI\] as a dual dose combination in a single inhaler (ELLIPTA) via inhalation for 12 weeks.	Fluticasone Furoate [FF] 200 ug/ Umeclidinium [UMEC] 62.5 ug/Vilanterol [VI] 25 ug Participants with inadequately controlled asthma received a single dose of 200 ug Fluticasone Furoate \[FF\]/ 62.5 ug umeclidinium \[UMEC\] / 25 ug Vilanterol \[VI\] as a fixed dose combination in a single inhaler (ELLIPTA) via inhalation for 12 weeks.
Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 12 (100ug FF)	0.078 Liters Standard Error 0.0321	0.136 Liters Standard Error 0.0316	—	—

SECONDARY outcome

Timeframe: Baseline (pre-dose at Day 1) and Week 12

Population: Intent-to-Treat (ITT) Population comprised of all randomized participants who received 200ug FF, excluding those who were randomized in error and did not receive the study drug. Only those participants with data available at specified time points have been analyzed

FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 on treatment is defined as the highest FEV1 value obtained prior to the morning dose of investigational product. Baseline value is the latest acceptable assessment with non-missing value at the randomization visit (Visit 2)

Outcome measures

Outcome measures
Measure	Fluticasone Furoate [FF] 100 Microgram[ug] / Vilanterol [VI] 25 ug n=84 Participants Participants with inadequately controlled asthma received a single dose of 100 ug fluticasone furoate \[FF\] and 25 ug vilanterol \[VI\] as a dual dose combination in a single inhaler (ELLIPTA) via inhalation for 12 weeks.	Fluticasone Furoate [FF] 100 ug/ Umeclidinium [UMEC] 62.5 ug/ Vilanterol [VI] 25 ug n=82 Participants Participants with inadequately controlled asthma received a single dose of 100 ug fluticasone furoate \[FF\] /62.5 ug umeclidinium \[UMEC\] /25 ug vilanterol \[VI\] as a fixed dose combination in a single inhaler (ELLIPTA) via inhalation for 12 weeks.	Fluticasone Furoate [FF] 200 ug / Vilanterol [VI] 25 ug Participants with inadequately controlled asthma received a single dose of 200 ug Fluticasone Furoate \[FF\] and 25 ug Vilanterol \[VI\] as a dual dose combination in a single inhaler (ELLIPTA) via inhalation for 12 weeks.	Fluticasone Furoate [FF] 200 ug/ Umeclidinium [UMEC] 62.5 ug/Vilanterol [VI] 25 ug Participants with inadequately controlled asthma received a single dose of 200 ug Fluticasone Furoate \[FF\]/ 62.5 ug umeclidinium \[UMEC\] / 25 ug Vilanterol \[VI\] as a fixed dose combination in a single inhaler (ELLIPTA) via inhalation for 12 weeks.
Change From Baseline in Trough FEV1 at Week 12 (200ug FF)	0.121 Liters Standard Error 0.0319	0.116 Liters Standard Error 0.0325	—	—

SECONDARY outcome

Timeframe: Baseline (pre-dose at Day 1) and Week 12

Population: ITT population. Intent-to-Treat (ITT) Population comprised of all randomized participants, excluding those who were randomized in error and did not receive the study drug. Only those participants with data available at specified time points have been analyzed.

ACQ-7 is a 7-item questionnaire to assess asthma control in participants. Six attributes are measured with a patient-completed questionnaire, and the questions are designed to be self-completed by the participant. The six patient-reported questions enquire about the frequency and/or severity of symptoms over the previous week. The response options for all these questions consist of a zero (no impairment/limitation) to six (total impairment/ limitation) scale. The recall period is the past week. The seventh attribute of the ACQ-7 is lung function (FEV1%-predicted) which was assessed via study visit spirometry. All 7 items of ACQ have response on 0-6 ordinal scale (0=no impairment/limitation, 6=total impairment/limitation). The total score is calculated as the average of all non-missing item responses, ranges from 0 to 6. Higher score indicates worst symptoms.

Outcome measures

Outcome measures
Measure	Fluticasone Furoate [FF] 100 Microgram[ug] / Vilanterol [VI] 25 ug n=83 Participants Participants with inadequately controlled asthma received a single dose of 100 ug fluticasone furoate \[FF\] and 25 ug vilanterol \[VI\] as a dual dose combination in a single inhaler (ELLIPTA) via inhalation for 12 weeks.	Fluticasone Furoate [FF] 100 ug/ Umeclidinium [UMEC] 62.5 ug/ Vilanterol [VI] 25 ug n=86 Participants Participants with inadequately controlled asthma received a single dose of 100 ug fluticasone furoate \[FF\] /62.5 ug umeclidinium \[UMEC\] /25 ug vilanterol \[VI\] as a fixed dose combination in a single inhaler (ELLIPTA) via inhalation for 12 weeks.	Fluticasone Furoate [FF] 200 ug / Vilanterol [VI] 25 ug n=84 Participants Participants with inadequately controlled asthma received a single dose of 200 ug Fluticasone Furoate \[FF\] and 25 ug Vilanterol \[VI\] as a dual dose combination in a single inhaler (ELLIPTA) via inhalation for 12 weeks.	Fluticasone Furoate [FF] 200 ug/ Umeclidinium [UMEC] 62.5 ug/Vilanterol [VI] 25 ug n=81 Participants Participants with inadequately controlled asthma received a single dose of 200 ug Fluticasone Furoate \[FF\]/ 62.5 ug umeclidinium \[UMEC\] / 25 ug Vilanterol \[VI\] as a fixed dose combination in a single inhaler (ELLIPTA) via inhalation for 12 weeks.
Change From Baseline in Asthma Control Questionnaire (ACQ-7) Total Score at Week 12	-0.940 Scores on a scale Standard Error 0.0586	-0.968 Scores on a scale Standard Error 0.0579	-0.926 Scores on a scale Standard Error 0.0584	-0.814 Scores on a scale Standard Error 0.0595

Adverse Events

Fluticasone Furoate [FF] 100 Microgram[ug] / Vilanterol [VI] 25 ug

Serious events: 2 serious events

Other events: 16 other events

Deaths: 0 deaths

Fluticasone Furoate [FF] 100 ug/ Umeclidinium [UMEC] 62.5 ug/ Vilanterol [VI] 25 ug

Serious events: 3 serious events

Other events: 18 other events

Deaths: 0 deaths

Fluticasone Furoate [FF] 200 ug / Vilanterol [VI] 25 ug

Serious events: 3 serious events

Other events: 22 other events

Deaths: 0 deaths

Fluticasone Furoate [FF] 200 ug/ Umeclidinium [UMEC] 62.5 ug/Vilanterol [VI] 25 ug

Serious events: 1 serious events

Other events: 18 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Fluticasone Furoate [FF] 100 Microgram[ug] / Vilanterol [VI] 25 ug n=90 participants at risk Participants with inadequately controlled asthma received a single dose of 100 ug fluticasone furoate \[FF\] and 25 ug vilanterol \[VI\] as a dual dose combination in a single inhaler (ELLIPTA) via inhalation for 12 weeks.	Fluticasone Furoate [FF] 100 ug/ Umeclidinium [UMEC] 62.5 ug/ Vilanterol [VI] 25 ug n=90 participants at risk Participants with inadequately controlled asthma received a single dose of 100 ug fluticasone furoate \[FF\] /62.5 ug umeclidinium \[UMEC\] /25 ug vilanterol \[VI\] as a fixed dose combination in a single inhaler (ELLIPTA) via inhalation for 12 weeks.	Fluticasone Furoate [FF] 200 ug / Vilanterol [VI] 25 ug n=89 participants at risk Participants with inadequately controlled asthma received a single dose of 200 ug Fluticasone Furoate \[FF\] and 25 ug Vilanterol \[VI\] as a dual dose combination in a single inhaler (ELLIPTA) via inhalation for 12 weeks.	Fluticasone Furoate [FF] 200 ug/ Umeclidinium [UMEC] 62.5 ug/Vilanterol [VI] 25 ug n=88 participants at risk Participants with inadequately controlled asthma received a single dose of 200 ug Fluticasone Furoate \[FF\]/ 62.5 ug umeclidinium \[UMEC\] / 25 ug Vilanterol \[VI\] as a fixed dose combination in a single inhaler (ELLIPTA) via inhalation for 12 weeks.
Infections and infestations Hepatitis E	0.00% 0/90 • All-cause mortality, Non-serious AEs and serious AEs were collected up to approximately 12 weeks. Data for All-Cause Mortality was collected for the ITT Population (all randomized participants, excluding those who were randomized in error). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).	1.1% 1/90 • Number of events 1 • All-cause mortality, Non-serious AEs and serious AEs were collected up to approximately 12 weeks. Data for All-Cause Mortality was collected for the ITT Population (all randomized participants, excluding those who were randomized in error). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).	0.00% 0/89 • All-cause mortality, Non-serious AEs and serious AEs were collected up to approximately 12 weeks. Data for All-Cause Mortality was collected for the ITT Population (all randomized participants, excluding those who were randomized in error). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).	0.00% 0/88 • All-cause mortality, Non-serious AEs and serious AEs were collected up to approximately 12 weeks. Data for All-Cause Mortality was collected for the ITT Population (all randomized participants, excluding those who were randomized in error). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
Infections and infestations Pneumonia	0.00% 0/90 • All-cause mortality, Non-serious AEs and serious AEs were collected up to approximately 12 weeks. Data for All-Cause Mortality was collected for the ITT Population (all randomized participants, excluding those who were randomized in error). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).	1.1% 1/90 • Number of events 1 • All-cause mortality, Non-serious AEs and serious AEs were collected up to approximately 12 weeks. Data for All-Cause Mortality was collected for the ITT Population (all randomized participants, excluding those who were randomized in error). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).	0.00% 0/89 • All-cause mortality, Non-serious AEs and serious AEs were collected up to approximately 12 weeks. Data for All-Cause Mortality was collected for the ITT Population (all randomized participants, excluding those who were randomized in error). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).	0.00% 0/88 • All-cause mortality, Non-serious AEs and serious AEs were collected up to approximately 12 weeks. Data for All-Cause Mortality was collected for the ITT Population (all randomized participants, excluding those who were randomized in error). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
Infections and infestations Vestibular neuronitis	0.00% 0/90 • All-cause mortality, Non-serious AEs and serious AEs were collected up to approximately 12 weeks. Data for All-Cause Mortality was collected for the ITT Population (all randomized participants, excluding those who were randomized in error). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).	0.00% 0/90 • All-cause mortality, Non-serious AEs and serious AEs were collected up to approximately 12 weeks. Data for All-Cause Mortality was collected for the ITT Population (all randomized participants, excluding those who were randomized in error). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).	1.1% 1/89 • Number of events 1 • All-cause mortality, Non-serious AEs and serious AEs were collected up to approximately 12 weeks. Data for All-Cause Mortality was collected for the ITT Population (all randomized participants, excluding those who were randomized in error). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).	0.00% 0/88 • All-cause mortality, Non-serious AEs and serious AEs were collected up to approximately 12 weeks. Data for All-Cause Mortality was collected for the ITT Population (all randomized participants, excluding those who were randomized in error). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
Skin and subcutaneous tissue disorders Eczema	1.1% 1/90 • Number of events 1 • All-cause mortality, Non-serious AEs and serious AEs were collected up to approximately 12 weeks. Data for All-Cause Mortality was collected for the ITT Population (all randomized participants, excluding those who were randomized in error). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).	1.1% 1/90 • Number of events 1 • All-cause mortality, Non-serious AEs and serious AEs were collected up to approximately 12 weeks. Data for All-Cause Mortality was collected for the ITT Population (all randomized participants, excluding those who were randomized in error). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).	0.00% 0/89 • All-cause mortality, Non-serious AEs and serious AEs were collected up to approximately 12 weeks. Data for All-Cause Mortality was collected for the ITT Population (all randomized participants, excluding those who were randomized in error). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).	0.00% 0/88 • All-cause mortality, Non-serious AEs and serious AEs were collected up to approximately 12 weeks. Data for All-Cause Mortality was collected for the ITT Population (all randomized participants, excluding those who were randomized in error). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
Congenital, familial and genetic disorders Myocardial bridging	0.00% 0/90 • All-cause mortality, Non-serious AEs and serious AEs were collected up to approximately 12 weeks. Data for All-Cause Mortality was collected for the ITT Population (all randomized participants, excluding those who were randomized in error). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).	0.00% 0/90 • All-cause mortality, Non-serious AEs and serious AEs were collected up to approximately 12 weeks. Data for All-Cause Mortality was collected for the ITT Population (all randomized participants, excluding those who were randomized in error). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).	1.1% 1/89 • Number of events 1 • All-cause mortality, Non-serious AEs and serious AEs were collected up to approximately 12 weeks. Data for All-Cause Mortality was collected for the ITT Population (all randomized participants, excluding those who were randomized in error). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).	0.00% 0/88 • All-cause mortality, Non-serious AEs and serious AEs were collected up to approximately 12 weeks. Data for All-Cause Mortality was collected for the ITT Population (all randomized participants, excluding those who were randomized in error). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
Metabolism and nutrition disorders Type 2 diabetes mellitus	0.00% 0/90 • All-cause mortality, Non-serious AEs and serious AEs were collected up to approximately 12 weeks. Data for All-Cause Mortality was collected for the ITT Population (all randomized participants, excluding those who were randomized in error). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).	0.00% 0/90 • All-cause mortality, Non-serious AEs and serious AEs were collected up to approximately 12 weeks. Data for All-Cause Mortality was collected for the ITT Population (all randomized participants, excluding those who were randomized in error). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).	0.00% 0/89 • All-cause mortality, Non-serious AEs and serious AEs were collected up to approximately 12 weeks. Data for All-Cause Mortality was collected for the ITT Population (all randomized participants, excluding those who were randomized in error). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).	1.1% 1/88 • Number of events 1 • All-cause mortality, Non-serious AEs and serious AEs were collected up to approximately 12 weeks. Data for All-Cause Mortality was collected for the ITT Population (all randomized participants, excluding those who were randomized in error). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Intraductal proliferative breast lesion	0.00% 0/90 • All-cause mortality, Non-serious AEs and serious AEs were collected up to approximately 12 weeks. Data for All-Cause Mortality was collected for the ITT Population (all randomized participants, excluding those who were randomized in error). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).	0.00% 0/90 • All-cause mortality, Non-serious AEs and serious AEs were collected up to approximately 12 weeks. Data for All-Cause Mortality was collected for the ITT Population (all randomized participants, excluding those who were randomized in error). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).	1.1% 1/89 • Number of events 1 • All-cause mortality, Non-serious AEs and serious AEs were collected up to approximately 12 weeks. Data for All-Cause Mortality was collected for the ITT Population (all randomized participants, excluding those who were randomized in error). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).	0.00% 0/88 • All-cause mortality, Non-serious AEs and serious AEs were collected up to approximately 12 weeks. Data for All-Cause Mortality was collected for the ITT Population (all randomized participants, excluding those who were randomized in error). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
Respiratory, thoracic and mediastinal disorders Asthma	1.1% 1/90 • Number of events 1 • All-cause mortality, Non-serious AEs and serious AEs were collected up to approximately 12 weeks. Data for All-Cause Mortality was collected for the ITT Population (all randomized participants, excluding those who were randomized in error). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).	0.00% 0/90 • All-cause mortality, Non-serious AEs and serious AEs were collected up to approximately 12 weeks. Data for All-Cause Mortality was collected for the ITT Population (all randomized participants, excluding those who were randomized in error). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).	0.00% 0/89 • All-cause mortality, Non-serious AEs and serious AEs were collected up to approximately 12 weeks. Data for All-Cause Mortality was collected for the ITT Population (all randomized participants, excluding those who were randomized in error). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).	0.00% 0/88 • All-cause mortality, Non-serious AEs and serious AEs were collected up to approximately 12 weeks. Data for All-Cause Mortality was collected for the ITT Population (all randomized participants, excluding those who were randomized in error). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).

Other adverse events

Other adverse events
Measure	Fluticasone Furoate [FF] 100 Microgram[ug] / Vilanterol [VI] 25 ug n=90 participants at risk Participants with inadequately controlled asthma received a single dose of 100 ug fluticasone furoate \[FF\] and 25 ug vilanterol \[VI\] as a dual dose combination in a single inhaler (ELLIPTA) via inhalation for 12 weeks.	Fluticasone Furoate [FF] 100 ug/ Umeclidinium [UMEC] 62.5 ug/ Vilanterol [VI] 25 ug n=90 participants at risk Participants with inadequately controlled asthma received a single dose of 100 ug fluticasone furoate \[FF\] /62.5 ug umeclidinium \[UMEC\] /25 ug vilanterol \[VI\] as a fixed dose combination in a single inhaler (ELLIPTA) via inhalation for 12 weeks.	Fluticasone Furoate [FF] 200 ug / Vilanterol [VI] 25 ug n=89 participants at risk Participants with inadequately controlled asthma received a single dose of 200 ug Fluticasone Furoate \[FF\] and 25 ug Vilanterol \[VI\] as a dual dose combination in a single inhaler (ELLIPTA) via inhalation for 12 weeks.	Fluticasone Furoate [FF] 200 ug/ Umeclidinium [UMEC] 62.5 ug/Vilanterol [VI] 25 ug n=88 participants at risk Participants with inadequately controlled asthma received a single dose of 200 ug Fluticasone Furoate \[FF\]/ 62.5 ug umeclidinium \[UMEC\] / 25 ug Vilanterol \[VI\] as a fixed dose combination in a single inhaler (ELLIPTA) via inhalation for 12 weeks.
Infections and infestations Upper respiratory tract infection	8.9% 8/90 • Number of events 11 • All-cause mortality, Non-serious AEs and serious AEs were collected up to approximately 12 weeks. Data for All-Cause Mortality was collected for the ITT Population (all randomized participants, excluding those who were randomized in error). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).	7.8% 7/90 • Number of events 7 • All-cause mortality, Non-serious AEs and serious AEs were collected up to approximately 12 weeks. Data for All-Cause Mortality was collected for the ITT Population (all randomized participants, excluding those who were randomized in error). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).	11.2% 10/89 • Number of events 15 • All-cause mortality, Non-serious AEs and serious AEs were collected up to approximately 12 weeks. Data for All-Cause Mortality was collected for the ITT Population (all randomized participants, excluding those who were randomized in error). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).	4.5% 4/88 • Number of events 4 • All-cause mortality, Non-serious AEs and serious AEs were collected up to approximately 12 weeks. Data for All-Cause Mortality was collected for the ITT Population (all randomized participants, excluding those who were randomized in error). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
Infections and infestations COVID-19	5.6% 5/90 • Number of events 5 • All-cause mortality, Non-serious AEs and serious AEs were collected up to approximately 12 weeks. Data for All-Cause Mortality was collected for the ITT Population (all randomized participants, excluding those who were randomized in error). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).	3.3% 3/90 • Number of events 3 • All-cause mortality, Non-serious AEs and serious AEs were collected up to approximately 12 weeks. Data for All-Cause Mortality was collected for the ITT Population (all randomized participants, excluding those who were randomized in error). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).	5.6% 5/89 • Number of events 5 • All-cause mortality, Non-serious AEs and serious AEs were collected up to approximately 12 weeks. Data for All-Cause Mortality was collected for the ITT Population (all randomized participants, excluding those who were randomized in error). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).	5.7% 5/88 • Number of events 5 • All-cause mortality, Non-serious AEs and serious AEs were collected up to approximately 12 weeks. Data for All-Cause Mortality was collected for the ITT Population (all randomized participants, excluding those who were randomized in error). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
Infections and infestations Nasopharyngitis	2.2% 2/90 • Number of events 3 • All-cause mortality, Non-serious AEs and serious AEs were collected up to approximately 12 weeks. Data for All-Cause Mortality was collected for the ITT Population (all randomized participants, excluding those who were randomized in error). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).	3.3% 3/90 • Number of events 3 • All-cause mortality, Non-serious AEs and serious AEs were collected up to approximately 12 weeks. Data for All-Cause Mortality was collected for the ITT Population (all randomized participants, excluding those who were randomized in error). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).	4.5% 4/89 • Number of events 5 • All-cause mortality, Non-serious AEs and serious AEs were collected up to approximately 12 weeks. Data for All-Cause Mortality was collected for the ITT Population (all randomized participants, excluding those who were randomized in error). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).	4.5% 4/88 • Number of events 4 • All-cause mortality, Non-serious AEs and serious AEs were collected up to approximately 12 weeks. Data for All-Cause Mortality was collected for the ITT Population (all randomized participants, excluding those who were randomized in error). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
Infections and infestations Rhinitis	0.00% 0/90 • All-cause mortality, Non-serious AEs and serious AEs were collected up to approximately 12 weeks. Data for All-Cause Mortality was collected for the ITT Population (all randomized participants, excluding those who were randomized in error). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).	2.2% 2/90 • Number of events 2 • All-cause mortality, Non-serious AEs and serious AEs were collected up to approximately 12 weeks. Data for All-Cause Mortality was collected for the ITT Population (all randomized participants, excluding those who were randomized in error). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).	3.4% 3/89 • Number of events 5 • All-cause mortality, Non-serious AEs and serious AEs were collected up to approximately 12 weeks. Data for All-Cause Mortality was collected for the ITT Population (all randomized participants, excluding those who were randomized in error). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).	3.4% 3/88 • Number of events 5 • All-cause mortality, Non-serious AEs and serious AEs were collected up to approximately 12 weeks. Data for All-Cause Mortality was collected for the ITT Population (all randomized participants, excluding those who were randomized in error). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
Infections and infestations Pneumonia	0.00% 0/90 • All-cause mortality, Non-serious AEs and serious AEs were collected up to approximately 12 weeks. Data for All-Cause Mortality was collected for the ITT Population (all randomized participants, excluding those who were randomized in error). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).	3.3% 3/90 • Number of events 3 • All-cause mortality, Non-serious AEs and serious AEs were collected up to approximately 12 weeks. Data for All-Cause Mortality was collected for the ITT Population (all randomized participants, excluding those who were randomized in error). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).	2.2% 2/89 • Number of events 2 • All-cause mortality, Non-serious AEs and serious AEs were collected up to approximately 12 weeks. Data for All-Cause Mortality was collected for the ITT Population (all randomized participants, excluding those who were randomized in error). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).	0.00% 0/88 • All-cause mortality, Non-serious AEs and serious AEs were collected up to approximately 12 weeks. Data for All-Cause Mortality was collected for the ITT Population (all randomized participants, excluding those who were randomized in error). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
General disorders Pyrexia	1.1% 1/90 • Number of events 1 • All-cause mortality, Non-serious AEs and serious AEs were collected up to approximately 12 weeks. Data for All-Cause Mortality was collected for the ITT Population (all randomized participants, excluding those who were randomized in error). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).	1.1% 1/90 • Number of events 1 • All-cause mortality, Non-serious AEs and serious AEs were collected up to approximately 12 weeks. Data for All-Cause Mortality was collected for the ITT Population (all randomized participants, excluding those who were randomized in error). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).	1.1% 1/89 • Number of events 1 • All-cause mortality, Non-serious AEs and serious AEs were collected up to approximately 12 weeks. Data for All-Cause Mortality was collected for the ITT Population (all randomized participants, excluding those who were randomized in error). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).	3.4% 3/88 • Number of events 5 • All-cause mortality, Non-serious AEs and serious AEs were collected up to approximately 12 weeks. Data for All-Cause Mortality was collected for the ITT Population (all randomized participants, excluding those who were randomized in error). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).

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