Trial Outcomes & Findings for An Efficacy and Safety Study of Fluticasone Furoate/Vilanterol (FF/VI) 200/25 Microgram (mcg) , FF/VI 100/25 mcg, and FF 100 mcg in Adults and Adolescents With Persistent Asthma. (NCT NCT01686633)

Last Updated: 2018-01-24

Results Overview

Pulmonary function was measured by FEV1, defined as the maximal amount of air that can be forcefully exhaled in one second. The weighted mean was calculated from the pre-dose FEV1 (within 30 minutes prior to dosing) and post-dose FEV1 measurements at 5, 15, and 30 minutes and at 1, 2, 3, 4, 5, 12, 16, 20, 23, and 24 hours on Day 84/Week 12. At each time point, the highest of three technically acceptable measurements was recorded. Change from Baseline was calculated as the weighted mean of the 24-hour serial FEV1 measures on Day 84/Week 12 minus the Baseline value. Baseline was the pre-dose FEV1 measurement value obtained at Visit 3. The analysis was performed using an Analysis of Covariance (ANCOVA) model with covariates of Baseline FEV1, region, sex, age, and treatment.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

1040 participants

Primary outcome timeframe

Baseline and Week 12

Results posted on

2018-01-24

Participant Flow

Participants meeting eligibility criteria at the Screening visit entered a 4-week Run-in Period for Baseline safety evaluations and measures of asthma status. Participants were then randomized to a 12-week Treatment Period. A total of 2019 participants were screened; 1039 were randomized and received \>=1 dose of study treatment.

One participant was determined to have been randomized at each of two United States sites. Upon discovery of the duplicate enrollment, the participant was withdrawn. To account for only one randomization by this participant, a total randomized population of 1039 was used as the basis for the study analysis.

Participant milestones

Participant milestones
Measure	FF 100 µg OD Participants received Fluticasone Furoate (FF) 100 microgram (µg) inhalation powder once daily (OD) in the evening from a dry powder inhaler (DPI) for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.	FF/VI 100/25 µg OD Participants received FF/Vilanterol (VI) 100/25 µg inhalation powder OD in the evening from a DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.	FF/VI 200/25 µg OD Participants received FF/VI 200/25 µg inhalation powder OD in the evening from a DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
Overall Study STARTED	347	346	346
Overall Study COMPLETED	296	314	321
Overall Study NOT COMPLETED	51	32	25

Reasons for withdrawal

Reasons for withdrawal
Measure	FF 100 µg OD Participants received Fluticasone Furoate (FF) 100 microgram (µg) inhalation powder once daily (OD) in the evening from a dry powder inhaler (DPI) for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.	FF/VI 100/25 µg OD Participants received FF/Vilanterol (VI) 100/25 µg inhalation powder OD in the evening from a DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.	FF/VI 200/25 µg OD Participants received FF/VI 200/25 µg inhalation powder OD in the evening from a DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
Overall Study Lack of Efficacy	33	13	11
Overall Study Withdrawal by Subject	8	8	5
Overall Study Physician Decision	3	4	4
Overall Study Adverse Event	4	3	3
Overall Study Protocol Violation	2	3	0
Overall Study Protocol-defined Stopping Criteria	1	0	1
Overall Study Lost to Follow-up	0	1	1

Baseline Characteristics

An Efficacy and Safety Study of Fluticasone Furoate/Vilanterol (FF/VI) 200/25 Microgram (mcg) , FF/VI 100/25 mcg, and FF 100 mcg in Adults and Adolescents With Persistent Asthma.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	FF 100 µg OD n=347 Participants Participants received FF 100 µg inhalation powder OD in the evening from a DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.	FF/VI 100/25 µg OD n=346 Participants Participants received FF/VI 100/25 µg inhalation powder OD in the evening from a DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.	FF/VI 200/25 µg OD n=346 Participants Participants received FF/VI 200/25 µg inhalation powder OD in the evening from a DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.	Total n=1039 Participants Total of all reporting groups
Age, Continuous	44.7 Years STANDARD_DEVIATION 15.89 • n=5 Participants	45.9 Years STANDARD_DEVIATION 16.14 • n=7 Participants	46.6 Years STANDARD_DEVIATION 14.72 • n=5 Participants	45.7 Years STANDARD_DEVIATION 15.60 • n=4 Participants
Sex: Female, Male Female	199 Participants n=5 Participants	205 Participants n=7 Participants	224 Participants n=5 Participants	628 Participants n=4 Participants
Sex: Female, Male Male	148 Participants n=5 Participants	141 Participants n=7 Participants	122 Participants n=5 Participants	411 Participants n=4 Participants
Race/Ethnicity, Customized African American/African Heritage	26 participants n=5 Participants	20 participants n=7 Participants	28 participants n=5 Participants	74 participants n=4 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 participants n=5 Participants	0 participants n=7 Participants	2 participants n=5 Participants	2 participants n=4 Participants
Race/Ethnicity, Customized Asian - East Asian Heritage	0 participants n=5 Participants	1 participants n=7 Participants	0 participants n=5 Participants	1 participants n=4 Participants
Race/Ethnicity, Customized Asian - Japanese Heritage	1 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants	1 participants n=4 Participants
Race/Ethnicity, Customized Asian - South East Asian Heritage	3 participants n=5 Participants	1 participants n=7 Participants	2 participants n=5 Participants	6 participants n=4 Participants
Race/Ethnicity, Customized Native Hawaiian or other Pacific Islander	0 participants n=5 Participants	1 participants n=7 Participants	0 participants n=5 Participants	1 participants n=4 Participants
Race/Ethnicity, Customized White - White/Caucasian/European Heritage	305 participants n=5 Participants	307 participants n=7 Participants	300 participants n=5 Participants	912 participants n=4 Participants
Race/Ethnicity, Customized Mixed Race	12 participants n=5 Participants	16 participants n=7 Participants	13 participants n=5 Participants	41 participants n=4 Participants
Race/Ethnicity, Customized Missing	0 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants	1 participants n=4 Participants

PRIMARY outcome

Timeframe: Baseline and Week 12

Population: Intent-to-Treat (ITT) Population: all participants randomized to treatment, who received at least one dose of the study medication. Only those participants with non-missing covariates and Week 12 weighted mean data were analyzed.

Outcome measures

Outcome measures
Measure	FF 100 µg OD n=288 Participants Participants received FF 100 µg inhalation powder OD in the evening from a DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.	FF/VI 100/25 µg OD n=312 Participants Participants received FF/VI 100/25 µg inhalation powder OD in the evening from a DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.	FF/VI 200/25 µg OD n=312 Participants Participants received FF/VI 200/25 µg inhalation powder OD in the evening from a DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
Change From Baseline in Weighted Mean Forced Expiratory Volume in One Second (FEV1) Over 0 to 24 Hours Post-dose at the End of the 12-week Treatment Period	0.366 Liters Standard Error 0.0231	0.474 Liters Standard Error 0.0221	0.499 Liters Standard Error 0.0222

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: ITT Population. Only those participants with non-missing covariates and post-Baseline FEV1 data were analyzed.

Pulmonary function was measured by FEV1, defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 is defined as a pre-dose FEV1 measurement taken at a clinic visit while still on-treatment. Change from Baseline in trough FEV1 at the end of the 12-week treatment period was defined using the 24-hour post-dose serial FEV1 measurement taken at the Week 12 clinic visit. Change from Baseline was calculated as the Week 12 trough FEV1 value minus the Baseline value. The analysis was performed using an ANCOVA model with covariates of Baseline trough FEV1, region, sex, age, and treatment. The last observation carried forward (LOCF) method was used to impute missing data, in which the last non-missing post-Baseline on-treatment measurement at scheduled clinic visits was used to impute the missing measurements.

Outcome measures

Outcome measures
Measure	FF 100 µg OD n=336 Participants Participants received FF 100 µg inhalation powder OD in the evening from a DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.	FF/VI 100/25 µg OD n=334 Participants Participants received FF/VI 100/25 µg inhalation powder OD in the evening from a DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.	FF/VI 200/25 µg OD n=337 Participants Participants received FF/VI 200/25 µg inhalation powder OD in the evening from a DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
Change From Baseline in Clinic Visit Trough FEV1 at the End of the 12-week Treatment Period	0.365 Liters Standard Error 0.0220	0.441 Liters Standard Error 0.0221	0.457 Liters Standard Error 0.0220

SECONDARY outcome

Timeframe: Baseline and Weeks 1-12

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

The number of inhalations of rescue albuterol/salbutamol inhalation aerosol used during the day and night was recorded by the participants in a daily electronic diary (eDiary). A 24-hour (hr) period in which a participant's responses to both the morning and evening assessments indicated no use of rescue medication was considered to be rescue free. The Baseline value was derived from the last 7 days of the daily eDiary prior to the randomization of the participant. Change from Baseline was calculated as the averaged value during the 12-week treatment period minus the Baseline value. The analysis was performed using an ANCOVA model with covariates of Baseline, region, sex, age, and treatment.

Outcome measures

Outcome measures
Measure	FF 100 µg OD n=346 Participants Participants received FF 100 µg inhalation powder OD in the evening from a DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.	FF/VI 100/25 µg OD n=345 Participants Participants received FF/VI 100/25 µg inhalation powder OD in the evening from a DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.	FF/VI 200/25 µg OD n=346 Participants Participants received FF/VI 200/25 µg inhalation powder OD in the evening from a DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
Change From Baseline in the Percentage of Rescue-free 24-hour (hr) Periods During the 12-week Treatment Period	22.6 Percentage of rescue-free 24-hr periods Standard Error 1.84	34.8 Percentage of rescue-free 24-hr periods Standard Error 1.85	35.8 Percentage of rescue-free 24-hr periods Standard Error 1.85

SECONDARY outcome

Timeframe: Baseline and Weeks 1-12

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

Asthma symptoms were recorded in a daily eDairy by the participants every day in the morning and evening before taking any rescue or study medication and before the peak expiratory flow measurement. A 24-hour (hr) period in which a participant's responses to both the morning and evening assessments indicated no symptoms was considered to be symptom free. The Baseline value was derived from the last 7 days of the daily eDiary prior to the randomization of the participant. Change from Baseline was calculated as the averaged value during the 12-week treatment period minus the Baseline value. The analysis was performed using an ANCOVA model with covariates of Baseline, region, sex, age, and treatment.

Outcome measures

Outcome measures
Measure	FF 100 µg OD n=346 Participants Participants received FF 100 µg inhalation powder OD in the evening from a DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.	FF/VI 100/25 µg OD n=345 Participants Participants received FF/VI 100/25 µg inhalation powder OD in the evening from a DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.	FF/VI 200/25 µg OD n=346 Participants Participants received FF/VI 200/25 µg inhalation powder OD in the evening from a DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
Change From Baseline in the Percentage of Symptom-free 24-hour (hr) Periods During the 12-week Treatment Period	19.4 Percentage of symptom-free 24-hr periods Standard Error 1.74	27.2 Percentage of symptom-free 24-hr periods Standard Error 1.74	29.0 Percentage of symptom-free 24-hr periods Standard Error 1.74

SECONDARY outcome

Timeframe: Baseline and Weeks 1-12

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

Peak Expiratory Flow (PEF) is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. PEF was measured by the participants using a hand-held electronic peak flow meter each evening prior to the dose of study medication and any rescue albuterol/salbutamol inhalation aerosol use and each morning. The best of three measurements was recorded. Change from Baseline (defined as the last 7 days prior to randomization of the participants) was calculated as the value of the averaged daily AM PEF over the 12-week treatment period minus the Baseline value. The analysis was performed using an ANCOVA model with covariates of Baseline, region, sex, age, and treatment.

Outcome measures

Outcome measures
Measure	FF 100 µg OD n=346 Participants Participants received FF 100 µg inhalation powder OD in the evening from a DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.	FF/VI 100/25 µg OD n=345 Participants Participants received FF/VI 100/25 µg inhalation powder OD in the evening from a DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.	FF/VI 200/25 µg OD n=345 Participants Participants received FF/VI 200/25 µg inhalation powder OD in the evening from a DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
Change From Baseline in Daily Morning (AM) Peak Expiratory Flow (PEF) Averaged Over the 12-week Treatment Period	19.1 Liters per minute Standard Error 2.25	44.3 Liters per minute Standard Error 2.25	47.7 Liters per minute Standard Error 2.25

SECONDARY outcome

Timeframe: Baseline and Weeks 1-12

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

PEF is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. PEF was measured by the participants using a hand-held electronic peak flow meter each evening prior to the dose of study medication and any rescue albuterol/salbutamol inhalation aerosol use and each morning. The best of three measurements was recorded. Change from Baseline (defined as the last 7 days prior to randomization of the participants) was calculated as the value of the averaged daily PM PEF over the 12-week treatment period minus the Baseline value. The analysis was performed using an ANCOVA model with covariates of Baseline, region, sex, age, and treatment.

Outcome measures

Outcome measures
Measure	FF 100 µg OD n=346 Participants Participants received FF 100 µg inhalation powder OD in the evening from a DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.	FF/VI 100/25 µg OD n=345 Participants Participants received FF/VI 100/25 µg inhalation powder OD in the evening from a DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.	FF/VI 200/25 µg OD n=346 Participants Participants received FF/VI 200/25 µg inhalation powder OD in the evening from a DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
Change From Baseline in Daily Evening (PM) PEF Averaged Over the 12-week Treatment Period	15.5 Liters per minute Standard Error 2.24	39.7 Liters per minute Standard Error 2.24	41.7 Liters per minute Standard Error 2.24

Adverse Events

FF 100 µg OD

Serious events: 3 serious events

Other events: 67 other events

Deaths: 0 deaths

FF/VI 100/25 µg OD

Serious events: 4 serious events

Other events: 54 other events

Deaths: 0 deaths

FF/VI 200/25 µg OD

Serious events: 1 serious events

Other events: 52 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	FF 100 µg OD n=347 participants at risk Participants received FF 100 µg inhalation powder OD in the evening from a DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.	FF/VI 100/25 µg OD n=346 participants at risk Participants received FF/VI 100/25 µg inhalation powder OD in the evening from a DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.	FF/VI 200/25 µg OD n=346 participants at risk Participants received FF/VI 200/25 µg inhalation powder OD in the evening from a DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
Infections and infestations Pneumonia	0.58% 2/347 • Serious Adverse Events (SAEs) and non-serious AEs were collected from the first dose of study medication up to Week 12/Early Withdrawal. SAEs and AEs were collected in members of Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of the study medication.	0.00% 0/346 • Serious Adverse Events (SAEs) and non-serious AEs were collected from the first dose of study medication up to Week 12/Early Withdrawal. SAEs and AEs were collected in members of Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of the study medication.	0.00% 0/346 • Serious Adverse Events (SAEs) and non-serious AEs were collected from the first dose of study medication up to Week 12/Early Withdrawal. SAEs and AEs were collected in members of Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of the study medication.
Gastrointestinal disorders Pancreatitis acute	0.00% 0/347 • Serious Adverse Events (SAEs) and non-serious AEs were collected from the first dose of study medication up to Week 12/Early Withdrawal. SAEs and AEs were collected in members of Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of the study medication.	0.29% 1/346 • Serious Adverse Events (SAEs) and non-serious AEs were collected from the first dose of study medication up to Week 12/Early Withdrawal. SAEs and AEs were collected in members of Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of the study medication.	0.00% 0/346 • Serious Adverse Events (SAEs) and non-serious AEs were collected from the first dose of study medication up to Week 12/Early Withdrawal. SAEs and AEs were collected in members of Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of the study medication.
Hepatobiliary disorders Biliary colic	0.00% 0/347 • Serious Adverse Events (SAEs) and non-serious AEs were collected from the first dose of study medication up to Week 12/Early Withdrawal. SAEs and AEs were collected in members of Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of the study medication.	0.29% 1/346 • Serious Adverse Events (SAEs) and non-serious AEs were collected from the first dose of study medication up to Week 12/Early Withdrawal. SAEs and AEs were collected in members of Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of the study medication.	0.00% 0/346 • Serious Adverse Events (SAEs) and non-serious AEs were collected from the first dose of study medication up to Week 12/Early Withdrawal. SAEs and AEs were collected in members of Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of the study medication.
Injury, poisoning and procedural complications Thermal burn	0.00% 0/347 • Serious Adverse Events (SAEs) and non-serious AEs were collected from the first dose of study medication up to Week 12/Early Withdrawal. SAEs and AEs were collected in members of Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of the study medication.	0.29% 1/346 • Serious Adverse Events (SAEs) and non-serious AEs were collected from the first dose of study medication up to Week 12/Early Withdrawal. SAEs and AEs were collected in members of Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of the study medication.	0.00% 0/346 • Serious Adverse Events (SAEs) and non-serious AEs were collected from the first dose of study medication up to Week 12/Early Withdrawal. SAEs and AEs were collected in members of Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of the study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Borderline mucinous tumour of ovary	0.29% 1/347 • Serious Adverse Events (SAEs) and non-serious AEs were collected from the first dose of study medication up to Week 12/Early Withdrawal. SAEs and AEs were collected in members of Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of the study medication.	0.00% 0/346 • Serious Adverse Events (SAEs) and non-serious AEs were collected from the first dose of study medication up to Week 12/Early Withdrawal. SAEs and AEs were collected in members of Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of the study medication.	0.00% 0/346 • Serious Adverse Events (SAEs) and non-serious AEs were collected from the first dose of study medication up to Week 12/Early Withdrawal. SAEs and AEs were collected in members of Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of the study medication.
Nervous system disorders Occipital neuralgia	0.00% 0/347 • Serious Adverse Events (SAEs) and non-serious AEs were collected from the first dose of study medication up to Week 12/Early Withdrawal. SAEs and AEs were collected in members of Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of the study medication.	0.29% 1/346 • Serious Adverse Events (SAEs) and non-serious AEs were collected from the first dose of study medication up to Week 12/Early Withdrawal. SAEs and AEs were collected in members of Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of the study medication.	0.00% 0/346 • Serious Adverse Events (SAEs) and non-serious AEs were collected from the first dose of study medication up to Week 12/Early Withdrawal. SAEs and AEs were collected in members of Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of the study medication.
Pregnancy, puerperium and perinatal conditions Abortion threatened	0.00% 0/347 • Serious Adverse Events (SAEs) and non-serious AEs were collected from the first dose of study medication up to Week 12/Early Withdrawal. SAEs and AEs were collected in members of Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of the study medication.	0.00% 0/346 • Serious Adverse Events (SAEs) and non-serious AEs were collected from the first dose of study medication up to Week 12/Early Withdrawal. SAEs and AEs were collected in members of Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of the study medication.	0.29% 1/346 • Serious Adverse Events (SAEs) and non-serious AEs were collected from the first dose of study medication up to Week 12/Early Withdrawal. SAEs and AEs were collected in members of Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of the study medication.

Other adverse events

Other adverse events
Measure	FF 100 µg OD n=347 participants at risk Participants received FF 100 µg inhalation powder OD in the evening from a DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.	FF/VI 100/25 µg OD n=346 participants at risk Participants received FF/VI 100/25 µg inhalation powder OD in the evening from a DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.	FF/VI 200/25 µg OD n=346 participants at risk Participants received FF/VI 200/25 µg inhalation powder OD in the evening from a DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
Infections and infestations Nasopharyngitis	7.5% 26/347 • Serious Adverse Events (SAEs) and non-serious AEs were collected from the first dose of study medication up to Week 12/Early Withdrawal. SAEs and AEs were collected in members of Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of the study medication.	6.4% 22/346 • Serious Adverse Events (SAEs) and non-serious AEs were collected from the first dose of study medication up to Week 12/Early Withdrawal. SAEs and AEs were collected in members of Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of the study medication.	7.2% 25/346 • Serious Adverse Events (SAEs) and non-serious AEs were collected from the first dose of study medication up to Week 12/Early Withdrawal. SAEs and AEs were collected in members of Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of the study medication.
Infections and infestations Upper respiratory tract infection	3.5% 12/347 • Serious Adverse Events (SAEs) and non-serious AEs were collected from the first dose of study medication up to Week 12/Early Withdrawal. SAEs and AEs were collected in members of Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of the study medication.	2.3% 8/346 • Serious Adverse Events (SAEs) and non-serious AEs were collected from the first dose of study medication up to Week 12/Early Withdrawal. SAEs and AEs were collected in members of Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of the study medication.	2.0% 7/346 • Serious Adverse Events (SAEs) and non-serious AEs were collected from the first dose of study medication up to Week 12/Early Withdrawal. SAEs and AEs were collected in members of Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of the study medication.
Nervous system disorders Headache	9.2% 32/347 • Serious Adverse Events (SAEs) and non-serious AEs were collected from the first dose of study medication up to Week 12/Early Withdrawal. SAEs and AEs were collected in members of Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of the study medication.	8.4% 29/346 • Serious Adverse Events (SAEs) and non-serious AEs were collected from the first dose of study medication up to Week 12/Early Withdrawal. SAEs and AEs were collected in members of Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of the study medication.	8.4% 29/346 • Serious Adverse Events (SAEs) and non-serious AEs were collected from the first dose of study medication up to Week 12/Early Withdrawal. SAEs and AEs were collected in members of Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of the study medication.

Additional Information

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