Trial Outcomes & Findings for Safety and Efficacy Study of Fluticasone Furoate/Vilanterol (FF/VI) Fixed Dose Combination (FDC) Compared to FF Alone in Subjects With Asthma (NCT NCT03248128)
NCT ID: NCT03248128
Last Updated: 2025-06-22
Results Overview
Pulmonary function was measured by FEV1, defined as the maximal amount of air that can be forcefully exhaled in one second using a standardized calibrated spirometer. Weighted mean FEV1 was derived using the post-dose assessments (after 30 minutes and 1, 2, 3, 4 hours) with their actual times and using the pre-dose assessment as the 0 hour measurement.
COMPLETED
PHASE3
906 participants
Week 12
2025-06-22
Participant Flow
2402 participants screened, 906 participants were randomized, of which 4 participants did not receive study treatment. 902 participants received at least 1 dose of study medication creating the Intent to treat (ITT) Population.
Participant milestones
| Measure |
Participants Who Received Fluticasone Furoate/Vilanterol (FF/ VI) Fixed Dose Combination (FDC)
5-11 years old pediatric population were administered FF/VI as a FDC of 50/25 micrograms (mcg) and the 12-17 years old adolescent population received 100/25 mcg once daily via ELLIPTA dry powder inhaler (DPI). Each participant, in addition used albuterol/salbutamol (inhalation aerosol or nebuliser) as required throughout the entire study period as rescue medication for symptomatic relief of asthma symptoms.
|
Participants Who Received FF
5-11 years old pediatric population were administered FF as a monotherapy of 50 mcg and the 12-17 years old adolescent population received 100 mcg once daily via ELLIPTA DPI. Each participant, in addition used albuterol/salbutamol (inhalation aerosol or nebuliser) as required throughout the entire study period as rescue medication for symptomatic relief of asthma symptoms.
|
|---|---|---|
|
Overall Study
STARTED
|
455
|
451
|
|
Overall Study
ITT Population
|
454
|
448
|
|
Overall Study
COMPLETED
|
433
|
431
|
|
Overall Study
NOT COMPLETED
|
22
|
20
|
Reasons for withdrawal
| Measure |
Participants Who Received Fluticasone Furoate/Vilanterol (FF/ VI) Fixed Dose Combination (FDC)
5-11 years old pediatric population were administered FF/VI as a FDC of 50/25 micrograms (mcg) and the 12-17 years old adolescent population received 100/25 mcg once daily via ELLIPTA dry powder inhaler (DPI). Each participant, in addition used albuterol/salbutamol (inhalation aerosol or nebuliser) as required throughout the entire study period as rescue medication for symptomatic relief of asthma symptoms.
|
Participants Who Received FF
5-11 years old pediatric population were administered FF as a monotherapy of 50 mcg and the 12-17 years old adolescent population received 100 mcg once daily via ELLIPTA DPI. Each participant, in addition used albuterol/salbutamol (inhalation aerosol or nebuliser) as required throughout the entire study period as rescue medication for symptomatic relief of asthma symptoms.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
16
|
14
|
|
Overall Study
Site Closed
|
4
|
3
|
|
Overall Study
Randomized, but did not receive treatment
|
1
|
3
|
Baseline Characteristics
Safety and Efficacy Study of Fluticasone Furoate/Vilanterol (FF/VI) Fixed Dose Combination (FDC) Compared to FF Alone in Subjects With Asthma
Baseline characteristics by cohort
| Measure |
Participants Who Received FF/ VI FDC
n=454 Participants
5-11 years old pediatric population were administered FF/VI as a FDC of 50/25 mcg and the 12-17 years old adolescent population received 100/25 mcg once daily via ELLIPTA DPI. Each participant, in addition used albuterol/salbutamol (inhalation aerosol or nebuliser) as required throughout the entire study period as rescue medication for symptomatic relief of asthma symptoms.
|
Participants Who Received FF
n=448 Participants
5-11 years old pediatric population were administered FF as a monotherapy of 50 mcg and the 12-17 years old adolescent population received 100 mcg once daily via ELLIPTA DPI. Each participant, in addition used albuterol/salbutamol (inhalation aerosol or nebuliser) as required throughout the entire study period as rescue medication for symptomatic relief of asthma symptoms.
|
Total
n=902 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
9.9 YEARS
STANDARD_DEVIATION 3.02 • n=93 Participants
|
10.0 YEARS
STANDARD_DEVIATION 2.97 • n=4 Participants
|
10.0 YEARS
STANDARD_DEVIATION 2.99 • n=27 Participants
|
|
Sex: Female, Male
Female
|
165 Participants
n=93 Participants
|
191 Participants
n=4 Participants
|
356 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
289 Participants
n=93 Participants
|
257 Participants
n=4 Participants
|
546 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
African American/African Heritage
|
34 Participants
n=93 Participants
|
40 Participants
n=4 Participants
|
74 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
22 Participants
n=93 Participants
|
29 Participants
n=4 Participants
|
51 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Asian
|
32 Participants
n=93 Participants
|
26 Participants
n=4 Participants
|
58 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Multiple
|
31 Participants
n=93 Participants
|
33 Participants
n=4 Participants
|
64 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
White
|
335 Participants
n=93 Participants
|
320 Participants
n=4 Participants
|
655 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Week 12Population: ITT population (5-17 years old) included all randomized participants who received at least one dose of study treatment. Only those participants with data available at the specified time point have been analyzed.
Pulmonary function was measured by FEV1, defined as the maximal amount of air that can be forcefully exhaled in one second using a standardized calibrated spirometer. Weighted mean FEV1 was derived using the post-dose assessments (after 30 minutes and 1, 2, 3, 4 hours) with their actual times and using the pre-dose assessment as the 0 hour measurement.
Outcome measures
| Measure |
Participants Who Received FF/ VI FDC
n=397 Participants
5-11 years old pediatric population were administered FF/VI as a FDC of 50/25 mcg and the 12-17 years old adolescent population received 100/25 mcg once daily via ELLIPTA DPI. Each participant, in addition used albuterol/salbutamol (inhalation aerosol or nebuliser) as required throughout the entire study period as rescue medication for symptomatic relief of asthma symptoms.
|
Participants Who Received FF
n=399 Participants
5-11 years old pediatric population were administered FF as a monotherapy of 50 mcg and the 12-17 years old adolescent population received 100 mcg once daily via ELLIPTA DPI. Each participant, in addition used albuterol/salbutamol (inhalation aerosol or nebuliser) as required throughout the entire study period as rescue medication for symptomatic relief of asthma symptoms.
|
|---|---|---|
|
Absolute Weighted Mean of Forced Expiratory Volume in 1 Second (FEV1) (0-4 Hours) at Week 12 in 5-17 Year Old Population
|
2.082 Liters
Standard Deviation 0.7598
|
1.994 Liters
Standard Deviation 0.6998
|
PRIMARY outcome
Timeframe: Baseline and Week 1-12Population: ITT population (5-11 years old) was a subset of the ITT (5-17 years old) population for participants 11 years old and younger at screening (Visit 1). Only those participants with data available at specified time points have been analyzed.
PEF was defined as the maximum speed of expiration of a participant. PEF was measured using a hand-held electronic peak flow meter each morning prior to the dose of study medication and any rescue albuterol/salbutamol inhalation aerosol use. The best of three measurements were recorded in the electronic patient diary. The mean morning PEF was calculated for each participant as an averaged mean over weeks 1-12 of the treatment period. Baseline was defined as the average of measurements with a non-missing value from Day -6 to Day 1 of pre-dose.
Outcome measures
| Measure |
Participants Who Received FF/ VI FDC
n=336 Participants
5-11 years old pediatric population were administered FF/VI as a FDC of 50/25 mcg and the 12-17 years old adolescent population received 100/25 mcg once daily via ELLIPTA DPI. Each participant, in addition used albuterol/salbutamol (inhalation aerosol or nebuliser) as required throughout the entire study period as rescue medication for symptomatic relief of asthma symptoms.
|
Participants Who Received FF
n=335 Participants
5-11 years old pediatric population were administered FF as a monotherapy of 50 mcg and the 12-17 years old adolescent population received 100 mcg once daily via ELLIPTA DPI. Each participant, in addition used albuterol/salbutamol (inhalation aerosol or nebuliser) as required throughout the entire study period as rescue medication for symptomatic relief of asthma symptoms.
|
|---|---|---|
|
Change From Baseline in Mean Pre-dose Morning Peak Expiratory Flow (AM PEF) in 5-11 Year Old Population
|
11.9 Liters per minute (L/min)
Standard Deviation 37.63
|
8.9 Liters per minute (L/min)
Standard Deviation 35.62
|
SECONDARY outcome
Timeframe: Baseline and Week 1-12Population: ITT population (5-17 years old). Only those participants with data available at specified time points has been analyzed.
PEF was defined as the maximum speed of expiration of a participant. PEF was measured using a hand-held electronic peak flow meter each morning prior to the dose of study medication and any rescue albuterol/salbutamol inhalation aerosol use. The best of three measurements were recorded in the daily diary. The mean morning PEF was calculated for each participant as an averaged mean over weeks 1-12 of the treatment period. Baseline was defined as the average of measurements with a non-missing value from Day -6 to Day 1 of pre-dose.
Outcome measures
| Measure |
Participants Who Received FF/ VI FDC
n=453 Participants
5-11 years old pediatric population were administered FF/VI as a FDC of 50/25 mcg and the 12-17 years old adolescent population received 100/25 mcg once daily via ELLIPTA DPI. Each participant, in addition used albuterol/salbutamol (inhalation aerosol or nebuliser) as required throughout the entire study period as rescue medication for symptomatic relief of asthma symptoms.
|
Participants Who Received FF
n=447 Participants
5-11 years old pediatric population were administered FF as a monotherapy of 50 mcg and the 12-17 years old adolescent population received 100 mcg once daily via ELLIPTA DPI. Each participant, in addition used albuterol/salbutamol (inhalation aerosol or nebuliser) as required throughout the entire study period as rescue medication for symptomatic relief of asthma symptoms.
|
|---|---|---|
|
Change From Baseline in Mean Pre-dose AM PEF Period in 5-17 Year Old Population
|
14.9 L/min
Standard Deviation 39.94
|
9.3 L/min
Standard Deviation 38.95
|
SECONDARY outcome
Timeframe: Week 12Population: ITT population (5-11 years old). Only those participants with data available at specified time point have been analyzed.
Pulmonary function was measured by FEV1, defined as the maximal amount of air that can be forcefully exhaled in one second using a standardized calibrated spirometer. Weighted mean FEV1 was derived using the post-dose assessments (after 30 minutes and 1, 2, 3, 4 hours) with their actual times and using the pre-dose assessment as the 0 hour measurement.
Outcome measures
| Measure |
Participants Who Received FF/ VI FDC
n=289 Participants
5-11 years old pediatric population were administered FF/VI as a FDC of 50/25 mcg and the 12-17 years old adolescent population received 100/25 mcg once daily via ELLIPTA DPI. Each participant, in addition used albuterol/salbutamol (inhalation aerosol or nebuliser) as required throughout the entire study period as rescue medication for symptomatic relief of asthma symptoms.
|
Participants Who Received FF
n=291 Participants
5-11 years old pediatric population were administered FF as a monotherapy of 50 mcg and the 12-17 years old adolescent population received 100 mcg once daily via ELLIPTA DPI. Each participant, in addition used albuterol/salbutamol (inhalation aerosol or nebuliser) as required throughout the entire study period as rescue medication for symptomatic relief of asthma symptoms.
|
|---|---|---|
|
Absolute Weighted Mean of FEV1 (0-4 Hours) at Week 12 in 5-11 Year Old Population
|
1.762 Liters
Standard Deviation 0.4977
|
1.711 Liters
Standard Deviation 0.4817
|
SECONDARY outcome
Timeframe: Baseline and Week 1-12Population: ITT population (5-17 years old). Only those participants with data available at specified time points have been analyzed.
The number of inhalations of rescue albuterol/salbutamol aerosol used during the day and night were recorded in a daily electronic diary. Percentages of rescue-free 24-hour periods was calculated based on the number of 24-hour periods on which a participant recorded no use of albuterol/salbutamol divided by the length of the time period being assessed (with non-missing values of rescue medication recorded, respectively). A 24-hour period in which the response of participants to both the morning and evening assessments indicated no use of rescue medication was considered as rescue free. Baseline was calculated from the evening (Day -7 to Day -1) and morning (Day -6 to Day 1) measurements. Change from Baseline was calculated as the averaged value during the 12-week treatment period minus the Baseline value.
Outcome measures
| Measure |
Participants Who Received FF/ VI FDC
n=453 Participants
5-11 years old pediatric population were administered FF/VI as a FDC of 50/25 mcg and the 12-17 years old adolescent population received 100/25 mcg once daily via ELLIPTA DPI. Each participant, in addition used albuterol/salbutamol (inhalation aerosol or nebuliser) as required throughout the entire study period as rescue medication for symptomatic relief of asthma symptoms.
|
Participants Who Received FF
n=447 Participants
5-11 years old pediatric population were administered FF as a monotherapy of 50 mcg and the 12-17 years old adolescent population received 100 mcg once daily via ELLIPTA DPI. Each participant, in addition used albuterol/salbutamol (inhalation aerosol or nebuliser) as required throughout the entire study period as rescue medication for symptomatic relief of asthma symptoms.
|
|---|---|---|
|
Change From Baseline in the Percentage of Rescue-free 24-hour Periods Over Weeks 1-12 of the Treatment Period in 5-17 Year Old Population
|
25.9 Percentage
Standard Deviation 33.78
|
25.8 Percentage
Standard Deviation 36.55
|
SECONDARY outcome
Timeframe: Baseline and Week 1-12Population: ITT population (5-17 years old). Only those participants with data available at specified time points have been analyzed.
The symptom-free days were recorded in a daily electronic diary every day in the morning and evening before taking any rescue or study medication and before the PEF measurement. Percentages of symptom-free 24-hour periods was calculated based on the number of 24-hour periods on which a participant recorded no symptoms divided by the length of the time period being assessed (with non-missing values of rescue medication recorded, respectively). A 24-hour period in which the response of participants to both the morning and evening assessments indicated no symptoms was considered as symptom free. Baseline was calculated from evening (Day -7 to Day -1) and morning (Day -6 to Day 1) measurements. Change from Baseline was calculated as the averaged value during the 12-week treatment period minus the Baseline value.
Outcome measures
| Measure |
Participants Who Received FF/ VI FDC
n=453 Participants
5-11 years old pediatric population were administered FF/VI as a FDC of 50/25 mcg and the 12-17 years old adolescent population received 100/25 mcg once daily via ELLIPTA DPI. Each participant, in addition used albuterol/salbutamol (inhalation aerosol or nebuliser) as required throughout the entire study period as rescue medication for symptomatic relief of asthma symptoms.
|
Participants Who Received FF
n=447 Participants
5-11 years old pediatric population were administered FF as a monotherapy of 50 mcg and the 12-17 years old adolescent population received 100 mcg once daily via ELLIPTA DPI. Each participant, in addition used albuterol/salbutamol (inhalation aerosol or nebuliser) as required throughout the entire study period as rescue medication for symptomatic relief of asthma symptoms.
|
|---|---|---|
|
Change From Baseline in the Percentage of Symptom-free 24-hour Periods Over Weeks 1-12 of the Treatment Period in 5-17 Year Old Population
|
25.7 Percentage
Standard Deviation 32.77
|
24.6 Percentage
Standard Deviation 34.62
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: ITT population (5-17 years old). Only those participants with data available at the specified time point has been analyzed.
Pulmonary function was measured by FEV1, defined as the maximal amount of air that can be forcefully exhaled in one second. Morning FEV1 was measured using the pre-dose serial spirometry assessment at the Week 12. Baseline was defined as the pre-dose assessment with a non missing value on Visit 2 (Day -5).
Outcome measures
| Measure |
Participants Who Received FF/ VI FDC
n=417 Participants
5-11 years old pediatric population were administered FF/VI as a FDC of 50/25 mcg and the 12-17 years old adolescent population received 100/25 mcg once daily via ELLIPTA DPI. Each participant, in addition used albuterol/salbutamol (inhalation aerosol or nebuliser) as required throughout the entire study period as rescue medication for symptomatic relief of asthma symptoms.
|
Participants Who Received FF
n=413 Participants
5-11 years old pediatric population were administered FF as a monotherapy of 50 mcg and the 12-17 years old adolescent population received 100 mcg once daily via ELLIPTA DPI. Each participant, in addition used albuterol/salbutamol (inhalation aerosol or nebuliser) as required throughout the entire study period as rescue medication for symptomatic relief of asthma symptoms.
|
|---|---|---|
|
Change From Baseline in Morning (AM) FEV1 at Week 12 in 5-17 Year Old Population
|
0.312 Liters
Standard Deviation 0.3865
|
0.275 Liters
Standard Deviation 0.3512
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: ITT population (5-17 years old). Only those participants with data available at specified time points have been analyzed.
Asthma control as measured by improvements in ACQ-5, a five-item questionnaire with response options for each question rated from 0 to 6 scale. A score of 0 indicates well controlled asthma and a score of 6 indicates extremely poorly controlled asthma. Individual questions (concerning nocturnal awakening, waking in the morning, activity limitation, shortness of breath and wheeze) are equally weighted and the ACQ-5 score is calculated as the mean of these 5 item responses. A lower mean score indicates greater asthma control and higher mean score indicates lesser asthma control. Baseline was defined as the pre-dose assessment with a non-missing value on Visit 3 (Day 1).
Outcome measures
| Measure |
Participants Who Received FF/ VI FDC
n=385 Participants
5-11 years old pediatric population were administered FF/VI as a FDC of 50/25 mcg and the 12-17 years old adolescent population received 100/25 mcg once daily via ELLIPTA DPI. Each participant, in addition used albuterol/salbutamol (inhalation aerosol or nebuliser) as required throughout the entire study period as rescue medication for symptomatic relief of asthma symptoms.
|
Participants Who Received FF
n=378 Participants
5-11 years old pediatric population were administered FF as a monotherapy of 50 mcg and the 12-17 years old adolescent population received 100 mcg once daily via ELLIPTA DPI. Each participant, in addition used albuterol/salbutamol (inhalation aerosol or nebuliser) as required throughout the entire study period as rescue medication for symptomatic relief of asthma symptoms.
|
|---|---|---|
|
Change From Baseline in Asthma Control Questionnaire (ACQ-5) Score at Week 24 in 5-17 Year Old Population
|
-1.21 Scores on a scale
Standard Deviation 0.935
|
-1.09 Scores on a scale
Standard Deviation 0.976
|
SECONDARY outcome
Timeframe: Baseline and Week 1-12Population: ITT population (5-11 years old). Only those participants with data available at specified time points have been analyzed.
The number of inhalations of rescue albuterol/salbutamol aerosol used during the day and night were recorded in a daily electronic diary. Percentages of rescue-free 24-hour periods was calculated based on the number of 24-hour periods on which a participant recorded no use of albuterol/salbutamol divided by the length of the time period being assessed (with non-missing values of rescue medication recorded, respectively). A 24-hour period in which the response of participants to both the morning and evening assessments indicated no use of rescue medication was considered as rescue free. Baseline was calculated from the evening (Day -7 to Day -1) and morning (Day -6 to Day 1) measurements. Change from Baseline was calculated as the averaged value during the 12-week treatment period minus the Baseline value.
Outcome measures
| Measure |
Participants Who Received FF/ VI FDC
n=336 Participants
5-11 years old pediatric population were administered FF/VI as a FDC of 50/25 mcg and the 12-17 years old adolescent population received 100/25 mcg once daily via ELLIPTA DPI. Each participant, in addition used albuterol/salbutamol (inhalation aerosol or nebuliser) as required throughout the entire study period as rescue medication for symptomatic relief of asthma symptoms.
|
Participants Who Received FF
n=335 Participants
5-11 years old pediatric population were administered FF as a monotherapy of 50 mcg and the 12-17 years old adolescent population received 100 mcg once daily via ELLIPTA DPI. Each participant, in addition used albuterol/salbutamol (inhalation aerosol or nebuliser) as required throughout the entire study period as rescue medication for symptomatic relief of asthma symptoms.
|
|---|---|---|
|
Change From Baseline in the Percentage of Rescue-free 24-hour Periods Over Weeks 1-12 of the Treatment Period in 5-11 Year Old Population
|
27.3 Percentage
Standard Deviation 34.4
|
25.6 Percentage
Standard Deviation 37.03
|
SECONDARY outcome
Timeframe: Baseline and Week 1-12Population: ITT population (5-11 years old). Only those participants with data available at specified time points have been analyzed.
The symptom-free days were recorded in a daily electronic diary every day in the morning and evening before taking any rescue or study medication and before the PEF measurement. Percentages of symptom-free 24-hour periods was calculated based on the number of 24-hour periods on which a participant recorded no symptoms divided by the length of the time period being assessed (with non-missing values of rescue medication recorded, respectively). A 24-hour period in which the response of participants to both the morning and evening assessments indicated no symptoms was considered as symptom free. Baseline was calculated from evening (Day -7 to Day -1) and morning (Day -6 to Day 1) measurements. Change from Baseline was calculated as the averaged value during the 12-week treatment period minus the Baseline value.
Outcome measures
| Measure |
Participants Who Received FF/ VI FDC
n=336 Participants
5-11 years old pediatric population were administered FF/VI as a FDC of 50/25 mcg and the 12-17 years old adolescent population received 100/25 mcg once daily via ELLIPTA DPI. Each participant, in addition used albuterol/salbutamol (inhalation aerosol or nebuliser) as required throughout the entire study period as rescue medication for symptomatic relief of asthma symptoms.
|
Participants Who Received FF
n=335 Participants
5-11 years old pediatric population were administered FF as a monotherapy of 50 mcg and the 12-17 years old adolescent population received 100 mcg once daily via ELLIPTA DPI. Each participant, in addition used albuterol/salbutamol (inhalation aerosol or nebuliser) as required throughout the entire study period as rescue medication for symptomatic relief of asthma symptoms.
|
|---|---|---|
|
Change From Baseline in the Percentage of Symptom-free 24-hour Periods Over Weeks 1-12 of the Treatment Period in 5-11 Year Old Population
|
27.2 Percentage
Standard Deviation 33.16
|
25.8 Percentage
Standard Deviation 34.94
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: ITT population (5-11 years old). Only those participants with data available at specified time points have been analyzed.
Pulmonary function was measured by FEV1, defined as the maximal amount of air that can be forcefully exhaled in one second. Morning FEV1 was measured using the pre-dose serial spirometry assessment at the Week 12. Baseline was defined as the pre-dose assessment with a non-missing value on Visit 2 (Day -5).
Outcome measures
| Measure |
Participants Who Received FF/ VI FDC
n=307 Participants
5-11 years old pediatric population were administered FF/VI as a FDC of 50/25 mcg and the 12-17 years old adolescent population received 100/25 mcg once daily via ELLIPTA DPI. Each participant, in addition used albuterol/salbutamol (inhalation aerosol or nebuliser) as required throughout the entire study period as rescue medication for symptomatic relief of asthma symptoms.
|
Participants Who Received FF
n=304 Participants
5-11 years old pediatric population were administered FF as a monotherapy of 50 mcg and the 12-17 years old adolescent population received 100 mcg once daily via ELLIPTA DPI. Each participant, in addition used albuterol/salbutamol (inhalation aerosol or nebuliser) as required throughout the entire study period as rescue medication for symptomatic relief of asthma symptoms.
|
|---|---|---|
|
Change From Baseline in Morning (AM) FEV1 at Week 12 in 5-11 Year Old Population
|
0.263 Liters
Standard Deviation 0.3029
|
0.245 Liters
Standard Deviation 0.3192
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: ITT population (5-11 years old). Only those participants with data available at specified time points have been analyzed.
Asthma control as measured by improvements in ACQ-5, a five-item questionnaire with response options for each question rated from 0 to 6 scale. A score of 0 indicates well controlled asthma and a score of 6 indicates extremely poorly controlled asthma. Individual questions (concerning nocturnal awakening, waking in the morning, activity limitation, shortness of breath and wheeze) are equally weighted and the ACQ-5 score is calculated as the mean of these 5 item responses. A lower mean score indicates greater asthma control and higher mean score indicates lesser asthma control. Baseline was defined as the pre-dose assessment with a non-missing value on Visit 3 (Day 1).
Outcome measures
| Measure |
Participants Who Received FF/ VI FDC
n=291 Participants
5-11 years old pediatric population were administered FF/VI as a FDC of 50/25 mcg and the 12-17 years old adolescent population received 100/25 mcg once daily via ELLIPTA DPI. Each participant, in addition used albuterol/salbutamol (inhalation aerosol or nebuliser) as required throughout the entire study period as rescue medication for symptomatic relief of asthma symptoms.
|
Participants Who Received FF
n=286 Participants
5-11 years old pediatric population were administered FF as a monotherapy of 50 mcg and the 12-17 years old adolescent population received 100 mcg once daily via ELLIPTA DPI. Each participant, in addition used albuterol/salbutamol (inhalation aerosol or nebuliser) as required throughout the entire study period as rescue medication for symptomatic relief of asthma symptoms.
|
|---|---|---|
|
Change From Baseline ACQ-5 Score at Week 24 in 5-11 Year Old Population
|
-1.25 Scores on a scale
Standard Deviation 0.944
|
-1.13 Scores on a scale
Standard Deviation 0.975
|
SECONDARY outcome
Timeframe: Up to week 25Population: ITT (5-17 years old) population
An AE is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. SAE is defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; is a congenital anomaly/birth defect and important medical events may jeopardize the participant or may require medical or surgical intervention/SOC to prevent one of the other outcomes mentioned before.
Outcome measures
| Measure |
Participants Who Received FF/ VI FDC
n=454 Participants
5-11 years old pediatric population were administered FF/VI as a FDC of 50/25 mcg and the 12-17 years old adolescent population received 100/25 mcg once daily via ELLIPTA DPI. Each participant, in addition used albuterol/salbutamol (inhalation aerosol or nebuliser) as required throughout the entire study period as rescue medication for symptomatic relief of asthma symptoms.
|
Participants Who Received FF
n=448 Participants
5-11 years old pediatric population were administered FF as a monotherapy of 50 mcg and the 12-17 years old adolescent population received 100 mcg once daily via ELLIPTA DPI. Each participant, in addition used albuterol/salbutamol (inhalation aerosol or nebuliser) as required throughout the entire study period as rescue medication for symptomatic relief of asthma symptoms.
|
|---|---|---|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) in 5-17 Year Old Population
AEs
|
183 Participants
|
164 Participants
|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) in 5-17 Year Old Population
SAEs
|
5 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Week 24Population: ITT population (5-17 years old). Only those participants with data available at the specified time point have been analyzed.
A single 12-lead ECG was obtained using an ECG machine that automatically calculates the heartrate and measures PR, QRS, QT, and QT interval corrected (QTc).
Outcome measures
| Measure |
Participants Who Received FF/ VI FDC
n=402 Participants
5-11 years old pediatric population were administered FF/VI as a FDC of 50/25 mcg and the 12-17 years old adolescent population received 100/25 mcg once daily via ELLIPTA DPI. Each participant, in addition used albuterol/salbutamol (inhalation aerosol or nebuliser) as required throughout the entire study period as rescue medication for symptomatic relief of asthma symptoms.
|
Participants Who Received FF
n=398 Participants
5-11 years old pediatric population were administered FF as a monotherapy of 50 mcg and the 12-17 years old adolescent population received 100 mcg once daily via ELLIPTA DPI. Each participant, in addition used albuterol/salbutamol (inhalation aerosol or nebuliser) as required throughout the entire study period as rescue medication for symptomatic relief of asthma symptoms.
|
|---|---|---|
|
Number of Participants With Abnormal Electrocardiogram (ECG) Findings in 5-17 Year Old Population
|
64 Participants
|
49 Participants
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: ITT population (5-17 years old). Only those participants with data available at specified time points have been analyzed.
Blood samples were collected for evaluation of fasting blood glucose pre and post-treatment. Baseline was defined as Visit 1 (Screening).
Outcome measures
| Measure |
Participants Who Received FF/ VI FDC
n=370 Participants
5-11 years old pediatric population were administered FF/VI as a FDC of 50/25 mcg and the 12-17 years old adolescent population received 100/25 mcg once daily via ELLIPTA DPI. Each participant, in addition used albuterol/salbutamol (inhalation aerosol or nebuliser) as required throughout the entire study period as rescue medication for symptomatic relief of asthma symptoms.
|
Participants Who Received FF
n=388 Participants
5-11 years old pediatric population were administered FF as a monotherapy of 50 mcg and the 12-17 years old adolescent population received 100 mcg once daily via ELLIPTA DPI. Each participant, in addition used albuterol/salbutamol (inhalation aerosol or nebuliser) as required throughout the entire study period as rescue medication for symptomatic relief of asthma symptoms.
|
|---|---|---|
|
Change From Baseline in Fasting Glucose in 5-17 Year Old Population
|
-0.12 mmol/L
Standard Deviation 0.587
|
-0.15 mmol/L
Standard Deviation 0.626
|
SECONDARY outcome
Timeframe: Up to week 24Population: ITT population (5-17 years old)
Asthma exacerbation was defined as deterioration of asthma requiring the use of systemic corticosteroids (tablets, suspension or injection) for at least three days or a single depot corticosteroid injection or an in-patient hospitalization or emergency department visit due to asthma that required systemic corticosteroids.
Outcome measures
| Measure |
Participants Who Received FF/ VI FDC
n=454 Participants
5-11 years old pediatric population were administered FF/VI as a FDC of 50/25 mcg and the 12-17 years old adolescent population received 100/25 mcg once daily via ELLIPTA DPI. Each participant, in addition used albuterol/salbutamol (inhalation aerosol or nebuliser) as required throughout the entire study period as rescue medication for symptomatic relief of asthma symptoms.
|
Participants Who Received FF
n=448 Participants
5-11 years old pediatric population were administered FF as a monotherapy of 50 mcg and the 12-17 years old adolescent population received 100 mcg once daily via ELLIPTA DPI. Each participant, in addition used albuterol/salbutamol (inhalation aerosol or nebuliser) as required throughout the entire study period as rescue medication for symptomatic relief of asthma symptoms.
|
|---|---|---|
|
Number of Participants With Any Incidence of Asthma Exacerbation Over the 24-week Treatment Period in 5-17 Year Old Population
|
33 Participants
|
38 Participants
|
SECONDARY outcome
Timeframe: Up to week 25Population: Data only for the ITT (5-11 years old) population have been presented.
An AE is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. SAE is defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; is a congenital anomaly/birth defect and important medical events may jeopardize the participant or may require medical or surgical intervention/Standard of care (SOC) to prevent one of the other outcomes mentioned before.
Outcome measures
| Measure |
Participants Who Received FF/ VI FDC
n=337 Participants
5-11 years old pediatric population were administered FF/VI as a FDC of 50/25 mcg and the 12-17 years old adolescent population received 100/25 mcg once daily via ELLIPTA DPI. Each participant, in addition used albuterol/salbutamol (inhalation aerosol or nebuliser) as required throughout the entire study period as rescue medication for symptomatic relief of asthma symptoms.
|
Participants Who Received FF
n=336 Participants
5-11 years old pediatric population were administered FF as a monotherapy of 50 mcg and the 12-17 years old adolescent population received 100 mcg once daily via ELLIPTA DPI. Each participant, in addition used albuterol/salbutamol (inhalation aerosol or nebuliser) as required throughout the entire study period as rescue medication for symptomatic relief of asthma symptoms.
|
|---|---|---|
|
Number of Participants With AEs and SAEs in 5-11 Year Old Population
AEs
|
133 Participants
|
122 Participants
|
|
Number of Participants With AEs and SAEs in 5-11 Year Old Population
SAEs
|
4 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Week 24Population: ITT population (5-11 years old). Only those participants with data available at the specified time point have been analyzed.
A single 12-lead ECG was obtained using an ECG machine that automatically calculates the heartrate and measures PR, QRS, QT, and QTc.
Outcome measures
| Measure |
Participants Who Received FF/ VI FDC
n=303 Participants
5-11 years old pediatric population were administered FF/VI as a FDC of 50/25 mcg and the 12-17 years old adolescent population received 100/25 mcg once daily via ELLIPTA DPI. Each participant, in addition used albuterol/salbutamol (inhalation aerosol or nebuliser) as required throughout the entire study period as rescue medication for symptomatic relief of asthma symptoms.
|
Participants Who Received FF
n=298 Participants
5-11 years old pediatric population were administered FF as a monotherapy of 50 mcg and the 12-17 years old adolescent population received 100 mcg once daily via ELLIPTA DPI. Each participant, in addition used albuterol/salbutamol (inhalation aerosol or nebuliser) as required throughout the entire study period as rescue medication for symptomatic relief of asthma symptoms.
|
|---|---|---|
|
Number of Participants With Abnormal ECG Findings in 5-11 Year Old Population
|
53 Participants
|
40 Participants
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: ITT population (5-11 years old). Only those participants with data available at specified time point have been analyzed.
Blood samples were collected for evaluation of fasting blood glucose pre and post-treatment. Baseline was defined as Visit 1 (Screening).
Outcome measures
| Measure |
Participants Who Received FF/ VI FDC
n=274 Participants
5-11 years old pediatric population were administered FF/VI as a FDC of 50/25 mcg and the 12-17 years old adolescent population received 100/25 mcg once daily via ELLIPTA DPI. Each participant, in addition used albuterol/salbutamol (inhalation aerosol or nebuliser) as required throughout the entire study period as rescue medication for symptomatic relief of asthma symptoms.
|
Participants Who Received FF
n=288 Participants
5-11 years old pediatric population were administered FF as a monotherapy of 50 mcg and the 12-17 years old adolescent population received 100 mcg once daily via ELLIPTA DPI. Each participant, in addition used albuterol/salbutamol (inhalation aerosol or nebuliser) as required throughout the entire study period as rescue medication for symptomatic relief of asthma symptoms.
|
|---|---|---|
|
Change From Baseline in Fasting Glucose in 5-11 Year Old Population
|
-0.13 mmol/L
Standard Deviation 0.563
|
-0.17 mmol/L
Standard Deviation 0.638
|
SECONDARY outcome
Timeframe: Up to week 24Population: Data only for the ITT (5-11 years old) population have been presented.
Asthma exacerbation was defined as deterioration of asthma requiring the use of systemic corticosteroids (tablets, suspension or injection) for at least three days or a single depot corticosteroid injection or an in-patient hospitalization or emergency department visit due to asthma that required systemic corticosteroids.
Outcome measures
| Measure |
Participants Who Received FF/ VI FDC
n=337 Participants
5-11 years old pediatric population were administered FF/VI as a FDC of 50/25 mcg and the 12-17 years old adolescent population received 100/25 mcg once daily via ELLIPTA DPI. Each participant, in addition used albuterol/salbutamol (inhalation aerosol or nebuliser) as required throughout the entire study period as rescue medication for symptomatic relief of asthma symptoms.
|
Participants Who Received FF
n=336 Participants
5-11 years old pediatric population were administered FF as a monotherapy of 50 mcg and the 12-17 years old adolescent population received 100 mcg once daily via ELLIPTA DPI. Each participant, in addition used albuterol/salbutamol (inhalation aerosol or nebuliser) as required throughout the entire study period as rescue medication for symptomatic relief of asthma symptoms.
|
|---|---|---|
|
Number of Participants With Any Incidence of Asthma Exacerbation Over the 24-week Treatment Period in 5-11 Year Old Population
|
27 Participants
|
32 Participants
|
Adverse Events
Participants Who Received FF/ VI FDC
Participants Who Received FF
Serious adverse events
| Measure |
Participants Who Received FF/ VI FDC
n=454 participants at risk
5-11 years old pediatric population were administered FF/VI as a FDC of 50/25 mcg and the 12-17 years old adolescent population received 100/25 mcg once daily via ELLIPTA DPI. Each participant, in addition used albuterol/salbutamol (inhalation aerosol or nebuliser) as required throughout the entire study period as rescue medication for symptomatic relief of asthma symptoms.
|
Participants Who Received FF
n=448 participants at risk
5-11 years old pediatric population were administered FF as a monotherapy of 50 mcg and the 12-17 years old adolescent population received 100 mcg once daily via ELLIPTA DPI. Each participant, in addition used albuterol/salbutamol (inhalation aerosol or nebuliser) as required throughout the entire study period as rescue medication for symptomatic relief of asthma symptoms.
|
|---|---|---|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.22%
1/454 • Number of events 1 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 25 weeks (which included one week of follow up contact after completion of the treatment period).
|
0.00%
0/448 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 25 weeks (which included one week of follow up contact after completion of the treatment period).
|
|
Infections and infestations
Appendicitis
|
0.22%
1/454 • Number of events 1 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 25 weeks (which included one week of follow up contact after completion of the treatment period).
|
0.00%
0/448 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 25 weeks (which included one week of follow up contact after completion of the treatment period).
|
|
Infections and infestations
Gastroenteritis rotavirus
|
0.22%
1/454 • Number of events 1 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 25 weeks (which included one week of follow up contact after completion of the treatment period).
|
0.00%
0/448 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 25 weeks (which included one week of follow up contact after completion of the treatment period).
|
|
Infections and infestations
Helicobacter gastritis
|
0.00%
0/454 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 25 weeks (which included one week of follow up contact after completion of the treatment period).
|
0.22%
1/448 • Number of events 1 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 25 weeks (which included one week of follow up contact after completion of the treatment period).
|
|
Infections and infestations
Sinusitis
|
0.00%
0/454 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 25 weeks (which included one week of follow up contact after completion of the treatment period).
|
0.22%
1/448 • Number of events 1 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 25 weeks (which included one week of follow up contact after completion of the treatment period).
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.44%
2/454 • Number of events 2 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 25 weeks (which included one week of follow up contact after completion of the treatment period).
|
0.67%
3/448 • Number of events 3 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 25 weeks (which included one week of follow up contact after completion of the treatment period).
|
Other adverse events
| Measure |
Participants Who Received FF/ VI FDC
n=454 participants at risk
5-11 years old pediatric population were administered FF/VI as a FDC of 50/25 mcg and the 12-17 years old adolescent population received 100/25 mcg once daily via ELLIPTA DPI. Each participant, in addition used albuterol/salbutamol (inhalation aerosol or nebuliser) as required throughout the entire study period as rescue medication for symptomatic relief of asthma symptoms.
|
Participants Who Received FF
n=448 participants at risk
5-11 years old pediatric population were administered FF as a monotherapy of 50 mcg and the 12-17 years old adolescent population received 100 mcg once daily via ELLIPTA DPI. Each participant, in addition used albuterol/salbutamol (inhalation aerosol or nebuliser) as required throughout the entire study period as rescue medication for symptomatic relief of asthma symptoms.
|
|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
10.4%
47/454 • Number of events 60 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 25 weeks (which included one week of follow up contact after completion of the treatment period).
|
7.6%
34/448 • Number of events 42 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 25 weeks (which included one week of follow up contact after completion of the treatment period).
|
|
Infections and infestations
Rhinitis
|
3.3%
15/454 • Number of events 16 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 25 weeks (which included one week of follow up contact after completion of the treatment period).
|
1.3%
6/448 • Number of events 6 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 25 weeks (which included one week of follow up contact after completion of the treatment period).
|
|
Infections and infestations
Upper respiratory tract infection
|
7.0%
32/454 • Number of events 42 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 25 weeks (which included one week of follow up contact after completion of the treatment period).
|
5.6%
25/448 • Number of events 27 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 25 weeks (which included one week of follow up contact after completion of the treatment period).
|
|
Nervous system disorders
Headache
|
3.1%
14/454 • Number of events 23 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 25 weeks (which included one week of follow up contact after completion of the treatment period).
|
2.0%
9/448 • Number of events 13 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 25 weeks (which included one week of follow up contact after completion of the treatment period).
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
4.2%
19/454 • Number of events 22 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 25 weeks (which included one week of follow up contact after completion of the treatment period).
|
1.3%
6/448 • Number of events 8 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 25 weeks (which included one week of follow up contact after completion of the treatment period).
|
Additional Information
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