Trial Outcomes & Findings for Study FFR116364, a Placebo-controlled Study of GW685698X in Paediatric Subjects With Perennial Allergic Rhinitis (NCT NCT01630135)

Last Updated: 2017-01-11

Results Overview

The 3TNSS is the sum of the 3 individual symptom scores for sneezing, rhinorrhea, and nasal congestion. Each symptom is scored on a scale from 0 to 3; the range of sums for the 3TNSS is 0 to 9. The symptoms were evaluated using a scale of 0, 1, 2, or 3; a larger score indicates more severe symptoms. The participant's parent/guardian who signed the informed consent form (ICF) or the participant themself scored nasal symptoms every day during the screening period and the treatment period. The Baseline value is defined as the average 3TNSS over the last 4 consecutive days prior to Visit 2 (start of the treatment period). For the entire assessment period, a mean score for each participant was calculated using available diary data from the assessment periods, taking the average of non-missing data during the period. Change from Baseline was calculated as the mean score for the entire treatment period minus the score at Baseline.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

261 participants

Primary outcome timeframe

Baseline through the entire treatment period (2 weeks)

Results posted on

2017-01-11

Participant Flow

Participant milestones

Participant milestones
Measure	Fluticasone Furoate 55 µg Per Day Fluticasone furoate nasal spray (55 micrograms \[µg\] per day) was administered as one spray into each nostril (27.5 μg per spray) once daily in the morning for 2 weeks.	Placebo Matching placebo nasal spray was administered as one spray into each nostril once daily in the morning for 2 weeks.
Overall Study STARTED	131	130
Overall Study COMPLETED	131	128
Overall Study NOT COMPLETED	0	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Fluticasone Furoate 55 µg Per Day Fluticasone furoate nasal spray (55 micrograms \[µg\] per day) was administered as one spray into each nostril (27.5 μg per spray) once daily in the morning for 2 weeks.	Placebo Matching placebo nasal spray was administered as one spray into each nostril once daily in the morning for 2 weeks.
Overall Study Protocol-defined Stopping Criteria Met	0	2

Baseline Characteristics

Study FFR116364, a Placebo-controlled Study of GW685698X in Paediatric Subjects With Perennial Allergic Rhinitis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Fluticasone Furoate 55 µg Per Day n=131 Participants Fluticasone furoate nasal spray (55 micrograms \[µg\] per day) was administered as one spray into each nostril (27.5 μg per spray) once daily in the morning for 2 weeks.	Placebo n=130 Participants Matching placebo nasal spray was administered as one spray into each nostril once daily in the morning for 2 weeks.	Total n=261 Participants Total of all reporting groups
Age, Continuous	10.0 Years STANDARD_DEVIATION 2.32 • n=5 Participants	10.1 Years STANDARD_DEVIATION 2.22 • n=7 Participants	10.1 Years STANDARD_DEVIATION 2.26 • n=5 Participants
Gender Female	46 Participants n=5 Participants	51 Participants n=7 Participants	97 Participants n=5 Participants
Gender Male	85 Participants n=5 Participants	79 Participants n=7 Participants	164 Participants n=5 Participants
Race/Ethnicity, Customized Asian - Japanese Heritage	131 participants n=5 Participants	130 participants n=7 Participants	261 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline through the entire treatment period (2 weeks)

Population: Full Analysis Set (FAS): all participants meeting the primary criteria for enrollment, without any major good clinical practice (GCP) deviation, who received at least one dose of the assigned treatment and had diary assessment for 3TNSS after receiving a dose of study medication

Outcome measures

Outcome measures
Measure	Placebo n=130 Participants Matching placebo nasal spray was administered as one spray into each nostril once daily in the morning for 2 weeks.	Fluticasone Furoate 55 µg Per Day n=131 Participants Fluticasone furoate nasal spray (55 micrograms \[µg\] per day) was administered as one spray into each nostril (27.5 μg per spray) once daily in the morning for 2 weeks.
Mean Change From Baseline in the 3 Total Nasal Symptom Score (3TNSS) Over the Entire Treatment Period	-0.89 Scores on a scale Standard Error 0.12	-1.98 Scores on a scale Standard Error 0.12

SECONDARY outcome

Timeframe: Baseline; Week 1 and Week 2

Population: FAS. Change from Baseline was analyzed for only those participants who were available for assessment at both Baseline and the indicated assessment period. The analysis was based on ANCOVA with a model adjusting for Treatment, Baseline, Age, and Sex.

The 3TNSS is the sum of the 3 individual symptom scores for sneezing, rhinorrhea, and nasal congestion. Each symptom is scored on a scale from 0 to 3; the range of sums for the 3TNSS is 0 to 9. The symptoms were evaluated using a scale of 0, 1, 2, or 3; a larger score indicates more severe symptoms. The participant's parent/guardian who signed the ICF or the participant themself scored nasal symptoms every day during the screening period and the treatment period. The Baseline value is defined as the average 3TNSS over the last 4 consecutive days prior to Visit 2 (start of the treatment period). For Week 1 and Week 2, a mean score for each participant was calculated using available diary data from the assessment periods, taking the average of non-missing data during the period. Change from Baseline was calculated as the mean score at Week 1 and Week 2 minus the score at Baseline.

Outcome measures

Outcome measures
Measure	Placebo n=130 Participants Matching placebo nasal spray was administered as one spray into each nostril once daily in the morning for 2 weeks.	Fluticasone Furoate 55 µg Per Day n=131 Participants Fluticasone furoate nasal spray (55 micrograms \[µg\] per day) was administered as one spray into each nostril (27.5 μg per spray) once daily in the morning for 2 weeks.
Mean Change From Baseline in 3TNSS at Week 1 and Week 2 Week 1, n=131, 130	-0.70 Scores on a scale Standard Error 0.12	-1.60 Scores on a scale Standard Error 0.12
Mean Change From Baseline in 3TNSS at Week 1 and Week 2 Week 2, n=131, 128	-1.10 Scores on a scale Standard Error 0.13	-2.38 Scores on a scale Standard Error 0.13

SECONDARY outcome

Timeframe: Baseline through the entire treatment period (2 weeks), Week 1, and Week 2

Population: FAS. Only those participants who were available for assessment at both Baseline and the indicated assessment period were analyzed. Participants were analyzed for the entire treatment period if they had an assessment on any day during Week 1 and Week 2. The analysis was based on an ANCOVA with a model adjusting for Treatment, Baseline, Age, and Sex.

The 3TNSS is the sum of the 3 individual symptom scores for sneezing, rhinorrhea, and nasal congestion. Each symptom is scored on a scale from 0 to 3; the range of sums for the 3TNSS is 0 to 9. The symptoms were evaluated using a scale of 0, 1, 2, or 3; a larger score indicates more severe symptoms. The participant's parent/guardian who signed the ICF or the participant themself scored nasal symptoms every day during the screening period and the treatment period. The Baseline value is defined as the average 3TNSS over the last 4 consecutive days prior to Visit 2 (start of the treatment period). For the entire treatment period (Weeks 1 and 2), Week 1, and Week 2, a mean score for each participant was calculated using available diary data from the assessment periods, taking the average of non-missing data during the period. Percent change from Baseline=(mean score at the post-Baseline assessment minus the score at Baseline) divided by the Baseline value \* 100.

Outcome measures

Outcome measures
Measure	Placebo n=130 Participants Matching placebo nasal spray was administered as one spray into each nostril once daily in the morning for 2 weeks.	Fluticasone Furoate 55 µg Per Day n=131 Participants Fluticasone furoate nasal spray (55 micrograms \[µg\] per day) was administered as one spray into each nostril (27.5 μg per spray) once daily in the morning for 2 weeks.
Mean Percent Change From Baseline in 3TNSS Over the Entire Treatment Period, at Week 1, and at Week 2 Entire treatment period, n=131, 130	-17.74 Percent change Standard Error 2.36	-39.76 Percent change Standard Error 2.38
Mean Percent Change From Baseline in 3TNSS Over the Entire Treatment Period, at Week 1, and at Week 2 Week 1, n=131, 130	-13.89 Percent change Standard Error 2.44	-31.96 Percent change Standard Error 2.46
Mean Percent Change From Baseline in 3TNSS Over the Entire Treatment Period, at Week 1, and at Week 2 Week 2, n=131, 128	-21.95 Percent change Standard Error 2.70	-47.89 Percent change Standard Error 2.70

SECONDARY outcome

Timeframe: Baseline; Days 1 through 14

Population: FAS. Change from Baseline was analyzed for only those participants who were available for assessment at both Baseline and the indicated study day (Days 1 through 14). The analysis was based on an ANCOVA with a model adjusting for Treatment, Baseline, Age, and Sex.

The 3TNSS is the sum of the 3 individual symptom scores for sneezing, rhinorrhea, and nasal congestion. Each symptom is scored on a scale from 0 to 3; the range of sums for the 3TNSS is 0 to 9. The symptoms were evaluated using a scale of 0, 1, 2, or 3; a larger score indicates more severe symptoms. The participant's parent/guardian who signed the ICF or the participant themself scored nasal symptoms every day during the screening period and the treatment period. The Baseline value is defined as the average 3TNSS over the last 4 consecutive days prior to Visit 2 (start of the treatment period). Change from Baseline was calculated as the mean score at the indicated day minus the score at Baseline.

Outcome measures

Outcome measures
Measure	Placebo n=130 Participants Matching placebo nasal spray was administered as one spray into each nostril once daily in the morning for 2 weeks.	Fluticasone Furoate 55 µg Per Day n=131 Participants Fluticasone furoate nasal spray (55 micrograms \[µg\] per day) was administered as one spray into each nostril (27.5 μg per spray) once daily in the morning for 2 weeks.
Mean Change From Baseline in 3TNSS at the Indicated Days Day 13, n=122, 123	-1.20 Scores on a scale Standard Error 0.16	-2.47 Scores on a scale Standard Error 0.16
Mean Change From Baseline in 3TNSS at the Indicated Days Day 1, n=130, 130	-0.52 Scores on a scale Standard Error 0.12	-0.71 Scores on a scale Standard Error 0.13
Mean Change From Baseline in 3TNSS at the Indicated Days Day 2, n=131, 130	-0.41 Scores on a scale Standard Error 0.14	-1.33 Scores on a scale Standard Error 0.14
Mean Change From Baseline in 3TNSS at the Indicated Days Day 3, n=131, 130	-0.61 Scores on a scale Standard Error 0.15	-1.53 Scores on a scale Standard Error 0.15
Mean Change From Baseline in 3TNSS at the Indicated Days Day 4, n=131, 130	-0.77 Scores on a scale Standard Error 0.15	-1.69 Scores on a scale Standard Error 0.15
Mean Change From Baseline in 3TNSS at the Indicated Days Day 5, n=131, 130	-0.77 Scores on a scale Standard Error 0.16	-1.89 Scores on a scale Standard Error 0.16
Mean Change From Baseline in 3TNSS at the Indicated Days Day 6, n=131, 130	-0.97 Scores on a scale Standard Error 0.16	-1.95 Scores on a scale Standard Error 0.16
Mean Change From Baseline in 3TNSS at the Indicated Days Day 7, n=131, 130	-0.87 Scores on a scale Standard Error 0.16	-2.05 Scores on a scale Standard Error 0.16
Mean Change From Baseline in 3TNSS at the Indicated Days Day 8, n=131, 128	-1.05 Scores on a scale Standard Error 0.16	-2.14 Scores on a scale Standard Error 0.16
Mean Change From Baseline in 3TNSS at the Indicated Days Day 9, n=131, 128	-1.07 Scores on a scale Standard Error 0.16	-2.29 Scores on a scale Standard Error 0.16
Mean Change From Baseline in 3TNSS at the Indicated Days Day 10, n=131, 128	-1.01 Scores on a scale Standard Error 0.16	-2.32 Scores on a scale Standard Error 0.16
Mean Change From Baseline in 3TNSS at the Indicated Days Day 11, n=131, 128	-1.19 Scores on a scale Standard Error 0.16	-2.36 Scores on a scale Standard Error 0.16
Mean Change From Baseline in 3TNSS at the Indicated Days Day 12, n=131, 128	-1.21 Scores on a scale Standard Error 0.15	-2.54 Scores on a scale Standard Error 0.15
Mean Change From Baseline in 3TNSS at the Indicated Days Day 14, n=105, 115	-0.93 Scores on a scale Standard Error 0.16	-2.65 Scores on a scale Standard Error 0.17

SECONDARY outcome

Timeframe: Baseline through the entire treatment period (2 weeks), Week 1, and Week 2

The 4TNSS is the sum of the 4 individual symptom scores for sneezing, rhinorrhea, nasal congestion, and nasal itching. Each symptom is scored on a scale from 0 to 3; the range of sums for the 4TNSS is 0 to 12. The symptoms were evaluated using a scale of 0, 1, 2, or 3; a larger score indicates more severe symptoms. The participant's parent/guardian who signed the ICF or the participant themself scored nasal symptoms every day during the screening period and the treatment period. The Baseline value is defined as the average of the 4TNSS in the last 4 consecutive days prior to Visit 2 (start of the treatment period). A mean score for each participant was calculated using available diary data from the assessment periods, taking the average of non-missing data during the period. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.

Outcome measures

Outcome measures
Measure	Placebo n=130 Participants Matching placebo nasal spray was administered as one spray into each nostril once daily in the morning for 2 weeks.	Fluticasone Furoate 55 µg Per Day n=131 Participants Fluticasone furoate nasal spray (55 micrograms \[µg\] per day) was administered as one spray into each nostril (27.5 μg per spray) once daily in the morning for 2 weeks.
Mean Change From Baseline in the 4 Total Nasal Symptom Score (4TNSS) Over the Entire Treatment Period, at Week 1, and at Week 2 Entire Treatment Period, n=131, 130	-1.01 Scores on a scale Standard Error 0.15	-2.40 Scores on a scale Standard Error 0.15
Mean Change From Baseline in the 4 Total Nasal Symptom Score (4TNSS) Over the Entire Treatment Period, at Week 1, and at Week 2 Week 1, n=131, 130	-0.74 Scores on a scale Standard Error 0.15	-1.94 Scores on a scale Standard Error 0.15
Mean Change From Baseline in the 4 Total Nasal Symptom Score (4TNSS) Over the Entire Treatment Period, at Week 1, and at Week 2 Week 2, n= 131, 128	-1.29 Scores on a scale Standard Error 0.16	-2.89 Scores on a scale Standard Error 0.16

SECONDARY outcome

Timeframe: Baseline through the entire treatment period (2 weeks), Week 1, and Week 2

The 4TNSS is the sum of the 4 individual symptom scores for sneezing, rhinorrhea, nasal congestion, and nasal itching. Each symptom is scored on a scale from 0 to 3; the range of sums for the 4TNSS is 0 to 12. The symptoms were evaluated using a scale of 0, 1, 2, or 3; a larger score indicates more severe symptoms. The participant's parent/guardian who signed the ICF or the participant themself scored nasal symptoms every day during the screening period and the treatment period. The Baseline value is defined as the average 4TNSS over the last 4 consecutive days prior to Visit 2 (start of the treatment period). For the entire treatment period (Weeks 1 and 2), Week 1, and Week 2, a mean score for each participant was calculated using available diary data from the assessment periods, taking the average of non-missing data during the period. Percent change from Baseline=(mean score at the post-Baseline assessment minus the score at Baseline) divided by the Baseline value \* 100.

Outcome measures

Outcome measures
Measure	Placebo n=130 Participants Matching placebo nasal spray was administered as one spray into each nostril once daily in the morning for 2 weeks.	Fluticasone Furoate 55 µg Per Day n=131 Participants Fluticasone furoate nasal spray (55 micrograms \[µg\] per day) was administered as one spray into each nostril (27.5 μg per spray) once daily in the morning for 2 weeks.
Mean Percent Change From Baseline in the 4TNSS Over the Entire Treatment Period, at Week 1, and at Week 2 Entire Treatment Period, n=131, 130	-16.09 Percent change Standard Error 2.44	-40.42 Percent change Standard Error 2.46
Mean Percent Change From Baseline in the 4TNSS Over the Entire Treatment Period, at Week 1, and at Week 2 Week 1, n=131, 130	-11.54 Percent change Standard Error 2.52	-32.55 Percent change Standard Error 2.54
Mean Percent Change From Baseline in the 4TNSS Over the Entire Treatment Period, at Week 1, and at Week 2 Week 2, n= 131, 128	-20.92 Percent change Standard Error 2.78	-48.58 Percent change Standard Error 2.78

SECONDARY outcome

Timeframe: Baseline through the entire treatment period (2 weeks), Week 1, and Week 2

Four individual symptoms (sneezing, rhinorrhea, nasal congestion, and nasal itching) were scored on a scale from 0 to 3 using a scale of 0, 1, 2, or 3; a larger score indicates more severe symptoms. The participant's parent/guardian who signed the ICF or the participant themself scored nasal symptoms every day during the screening period and the treatment period. The Baseline value is defined as the average of the symptom scores in the last 4 consecutive days prior to Visit 2 (start of the treatment period). A mean score for each participant was calculated using available diary data from the assessment periods, taking the average of non-missing data during the period. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.

Outcome measures

Outcome measures
Measure	Placebo n=130 Participants Matching placebo nasal spray was administered as one spray into each nostril once daily in the morning for 2 weeks.	Fluticasone Furoate 55 µg Per Day n=131 Participants Fluticasone furoate nasal spray (55 micrograms \[µg\] per day) was administered as one spray into each nostril (27.5 μg per spray) once daily in the morning for 2 weeks.
Mean Change From Baseline in Rhinorrhea, Nasal Congestion, Sneezing, and Nasal Itching Over the Entire Treatment Period (ETP), at Week 1, and at Week 2 Rhinorrhea, ETP, n=131, 130	-0.31 Scores on a scale Standard Error 0.05	-0.69 Scores on a scale Standard Error 0.05
Mean Change From Baseline in Rhinorrhea, Nasal Congestion, Sneezing, and Nasal Itching Over the Entire Treatment Period (ETP), at Week 1, and at Week 2 Rhinorrhea, Week 1, n=131, 130	-0.23 Scores on a scale Standard Error 0.05	-0.55 Scores on a scale Standard Error 0.05
Mean Change From Baseline in Rhinorrhea, Nasal Congestion, Sneezing, and Nasal Itching Over the Entire Treatment Period (ETP), at Week 1, and at Week 2 Rhinorrhea, Week 2, n=131, 128	-0.40 Scores on a scale Standard Error 0.06	-0.85 Scores on a scale Standard Error 0.06
Mean Change From Baseline in Rhinorrhea, Nasal Congestion, Sneezing, and Nasal Itching Over the Entire Treatment Period (ETP), at Week 1, and at Week 2 Nasal congestion, ETP, n=131, 130	-0.36 Scores on a scale Standard Error 0.05	-0.70 Scores on a scale Standard Error 0.05
Mean Change From Baseline in Rhinorrhea, Nasal Congestion, Sneezing, and Nasal Itching Over the Entire Treatment Period (ETP), at Week 1, and at Week 2 Nasal congestion, Week 1, n=131, 130	-0.29 Scores on a scale Standard Error 0.05	-0.56 Scores on a scale Standard Error 0.05
Mean Change From Baseline in Rhinorrhea, Nasal Congestion, Sneezing, and Nasal Itching Over the Entire Treatment Period (ETP), at Week 1, and at Week 2 Nasal congestion, Week 2, n=131, 128	-0.43 Scores on a scale Standard Error 0.05	-0.84 Scores on a scale Standard Error 0.05
Mean Change From Baseline in Rhinorrhea, Nasal Congestion, Sneezing, and Nasal Itching Over the Entire Treatment Period (ETP), at Week 1, and at Week 2 Sneezing, ETP, n=131, 130	-0.21 Scores on a scale Standard Error 0.04	-0.60 Scores on a scale Standard Error 0.04
Mean Change From Baseline in Rhinorrhea, Nasal Congestion, Sneezing, and Nasal Itching Over the Entire Treatment Period (ETP), at Week 1, and at Week 2 Sneezing, Week 1, n=131, 130	-0.16 Scores on a scale Standard Error 0.04	-0.50 Scores on a scale Standard Error 0.04
Mean Change From Baseline in Rhinorrhea, Nasal Congestion, Sneezing, and Nasal Itching Over the Entire Treatment Period (ETP), at Week 1, and at Week 2 Sneezing, Week 2, n= 131, 128	-0.27 Scores on a scale Standard Error 0.05	-0.71 Scores on a scale Standard Error 0.05
Mean Change From Baseline in Rhinorrhea, Nasal Congestion, Sneezing, and Nasal Itching Over the Entire Treatment Period (ETP), at Week 1, and at Week 2 Nasal itching, ETP, n=131, 130	-0.12 Scores on a scale Standard Error 0.04	-0.41 Scores on a scale Standard Error 0.04
Mean Change From Baseline in Rhinorrhea, Nasal Congestion, Sneezing, and Nasal Itching Over the Entire Treatment Period (ETP), at Week 1, and at Week 2 Nasal itching, Week 1, n=131, 130	-0.04 Scores on a scale Standard Error 0.05	-0.33 Scores on a scale Standard Error 0.05
Mean Change From Baseline in Rhinorrhea, Nasal Congestion, Sneezing, and Nasal Itching Over the Entire Treatment Period (ETP), at Week 1, and at Week 2 Nasal itching, Week 2, n= 131, 128	-0.19 Scores on a scale Standard Error 0.05	-0.49 Scores on a scale Standard Error 0.05

SECONDARY outcome

Timeframe: Baseline through the entire treatment period (2 weeks), Week 1, and Week 2

Symptoms of eye itching, tearing, and redness were scored by the participant's parent/guardian who signed the ICF or the participant themself using a scale of 0, 1, 2, or 3 (a larger score indicates more severe symptoms) and were recorded in the participant's diary. The TOSS is the sum of all three symtpom scores and ranges from 0 to 9. The mean of the Baseline period is defined as the mean score of 4 consecutive days prior to Visit 2 (start of the treatment period). The mean of each assessment period is defined as the mean score of the entire treatment period (Weeks 1 and 2), Week 1, and Week 2. For each assessment period, a mean score for each participant was calculated using available diary data from the assessment periods, taking the average of non-missing data during the period. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.

Outcome measures

Outcome measures
Measure	Placebo n=130 Participants Matching placebo nasal spray was administered as one spray into each nostril once daily in the morning for 2 weeks.	Fluticasone Furoate 55 µg Per Day n=131 Participants Fluticasone furoate nasal spray (55 micrograms \[µg\] per day) was administered as one spray into each nostril (27.5 μg per spray) once daily in the morning for 2 weeks.
Mean Change From Baseline in the Total Ocular Symptom Score (TOSS) Over the Entire Treatment Period, at Week 1, and at Week 2 Week 2, n= 131, 128	-0.39 Scores on a scale Standard Error 0.10	-0.61 Scores on a scale Standard Error 0.10
Mean Change From Baseline in the Total Ocular Symptom Score (TOSS) Over the Entire Treatment Period, at Week 1, and at Week 2 Entire Treatment Period, n=131, 130	-0.32 Scores on a scale Standard Error 0.09	-0.46 Scores on a scale Standard Error 0.09
Mean Change From Baseline in the Total Ocular Symptom Score (TOSS) Over the Entire Treatment Period, at Week 1, and at Week 2 Week 1, n=131, 130	-0.22 Scores on a scale Standard Error 0.09	-0.31 Scores on a scale Standard Error 0.09

SECONDARY outcome

Timeframe: Baseline through the entire treatment period (2 weeks), Week 1, and Week 2

Population: FAS. Only those participants with BL TOSS \>0 who were available for assessment at both BL and the indicated assessment period were analyzed. Participants were analyzed for the entire treatment period if they had an assessment on any day during Week 1 and Week 2. Analysis was based on an ANCOVA with a model adjusting for Treatment, BL, Age, and Sex.

Outcome measures

Outcome measures
Measure	Placebo n=92 Participants Matching placebo nasal spray was administered as one spray into each nostril once daily in the morning for 2 weeks.	Fluticasone Furoate 55 µg Per Day n=99 Participants Fluticasone furoate nasal spray (55 micrograms \[µg\] per day) was administered as one spray into each nostril (27.5 μg per spray) once daily in the morning for 2 weeks.
Mean Change From Baseline (BL) in the Total Ocular Symptom Score (TOSS) for the Baseline TOSS >0 Over the Entire Treatment Period, at Week 1, and at Week 2 Entire Treatment Period, n=99, 92	-0.47 Scores on a scale Standard Error 0.11	-0.77 Scores on a scale Standard Error 0.11
Mean Change From Baseline (BL) in the Total Ocular Symptom Score (TOSS) for the Baseline TOSS >0 Over the Entire Treatment Period, at Week 1, and at Week 2 Week 1, n=99, 92	-0.35 Scores on a scale Standard Error 0.11	-0.56 Scores on a scale Standard Error 0.11
Mean Change From Baseline (BL) in the Total Ocular Symptom Score (TOSS) for the Baseline TOSS >0 Over the Entire Treatment Period, at Week 1, and at Week 2 Week 2, n= 99, 90	-0.56 Scores on a scale Standard Error 0.13	-0.99 Scores on a scale Standard Error 0.13

SECONDARY outcome

Timeframe: Baseline through the entire treatment period (2 weeks), Week 1, and Week 2

Symptoms of eye itching, tearing, and redness were scored by the participant's (par.) parent/guardian who signed the ICF or the par. themself using a scale of 0, 1, 2, or 3 (a larger score indicates more severe symptoms) and were recorded in the par.'s diary. The TOSS is the sum of all 3 symptom scores and ranges from 0 to 9. The mean of the BL period is defined as the mean score of 4 consecutive days prior to Visit 2 (start of the treatment period). The mean of each assessment period is defined as the mean score of the entire treatment period (Weeks 1 and 2), Week 1, and Week 2. For each assessment period, a mean score for each par. was calculated using available diary data from the assessment periods, taking the average of non-missing data during the period. Percent change from BL=(mean score at post-BL assessment minus score at BL) divided by the BL value \* 100. Par. with a BL TOSS of 0 were not analyzed because percent change from BL could not be calculated.

Outcome measures

Outcome measures
Measure	Placebo n=92 Participants Matching placebo nasal spray was administered as one spray into each nostril once daily in the morning for 2 weeks.	Fluticasone Furoate 55 µg Per Day n=99 Participants Fluticasone furoate nasal spray (55 micrograms \[µg\] per day) was administered as one spray into each nostril (27.5 μg per spray) once daily in the morning for 2 weeks.
Mean Percent Change From Baseline (BL) in the TOSS Over the Entire Treatment Period, at Week 1, and at Week 2 Entire Treatment Period, n=99, 92	1.57 Percent change Standard Error 11.64	-20.97 Percent change Standard Error 11.39
Mean Percent Change From Baseline (BL) in the TOSS Over the Entire Treatment Period, at Week 1, and at Week 2 Week 1, n=99, 92	5.37 Percent change Standard Error 11.14	-9.20 Percent change Standard Error 10.90
Mean Percent Change From Baseline (BL) in the TOSS Over the Entire Treatment Period, at Week 1, and at Week 2 Week 2, n= 99, 90	-1.70 Percent change Standard Error 13.69	-33.52 Percent change Standard Error 13.27

SECONDARY outcome

Timeframe: Baseline through the entire treatment period (2 weeks), Week 1, and Week 2

Outcome measures

Outcome measures
Measure	Placebo n=92 Participants Matching placebo nasal spray was administered as one spray into each nostril once daily in the morning for 2 weeks.	Fluticasone Furoate 55 µg Per Day n=99 Participants Fluticasone furoate nasal spray (55 micrograms \[µg\] per day) was administered as one spray into each nostril (27.5 μg per spray) once daily in the morning for 2 weeks.
Mean Percent Change From Baseline (BL) in the TOSS for the Baseline TOSS >0 Over the Entire Treatment Period, at Week 1, and at Week 2 Entire Treatment Period, n=99, 92	1.57 Percent change Standard Error 11.64	-20.97 Percent change Standard Error 11.39
Mean Percent Change From Baseline (BL) in the TOSS for the Baseline TOSS >0 Over the Entire Treatment Period, at Week 1, and at Week 2 Week 1, n=99, 92	5.37 Percent change Standard Error 11.14	-9.20 Percent change Standard Error 10.90
Mean Percent Change From Baseline (BL) in the TOSS for the Baseline TOSS >0 Over the Entire Treatment Period, at Week 1, and at Week 2 Week 2, n=99, 90	-1.70 Percent change Standard Error 13.69	-33.52 Percent change Standard Error 13.27

SECONDARY outcome

Timeframe: Baseline through the entire treatment period (2 weeks), Week 1, and Week 2

Symptoms of eye itching, tearing, and redness were scored by the participant's parent/guardian who signed the ICF or the participant themself using a scale of 0, 1, 2, or 3 (a larger score indicates more severe symptoms) and were recorded in the participant's diary. The mean of the Baseline period is defined as the mean score of 4 consecutive days prior to Visit 2 (start of the treatment period). The mean of each assessment period is defined as the mean score of the entire treatment period (Weeks 1 and 2), Week 1, and Week 2. For each assessment period, a mean score for each participant was calculated using available diary data from the assessment periods, taking the average of non-missing data during the period. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.

Outcome measures

Outcome measures
Measure	Placebo n=130 Participants Matching placebo nasal spray was administered as one spray into each nostril once daily in the morning for 2 weeks.	Fluticasone Furoate 55 µg Per Day n=131 Participants Fluticasone furoate nasal spray (55 micrograms \[µg\] per day) was administered as one spray into each nostril (27.5 μg per spray) once daily in the morning for 2 weeks.
Mean Change From Baseline in the Individual Ocular Symptom Scores (Eye Itching, Tearing, and Redness) Over the Entire Treatment Period, at Week 1, and at Week 2 Eye itching, Entire Treatment Period, n=131, 130	-0.18 Scores on a scale Standard Error 0.04	-0.24 Scores on a scale Standard Error 0.04
Mean Change From Baseline in the Individual Ocular Symptom Scores (Eye Itching, Tearing, and Redness) Over the Entire Treatment Period, at Week 1, and at Week 2 Eye itching, Week 1, n=131, 130	-0.13 Scores on a scale Standard Error 0.04	-0.15 Scores on a scale Standard Error 0.04
Mean Change From Baseline in the Individual Ocular Symptom Scores (Eye Itching, Tearing, and Redness) Over the Entire Treatment Period, at Week 1, and at Week 2 Eye itching Week 2, n=131, 128	-0.23 Scores on a scale Standard Error 0.05	-0.34 Scores on a scale Standard Error 0.05
Mean Change From Baseline in the Individual Ocular Symptom Scores (Eye Itching, Tearing, and Redness) Over the Entire Treatment Period, at Week 1, and at Week 2 Tearing, Entire Treatment Period, n=131, 130	-0.05 Scores on a scale Standard Error 0.03	-0.10 Scores on a scale Standard Error 0.03
Mean Change From Baseline in the Individual Ocular Symptom Scores (Eye Itching, Tearing, and Redness) Over the Entire Treatment Period, at Week 1, and at Week 2 Tearing, Week 1, n=131, 130	-0.03 Scores on a scale Standard Error 0.03	-0.09 Scores on a scale Standard Error 0.03
Mean Change From Baseline in the Individual Ocular Symptom Scores (Eye Itching, Tearing, and Redness) Over the Entire Treatment Period, at Week 1, and at Week 2 Tearing, Week 2, n=131, 128	-0.07 Scores on a scale Standard Error 0.03	-0.11 Scores on a scale Standard Error 0.03
Mean Change From Baseline in the Individual Ocular Symptom Scores (Eye Itching, Tearing, and Redness) Over the Entire Treatment Period, at Week 1, and at Week 2 Redness, Entire Treatment Period, n=131, 130	-0.09 Scores on a scale Standard Error 0.03	-0.11 Scores on a scale Standard Error 0.03
Mean Change From Baseline in the Individual Ocular Symptom Scores (Eye Itching, Tearing, and Redness) Over the Entire Treatment Period, at Week 1, and at Week 2 Redness, Week 1, n=131, 130	-0.07 Scores on a scale Standard Error 0.03	-0.07 Scores on a scale Standard Error 0.03
Mean Change From Baseline in the Individual Ocular Symptom Scores (Eye Itching, Tearing, and Redness) Over the Entire Treatment Period, at Week 1, and at Week 2 Redness, Week 2, n=130, 128	-0.10 Scores on a scale Standard Error 0.04	-0.16 Scores on a scale Standard Error 0.04

SECONDARY outcome

Timeframe: Baseline through the entire treatment period (2 weeks), Week 1, and Week 2

The participant's parent/guardian who signed the ICF or the participant themself scored the participant's troubles with daily life once daily using the following scale: 0, None; 1, Few troubles; 2, Intermediate between 3 and 1; or 3, Painful and complicating daily life. The mean of the Baseline period is defined as the mean score of 4 consecutive days prior to Visit 2 (start of the treatment period). The mean of each assessment period is defined as the mean score of the entire treatment period (Weeks 1 and 2), Week 1, and Week 2. For each assessment period, a mean score for each participant was calculated using available diary data from the assessment periods, taking the average of non-missing data during the period. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.

Outcome measures

Outcome measures
Measure	Placebo n=130 Participants Matching placebo nasal spray was administered as one spray into each nostril once daily in the morning for 2 weeks.	Fluticasone Furoate 55 µg Per Day n=131 Participants Fluticasone furoate nasal spray (55 micrograms \[µg\] per day) was administered as one spray into each nostril (27.5 μg per spray) once daily in the morning for 2 weeks.
Mean Change From Baseline in the Score of Troubles With Daily Life Over the Entire Treatment Period, at Week 1, and at Week 2 Entire Treatment Period, n=131, 130	-0.13 Scores on a scale Standard Error 0.04	-0.43 Scores on a scale Standard Error 0.04
Mean Change From Baseline in the Score of Troubles With Daily Life Over the Entire Treatment Period, at Week 1, and at Week 2 Week 1, n=131, 130	-0.10 Scores on a scale Standard Error 0.04	-0.33 Scores on a scale Standard Error 0.04
Mean Change From Baseline in the Score of Troubles With Daily Life Over the Entire Treatment Period, at Week 1, and at Week 2 Week 2, n=131, 128	-0.16 Scores on a scale Standard Error 0.05	-0.53 Scores on a scale Standard Error 0.05

SECONDARY outcome

Timeframe: Baseline, Week 1, and Week 2/Early Withdrawal (EW)

Population: FAS. Participants who were withdrawn before Visit 3 (Week 1) were not included in the analysis for Week 1.

Rhinoscopy was assessed by the investigator by scoring swelling of inferior turbinate mucosa (SOITM) scored as 0 (none), 1 (possible to see center of the middle turbinate), 2 (between 3 and 1), or 3 (impossible to see middle turbinate); color of inferior turbinate mucosa (COITM) scored as 0 (normal), 1 (pink), 2 (red), or 3 (pale); quantity of nasal discharge (QTND) scored as 0 (none), 1 (small amount adhered), 2 (between 3 and 1), or 3 (filled); and quality of nasal discharge (QLND) scored as 0 (none), 1 (pyoid), 2 (viscous), or 3 (watery).

Outcome measures

Outcome measures
Measure	Placebo n=130 Participants Matching placebo nasal spray was administered as one spray into each nostril once daily in the morning for 2 weeks.	Fluticasone Furoate 55 µg Per Day n=131 Participants Fluticasone furoate nasal spray (55 micrograms \[µg\] per day) was administered as one spray into each nostril (27.5 μg per spray) once daily in the morning for 2 weeks.
Number of Participants With the Indicated Scores for Rhinoscopy Findings (Swelling of Inferior Turbinate Mucosa, Color of Inferior Turbinate Mucosa, Quantity of Nasal Discharge, and Quality of Nasal Discharge) at Baseline, Week 1, and Week 2/EW SOITM, Week 1, Score 2, n=131, 128	44 participants	53 participants
Number of Participants With the Indicated Scores for Rhinoscopy Findings (Swelling of Inferior Turbinate Mucosa, Color of Inferior Turbinate Mucosa, Quantity of Nasal Discharge, and Quality of Nasal Discharge) at Baseline, Week 1, and Week 2/EW SOITM, Week 1, Score 3, n=131, 128	24 participants	24 participants
Number of Participants With the Indicated Scores for Rhinoscopy Findings (Swelling of Inferior Turbinate Mucosa, Color of Inferior Turbinate Mucosa, Quantity of Nasal Discharge, and Quality of Nasal Discharge) at Baseline, Week 1, and Week 2/EW SOITM, Week 2/EW, Score 0, n=131, 130	19 participants	19 participants
Number of Participants With the Indicated Scores for Rhinoscopy Findings (Swelling of Inferior Turbinate Mucosa, Color of Inferior Turbinate Mucosa, Quantity of Nasal Discharge, and Quality of Nasal Discharge) at Baseline, Week 1, and Week 2/EW SOITM, Week 2/EW, Score 1, n=131, 130	45 participants	62 participants
Number of Participants With the Indicated Scores for Rhinoscopy Findings (Swelling of Inferior Turbinate Mucosa, Color of Inferior Turbinate Mucosa, Quantity of Nasal Discharge, and Quality of Nasal Discharge) at Baseline, Week 1, and Week 2/EW SOITM, Week 2/EW, Score 2, n=131, 130	42 participants	37 participants
Number of Participants With the Indicated Scores for Rhinoscopy Findings (Swelling of Inferior Turbinate Mucosa, Color of Inferior Turbinate Mucosa, Quantity of Nasal Discharge, and Quality of Nasal Discharge) at Baseline, Week 1, and Week 2/EW QLND, Baseline, Score 0, n=131, 130	6 participants	9 participants
Number of Participants With the Indicated Scores for Rhinoscopy Findings (Swelling of Inferior Turbinate Mucosa, Color of Inferior Turbinate Mucosa, Quantity of Nasal Discharge, and Quality of Nasal Discharge) at Baseline, Week 1, and Week 2/EW QLND, Baseline, Score 1, n=131, 130	0 participants	0 participants
Number of Participants With the Indicated Scores for Rhinoscopy Findings (Swelling of Inferior Turbinate Mucosa, Color of Inferior Turbinate Mucosa, Quantity of Nasal Discharge, and Quality of Nasal Discharge) at Baseline, Week 1, and Week 2/EW SOITM, Week 2/EW, Score 3, n=131, 130	24 participants	13 participants
Number of Participants With the Indicated Scores for Rhinoscopy Findings (Swelling of Inferior Turbinate Mucosa, Color of Inferior Turbinate Mucosa, Quantity of Nasal Discharge, and Quality of Nasal Discharge) at Baseline, Week 1, and Week 2/EW COITM, Baseline, Score 0, n=131, 130	2 participants	2 participants
Number of Participants With the Indicated Scores for Rhinoscopy Findings (Swelling of Inferior Turbinate Mucosa, Color of Inferior Turbinate Mucosa, Quantity of Nasal Discharge, and Quality of Nasal Discharge) at Baseline, Week 1, and Week 2/EW COITM, Baseline, Score 1, n=131, 130	31 participants	13 participants
Number of Participants With the Indicated Scores for Rhinoscopy Findings (Swelling of Inferior Turbinate Mucosa, Color of Inferior Turbinate Mucosa, Quantity of Nasal Discharge, and Quality of Nasal Discharge) at Baseline, Week 1, and Week 2/EW COITM, Baseline, Score 2, n=131, 130	29 participants	28 participants
Number of Participants With the Indicated Scores for Rhinoscopy Findings (Swelling of Inferior Turbinate Mucosa, Color of Inferior Turbinate Mucosa, Quantity of Nasal Discharge, and Quality of Nasal Discharge) at Baseline, Week 1, and Week 2/EW COITM, Baseline, Score 3, n=131, 130	68 participants	88 participants
Number of Participants With the Indicated Scores for Rhinoscopy Findings (Swelling of Inferior Turbinate Mucosa, Color of Inferior Turbinate Mucosa, Quantity of Nasal Discharge, and Quality of Nasal Discharge) at Baseline, Week 1, and Week 2/EW COITM, Week 1, Score 0, n= 131, 128	2 participants	5 participants
Number of Participants With the Indicated Scores for Rhinoscopy Findings (Swelling of Inferior Turbinate Mucosa, Color of Inferior Turbinate Mucosa, Quantity of Nasal Discharge, and Quality of Nasal Discharge) at Baseline, Week 1, and Week 2/EW COITM, Week 1, Score 1, n= 131, 128	43 participants	45 participants
Number of Participants With the Indicated Scores for Rhinoscopy Findings (Swelling of Inferior Turbinate Mucosa, Color of Inferior Turbinate Mucosa, Quantity of Nasal Discharge, and Quality of Nasal Discharge) at Baseline, Week 1, and Week 2/EW COITM, Week 1, Score 2, n= 131, 128	27 participants	23 participants
Number of Participants With the Indicated Scores for Rhinoscopy Findings (Swelling of Inferior Turbinate Mucosa, Color of Inferior Turbinate Mucosa, Quantity of Nasal Discharge, and Quality of Nasal Discharge) at Baseline, Week 1, and Week 2/EW COITM, Week 1, Score 3, n= 131, 128	56 participants	58 participants
Number of Participants With the Indicated Scores for Rhinoscopy Findings (Swelling of Inferior Turbinate Mucosa, Color of Inferior Turbinate Mucosa, Quantity of Nasal Discharge, and Quality of Nasal Discharge) at Baseline, Week 1, and Week 2/EW COITM, Week 2/EW, Score 0, n=131, 130	10 participants	7 participants
Number of Participants With the Indicated Scores for Rhinoscopy Findings (Swelling of Inferior Turbinate Mucosa, Color of Inferior Turbinate Mucosa, Quantity of Nasal Discharge, and Quality of Nasal Discharge) at Baseline, Week 1, and Week 2/EW COITM, Week 2/EW, Score 1, n=131, 130	51 participants	68 participants
Number of Participants With the Indicated Scores for Rhinoscopy Findings (Swelling of Inferior Turbinate Mucosa, Color of Inferior Turbinate Mucosa, Quantity of Nasal Discharge, and Quality of Nasal Discharge) at Baseline, Week 1, and Week 2/EW COITM, Week 2/EW, Score 2, n=131, 130	20 participants	17 participants
Number of Participants With the Indicated Scores for Rhinoscopy Findings (Swelling of Inferior Turbinate Mucosa, Color of Inferior Turbinate Mucosa, Quantity of Nasal Discharge, and Quality of Nasal Discharge) at Baseline, Week 1, and Week 2/EW COITM, Week 2/EW, Score 3, n=131, 130	49 participants	39 participants
Number of Participants With the Indicated Scores for Rhinoscopy Findings (Swelling of Inferior Turbinate Mucosa, Color of Inferior Turbinate Mucosa, Quantity of Nasal Discharge, and Quality of Nasal Discharge) at Baseline, Week 1, and Week 2/EW QTND, Baseline, Score 0, n=131, 130	6 participants	8 participants
Number of Participants With the Indicated Scores for Rhinoscopy Findings (Swelling of Inferior Turbinate Mucosa, Color of Inferior Turbinate Mucosa, Quantity of Nasal Discharge, and Quality of Nasal Discharge) at Baseline, Week 1, and Week 2/EW QTND, Baseline, Score 1, n=131, 130	53 participants	52 participants
Number of Participants With the Indicated Scores for Rhinoscopy Findings (Swelling of Inferior Turbinate Mucosa, Color of Inferior Turbinate Mucosa, Quantity of Nasal Discharge, and Quality of Nasal Discharge) at Baseline, Week 1, and Week 2/EW QTND, Baseline, Score 2, n=131, 130	63 participants	60 participants
Number of Participants With the Indicated Scores for Rhinoscopy Findings (Swelling of Inferior Turbinate Mucosa, Color of Inferior Turbinate Mucosa, Quantity of Nasal Discharge, and Quality of Nasal Discharge) at Baseline, Week 1, and Week 2/EW QTND, Baseline, Score 3, n=131, 130	8 participants	11 participants
Number of Participants With the Indicated Scores for Rhinoscopy Findings (Swelling of Inferior Turbinate Mucosa, Color of Inferior Turbinate Mucosa, Quantity of Nasal Discharge, and Quality of Nasal Discharge) at Baseline, Week 1, and Week 2/EW QTND, Week 1, Score 0, n= 131, 128	18 participants	38 participants
Number of Participants With the Indicated Scores for Rhinoscopy Findings (Swelling of Inferior Turbinate Mucosa, Color of Inferior Turbinate Mucosa, Quantity of Nasal Discharge, and Quality of Nasal Discharge) at Baseline, Week 1, and Week 2/EW QTND, Week 1, Score 1, n= 131, 128	62 participants	57 participants
Number of Participants With the Indicated Scores for Rhinoscopy Findings (Swelling of Inferior Turbinate Mucosa, Color of Inferior Turbinate Mucosa, Quantity of Nasal Discharge, and Quality of Nasal Discharge) at Baseline, Week 1, and Week 2/EW QTND, Week 1, Score 2, n= 131, 128	42 participants	32 participants
Number of Participants With the Indicated Scores for Rhinoscopy Findings (Swelling of Inferior Turbinate Mucosa, Color of Inferior Turbinate Mucosa, Quantity of Nasal Discharge, and Quality of Nasal Discharge) at Baseline, Week 1, and Week 2/EW QTND, Week 1, Score 3, n= 131, 128	6 participants	4 participants
Number of Participants With the Indicated Scores for Rhinoscopy Findings (Swelling of Inferior Turbinate Mucosa, Color of Inferior Turbinate Mucosa, Quantity of Nasal Discharge, and Quality of Nasal Discharge) at Baseline, Week 1, and Week 2/EW QTND, Week 2/EW, Score 0, n=131, 130	37 participants	63 participants
Number of Participants With the Indicated Scores for Rhinoscopy Findings (Swelling of Inferior Turbinate Mucosa, Color of Inferior Turbinate Mucosa, Quantity of Nasal Discharge, and Quality of Nasal Discharge) at Baseline, Week 1, and Week 2/EW QTND, Week 2/EW, Score 1, n=131, 130	57 participants	49 participants
Number of Participants With the Indicated Scores for Rhinoscopy Findings (Swelling of Inferior Turbinate Mucosa, Color of Inferior Turbinate Mucosa, Quantity of Nasal Discharge, and Quality of Nasal Discharge) at Baseline, Week 1, and Week 2/EW QTND, Week 2/EW, Score 2, n=131, 130	31 participants	18 participants
Number of Participants With the Indicated Scores for Rhinoscopy Findings (Swelling of Inferior Turbinate Mucosa, Color of Inferior Turbinate Mucosa, Quantity of Nasal Discharge, and Quality of Nasal Discharge) at Baseline, Week 1, and Week 2/EW QTND, Week 2/EW, Score 3, n=131, 130	5 participants	1 participants
Number of Participants With the Indicated Scores for Rhinoscopy Findings (Swelling of Inferior Turbinate Mucosa, Color of Inferior Turbinate Mucosa, Quantity of Nasal Discharge, and Quality of Nasal Discharge) at Baseline, Week 1, and Week 2/EW SOITM, Baseline, Score 0, n=131, 130	7 participants	2 participants
Number of Participants With the Indicated Scores for Rhinoscopy Findings (Swelling of Inferior Turbinate Mucosa, Color of Inferior Turbinate Mucosa, Quantity of Nasal Discharge, and Quality of Nasal Discharge) at Baseline, Week 1, and Week 2/EW SOITM, Baseline, Score 1, n=131, 130	32 participants	24 participants
Number of Participants With the Indicated Scores for Rhinoscopy Findings (Swelling of Inferior Turbinate Mucosa, Color of Inferior Turbinate Mucosa, Quantity of Nasal Discharge, and Quality of Nasal Discharge) at Baseline, Week 1, and Week 2/EW SOITM, Baseline, Score 2, n=131, 130	55 participants	54 participants
Number of Participants With the Indicated Scores for Rhinoscopy Findings (Swelling of Inferior Turbinate Mucosa, Color of Inferior Turbinate Mucosa, Quantity of Nasal Discharge, and Quality of Nasal Discharge) at Baseline, Week 1, and Week 2/EW SOITM, Baseline, Score 3, n=131, 130	36 participants	51 participants
Number of Participants With the Indicated Scores for Rhinoscopy Findings (Swelling of Inferior Turbinate Mucosa, Color of Inferior Turbinate Mucosa, Quantity of Nasal Discharge, and Quality of Nasal Discharge) at Baseline, Week 1, and Week 2/EW SOITM, Week 1, Score 0, n=131, 128	5 participants	9 participants
Number of Participants With the Indicated Scores for Rhinoscopy Findings (Swelling of Inferior Turbinate Mucosa, Color of Inferior Turbinate Mucosa, Quantity of Nasal Discharge, and Quality of Nasal Discharge) at Baseline, Week 1, and Week 2/EW SOITM, Week 1, Score 1, n=131, 128	55 participants	45 participants
Number of Participants With the Indicated Scores for Rhinoscopy Findings (Swelling of Inferior Turbinate Mucosa, Color of Inferior Turbinate Mucosa, Quantity of Nasal Discharge, and Quality of Nasal Discharge) at Baseline, Week 1, and Week 2/EW QLND, Baseline, Score 2, n=131, 130	27 participants	29 participants
Number of Participants With the Indicated Scores for Rhinoscopy Findings (Swelling of Inferior Turbinate Mucosa, Color of Inferior Turbinate Mucosa, Quantity of Nasal Discharge, and Quality of Nasal Discharge) at Baseline, Week 1, and Week 2/EW QLND, Baseline, Score 3, n=131, 130	97 participants	93 participants
Number of Participants With the Indicated Scores for Rhinoscopy Findings (Swelling of Inferior Turbinate Mucosa, Color of Inferior Turbinate Mucosa, Quantity of Nasal Discharge, and Quality of Nasal Discharge) at Baseline, Week 1, and Week 2/EW QLND, Week 1, Score 0, n= 131, 128	18 participants	39 participants
Number of Participants With the Indicated Scores for Rhinoscopy Findings (Swelling of Inferior Turbinate Mucosa, Color of Inferior Turbinate Mucosa, Quantity of Nasal Discharge, and Quality of Nasal Discharge) at Baseline, Week 1, and Week 2/EW QLND, Week 1, Score 1, n= 131, 128	5 participants	2 participants
Number of Participants With the Indicated Scores for Rhinoscopy Findings (Swelling of Inferior Turbinate Mucosa, Color of Inferior Turbinate Mucosa, Quantity of Nasal Discharge, and Quality of Nasal Discharge) at Baseline, Week 1, and Week 2/EW QLND, Week 1, Score 2, n= 131, 128	27 participants	24 participants
Number of Participants With the Indicated Scores for Rhinoscopy Findings (Swelling of Inferior Turbinate Mucosa, Color of Inferior Turbinate Mucosa, Quantity of Nasal Discharge, and Quality of Nasal Discharge) at Baseline, Week 1, and Week 2/EW QLND, Week 1, Score 3, n= 131, 128	78 participants	66 participants
Number of Participants With the Indicated Scores for Rhinoscopy Findings (Swelling of Inferior Turbinate Mucosa, Color of Inferior Turbinate Mucosa, Quantity of Nasal Discharge, and Quality of Nasal Discharge) at Baseline, Week 1, and Week 2/EW QLND, Week 2/EW, Score 0, n=131, 130	33 participants	62 participants
Number of Participants With the Indicated Scores for Rhinoscopy Findings (Swelling of Inferior Turbinate Mucosa, Color of Inferior Turbinate Mucosa, Quantity of Nasal Discharge, and Quality of Nasal Discharge) at Baseline, Week 1, and Week 2/EW QLND, Week 2/EW, Score 1, n=131, 130	3 participants	3 participants
Number of Participants With the Indicated Scores for Rhinoscopy Findings (Swelling of Inferior Turbinate Mucosa, Color of Inferior Turbinate Mucosa, Quantity of Nasal Discharge, and Quality of Nasal Discharge) at Baseline, Week 1, and Week 2/EW QLND, Week 2/EW, Score 2, n=131, 130	29 participants	26 participants
Number of Participants With the Indicated Scores for Rhinoscopy Findings (Swelling of Inferior Turbinate Mucosa, Color of Inferior Turbinate Mucosa, Quantity of Nasal Discharge, and Quality of Nasal Discharge) at Baseline, Week 1, and Week 2/EW QLND, Week 2/EW, Score 3, n=131, 130	65 participants	40 participants

SECONDARY outcome

Timeframe: Week 2/EW

Population: FAS

The investigator evaluated the participant's overall response to therapy (defined as improvement in the symptoms of allergic rhinitis) compared with Visit 2 (start of the treatment period), using the following 7-point categorical scale: 1=significantly improved, 2=moderately improved, 3=mildly improved, 4=no change, 5=mildly worse, 6=moderately worse, and 7=significantly worse.

Outcome measures

Outcome measures
Measure	Placebo n=130 Participants Matching placebo nasal spray was administered as one spray into each nostril once daily in the morning for 2 weeks.	Fluticasone Furoate 55 µg Per Day n=131 Participants Fluticasone furoate nasal spray (55 micrograms \[µg\] per day) was administered as one spray into each nostril (27.5 μg per spray) once daily in the morning for 2 weeks.
Number of Participants With the Indicated Overall Response to Therapy, as Assessed by the Investigator Significantly improved	12 participants	32 participants
Number of Participants With the Indicated Overall Response to Therapy, as Assessed by the Investigator Moderately improved	25 participants	38 participants
Number of Participants With the Indicated Overall Response to Therapy, as Assessed by the Investigator Mildly improved	31 participants	36 participants
Number of Participants With the Indicated Overall Response to Therapy, as Assessed by the Investigator No change	54 participants	22 participants
Number of Participants With the Indicated Overall Response to Therapy, as Assessed by the Investigator Mildly worse	5 participants	1 participants
Number of Participants With the Indicated Overall Response to Therapy, as Assessed by the Investigator Moderately worse	2 participants	2 participants
Number of Participants With the Indicated Overall Response to Therapy, as Assessed by the Investigator Significantly worse	1 participants	0 participants

SECONDARY outcome

Timeframe: Week 2/EW

Population: FAS

The participant's parent/guardian who signed the ICF or the participant themself evaluated the participant's overall response to therapy (defined as improvement in the symptoms of allergic rhinitis) compared with Visit 2 (start of the treatment period), using the following 7-point categorical scale: 1=significantly improved, 2=moderately improved, 3=mildly improved, 4=no change, 5=mildly worse, 6=moderately worse, and 7=significantly worse.

Outcome measures

Outcome measures
Measure	Placebo n=130 Participants Matching placebo nasal spray was administered as one spray into each nostril once daily in the morning for 2 weeks.	Fluticasone Furoate 55 µg Per Day n=131 Participants Fluticasone furoate nasal spray (55 micrograms \[µg\] per day) was administered as one spray into each nostril (27.5 μg per spray) once daily in the morning for 2 weeks.
Number of Participants With the Indicated Overall Response to Therapy, as Assessed by the Participant's Parent/Guardian or the Participant Significantly improved	2 participants	28 participants
Number of Participants With the Indicated Overall Response to Therapy, as Assessed by the Participant's Parent/Guardian or the Participant Moderately improved	26 participants	51 participants
Number of Participants With the Indicated Overall Response to Therapy, as Assessed by the Participant's Parent/Guardian or the Participant Mildly improved	48 participants	34 participants
Number of Participants With the Indicated Overall Response to Therapy, as Assessed by the Participant's Parent/Guardian or the Participant No change	51 participants	18 participants
Number of Participants With the Indicated Overall Response to Therapy, as Assessed by the Participant's Parent/Guardian or the Participant Mildly worse	3 participants	0 participants
Number of Participants With the Indicated Overall Response to Therapy, as Assessed by the Participant's Parent/Guardian or the Participant Moderately worse	0 participants	0 participants
Number of Participants With the Indicated Overall Response to Therapy, as Assessed by the Participant's Parent/Guardian or the Participant Significantly worse	0 participants	0 participants

Adverse Events

Fluticasone Furoate 55 µg Per Day

Serious events: 0 serious events

Other events: 23 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 25 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

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