Trial Outcomes & Findings for Study FFR116365, an Open-label Study of GW685698X in Paediatric Subjects With Perennial Allergic Rhinitis (NCT NCT01622231)

Last Updated: 2017-01-09

Results Overview

An AE is defined as 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. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, is an other important medical event, or is an event of possible drug-induced liver injury. Refer to the general AE/SAE module for a list of AEs (occurring at a frequency threshold \>=5%) and SAEs.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

61 participants

Primary outcome timeframe

From the start of study treatment (Visit 2) until follow-up contact (Visit 6) (up to 13 weeks)

Results posted on

2017-01-09

Participant Flow

Participants who met the inclusion criteria at Visit 1/1A entered a Screening Period (Visit 1 to 2). Participants who met the eligibility criteria for randomization entered the Treatment Period (Visit 2 to 5), during which they received GW685698X 55 micrograms (µg) once daily (QD) for a period of 12 weeks.

Participant milestones

Participant milestones
Measure	GW685698X 55 μg QD Participants received GW685698X nasal spray (55 micrograms \[µg\]) as one spray into each nostril (27.5 μg per spray) once daily (QD) in the morning for 12 weeks.
Overall Study STARTED	61
Overall Study COMPLETED	59
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	GW685698X 55 μg QD Participants received GW685698X nasal spray (55 micrograms \[µg\]) as one spray into each nostril (27.5 μg per spray) once daily (QD) in the morning for 12 weeks.
Overall Study Physician Decision	1
Overall Study Withdrawal by Subject	1

Baseline Characteristics

Study FFR116365, an Open-label Study of GW685698X in Paediatric Subjects With Perennial Allergic Rhinitis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	GW685698X 55 μg QD n=61 Participants Participants received GW685698X nasal spray (55 micrograms \[µg\]) as one spray into each nostril (27.5 μg per spray) once daily (QD) in the morning for 12 weeks.
Age, Continuous	8.0 Years STANDARD_DEVIATION 3.59 • n=5 Participants
Gender Female	19 Participants n=5 Participants
Gender Male	42 Participants n=5 Participants
Race/Ethnicity, Customized Asian - Japanese Heritage	61 participants n=5 Participants

PRIMARY outcome

Timeframe: From the start of study treatment (Visit 2) until follow-up contact (Visit 6) (up to 13 weeks)

Population: Safety Population: all participants who received at least one dose of medication

Outcome measures

Outcome measures
Measure	GW685698X 55 μg QD n=61 Participants Participants received GW685698X nasal spray (55 micrograms \[µg\]) as one spray into each nostril (27.5 μg per spray) once daily (QD) in the morning for 12 weeks.
Number of Participants With Any Non-serious Adverse Event (AE) and Any Serious Adverse Event (SAE) Any AE	41 participants
Number of Participants With Any Non-serious Adverse Event (AE) and Any Serious Adverse Event (SAE) Any SAE	0 participants

SECONDARY outcome

Timeframe: Baseline, Week 4, and Week 12/Early Withdrawal

Population: Safety Population. Only those participants available at the indicated time points were assessed.

Change from Baseline was calculated as the value at the post-Baseline time points minus the value at Baseline. Basophils, eosinophils, lymphocytes, monocytes, and total neutrophil counts are measured as the percentage of cells in white blood cells.

Outcome measures

Outcome measures
Measure	GW685698X 55 μg QD n=61 Participants Participants received GW685698X nasal spray (55 micrograms \[µg\]) as one spray into each nostril (27.5 μg per spray) once daily (QD) in the morning for 12 weeks.
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophil Count at Week 4 and Week 12/Early Withdrawal Basophils, Week 4, n=60	-0.08 Percentage of cells Standard Deviation 0.353
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophil Count at Week 4 and Week 12/Early Withdrawal Basophils, Week 12/early withdrawal, n=61	-0.12 Percentage of cells Standard Deviation 0.356
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophil Count at Week 4 and Week 12/Early Withdrawal Eosinophils, Week 4, n=60	-0.29 Percentage of cells Standard Deviation 2.538
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophil Count at Week 4 and Week 12/Early Withdrawal Eosinophils, Week 12/early withdrawal, n=61	-1.38 Percentage of cells Standard Deviation 2.991
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophil Count at Week 4 and Week 12/Early Withdrawal Lymphocytes, Week 4, n=60	-1.22 Percentage of cells Standard Deviation 6.863
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophil Count at Week 4 and Week 12/Early Withdrawal Lymphocytes, Week 12/early withdrawal, n=61	-1.77 Percentage of cells Standard Deviation 8.181
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophil Count at Week 4 and Week 12/Early Withdrawal Monocytes, Week 4, n=60	0.24 Percentage of cells Standard Deviation 1.604
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophil Count at Week 4 and Week 12/Early Withdrawal Monocytes, Week 12/early withdrawal, n=61	0.26 Percentage of cells Standard Deviation 1.714
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophil Count at Week 4 and Week 12/Early Withdrawal Total Neutrophils, Week 4, n=60	1.36 Percentage of cells Standard Deviation 8.355
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophil Count at Week 4 and Week 12/Early Withdrawal Total Neutrophils, Week 12/early withdrawal, n=61	3.02 Percentage of cells Standard Deviation 9.684

SECONDARY outcome

Timeframe: Baseline, Week 4, and Week 12/Early Withdrawal

Population: Safety Population. Only those participants available at the indicated time points were assessed.

Change from Baseline was calculated as the value at the post-Baseline time points minus the value at Baseline.

Outcome measures

Outcome measures
Measure	GW685698X 55 μg QD n=61 Participants Participants received GW685698X nasal spray (55 micrograms \[µg\]) as one spray into each nostril (27.5 μg per spray) once daily (QD) in the morning for 12 weeks.
Change From Baseline in Hemoglobin at Week 4 and Week 12/Early Withdrawal Hemoglobin, Week 4, n=60	-1.9 Grams per liter (grams/L) Standard Deviation 7.34
Change From Baseline in Hemoglobin at Week 4 and Week 12/Early Withdrawal Hemoglobin, Week 12/early withdrawal, n=61	0.1 Grams per liter (grams/L) Standard Deviation 6.09

SECONDARY outcome

Timeframe: Baseline, Week 4, and Week 12/Early Withdrawal

Population: Safety Population. Only those participants available at the indicated time points were assessed.

Change from Baseline was calculated as the value at the post-Baseline time points minus the value at Baseline.

Outcome measures

Outcome measures
Measure	GW685698X 55 μg QD n=61 Participants Participants received GW685698X nasal spray (55 micrograms \[µg\]) as one spray into each nostril (27.5 μg per spray) once daily (QD) in the morning for 12 weeks.
Change From Baseline in Platelet Count and White Blood Cell (WBC) Count at Week 4 and Week 12/Early Withdrawal Platelet count, Week 4, n=60	-0.4 giga (10^9) cells (GI)/L Standard Deviation 54.95
Change From Baseline in Platelet Count and White Blood Cell (WBC) Count at Week 4 and Week 12/Early Withdrawal Platelet count, Week 12/early withdrawal, n=61	-2.9 giga (10^9) cells (GI)/L Standard Deviation 56.26
Change From Baseline in Platelet Count and White Blood Cell (WBC) Count at Week 4 and Week 12/Early Withdrawal WBC count, Week 4, n=60	-0.45 giga (10^9) cells (GI)/L Standard Deviation 1.860
Change From Baseline in Platelet Count and White Blood Cell (WBC) Count at Week 4 and Week 12/Early Withdrawal WBC count, Week 12/early withdrawal, n=61	-0.00 giga (10^9) cells (GI)/L Standard Deviation 2.092

SECONDARY outcome

Timeframe: Baseline, Week 4, and Week 12/Early Withdrawal

Population: Safety Population. Only those participants available at the indicated time points were assessed.

Change from Baseline was calculated as the value at the post-Baseline time points minus the value at Baseline.

Outcome measures

Outcome measures
Measure	GW685698X 55 μg QD n=61 Participants Participants received GW685698X nasal spray (55 micrograms \[µg\]) as one spray into each nostril (27.5 μg per spray) once daily (QD) in the morning for 12 weeks.
Change From Baseline in Red Blood Cell (RBC) Count at Week 4 and Week 12/Early Withdrawal RBC count, Week 4, n=60	-0.081 tera (10^12) cells (TI)/L Standard Deviation 0.2386
Change From Baseline in Red Blood Cell (RBC) Count at Week 4 and Week 12/Early Withdrawal RBC count, Week 12/early withdrawal, n=61	-0.039 tera (10^12) cells (TI)/L Standard Deviation 0.2080

SECONDARY outcome

Timeframe: Baseline, Week 4, and Week 12/Early Withdrawal

Population: Safety Population. Only those participants available at the indicated time points were assessed.

Change from Baseline was calculated as the value at the post-Baseline time points minus the value at Baseline.

Outcome measures

Outcome measures
Measure	GW685698X 55 μg QD n=61 Participants Participants received GW685698X nasal spray (55 micrograms \[µg\]) as one spray into each nostril (27.5 μg per spray) once daily (QD) in the morning for 12 weeks.
Change From Baseline in Hematocrit at Week 4 and Week 12/Early Withdrawal Hematocrit, Week 4, n=60	-0.0061 Proportion of RBCs in blood Standard Deviation 0.01965
Change From Baseline in Hematocrit at Week 4 and Week 12/Early Withdrawal Hematocrit, Week 12/early withdrawal, n=61	-0.0062 Proportion of RBCs in blood Standard Deviation 0.01824

SECONDARY outcome

Timeframe: Baseline, Week 4, and Week 12/Early Withdrawal

Population: Safety Population. Only those participants available at the indicated time points were assessed.

Change from Baseline was calculated as the value at the post-Baseline time points minus the value at Baseline.

Outcome measures

Outcome measures
Measure	GW685698X 55 μg QD n=61 Participants Participants received GW685698X nasal spray (55 micrograms \[µg\]) as one spray into each nostril (27.5 μg per spray) once daily (QD) in the morning for 12 weeks.
Change From Baseline in Albumin and Total Protein at Week 4 and Week 12/Early Withdrawal Albumin, Week 12/early withdrawal, n=61	-0.8 grams/L Standard Deviation 1.93
Change From Baseline in Albumin and Total Protein at Week 4 and Week 12/Early Withdrawal Albumin, Week 4, n=60	-1.4 grams/L Standard Deviation 2.05
Change From Baseline in Albumin and Total Protein at Week 4 and Week 12/Early Withdrawal Total protein, Week 4, n=60	-1.8 grams/L Standard Deviation 3.41
Change From Baseline in Albumin and Total Protein at Week 4 and Week 12/Early Withdrawal Total protein, Week 12/early withdrawal, n=61	-0.9 grams/L Standard Deviation 3.36

SECONDARY outcome

Timeframe: Baseline, Week 4, and Week 12/Early Withdrawal

Population: Safety Population. Only those participants available at the indicated time points were assessed.

Change from Baseline was calculated as the value at the post-Baseline time points minus the value at Baseline.

Outcome measures

Outcome measures
Measure	GW685698X 55 μg QD n=61 Participants Participants received GW685698X nasal spray (55 micrograms \[µg\]) as one spray into each nostril (27.5 μg per spray) once daily (QD) in the morning for 12 weeks.
Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyltransferase (GGT) at Week 4 and Week 12/Early Withdrawal ALP, Week 4, n=60	-49.9 International units (IU)/L Standard Deviation 89.43
Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyltransferase (GGT) at Week 4 and Week 12/Early Withdrawal ALP, Week 12/early withdrawal, n=61	88.5 International units (IU)/L Standard Deviation 586.10
Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyltransferase (GGT) at Week 4 and Week 12/Early Withdrawal ALT, Week 4, n=60	0.7 International units (IU)/L Standard Deviation 4.19
Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyltransferase (GGT) at Week 4 and Week 12/Early Withdrawal ALT, Week 12/early withdrawal, n=61	0.4 International units (IU)/L Standard Deviation 4.72
Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyltransferase (GGT) at Week 4 and Week 12/Early Withdrawal AST, Week 4, n=60	-0.3 International units (IU)/L Standard Deviation 3.45
Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyltransferase (GGT) at Week 4 and Week 12/Early Withdrawal AST, Week 12/early withdrawal, n=61	0.2 International units (IU)/L Standard Deviation 3.39
Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyltransferase (GGT) at Week 4 and Week 12/Early Withdrawal GGT, Week 4, n=60	-0.1 International units (IU)/L Standard Deviation 1.63
Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyltransferase (GGT) at Week 4 and Week 12/Early Withdrawal GGT, Week 12/early withdrawal, n=61	0.1 International units (IU)/L Standard Deviation 1.95

SECONDARY outcome

Timeframe: Baseline, Week 4, and Week 12/Early Withdrawal

Population: Safety Population. Only those participants available at the indicated time points were assessed.

Change from Baseline was calculated as the value at the post-Baseline time points minus the value at Baseline.

Outcome measures

Outcome measures
Measure	GW685698X 55 μg QD n=61 Participants Participants received GW685698X nasal spray (55 micrograms \[µg\]) as one spray into each nostril (27.5 μg per spray) once daily (QD) in the morning for 12 weeks.
Change From Baseline in Direct Bilirubin, Total Bilirubin, and Creatinine at Week 4 and Week 12/Early Withdrawal Direct bilirubin, Week 4, n=60	0.114 Micromoles (μmol)/L Standard Deviation 0.9889
Change From Baseline in Direct Bilirubin, Total Bilirubin, and Creatinine at Week 4 and Week 12/Early Withdrawal Direct bilirubin, Week 12/early withdrawal, n=61	-0.028 Micromoles (μmol)/L Standard Deviation 0.8545
Change From Baseline in Direct Bilirubin, Total Bilirubin, and Creatinine at Week 4 and Week 12/Early Withdrawal Total bilirubin, Week 4, n=60	0.370 Micromoles (μmol)/L Standard Deviation 2.2504
Change From Baseline in Direct Bilirubin, Total Bilirubin, and Creatinine at Week 4 and Week 12/Early Withdrawal Total bilirubin, Week 12/early withdrawal, n=61	-0.533 Micromoles (μmol)/L Standard Deviation 2.2844
Change From Baseline in Direct Bilirubin, Total Bilirubin, and Creatinine at Week 4 and Week 12/Early Withdrawal Creatinine, Week 4, n=60	-1.6649 Micromoles (μmol)/L Standard Deviation 5.21356
Change From Baseline in Direct Bilirubin, Total Bilirubin, and Creatinine at Week 4 and Week 12/Early Withdrawal Creatinine, Week 12/early withdrawal, n=61	-0.5797 Micromoles (μmol)/L Standard Deviation 5.63473

SECONDARY outcome

Timeframe: Baseline, Week 4, and Week 12/Early Withdrawal

Population: Safety Population. Only those participants available at the indicated time points were assessed.

Change from Baseline was calculated as the value at the post-Baseline time points minus the value at Baseline.

Outcome measures

Outcome measures
Measure	GW685698X 55 μg QD n=61 Participants Participants received GW685698X nasal spray (55 micrograms \[µg\]) as one spray into each nostril (27.5 μg per spray) once daily (QD) in the morning for 12 weeks.
Change From Baseline in Calcium, Chloride, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Week 4 and Week 12/Early Withdrawal Calcium, Week 4, n=60	-0.0541 Millimoles (mmol)/L Standard Deviation 0.09085
Change From Baseline in Calcium, Chloride, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Week 4 and Week 12/Early Withdrawal Calcium, Week 12/early withdrawal, n=61	-0.0372 Millimoles (mmol)/L Standard Deviation 0.07480
Change From Baseline in Calcium, Chloride, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Week 4 and Week 12/Early Withdrawal Chloride, Week 4, n=60	1.3 Millimoles (mmol)/L Standard Deviation 2.27
Change From Baseline in Calcium, Chloride, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Week 4 and Week 12/Early Withdrawal Chloride, Week 12/early withdrawal, n=61	1.1 Millimoles (mmol)/L Standard Deviation 2.04
Change From Baseline in Calcium, Chloride, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Week 4 and Week 12/Early Withdrawal Potassium, Week 4, n=60	-0.13 Millimoles (mmol)/L Standard Deviation 0.378
Change From Baseline in Calcium, Chloride, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Week 4 and Week 12/Early Withdrawal Potassium, Week 12/early withdrawal, n=61	-0.06 Millimoles (mmol)/L Standard Deviation 0.380
Change From Baseline in Calcium, Chloride, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Week 4 and Week 12/Early Withdrawal Sodium, Week 4, n=60	-0.4 Millimoles (mmol)/L Standard Deviation 1.70
Change From Baseline in Calcium, Chloride, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Week 4 and Week 12/Early Withdrawal Sodium, Week 12/early withdrawal, n=61	-1.2 Millimoles (mmol)/L Standard Deviation 1.58
Change From Baseline in Calcium, Chloride, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Week 4 and Week 12/Early Withdrawal Urea/BUN, Week 4, n=60	-0.4998 Millimoles (mmol)/L Standard Deviation 1.12504
Change From Baseline in Calcium, Chloride, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Week 4 and Week 12/Early Withdrawal Urea/BUN, Week 12/early withdrawal, n=61	-0.0954 Millimoles (mmol)/L Standard Deviation 1.18765

SECONDARY outcome

Timeframe: Baseline through the entire treatment period (12 weeks), Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12

Population: FAS Population. Only those participants available at the indicated time points were assessed.

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.

Outcome measures

Outcome measures
Measure	GW685698X 55 μg QD n=61 Participants Participants received GW685698X nasal spray (55 micrograms \[µg\]) as one spray into each nostril (27.5 μg per spray) once daily (QD) in the morning for 12 weeks.
Mean Change From Baseline in the 3 Total Nasal Symptom Score (3TNSS) Over the Entire Treatment Period, Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12 Entire Treatment Period, n=61	-2.2 Scores on a scale Standard Deviation 1.65
Mean Change From Baseline in the 3 Total Nasal Symptom Score (3TNSS) Over the Entire Treatment Period, Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12 Week 1 to 2, n=61	-1.6 Scores on a scale Standard Deviation 1.58
Mean Change From Baseline in the 3 Total Nasal Symptom Score (3TNSS) Over the Entire Treatment Period, Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12 Week 3 to 4, n=61	-2.5 Scores on a scale Standard Deviation 1.84
Mean Change From Baseline in the 3 Total Nasal Symptom Score (3TNSS) Over the Entire Treatment Period, Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12 Week 7 to 8, n=60	-2.4 Scores on a scale Standard Deviation 1.86
Mean Change From Baseline in the 3 Total Nasal Symptom Score (3TNSS) Over the Entire Treatment Period, Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12 Week 11 to 12, n=60	-2.0 Scores on a scale Standard Deviation 2.07

SECONDARY outcome

Timeframe: Baseline through the entire treatment period (12 weeks), Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12

Population: FAS Population. Only those participants available at the indicated time points were assessed.

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. 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	GW685698X 55 μg QD n=61 Participants Participants received GW685698X nasal spray (55 micrograms \[µg\]) as one spray into each nostril (27.5 μg per spray) once daily (QD) in the morning for 12 weeks.
Mean Percent Change From Baseline in the 3 Total Nasal Symptom Score (3TNSS) Over the Entire Treatment Period, Week 1to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12 Entire Treatment Period, n=61	-46.9 Percent change Standard Deviation 33.25
Mean Percent Change From Baseline in the 3 Total Nasal Symptom Score (3TNSS) Over the Entire Treatment Period, Week 1to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12 Week 1 to 2, n=61	-31.6 Percent change Standard Deviation 36.36
Mean Percent Change From Baseline in the 3 Total Nasal Symptom Score (3TNSS) Over the Entire Treatment Period, Week 1to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12 Week 3 to 4, n=61	-53.2 Percent change Standard Deviation 36.81
Mean Percent Change From Baseline in the 3 Total Nasal Symptom Score (3TNSS) Over the Entire Treatment Period, Week 1to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12 Week 7 to 8, n=60	-50.9 Percent change Standard Deviation 38.00
Mean Percent Change From Baseline in the 3 Total Nasal Symptom Score (3TNSS) Over the Entire Treatment Period, Week 1to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12 Week 11 to 12, n=60	-40.7 Percent change Standard Deviation 41.58

SECONDARY outcome

Timeframe: Baseline, Day 1 to Day 84

Population: Full Analysis Set (FAS) Population: 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.

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 BL 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 BL was calculated as the mean score for the entire treatment period minus the score at BL. Only those participants available at the indicated time points were assessed.

Outcome measures

Outcome measures
Measure	GW685698X 55 μg QD n=61 Participants Participants received GW685698X nasal spray (55 micrograms \[µg\]) as one spray into each nostril (27.5 μg per spray) once daily (QD) in the morning for 12 weeks.
Mean Change From Baseline (BL) in Daily Variation of the 3 Total Nasal Symptom Score (3TNSS) Day 1, n=61	-0.5 Scores on a scale Standard Deviation 1.81
Mean Change From Baseline (BL) in Daily Variation of the 3 Total Nasal Symptom Score (3TNSS) Day 2, n=61	-0.8 Scores on a scale Standard Deviation 1.90
Mean Change From Baseline (BL) in Daily Variation of the 3 Total Nasal Symptom Score (3TNSS) Day 3, n=61	-0.9 Scores on a scale Standard Deviation 1.64
Mean Change From Baseline (BL) in Daily Variation of the 3 Total Nasal Symptom Score (3TNSS) Day 4, n=61	-1.3 Scores on a scale Standard Deviation 1.76
Mean Change From Baseline (BL) in Daily Variation of the 3 Total Nasal Symptom Score (3TNSS) Day 5, n=61	-1.4 Scores on a scale Standard Deviation 1.75
Mean Change From Baseline (BL) in Daily Variation of the 3 Total Nasal Symptom Score (3TNSS) Day 6, n=61	-1.3 Scores on a scale Standard Deviation 1.76
Mean Change From Baseline (BL) in Daily Variation of the 3 Total Nasal Symptom Score (3TNSS) Day 7, n=61	-1.6 Scores on a scale Standard Deviation 1.83
Mean Change From Baseline (BL) in Daily Variation of the 3 Total Nasal Symptom Score (3TNSS) Day 8, n=61	-1.9 Scores on a scale Standard Deviation 1.94
Mean Change From Baseline (BL) in Daily Variation of the 3 Total Nasal Symptom Score (3TNSS) Day 9, n=61	-1.9 Scores on a scale Standard Deviation 2.12
Mean Change From Baseline (BL) in Daily Variation of the 3 Total Nasal Symptom Score (3TNSS) Day 10, n=61	-2.0 Scores on a scale Standard Deviation 1.90
Mean Change From Baseline (BL) in Daily Variation of the 3 Total Nasal Symptom Score (3TNSS) Day 11, n=61	-1.8 Scores on a scale Standard Deviation 2.18
Mean Change From Baseline (BL) in Daily Variation of the 3 Total Nasal Symptom Score (3TNSS) Day 12, n=61	-1.9 Scores on a scale Standard Deviation 1.98
Mean Change From Baseline (BL) in Daily Variation of the 3 Total Nasal Symptom Score (3TNSS) Day 13, n=61	-2.3 Scores on a scale Standard Deviation 2.12
Mean Change From Baseline (BL) in Daily Variation of the 3 Total Nasal Symptom Score (3TNSS) Day 14, n=61	-2.2 Scores on a scale Standard Deviation 2.21
Mean Change From Baseline (BL) in Daily Variation of the 3 Total Nasal Symptom Score (3TNSS) Day 15, n=61	-2.5 Scores on a scale Standard Deviation 2.12
Mean Change From Baseline (BL) in Daily Variation of the 3 Total Nasal Symptom Score (3TNSS) Day 16, n=61	-2.3 Scores on a scale Standard Deviation 2.05
Mean Change From Baseline (BL) in Daily Variation of the 3 Total Nasal Symptom Score (3TNSS) Day 17, n=61	-2.4 Scores on a scale Standard Deviation 2.01
Mean Change From Baseline (BL) in Daily Variation of the 3 Total Nasal Symptom Score (3TNSS) Day 18, n=61	-2.5 Scores on a scale Standard Deviation 1.96
Mean Change From Baseline (BL) in Daily Variation of the 3 Total Nasal Symptom Score (3TNSS) Day 19, n=61	-2.6 Scores on a scale Standard Deviation 2.01
Mean Change From Baseline (BL) in Daily Variation of the 3 Total Nasal Symptom Score (3TNSS) Day 20, n=61	-2.7 Scores on a scale Standard Deviation 2.00
Mean Change From Baseline (BL) in Daily Variation of the 3 Total Nasal Symptom Score (3TNSS) Day 21, n=61	-2.5 Scores on a scale Standard Deviation 2.08
Mean Change From Baseline (BL) in Daily Variation of the 3 Total Nasal Symptom Score (3TNSS) Day 22, n=61	-2.6 Scores on a scale Standard Deviation 2.03
Mean Change From Baseline (BL) in Daily Variation of the 3 Total Nasal Symptom Score (3TNSS) Day 23, n=61	-2.4 Scores on a scale Standard Deviation 2.04
Mean Change From Baseline (BL) in Daily Variation of the 3 Total Nasal Symptom Score (3TNSS) Day 24, n=61	-2.4 Scores on a scale Standard Deviation 2.13
Mean Change From Baseline (BL) in Daily Variation of the 3 Total Nasal Symptom Score (3TNSS) Day 25, n=61	-2.5 Scores on a scale Standard Deviation 1.91
Mean Change From Baseline (BL) in Daily Variation of the 3 Total Nasal Symptom Score (3TNSS) Day 26, n=61	-2.5 Scores on a scale Standard Deviation 2.08
Mean Change From Baseline (BL) in Daily Variation of the 3 Total Nasal Symptom Score (3TNSS) Day 27, n=61	-2.5 Scores on a scale Standard Deviation 1.97
Mean Change From Baseline (BL) in Daily Variation of the 3 Total Nasal Symptom Score (3TNSS) Day 28, n=61	-2.4 Scores on a scale Standard Deviation 1.99
Mean Change From Baseline (BL) in Daily Variation of the 3 Total Nasal Symptom Score (3TNSS) Day 29, n=60	-2.4 Scores on a scale Standard Deviation 1.81
Mean Change From Baseline (BL) in Daily Variation of the 3 Total Nasal Symptom Score (3TNSS) Day 30, n=60	-2.5 Scores on a scale Standard Deviation 1.79
Mean Change From Baseline (BL) in Daily Variation of the 3 Total Nasal Symptom Score (3TNSS) Day 31, n=60	-2.6 Scores on a scale Standard Deviation 1.90
Mean Change From Baseline (BL) in Daily Variation of the 3 Total Nasal Symptom Score (3TNSS) Day 32, n=60	-2.4 Scores on a scale Standard Deviation 2.16
Mean Change From Baseline (BL) in Daily Variation of the 3 Total Nasal Symptom Score (3TNSS) Day 33, n=60	-2.5 Scores on a scale Standard Deviation 1.99
Mean Change From Baseline (BL) in Daily Variation of the 3 Total Nasal Symptom Score (3TNSS) Day 34, n=60	-2.4 Scores on a scale Standard Deviation 2.30
Mean Change From Baseline (BL) in Daily Variation of the 3 Total Nasal Symptom Score (3TNSS) Day 35, n=60	-2.4 Scores on a scale Standard Deviation 2.43
Mean Change From Baseline (BL) in Daily Variation of the 3 Total Nasal Symptom Score (3TNSS) Day 36, n=60	-2.2 Scores on a scale Standard Deviation 2.21
Mean Change From Baseline (BL) in Daily Variation of the 3 Total Nasal Symptom Score (3TNSS) Day 37, n=60	-2.4 Scores on a scale Standard Deviation 2.23
Mean Change From Baseline (BL) in Daily Variation of the 3 Total Nasal Symptom Score (3TNSS) Day 38, n=60	-2.4 Scores on a scale Standard Deviation 2.41
Mean Change From Baseline (BL) in Daily Variation of the 3 Total Nasal Symptom Score (3TNSS) Day 39, n=60	-2.2 Scores on a scale Standard Deviation 2.30
Mean Change From Baseline (BL) in Daily Variation of the 3 Total Nasal Symptom Score (3TNSS) Day 40, n=60	-2.2 Scores on a scale Standard Deviation 2.17
Mean Change From Baseline (BL) in Daily Variation of the 3 Total Nasal Symptom Score (3TNSS) Day 41, n=60	-2.3 Scores on a scale Standard Deviation 1.85
Mean Change From Baseline (BL) in Daily Variation of the 3 Total Nasal Symptom Score (3TNSS) Day 42, n=60	-2.6 Scores on a scale Standard Deviation 1.80
Mean Change From Baseline (BL) in Daily Variation of the 3 Total Nasal Symptom Score (3TNSS) Day 43, n=60	-2.4 Scores on a scale Standard Deviation 2.20
Mean Change From Baseline (BL) in Daily Variation of the 3 Total Nasal Symptom Score (3TNSS) Day 44, n=60	-2.5 Scores on a scale Standard Deviation 2.16
Mean Change From Baseline (BL) in Daily Variation of the 3 Total Nasal Symptom Score (3TNSS) Day 45, n=60	-2.2 Scores on a scale Standard Deviation 2.24
Mean Change From Baseline (BL) in Daily Variation of the 3 Total Nasal Symptom Score (3TNSS) Day 46, n=60	-2.5 Scores on a scale Standard Deviation 1.89
Mean Change From Baseline (BL) in Daily Variation of the 3 Total Nasal Symptom Score (3TNSS) Day 47, n=60	-2.5 Scores on a scale Standard Deviation 2.07
Mean Change From Baseline (BL) in Daily Variation of the 3 Total Nasal Symptom Score (3TNSS) Day 48, n=60	-2.4 Scores on a scale Standard Deviation 2.27
Mean Change From Baseline (BL) in Daily Variation of the 3 Total Nasal Symptom Score (3TNSS) Day 49, n=60	-2.4 Scores on a scale Standard Deviation 2.15
Mean Change From Baseline (BL) in Daily Variation of the 3 Total Nasal Symptom Score (3TNSS) Day 50, n=60	-2.4 Scores on a scale Standard Deviation 2.33
Mean Change From Baseline (BL) in Daily Variation of the 3 Total Nasal Symptom Score (3TNSS) Day 51, n=60	-2.4 Scores on a scale Standard Deviation 2.34
Mean Change From Baseline (BL) in Daily Variation of the 3 Total Nasal Symptom Score (3TNSS) Day 52, n=60	-2.4 Scores on a scale Standard Deviation 1.99
Mean Change From Baseline (BL) in Daily Variation of the 3 Total Nasal Symptom Score (3TNSS) Day 53, n=60	-2.5 Scores on a scale Standard Deviation 1.90
Mean Change From Baseline (BL) in Daily Variation of the 3 Total Nasal Symptom Score (3TNSS) Day 54, n=60	-2.2 Scores on a scale Standard Deviation 1.98
Mean Change From Baseline (BL) in Daily Variation of the 3 Total Nasal Symptom Score (3TNSS) Day 55, n=60	-2.2 Scores on a scale Standard Deviation 2.11
Mean Change From Baseline (BL) in Daily Variation of the 3 Total Nasal Symptom Score (3TNSS) Day 56, n=60	-2.3 Scores on a scale Standard Deviation 2.11
Mean Change From Baseline (BL) in Daily Variation of the 3 Total Nasal Symptom Score (3TNSS) Day 57, n=60	-2.4 Scores on a scale Standard Deviation 1.94
Mean Change From Baseline (BL) in Daily Variation of the 3 Total Nasal Symptom Score (3TNSS) Day 58, n=60	-2.4 Scores on a scale Standard Deviation 1.98
Mean Change From Baseline (BL) in Daily Variation of the 3 Total Nasal Symptom Score (3TNSS) Day 59, n=60	-2.6 Scores on a scale Standard Deviation 2.09
Mean Change From Baseline (BL) in Daily Variation of the 3 Total Nasal Symptom Score (3TNSS) Day 60, n=60	-2.8 Scores on a scale Standard Deviation 1.75
Mean Change From Baseline (BL) in Daily Variation of the 3 Total Nasal Symptom Score (3TNSS) Day 61, n=60	-2.5 Scores on a scale Standard Deviation 1.78
Mean Change From Baseline (BL) in Daily Variation of the 3 Total Nasal Symptom Score (3TNSS) Day 62, n=60	-2.6 Scores on a scale Standard Deviation 1.65
Mean Change From Baseline (BL) in Daily Variation of the 3 Total Nasal Symptom Score (3TNSS) Day 63, n=60	-2.7 Scores on a scale Standard Deviation 1.77
Mean Change From Baseline (BL) in Daily Variation of the 3 Total Nasal Symptom Score (3TNSS) Day 64, n=60	-2.6 Scores on a scale Standard Deviation 1.96
Mean Change From Baseline (BL) in Daily Variation of the 3 Total Nasal Symptom Score (3TNSS) Day 65, n=60	-2.5 Scores on a scale Standard Deviation 2.07
Mean Change From Baseline (BL) in Daily Variation of the 3 Total Nasal Symptom Score (3TNSS) Day 66, n=60	-2.2 Scores on a scale Standard Deviation 2.24
Mean Change From Baseline (BL) in Daily Variation of the 3 Total Nasal Symptom Score (3TNSS) Day 67, n=60	-2.4 Scores on a scale Standard Deviation 2.10
Mean Change From Baseline (BL) in Daily Variation of the 3 Total Nasal Symptom Score (3TNSS) Day 68, n=60	-2.3 Scores on a scale Standard Deviation 2.23
Mean Change From Baseline (BL) in Daily Variation of the 3 Total Nasal Symptom Score (3TNSS) Day 69, n=60	-2.4 Scores on a scale Standard Deviation 1.96
Mean Change From Baseline (BL) in Daily Variation of the 3 Total Nasal Symptom Score (3TNSS) Day 70, n=60	-2.5 Scores on a scale Standard Deviation 1.79
Mean Change From Baseline (BL) in Daily Variation of the 3 Total Nasal Symptom Score (3TNSS) Day 71, n=60	-2.4 Scores on a scale Standard Deviation 1.99
Mean Change From Baseline (BL) in Daily Variation of the 3 Total Nasal Symptom Score (3TNSS) Day 72, n=60	-2.1 Scores on a scale Standard Deviation 1.97
Mean Change From Baseline (BL) in Daily Variation of the 3 Total Nasal Symptom Score (3TNSS) Day 73, n=60	-2.0 Scores on a scale Standard Deviation 2.17
Mean Change From Baseline (BL) in Daily Variation of the 3 Total Nasal Symptom Score (3TNSS) Day 74, n=59	-1.6 Scores on a scale Standard Deviation 2.37
Mean Change From Baseline (BL) in Daily Variation of the 3 Total Nasal Symptom Score (3TNSS) Day 75, n=59	-1.8 Scores on a scale Standard Deviation 2.34
Mean Change From Baseline (BL) in Daily Variation of the 3 Total Nasal Symptom Score (3TNSS) Day 76, n=59	-1.8 Scores on a scale Standard Deviation 2.56
Mean Change From Baseline (BL) in Daily Variation of the 3 Total Nasal Symptom Score (3TNSS) Day 77, n=59	-2.1 Scores on a scale Standard Deviation 2.59
Mean Change From Baseline (BL) in Daily Variation of the 3 Total Nasal Symptom Score (3TNSS) Day 78, n=59	-2.1 Scores on a scale Standard Deviation 2.49
Mean Change From Baseline (BL) in Daily Variation of the 3 Total Nasal Symptom Score (3TNSS) Day 79, n=59	-1.9 Scores on a scale Standard Deviation 2.35
Mean Change From Baseline (BL) in Daily Variation of the 3 Total Nasal Symptom Score (3TNSS) Day 80, n=59	-1.8 Scores on a scale Standard Deviation 2.15
Mean Change From Baseline (BL) in Daily Variation of the 3 Total Nasal Symptom Score (3TNSS) Day 81, n=50	-1.9 Scores on a scale Standard Deviation 2.25
Mean Change From Baseline (BL) in Daily Variation of the 3 Total Nasal Symptom Score (3TNSS) Day 82, n=43	-1.7 Scores on a scale Standard Deviation 2.45
Mean Change From Baseline (BL) in Daily Variation of the 3 Total Nasal Symptom Score (3TNSS) Day 83, n=39	-1.2 Scores on a scale Standard Deviation 2.55
Mean Change From Baseline (BL) in Daily Variation of the 3 Total Nasal Symptom Score (3TNSS) Day 84, n=31	-1.2 Scores on a scale Standard Deviation 2.55

SECONDARY outcome

Timeframe: Baseline through the entire treatment period (12 weeks), Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12

Population: FAS Population. Only those participants available at the indicated time points were assessed.

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	GW685698X 55 μg QD n=61 Participants Participants received GW685698X nasal spray (55 micrograms \[µg\]) as one spray into each nostril (27.5 μg per spray) once daily (QD) in the morning for 12 weeks.
Mean Change From Baseline in the 4 Total Nasal Symptom Score (4TNSS) Over the Entire Treatment Period, Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12 Scores on a scale	-2.6 Scores on a scale Standard Deviation 2.01
Mean Change From Baseline in the 4 Total Nasal Symptom Score (4TNSS) Over the Entire Treatment Period, Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12 Week 1 to 2 n=61	-1.8 Scores on a scale Standard Deviation 1.93
Mean Change From Baseline in the 4 Total Nasal Symptom Score (4TNSS) Over the Entire Treatment Period, Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12 Week 3 to 4, n=61	-2.9 Scores on a scale Standard Deviation 2.26
Mean Change From Baseline in the 4 Total Nasal Symptom Score (4TNSS) Over the Entire Treatment Period, Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12 Week 7 to 8, n=60	-2.8 Scores on a scale Standard Deviation 2.26
Mean Change From Baseline in the 4 Total Nasal Symptom Score (4TNSS) Over the Entire Treatment Period, Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12 Week 11 to 12, n=60	-2.3 Scores on a scale Standard Deviation 2.50

SECONDARY outcome

Timeframe: Baseline through the entire treatment period (12 weeks), Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12

Population: FAS Population. Only those participants available at the indicated time points were assessed.

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. 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	GW685698X 55 μg QD n=61 Participants Participants received GW685698X nasal spray (55 micrograms \[µg\]) as one spray into each nostril (27.5 μg per spray) once daily (QD) in the morning for 12 weeks.
Mean Percent Change From Baseline in the 4 Total Nasal Symptom Score (4TNSS) Over the Entire Treatment Period, Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12 Entire Treatment Period, n=61	-47.1 Percent change Standard Deviation 34.06
Mean Percent Change From Baseline in the 4 Total Nasal Symptom Score (4TNSS) Over the Entire Treatment Period, Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12 Week 1 to 2, n=61	-31.3 Percent change Standard Deviation 38.42
Mean Percent Change From Baseline in the 4 Total Nasal Symptom Score (4TNSS) Over the Entire Treatment Period, Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12 Week 3 to 4, n=61	-52.8 Percent change Standard Deviation 38.62
Mean Percent Change From Baseline in the 4 Total Nasal Symptom Score (4TNSS) Over the Entire Treatment Period, Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12 Week 7 to 8, n=60	-51.3 Percent change Standard Deviation 38.90
Mean Percent Change From Baseline in the 4 Total Nasal Symptom Score (4TNSS) Over the Entire Treatment Period, Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12 Week 11 to 12, n=60	-42.0 Percent change Standard Deviation 41.95

SECONDARY outcome

Timeframe: Baseline through the entire treatment period (12 weeks), Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12

Population: FAS Population. Only those participants available at the indicated time points were assessed.

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 (12 weeks), Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12. 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	GW685698X 55 μg QD n=61 Participants Participants received GW685698X nasal spray (55 micrograms \[µg\]) as one spray into each nostril (27.5 μg per spray) once daily (QD) in the morning for 12 weeks.
Mean Change From Baseline in the Total Ocular Symptom Score (TOSS) Over the Entire Treatment Period, Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12 Entire Treatment Period, n=61	-0.2 Scores on a scale Standard Deviation 1.00
Mean Change From Baseline in the Total Ocular Symptom Score (TOSS) Over the Entire Treatment Period, Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12 Week 1 to 2, n=61	-0.1 Scores on a scale Standard Deviation 0.88
Mean Change From Baseline in the Total Ocular Symptom Score (TOSS) Over the Entire Treatment Period, Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12 Week 3 to 4, n=61	-0.1 Scores on a scale Standard Deviation 1.08
Mean Change From Baseline in the Total Ocular Symptom Score (TOSS) Over the Entire Treatment Period, Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12 Week 7 to 8, n=60	-0.2 Scores on a scale Standard Deviation 1.20
Mean Change From Baseline in the Total Ocular Symptom Score (TOSS) Over the Entire Treatment Period, Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12 Week 11 to 12, n=60	-0.3 Scores on a scale Standard Deviation 1.06

SECONDARY outcome

Timeframe: Baseline through the entire treatment period (12 weeks), Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12

Population: FAS Population. Only those participants available at the indicated time points were assessed.

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 (12 weeks), Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12. 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. 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	GW685698X 55 μg QD n=61 Participants Participants received GW685698X nasal spray (55 micrograms \[µg\]) as one spray into each nostril (27.5 μg per spray) once daily (QD) in the morning for 12 weeks.
Mean Percent Change From Baseline in the Total Ocular Symptom Score (TOSS) Over the Entire Treatment Period, Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12 Entire Treatment Period, n=36	7.1 Percent change Standard Deviation 180.60
Mean Percent Change From Baseline in the Total Ocular Symptom Score (TOSS) Over the Entire Treatment Period, Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12 Week 1 to 2, n=36	4.6 Percent change Standard Deviation 138.41
Mean Percent Change From Baseline in the Total Ocular Symptom Score (TOSS) Over the Entire Treatment Period, Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12 Week 3 to 4, n=36	17.5 Percent change Standard Deviation 214.79
Mean Percent Change From Baseline in the Total Ocular Symptom Score (TOSS) Over the Entire Treatment Period, Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12 Week 7 to 8, n=35	29.0 Percent change Standard Deviation 251.46
Mean Percent Change From Baseline in the Total Ocular Symptom Score (TOSS) Over the Entire Treatment Period, Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12 Week 11 to 12, n=35	-22.5 Percent change Standard Deviation 163.35

SECONDARY outcome

Timeframe: Baseline through the entire treatment period (12 weeks), Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12

Population: FAS Population. Only those participants available at the indicated time points were assessed.

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	GW685698X 55 μg QD n=61 Participants Participants received GW685698X nasal spray (55 micrograms \[µg\]) as one spray into each nostril (27.5 μg per spray) once daily (QD) in the morning for 12 weeks.
Mean Change From Baseline in Sneezing, Rhinorrhea, Nasal Congestion, and Nasal Itching Over the Entire Treatment Period, Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12 Sneezing, Entire Treatment Period, n=61	-0.7 Scores on a scale Standard Deviation 0.74
Mean Change From Baseline in Sneezing, Rhinorrhea, Nasal Congestion, and Nasal Itching Over the Entire Treatment Period, Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12 Sneezing, Week 1 to 2, n=61	-0.5 Scores on a scale Standard Deviation 0.67
Mean Change From Baseline in Sneezing, Rhinorrhea, Nasal Congestion, and Nasal Itching Over the Entire Treatment Period, Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12 Sneezing, Week 3 to 4, n=61	-0.8 Scores on a scale Standard Deviation 0.75
Mean Change From Baseline in Sneezing, Rhinorrhea, Nasal Congestion, and Nasal Itching Over the Entire Treatment Period, Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12 Sneezing, Week 7 to 8, n=60	-0.7 Scores on a scale Standard Deviation 0.81
Mean Change From Baseline in Sneezing, Rhinorrhea, Nasal Congestion, and Nasal Itching Over the Entire Treatment Period, Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12 Sneezing, Week 11 to 12, n=60	-0.6 Scores on a scale Standard Deviation 0.88
Mean Change From Baseline in Sneezing, Rhinorrhea, Nasal Congestion, and Nasal Itching Over the Entire Treatment Period, Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12 Rhinorrhea, Entire Treatment Period, n=61	-0.8 Scores on a scale Standard Deviation 0.65
Mean Change From Baseline in Sneezing, Rhinorrhea, Nasal Congestion, and Nasal Itching Over the Entire Treatment Period, Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12 Rhinorrhea, Week 1 to 2, n=61	-0.5 Scores on a scale Standard Deviation 0.62
Mean Change From Baseline in Sneezing, Rhinorrhea, Nasal Congestion, and Nasal Itching Over the Entire Treatment Period, Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12 Rhinorrhea, Week 3 to 4, n=61	-0.9 Scores on a scale Standard Deviation 0.76
Mean Change From Baseline in Sneezing, Rhinorrhea, Nasal Congestion, and Nasal Itching Over the Entire Treatment Period, Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12 Rhinorrhea, Week 7 to 8, n=60	-0.8 Scores on a scale Standard Deviation 0.73
Mean Change From Baseline in Sneezing, Rhinorrhea, Nasal Congestion, and Nasal Itching Over the Entire Treatment Period, Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12 Rhinorrhea, Week 11 to 12, n=60	-0.7 Scores on a scale Standard Deviation 0.85
Mean Change From Baseline in Sneezing, Rhinorrhea, Nasal Congestion, and Nasal Itching Over the Entire Treatment Period, Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12 Nasal Congestion, Entire Treatment Period, n=61	-0.8 Scores on a scale Standard Deviation 0.66
Mean Change From Baseline in Sneezing, Rhinorrhea, Nasal Congestion, and Nasal Itching Over the Entire Treatment Period, Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12 Nasal Congestion, Week 1 to 2, n=61	-0.5 Scores on a scale Standard Deviation 0.63
Mean Change From Baseline in Sneezing, Rhinorrhea, Nasal Congestion, and Nasal Itching Over the Entire Treatment Period, Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12 Nasal Congestion, Week 3 to 4, n=61	-0.9 Scores on a scale Standard Deviation 0.76
Mean Change From Baseline in Sneezing, Rhinorrhea, Nasal Congestion, and Nasal Itching Over the Entire Treatment Period, Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12 Nasal Congestion, Week 7 to 8, n=60	-0.8 Scores on a scale Standard Deviation 0.72
Mean Change From Baseline in Sneezing, Rhinorrhea, Nasal Congestion, and Nasal Itching Over the Entire Treatment Period, Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12 Nasal Congestion, Week 11 to 12, n=60	-0.7 Scores on a scale Standard Deviation 0.85
Mean Change From Baseline in Sneezing, Rhinorrhea, Nasal Congestion, and Nasal Itching Over the Entire Treatment Period, Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12 Nasal Itching, Entire Treatment Period, n=61	-0.4 Scores on a scale Standard Deviation 0.58
Mean Change From Baseline in Sneezing, Rhinorrhea, Nasal Congestion, and Nasal Itching Over the Entire Treatment Period, Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12 Nasal Itching, Week 1 to 2, n=61	-0.2 Scores on a scale Standard Deviation 0.55
Mean Change From Baseline in Sneezing, Rhinorrhea, Nasal Congestion, and Nasal Itching Over the Entire Treatment Period, Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12 Nasal Itching, Week 3 to 4, n=61	-0.4 Scores on a scale Standard Deviation 0.63
Mean Change From Baseline in Sneezing, Rhinorrhea, Nasal Congestion, and Nasal Itching Over the Entire Treatment Period, Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12 Nasal Itching, Week 7 to 8, n=60	-0.4 Scores on a scale Standard Deviation 0.67
Mean Change From Baseline in Sneezing, Rhinorrhea, Nasal Congestion, and Nasal Itching Over the Entire Treatment Period, Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12 Nasal Itching, Week 11 to 12, n=60	-0.3 Scores on a scale Standard Deviation 0.69

SECONDARY outcome

Timeframe: Baseline through the entire treatment period (12 weeks), Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12

Population: FAS Population. Only those participants available at the indicated time points were assessed.

Three individual symptoms (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 (12 weeks), Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12. 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	GW685698X 55 μg QD n=61 Participants Participants received GW685698X nasal spray (55 micrograms \[µg\]) as one spray into each nostril (27.5 μg per spray) once daily (QD) in the morning for 12 weeks.
Mean Change From Baseline in Eye Itching, Tearing, and Redness Over the Entire Treatment Period, Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12 Eye Itching, Entire Treatment Period, n=61	-0.2 Scores on a scale Standard Deviation 0.57
Mean Change From Baseline in Eye Itching, Tearing, and Redness Over the Entire Treatment Period, Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12 Eye Itching, Week 1 to 2, n=61	-0.1 Scores on a scale Standard Deviation 0.53
Mean Change From Baseline in Eye Itching, Tearing, and Redness Over the Entire Treatment Period, Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12 Eye Itching, Week 3 to 4, n=61	-0.1 Scores on a scale Standard Deviation 0.61
Mean Change From Baseline in Eye Itching, Tearing, and Redness Over the Entire Treatment Period, Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12 Eye Itching, Week 7 to 8, n=60	-0.2 Scores on a scale Standard Deviation 0.68
Mean Change From Baseline in Eye Itching, Tearing, and Redness Over the Entire Treatment Period, Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12 Eye Itching, Week 11 to 12, n=60	-0.2 Scores on a scale Standard Deviation 0.59
Mean Change From Baseline in Eye Itching, Tearing, and Redness Over the Entire Treatment Period, Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12 Tearing, Entire Treatment Period, n=61	0.0 Scores on a scale Standard Deviation 0.25
Mean Change From Baseline in Eye Itching, Tearing, and Redness Over the Entire Treatment Period, Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12 Tearing, Week 1 to 2, n=61	0.0 Scores on a scale Standard Deviation 0.22
Mean Change From Baseline in Eye Itching, Tearing, and Redness Over the Entire Treatment Period, Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12 Tearing, Week 3 to 4, n=61	0.0 Scores on a scale Standard Deviation 0.29
Mean Change From Baseline in Eye Itching, Tearing, and Redness Over the Entire Treatment Period, Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12 Tearing, Week 7 to 8, n=60	0.0 Scores on a scale Standard Deviation 0.28
Mean Change From Baseline in Eye Itching, Tearing, and Redness Over the Entire Treatment Period, Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12 Tearing, Week 11 to 12, n=60	0.0 Scores on a scale Standard Deviation 0.26
Mean Change From Baseline in Eye Itching, Tearing, and Redness Over the Entire Treatment Period, Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12 Redness, Entire Treatment Period, n=61	-0.1 Scores on a scale Standard Deviation 0.34
Mean Change From Baseline in Eye Itching, Tearing, and Redness Over the Entire Treatment Period, Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12 Redness, Week 1 to 2, n=61	-0.0 Scores on a scale Standard Deviation 0.32
Mean Change From Baseline in Eye Itching, Tearing, and Redness Over the Entire Treatment Period, Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12 Redness, Week 3 to 4, n=61	-0.0 Scores on a scale Standard Deviation 0.35
Mean Change From Baseline in Eye Itching, Tearing, and Redness Over the Entire Treatment Period, Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12 Redness, Week 7 to 8, n=60	-0.0 Scores on a scale Standard Deviation 0.43
Mean Change From Baseline in Eye Itching, Tearing, and Redness Over the Entire Treatment Period, Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12 Redness, Week 11 to 12, n=60	-0.1 Scores on a scale Standard Deviation 0.39

SECONDARY outcome

Timeframe: Baseline through the entire treatment period (12 weeks), Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12

Population: FAS Population. Only those participants available at the indicated time points were assessed.

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, Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12. 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	GW685698X 55 μg QD n=61 Participants Participants received GW685698X nasal spray (55 micrograms \[µg\]) as one spray into each nostril (27.5 μg per spray) once daily (QD) in the morning for 12 weeks.
Mean Change From Baseline in the Score of Troubles With Daily Life Over the Entire Treatment Period, Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12 Entire Treatment Period, n=61	-0.5 Scores on a scale Standard Deviation 0.61
Mean Change From Baseline in the Score of Troubles With Daily Life Over the Entire Treatment Period, Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12 Week 1 to 2, n=61	-0.3 Scores on a scale Standard Deviation 0.52
Mean Change From Baseline in the Score of Troubles With Daily Life Over the Entire Treatment Period, Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12 Week 3 to 4, n=61	-0.5 Scores on a scale Standard Deviation 0.65
Mean Change From Baseline in the Score of Troubles With Daily Life Over the Entire Treatment Period, Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12 Week 7 to 8, n=60	-0.6 Scores on a scale Standard Deviation 0.72
Mean Change From Baseline in the Score of Troubles With Daily Life Over the Entire Treatment Period, Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12 Week 11 to 12, n=60	-0.4 Scores on a scale Standard Deviation 0.75

SECONDARY outcome

Timeframe: Baseline, Week 4, Week 8, and Week 12/early withdrawal

Population: FAS Population. Only those participants available at the indicated time points were assessed.

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	GW685698X 55 μg QD n=61 Participants Participants received GW685698X nasal spray (55 micrograms \[µg\]) as one spray into each nostril (27.5 μg per spray) once daily (QD) in the morning for 12 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) SOITM, Baseline, Score 0, n=61	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) SOITM, Baseline, Score 1, n=61	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) SOITM, Baseline, Score 2, n=61	35 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) SOITM, Baseline, Score 3, n=61	14 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) SOITM, Week 4, Score 0, n=60	15 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) SOITM, Week 4, Score 1, n=60	21 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) SOITM, Week 4, Score 2, n=60	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) SOITM, Week 4, Score 3, n=60	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) SOITM, Week 8, Score 0, n=60	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) SOITM, Week 8, Score 1, n=60	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) SOITM, Week 8, Score 2, n=60	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) SOITM, Week 8, Score 3, n=60	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) SOITM, Week 12/early withdrawal, Score 0, n=61	21 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) SOITM, Week 12/early withdrawal, Score 1, n=61	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) SOITM, Week 12/early withdrawal, Score 2, n=61	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) SOITM, Week 12/early withdrawal, Score 3, n=61	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) COITM, Baseline, Score 0, n=61	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) COITM, Baseline, Score 1, n=61	10 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) COITM, Baseline, Score 2, n=61	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) COITM, Baseline, Score 3, n=61	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) COITM, Week 4, Score 0, n=60	10 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) COITM, Week 4, Score 1, n=60	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) COITM, Week 4, Score 2, n=60	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) COITM, Week 4, Score 3, n=60	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) COITM, Week 8, Score 0, n=60	12 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) COITM, Week 8, Score 1, n=60	30 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) COITM, Week 8, Score 2, n=60	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) COITM, Week 8, Score 3, n=60	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) COITM, Week 12/early withdrawal, Score 0, n=61	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) COITM, Week 12/early withdrawal, Score 1, n=61	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) COITM, Week 12/early withdrawal, Score 2, n=61	10 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) COITM, Week 12/early withdrawal, Score 3, n=61	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) QTND, Baseline, Score 0, n=61	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) QTND, Baseline, Score 1, n=61	16 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) QTND, Baseline, Score 2, n=61	33 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) QTND, Baseline, Score 3, n=61	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) QTND, Week 4, Score 0, n=60	30 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) QTND, Week 4, Score 1, n=60	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) QTND, Week 4, Score 2, n=60	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) QTND, Week 4, Score 3, n=60	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) QTND, Week 8, Score 0, n=60	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) QTND, Week 8, Score 1, n=60	25 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) QTND, Week 8, Score 2, n=60	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) QTND, Week 8, Score 3, n=60	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) QTND, Week 12/early withdrawal, Score 0, n=61	34 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) QTND, Week 12/early withdrawal, Score 1, n=61	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) QTND, Week 12/early withdrawal, Score 2, n=61	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) QTND, Week 12/early withdrawal, Score 3, n=61	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) QLND, Baseline, Score 0, n=61	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) QLND, Baseline, Score 1, n=61	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) QLND, Baseline, Score 2, n=61	14 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) QLND, Baseline, Score 3, n=61	43 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) QLND, Week 4, Score 0, n=60	30 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) QLND, Week 4, Score 1, n=60	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) QLND, Week 4, Score 2, n=60	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) QLND, Week 4, Score 3, n=60	15 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) QLND, Week 8, Score 0, n=60	30 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) QLND, Week 8, Score 1, n=60	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) QLND, Week 8, Score 2, n=60	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) QLND, Week 8, Score 3, n=60	12 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) QLND, Week 12/early withdrawal, Score 0, n=61	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) QLND, Week 12/early withdrawal, Score 1, n=61	10 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) QLND, Week 12/early withdrawal, Score 2, n=61	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) QLND, Week 12/early withdrawal, Score 3, n=61	12 participants

SECONDARY outcome

Timeframe: Week 12/early withdrawal

Population: FAS Population

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	GW685698X 55 μg QD n=61 Participants Participants received GW685698X nasal spray (55 micrograms \[µg\]) as one spray into each nostril (27.5 μg per spray) once daily (QD) in the morning for 12 weeks.
Number of Participants With the Indicated Overall Response to Therapy, as Assessed by the Investigator Significantly Improved	25 participants
Number of Participants With the Indicated Overall Response to Therapy, as Assessed by the Investigator Moderately Improved	28 participants
Number of Participants With the Indicated Overall Response to Therapy, as Assessed by the Investigator Mildly Improved	3 participants
Number of Participants With the Indicated Overall Response to Therapy, as Assessed by the Investigator No Change	5 participants
Number of Participants With the Indicated Overall Response to Therapy, as Assessed by the Investigator Mildly Worse	0 participants
Number of Participants With the Indicated Overall Response to Therapy, as Assessed by the Investigator Moderately Worse	0 participants
Number of Participants With the Indicated Overall Response to Therapy, as Assessed by the Investigator Significantly Worse	0 participants

SECONDARY outcome

Timeframe: Week 12/early withdrawal

Population: FAS Population

The participant's parent/guardian who signed the ICF or the participant himself/herself 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	GW685698X 55 μg QD n=61 Participants Participants received GW685698X nasal spray (55 micrograms \[µg\]) as one spray into each nostril (27.5 μg per spray) once daily (QD) in the morning for 12 weeks.
Number of Participants With the Indicated Overall Response to Therapy, as Assessed by the Participant's Parent/Guardian or the Participant Significantly Improved	13 participants
Number of Participants With the Indicated Overall Response to Therapy, as Assessed by the Participant's Parent/Guardian or the Participant Moderately Improved	31 participants
Number of Participants With the Indicated Overall Response to Therapy, as Assessed by the Participant's Parent/Guardian or the Participant Mildly Improved	12 participants
Number of Participants With the Indicated Overall Response to Therapy, as Assessed by the Participant's Parent/Guardian or the Participant No Change	4 participants
Number of Participants With the Indicated Overall Response to Therapy, as Assessed by the Participant's Parent/Guardian or the Participant Mildly Worse	1 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
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

SECONDARY outcome

Timeframe: Between 0.5 to 2 hours after final dosing at Week 12 (Visit 5)

Population: PK Concentration Population: all participants from whom a PK sample was obtained and analyzed. Only those participants aged \>=2 to \<6 years were assessed.

Pharmacokinetic (PK) samples were collected to analyze the plasma concentration of GW685698X.

Outcome measures

Outcome measures
Measure	GW685698X 55 μg QD n=19 Participants Participants received GW685698X nasal spray (55 micrograms \[µg\]) as one spray into each nostril (27.5 μg per spray) once daily (QD) in the morning for 12 weeks.
Number of Participants With the Indicated Plasma Concentration of GW685698X for Participants Aged >=2 to <6 Years Not Quantifiable (<10 picograms/milliliter [pg/mL]	17 participants
Number of Participants With the Indicated Plasma Concentration of GW685698X for Participants Aged >=2 to <6 Years >=10 to <20 pg/mL	2 participants
Number of Participants With the Indicated Plasma Concentration of GW685698X for Participants Aged >=2 to <6 Years >=20 to <30 pg/mL	0 participants
Number of Participants With the Indicated Plasma Concentration of GW685698X for Participants Aged >=2 to <6 Years >=30 pg/mL	0 participants

SECONDARY outcome

Timeframe: Between 0.5 to 2 hours after final dosing at Week 12 (Visit 5)

Population: PK Concentration Population. Only those participants aged \>=6 to \<15 years were assessed.

PK samples were collected to analyze the plasma concentration of GW685698X.

Outcome measures

Outcome measures
Measure	GW685698X 55 μg QD n=40 Participants Participants received GW685698X nasal spray (55 micrograms \[µg\]) as one spray into each nostril (27.5 μg per spray) once daily (QD) in the morning for 12 weeks.
Number of Participants With the Indicated Plasma Concentration of GW685698X for Participants Aged >=6 to <15 Years Not Quantifiable (<10 pg/mL)	37 participants
Number of Participants With the Indicated Plasma Concentration of GW685698X for Participants Aged >=6 to <15 Years >=10 to <20 pg/mL	2 participants
Number of Participants With the Indicated Plasma Concentration of GW685698X for Participants Aged >=6 to <15 Years >=20 to <30 pg/mL	1 participants
Number of Participants With the Indicated Plasma Concentration of GW685698X for Participants Aged >=6 to <15 Years >=30 pg/mL	0 participants

Adverse Events

GW685698X 55 μg QD

Serious events: 0 serious events

Other events: 23 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	GW685698X 55 μg QD n=61 participants at risk Participants received GW685698X nasal spray (55 micrograms \[µg\]) as one spray into each nostril (27.5 μg per spray) once daily (QD) in the morning for 12 weeks.
Infections and infestations Nasopharyngitis	24.6% 15/61 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment (Visit 2) until follow-up contact (Visit 6) (up to 13 weeks). SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of study medication, according to the actual treatment received.
Infections and infestations Acute sinusitis	13.1% 8/61 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment (Visit 2) until follow-up contact (Visit 6) (up to 13 weeks). SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of study medication, according to the actual treatment received.

Additional Information

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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.
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