Trial Outcomes & Findings for Once-Daily Investigational Nasal Spray In Adults And Adolescents With Perennial Allergic Rhinitis (PAR) (NCT NCT00289198)

Last Updated: 2018-04-13

Results Overview

TNSS is the sum of symptom scores for rhinorrhea, nasal congestion, nasal itching, and sneezing (each scored on a scale of 0 \[none\] to 3 \[severe\]; total possible score of 0 to 12). The rTNSS is a rating of the severity of symptoms over the previous 12 hours and is performed in morning (AM) and evening (PM). Daily rTNSS is defined as average of the PM rTNSS and the AM rTNSS of the next day prior to AM dosing. The Baseline daily rTNSS is defined as the average of the daily rTNSS over 4 consecutive 24 hour periods prior to randomization plus randomization day AM assessment. Change from Baseline was calculated as average of the non-missing daily rTNSS minus Baseline daily rTNSS. Analysis was performed using analysis of covariance (ANCOVA), adjusting for Baseline daily rTNSS, country, age, and gender. The Intent To Treat (ITT) Population comprised of all randomized participants who received \>=1 dose of study drug. Only those participants available at the specified time points were analyzed

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

301 participants

Primary outcome timeframe

Baseline (Day 1) and up to Week 6

Results posted on

2018-04-13

Participant Flow

This study was conducted from 07 February 2006 till 23 June 2006 at 40 centers across the globe. A total of 288 participants with perennial allergic rhinitis (PAR) were planned to be enrolled.

Following a 7 to 14 day screening period, participants who met randomisation criteria were randomised to 6 weeks of treatment with fluticasone furoate or placebo nasal spray once daily. A total of 302 participants were randomised, 151 in each of the treatment groups.

Participant milestones

Participant milestones
Measure	Placebo Eligible participants received aqueous nasal spray of matching Placebo once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug.	Fluticasone Furoate Eligible participants received aqueous nasal spray of Fluticasone furoate 100 micrograms (mcg) once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray (27.5 mcg per spray) into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug.
Overall Study STARTED	151	151
Overall Study COMPLETED	120	121
Overall Study NOT COMPLETED	31	30

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Eligible participants received aqueous nasal spray of matching Placebo once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug.	Fluticasone Furoate Eligible participants received aqueous nasal spray of Fluticasone furoate 100 micrograms (mcg) once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray (27.5 mcg per spray) into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug.
Overall Study Adverse Event	0	2
Overall Study Protocol Violation	2	1
Overall Study Withdrawal by Subject	4	1
Overall Study Lack of Efficacy	2	0
Overall Study Other: Low compliance	0	1
Overall Study Other: Physician's decision	0	1
Overall Study Other: Unable to attend on schedule	2	1
Overall Study Other: Miscalculation of the visit date	21	22
Overall Study Other: Impossible to come on visit	0	1

Baseline Characteristics

Once-Daily Investigational Nasal Spray In Adults And Adolescents With Perennial Allergic Rhinitis (PAR)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Fluticasone Furoate n=151 Participants Eligible participants received aqueous nasal spray of Fluticasone furoate 100 mcg once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug.	Placebo n=151 Participants Eligible participants received aqueous nasal spray of matching Placebo once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug.	Total n=302 Participants Total of all reporting groups
Age, Continuous	37.1 Years STANDARD_DEVIATION 16.57 • n=5 Participants	37.2 Years STANDARD_DEVIATION 16.20 • n=7 Participants	37.1 Years STANDARD_DEVIATION 16.36 • n=5 Participants
Sex: Female, Male Female	85 Participants n=5 Participants	86 Participants n=7 Participants	171 Participants n=5 Participants
Sex: Female, Male Male	66 Participants n=5 Participants	65 Participants n=7 Participants	131 Participants n=5 Participants
Race/Ethnicity, Customized African American/African Heritage	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Asian - Central/South Asian Heritage	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race/Ethnicity, Customized Asian - East Asian Heritage	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized Asian - South East Asian Heritage	6 Participants n=5 Participants	4 Participants n=7 Participants	10 Participants n=5 Participants
Race/Ethnicity, Customized Native Hawaiian or other Pacific Islander	3 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants
Race/Ethnicity, Customized White - Arabic/North African Heritage	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized White - White/Caucasian/European Heritage	135 Participants n=5 Participants	139 Participants n=7 Participants	274 Participants n=5 Participants
Race/Ethnicity, Customized Mixed Race	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline (Day 1) and up to Week 6

Population: ITT population. Data is presented for the participants available at the time of assessment.

Outcome measures

Outcome measures
Measure	Placebo n=150 Participants Eligible participants received aqueous nasal spray of matching Placebo once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug.	Fluticasone Furoate n=151 Participants Eligible participants received aqueous nasal spray of Fluticasone furoate 100 mcg once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug.
Mean Change From Baseline (Day 1) Over the Entire Treatment Period in Daily, Reflective Total Nasal Symptom Scores (rTNSS) Over 6 Weeks	-2.69 Scores on a scale Standard Error 0.18	-3.95 Scores on a scale Standard Error 0.18

SECONDARY outcome

Timeframe: Baseline (Day 1) and up to Week 6

Population: ITT population. Data is presented for the participants available at the time of assessment.

The AM pre-dose iTNSS is the sum of the 4 individual nasal symptom score assessments for rhinorrhea, nasal congestion, nasal itching, and sneezing performed at the moment immediately prior to taking the daily dose; each individual symptom score ranged on a scale of 0 to 3 where 0 indicated healthy condition and 3 indicated severity of the symptoms. The total score ranged on a scale of 0 to 12 where 0 indicated healthy condition and 12 indicated worst condition of symptoms. Baseline iTNSS is defined as the average of the non-missing values for iTNSS during the Baseline period where the Baseline period included the randomization day and the 3 consecutive days prior to randomization. Change from Baseline was calculated as score over the entire treatment period minus Baseline value. Analysis was performed using ANCOVA, adjusting for Baseline value, country, age, and gender. Only those participants available at the specified time points were analyzed.

Outcome measures

Outcome measures
Measure	Placebo n=149 Participants Eligible participants received aqueous nasal spray of matching Placebo once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug.	Fluticasone Furoate n=150 Participants Eligible participants received aqueous nasal spray of Fluticasone furoate 100 mcg once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug.
Mean Change From Baseline (Day 1) in AM, Pre-dose, Instantaneous Total Nasal Symptom (iTNSS) Scores Over the Entire Treatment Period	-2.36 Scores on a scale Standard Error 0.18	-3.82 Scores on a scale Standard Error 0.18

SECONDARY outcome

Timeframe: Up to 6 weeks

Population: ITT population. Data is presented for the participants available at the time of assessment.

Response to therapy is defined as the effectiveness of FF for relieving allergic rhinitis symptoms over the entire treatment period. Response was, evaluated at the end of the study (Week 6) using a 7-point categorical scale, categorized as: 1=significantly improved, 2=moderately improved, 3=mildly improved, 4=no change, 5=mildly worse, 6=moderately worse, 7=significantly worse. Analysis was performed using logistic regression to evaluate treatment effect, adjusting for age, gender, and country. Effectiveness of the study drug for relieving allergic rhinitis symptoms over the entire treatment period was compared with Placebo.

Outcome measures

Outcome measures
Measure	Placebo n=151 Participants Eligible participants received aqueous nasal spray of matching Placebo once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug.	Fluticasone Furoate n=151 Participants Eligible participants received aqueous nasal spray of Fluticasone furoate 100 mcg once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug.
Number of Participants With Response to Therapy Over Entire Treatment Period Significantly Improved	21 Participants	56 Participants
Number of Participants With Response to Therapy Over Entire Treatment Period Mildly Worse	5 Participants	2 Participants
Number of Participants With Response to Therapy Over Entire Treatment Period Moderately Improved	38 Participants	37 Participants
Number of Participants With Response to Therapy Over Entire Treatment Period Mildly Improved	37 Participants	31 Participants
Number of Participants With Response to Therapy Over Entire Treatment Period No Change	45 Participants	20 Participants
Number of Participants With Response to Therapy Over Entire Treatment Period Moderately Worse	3 Participants	3 Participants
Number of Participants With Response to Therapy Over Entire Treatment Period Significantly Worse	2 Participants	2 Participants

SECONDARY outcome

Timeframe: Baseline (Day 1) and up to 6 weeks

Population: ITT population. Data is presented for the participants available at the time of assessment.

TNSS is the sum of symptom scores for rhinorrhea, nasal congestion, nasal itching, and sneezing (each scored on a scale of 0 \[none\] to 3 \[severe\]; total possible score of 0 to 12). The AM rTNSS is a rating of the severity of symptoms performed in the morning prior to administering the dose of study drug and assesses how the participant felt during the night (preceding 12 hours). Baseline rTNSS is defined as the average of the non-missing values for rTNSS during the Baseline period where the Baseline period included the randomization day and the 3 consecutive days prior to randomization. Change from Baseline was calculated as score over the entire treatment period minus Baseline value. Analysis was performed using ANCOVA, adjusting for Baseline value, country, age, and gender. Only those participants available at the specified time points were analyzed.

Outcome measures

Outcome measures
Measure	Placebo n=149 Participants Eligible participants received aqueous nasal spray of matching Placebo once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug.	Fluticasone Furoate n=150 Participants Eligible participants received aqueous nasal spray of Fluticasone furoate 100 mcg once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug.
Mean Change From Baseline (Day 1) in AM rTNSS Over the Entire Treatment Period	-2.66 Scores on a scale Standard Error 0.17	-3.93 Scores on a scale Standard Error 0.17

SECONDARY outcome

Timeframe: Baseline (Day 1) and up to 6 weeks

Population: ITT population. Data is presented for the participants available at the time of assessment.

TNSS is the sum of symptom scores for rhinorrhea, nasal congestion, nasal itching, and sneezing (each scored on a scale of 0 \[none\] to 3 \[severe\]; total possible score of 0 to 12). The PM rTNSS is a rating of the severity of symptoms performed approximately 12 hours after dosing and before bedtime and assesses how the participant felt during the day. Baseline rTNSS is defined as the average of the non-missing values for rTNSS during the Baseline period where the baseline period includes the 4 consecutive days prior to randomization. Change from Baseline was calculated as score over the entire treatment period minus Baseline value. Analysis was performed using ANCOVA, adjusting for Baseline value, country, age, and gender. Only those participants available at the specified time points were analyzed.

Outcome measures

Outcome measures
Measure	Placebo n=150 Participants Eligible participants received aqueous nasal spray of matching Placebo once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug.	Fluticasone Furoate n=150 Participants Eligible participants received aqueous nasal spray of Fluticasone furoate 100 mcg once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug.
Mean Change From Baseline (Day 1) in PM rTNSS Over the Entire Treatment Period	-2.73 Scores on a scale Standard Error 0.18	-4.02 Scores on a scale Standard Error 0.18

SECONDARY outcome

Timeframe: Baseline (Day 1) and up to 6 weeks

Population: ITT population. Data is presented for the participants available at the time of assessment.

Outcome measures

Outcome measures
Measure	Placebo n=150 Participants Eligible participants received aqueous nasal spray of matching Placebo once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug.	Fluticasone Furoate n=151 Participants Eligible participants received aqueous nasal spray of Fluticasone furoate 100 mcg once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug.
Mean Percent Change From Baseline (Day 1) in Daily rTNSS Over the Entire Treatment Period	-30.23 Percent change Standard Error 2.22	-44.35 Percent change Standard Error 2.21

SECONDARY outcome

Timeframe: Baseline and up to 6 weeks

Population: ITT population. Data is presented for the participants available at the time of assessment.

TNSS is the sum of symptom scores for rhinorrhea, nasal congestion, nasal itching, and sneezing (each scored on a scale of 0 \[none\] to 3 \[severe\]; total possible score of 0 to 12). The rTNSS is a rating of the severity of symptoms over the previous 12 hours and is performed in morning (AM) and evening (PM). Daily rTNSS is defined as average of the PM rTNSS and the AM rTNSS of the next day prior to AM dosing. The BL daily rTNSS is defined as the average of the daily rTNSS over 4 consecutive 24-hour periods prior to randomization plus randomization day AM assessment. Change from Baseline was calculated as average of the non-missing daily rTNSS minus Baseline daily rTNSS. Analysis was performed using ANCOVA, adjusting for BL daily rTNSS, country, age, and gender. Only those participants available at the specified time points were analyzed. Change from Baseline is the value at indicated time-point minus the baseline value\*100.

Outcome measures

Outcome measures
Measure	Placebo n=149 Participants Eligible participants received aqueous nasal spray of matching Placebo once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug.	Fluticasone Furoate n=150 Participants Eligible participants received aqueous nasal spray of Fluticasone furoate 100 mcg once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug.
Mean Percent Change From Baseline (Day 1) in AM Pre-Dose iTNSS Over the Entire Treatment Period	-24.67 Percent change Standard Error 2.66	-44.70 Percent change Standard Error 2.66

SECONDARY outcome

Timeframe: Baseline (Day 1) and up to 6 weeks

Population: ITT population. Only those participants available at the time of assessment were analyzed.

The individual nasal symptom scores (INSS) for rhinorrhea, nasal congestion, nasal itching and sneezing were assessed on a 4 point (0 \[none\] to 3 \[severe\]) categorical scale and larger score indicates severe symptoms. The INSS is a rating of the severity of symptoms over the previous 12 hours and is performed in AM and PM. Daily INSS is defined as average of the PM INSS and the AM INSS of the next day prior to AM dosing. The Baseline daily INSS is defined as the average of the daily INSS over 4 consecutive 24-hour periods prior to randomization plus randomization day AM assessment. Change from Baseline was calculated as average of the non-missing daily INSS minus Baseline daily INSS. Analysis was performed using ANCOVA, adjusting for Baseline value, country, age, and gender.

Outcome measures

Outcome measures
Measure	Placebo n=150 Participants Eligible participants received aqueous nasal spray of matching Placebo once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug.	Fluticasone Furoate n=151 Participants Eligible participants received aqueous nasal spray of Fluticasone furoate 100 mcg once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug.
Mean Change From Baseline (Day 1) in Daily Reflective Individual Nasal Symptom Scores (rINSS) Over the Entire Treatment Period Rhinorrhea	-0.67 Scores on a scale Standard Error 0.05	-0.94 Scores on a scale Standard Error 0.05
Mean Change From Baseline (Day 1) in Daily Reflective Individual Nasal Symptom Scores (rINSS) Over the Entire Treatment Period Nasal Congestion	-0.69 Scores on a scale Standard Error 0.05	-0.97 Scores on a scale Standard Error 0.05
Mean Change From Baseline (Day 1) in Daily Reflective Individual Nasal Symptom Scores (rINSS) Over the Entire Treatment Period Nasal Itching	-0.65 Scores on a scale Standard Error 0.05	-0.98 Scores on a scale Standard Error 0.05
Mean Change From Baseline (Day 1) in Daily Reflective Individual Nasal Symptom Scores (rINSS) Over the Entire Treatment Period Sneezing	-0.68 Scores on a scale Standard Error 0.05	-1.07 Scores on a scale Standard Error 0.05

SECONDARY outcome

Timeframe: Baseline (Day 1) and up to 6 weeks

Population: ITT population. Data is presented for the participants available at the time of assessment.

The iINSS score for rhinorrhea, nasal congestion, nasal itching and sneezing were assessed on a 4 point (0 \[none\] to 3 \[severe\]) categorical scale and larger score indicates severe symptoms. The AM pre-dose iINSS is a rating of the severity of symptoms performed at the moment immediately prior to dosing. Baseline iINSS is defined as the average of the non-missing values for iINSS during the Baseline period where the Baseline period included the randomization day and the 3 consecutive days prior to randomization. Change from Baseline was calculated as score over the entire treatment period minus Baseline value. Analysis was performed using ANCOVA, adjusting for Baseline value, country, age, and gender. Only those participants available at the specified time points were analyzed.

Outcome measures

Outcome measures
Measure	Placebo n=149 Participants Eligible participants received aqueous nasal spray of matching Placebo once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug.	Fluticasone Furoate n=150 Participants Eligible participants received aqueous nasal spray of Fluticasone furoate 100 mcg once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug.
Mean Change From Baseline (Day 1) in AM Pre-dose Instantaneous Individual Nasal Symptom Score (iINSS) Over the Entire Treatment Period Rhinorrhea	-0.57 Scores on a scale Standard Error 0.05	-0.93 Scores on a scale Standard Error 0.05
Mean Change From Baseline (Day 1) in AM Pre-dose Instantaneous Individual Nasal Symptom Score (iINSS) Over the Entire Treatment Period Nasal Congestion	-0.55 Scores on a scale Standard Error 0.05	-0.92 Scores on a scale Standard Error 0.05
Mean Change From Baseline (Day 1) in AM Pre-dose Instantaneous Individual Nasal Symptom Score (iINSS) Over the Entire Treatment Period Nasal Itching	-0.61 Scores on a scale Standard Error 0.05	-0.98 Scores on a scale Standard Error 0.05
Mean Change From Baseline (Day 1) in AM Pre-dose Instantaneous Individual Nasal Symptom Score (iINSS) Over the Entire Treatment Period Sneezing	-0.63 Scores on a scale Standard Error 0.05	-1.00 Scores on a scale Standard Error 0.05

SECONDARY outcome

Timeframe: Baseline (Day 1) and up to 6 weeks

Population: ITT population. Data is presented for the participants available at the time of assessment.

INSS for rhinorrhea, nasal congestion, nasal itching and sneezing were assessed on a 4 point (0 \[none\] to 3 \[severe\]) categorical scale and larger score indicates severe symptoms. The AM rINSS is a rating of the severity of symptoms performed in the morning prior to administering the dose of study drug and assesses how the participant felt during the night (preceding 12 hours). Baseline rINSS is defined as the average of the non-missing values for rINSS during the Baseline period where the Baseline period included the randomization day and the 3 consecutive days prior to randomization. Change from Baseline was calculated as score over the entire treatment period minus Baseline value. Analysis was performed using ANCOVA, adjusting for Baseline value, country, age, and gender. Only those par. available at the specified time points were analyzed.

Outcome measures

Outcome measures
Measure	Placebo n=149 Participants Eligible participants received aqueous nasal spray of matching Placebo once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug.	Fluticasone Furoate n=150 Participants Eligible participants received aqueous nasal spray of Fluticasone furoate 100 mcg once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug.
Mean Change From Baseline (Day 1) in AM rINSS Over the Entire Treatment Rhinorrhea	-0.67 Scores on a scale Standard Error 0.05	-0.95 Scores on a scale Standard Error 0.05
Mean Change From Baseline (Day 1) in AM rINSS Over the Entire Treatment Nasal Congestion	-0.66 Scores on a scale Standard Error 0.05	-0.98 Scores on a scale Standard Error 0.05
Mean Change From Baseline (Day 1) in AM rINSS Over the Entire Treatment Nasal Itching	-0.64 Scores on a scale Standard Error 0.05	-0.96 Scores on a scale Standard Error 0.05
Mean Change From Baseline (Day 1) in AM rINSS Over the Entire Treatment Sneezing	-0.69 Scores on a scale Standard Error 0.05	-1.06 Scores on a scale Standard Error 0.05

SECONDARY outcome

Timeframe: Baseline (Day 1) and up to 6 weeks

Population: ITT population

rINSS for rhinorrhea, nasal congestion, nasal itching and sneezing were assessed on a 4 point (0 \[none\] to 3 \[severe\]) categorical scale and larger score indicates severe symptoms. The PM rINSS is a rating of the severity of symptoms performed approximately 12 hours after dosing and before bedtime and assesses how the participant felt during the day. Baseline rINSS is defined as the average of the non-missing values for rINSS during the Baseline period where the Baseline period included the 4 consecutive days prior to randomization. Change from Baseline was calculated as score over the entire treatment period minus Baseline value. Analysis was performed using ANCOVA, adjusting for Baseline value, country, age, and gender. Only those par. available at the specified time points were analyzed.

Outcome measures

Outcome measures
Measure	Placebo n=150 Participants Eligible participants received aqueous nasal spray of matching Placebo once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug.	Fluticasone Furoate n=150 Participants Eligible participants received aqueous nasal spray of Fluticasone furoate 100 mcg once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug.
Mean Change From Baseline (Day 1) in PM rINSS Over the Entire Treatment Period Rhinorrhea	-0.66 Scores on a scale Standard Error 0.05	-0.96 Scores on a scale Standard Error 0.05
Mean Change From Baseline (Day 1) in PM rINSS Over the Entire Treatment Period Nasal Congestion	-0.70 Scores on a scale Standard Error 0.05	-0.97 Scores on a scale Standard Error 0.05
Mean Change From Baseline (Day 1) in PM rINSS Over the Entire Treatment Period Nasal Itching	-0.68 Scores on a scale Standard Error 0.05	-1.01 Scores on a scale Standard Error 0.05
Mean Change From Baseline (Day 1) in PM rINSS Over the Entire Treatment Period Sneezing	-0.68 Scores on a scale Standard Error 0.05	-1.09 Scores on a scale Standard Error 0.05

SECONDARY outcome

Timeframe: Baseline (Day 1) and up to 6 weeks

Population: ITT population. Data is presented for the participants available at the time of assessment.

TOSS is defined as the sum of the 3 individual ocular symptom scores for itching/burning eyes, tearing/watering eyes, and eye redness, and ranges from 0 to 9. Each symptom is scored on a 4 point (0 \[none\] to 3 \[severe\]) categorical scale. The rTOSS is a rating of the severity of symptoms over the previous 12 hours and is performed in AM and PM. Daily rTOSS is defined as average of the PM rTOSS and the AM rTOSS of the next day prior to AM dosing. The BL daily rTOSS is defined as the average of the daily rTOSS over 4 consecutive 24-hour periods prior to randomization plus randomization day AM assessment. Change from BL was calculated as average of the non-missing daily rTOSS minus BL daily rTOSS. Analysis was performed using ANCOVA, adjusting for BL value, country, age, and gender. Only those participants available at the specified time points were analyzed.

Outcome measures

Outcome measures
Measure	Placebo n=150 Participants Eligible participants received aqueous nasal spray of matching Placebo once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug.	Fluticasone Furoate n=151 Participants Eligible participants received aqueous nasal spray of Fluticasone furoate 100 mcg once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug.
Mean Change From Baseline (Day 1) in Daily Reflective Total Ocular Symptom Score (rTOSS) Over the Entire Treatment Period	-1.41 Scores on a scale Standard Deviation 0.13	-1.92 Scores on a scale Standard Deviation 0.13

SECONDARY outcome

Timeframe: Baseline (Day 1) and up to 6 weeks

Population: ITT population. Data is presented for the participants available at the time of assessment.

The TOSS score is defined as the sum of the 3 individual ocular symptom scores for itching/burning eyes, tearing/watering eyes, and eye redness, and ranges from 0 to 9. Each symptom is scored on a 4 point (0 \[none\] to 3 \[severe\]) categorical scale. The AM pre-dose iTOSS is a rating of the severity of symptoms performed at the moment immediately prior to dosing. Baseline iTOSS is defined as the average of the non-missing values for iTOSS during the Baseline period where the Baseline period included the randomization day and the 3 consecutive days prior to randomization. Change from Baseline was calculated as score over the entire treatment period minus Baseline value. Analysis was performed using ANCOVA, adjusting for Baseline value, country, age, and gender.

Outcome measures

Outcome measures
Measure	Placebo n=149 Participants Eligible participants received aqueous nasal spray of matching Placebo once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug.	Fluticasone Furoate n=150 Participants Eligible participants received aqueous nasal spray of Fluticasone furoate 100 mcg once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug.
Mean Change From Baseline (Day 1) in AM Pre-dose Instantaneous TOSS (iTOSS) Over the Entire Treatment Period	-1.26 Scores on a scale Standard Error 0.13	-1.76 Scores on a scale Standard Error 0.13

SECONDARY outcome

Timeframe: Baseline (Day 1) and up to 6 weeks

Population: ITT population. Data is presented for the participants available at the time of assessment.

The TOSS score is defined as the sum of the 3 individual ocular symptom scores for itching/burning eyes, tearing/watering eyes, and eye redness, and ranges from 0 to 9. Each symptom is scored on a 4 point (0 \[none\] to 3 \[severe\]) categorical scale and larger score indicates more severe symptoms. The AM rTOSS is a rating of the severity of symptoms performed in the morning prior to administering the dose of study drug and assesses how the participant felt during the night (preceding 12 hours). Baseline rTOSS is defined as the average of the non-missing values for rTOSS during the Baseline period where the Baseline period includes the randomization day and the 3 consecutive days prior to randomization. Change from Baseline was calculated as score over the entire treatment period minus Baseline value. Analysis was performed using ANCOVA, adjusting for Baseline value, country, age, and gender. Only those participants available at the specified time points were analyzed

Outcome measures

Outcome measures
Measure	Placebo n=149 Participants Eligible participants received aqueous nasal spray of matching Placebo once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug.	Fluticasone Furoate n=150 Participants Eligible participants received aqueous nasal spray of Fluticasone furoate 100 mcg once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug.
Mean Change From Baseline (Day 1) in AM rTOSS Over the Entire Treatment Period	-1.39 Scores on a scale Standard Deviation 0.13	-1.92 Scores on a scale Standard Deviation 0.13

SECONDARY outcome

Timeframe: Baseline (Day 1) and up to 6 weeks

Population: ITT population. Data is presented for the participants available at the time of assessment.

The TOSS score is defined as the sum of the 3 individual ocular symptom scores for itching/burning eyes, tearing/watering eyes, and eye redness, and ranges from 0 to 9. Each symptom is scored on a 4 point (0 \[none\] to 3 \[severe\]) categorical scale. The PM rTOSS is a rating of the severity of symptoms performed approximately 12 hours after dosing and before bedtime and assesses how the participant felt during the day. Baseline rTOSS is defined as the average of the non-missing values for rTOSS during the Baseline period where the baseline period includes the 4 consecutive days prior to randomization. Change from Baseline was calculated as score over the entire treatment period minus Baseline value. Analysis was performed using ANCOVA, adjusting for Baseline value, country, age, and gender. Only those participants available at the specified time points were analyzed.

Outcome measures

Outcome measures
Measure	Placebo n=150 Participants Eligible participants received aqueous nasal spray of matching Placebo once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug.	Fluticasone Furoate n=150 Participants Eligible participants received aqueous nasal spray of Fluticasone furoate 100 mcg once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug.
Mean Change From Baseline (Day 1) in PM rTOSS Over the Entire Treatment Period	-1.44 Scores on a scale Standard Error 0.13	-1.93 Scores on a scale Standard Error 0.13

SECONDARY outcome

Timeframe: Baseline (Day 1) and up to 6 weeks

Population: ITT population. Data is presented for the participants available at the time of assessment.

Individual ocular symptom scores (IOSS) for itching/burning eyes, tearing/watering eyes, and eye redness were assessed on a 4 point (0 \[none\]to 3 \[severe\]) categorical scale. The IOSS is a rating of the severity of symptoms over the previous 12 hours and is performed in AM and PM. Daily IOSS is defined as average of the PM IOSS and the AM IOSS of the next day prior to AM dosing. The BL daily IOSS is defined as the average of the daily IOSS over 4 consecutive 24-hour periods prior to randomization plus randomization day AM assessment. Change from BL was calculated as average of the non-missing daily IOSS minus BL daily IOSS. Analysis was performed using ANCOVA, adjusting for BL value, country, age, and gender.

Outcome measures

Outcome measures
Measure	Placebo n=150 Participants Eligible participants received aqueous nasal spray of matching Placebo once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug.	Fluticasone Furoate n=151 Participants Eligible participants received aqueous nasal spray of Fluticasone furoate 100 mcg once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug.
Mean Change From Baseline (Day 1) in Daily Reflective Individual Ocular Symptom Scores (iIOSS) Over the Entire Treatment Period Eye itching/burning	-0.47 Scores on a scale Standard Error 0.05	-0.69 Scores on a scale Standard Error 0.05
Mean Change From Baseline (Day 1) in Daily Reflective Individual Ocular Symptom Scores (iIOSS) Over the Entire Treatment Period Eye tearing/watering	-0.48 Scores on a scale Standard Error 0.05	-0.62 Scores on a scale Standard Error 0.05
Mean Change From Baseline (Day 1) in Daily Reflective Individual Ocular Symptom Scores (iIOSS) Over the Entire Treatment Period Eye redness	-0.45 Scores on a scale Standard Error 0.04	-0.61 Scores on a scale Standard Error 0.04

SECONDARY outcome

Timeframe: Baseline (Day 1) and up to 6 weeks

Population: ITT population. Data is presented for the participants available at the time of assessment.

IOSS for itching/burning eyes, tearing/watering eyes, and eye redness were assessed on a 4 point (0 \[none\]to 3 \[severe\]) categorical scale. The AM pre-dose iIOSS is a rating of the severity of symptoms performed at the moment immediately prior to dosing. Baseline iIOSS is defined as the average of the non-missing values for iIOSS during the Baseline period where the Baseline period includes the randomization day and the 3 consecutive days prior to randomization. Change from Baseline is calculated as the score over the entire treatment period minus the score at Baseline. Analysis was performed using ANCOVA, adjusting for Baseline value, country, age, and gender.

Outcome measures

Outcome measures
Measure	Placebo n=149 Participants Eligible participants received aqueous nasal spray of matching Placebo once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug.	Fluticasone Furoate n=150 Participants Eligible participants received aqueous nasal spray of Fluticasone furoate 100 mcg once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug.
Mean Change From Baseline (Day 1) in AM Pre-Dose Instantaneous Individual Ocular Symptom Score (iIOSS) Over the Entire Treatment Period Eye itching/burning	-0.39 Scores on a scale Standard Error 0.05	-0.6 Scores on a scale Standard Error 0.5
Mean Change From Baseline (Day 1) in AM Pre-Dose Instantaneous Individual Ocular Symptom Score (iIOSS) Over the Entire Treatment Period Eye tearing/watering	-0.43 Scores on a scale Standard Error 0.05	-0.59 Scores on a scale Standard Error 0.05
Mean Change From Baseline (Day 1) in AM Pre-Dose Instantaneous Individual Ocular Symptom Score (iIOSS) Over the Entire Treatment Period Eye redness	-0.45 Scores on a scale Standard Error 0.05	-0.56 Scores on a scale Standard Error 0.05

SECONDARY outcome

Timeframe: Baseline (Day 1) and up to 6 weeks

Population: ITT population. Data is presented for the participants available at the time of assessment.

rIOSS for itching/burning eyes, tearing/watering eyes, and eye redness were assessed on a 4 point (0 \[none\]to 3 \[severe\]) categorical scale. The AM rIOSS is a rating of the severity of symptoms performed in the morning prior to administering the dose of study drug and assesses how the participant felt during the night (preceding 12 hours). Baseline rIOSS is defined as the average of the non-missing values for rIOSS during the Baseline period where the Baseline period includes the randomization day and the 3 consecutive days prior to randomization. Change from Baseline was calculated as score over the entire treatment period minus Baseline value. Analysis was performed using ANCOVA, adjusting for Baseline value, country, age, and gender.

Outcome measures

Outcome measures
Measure	Placebo n=149 Participants Eligible participants received aqueous nasal spray of matching Placebo once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug.	Fluticasone Furoate n=150 Participants Eligible participants received aqueous nasal spray of Fluticasone furoate 100 mcg once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug.
Mean Change From Baseline (Day 1) in AM Reflective Individual Ocular Symptom Score (rIOSS) Over the Entire Treatment Period Eye itching/burning	-0.48 Scores on a scale Standard Error 0.05	-0.69 Scores on a scale Standard Error 0.05
Mean Change From Baseline (Day 1) in AM Reflective Individual Ocular Symptom Score (rIOSS) Over the Entire Treatment Period Eye tearing/watering	-0.48 Scores on a scale Standard Error 0.05	-0.62 Scores on a scale Standard Error 0.05
Mean Change From Baseline (Day 1) in AM Reflective Individual Ocular Symptom Score (rIOSS) Over the Entire Treatment Period Eye redness	-0.44 Scores on a scale Standard Error 0.05	-0.61 Scores on a scale Standard Error 0.05

SECONDARY outcome

Timeframe: Baseline (Day 1) and up to 6 weeks

Population: ITT population. Data is presented for the participants available at the time of assessment.

IOSS for itching/burning eyes, tearing/watering eyes, and eye redness were assessed on a 4 point (0 \[none\]to 3 \[severe\]) categorical scale. The PM rIOSS is a rating of the severity of symptoms performed approximately 12 hours after dosing and before bedtime and assesses how the participant felt during the day. Baseline rIOSS is defined as the average of the non-missing values for rIOSS during the Baseline period where the baseline period includes the 4 consecutive days prior to randomization. Change from Baseline is calculated as the score over the entire treatment period minus the score at Baseline. Analysis was performed using ANCOVA, adjusting for Baseline value, country, age, and gender.

Outcome measures

Outcome measures
Measure	Placebo n=150 Participants Eligible participants received aqueous nasal spray of matching Placebo once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug.	Fluticasone Furoate n=150 Participants Eligible participants received aqueous nasal spray of Fluticasone furoate 100 mcg once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug.
Mean Change From Baseline (Day 1) in PM rIOSS Over the Entire Treatment Period Eye itching/burning	-0.47 Scores on a scale Standard Error 0.05	-0.69 Scores on a scale Standard Error 0.05
Mean Change From Baseline (Day 1) in PM rIOSS Over the Entire Treatment Period Eye tearing/watering	-0.49 Scores on a scale Standard Error 0.05	-0.62 Scores on a scale Standard Error 0.05
Mean Change From Baseline (Day 1) in PM rIOSS Over the Entire Treatment Period Eye redness	-0.47 Scores on a scale Standard Error 0.05	-0.61 Scores on a scale Standard Error 0.05

SECONDARY outcome

Timeframe: Baseline (Day 1) and up to 6 weeks

Population: ITT population. Data is presented for the participants available at the time of assessment.

PNIF is the tool for determining the extent of nasal airway obstruction. Participants used a portable hand-held inspiratory flow meter and face mask to measure and record PNIF. PNIF measurements was completed and recorded following assessment of allergy symptoms in the AM (prior to taking study medication), and 12 hours later in the PM (after recording allergy symptoms). Three measurements were taken and the highest measurement recorded on the electronic diary. Daily PNIF is defined as average of PM PNIF and AM PNIF of the next day prior to AM dosing. The Baseline is defined as average of the last 8 readings (4 AM and 4 PM) of PNIF measurement over the four 24-hour periods prior to randomization. Change from Baseline is calculated as the value over the entire treatment period minus the value at Baseline. Analysis was performed using ANCOVA, adjusting for BL value, country, age, and gender.

Outcome measures

Outcome measures
Measure	Placebo n=150 Participants Eligible participants received aqueous nasal spray of matching Placebo once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug.	Fluticasone Furoate n=151 Participants Eligible participants received aqueous nasal spray of Fluticasone furoate 100 mcg once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug.
Mean Change From Baseline (Day 1) in Daily Peak Nasal Inspiratory Flow (PNIF) Over the Entire Treatment Period	17.35 Liters per minute Standard Error 2.13	25.72 Liters per minute Standard Error 2.13

SECONDARY outcome

Timeframe: Baseline (Day 1) and up to 6 weeks

Population: ITT population. Data is presented for the participants available at the time of assessment.

PNIF is the tool for determining the extent of nasal airway obstruction. Participants used a portable hand-held inspiratory flow meter and face mask to measure and record PNIF. AM PNIF measurements was completed and recorded following assessment of allergy symptoms in the AM (prior to taking study medication). Three measurements were taken and the highest measurement recorded on the electronic diary. Baseline AM PNIF is defined as the average of the non-missing values for PNIF during the Baseline period where the Baseline period includes the randomization day and the 3 consecutive days prior to randomization. Change from Baseline is calculated as the value over the entire treatment period minus the value at Baseline. Analysis was performed using ANCOVA, adjusting for Baseline value, country, age, and gender.

Outcome measures

Outcome measures
Measure	Placebo n=149 Participants Eligible participants received aqueous nasal spray of matching Placebo once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug.	Fluticasone Furoate n=150 Participants Eligible participants received aqueous nasal spray of Fluticasone furoate 100 mcg once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug.
Mean Change From Baseline (Day 1) in AM PNIF Over the Entire Treatment Period	16.33 Liters per minute Standard Error 2.16	25.61 Liters per minute Standard Error 2.17

SECONDARY outcome

Timeframe: Baseline (Day 1) and up to 6 weeks

Population: ITT population. Data is presented for the participants available at the time of assessment.

The PNIF score is the tool for determining the extent of nasal airway obstruction. Participants used a portable hand-held inspiratory flow meter and face mask to measure and record PNIF. PM PNIF measurements was completed and recorded after assessment of allergy symptoms in the PM (12 hours after study medication). Three measurements were taken on each occasion and the highest measurement recorded on the electronic diary. Baseline PM PNIF is defined as the average of the non-missing values for PNIF during the Baseline period where the Baseline period includes the 4 consecutive days prior to randomization. Change from baseline is calculated as the value over the entire treatment period minus the value at Baseline. Analysis was performed using ANCOVA, adjusting for Baseline value, country, age, and gender.

Outcome measures

Outcome measures
Measure	Placebo n=150 Participants Eligible participants received aqueous nasal spray of matching Placebo once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug.	Fluticasone Furoate n=147 Participants Eligible participants received aqueous nasal spray of Fluticasone furoate 100 mcg once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug.
Mean Change From Baseline (Day 1) in PM PNIF Over the Entire Treatment Period	18.51 Liters per minute Standard Error 2.15	26.15 Liters per minute Standard Error 2.20

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 66 other events

Deaths: 0 deaths

Fluticasone Furoate

Serious events: 1 serious events

Other events: 77 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo n=151 participants at risk Eligible participants received aqueous nasal spray of matching Placebo once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug.	Fluticasone Furoate n=151 participants at risk Eligible participants received aqueous nasal spray of Fluticasone furoate 100 micrograms (mcg) once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug.
Infections and infestations Acute sinusitis	0.00% 0/151 • Serious adverse events (SAEs) and non-serious adverse events (nSAEs) were collected from the start of study treatment until follow-up period (Up to 48 days). SAEs and non-serious AEs were reported for members of the ITT population that comprised of all participants who were randomised to treatment, and received at least one dose of study drug.	0.66% 1/151 • Serious adverse events (SAEs) and non-serious adverse events (nSAEs) were collected from the start of study treatment until follow-up period (Up to 48 days). SAEs and non-serious AEs were reported for members of the ITT population that comprised of all participants who were randomised to treatment, and received at least one dose of study drug.

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