Trial Outcomes & Findings for Study Of Adults And Adolescents With Vasomotor Rhinitis (NCT NCT00117325)

Last Updated: 2018-03-13

Results Overview

The daily rTNSS was the average of the AM (morning) and PM (before bed time) rTNSS assessments. Each rTNSS assessment comprised the sum of the three nasal symptom scores for rhinorrhea, nasal congestion and postnasal drip where each symptom was scored on a scale of 0 (no symptoms) to 3 (severe symptoms).. The severity of symptoms was defined as 0: none-symptom was not present, 1: mild-sign/symptom was clearly present but minimal awareness; easily tolerated, 2: moderate-definite awareness of sign/symptom that was bothersome but tolerable, 3: severe (sign/symptom was hard to tolerate; causes interference with activities of daily living and/or sleeping. Change from Baseline was calculated as any post-Baseline value minus the Baseline value. Baseline visit was 4 days prior to randomization (Day 1).

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

352 participants

Primary outcome timeframe

Baseline (4 days prior to randomization [Day 1]) and up to Week 4

Results posted on

2018-03-13

Participant Flow

The actual dose delivered from the product was 27.5 micrograms (µg) /actuation, which is therefore proposed as the label claim rather than 25 µg/actuation. Based on this spray content assessment, the dose examined in this study was actually 110 µg rather than the 100 µg dose indicated in the protocol.

Out of 901 participants screened, 549 participants were screen failures and hence were not randomized into the study. Out of 901 participants screened, 352 participants were randomized from 11 July 2005 to 16 January 2006.

Participant milestones

Participant milestones
Measure	Placebo Participants received placebo matching with GW685698X aqueous nasal spray 110 microgram (mcg) administered as two sprays from the device into each nostril once daily every morning up to 4 weeks.	Fluticasone Furoate 110 mcg QD Participants received Fluticasone Furoate (GW 685698X) aqueous nasal spray 110 mcg administered as two sprays from the device into each nostril once daily every morning up to 4 weeks.
Overall Study STARTED	173	179
Overall Study COMPLETED	160	167
Overall Study NOT COMPLETED	13	12

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Participants received placebo matching with GW685698X aqueous nasal spray 110 microgram (mcg) administered as two sprays from the device into each nostril once daily every morning up to 4 weeks.	Fluticasone Furoate 110 mcg QD Participants received Fluticasone Furoate (GW 685698X) aqueous nasal spray 110 mcg administered as two sprays from the device into each nostril once daily every morning up to 4 weeks.
Overall Study Adverse Event	3	3
Overall Study Lost to Follow-up	1	1
Overall Study Protocol Violation	2	3
Overall Study Withdrawal by Subject	3	2
Overall Study Lack of Efficacy	1	0
Overall Study Use of prohibited medicine	1	2
Overall Study Early termination	1	1
Overall Study Admisnitrative	1	0

Baseline Characteristics

Study Of Adults And Adolescents With Vasomotor Rhinitis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=173 Participants Participants received placebo matching with GW685698X aqueous nasal spray 110 mcg administered as two sprays from the device into each nostril once daily every morning up to 4 weeks.	Fluticasone Furoate 110 mcg QD n=179 Participants Participants received GW685698X aqueous nasal spray 110 mcg administered as two sprays from the device into each nostril once daily every morning up to 4 weeks.	Total n=352 Participants Total of all reporting groups
Age, Continuous	45.0 Years STANDARD_DEVIATION 14.66 • n=5 Participants	46.6 Years STANDARD_DEVIATION 16.77 • n=7 Participants	45.8 Years STANDARD_DEVIATION 15.77 • n=5 Participants
Sex: Female, Male Female	122 Participants n=5 Participants	125 Participants n=7 Participants	247 Participants n=5 Participants
Sex: Female, Male Male	51 Participants n=5 Participants	54 Participants n=7 Participants	105 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	6 Participants n=5 Participants	4 Participants n=7 Participants	10 Participants n=5 Participants
Race (NIH/OMB) White	163 Participants n=5 Participants	169 Participants n=7 Participants	332 Participants n=5 Participants
Race (NIH/OMB) More than one race	3 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline (4 days prior to randomization [Day 1]) and up to Week 4

Population: Due to irregularities found during a compliance audit, a reduced intent-to-treat (RITT) population was defined which excludes two participants from one of the investigative sites.

Outcome measures

Outcome measures
Measure	Placebo n=170 Participants Participants received placebo matching with GW685698X aqueous nasal spray 110 mcg administered as two sprays from the device into each nostril once daily every morning up to 4 weeks.	Fluticasone Furoate 110 mcg QD n=176 Participants Participants received GW685698X aqueous nasal spray 110 mcg administered as two sprays from the device into each nostril once daily every morning up to 4 weeks.
Mean Change From Baseline Over the Entire Treatment Period in Daily Reflective Total Nasal Symptom Score (rTNSS)	-1.71 Score on scale Standard Error 0.16	-2.05 Score on scale Standard Error 0.15

SECONDARY outcome

Timeframe: Baseline (4 days prior to randomization [Day 1]) and up to Week 4

Population: Reduced ITT Population. Only those participants with data available at the indicated time points were analyzed.

The AM, pre-dose, iTNSS is the sum of the 3 individual nasal symptom score assessments for rhinorrhea, nasal congestion and postnasal drip performed at the moment immediately prior to taking their dose where each symptom was scored on a scale of 0 to 3 (0= no symptoms, 3= severe symptoms). . The severity of symptoms was defined as 0: none-symptom was not present, 1: mild-sign/symptom was clearly present but minimal awareness; easily tolerated, 2: moderate-definite awareness of sign/symptom that was bothersome but tolerable, 3: severe (sign/symptom was hard to tolerate; causes interference with activities of daily living and/or sleeping. Change from baseline was calculated as endpoint value minus the baseline value. Baseline visit was 4 days prior to randomization (Day 1).

Outcome measures

Outcome measures
Measure	Placebo n=170 Participants Participants received placebo matching with GW685698X aqueous nasal spray 110 mcg administered as two sprays from the device into each nostril once daily every morning up to 4 weeks.	Fluticasone Furoate 110 mcg QD n=176 Participants Participants received GW685698X aqueous nasal spray 110 mcg administered as two sprays from the device into each nostril once daily every morning up to 4 weeks.
Mean Change From Baseline Over the Entire Treatment Period in Morning (AM), Pre-dose, Instantaneous Total Nasal Symptom Scores (iTNSS)	-1.48 Score on scale Standard Error 0.16	-1.87 Score on scale Standard Error 0.16

SECONDARY outcome

Timeframe: Up to 4 weeks

Population: RITT population. Only those participants with data available at the indicated time points were analyzed.

The overall evaluation of Response to Therapy was based on a 7-point categorical scale where the participants rated their perception of the change or lack of change in their VMR (Vasomotor rhinitis) symptoms at the end of the study. The 7 categories were: 1=significantly improved, 2=moderately improved, 3= mildly improved, 4= no change, 5= mildly worse, 6= moderately worse, and 7= significantly worse.

Outcome measures

Outcome measures
Measure	Placebo n=168 Participants Participants received placebo matching with GW685698X aqueous nasal spray 110 mcg administered as two sprays from the device into each nostril once daily every morning up to 4 weeks.	Fluticasone Furoate 110 mcg QD n=176 Participants Participants received GW685698X aqueous nasal spray 110 mcg administered as two sprays from the device into each nostril once daily every morning up to 4 weeks.
Number of Participants With Overall Evaluation of Response to Therapy Significantly Improved	26 Participants	33 Participants
Number of Participants With Overall Evaluation of Response to Therapy Moderately Improved	37 Participants	40 Participants
Number of Participants With Overall Evaluation of Response to Therapy Mildly Improved	45 Participants	47 Participants
Number of Participants With Overall Evaluation of Response to Therapy No Change	52 Participants	50 Participants
Number of Participants With Overall Evaluation of Response to Therapy Mildly Worse	1 Participants	3 Participants
Number of Participants With Overall Evaluation of Response to Therapy Moderately Worse	4 Participants	1 Participants
Number of Participants With Overall Evaluation of Response to Therapy Significantly Worse	3 Participants	2 Participants

SECONDARY outcome

Timeframe: Baseline (4 days prior to randomization [Day 1]) and up to Week 4

Population: RITT population. Only those participants with data available at the indicated time points were analyzed.

The rTNSS is a rating of the severity of symptoms over the previous 12 hours and is performed in the AM (AM rTNSS). . The severity of symptoms was defined as 0: none-symptom was not present, 1: mild-sign/symptom was clearly present but minimal awareness; easily tolerated, 2: moderate-definite awareness of sign/symptom that was bothersome but tolerable, 3: severe (sign/symptom was hard to tolerate; causes interference with activities of daily living and/or sleeping. The TNSS was the sum of the individual symptom scores for rhinorrhoea, nasal congestion and post-nasal drip which was scored on a scale of 0-3. Change from Baseline was calculated as post randomization value minus the Baseline value. Baseline visit was 4 days prior to randomization (Day 1).

Outcome measures

Outcome measures
Measure	Placebo n=170 Participants Participants received placebo matching with GW685698X aqueous nasal spray 110 mcg administered as two sprays from the device into each nostril once daily every morning up to 4 weeks.	Fluticasone Furoate 110 mcg QD n=176 Participants Participants received GW685698X aqueous nasal spray 110 mcg administered as two sprays from the device into each nostril once daily every morning up to 4 weeks.
Mean Change From Baseline Over the Entire Treatment Period in AM Pre-dose rTNSS	-1.69 Score on scale Standard Error 0.16	-2.04 Score on scale Standard Error 0.16

SECONDARY outcome

Timeframe: Baseline (4 days prior to randomization [Day 1]) and up to Week 4

Population: RITT Population. Only those participants with data available at the indicated time points were analyzed.

The TNSS was the sum of the individual symptom scores for rhinorrhoea, nasal congestion and post-nasal drip which was scored on a scale of 0-3. The severity of symptoms was defined as 0: none-symptom was not present, 1: mild-sign/symptom was clearly present but minimal awareness; easily tolerated, 2: moderate-definite awareness of sign/symptom that was bothersome but tolerable, 3: severe (sign/symptom was hard to tolerate; causes interference with activities of daily living and/or sleeping. The rTNSS is a rating of the severity of symptoms over the previous 12 hours and is performed in the PM (PM rTNSS). Change from Baseline was calculated as any post-Baseline value minus the Baseline value. Baseline visit was 4 days prior to randomization (Day 1).

Outcome measures

Outcome measures
Measure	Placebo n=172 Participants Participants received placebo matching with GW685698X aqueous nasal spray 110 mcg administered as two sprays from the device into each nostril once daily every morning up to 4 weeks.	Fluticasone Furoate 110 mcg QD n=178 Participants Participants received GW685698X aqueous nasal spray 110 mcg administered as two sprays from the device into each nostril once daily every morning up to 4 weeks.
Mean Change From Baseline Over the Entire Treatment Period in Evening (PM) rTNSS	-1.77 Score on scale Standard Error 0.16	-2.07 Score on scale Standard Error 0.15

SECONDARY outcome

Timeframe: Baseline (4 days prior to randomization [Day 1]) and up to Week 4

Population: RITT Population. Only those participants with data available at the indicated time points were analyzed.

The daily rTNSS was the average of the AM (morning) and PM (before bed time) rTNSS assessments.The TNSS was the sum of the individual symptom scores for rhinorrhoea, nasal congestion and post-nasal drip which was scored on a scale of 0-3. The severity of symptoms was defined as 0: none-symptom was not present, 1: mild-sign/symptom was clearly present but minimal awareness; easily tolerated, 2: moderate-definite awareness of sign/symptom that was bothersome but tolerable, 3: severe (sign/symptom was hard to tolerate; causes interference with activities of daily living and/or sleeping. Change from Baseline was calculated as any post-Baseline value minus the Baseline value. Baseline visit was 4 days prior to randomization (Day 1).

Outcome measures

Outcome measures
Measure	Placebo n=170 Participants Participants received placebo matching with GW685698X aqueous nasal spray 110 mcg administered as two sprays from the device into each nostril once daily every morning up to 4 weeks.	Fluticasone Furoate 110 mcg QD n=176 Participants Participants received GW685698X aqueous nasal spray 110 mcg administered as two sprays from the device into each nostril once daily every morning up to 4 weeks.
Mean Percent Change From Baseline Over the Entire Treatment Period in Daily rTNSS	-26.14 Percent change in score Standard Error 2.45	-30.65 Percent change in score Standard Error 2.40

SECONDARY outcome

Timeframe: Baseline (4 days prior to randomization [Day 1]) and up to Week 4

Population: RITT Population. Only those participants with data available at the indicated time points were analyzed.

The AM, pre-dose, iTNSS is the sum of the 3 individual nasal symptom score assessments for rhinorrhea, nasal congestion and postnasal drip performed at the moment immediately prior to taking their dose where each symptom was scored on a scale of 0 to 3. The severity of symptoms was defined as 0: none-symptom was not present, 1: mild-sign/symptom was clearly present but minimal awareness; easily tolerated, 2: moderate-definite awareness of sign/symptom that was bothersome but tolerable, 3: severe (sign/symptom was hard to tolerate; causes interference with activities of daily living and/or sleeping. Change from Baseline was calculated as any post-Baseline value minus the Baseline value. Baseline visit was 4 days prior to randomization (Day 1).

Outcome measures

Outcome measures
Measure	Placebo n=170 Participants Participants received placebo matching with GW685698X aqueous nasal spray 110 mcg administered as two sprays from the device into each nostril once daily every morning up to 4 weeks.	Fluticasone Furoate 110 mcg QD n=176 Participants Participants received GW685698X aqueous nasal spray 110 mcg administered as two sprays from the device into each nostril once daily every morning up to 4 weeks.
Mean Percent Change From Baseline Over the Entire Treatment Period in AM, Pre-dose iTNSS	-21.09 Percent change in score Standard Error 2.54	-27.46 Percent change in score Standard Error 2.50

SECONDARY outcome

Timeframe: Baseline (4 days prior to randomization [Day 1]) and up to Week 4

Population: RITT Population. Only those participants with data available at the specified time points were analyzed.

The TNSS was the sum of the individual symptom scores for rhinorrhoea, nasal congestion and post-nasal drip which was scored on a scale of 0-3. The severity of symptoms was defined as 0: none-symptom was not present, 1: mild-sign/symptom was clearly present but minimal awareness; easily tolerated, 2: moderate-definite awareness of sign/symptom that was bothersome but tolerable, 3: severe (sign/symptom was hard to tolerate; causes interference with activities of daily living and/or sleeping. The daily reflective nasal symptom scores was the average of the AM (morning) and PM (before bed time) rTNSS assessments. Each rTNSS assessment comprised the sum of the three nasal symptom. Change from Baseline was calculated as any post-Baseline value minus the Baseline value. Baseline visit was 4 days prior to randomization (Day 1).

Outcome measures

Outcome measures
Measure	Placebo n=172 Participants Participants received placebo matching with GW685698X aqueous nasal spray 110 mcg administered as two sprays from the device into each nostril once daily every morning up to 4 weeks.	Fluticasone Furoate 110 mcg QD n=178 Participants Participants received GW685698X aqueous nasal spray 110 mcg administered as two sprays from the device into each nostril once daily every morning up to 4 weeks.
Mean Change From Baseline Over the Entire Treatment Period in Individual Daily, Reflective Nasal Symptom Scores for Rhinorrhea, Nasal Congestion and Post-nasal Drip Rhinorrhea	-0.50 Score on scale Standard Error 0.06	-0.62 Score on scale Standard Error 0.06
Mean Change From Baseline Over the Entire Treatment Period in Individual Daily, Reflective Nasal Symptom Scores for Rhinorrhea, Nasal Congestion and Post-nasal Drip Nasal Congestion	-0.68 Score on scale Standard Error 0.06	-0.81 Score on scale Standard Error 0.06
Mean Change From Baseline Over the Entire Treatment Period in Individual Daily, Reflective Nasal Symptom Scores for Rhinorrhea, Nasal Congestion and Post-nasal Drip Post-nasal Drip	-0.51 Score on scale Standard Error 0.06	-0.61 Score on scale Standard Error 0.06

SECONDARY outcome

Timeframe: Baseline (4 days prior to randomization [Day 1]) and up to Week 4

Population: RITT Population. Only those participants with data available at the specified time points were analyzed.

The AM, pre-dose, instantaneous nasal symptom score is the sum of the 3 individual nasal symptom score assessments for rhinorrhea, nasal congestion and postnasal drip performed at the moment immediately prior to taking their dose where each symptom was scored on a scale of 0 to 3 (0= no symptoms, 3= severe symptoms). Change from Baseline was calculated as any post-Baseline value minus the Baseline value. Baseline visit was 4 days prior to randomization (Day 1).

Outcome measures

Outcome measures
Measure	Placebo n=172 Participants Participants received placebo matching with GW685698X aqueous nasal spray 110 mcg administered as two sprays from the device into each nostril once daily every morning up to 4 weeks.	Fluticasone Furoate 110 mcg QD n=178 Participants Participants received GW685698X aqueous nasal spray 110 mcg administered as two sprays from the device into each nostril once daily every morning up to 4 weeks.
Mean Change From Baseline Over the Entire Treatment Period in Individual AM, Pre-dose, Instantaneous, Nasal Symptom Scores for Rhinorrhea, Nasal Congestion and Postnasal Drip Rhinorrhea	-0.44 Score on scale Standard Error 0.06	-0.56 Score on scale Standard Error 0.06
Mean Change From Baseline Over the Entire Treatment Period in Individual AM, Pre-dose, Instantaneous, Nasal Symptom Scores for Rhinorrhea, Nasal Congestion and Postnasal Drip Nasal congestion	-0.54 Score on scale Standard Error 0.06	-0.70 Score on scale Standard Error 0.06
Mean Change From Baseline Over the Entire Treatment Period in Individual AM, Pre-dose, Instantaneous, Nasal Symptom Scores for Rhinorrhea, Nasal Congestion and Postnasal Drip Post-nasal drip	-0.48 Score on scale Standard Error 0.06	-0.60 Score on scale Standard Error 0.06

SECONDARY outcome

Timeframe: Baseline (4 days prior to randomization [Day 1]) and up to Week 4

Population: RITT Population. Only those participants with data available at the specified time points were analyzed.

The reflective nasal symptom score is a rating of the severity of symptoms over the previous 12 hours and is performed in the AM (AM rTNSS). Score assessments for rhinorrhea, nasal congestion and postnasal drip performed at the moment immediately prior to taking their dose where each symptom was scored on a scale of 0 to 3 (0= no symptoms, 3= severe symptoms). Change from Baseline was calculated as any post-Baseline value minus the Baseline value. Baseline visit was 4 days prior to randomization (Day 1).

Outcome measures

Outcome measures
Measure	Placebo n=172 Participants Participants received placebo matching with GW685698X aqueous nasal spray 110 mcg administered as two sprays from the device into each nostril once daily every morning up to 4 weeks.	Fluticasone Furoate 110 mcg QD n=178 Participants Participants received GW685698X aqueous nasal spray 110 mcg administered as two sprays from the device into each nostril once daily every morning up to 4 weeks.
Mean Change From Baseline Over the Entire Treatment Period in Individual AM, Reflective Nasal Symptom Scores for Rhinorrhea, Nasal Congestion and Postnasal Drip Rhinorrhea	-0.48 Score on scale Standard Error 0.06	-0.61 Score on scale Standard Error 0.06
Mean Change From Baseline Over the Entire Treatment Period in Individual AM, Reflective Nasal Symptom Scores for Rhinorrhea, Nasal Congestion and Postnasal Drip Nasal congestion	-0.65 Score on scale Standard Error 0.06	-0.78 Score on scale Standard Error 0.06
Mean Change From Baseline Over the Entire Treatment Period in Individual AM, Reflective Nasal Symptom Scores for Rhinorrhea, Nasal Congestion and Postnasal Drip Post-nasal drip	-0.55 Score on scale Standard Error 0.06	-0.64 Score on scale Standard Error 0.06

SECONDARY outcome

Timeframe: Baseline (4 days prior to randomization [Day 1]) and up to Week 4

Population: RITT Population. Only those participants with data available at the specified time points were analyzed.

The reflective nasal symptom score is a rating of the severity of symptoms over the previous 12 hours and was performed in the PM (PM rTNSS). Score assessments for rhinorrhea, nasal congestion and postnasal drip performed at the moment immediately prior to taking their dose where each symptom was scored on a scale of 0 to 3 (0= no symptoms, 3= severe symptoms). Change from Baseline was calculated as any post-Baseline value minus the Baseline value. Baseline visit was 4 days prior to randomization (Day 1).

Outcome measures

Outcome measures
Measure	Placebo n=172 Participants Participants received placebo matching with GW685698X aqueous nasal spray 110 mcg administered as two sprays from the device into each nostril once daily every morning up to 4 weeks.	Fluticasone Furoate 110 mcg QD n=178 Participants Participants received GW685698X aqueous nasal spray 110 mcg administered as two sprays from the device into each nostril once daily every morning up to 4 weeks.
Mean Change From Baseline Over the Entire Treatment Period in Individual PM, Reflective, Nasal Symptom Scores for Rhinorrhea, Nasal Congestion and Postnasal Drip Rhinorrhea	-0.53 Score on scale Standard Error 0.06	-0.59 Score on scale Standard Error 0.06
Mean Change From Baseline Over the Entire Treatment Period in Individual PM, Reflective, Nasal Symptom Scores for Rhinorrhea, Nasal Congestion and Postnasal Drip Nasal congestion	-0.73 Score on scale Standard Error 0.06	-0.84 Score on scale Standard Error 0.06
Mean Change From Baseline Over the Entire Treatment Period in Individual PM, Reflective, Nasal Symptom Scores for Rhinorrhea, Nasal Congestion and Postnasal Drip Post-nasal drip	-0.49 Score on scale Standard Error 0.06	-0.59 Score on scale Standard Error 0.06

SECONDARY outcome

Timeframe: Baseline (4 days prior to randomization [Day 1]) and Daily for 28 days

Population: RITT population. Only those participants with data available at the specified time points were analyzed.

The onset of treatment effect was assessed by the mean change from Baseline in AM iTNSS (Days 1 to 28), the mean change from Baseline in daily rTNSS (Days 1 to 28), and mean change from Baseline in AM rTNSS and PM rTNSS. The time to maximum effect was also evaluated by the mean change from Baseline in daily rTNSS for Days 1 to 28. Change from Baseline was calculated as any post-Baseline value minus the Baseline value. Baseline visit was 4 days prior to randomization (Day 1).

Outcome measures

Outcome measures
Measure	Placebo n=172 Participants Participants received placebo matching with GW685698X aqueous nasal spray 110 mcg administered as two sprays from the device into each nostril once daily every morning up to 4 weeks.	Fluticasone Furoate 110 mcg QD n=178 Participants Participants received GW685698X aqueous nasal spray 110 mcg administered as two sprays from the device into each nostril once daily every morning up to 4 weeks.
Mean Scores Changes From Baseline as a Function of Time AM iTNSS Day 4	-0.96 Score on scale Standard Error 0.18	-1.22 Score on scale Standard Error 0.18
Mean Scores Changes From Baseline as a Function of Time AM iTNSS Day 21	-1.97 Score on scale Standard Error 0.22	-2.26 Score on scale Standard Error 0.22
Mean Scores Changes From Baseline as a Function of Time AM iTNSS Day 25	-1.93 Score on scale Standard Error 0.22	-2.36 Score on scale Standard Error 0.22
Mean Scores Changes From Baseline as a Function of Time AM iTNSS Day 26	-2.10 Score on scale Standard Error 0.23	-2.68 Score on scale Standard Error 0.22
Mean Scores Changes From Baseline as a Function of Time AM rTNSS Day 4	-1.11 Score on scale Standard Error 0.18	-1.45 Score on scale Standard Error 0.18
Mean Scores Changes From Baseline as a Function of Time AM rTNSS Day 5	-1.33 Score on scale Standard Error 0.19	-1.48 Score on scale Standard Error 0.18
Mean Scores Changes From Baseline as a Function of Time AM rTNSS Day 8	-1.74 Score on scale Standard Error 0.21	-1.85 Score on scale Standard Error 0.20
Mean Scores Changes From Baseline as a Function of Time AM rTNSS Day 10	-1.65 Score on scale Standard Error 0.21	-2.10 Score on scale Standard Error 0.20
Mean Scores Changes From Baseline as a Function of Time AM rTNSS Day 11	-1.66 Score on scale Standard Error 0.21	-1.96 Score on scale Standard Error 0.20
Mean Scores Changes From Baseline as a Function of Time AM rTNSS Day 12	-1.82 Score on scale Standard Error 0.21	-2.05 Score on scale Standard Error 0.20
Mean Scores Changes From Baseline as a Function of Time AM rTNSS Day 13	-1.87 Score on scale Standard Error 0.22	-2.06 Score on scale Standard Error 0.21
Mean Scores Changes From Baseline as a Function of Time AM rTNSS Day 16	-1.75 Score on scale Standard Error 0.22	-2.37 Score on scale Standard Error 0.21
Mean Scores Changes From Baseline as a Function of Time AM rTNSS Day 2	-0.97 Score on scale Standard Error 0.18	-1.20 Score on scale Standard Error 0.17
Mean Scores Changes From Baseline as a Function of Time AM rTNSS Day 3	-1.12 Score on scale Standard Error 0.18	-1.37 Score on scale Standard Error 0.18
Mean Scores Changes From Baseline as a Function of Time AM rTNSS Day 6	-1.30 Score on scale Standard Error 0.20	-1.59 Score on scale Standard Error 0.20
Mean Scores Changes From Baseline as a Function of Time AM rTNSS Day 7	-1.28 Score on scale Standard Error 0.21	-1.69 Score on scale Standard Error 0.20
Mean Scores Changes From Baseline as a Function of Time AM rTNSS Day 9	-1.73 Score on scale Standard Error 0.21	-1.94 Score on scale Standard Error 0.21
Mean Scores Changes From Baseline as a Function of Time AM rTNSS Day 14	-1.84 Score on scale Standard Error 0.21	-2.14 Score on scale Standard Error 0.20
Mean Scores Changes From Baseline as a Function of Time AM rTNSS Day 15	-1.67 Score on scale Standard Error 0.22	-2.15 Score on scale Standard Error 0.21
Mean Scores Changes From Baseline as a Function of Time AM rTNSS Day 17	-2.12 Score on scale Standard Error 0.22	-2.62 Score on scale Standard Error 0.22
Mean Scores Changes From Baseline as a Function of Time AM rTNSS Day 18	-2.22 Score on scale Standard Error 0.21	-2.48 Score on scale Standard Error 0.21
Mean Scores Changes From Baseline as a Function of Time AM rTNSS Day 19	-1.83 Score on scale Standard Error 0.22	-2.37 Score on scale Standard Error 0.21
Mean Scores Changes From Baseline as a Function of Time AM rTNSS Day 20	-2.18 Score on scale Standard Error 0.22	-2.42 Score on scale Standard Error 0.22
Mean Scores Changes From Baseline as a Function of Time AM rTNSS Day 21	-2.07 Score on scale Standard Error 0.22	-2.64 Score on scale Standard Error 0.22
Mean Scores Changes From Baseline as a Function of Time AM rTNSS Day 22	-2.02 Score on scale Standard Error 0.23	-2.44 Score on scale Standard Error 0.22
Mean Scores Changes From Baseline as a Function of Time AM rTNSS Day 23	-1.96 Score on scale Standard Error 0.23	-2.17 Score on scale Standard Error 0.22
Mean Scores Changes From Baseline as a Function of Time AM rTNSS Day 24	-2.03 Score on scale Standard Error 0.23	-2.57 Score on scale Standard Error 0.22
Mean Scores Changes From Baseline as a Function of Time AM rTNSS Day 25	-2.22 Score on scale Standard Error 0.23	-2.45 Score on scale Standard Error 0.22
Mean Scores Changes From Baseline as a Function of Time AM rTNSS Day 26	-2.19 Score on scale Standard Error 0.23	-2.59 Score on scale Standard Error 0.23
Mean Scores Changes From Baseline as a Function of Time AM rTNSS Day 27	-2.23 Score on scale Standard Error 0.23	-2.54 Score on scale Standard Error 0.23
Mean Scores Changes From Baseline as a Function of Time AM rTNSS Day 28	-1.82 Score on scale Standard Error 0.30	-2.55 Score on scale Standard Error 0.27
Mean Scores Changes From Baseline as a Function of Time PM rTNSS Day 1	-0.88 Score on scale Standard Error 0.20	-0.97 Score on scale Standard Error 0.19
Mean Scores Changes From Baseline as a Function of Time PM rTNSS Day 2	-0.91 Score on scale Standard Error 0.18	-1.19 Score on scale Standard Error 0.17
Mean Scores Changes From Baseline as a Function of Time PM rTNSS Day 3	-1.10 Score on scale Standard Error 0.19	-1.39 Score on scale Standard Error 0.19
Mean Scores Changes From Baseline as a Function of Time PM rTNSS Day 4	-1.17 Score on scale Standard Error 0.19	-1.42 Score on scale Standard Error 0.19
Mean Scores Changes From Baseline as a Function of Time PM rTNSS Day 5	-1.06 Score on scale Standard Error 0.19	-1.29 Score on scale Standard Error 0.18
Mean Scores Changes From Baseline as a Function of Time PM rTNSS Day 6	-1.13 Score on scale Standard Error 0.21	-1.42 Score on scale Standard Error 0.20
Mean Scores Changes From Baseline as a Function of Time PM rTNSS Day 7	-1.48 Score on scale Standard Error 0.20	-1.64 Score on scale Standard Error 0.20
Mean Scores Changes From Baseline as a Function of Time PM rTNSS Day 8	-1.34 Score on scale Standard Error 0.20	-1.73 Score on scale Standard Error 0.19
Mean Scores Changes From Baseline as a Function of Time PM rTNSS Day 9	-1.49 Score on scale Standard Error 0.21	-1.89 Score on scale Standard Error 0.20
Mean Scores Changes From Baseline as a Function of Time PM rTNSS Day 10	-1.58 Score on scale Standard Error 0.21	-2.07 Score on scale Standard Error 0.21
Mean Scores Changes From Baseline as a Function of Time PM rTNSS Day 11	-1.62 Score on scale Standard Error 0.22	-2.02 Score on scale Standard Error 0.22
Mean Scores Changes From Baseline as a Function of Time PM rTNSS Day 12	-1.86 Score on scale Standard Error 0.21	-2.29 Score on scale Standard Error 0.21
Mean Scores Changes From Baseline as a Function of Time PM rTNSS Day 13	-1.91 Score on scale Standard Error 0.22	-2.18 Score on scale Standard Error 0.21
Mean Scores Changes From Baseline as a Function of Time PM rTNSS Day 14	-1.85 Score on scale Standard Error 0.23	-2.15 Score on scale Standard Error 0.22
Mean Scores Changes From Baseline as a Function of Time PM rTNSS Day 15	-1.78 Score on scale Standard Error 0.22	-2.15 Score on scale Standard Error 0.21
Mean Scores Changes From Baseline as a Function of Time PM rTNSS Day 16	-1.84 Score on scale Standard Error 0.23	-2.33 Score on scale Standard Error 0.22
Mean Scores Changes From Baseline as a Function of Time PM rTNSS Day 17	-1.81 Score on scale Standard Error 0.22	-2.51 Score on scale Standard Error 0.22
Mean Scores Changes From Baseline as a Function of Time PM rTNSS Day 18	-2.22 Score on scale Standard Error 0.22	-2.54 Score on scale Standard Error 0.23
Mean Scores Changes From Baseline as a Function of Time PM rTNSS Day 19	-2.23 Score on scale Standard Error 0.21	-2.53 Score on scale Standard Error 0.21
Mean Scores Changes From Baseline as a Function of Time PM rTNSS Day 20	-2.17 Score on scale Standard Error 0.21	-2.52 Score on scale Standard Error 0.20
Mean Scores Changes From Baseline as a Function of Time PM rTNSS Day 21	-2.19 Score on scale Standard Error 0.23	-2.48 Score on scale Standard Error 0.22
Mean Scores Changes From Baseline as a Function of Time PM rTNSS Day 22	-2.03 Score on scale Standard Error 0.22	-2.53 Score on scale Standard Error 0.22
Mean Scores Changes From Baseline as a Function of Time PM rTNSS Day 23	-2.06 Score on scale Standard Error 0.23	-2.41 Score on scale Standard Error 0.22
Mean Scores Changes From Baseline as a Function of Time PM rTNSS Day 24	-2.25 Score on scale Standard Error 0.22	-2.64 Score on scale Standard Error 0.21
Mean Scores Changes From Baseline as a Function of Time PM rTNSS Day 25	-2.39 Score on scale Standard Error 0.23	-2.42 Score on scale Standard Error 0.22
Mean Scores Changes From Baseline as a Function of Time PM rTNSS Day 26	-2.31 Score on scale Standard Error 0.23	-2.54 Score on scale Standard Error 0.22
Mean Scores Changes From Baseline as a Function of Time PM rTNSS Day 27	-2.25 Score on scale Standard Error 0.23	-2.54 Score on scale Standard Error 0.22
Mean Scores Changes From Baseline as a Function of Time PM rTNSS Day 28	-2.07 Score on scale Standard Error 0.30	-2.68 Score on scale Standard Error 0.28
Mean Scores Changes From Baseline as a Function of Time AM iTNSS Day 1	-0.47 Score on scale Standard Error 0.16	-0.92 Score on scale Standard Error 0.16
Mean Scores Changes From Baseline as a Function of Time AM iTNSS Day 2	-0.69 Score on scale Standard Error 0.17	-1.01 Score on scale Standard Error 0.17
Mean Scores Changes From Baseline as a Function of Time AM iTNSS Day 3	-0.75 Score on scale Standard Error 0.18	-1.14 Score on scale Standard Error 0.18
Mean Scores Changes From Baseline as a Function of Time AM iTNSS Day 5	-1.15 Score on scale Standard Error 0.20	-1.45 Score on scale Standard Error 0.19
Mean Scores Changes From Baseline as a Function of Time AM iTNSS Day 6	-1.01 Score on scale Standard Error 0.20	-1.59 Score on scale Standard Error 0.19
Mean Scores Changes From Baseline as a Function of Time AM iTNSS Day 7	-1.17 Score on scale Standard Error 0.20	-1.55 Score on scale Standard Error 0.19
Mean Scores Changes From Baseline as a Function of Time AM iTNSS Day 8	-1.38 Score on scale Standard Error 0.20	-1.61 Score on scale Standard Error 0.20
Mean Scores Changes From Baseline as a Function of Time AM iTNSS Day 9	-1.47 Score on scale Standard Error 0.20	-1.66 Score on scale Standard Error 0.20
Mean Scores Changes From Baseline as a Function of Time AM iTNSS Day 10	-1.31 Score on scale Standard Error 0.21	-1.78 Score on scale Standard Error 0.21
Mean Scores Changes From Baseline as a Function of Time AM iTNSS Day 11	-1.48 Score on scale Standard Error 0.22	-1.66 Score on scale Standard Error 0.21
Mean Scores Changes From Baseline as a Function of Time AMiTNSS Day 12	-1.52 Score on scale Standard Error 0.22	-1.86 Score on scale Standard Error 0.21
Mean Scores Changes From Baseline as a Function of Time AM iTNSS Day 13	-1.48 Score on scale Standard Error 0.22	-1.83 Score on scale Standard Error 0.21
Mean Scores Changes From Baseline as a Function of Time AM iTNSS Day 14	-1.72 Score on scale Standard Error 0.21	-1.95 Score on scale Standard Error 0.20
Mean Scores Changes From Baseline as a Function of Time AM iTNSS Day 15	-1.54 Score on scale Standard Error 0.21	-1.92 Score on scale Standard Error 0.21
Mean Scores Changes From Baseline as a Function of Time AM iTNSS Day 16	-1.56 Score on scale Standard Error 0.21	-1.99 Score on scale Standard Error 0.21
Mean Scores Changes From Baseline as a Function of Time AM iTNSS Day 17	-1.64 Score on scale Standard Error 0.22	-2.20 Score on scale Standard Error 0.22
Mean Scores Changes From Baseline as a Function of Time AM iTNSS Day 18	-1.75 Score on scale Standard Error 0.21	-2.21 Score on scale Standard Error 0.21
Mean Scores Changes From Baseline as a Function of Time AM iTNSS Day 19	-1.70 Score on scale Standard Error 0.21	-2.33 Score on scale Standard Error 0.21
Mean Scores Changes From Baseline as a Function of Time AM iTNSS Day 20	-1.89 Score on scale Standard Error 0.22	-2.11 Score on scale Standard Error 0.21
Mean Scores Changes From Baseline as a Function of Time AM iTNSS Day 22	-1.73 Score on scale Standard Error 0.22	-2.32 Score on scale Standard Error 0.22
Mean Scores Changes From Baseline as a Function of Time AM iTNSS Day 23	-1.80 Score on scale Standard Error 0.23	-2.27 Score on scale Standard Error 0.22
Mean Scores Changes From Baseline as a Function of Time AM iTNSS Day 24	-1.93 Score on scale Standard Error 0.23	-2.40 Score on scale Standard Error 0.22
Mean Scores Changes From Baseline as a Function of Time AM iTNSS Day 27	-2.01 Score on scale Standard Error 0.23	-2.49 Score on scale Standard Error 0.22
Mean Scores Changes From Baseline as a Function of Time AM iTNSS Day 28	-1.96 Score on scale Standard Error 0.28	-2.62 Score on scale Standard Error 0.26
Mean Scores Changes From Baseline as a Function of Time rTNSS Day 1	-0.71 Score on scale Standard Error 0.16	-0.93 Score on scale Standard Error 0.15
Mean Scores Changes From Baseline as a Function of Time rTNSS Day 2	-0.91 Score on scale Standard Error 0.16	-1.17 Score on scale Standard Error 0.16
Mean Scores Changes From Baseline as a Function of Time rTNSS Day 3	-1.07 Score on scale Standard Error 0.17	-1.38 Score on scale Standard Error 0.16
Mean Scores Changes From Baseline as a Function of Time rTNSS Day 4	-1.15 Score on scale Standard Error 0.17	-1.43 Score on scale Standard Error 0.16
Mean Scores Changes From Baseline as a Function of Time rTNSS Day 5	-1.22 Score on scale Standard Error 0.17	-1.35 Score on scale Standard Error 0.17
Mean Scores Changes From Baseline as a Function of Time rTNSS Day 6	-1.21 Score on scale Standard Error 0.19	-1.51 Score on scale Standard Error 0.18
Mean Scores Changes From Baseline as a Function of Time rTNSS Day 7	-1.37 Score on scale Standard Error 0.19	-1.66 Score on scale Standard Error 0.18
Mean Scores Changes From Baseline as a Function of Time rTNSS Day 8	-1.58 Score on scale Standard Error 0.18	-1.82 Score on scale Standard Error 0.18
Mean Scores Changes From Baseline as a Function of Time rTNSS Day 9	-1.55 Score on scale Standard Error 0.20	-1.92 Score on scale Standard Error 0.19
Mean Scores Changes From Baseline as a Function of Time rTNSS Day 10	-1.60 Score on scale Standard Error 0.20	-2.06 Score on scale Standard Error 0.19
Mean Scores Changes From Baseline as a Function of Time rTNSS Day 11	-1.65 Score on scale Standard Error 0.20	-1.96 Score on scale Standard Error 0.20
Mean Scores Changes From Baseline as a Function of Time rTNSS Day 12	-1.81 Score on scale Standard Error 0.19	-2.14 Score on scale Standard Error 0.19
Mean Scores Changes From Baseline as a Function of Time rTNSS Day 13	-1.87 Score on scale Standard Error 0.20	-2.12 Score on scale Standard Error 0.20
Mean Scores Changes From Baseline as a Function of Time rTNSS Day 14	-1.83 Score on scale Standard Error 0.20	-2.17 Score on scale Standard Error 0.20
Mean Scores Changes From Baseline as a Function of Time rTNSS Day 15	-1.70 Score on scale Standard Error 0.20	-2.11 Score on scale Standard Error 0.20
Mean Scores Changes From Baseline as a Function of Time rTNSS Day 16	-1.82 Score on scale Standard Error 0.20	-2.38 Score on scale Standard Error 0.20
Mean Scores Changes From Baseline as a Function of Time rTNSS Day 17	-1.94 Score on scale Standard Error 0.21	-2.53 Score on scale Standard Error 0.20
Mean Scores Changes From Baseline as a Function of Time rTNSS Day 18	-2.21 Score on scale Standard Error 0.20	-2.51 Score on scale Standard Error 0.20
Mean Scores Changes From Baseline as a Function of Time rTNSS Day 19	-1.99 Score on scale Standard Error 0.20	-2.44 Score on scale Standard Error 0.20
Mean Scores Changes From Baseline as a Function of Time rTNSS Day 20	-2.16 Score on scale Standard Error 0.20	-2.47 Score on scale Standard Error 0.20
Mean Scores Changes From Baseline as a Function of Time rTNSS Day 21	-2.12 Score on scale Standard Error 0.21	-2.54 Score on scale Standard Error 0.20
Mean Scores Changes From Baseline as a Function of Time rTNSS Day 22	-2.01 Score on scale Standard Error 0.21	-2.47 Score on scale Standard Error 0.21
Mean Scores Changes From Baseline as a Function of Time rTNSS Day 23	-1.99 Score on scale Standard Error 0.21	-2.30 Score on scale Standard Error 0.20
Mean Scores Changes From Baseline as a Function of Time rTNSS Day 24	-2.12 Score on scale Standard Error 0.21	-2.60 Score on scale Standard Error 0.20
Mean Scores Changes From Baseline as a Function of Time rTNSS Day 25	-2.28 Score on scale Standard Error 0.22	-2.44 Score on scale Standard Error 0.21
Mean Scores Changes From Baseline as a Function of Time rTNSS Day 26	-2.25 Score on scale Standard Error 0.22	-2.57 Score on scale Standard Error 0.21
Mean Scores Changes From Baseline as a Function of Time rTNSS Day 27	-2.23 Score on scale Standard Error 0.22	-2.51 Score on scale Standard Error 0.21
Mean Scores Changes From Baseline as a Function of Time rTNSS Day 28	-1.93 Score on scale Standard Error 0.28	-2.58 Score on scale Standard Error 0.26
Mean Scores Changes From Baseline as a Function of Time AM rTNSS Day 1	-0.70 Score on scale Standard Error 0.18	-1.02 Score on scale Standard Error 0.17

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 65 other events

Deaths: 0 deaths

Fluticasone Furoate 110mcg QD

Serious events: 0 serious events

Other events: 61 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Results disclosure agreements

Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Publication restrictions are in place

Restriction type: OTHER

Other adverse events
Measure	Placebo n=173 participants at risk Participants received placebo matching with GW685698X aqueous nasal spray 110 mcg administered as two sprays from the device into each nostril once daily every morning up to 4 weeks.	Fluticasone Furoate 110mcg QD n=179 participants at risk Participants received GW685698X aqueous nasal spray 110 mcg administered as two sprays from the device into each nostril once daily every morning up to 4 weeks.
Nervous system disorders Headache	13.3% 23/173 • AEs were collected from screening up to 32 days ITT Population (participants who were randomized and received at least one dose of study drug was used for the analysis of serious adverse event (SAE) and non-serious AEs. Non-serious AEs have been reported for the treatment period (28 days).	6.7% 12/179 • AEs were collected from screening up to 32 days ITT Population (participants who were randomized and received at least one dose of study drug was used for the analysis of serious adverse event (SAE) and non-serious AEs. Non-serious AEs have been reported for the treatment period (28 days).
Nervous system disorders Sinus headache	1.7% 3/173 • AEs were collected from screening up to 32 days ITT Population (participants who were randomized and received at least one dose of study drug was used for the analysis of serious adverse event (SAE) and non-serious AEs. Non-serious AEs have been reported for the treatment period (28 days).	1.1% 2/179 • AEs were collected from screening up to 32 days ITT Population (participants who were randomized and received at least one dose of study drug was used for the analysis of serious adverse event (SAE) and non-serious AEs. Non-serious AEs have been reported for the treatment period (28 days).
Nervous system disorders Migraine	0.00% 0/173 • AEs were collected from screening up to 32 days ITT Population (participants who were randomized and received at least one dose of study drug was used for the analysis of serious adverse event (SAE) and non-serious AEs. Non-serious AEs have been reported for the treatment period (28 days).	1.1% 2/179 • AEs were collected from screening up to 32 days ITT Population (participants who were randomized and received at least one dose of study drug was used for the analysis of serious adverse event (SAE) and non-serious AEs. Non-serious AEs have been reported for the treatment period (28 days).
Nervous system disorders Dizziness	0.58% 1/173 • AEs were collected from screening up to 32 days ITT Population (participants who were randomized and received at least one dose of study drug was used for the analysis of serious adverse event (SAE) and non-serious AEs. Non-serious AEs have been reported for the treatment period (28 days).	0.00% 0/179 • AEs were collected from screening up to 32 days ITT Population (participants who were randomized and received at least one dose of study drug was used for the analysis of serious adverse event (SAE) and non-serious AEs. Non-serious AEs have been reported for the treatment period (28 days).
Nervous system disorders Paraesthesia	0.58% 1/173 • AEs were collected from screening up to 32 days ITT Population (participants who were randomized and received at least one dose of study drug was used for the analysis of serious adverse event (SAE) and non-serious AEs. Non-serious AEs have been reported for the treatment period (28 days).	0.00% 0/179 • AEs were collected from screening up to 32 days ITT Population (participants who were randomized and received at least one dose of study drug was used for the analysis of serious adverse event (SAE) and non-serious AEs. Non-serious AEs have been reported for the treatment period (28 days).
Nervous system disorders Tension headache	0.00% 0/173 • AEs were collected from screening up to 32 days ITT Population (participants who were randomized and received at least one dose of study drug was used for the analysis of serious adverse event (SAE) and non-serious AEs. Non-serious AEs have been reported for the treatment period (28 days).	0.56% 1/179 • AEs were collected from screening up to 32 days ITT Population (participants who were randomized and received at least one dose of study drug was used for the analysis of serious adverse event (SAE) and non-serious AEs. Non-serious AEs have been reported for the treatment period (28 days).
Infections and infestations Nasopharyngitis	4.6% 8/173 • AEs were collected from screening up to 32 days ITT Population (participants who were randomized and received at least one dose of study drug was used for the analysis of serious adverse event (SAE) and non-serious AEs. Non-serious AEs have been reported for the treatment period (28 days).	4.5% 8/179 • AEs were collected from screening up to 32 days ITT Population (participants who were randomized and received at least one dose of study drug was used for the analysis of serious adverse event (SAE) and non-serious AEs. Non-serious AEs have been reported for the treatment period (28 days).
Infections and infestations Upper respiratory tract infection	2.3% 4/173 • AEs were collected from screening up to 32 days ITT Population (participants who were randomized and received at least one dose of study drug was used for the analysis of serious adverse event (SAE) and non-serious AEs. Non-serious AEs have been reported for the treatment period (28 days).	0.56% 1/179 • AEs were collected from screening up to 32 days ITT Population (participants who were randomized and received at least one dose of study drug was used for the analysis of serious adverse event (SAE) and non-serious AEs. Non-serious AEs have been reported for the treatment period (28 days).
Infections and infestations Influenza	0.00% 0/173 • AEs were collected from screening up to 32 days ITT Population (participants who were randomized and received at least one dose of study drug was used for the analysis of serious adverse event (SAE) and non-serious AEs. Non-serious AEs have been reported for the treatment period (28 days).	1.1% 2/179 • AEs were collected from screening up to 32 days ITT Population (participants who were randomized and received at least one dose of study drug was used for the analysis of serious adverse event (SAE) and non-serious AEs. Non-serious AEs have been reported for the treatment period (28 days).
Infections and infestations Sinusitis	0.58% 1/173 • AEs were collected from screening up to 32 days ITT Population (participants who were randomized and received at least one dose of study drug was used for the analysis of serious adverse event (SAE) and non-serious AEs. Non-serious AEs have been reported for the treatment period (28 days).	0.56% 1/179 • AEs were collected from screening up to 32 days ITT Population (participants who were randomized and received at least one dose of study drug was used for the analysis of serious adverse event (SAE) and non-serious AEs. Non-serious AEs have been reported for the treatment period (28 days).
Infections and infestations Urinary tract infection	1.2% 2/173 • AEs were collected from screening up to 32 days ITT Population (participants who were randomized and received at least one dose of study drug was used for the analysis of serious adverse event (SAE) and non-serious AEs. Non-serious AEs have been reported for the treatment period (28 days).	0.00% 0/179 • AEs were collected from screening up to 32 days ITT Population (participants who were randomized and received at least one dose of study drug was used for the analysis of serious adverse event (SAE) and non-serious AEs. Non-serious AEs have been reported for the treatment period (28 days).
Infections and infestations Viral infection	0.58% 1/173 • AEs were collected from screening up to 32 days ITT Population (participants who were randomized and received at least one dose of study drug was used for the analysis of serious adverse event (SAE) and non-serious AEs. Non-serious AEs have been reported for the treatment period (28 days).	0.56% 1/179 • AEs were collected from screening up to 32 days ITT Population (participants who were randomized and received at least one dose of study drug was used for the analysis of serious adverse event (SAE) and non-serious AEs. Non-serious AEs have been reported for the treatment period (28 days).
Infections and infestations Acute tonsillitis	0.00% 0/173 • AEs were collected from screening up to 32 days ITT Population (participants who were randomized and received at least one dose of study drug was used for the analysis of serious adverse event (SAE) and non-serious AEs. Non-serious AEs have been reported for the treatment period (28 days).	0.56% 1/179 • AEs were collected from screening up to 32 days ITT Population (participants who were randomized and received at least one dose of study drug was used for the analysis of serious adverse event (SAE) and non-serious AEs. Non-serious AEs have been reported for the treatment period (28 days).
Infections and infestations Cellulitis	0.58% 1/173 • AEs were collected from screening up to 32 days ITT Population (participants who were randomized and received at least one dose of study drug was used for the analysis of serious adverse event (SAE) and non-serious AEs. Non-serious AEs have been reported for the treatment period (28 days).	0.00% 0/179 • AEs were collected from screening up to 32 days ITT Population (participants who were randomized and received at least one dose of study drug was used for the analysis of serious adverse event (SAE) and non-serious AEs. Non-serious AEs have been reported for the treatment period (28 days).
Infections and infestations Cystitis	0.58% 1/173 • AEs were collected from screening up to 32 days ITT Population (participants who were randomized and received at least one dose of study drug was used for the analysis of serious adverse event (SAE) and non-serious AEs. Non-serious AEs have been reported for the treatment period (28 days).	0.00% 0/179 • AEs were collected from screening up to 32 days ITT Population (participants who were randomized and received at least one dose of study drug was used for the analysis of serious adverse event (SAE) and non-serious AEs. Non-serious AEs have been reported for the treatment period (28 days).
Infections and infestations Gastroenteritis	0.58% 1/173 • AEs were collected from screening up to 32 days ITT Population (participants who were randomized and received at least one dose of study drug was used for the analysis of serious adverse event (SAE) and non-serious AEs. Non-serious AEs have been reported for the treatment period (28 days).	0.00% 0/179 • AEs were collected from screening up to 32 days ITT Population (participants who were randomized and received at least one dose of study drug was used for the analysis of serious adverse event (SAE) and non-serious AEs. Non-serious AEs have been reported for the treatment period (28 days).
Infections and infestations Gastroenteritis viral	0.58% 1/173 • AEs were collected from screening up to 32 days ITT Population (participants who were randomized and received at least one dose of study drug was used for the analysis of serious adverse event (SAE) and non-serious AEs. Non-serious AEs have been reported for the treatment period (28 days).	0.00% 0/179 • AEs were collected from screening up to 32 days ITT Population (participants who were randomized and received at least one dose of study drug was used for the analysis of serious adverse event (SAE) and non-serious AEs. Non-serious AEs have been reported for the treatment period (28 days).
Infections and infestations Herpes simplex	0.58% 1/173 • AEs were collected from screening up to 32 days ITT Population (participants who were randomized and received at least one dose of study drug was used for the analysis of serious adverse event (SAE) and non-serious AEs. Non-serious AEs have been reported for the treatment period (28 days).	0.00% 0/179 • AEs were collected from screening up to 32 days ITT Population (participants who were randomized and received at least one dose of study drug was used for the analysis of serious adverse event (SAE) and non-serious AEs. Non-serious AEs have been reported for the treatment period (28 days).
Infections and infestations Perianal abscess	0.00% 0/173 • AEs were collected from screening up to 32 days ITT Population (participants who were randomized and received at least one dose of study drug was used for the analysis of serious adverse event (SAE) and non-serious AEs. Non-serious AEs have been reported for the treatment period (28 days).	0.56% 1/179 • AEs were collected from screening up to 32 days ITT Population (participants who were randomized and received at least one dose of study drug was used for the analysis of serious adverse event (SAE) and non-serious AEs. Non-serious AEs have been reported for the treatment period (28 days).
Infections and infestations Tooth infection	0.00% 0/173 • AEs were collected from screening up to 32 days ITT Population (participants who were randomized and received at least one dose of study drug was used for the analysis of serious adverse event (SAE) and non-serious AEs. Non-serious AEs have been reported for the treatment period (28 days).	0.56% 1/179 • AEs were collected from screening up to 32 days ITT Population (participants who were randomized and received at least one dose of study drug was used for the analysis of serious adverse event (SAE) and non-serious AEs. Non-serious AEs have been reported for the treatment period (28 days).
Infections and infestations Viral pharyngitis	0.58% 1/173 • AEs were collected from screening up to 32 days ITT Population (participants who were randomized and received at least one dose of study drug was used for the analysis of serious adverse event (SAE) and non-serious AEs. Non-serious AEs have been reported for the treatment period (28 days).	0.00% 0/179 • AEs were collected from screening up to 32 days ITT Population (participants who were randomized and received at least one dose of study drug was used for the analysis of serious adverse event (SAE) and non-serious AEs. Non-serious AEs have been reported for the treatment period (28 days).
Respiratory, thoracic and mediastinal disorders Epistaxis	2.3% 4/173 • AEs were collected from screening up to 32 days ITT Population (participants who were randomized and received at least one dose of study drug was used for the analysis of serious adverse event (SAE) and non-serious AEs. Non-serious AEs have been reported for the treatment period (28 days).	2.2% 4/179 • AEs were collected from screening up to 32 days ITT Population (participants who were randomized and received at least one dose of study drug was used for the analysis of serious adverse event (SAE) and non-serious AEs. Non-serious AEs have been reported for the treatment period (28 days).
Respiratory, thoracic and mediastinal disorders Pharyngolaryngeal pain	0.58% 1/173 • AEs were collected from screening up to 32 days ITT Population (participants who were randomized and received at least one dose of study drug was used for the analysis of serious adverse event (SAE) and non-serious AEs. Non-serious AEs have been reported for the treatment period (28 days).	2.8% 5/179 • AEs were collected from screening up to 32 days ITT Population (participants who were randomized and received at least one dose of study drug was used for the analysis of serious adverse event (SAE) and non-serious AEs. Non-serious AEs have been reported for the treatment period (28 days).
Respiratory, thoracic and mediastinal disorders Dysphonia	0.58% 1/173 • AEs were collected from screening up to 32 days ITT Population (participants who were randomized and received at least one dose of study drug was used for the analysis of serious adverse event (SAE) and non-serious AEs. Non-serious AEs have been reported for the treatment period (28 days).	1.1% 2/179 • AEs were collected from screening up to 32 days ITT Population (participants who were randomized and received at least one dose of study drug was used for the analysis of serious adverse event (SAE) and non-serious AEs. Non-serious AEs have been reported for the treatment period (28 days).
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/173 • AEs were collected from screening up to 32 days ITT Population (participants who were randomized and received at least one dose of study drug was used for the analysis of serious adverse event (SAE) and non-serious AEs. Non-serious AEs have been reported for the treatment period (28 days).	1.1% 2/179 • AEs were collected from screening up to 32 days ITT Population (participants who were randomized and received at least one dose of study drug was used for the analysis of serious adverse event (SAE) and non-serious AEs. Non-serious AEs have been reported for the treatment period (28 days).
Respiratory, thoracic and mediastinal disorders Nasal congestion	1.2% 2/173 • AEs were collected from screening up to 32 days ITT Population (participants who were randomized and received at least one dose of study drug was used for the analysis of serious adverse event (SAE) and non-serious AEs. Non-serious AEs have been reported for the treatment period (28 days).	0.00% 0/179 • AEs were collected from screening up to 32 days ITT Population (participants who were randomized and received at least one dose of study drug was used for the analysis of serious adverse event (SAE) and non-serious AEs. Non-serious AEs have been reported for the treatment period (28 days).
Respiratory, thoracic and mediastinal disorders Nasal discomfort	0.00% 0/173 • AEs were collected from screening up to 32 days ITT Population (participants who were randomized and received at least one dose of study drug was used for the analysis of serious adverse event (SAE) and non-serious AEs. Non-serious AEs have been reported for the treatment period (28 days).	1.1% 2/179 • AEs were collected from screening up to 32 days ITT Population (participants who were randomized and received at least one dose of study drug was used for the analysis of serious adverse event (SAE) and non-serious AEs. Non-serious AEs have been reported for the treatment period (28 days).
Respiratory, thoracic and mediastinal disorders Nasal mucosal disorder	0.00% 0/173 • AEs were collected from screening up to 32 days ITT Population (participants who were randomized and received at least one dose of study drug was used for the analysis of serious adverse event (SAE) and non-serious AEs. Non-serious AEs have been reported for the treatment period (28 days).	0.56% 1/179 • AEs were collected from screening up to 32 days ITT Population (participants who were randomized and received at least one dose of study drug was used for the analysis of serious adverse event (SAE) and non-serious AEs. Non-serious AEs have been reported for the treatment period (28 days).
Respiratory, thoracic and mediastinal disorders Nasal polyps	0.00% 0/173 • AEs were collected from screening up to 32 days ITT Population (participants who were randomized and received at least one dose of study drug was used for the analysis of serious adverse event (SAE) and non-serious AEs. Non-serious AEs have been reported for the treatment period (28 days).	0.56% 1/179 • AEs were collected from screening up to 32 days ITT Population (participants who were randomized and received at least one dose of study drug was used for the analysis of serious adverse event (SAE) and non-serious AEs. Non-serious AEs have been reported for the treatment period (28 days).
Respiratory, thoracic and mediastinal disorders Nasal septum ulceration	0.58% 1/173 • AEs were collected from screening up to 32 days ITT Population (participants who were randomized and received at least one dose of study drug was used for the analysis of serious adverse event (SAE) and non-serious AEs. Non-serious AEs have been reported for the treatment period (28 days).	0.00% 0/179 • AEs were collected from screening up to 32 days ITT Population (participants who were randomized and received at least one dose of study drug was used for the analysis of serious adverse event (SAE) and non-serious AEs. Non-serious AEs have been reported for the treatment period (28 days).
Respiratory, thoracic and mediastinal disorders Nasal ulcer	0.58% 1/173 • AEs were collected from screening up to 32 days ITT Population (participants who were randomized and received at least one dose of study drug was used for the analysis of serious adverse event (SAE) and non-serious AEs. Non-serious AEs have been reported for the treatment period (28 days).	0.00% 0/179 • AEs were collected from screening up to 32 days ITT Population (participants who were randomized and received at least one dose of study drug was used for the analysis of serious adverse event (SAE) and non-serious AEs. Non-serious AEs have been reported for the treatment period (28 days).
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/173 • AEs were collected from screening up to 32 days ITT Population (participants who were randomized and received at least one dose of study drug was used for the analysis of serious adverse event (SAE) and non-serious AEs. Non-serious AEs have been reported for the treatment period (28 days).	0.56% 1/179 • AEs were collected from screening up to 32 days ITT Population (participants who were randomized and received at least one dose of study drug was used for the analysis of serious adverse event (SAE) and non-serious AEs. Non-serious AEs have been reported for the treatment period (28 days).
Respiratory, thoracic and mediastinal disorders Sinus congestion	0.00% 0/173 • AEs were collected from screening up to 32 days ITT Population (participants who were randomized and received at least one dose of study drug was used for the analysis of serious adverse event (SAE) and non-serious AEs. Non-serious AEs have been reported for the treatment period (28 days).	0.56% 1/179 • AEs were collected from screening up to 32 days ITT Population (participants who were randomized and received at least one dose of study drug was used for the analysis of serious adverse event (SAE) and non-serious AEs. Non-serious AEs have been reported for the treatment period (28 days).
Respiratory, thoracic and mediastinal disorders Throat irritation	0.58% 1/173 • AEs were collected from screening up to 32 days ITT Population (participants who were randomized and received at least one dose of study drug was used for the analysis of serious adverse event (SAE) and non-serious AEs. Non-serious AEs have been reported for the treatment period (28 days).	0.00% 0/179 • AEs were collected from screening up to 32 days ITT Population (participants who were randomized and received at least one dose of study drug was used for the analysis of serious adverse event (SAE) and non-serious AEs. Non-serious AEs have been reported for the treatment period (28 days).
Gastrointestinal disorders Diarrhoea	0.00% 0/173 • AEs were collected from screening up to 32 days ITT Population (participants who were randomized and received at least one dose of study drug was used for the analysis of serious adverse event (SAE) and non-serious AEs. Non-serious AEs have been reported for the treatment period (28 days).	2.8% 5/179 • AEs were collected from screening up to 32 days ITT Population (participants who were randomized and received at least one dose of study drug was used for the analysis of serious adverse event (SAE) and non-serious AEs. Non-serious AEs have been reported for the treatment period (28 days).
Gastrointestinal disorders Abdominal pain	0.58% 1/173 • AEs were collected from screening up to 32 days ITT Population (participants who were randomized and received at least one dose of study drug was used for the analysis of serious adverse event (SAE) and non-serious AEs. Non-serious AEs have been reported for the treatment period (28 days).	1.1% 2/179 • AEs were collected from screening up to 32 days ITT Population (participants who were randomized and received at least one dose of study drug was used for the analysis of serious adverse event (SAE) and non-serious AEs. Non-serious AEs have been reported for the treatment period (28 days).
Gastrointestinal disorders Nausea	0.58% 1/173 • AEs were collected from screening up to 32 days ITT Population (participants who were randomized and received at least one dose of study drug was used for the analysis of serious adverse event (SAE) and non-serious AEs. Non-serious AEs have been reported for the treatment period (28 days).	1.1% 2/179 • AEs were collected from screening up to 32 days ITT Population (participants who were randomized and received at least one dose of study drug was used for the analysis of serious adverse event (SAE) and non-serious AEs. Non-serious AEs have been reported for the treatment period (28 days).
Gastrointestinal disorders Abdominal pain upper	0.00% 0/173 • AEs were collected from screening up to 32 days ITT Population (participants who were randomized and received at least one dose of study drug was used for the analysis of serious adverse event (SAE) and non-serious AEs. Non-serious AEs have been reported for the treatment period (28 days).	1.1% 2/179 • AEs were collected from screening up to 32 days ITT Population (participants who were randomized and received at least one dose of study drug was used for the analysis of serious adverse event (SAE) and non-serious AEs. Non-serious AEs have been reported for the treatment period (28 days).
Gastrointestinal disorders Dyspepsia	1.2% 2/173 • AEs were collected from screening up to 32 days ITT Population (participants who were randomized and received at least one dose of study drug was used for the analysis of serious adverse event (SAE) and non-serious AEs. Non-serious AEs have been reported for the treatment period (28 days).	0.00% 0/179 • AEs were collected from screening up to 32 days ITT Population (participants who were randomized and received at least one dose of study drug was used for the analysis of serious adverse event (SAE) and non-serious AEs. Non-serious AEs have been reported for the treatment period (28 days).
Gastrointestinal disorders Stomach discomfort	0.58% 1/173 • AEs were collected from screening up to 32 days ITT Population (participants who were randomized and received at least one dose of study drug was used for the analysis of serious adverse event (SAE) and non-serious AEs. Non-serious AEs have been reported for the treatment period (28 days).	0.56% 1/179 • AEs were collected from screening up to 32 days ITT Population (participants who were randomized and received at least one dose of study drug was used for the analysis of serious adverse event (SAE) and non-serious AEs. Non-serious AEs have been reported for the treatment period (28 days).