Study Of Adults And Adolescents With Vasomotor Rhinitis | NCT00117325

Label	Type	Description	Intervention Names
GW685698X	Experimental	GW685698X	Drug: GW685698X

Name	Type	Description	Arm Group Labels	Other Names
GW685698X	Drug	Aqueous Nasal Spray 100mcg	GW685698X

Measure	Description	Time Frame
Mean Change From Baseline Over the Entire Treatment Period in Daily Reflective Total Nasal Symptom Score (rTNSS)	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).	Baseline (4 days prior to randomization [Day 1]) and up to Week 4

Measure	Description	Time Frame
Mean Change From Baseline Over the Entire Treatment Period in Morning (AM), Pre-dose, Instantaneous Total Nasal Symptom Scores (iTNSS)	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).

Name	Affiliation	Role
GSK Clinical Trials	GlaxoSmithKline	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
GSK Investigational Site		Beverly Hills	California	90212	United States
GSK Investigational Site

Label	URL
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.	View source

ID	Type	URL	Comment
FFR30006	Clinical Study Report	View IPD

ID	Title	Description
FG000	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.
FG001	Fluticasone Furoate 110 mcg QD

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Mean Change From Baseline Over the Entire Treatment Period in Daily Reflective Total Nasal Symptom Score (rTNSS)

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).

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.

Posted

Least Squares Mean

Standard Error

Score on scale

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

ID	Title	Description
OG000	Placebo	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.
OG001	Fluticasone Furoate 110 mcg QD	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.

Units	Counts
Participants	OG000170 OG001176

Title

Denominators

Categories

Title	Measurements
	OG000-1.71± 0.16 OG001-2.05± 0.15

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	Placebo versus Fluticasone Furoate 110 mcg QD Week 1-4 analysis.	ANCOVA	Analysis of covariance (ANCOVA) method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.	0.050		Mean Difference (Net)	-0.335			2-Sided	95	-0.67	0.00					Superiority or Other

Secondary

Mean Change From Baseline Over the Entire Treatment Period in Morning (AM), Pre-dose, Instantaneous Total Nasal Symptom Scores (iTNSS)

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).

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

Posted

Least Squares Mean

Standard Error

Score on scale

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

ID	Title	Description
OG000	Placebo	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.
OG001	Fluticasone Furoate 110 mcg QD	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.

Secondary

Number of Participants With Overall Evaluation of Response to Therapy

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.

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

Posted

Count of Participants

Participants

Up to 4 weeks

ID	Title	Description
OG000	Placebo	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.
OG001	Fluticasone Furoate 110 mcg QD	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.

Units	Counts
Participants

Secondary

Mean Change From Baseline Over the Entire Treatment Period in AM Pre-dose rTNSS

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).

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

Posted

Least Squares Mean

Standard Error

Score on scale

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

ID	Title	Description
OG000	Placebo	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.
OG001	Fluticasone Furoate 110 mcg QD	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.

Secondary

Mean Change From Baseline Over the Entire Treatment Period in Evening (PM) rTNSS

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).

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

Posted

Least Squares Mean

Standard Error

Score on scale

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

ID	Title	Description
OG000	Placebo	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.
OG001	Fluticasone Furoate 110 mcg QD	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.

Secondary

Mean Percent Change From Baseline Over the Entire Treatment Period in Daily rTNSS

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).

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

Posted

Least Squares Mean

Standard Error

Percent change in score

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

ID	Title	Description
OG000	Placebo	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.
OG001	Fluticasone Furoate 110 mcg QD	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.

Secondary

Mean Percent Change From Baseline Over the Entire Treatment Period in AM, Pre-dose iTNSS

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).

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

Posted

Least Squares Mean

Standard Error

Percent change in score

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

ID	Title	Description
OG000	Placebo	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.
OG001	Fluticasone Furoate 110 mcg QD	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.

Secondary

Mean Change From Baseline Over the Entire Treatment Period in Individual Daily, Reflective Nasal Symptom Scores for Rhinorrhea, Nasal Congestion and Post-nasal Drip

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).

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

Posted

Least Squares Mean

Standard Error

Score on scale

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

ID	Title	Description
OG000	Placebo	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.
OG001	Fluticasone Furoate 110 mcg QD

Secondary

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

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).

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

Posted

Least Squares Mean

Standard Error

Score on scale

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

ID	Title	Description
OG000	Placebo	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.
OG001	Fluticasone Furoate 110 mcg QD	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.

Secondary

Mean Change From Baseline Over the Entire Treatment Period in Individual AM, Reflective Nasal Symptom Scores for Rhinorrhea, Nasal Congestion and Postnasal Drip

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).

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

Posted

Least Squares Mean

Standard Error

Score on scale

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

ID	Title	Description
OG000	Placebo	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.
OG001	Fluticasone Furoate 110mcg QD	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.

Secondary

Mean Change From Baseline Over the Entire Treatment Period in Individual PM, Reflective, Nasal Symptom Scores for Rhinorrhea, Nasal Congestion and Postnasal Drip

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).

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

Posted

Least Squares Mean

Standard Error

Score on scale

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

ID	Title	Description
OG000	Placebo	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.
OG001	Fluticasone Furoate 110 mcg QD	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.

Secondary

Mean Scores Changes From Baseline as a Function of Time

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).

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

Posted

Least Squares Mean

Standard Error

Score on scale

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

ID	Title	Description
OG000	Placebo	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.
OG001	Fluticasone Furoate 110 mcg QD	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.

Units

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Headache	Nervous system disorders	MedDRA	Systematic Assessment	EG00023 affected173 at risk EG00112 affected179 at risk
Sinus headache	Nervous system disorders	MedDRA	Systematic Assessment	EG0003 affected173 at risk EG0012 affected179 at risk
Migraine	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 affected173 at risk EG0012 affected179 at risk
Dizziness	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 affected173 at risk EG0010 affected179 at risk
Paraesthesia	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 affected173 at risk EG0010 affected179 at risk
Tension headache	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 affected173 at risk EG0011 affected179 at risk
Nasopharyngitis	Infections and infestations	MedDRA	Systematic Assessment	EG0008 affected173 at risk EG0018 affected179 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA	Systematic Assessment	EG0004 affected173 at risk EG0011 affected179 at risk
Influenza	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected173 at risk EG0012 affected179 at risk
Sinusitis	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected173 at risk EG0011 affected179 at risk
Urinary tract infection	Infections and infestations	MedDRA	Systematic Assessment	EG0002 affected173 at risk EG0010 affected179 at risk
Viral infection	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected173 at risk EG0011 affected179 at risk
Acute tonsillitis	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected173 at risk EG0011 affected179 at risk
Cellulitis	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected173 at risk EG0010 affected179 at risk
Cystitis	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected173 at risk EG0010 affected179 at risk
Gastroenteritis	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected173 at risk EG0010 affected179 at risk
Gastroenteritis viral	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected173 at risk EG0010 affected179 at risk
Herpes simplex	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected173 at risk EG0010 affected179 at risk
Perianal abscess	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected173 at risk EG0011 affected179 at risk
Tooth infection	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected173 at risk EG0011 affected179 at risk
Viral pharyngitis	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected173 at risk EG0010 affected179 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0004 affected173 at risk EG0014 affected179 at risk
Pharyngolaryngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 affected173 at risk EG0015 affected179 at risk
Dysphonia	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 affected173 at risk EG0012 affected179 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0000 affected173 at risk EG0012 affected179 at risk
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0002 affected173 at risk EG0010 affected179 at risk
Nasal discomfort	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0000 affected173 at risk EG0012 affected179 at risk
Nasal mucosal disorder	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0000 affected173 at risk EG0011 affected179 at risk
Nasal polyps	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0000 affected173 at risk EG0011 affected179 at risk
Nasal septum ulceration	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 affected173 at risk EG0010 affected179 at risk
Nasal ulcer	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 affected173 at risk EG0010 affected179 at risk
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0000 affected173 at risk EG0011 affected179 at risk
Sinus congestion	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0000 affected173 at risk EG0011 affected179 at risk
Throat irritation	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 affected173 at risk EG0010 affected179 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected173 at risk EG0015 affected179 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected173 at risk EG0012 affected179 at risk
Nausea	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected173 at risk EG0012 affected179 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected173 at risk EG0012 affected179 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0002 affected173 at risk EG0010 affected179 at risk
Stomach discomfort	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected173 at risk EG0011 affected179 at risk
Toothache	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected173 at risk EG0011 affected179 at risk
Colitis ulcerative	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected173 at risk EG0010 affected179 at risk
Dry mouth	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected173 at risk EG0011 affected179 at risk
Gastric disorder	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected173 at risk EG0011 affected179 at risk
Glossodynia	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected173 at risk EG0010 affected179 at risk
Oral pain	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected173 at risk EG0010 affected179 at risk
Tongue haemorrhage	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected173 at risk EG0010 affected179 at risk
Tongue ulceration	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected173 at risk EG0011 affected179 at risk
Vomiting	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected173 at risk EG0011 affected179 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0002 affected173 at risk EG0013 affected179 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0002 affected173 at risk EG0012 affected179 at risk
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0003 affected173 at risk EG0010 affected179 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0003 affected173 at risk EG0010 affected179 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0001 affected173 at risk EG0011 affected179 at risk
Shoulder pain	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0001 affected173 at risk EG0011 affected179 at risk
Dry eye	Eye disorders	MedDRA	Systematic Assessment	EG0002 affected173 at risk EG0012 affected179 at risk
Conjunctivitis	Eye disorders	MedDRA	Systematic Assessment	EG0002 affected173 at risk EG0010 affected179 at risk
Eye pruritus	Eye disorders	MedDRA	Systematic Assessment	EG0000 affected173 at risk EG0012 affected179 at risk
Conjunctival oedema	Eye disorders	MedDRA	Systematic Assessment	EG0001 affected173 at risk EG0010 affected179 at risk
Lacrimation decreased	Eye disorders	MedDRA	Systematic Assessment	EG0000 affected173 at risk EG0011 affected179 at risk
Lacrimation increased	Eye disorders	MedDRA	Systematic Assessment	EG0000 affected173 at risk EG0011 affected179 at risk
Ocular hyperaemia	Eye disorders	MedDRA	Systematic Assessment	EG0001 affected173 at risk EG0010 affected179 at risk
Asthenia	General disorders	MedDRA	Systematic Assessment	EG0000 affected173 at risk EG0011 affected179 at risk
Chest discomfort	General disorders	MedDRA	Systematic Assessment	EG0000 affected173 at risk EG0011 affected179 at risk
Fatigue	General disorders	MedDRA	Systematic Assessment	EG0001 affected173 at risk EG0010 affected179 at risk
Ill-defined disorder	General disorders	MedDRA	Systematic Assessment	EG0000 affected173 at risk EG0011 affected179 at risk
Influenza like illness	General disorders	MedDRA	Systematic Assessment	EG0001 affected173 at risk EG0010 affected179 at risk
Injection site pain	General disorders	MedDRA	Systematic Assessment	EG0000 affected173 at risk EG0011 affected179 at risk
Irritability	General disorders	MedDRA	Systematic Assessment	EG0001 affected173 at risk EG0010 affected179 at risk
Malaise	General disorders	MedDRA	Systematic Assessment	EG0001 affected173 at risk EG0010 affected179 at risk
Pain	General disorders	MedDRA	Systematic Assessment	EG0000 affected173 at risk EG0011 affected179 at risk
Pyrexia	General disorders	MedDRA	Systematic Assessment	EG0001 affected173 at risk EG0010 affected179 at risk
Ear pain	Ear and labyrinth disorders	MedDRA	Systematic Assessment	EG0001 affected173 at risk EG0011 affected179 at risk
Hearing impaired	Ear and labyrinth disorders	MedDRA	Systematic Assessment	EG0001 affected173 at risk EG0010 affected179 at risk
Tinnitus	Ear and labyrinth disorders	MedDRA	Systematic Assessment	EG0000 affected173 at risk EG0011 affected179 at risk
Tympanic membrane disorder	Ear and labyrinth disorders	MedDRA	Systematic Assessment	EG0001 affected173 at risk EG0010 affected179 at risk
Vertigo	Ear and labyrinth disorders	MedDRA	Systematic Assessment	EG0000 affected173 at risk EG0011 affected179 at risk
Arthropod sting	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 affected173 at risk EG0011 affected179 at risk
Back injury	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 affected173 at risk EG0011 affected179 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 affected173 at risk EG0011 affected179 at risk
Muscle strain	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 affected173 at risk EG0011 affected179 at risk
Procedural pain	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 affected173 at risk EG0011 affected179 at risk
Skin laceration	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 affected173 at risk EG0010 affected179 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0001 affected173 at risk EG0011 affected179 at risk
Dermatitis allergic	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0001 affected173 at risk EG0010 affected179 at risk
Rash papular	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0001 affected173 at risk EG0010 affected179 at risk
Urticaria	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0001 affected173 at risk EG0010 affected179 at risk
Dysmenorrhoea	Reproductive system and breast disorders	MedDRA	Systematic Assessment	EG0003 affected173 at risk EG0011 affected179 at risk
Blood pressure increased	Investigations	MedDRA	Systematic Assessment	EG0001 affected173 at risk EG0010 affected179 at risk
Electrocardiogram T wave inversion	Investigations	MedDRA	Systematic Assessment	EG0000 affected173 at risk EG0011 affected179 at risk
Liver function test abnormal	Investigations	MedDRA	Systematic Assessment	EG0001 affected173 at risk EG0010 affected179 at risk
Insomnia	Psychiatric disorders	MedDRA	Systematic Assessment	EG0001 affected173 at risk EG0012 affected179 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG0000 affected173 at risk EG0011 affected179 at risk
Lymphadenopathy	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG0001 affected173 at risk EG0010 affected179 at risk
Biliary colic	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0001 affected173 at risk EG0010 affected179 at risk
Increased appetite	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0001 affected173 at risk EG0010 affected179 at risk

ID	Term
D012220	Rhinitis
D009668	Nose Diseases
D012140	Respiratory Tract Diseases
D010038	Otorhinolaryngologic Diseases

ID	Title	Description
BG000	Placebo	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.
BG001	Fluticasone Furoate 110 mcg QD	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.
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Placebo	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.	0	173	0	173	65	173
EG001	Fluticasone Furoate 110mcg QD	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.	0	179	0	179	61	179