Trial Outcomes & Findings for Assessment of Fluticasone Propionate on Ocular Allergy Symptoms (NCT NCT01817790)

Results Overview

The Reflective Total Ocular Symptom Score (rTOSS) is the sum of 3 individual participant-assessed symptom scores (eye itching/burning, eye tearing/watering, and eye redness), each evaluated using a scale of 0=None, 1=Mild, 2=Moderate, or 3=Severe, for a possible score of 0-9. Subjects completed rTOSS in the evening (PM rTOSS; 12 hours post morning nasal spray use) and once in the morning (AM score: prior to nasal spray use). Daily (i.e. during one dosing interval) rTOSS is defined as the average of the PM rTOSS and the AM rTOSS of the next day prior to AM dosing. The mean change from baseline in (daily, AM, PM) TOSS was calculated as the subject's treatment period mean (over 14 days; from Day 0 PM to Day 14 AM) minus the baseline period (placebo run-in) mean.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

626 participants

Primary outcome timeframe

Baseline to 14 days

Results posted on

2014-04-03

Participant Flow

Participants were recruited at 6 clinical sites in the US.

Of the 855 participants screened, 626 were randomized in the study. Of the 229 participants not randomized into the study, 151 did not meet the study criteria; 3 developed AEs; 10 were lost to follow-up; 4 violated protocol; 28 withdrew consent; and the remaining 33 were not randomized for other reasons.

Participant milestones

Participant milestones
Measure	Fluticasone Propionate Nasal Spray Two sprays of Fluticasone propionate nasal spray (50 mcg/spray) per nostril to be administered in morning (Total dose 200 mcg).	Placebo Nasal Spray Two sprays of placebo per nostril to be administered in morning.
Overall Study STARTED	314	312
Overall Study COMPLETED	310	304
Overall Study NOT COMPLETED	4	8

Reasons for withdrawal

Reasons for withdrawal
Measure	Fluticasone Propionate Nasal Spray Two sprays of Fluticasone propionate nasal spray (50 mcg/spray) per nostril to be administered in morning (Total dose 200 mcg).	Placebo Nasal Spray Two sprays of placebo per nostril to be administered in morning.
Overall Study Adverse Event	0	2
Overall Study Lost to Follow-up	0	1
Overall Study Protocol Violation	2	1
Overall Study Withdrawal by Subject	1	3
Overall Study Other: Could not attend appointment	1	1

Baseline Characteristics

Assessment of Fluticasone Propionate on Ocular Allergy Symptoms

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Fluticasone Propionate Nasal Spray n=314 Participants Two sprays of Fluticasone propionate nasal spray (50 mcg/spray) per nostril to be administered in morning (Total dose 200 mcg).	Placebo Nasal Spray n=312 Participants Two sprays of placebo per nostril to be administered in morning.	Total n=626 Participants Total of all reporting groups
Age, Continuous	40.4 Years STANDARD_DEVIATION 14.55 • n=93 Participants	40.5 Years STANDARD_DEVIATION 16.36 • n=4 Participants	40.5 Years STANDARD_DEVIATION 15.47 • n=27 Participants
Sex: Female, Male Female	212 Participants n=93 Participants	201 Participants n=4 Participants	413 Participants n=27 Participants
Sex: Female, Male Male	102 Participants n=93 Participants	111 Participants n=4 Participants	213 Participants n=27 Participants

PRIMARY outcome

Timeframe: Baseline to 14 days

Population: All subjects who were randomized into the study and received at least one dose of study product were included in the intent-to-treat (ITT) population. This analysis was conducted on ITT population.

The Reflective Total Ocular Symptom Score (rTOSS) is the sum of 3 individual participant-assessed symptom scores (eye itching/burning, eye tearing/watering, and eye redness), each evaluated using a scale of 0=None, 1=Mild, 2=Moderate, or 3=Severe, for a possible score of 0-9. Subjects completed rTOSS in the evening (PM rTOSS; 12 hours post morning nasal spray use) and once in the morning (AM score: prior to nasal spray use). Daily (i.e. during one dosing interval) rTOSS is defined as the average of the PM rTOSS and the AM rTOSS of the next day prior to AM dosing. The mean change from baseline in (daily, AM, PM) TOSS was calculated as the subject's treatment period mean (over 14 days; from Day 0 PM to Day 14 AM) minus the baseline period (placebo run-in) mean.

Outcome measures

Outcome measures
Measure	Fluticasone Propionate Nasal Spray n=314 Participants Fluticasone propionate nasal spray with strength per dose of 50 mcg/spray. Two sprays of study treatment per nostril to be administered in morning.	Placebo Nasal Spray n=312 Participants Two sprays of placebo per nostril to be administered in morning.
Mean Change From Baseline in Reflective Total Ocular Symptom Score (rTOSS)	-0.91 Score on a scale Standard Deviation 1.625	-0.63 Score on a scale Standard Deviation 1.525

SECONDARY outcome

Timeframe: Baseline to 14 days

Population: All subjects who were randomized into the study and received at least one dose of study product were included in the intent-to-treat (ITT) population. This analysis was conducted on ITT population.

rTOSS is the sum of 3 individual participant-assessed symptom scores (eye itching/ burning, eye tearing/watering, and eye redness), each evaluated using a scale of 0=None, 1=Mild, 2=Moderate, or 3=Severe, for a possible score of 0-9. For AM rToss, subjects completed rTOSS in the morning (AM score: prior to nasal spray use). The mean change from baseline in AM rTOSS was calculated as the subject's treatment period mean (over 14 days) minus the baseline period (placebo run-in) mean.

Outcome measures

Outcome measures
Measure	Fluticasone Propionate Nasal Spray n=314 Participants Fluticasone propionate nasal spray with strength per dose of 50 mcg/spray. Two sprays of study treatment per nostril to be administered in morning.	Placebo Nasal Spray n=312 Participants Two sprays of placebo per nostril to be administered in morning.
Mean Change From Baseline in AM rTOSS	-0.96 Score on a scale Standard Deviation 1.627	-0.68 Score on a scale Standard Deviation 1.573

SECONDARY outcome

Timeframe: Baseline to 14 days

Population: All subjects who were randomized into the study and received at least one dose of study product were included in the intent-to-treat (ITT) population. This analysis was conducted on ITT population.

rTOSS is the sum of 3 individual participant-assessed symptom scores (eye itching/ burning, eye tearing/watering, and eye redness), each evaluated using a scale of 0=None, 1=Mild, 2=Moderate, or 3=Severe, for a possible score of 0-9. For PM rTOSS, subjects completed rTOSS in the evening, 12 hours post morning nasal spray use. The mean change from baseline in PM rTOSS was calculated as the subject's treatment period mean (over 14 days) minus the baseline period (placebo run-in) mean.

Outcome measures

Outcome measures
Measure	Fluticasone Propionate Nasal Spray n=314 Participants Fluticasone propionate nasal spray with strength per dose of 50 mcg/spray. Two sprays of study treatment per nostril to be administered in morning.	Placebo Nasal Spray n=312 Participants Two sprays of placebo per nostril to be administered in morning.
Mean Change From Baseline in PM rTOSS	-0.87 Score on a scale Standard Deviation 1.735	-0.60 Score on a scale Standard Deviation 1.577

SECONDARY outcome

Timeframe: Baseline to 14 days

Population: All subjects who were randomized into the study and received at least one dose of study product were included in the intent-to-treat (ITT) population. This analysis was conducted on ITT population.

The AM Reflective Ocular Symptom Score was assessed individually for eye itching/burning using a scale of 0=None, 1=Mild, 2=Moderate, or 3=Severe, for a possible score of 0-9. For evaluation, subjects completed the scoring in the morning, prior to nasal spray use. The mean change from baseline in AM Reflective Ocular Symptom Score (eye itching and burning) was calculated as the subject's treatment period mean (over 14 days) minus the baseline period (placebo run-in) mean.

Outcome measures

Outcome measures
Measure	Fluticasone Propionate Nasal Spray n=314 Participants Fluticasone propionate nasal spray with strength per dose of 50 mcg/spray. Two sprays of study treatment per nostril to be administered in morning.	Placebo Nasal Spray n=312 Participants Two sprays of placebo per nostril to be administered in morning.
Mean Change From Baseline in Individual AM Reflective Ocular Symptom Scores for Eye Itching/Burning	-0.35 Score on a scale Standard Deviation 0.581	-0.28 Score on a scale Standard Deviation 0.553

SECONDARY outcome

Timeframe: Baseline to 14 days

Population: All subjects who were randomized into the study and received at least one dose of study product were included in the intent-to-treat (ITT) population. This analysis was conducted on ITT population.

The PM Reflective Ocular Symptom Score was assessed individually for eye itching/burning using a scale of 0=None, 1=Mild, 2=Moderate, or 3=Severe, for a possible score of 0-9. For evaluation, subjects completed the scoring in the evening, 12 hours post morning nasal spray use. The mean change from baseline in PM Reflective Ocular Symptom Score (eye itching and burning) was calculated as the subject's treatment period mean (over 14 days) minus the baseline period (placebo run-in) mean.

Outcome measures

Outcome measures
Measure	Fluticasone Propionate Nasal Spray n=314 Participants Fluticasone propionate nasal spray with strength per dose of 50 mcg/spray. Two sprays of study treatment per nostril to be administered in morning.	Placebo Nasal Spray n=312 Participants Two sprays of placebo per nostril to be administered in morning.
Mean Change From Baseline in Individual PM Reflective Ocular Symptom Scores for Eye Itching/Burning	-0.33 Score on a scale Standard Deviation 0.626	-0.24 Score on a scale Standard Deviation 0.554

SECONDARY outcome

Timeframe: Baseline to 14 days

Population: All subjects who were randomized into the study and received at least one dose of study product were included in the intent-to-treat (ITT) population. This analysis was conducted on ITT population.

The AM Reflective Ocular Symptom Score was assessed individually for eye tearing/watering using a scale of 0=None, 1=Mild, 2=Moderate, or 3=Severe, for a possible score of 0-9. For evaluation, subjects completed the scoring in the morning, prior to nasal spray use. The mean change from baseline in AM Reflective Ocular Symptom Score (eye tearing/watering) was calculated as the subject's treatment period mean (over 14 days) minus the baseline period (placebo run-in) mean.

Outcome measures

Outcome measures
Measure	Fluticasone Propionate Nasal Spray n=314 Participants Fluticasone propionate nasal spray with strength per dose of 50 mcg/spray. Two sprays of study treatment per nostril to be administered in morning.	Placebo Nasal Spray n=312 Participants Two sprays of placebo per nostril to be administered in morning.
Mean Change From Baseline in Individual AM Reflective Ocular Symptom Scores for Eye Tearing/Watering	-0.35 Score on a scale Standard Deviation 0.596	-0.24 Score on a scale Standard Deviation 0.589

SECONDARY outcome

Timeframe: Baseline to 14 days

Population: All subjects who were randomized into the study and received at least one dose of study product were included in the intent-to-treat (ITT) population. This analysis was conducted on ITT population.

The PM Reflective Ocular Symptom Score was assessed individually for eye tearing/watering using a scale of 0=None, 1=Mild, 2=Moderate, or 3=Severe, for a possible score of 0-9. For evaluation, subjects completed the scoring in the evening, 12 hours post morning nasal spray use. The mean change from baseline in PM Reflective Ocular Symptom Score (eye tearing/watering) was calculated as the subject's treatment period mean (over 14 days) minus the baseline period (placebo run-in) mean.

Outcome measures

Outcome measures
Measure	Fluticasone Propionate Nasal Spray n=314 Participants Fluticasone propionate nasal spray with strength per dose of 50 mcg/spray. Two sprays of study treatment per nostril to be administered in morning.	Placebo Nasal Spray n=312 Participants Two sprays of placebo per nostril to be administered in morning.
Mean Change From Baseline in Individual PM Reflective Ocular Symptom Scores for Eye Tearing/Watering	-0.32 Score on a scale Standard Deviation 0.653	-0.19 Score on a scale Standard Deviation 0.586

SECONDARY outcome

Timeframe: Baseline to 14 days

Population: All subjects who were randomized into the study and received at least one dose of study product were included in the intent-to-treat (ITT) population. This analysis was conducted on ITT population.

The AM Reflective Ocular Symptom Score was assessed individually for eye redness using a scale of 0=None, 1=Mild, 2=Moderate, or 3=Severe, for a possible score of 0-9. For evaluation, subjects completed the scoring in the morning, prior to nasal spray use. The mean change from baseline in AM Reflective Ocular Symptom Score (eye redness) was calculated as the subject's treatment period mean (over 14 days) minus the baseline period (placebo run-in) mean.

Outcome measures

Outcome measures
Measure	Fluticasone Propionate Nasal Spray n=314 Participants Fluticasone propionate nasal spray with strength per dose of 50 mcg/spray. Two sprays of study treatment per nostril to be administered in morning.	Placebo Nasal Spray n=312 Participants Two sprays of placebo per nostril to be administered in morning.
Mean Change From Baseline in Individual AM Reflective Ocular Symptom Scores for Eye Redness	-0.26 Score on a scale Standard Deviation 0.597	-0.17 Score on a scale Standard Deviation 0.613

SECONDARY outcome

Timeframe: Baseline to 14 days

Population: All subjects who were randomized into the study and received at least one dose of study product were included in the intent-to-treat (ITT) population. This analysis was conducted on ITT population.

The PM Reflective Ocular Symptom Score was assessed individually for eye redness using a scale of 0=None, 1=Mild, 2=Moderate, or 3=Severe, for a possible score of 0-9. For evaluation, subjects completed the scoring in the evening, 12 hours post morning nasal spray use. The mean change from baseline in PM Reflective Ocular Symptom Score (eye redness) was calculated as the subject's treatment period mean (over 14 days) minus the baseline period (placebo run-in) mean.

Outcome measures

Outcome measures
Measure	Fluticasone Propionate Nasal Spray n=314 Participants Fluticasone propionate nasal spray with strength per dose of 50 mcg/spray. Two sprays of study treatment per nostril to be administered in morning.	Placebo Nasal Spray n=312 Participants Two sprays of placebo per nostril to be administered in morning.
Mean Change From Baseline in Individual PM Reflective Ocular Symptom Scores for Eye Redness	-0.22 Score on a scale Standard Deviation 0.628	-0.17 Score on a scale Standard Deviation 0.635

SECONDARY outcome

Timeframe: Baseline to 14 days

Population: All subjects who were randomized into the study and received at least one dose of study product were included in the intent-to-treat (ITT) population. This analysis was conducted on ITT population.

Instantaneous total ocular symptom scores (iTOSS) assessments are self perceived evaluation of symptom severity immediately before the dose (how the subject feels at that point in time). iTOSS (possible score of 0-9) is the sum of 3 individual participant-assessed symptom scores for eye itching/burning, eye tearing/watering, and eye redness each evaluated using a scale of 0=None, 1=Mild, 2=Moderate, or 3=Severe. Mean changes from baseline were calculated as treatment period iTOSS minus baseline iTOSS.

Outcome measures

Outcome measures
Measure	Fluticasone Propionate Nasal Spray n=314 Participants Fluticasone propionate nasal spray with strength per dose of 50 mcg/spray. Two sprays of study treatment per nostril to be administered in morning.	Placebo Nasal Spray n=312 Participants Two sprays of placebo per nostril to be administered in morning.
Mean Change From Baseline in AM Pre-dose Instantaneous Total Ocular Symptom Scores (iTOSS)	-0.80 Score on a scale Standard Deviation 1.443	-0.55 Score on a scale Standard Deviation 1.531

SECONDARY outcome

Timeframe: Baseline to 14 days

Population: All subjects who were randomized into the study and received at least one dose of study product were included in the intent-to-treat (ITT) population. This analysis was conducted on ITT population.

The rNCSS is a participant perceived evaluation of overall congestion symptom severity (evaluated using a scale of 0=None, 1=Mild, 2=Moderate, or 3=Severe) which was completed once in the evening (PM), and once in the morning (AM). rNCSS is defined as the average of the PM rNCSS and the AM rNCSS of the next day prior to AM dosing. The mean change from baseline in rNCSS (daily, AM, PM)was calculated as the subject's treatment period mean (over 14 days; from Day 0 PM to Day 14 AM) minus the baseline period (placebo run-in) mean.

Outcome measures

Outcome measures
Measure	Fluticasone Propionate Nasal Spray n=314 Participants Fluticasone propionate nasal spray with strength per dose of 50 mcg/spray. Two sprays of study treatment per nostril to be administered in morning.	Placebo Nasal Spray n=312 Participants Two sprays of placebo per nostril to be administered in morning.
Mean Change From Baseline in Reflective Nasal Congestion Symptom Score (rNCSS)	-0.34 Score on a scale Standard Deviation 0.547	-0.20 Score on a scale Standard Deviation 0.443

SECONDARY outcome

Timeframe: Day 14

Population: All subjects who were randomized into the study and received at least one dose of study product were included in the intent-to-treat (ITT) population. This analysis was conducted on ITT population. In this outcome measure, in Fluticasone propionate group 313/314 participants, and in the placebo group 309/312 participants provided responses.

Overall response to therapy assessment was done using a 7-point categorical scale in which participants rated their response to therapy as follows: +3 = Significantly Improved; +2 = Moderately Improved; +1 = Mildly Improved; 0 = No Change; -1= Mildly Worse; -2 = Moderately Worse; -3 = Significantly Worse.

Outcome measures

Outcome measures
Measure	Fluticasone Propionate Nasal Spray n=313 Participants Fluticasone propionate nasal spray with strength per dose of 50 mcg/spray. Two sprays of study treatment per nostril to be administered in morning.	Placebo Nasal Spray n=309 Participants Two sprays of placebo per nostril to be administered in morning.
End-of-treatment Assessment of Response to Therapy for Ocular Symptoms Significantly improved	22 Participants	16 Participants
End-of-treatment Assessment of Response to Therapy for Ocular Symptoms Moderately Improved	76 Participants	59 Participants
End-of-treatment Assessment of Response to Therapy for Ocular Symptoms Mildly Improved	79 Participants	71 Participants
End-of-treatment Assessment of Response to Therapy for Ocular Symptoms No change	81 Participants	97 Participants
End-of-treatment Assessment of Response to Therapy for Ocular Symptoms Mildly Worse	21 Participants	20 Participants
End-of-treatment Assessment of Response to Therapy for Ocular Symptoms Moderatly Worse	24 Participants	24 Participants
End-of-treatment Assessment of Response to Therapy for Ocular Symptoms Significantly Worse	10 Participants	22 Participants

SECONDARY outcome

Timeframe: Baseline to 14 days

Population: All subjects who were randomized into the study and received at least one dose of study product were included in the intent-to-treat (ITT) population. This analysis was conducted on ITT population.

Conjunctival redness was evaluated as a clinical sign of SAR by the investigator. Scoring of severity was rated according to a 4-point scale: 0 = normal; 1 = Slightly pink; 2 = Moderately pink, some dilation; 3 = Intense red vessels, dilated.

Outcome measures

Outcome measures
Measure	Fluticasone Propionate Nasal Spray n=314 Participants Fluticasone propionate nasal spray with strength per dose of 50 mcg/spray. Two sprays of study treatment per nostril to be administered in morning.	Placebo Nasal Spray n=312 Participants Two sprays of placebo per nostril to be administered in morning.
Mean Change in Objective Assessment of Conjunctival Redness	-0.20 Score on a scale Standard Deviation 0.815	-0.15 Score on a scale Standard Deviation 0.736

SECONDARY outcome

Timeframe: Baseline to 14 days

Population: All subjects who were randomized into the study and received at least one dose of study product were included in the intent-to-treat (ITT) population. This analysis was conducted on ITT population. For analysis of nose symptoms, eye symptoms, and other symptoms, data of one participant each from the two groups are unavailable.

MiniRQLQ is a 14-item, disease-specific instrument for assessing the impact of allergic rhinitis on activities of daily living and overall well-being. It measures five domains of functional impairment that are most important to subjects with SAR: practical problems, nasal symptoms, eye symptoms, activity limitations, and other symptoms. Participants scored their degree of impairment on a seven-point scale. (0 - 6). Mini RQLQ final score is the average of sub-scales, ranges from 0 (best possible outcome) to 6 (worst possible outcome).

Outcome measures

Outcome measures
Measure	Fluticasone Propionate Nasal Spray n=314 Participants Fluticasone propionate nasal spray with strength per dose of 50 mcg/spray. Two sprays of study treatment per nostril to be administered in morning.	Placebo Nasal Spray n=311 Participants Two sprays of placebo per nostril to be administered in morning.
Mean Changes From Baseline in Mini Rhinoconjunctivitis Quality of Life Questionnaire (MiniRQLQ) Scores	-0.98 Score on a scale Standard Deviation 1.311	-0.49 Score on a scale Standard Deviation 1.091

SECONDARY outcome

Timeframe: Baseline to 14 days

Population: All subjects who were randomized into the study and received at least one dose of study product were included in the intent-to-treat (ITT) population. This analysis was conducted on ITT population.

MiniRQLQ is a 14-item, disease-specific instrument for assessing the impact of allergic rhinitis on activities of daily living and overall well-being. Activity limitations is one of the domains of Mini RQLQ scores. Participants scored their degree of impairment on a seven-point scale (0 = not troubled, 6 = extremely troubled).

Outcome measures

Outcome measures
Measure	Fluticasone Propionate Nasal Spray n=314 Participants Fluticasone propionate nasal spray with strength per dose of 50 mcg/spray. Two sprays of study treatment per nostril to be administered in morning.	Placebo Nasal Spray n=311 Participants Two sprays of placebo per nostril to be administered in morning.
Mean Changes From Baseline in Individual MiniRQLQ Scores: Domain - Activities	-0.93 Score on a scale Standard Deviation 1.384	-0.39 Score on a scale Standard Deviation 1.269

SECONDARY outcome

Timeframe: Baseline to 14 days

Population: All subjects who were randomized into the study and received at least one dose of study product were included in the intent-to-treat (ITT) population. This analysis was conducted on ITT population.

MiniRQLQ is a 14-item, disease-specific instrument for assessing the impact of allergic rhinitis on activities of daily living and overall well-being. 'Practical Problems' is one of the domains of Mini RQLQ scores. Participants scored their degree of impairment on a seven-point scale (0 = not troubled, 6 = extremely troubled).

Outcome measures

Outcome measures
Measure	Fluticasone Propionate Nasal Spray n=314 Participants Fluticasone propionate nasal spray with strength per dose of 50 mcg/spray. Two sprays of study treatment per nostril to be administered in morning.	Placebo Nasal Spray n=311 Participants Two sprays of placebo per nostril to be administered in morning.
Mean Changes From Baseline in Individual MiniRQLQ Scores: Domain - Practical Problems	-1.04 Score on a scale Standard Deviation 1.476	-0.57 Score on a scale Standard Deviation 1.258

SECONDARY outcome

Timeframe: Baseline to 14 days

Population: All subjects who were randomized into the study and received at least one dose of study product were included in the intent-to-treat (ITT) population. This analysis was conducted on ITT population. For analysis of nose symptoms, data of one participant each from the two groups are unavailable.

MiniRQLQ is a 14-item, disease-specific instrument for assessing the impact of allergic rhinitis on activities of daily living and overall well-being. "Nose Symptoms" is one of the domains of Mini RQLQ scores. Participants scored their degree of impairment on a seven-point scale (0 = not troubled, 6 = extremely troubled).

Outcome measures

Outcome measures
Measure	Fluticasone Propionate Nasal Spray n=313 Participants Fluticasone propionate nasal spray with strength per dose of 50 mcg/spray. Two sprays of study treatment per nostril to be administered in morning.	Placebo Nasal Spray n=310 Participants Two sprays of placebo per nostril to be administered in morning.
Mean Changes From Baseline in Individual MiniRQLQ Scores: Domain - Nose Symptoms	-1.09 Score on a scale Standard Deviation 1.456	-0.50 Score on a scale Standard Deviation 1.257

SECONDARY outcome

Timeframe: Baseline to 14 days

Population: All subjects who were randomized into the study and received at least one dose of study product were included in the intent-to-treat (ITT) population. This analysis was conducted on ITT population. For analysis of eye symptoms, data of one participant each from the two groups are unavailable.

MiniRQLQ is a 14-item, disease-specific instrument for assessing the impact of allergic rhinitis on activities of daily living and overall well-being. "Eye Symptoms" is one of the domains of Mini RQLQ scores. Participants scored their degree of impairment on a seven-point scale (0 = not troubled, 6 = extremely troubled).

Outcome measures

Outcome measures
Measure	Fluticasone Propionate Nasal Spray n=313 Participants Fluticasone propionate nasal spray with strength per dose of 50 mcg/spray. Two sprays of study treatment per nostril to be administered in morning.	Placebo Nasal Spray n=310 Participants Two sprays of placebo per nostril to be administered in morning.
Mean Changes From Baseline in Individual MiniRQLQ Scores: Domain - Eye Symptoms	-0.98 Score on a scale Standard Deviation 1.512	-0.55 Score on a scale Standard Deviation 1.284

SECONDARY outcome

Timeframe: Baseline to 14 days

Population: All subjects who were randomized into the study and received at least one dose of study product were included in the intent-to-treat (ITT) population. This analysis was conducted on ITT population. For analysis of "other symptoms", data of one participant each from the two groups are unavailable.

MiniRQLQ is a 14-item, disease-specific instrument for assessing the impact of allergic rhinitis on activities of daily living and overall well-being. "Other Symptoms" is one of the domains of Mini RQLQ scores. Participants scored their degree of impairment on a seven-point scale (0 = not troubled, 6 = extremely troubled).

Outcome measures

Outcome measures
Measure	Fluticasone Propionate Nasal Spray n=313 Participants Fluticasone propionate nasal spray with strength per dose of 50 mcg/spray. Two sprays of study treatment per nostril to be administered in morning.	Placebo Nasal Spray n=310 Participants Two sprays of placebo per nostril to be administered in morning.
Mean Changes From Baseline in Individual MiniRQLQ Scores: Domain - Other Symptoms	-0.89 Score on a scale Standard Deviation 1.607	-0.48 Score on a scale Standard Deviation 1.294

Adverse Events

Fluticasone Propionate Nasal Spray

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Placebo Nasal Spray

Serious events: 0 serious events

Other events: 8 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

Measure	Fluticasone Propionate Nasal Spray n=314 participants at risk Two sprays of Fluticasone propionate nasal spray (50 mcg/spray) per nostril to be administered in morning (Total dose 200 mcg).	Placebo Nasal Spray n=312 participants at risk Two sprays of placebo per nostril to be administered in morning.
General disorders Pain	0.00% 0/314 • Participants were followed for the duration of study, an average of 3 weeks.	0.32% 1/312 • Number of events 1 • Participants were followed for the duration of study, an average of 3 weeks.
General disorders Pyrexia	0.32% 1/314 • Number of events 1 • Participants were followed for the duration of study, an average of 3 weeks.	0.64% 2/312 • Number of events 2 • Participants were followed for the duration of study, an average of 3 weeks.
General disorders Thirst	0.32% 1/314 • Number of events 1 • Participants were followed for the duration of study, an average of 3 weeks.	0.00% 0/312 • Participants were followed for the duration of study, an average of 3 weeks.
Infections and infestations Bronchitis	0.00% 0/314 • Participants were followed for the duration of study, an average of 3 weeks.	0.64% 2/312 • Number of events 2 • Participants were followed for the duration of study, an average of 3 weeks.
Infections and infestations Gastrointestinal Viral	0.32% 1/314 • Number of events 1 • Participants were followed for the duration of study, an average of 3 weeks.	0.00% 0/312 • Participants were followed for the duration of study, an average of 3 weeks.
Infections and infestations Influenza	0.00% 0/314 • Participants were followed for the duration of study, an average of 3 weeks.	0.32% 1/312 • Number of events 1 • Participants were followed for the duration of study, an average of 3 weeks.
Nervous system disorders Headache	0.64% 2/314 • Number of events 2 • Participants were followed for the duration of study, an average of 3 weeks.	0.00% 0/312 • Participants were followed for the duration of study, an average of 3 weeks.
Nervous system disorders Migraine	0.00% 0/314 • Participants were followed for the duration of study, an average of 3 weeks.	0.32% 1/312 • Number of events 1 • Participants were followed for the duration of study, an average of 3 weeks.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/314 • Participants were followed for the duration of study, an average of 3 weeks.	0.32% 1/312 • Number of events 1 • Participants were followed for the duration of study, an average of 3 weeks.
Respiratory, thoracic and mediastinal disorders Respiratory Tract Congestion	0.00% 0/314 • Participants were followed for the duration of study, an average of 3 weeks.	0.32% 1/312 • Number of events 1 • Participants were followed for the duration of study, an average of 3 weeks.
Respiratory, thoracic and mediastinal disorders Throat Irritation	0.32% 1/314 • Number of events 1 • Participants were followed for the duration of study, an average of 3 weeks.	0.00% 0/312 • Participants were followed for the duration of study, an average of 3 weeks.
Cardiac disorders Palpitations	0.32% 1/314 • Number of events 1 • Participants were followed for the duration of study, an average of 3 weeks.	0.00% 0/312 • Participants were followed for the duration of study, an average of 3 weeks.
Immune system disorders Hypersensitivity	0.00% 0/314 • Participants were followed for the duration of study, an average of 3 weeks.	0.32% 1/312 • Number of events 1 • Participants were followed for the duration of study, an average of 3 weeks.
Injury, poisoning and procedural complications Laceration	0.32% 1/314 • Number of events 1 • Participants were followed for the duration of study, an average of 3 weeks.	0.00% 0/312 • Participants were followed for the duration of study, an average of 3 weeks.
Skin and subcutaneous tissue disorders Dermatitis	0.00% 0/314 • Participants were followed for the duration of study, an average of 3 weeks.	0.32% 1/312 • Number of events 1 • Participants were followed for the duration of study, an average of 3 weeks.
Vascular disorders Hypertension	0.32% 1/314 • Number of events 1 • Participants were followed for the duration of study, an average of 3 weeks.	0.00% 0/312 • Participants were followed for the duration of study, an average of 3 weeks.