Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study is designed to investigate the efficacy of fluticasone propionate (FP) on ocular symptoms associated with allergic rhinitis (AR).
While the current FP approved indication for GSK marketed formulation is limited to the treatment of nasal symptoms, several large well-controlled studies in which FP maintained adequate control of nasal symptoms when administered in a dose of 200 micrograms (mcg) once-daily (QD) also suggested improvement in ocular symptoms. This study will employ a randomized, double-blind, parallel group, multi-center design that compares FP and placebo nasal sprays in subjects with seasonal allergic rhinitis (SAR) to assess the effectiveness on ocular symptoms associated with AR.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fluticasone propionate nasal spray | Experimental | 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 | Placebo Comparator | Two sprays of placebo per nostril to be administered in morning. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluticasone propionate | Drug | Nasal spray formulation (200 mcg/day) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline in Reflective Total Ocular Symptom Score (rTOSS) | 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. | Baseline to 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline in AM rTOSS | 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. |
Not provided
Inclusion Criteria:
Participants with good general health (in the opinion of the investigator) with no clinically significant and relevant abnormalities of medical history
Participants with diagnosis of seasonal allergic rhinitis
Participants with allergic rhinitis symptom of at least moderate severity for randomization:
Participant residing within a geographical environment where exposure to mountain cedar pollen is significant during the entire study period.
Participant demonstrates understanding of the study and willingness to participate as evidenced by voluntary written informed consent/assent and has received a signed and dated copy of the informed consent/assent form. Children, ages 12 to 17 will be required to sign an assent form as part of the informed consent process.
Exclusion Criteria:
Participants with known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients.
Participants with nasal disorders like:
Participants who have historical or current evidence of clinically significant uncontrolled disease like asthma, cardiac arrhythmias, hypertension, diabetes mellitus, ocular herpes, glaucoma, hepatic or renal disease, malignancy etc.
Presence of or symptoms of an active bacterial or viral infection.
Participants who have conjunctivitis caused by an infectious agent.
Participants with current, single eye or bilateral cataracts or participants who had cataract surgery within/less than 3 months
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PPD Corporate Headquarters | Wilmington | North Carolina | 28401-3331 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25624132 | Derived | Ratner P, Van Bavel J, Mohar D, Jacobs RL, Hampel F, Howland W, Karwal R. Efficacy of daily intranasal fluticasone propionate on ocular symptoms associated with seasonal allergic rhinitis. Ann Allergy Asthma Immunol. 2015 Feb;114(2):141-7. doi: 10.1016/j.anai.2014.11.012. |
| Label | URL |
|---|---|
| Related References DeWester 2003 | View source |
Not provided
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.
Participants were recruited at 6 clinical sites in the US.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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). |
| FG001 | Placebo Nasal Spray | Two sprays of placebo per nostril to be administered in morning. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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). |
| BG001 | Placebo Nasal Spray |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 in Reflective Total Ocular Symptom Score (rTOSS) | 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. | 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. | Posted | Mean | Standard Deviation | Score on a scale | Baseline to 14 days |
|
Participants were followed for the duration of study, an average of 3 weeks.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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). |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pain | General disorders | MedDRA 15.1 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
Not provided
| ID | Term |
|---|---|
| D065631 | Rhinitis, Allergic |
| D006255 | Rhinitis, Allergic, Seasonal |
| ID | Term |
|---|---|
| D012220 | Rhinitis |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D012130 | Respiratory Hypersensitivity |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068298 | Fluticasone |
| ID | Term |
|---|---|
| D000730 | Androstadienes |
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Drug | Vehicle for Fluticasone propionate aqueous nasal spray |
|
| Baseline to 14 days |
| Mean Change From Baseline in PM rTOSS | 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. | Baseline to 14 days |
| Mean Change From Baseline in Individual AM Reflective Ocular Symptom Scores for Eye Itching/Burning | 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. | Baseline to 14 days |
| Mean Change From Baseline in Individual PM Reflective Ocular Symptom Scores for Eye Itching/Burning | 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. | Baseline to 14 days |
| Mean Change From Baseline in Individual AM Reflective Ocular Symptom Scores for Eye Tearing/Watering | 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. | Baseline to 14 days |
| Mean Change From Baseline in Individual PM Reflective Ocular Symptom Scores for Eye Tearing/Watering | 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. | Baseline to 14 days |
| Mean Change From Baseline in Individual AM Reflective Ocular Symptom Scores for Eye Redness | 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. | Baseline to 14 days |
| Mean Change From Baseline in Individual PM Reflective Ocular Symptom Scores for Eye Redness | 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. | Baseline to 14 days |
| Mean Change From Baseline in AM Pre-dose Instantaneous Total Ocular Symptom Scores (iTOSS) | 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. | Baseline to 14 days |
| Mean Change From Baseline in Reflective Nasal Congestion Symptom Score (rNCSS) | 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. | Baseline to 14 days |
| End-of-treatment Assessment of Response to Therapy for Ocular Symptoms | 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. | Day 14 |
| Mean Change in Objective Assessment of Conjunctival Redness | 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. | Baseline to 14 days |
| Mean Changes From Baseline in Mini Rhinoconjunctivitis Quality of Life Questionnaire (MiniRQLQ) Scores | 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). | Baseline to 14 days |
| Mean Changes From Baseline in Individual MiniRQLQ Scores: Domain - Activities | 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). | Baseline to 14 days |
| Mean Changes From Baseline in Individual MiniRQLQ Scores: Domain - Practical Problems | 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). | Baseline to 14 days |
| Mean Changes From Baseline in Individual MiniRQLQ Scores: Domain - Nose Symptoms | 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). | Baseline to 14 days |
| Mean Changes From Baseline in Individual MiniRQLQ Scores: Domain - Eye Symptoms | 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). | Baseline to 14 days |
| Mean Changes From Baseline in Individual MiniRQLQ Scores: Domain - Other Symptoms | 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). | Baseline to 14 days |
| Protocol Violation |
|
| Withdrawal by Subject |
|
| Other: Could not attend appointment |
|
Two sprays of placebo per nostril to be administered in morning.
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG000 | Fluticasone Propionate Nasal Spray | Fluticasone propionate nasal spray with strength per dose of 50 mcg/spray. Two sprays of study treatment per nostril to be administered in morning. |
| OG001 | Placebo Nasal Spray | Two sprays of placebo per nostril to be administered in morning. |
|
|
|
| Secondary | Mean Change From Baseline in AM rTOSS | 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. | 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. | Posted | Mean | Standard Deviation | Score on a scale | Baseline to 14 days |
|
|
|
|
| Secondary | Mean Change From Baseline in PM rTOSS | 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. | 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. | Posted | Mean | Standard Deviation | Score on a scale | Baseline to 14 days |
|
|
|
|
| Secondary | Mean Change From Baseline in Individual AM Reflective Ocular Symptom Scores for Eye Itching/Burning | 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. | 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. | Posted | Mean | Standard Deviation | Score on a scale | Baseline to 14 days |
|
|
|
|
| Secondary | Mean Change From Baseline in Individual PM Reflective Ocular Symptom Scores for Eye Itching/Burning | 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. | 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. | Posted | Mean | Standard Deviation | Score on a scale | Baseline to 14 days |
|
|
|
|
| Secondary | Mean Change From Baseline in Individual AM Reflective Ocular Symptom Scores for Eye Tearing/Watering | 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. | 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. | Posted | Mean | Standard Deviation | Score on a scale | Baseline to 14 days |
|
|
|
|
| Secondary | Mean Change From Baseline in Individual PM Reflective Ocular Symptom Scores for Eye Tearing/Watering | 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. | 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. | Posted | Mean | Standard Deviation | Score on a scale | Baseline to 14 days |
|
|
|
|
| Secondary | Mean Change From Baseline in Individual AM Reflective Ocular Symptom Scores for Eye Redness | 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. | 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. | Posted | Mean | Standard Deviation | Score on a scale | Baseline to 14 days |
|
|
|
|
| Secondary | Mean Change From Baseline in Individual PM Reflective Ocular Symptom Scores for Eye Redness | 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. | 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. | Posted | Mean | Standard Deviation | Score on a scale | Baseline to 14 days |
|
|
|
|
| Secondary | Mean Change From Baseline in AM Pre-dose Instantaneous Total Ocular Symptom Scores (iTOSS) | 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. | 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. | Posted | Mean | Standard Deviation | Score on a scale | Baseline to 14 days |
|
|
|
|
| Secondary | Mean Change From Baseline in Reflective Nasal Congestion Symptom Score (rNCSS) | 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. | 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. | Posted | Mean | Standard Deviation | Score on a scale | Baseline to 14 days |
|
|
|
|
| Secondary | End-of-treatment Assessment of Response to Therapy for Ocular Symptoms | 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. | 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. | Posted | Number | Participants | Day 14 |
|
|
|
|
| Secondary | Mean Change in Objective Assessment of Conjunctival Redness | 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. | 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. | Posted | Mean | Standard Deviation | Score on a scale | Baseline to 14 days |
|
|
|
|
| Secondary | Mean Changes From Baseline in Mini Rhinoconjunctivitis Quality of Life Questionnaire (MiniRQLQ) Scores | 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). | 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. | Posted | Mean | Standard Deviation | Score on a scale | Baseline to 14 days |
|
|
|
|
| Secondary | Mean Changes From Baseline in Individual MiniRQLQ Scores: Domain - Activities | 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). | 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. | Posted | Mean | Standard Deviation | Score on a scale | Baseline to 14 days |
|
|
|
|
| Secondary | Mean Changes From Baseline in Individual MiniRQLQ Scores: Domain - Practical Problems | 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). | 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. | Posted | Mean | Standard Deviation | Score on a scale | Baseline to 14 days |
|
|
|
|
| Secondary | Mean Changes From Baseline in Individual MiniRQLQ Scores: Domain - Nose Symptoms | 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). | 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. | Posted | Mean | Standard Deviation | Score on a scale | Baseline to 14 days |
|
|
|
|
| Secondary | Mean Changes From Baseline in Individual MiniRQLQ Scores: Domain - Eye Symptoms | 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). | 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. | Posted | Mean | Standard Deviation | Score on a scale | Baseline to 14 days |
|
|
|
|
| Secondary | Mean Changes From Baseline in Individual MiniRQLQ Scores: Domain - Other Symptoms | 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). | 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. | Posted | Mean | Standard Deviation | Score on a scale | Baseline to 14 days |
|
|
|
|
| 0 |
| 314 |
| 8 |
| 314 |
| EG001 | Placebo Nasal Spray | Two sprays of placebo per nostril to be administered in morning. | 0 | 312 | 8 | 312 |
| Pyrexia | General disorders | MedDRA 15.1 | Systematic Assessment |
|
| Thirst | General disorders | MedDRA 15.1 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Gastrointestinal Viral | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Migraine | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Respiratory Tract Congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Throat Irritation | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Palpitations | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
|
| Hypersensitivity | Immune system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Laceration | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
|
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 15.1 | Systematic Assessment |
|
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.
| D010038 |
| Otorhinolaryngologic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| Mildly Improved |
|
| No change |
|
| Mildly Worse |
|
| Moderatly Worse |
|
| Significantly Worse |
|