Allergic Rhinitis, Seasonal Allergic Rhinitis
Conditions
Brief summary
This study is designed to investigate the efficacy of fluticasone propionate (FP) on ocular symptoms associated with allergic rhinitis (AR).
Detailed description
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.
Interventions
DRUGFluticasone propionate
Nasal spray formulation (200 mcg/day)
DRUGPlacebo
Vehicle for Fluticasone propionate aqueous nasal spray
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Participants with good general health (in the opinion of the investigator) with no clinically significant and relevant abnormalities of medical history 2. Participants with diagnosis of seasonal allergic rhinitis 1. A clinical history (written or verbal confirmation) of allergic rhinitis with the seasonal onset and offset of nasal and ocular allergy symptoms during each of the last 2 mountain cedar pollen allergy seasons. 2. A positive skin test reaction to (at least) the relevant allergen, mountain cedar pollen, as determined by the skin pricks method performed within 12 months of Visit 1). 3. Participants with allergic rhinitis symptom of at least moderate severity for randomization: 1. An iTOSS of ≥ 4 and an iNCSS of ≥2 on the morning of randomization (Visit 3/Baseline). 2. An averaged (rTOSS) of ≥ 4, and an averaged rNCSS of ≥2 for three of the five days during the placebo lead in 4. Participant residing within a geographical environment where exposure to mountain cedar pollen is significant during the entire study period. 5. 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
1. Participants with known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients. 2. Participants with nasal disorders like: 1. injury or surgery to their nose that the investigator believes would interfere with participation in the study. 2. previously diagnosed with a severe physical obstruction of the nose (e.g., deviated septum) that could affect the deposition of double-blind intranasal study drug. 3. Rhinitis medicamentosa 3. 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. 4. Presence of or symptoms of an active bacterial or viral infection. 5. Participants who have conjunctivitis caused by an infectious agent. 6. Participants with current, single eye or bilateral cataracts or participants who had cataract surgery within/less than 3 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline in Reflective Total Ocular Symptom Score (rTOSS) | Baseline to 14 days | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline in PM rTOSS | Baseline to 14 days | 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. |
| Mean Change From Baseline in Individual AM Reflective Ocular Symptom Scores for Eye Itching/Burning | Baseline to 14 days | 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. |
| Mean Change From Baseline in Individual PM Reflective Ocular Symptom Scores for Eye Itching/Burning | Baseline to 14 days | 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. |
| Mean Change From Baseline in Individual AM Reflective Ocular Symptom Scores for Eye Tearing/Watering | Baseline to 14 days | 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. |
| Mean Change From Baseline in Individual PM Reflective Ocular Symptom Scores for Eye Tearing/Watering | Baseline to 14 days | 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. |
| Mean Change From Baseline in Individual AM Reflective Ocular Symptom Scores for Eye Redness | Baseline to 14 days | 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. |
| Mean Change From Baseline in Individual PM Reflective Ocular Symptom Scores for Eye Redness | Baseline to 14 days | 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. |
| Mean Change From Baseline in AM Pre-dose Instantaneous Total Ocular Symptom Scores (iTOSS) | Baseline to 14 days | 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. |
| Mean Change From Baseline in AM rTOSS | Baseline to 14 days | 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. |
| End-of-treatment Assessment of Response to Therapy for Ocular Symptoms | Day 14 | 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. |
| Mean Change in Objective Assessment of Conjunctival Redness | Baseline to 14 days | 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. |
| Mean Changes From Baseline in Mini Rhinoconjunctivitis Quality of Life Questionnaire (MiniRQLQ) Scores | Baseline to 14 days | 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). |
| Mean Changes From Baseline in Individual MiniRQLQ Scores: Domain - Activities | Baseline to 14 days | 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). |
| Mean Changes From Baseline in Individual MiniRQLQ Scores: Domain - Practical Problems | Baseline to 14 days | 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). |
| Mean Changes From Baseline in Individual MiniRQLQ Scores: Domain - Nose Symptoms | Baseline to 14 days | 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). |
| Mean Changes From Baseline in Individual MiniRQLQ Scores: Domain - Eye Symptoms | Baseline to 14 days | 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). |
| Mean Changes From Baseline in Individual MiniRQLQ Scores: Domain - Other Symptoms | Baseline to 14 days | 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). |
| Mean Change From Baseline in Reflective Nasal Congestion Symptom Score (rNCSS) | Baseline to 14 days | 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. |
Countries
United States
Participant flow
Recruitment details
Participants were recruited at 6 clinical sites in the US.
Pre-assignment details
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 by arm
| Arm | Count |
|---|---|
| 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). | 314 |
| Placebo Nasal Spray Two sprays of placebo per nostril to be administered in morning. | 312 |
| Total | 626 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 0 | 2 |
| Overall Study | Lost to Follow-up | 0 | 1 |
| Overall Study | Other: Could not attend appointment | 1 | 1 |
| Overall Study | Protocol Violation | 2 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 3 |
Baseline characteristics
| Characteristic | Fluticasone Propionate Nasal Spray | Placebo Nasal Spray | Total |
|---|---|---|---|
| Age, Continuous | 40.4 Years STANDARD_DEVIATION 14.55 | 40.5 Years STANDARD_DEVIATION 16.36 | 40.5 Years STANDARD_DEVIATION 15.47 |
| Sex: Female, Male Female | 212 Participants | 201 Participants | 413 Participants |
| Sex: Female, Male Male | 102 Participants | 111 Participants | 213 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 8 / 314 | 8 / 312 |
| serious Total, serious adverse events | 0 / 314 | 0 / 312 |
Outcome results
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fluticasone Propionate Nasal Spray | Mean Change From Baseline in Reflective Total Ocular Symptom Score (rTOSS) | -0.91 Score on a scale | Standard Deviation 1.625 |
| Placebo Nasal Spray | Mean Change From Baseline in Reflective Total Ocular Symptom Score (rTOSS) | -0.63 Score on a scale | Standard Deviation 1.525 |
Comparison: Null hypothesis was that no difference exists in the mean change from baseline in Daily rTOSS between the Fluticasone nasal spray and the placebo nasal spray.p-value: 0.002495% CI: [-0.59, -0.13]ANCOVA
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.
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fluticasone Propionate Nasal Spray | End-of-treatment Assessment of Response to Therapy for Ocular Symptoms | Mildly Improved | 79 Participants |
| Fluticasone Propionate Nasal Spray | End-of-treatment Assessment of Response to Therapy for Ocular Symptoms | Mildly Worse | 21 Participants |
| Fluticasone Propionate Nasal Spray | End-of-treatment Assessment of Response to Therapy for Ocular Symptoms | Moderately Improved | 76 Participants |
| Fluticasone Propionate Nasal Spray | End-of-treatment Assessment of Response to Therapy for Ocular Symptoms | Moderatly Worse | 24 Participants |
| Fluticasone Propionate Nasal Spray | End-of-treatment Assessment of Response to Therapy for Ocular Symptoms | No change | 81 Participants |
| Fluticasone Propionate Nasal Spray | End-of-treatment Assessment of Response to Therapy for Ocular Symptoms | Significantly Worse | 10 Participants |
| Fluticasone Propionate Nasal Spray | End-of-treatment Assessment of Response to Therapy for Ocular Symptoms | Significantly improved | 22 Participants |
| Placebo Nasal Spray | End-of-treatment Assessment of Response to Therapy for Ocular Symptoms | Significantly Worse | 22 Participants |
| Placebo Nasal Spray | End-of-treatment Assessment of Response to Therapy for Ocular Symptoms | Significantly improved | 16 Participants |
| Placebo Nasal Spray | End-of-treatment Assessment of Response to Therapy for Ocular Symptoms | Moderately Improved | 59 Participants |
| Placebo Nasal Spray | End-of-treatment Assessment of Response to Therapy for Ocular Symptoms | Mildly Improved | 71 Participants |
| Placebo Nasal Spray | End-of-treatment Assessment of Response to Therapy for Ocular Symptoms | No change | 97 Participants |
| Placebo Nasal Spray | End-of-treatment Assessment of Response to Therapy for Ocular Symptoms | Mildly Worse | 20 Participants |
| Placebo Nasal Spray | End-of-treatment Assessment of Response to Therapy for Ocular Symptoms | Moderatly Worse | 24 Participants |
Comparison: Null hypothesis was that no difference exists in the end of treatment assessment of response between the Fluticasone nasal spray and the placebo nasal spray.p-value: 0.0118Cochran-Mantel-Haenszel
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fluticasone Propionate Nasal Spray | Mean Change From Baseline in AM Pre-dose Instantaneous Total Ocular Symptom Scores (iTOSS) | -0.80 Score on a scale | Standard Deviation 1.443 |
| Placebo Nasal Spray | Mean Change From Baseline in AM Pre-dose Instantaneous Total Ocular Symptom Scores (iTOSS) | -0.55 Score on a scale | Standard Deviation 1.531 |
Comparison: Null hypothesis was that no difference exists in the mean change from baseline in AM iTOSS between the Fluticasone nasal spray and the placebo nasal spray.p-value: 0.012995% CI: [-0.5, -0.06]ANCOVA
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fluticasone Propionate Nasal Spray | Mean Change From Baseline in AM rTOSS | -0.96 Score on a scale | Standard Deviation 1.627 |
| Placebo Nasal Spray | Mean Change From Baseline in AM rTOSS | -0.68 Score on a scale | Standard Deviation 1.573 |
Comparison: Null hypothesis was that no difference exists in the mean change from baseline in AM rTOSS between the Fluticasone nasal spray and the placebo nasal spray.p-value: 0.005795% CI: [-0.56, -0.1]ANCOVA
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fluticasone Propionate Nasal Spray | 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 |
| Placebo Nasal Spray | Mean Change From Baseline in Individual AM Reflective Ocular Symptom Scores for Eye Itching/Burning | -0.28 Score on a scale | Standard Deviation 0.553 |
Comparison: Null hypothesis was that no difference exists in the mean change from baseline in AM reflective symptom scores for Eye itching/burning between the Fluticasone nasal spray and the placebo nasal spray.p-value: 0.011795% CI: [-0.19, -0.02]ANCOVA
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fluticasone Propionate Nasal Spray | Mean Change From Baseline in Individual AM Reflective Ocular Symptom Scores for Eye Redness | -0.26 Score on a scale | Standard Deviation 0.597 |
| Placebo Nasal Spray | Mean Change From Baseline in Individual AM Reflective Ocular Symptom Scores for Eye Redness | -0.17 Score on a scale | Standard Deviation 0.613 |
Comparison: Null hypothesis was that no difference exists in the mean change from baseline in AM reflective symptom scores for Eye Redness between the Fluticasone nasal spray and the placebo nasal spray.p-value: 0.030495% CI: [-0.18, -0.01]ANCOVA
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fluticasone Propionate Nasal Spray | 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 |
| Placebo Nasal Spray | Mean Change From Baseline in Individual AM Reflective Ocular Symptom Scores for Eye Tearing/Watering | -0.24 Score on a scale | Standard Deviation 0.589 |
Comparison: Null hypothesis was that no difference exists in the mean change from baseline in AM reflective symptom scores for Eye Tearing/Watering between the Fluticasone nasal spray and the placebo nasal spray.p-value: 0.002395% CI: [-0.22, -0.06]ANCOVA
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fluticasone Propionate Nasal Spray | 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 |
| Placebo Nasal Spray | Mean Change From Baseline in Individual PM Reflective Ocular Symptom Scores for Eye Itching/Burning | -0.24 Score on a scale | Standard Deviation 0.554 |
Comparison: Null hypothesis was that no difference exists in the mean change from baseline in PM reflective symptom scores for Eye itching/burning between the Fluticasone nasal spray and the placebo nasal spray.p-value: 0.000595% CI: [-0.23, -0.06]ANCOVA
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fluticasone Propionate Nasal Spray | Mean Change From Baseline in Individual PM Reflective Ocular Symptom Scores for Eye Redness | -0.22 Score on a scale | Standard Deviation 0.628 |
| Placebo Nasal Spray | Mean Change From Baseline in Individual PM Reflective Ocular Symptom Scores for Eye Redness | -0.17 Score on a scale | Standard Deviation 0.635 |
Comparison: Null hypothesis was that no difference exists in the mean change from baseline in PM reflective symptom scores for Eye Redness between the Fluticasone nasal spray and the placebo nasal spray.p-value: 0.036195% CI: [-0.19, -0.01]ANCOVA
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fluticasone Propionate Nasal Spray | 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 |
| Placebo Nasal Spray | Mean Change From Baseline in Individual PM Reflective Ocular Symptom Scores for Eye Tearing/Watering | -0.19 Score on a scale | Standard Deviation 0.586 |
Comparison: Null hypothesis was that no difference exists in the mean change from baseline in PM reflective symptom scores for Eye Tearing/watering between the Fluticasone nasal spray and the placebo nasal spray.p-value: <0.000195% CI: [-0.26, -0.09]ANCOVA
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fluticasone Propionate Nasal Spray | Mean Change From Baseline in PM rTOSS | -0.87 Score on a scale | Standard Deviation 1.735 |
| Placebo Nasal Spray | Mean Change From Baseline in PM rTOSS | -0.60 Score on a scale | Standard Deviation 1.577 |
Comparison: Null hypothesis was that no difference exists in the mean change from baseline in PM rTOSS between the Fluticasone nasal spray and the placebo nasal spray.p-value: 0.000995% CI: [-0.65, -0.17]ANCOVA
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fluticasone Propionate Nasal Spray | Mean Change From Baseline in Reflective Nasal Congestion Symptom Score (rNCSS) | -0.34 Score on a scale | Standard Deviation 0.547 |
| Placebo Nasal Spray | Mean Change From Baseline in Reflective Nasal Congestion Symptom Score (rNCSS) | -0.20 Score on a scale | Standard Deviation 0.443 |
Comparison: Null hypothesis was that no difference exists in the mean change from baseline in rNCSS between the Fluticasone nasal spray and the placebo nasal spray.p-value: 0.000295% CI: [-0.22, -0.07]ANCOVA
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fluticasone Propionate Nasal Spray | Mean Change in Objective Assessment of Conjunctival Redness | -0.20 Score on a scale | Standard Deviation 0.815 |
| Placebo Nasal Spray | Mean Change in Objective Assessment of Conjunctival Redness | -0.15 Score on a scale | Standard Deviation 0.736 |
Comparison: Null hypothesis was that no difference exists in the mean change from baseline in objective assessment of conjunctival redness between the Fluticasone nasal spray and the placebo nasal spray.p-value: 0.858695% CI: [-0.12, 0.1]ANCOVA
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).
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fluticasone Propionate Nasal Spray | Mean Changes From Baseline in Individual MiniRQLQ Scores: Domain - Activities | -0.93 Score on a scale | Standard Deviation 1.384 |
| Placebo Nasal Spray | Mean Changes From Baseline in Individual MiniRQLQ Scores: Domain - Activities | -0.39 Score on a scale | Standard Deviation 1.269 |
Comparison: Null hypothesis was that no difference exists in the mean change from baseline in 'Activities' domain of MiniRQLQ scores between the Flutical sone nasal spray and placebo nasal sprayp-value: <0.000195% CI: [-0.68, -0.3]ANCOVA
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).
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fluticasone Propionate Nasal Spray | Mean Changes From Baseline in Individual MiniRQLQ Scores: Domain - Eye Symptoms | -0.98 Score on a scale | Standard Deviation 1.512 |
| Placebo Nasal Spray | Mean Changes From Baseline in Individual MiniRQLQ Scores: Domain - Eye Symptoms | -0.55 Score on a scale | Standard Deviation 1.284 |
Comparison: Null hypothesis was that no difference exists in the mean change from baseline in 'Eye Symptoms' domain of MiniRQLQ scores between the Flutical sone nasal spray and placebo nasal spray.p-value: <0.000195% CI: [-0.65, -0.23]ANCOVA
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).
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fluticasone Propionate Nasal Spray | Mean Changes From Baseline in Individual MiniRQLQ Scores: Domain - Nose Symptoms | -1.09 Score on a scale | Standard Deviation 1.456 |
| Placebo Nasal Spray | Mean Changes From Baseline in Individual MiniRQLQ Scores: Domain - Nose Symptoms | -0.50 Score on a scale | Standard Deviation 1.257 |
Comparison: Null hypothesis was that no difference exists in the mean change from baseline in 'Nose Symptoms' domain of MiniRQLQ scores between the Flutical sone nasal spray and placebo nasal spray.p-value: <0.000195% CI: [-0.73, -0.33]ANCOVA
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).
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fluticasone Propionate Nasal Spray | Mean Changes From Baseline in Individual MiniRQLQ Scores: Domain - Other Symptoms | -0.89 Score on a scale | Standard Deviation 1.607 |
| Placebo Nasal Spray | Mean Changes From Baseline in Individual MiniRQLQ Scores: Domain - Other Symptoms | -0.48 Score on a scale | Standard Deviation 1.294 |
Comparison: Null hypothesis was that no difference exists in the mean change from baseline in 'Other Symptoms' domain of MiniRQLQ scores between the Flutical sone nasal spray and placebo nasal spray.p-value: <0.000195% CI: [-0.64, -0.21]ANCOVA
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).
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fluticasone Propionate Nasal Spray | Mean Changes From Baseline in Individual MiniRQLQ Scores: Domain - Practical Problems | -1.04 Score on a scale | Standard Deviation 1.476 |
| Placebo Nasal Spray | Mean Changes From Baseline in Individual MiniRQLQ Scores: Domain - Practical Problems | -0.57 Score on a scale | Standard Deviation 1.258 |
Comparison: Null hypothesis was that no difference exists in the mean change from baseline in 'Practical Problems' domain of MiniRQLQ scores between the Flutical sone nasal spray and placebo nasal spray.p-value: <0.000195% CI: [-0.64, -0.24]ANCOVA
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).
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fluticasone Propionate Nasal Spray | Mean Changes From Baseline in Mini Rhinoconjunctivitis Quality of Life Questionnaire (MiniRQLQ) Scores | -0.98 Score on a scale | Standard Deviation 1.311 |
| Placebo Nasal Spray | Mean Changes From Baseline in Mini Rhinoconjunctivitis Quality of Life Questionnaire (MiniRQLQ) Scores | -0.49 Score on a scale | Standard Deviation 1.091 |
Comparison: Null hypothesis was that no difference exists in the mean change from baseline in MiniRQLQ scores between the Fluticasone nasal spray and the placebo nasal spray.p-value: <0.000195% CI: [-0.65, -0.29]ANCOVA