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This Phase IV interventional study is a multi-center, randomized, double-blind, placebo-controlled parallel study to evaluate the efficacy and safety of FFNS110 mcg and 55 mcg once daily versus vehicle placebo aqueous nasal spray in chinese pediatric subjects ages 2 to 12 years with AR.
This study comprises screening and run-in period (4 to14 days), double-blind treatment period (28 days) and follows up period (3 to7 days). Subjects entering the study will participate for maximum of 50 days, including five clinical visits and a follow-up contact.
The study is planned to enroll approximately 360 subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FFNS 55 mcg Arm | Experimental | Each subject will be dispensed with two nasal spray device labelled as Device A and Device B containing either FF or Placebo. Subject's on their own or with assistance from parent/guardian will administer FFNS 55 mcg per day, one intranasal spray from Device A, once daily into each nostril (27.5 mcg per spray) and another spray of placebo nasal spray from Device B, once daily into each nostril, in the morning for 4 Weeks. |
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| FFNS 110 mcg Arm | Experimental | Each subject will be dispensed with two nasal spray device labelled as Device A and Device B containing FF or Placebo. Subject's on their own or with assistance from parent/guardian will administer FFNS 110 mcg per day, one intranasal spray from Device A, once daily into each nostril (27.5 mcg per spray) and another spray of placebo nasal spray from Device B, once daily into each nostril, in the morning for 4 Weeks. |
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| Placebo Arm | Placebo Comparator | Each subject will be dispensed with two nasal spray device labelled as Device A and Device B containing only placebo. Subject's on their own or with assistance from parent/guardian will administer one intranasal spray of placebo, from Device A and Device B, once daily into each nostril in the morning for 4 Weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FFNS | Drug | FF as a aqueous suspension for intranasal inhalation with unit dose strength of 27.5 mcg per dose administered via a metered side-actuated nasal spray device. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline in Daily, Reflective Total Nasal Symptom Scores (rTNSS) Over the First 2 Weeks Treatment Period | TNSS is a composite score of the four components (nasal congestion, itching, rhinorrhea and sneezing) with a total score of 0 to 12. A higher score means a worse nasal symptom. The score of each component ranges from 0 (no symptom) to 3 (severe symptoms). Participants were instructed to provide scores in a reflective manner using their diary. The daily rTNSS was the average of the morning rTNSS and evening rTNSS assessments. The daily scores were averaged to calculate the overall/total score. The morning reflective assessment was performed prior to administering the morning dose. The evening reflective assessment was performed approximately 12 hours after dosing but before bedtime. Baseline scores obtained over "4 days prior to randomization" were average of the last 8 rTNSS assessments (4 AM assessments, 4 PM assessments) over the consecutive four 24-hours periods prior to randomization. Change from Baseline was defined as post-dose visit value minus Baseline value. | Baseline and up to Week 2 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Showing Response to the Therapy After the First 2 Weeks Treatment on a 7-point Categorical Scale | Response was defined as effectiveness of study medication for relieving allergic rhinitis symptoms over the entire treatment period. Overall response to therapy was evaluated using the 7-point categorical scale ranging from 1 (significantly improved) to 7 (significantly worse). Number of participants showing response to therapy after the first 2 weeks have been presented. Only those participants with response to therapy over the entire treatment period were included in the analysis. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Xiamen | Fujian | 361003 | China | ||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33007780 | Background | Zhang Y, Wei P, Chen B, Li X, Luo X, Chen X, Xiang M, Li L, Zhao S, Xiao X, Yang X, Chen J, Fu Y, Xiao S, Liu H, Cheng L, Yao H. Intranasal fluticasone furoate in pediatric allergic rhinitis: randomized controlled study. Pediatr Res. 2021 May;89(7):1832-1839. doi: 10.1038/s41390-020-01180-0. Epub 2020 Oct 2. |
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IPD for this study is available via the Clinical Study Data Request site.
IPD is available via the Clinical Study Data Request site (copy the URL below to your browser)
Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
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This efficacy and safety study of fluticasone furoate (FF) was conducted at 16 centers in China. A total of 505 pediatric participants with allergic rhinitis were screened; of which 147 were screen and run-in failures and 358 were randomized in a 1:1:1 ratio to receive placebo, FF 55 micrograms (µg) or FF 110 µg once daily (QD).
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Participants received one spray of placebo from nasal spray device A (placebo nasal spray) followed by one spray from nasal spray device B (placebo nasal spray) into each nostril QD in the morning for 28-day treatment period. |
| FG001 | FF 55 µg QD |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 15, 2016 | Mar 8, 2018 |
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| Placebo | Other | Placebo as a aqueous suspension to match the other study treatments minus the active component(s) for intranasal inhalation administered via a metered side-actuated nasal spray device. |
|
| Week 2 |
| Mean Change From Baseline of Intranasal Finding Score by Anterior Rhinoscopy at the First 2 Weeks | The nasal concha mucosa symptoms score was used to evaluate change in anterior rhinoscopy. It is a composite score of four components including swelling of inferior nasal concha mucosa, color of inferior nasal concha mucosa, watery secretion volume and description of rhinorrhea. Severity of each of the component was assessed using the scale ranging from 0 (no symptom) to 3 (severe). The 4 components were averaged to obtain a total score which ranges from 0 to 12 where a higher score means a worse nasal symptom. Baseline was defined as 4 days prior to randomization, including the morning symptom assessment on the randomization date. Change from Baseline was defined as post-dose visit value minus Baseline value. Only those participants with data available at the specified time points were included in the analysis. | Baseline and up to Week 2 |
| Mean Change From Baseline Over the First 2 Weeks in the Daily, Reflective Total Ocular Symptoms Score (rTOSS) | TOSS is a composite score of the three components (eye itching and burning, eye watering and eye redness) with a total score of 0 to 9. Higher score means a worse symptom. The score of each component ranges from 0 (no symptom) to 3 (severe symptoms). The daily scores were averaged to calculate the overall/total score. Participants were instructed to provide scores and document their symptoms in a reflective manner twice daily using their diary at the same time of reflective nasal symptoms assessment. Baseline scores obtained over "4 days prior to randomization" were average of the last 8 rTNSS assessments (4 AM assessments, 4 PM assessments) over the consecutive four 24-hours periods prior to randomization. Change from Baseline was defined as post-dose visit value minus Baseline value | Baseline and up to Week 2 |
| Mean Change From Baseline in Rescue Loratadine Use (Mean Rescue-free Days) Over the First 2 Weeks Treatment Period | Loratadine was provided as a rescue medication to use if needed throughout the study treatment period. Participants were asked to document loratadine rescue medication use on the daily treatment diary. Baseline was defined as 4 days prior to randomization, including the morning symptom assessment on the randomization date. Change from Baseline was defined as post-dose visit value minus Baseline value. | Baseline and up to Week 2 |
| Mean Change From Baseline in Daily rTNSS Over the 4 Weeks Treatment Period | TNSS is a composite score of the four components (nasal congestion, itching, rhinorrhea and sneezing) with a total score of 0 to 12. A higher score means a worse nasal symptom. The score of each component ranges from 0 (no symptom) to 3 (severe symptoms). Participants were instructed to provide scores in a reflective manner using their diary. The daily rTNSS was the average of the morning rTNSS and evening rTNSS assessments. The daily scores were averaged to calculate the overall/total score. The morning reflective assessment was performed prior to administering the morning dose. The evening reflective assessment was performed approximately 12 hours after dosing but before bedtime. Baseline scores obtained over "4 days prior to randomization" were average of the last 8 rTNSS assessments (4 AM assessments, 4 PM assessments) over the consecutive four 24-hours periods prior to randomization. Change from Baseline was defined as post-dose visit value minus Baseline value. | Baseline and up to Week 4 |
| Number of Participants Showing Response to the Therapy After 4 Weeks Treatment on a 7-point Categorical Scale | Response was defined as effectiveness of study medication for relieving allergic rhinitis symptoms over the entire treatment period. Overall response to therapy was evaluated using the 7-point categorical scale ranging from 1 (significantly improved) to 7 (significantly worse). Number of participants showing response to therapy after the first 4 weeks have been presented. Only those participants with response to therapy over the entire treatment period were included in the analysis. | Week 4 |
| Mean Change From Baseline of Intranasal Finding Score by Anterior Rhinoscopy at the First 4 Weeks | The nasal concha mucosa symptoms score was used to evaluate change in anterior rhinoscopy. It is a composite score of four components including swelling of inferior nasal concha mucosa, color of inferior nasal concha mucosa, watery secretion volume and description of rhinorrhea. Severity of each of the component was assessed using the scale ranging from 0 (no symptom) to 3 (severe). The 4 components were averaged to obtain a total score which ranges from 0 to 12 where a higher score means a worse nasal symptom. Baseline was defined as 4 days prior to randomization, including the morning symptom assessment on the randomization date. Change from Baseline was defined as post-dose visit value minus Baseline value. Only those participants with data available at the specified time points were included in the analysis. | Baseline and up to Week 4 |
| Mean Change From Baseline in the Daily rTOSS Over the 4 Weeks Treatment Period | TOSS is a composite score of the three components (eye itching and burning, eye watering and eye redness) with a total score of 0 to 9. Higher score means a worse symptom. The score of each component ranges from 0 (no symptom) to 3 (severe symptoms). The daily scores were averaged to calculate the overall/total score. Participants were instructed to provide scores and document their symptoms in a reflective manner twice daily using their diary at the same time of reflective nasal symptoms assessment. Baseline scores obtained over "4 days prior to randomization" were average of the last 8 rTNSS assessments (4 AM assessments, 4 PM assessments) over the consecutive four 24-hours periods prior to randomization. Change from Baseline was defined as post-dose visit value minus Baseline value. | Baseline and up to Week 4 |
| Mean Change From Baseline in Rescue Loratadine Use (Mean Rescue-free Days) Over the First 4 Weeks Treatment Period | Loratadine was provided as a rescue medication to use if needed throughout the study treatment period. Participants were asked to document loratadine rescue medication use on the daily treatment diary. Baseline was defined as 4 days prior to randomization, including the morning symptom assessment on the randomization date. Change from Baseline was defined as post-dose visit value minus Baseline value. | Baseline and up to Week 4 |
| Number of Participants With Serious Adverse Events (SAEs) and Non-SAEs During the Treatment Period | An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability, is a congenital anomaly/birth defect, other situations and is associated with liver injury or impaired liver function. | Up to Week 4 |
| Number of Participants With Clinical Chemistry Values Outside the Normal Range | Blood samples were collected from participants at indicated time points to evaluate clinical chemistry values outside normal range. The clinical chemistry parameters including alanine aminotransferase (ALT), albumin, alkaline phosphatase (ALP), aspartate aminotransferase (AST), calcium, creatinine, direct bilirubin, glucose, potassium, sodium, total bilirubin, total protein and blood urea nitrogen (BUN) with values outside normal range is presented. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). | Week 4 |
| Number of Participants With Hematology Values Outside Normal Range | Blood samples were collected from participants at indicated time points to evaluate hematology values outside normal range. The hematology parameters including basophils, eosinophils, hematocrit, hemoglobin, lymphocytes, mean corpuscular hemoglobin (MCH), mean corpuscular volume (MCV), monocytes, platelet, red blood cells (RBC), total neutrophils, white blood cells (WBC) with values outside normal range is presented. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles). | Week 4 |
| Number of Participants With Urinalysis Values Outside Normal Range | Urine parameters including urine specific gravity and urine potential of hydrogen (pH) with values outside normal range is presented. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles). | Week 4 |
| Number of Participants With Change From Baseline in Nasal Examination | A detailed nasal examination of the mucosa, septum, secretions, nasal patency, size of any polyps and ulcers was performed at specific time points. Number of participants with improved or worsened conditions are presented. Improved condition was defined as increase in number of patencies and Worsened condition was defined as decrease in number of patencies, from Baseline to Week 4. The Baseline value for a nasal examination was the most recent recorded value for Week 4 before dosing on Day 1. Change from Baseline was defined as post-dose visit value minus Baseline value. | Baseline and Week 4 |
| Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Vital signs including SBP and DBP were measured in a semi-supine position after 5 minutes rest. The most recent recorded value for Week 4 before dosing on Day 1 was considered as Baseline value. Change from Baseline was defined as post-dose visit value minus Baseline value. Only those participants with data available for the specified time point were analyzed. | Baseline and Week 4 |
| Change From Baseline in Heart Rate | Vital signs including heart rate were measured in a semi-supine position after 5 minutes rest. The most recent recorded value for Week 4 before dosing on Day 1 was considered as Baseline value. Change from Baseline was defined as post-dose visit value minus Baseline value. Only those participants with data available for the specified time point were analyzed. | Baseline and Week 4 |
| Change From Baseline in Temperature | Vital signs including temperature were measured in a semi-supine position after 5 minutes rest. The most recent recorded value for Week 4 before dosing on Day 1 was considered as Baseline value. Change from Baseline was defined as post-dose visit value minus Baseline value. Only those participants with data available for the specified time point were analyzed. | Baseline and Week 4 |
| Change From Baseline in Respiration Rate | Vital signs including respiration rate were measured in a semi-supine position after 5 minutes rest. The most recent recorded value for Week 4 before dosing on Day 1 was considered as Baseline value. Change from Baseline was defined as post-dose visit value minus Baseline value. Only those participants with data available for the specified time point were analyzed. | Baseline and Week 4 |
| Shenzhen |
| Guangdong |
| 518038 |
| China |
| GSK Investigational Site | Changsha | Hunan | 410005 | China |
| GSK Investigational Site | Changsha | Hunan | 410011 | China |
| GSK Investigational Site | Nanjing | Jiangsu | 210029 | China |
| GSK Investigational Site | Taiyuan | Shanxi | 030016 | China |
| GSK Investigational Site | Wenzhou | Zhejiang | 323027 | China |
| GSK Investigational Site | Beijing | 100034 | China |
| GSK Investigational Site | Beijing | China |
| GSK Investigational Site | Changsha | China |
| GSK Investigational Site | Chongqing | 400014 | China |
| GSK Investigational Site | Fuzhou | 350025 | China |
| GSK Investigational Site | Hangzhou | 310052 | China |
| GSK Investigational Site | Shanghai | 200040 | China |
| GSK Investigational Site | Shanghai | 200092 | China |
| GSK Investigational Site | Shanghai | 200127 | China |
Participants received one spray of FF 55 µg from nasal spray device A (FF nasal spray) followed by one spray from nasal spray device B (placebo nasal spray) into each nostril QD in the morning for 28-day treatment period. |
| FG002 | FF 110 µg QD | Participants received one spray of FF 110 µg from nasal spray device A (FF nasal spray) followed by one spray from nasal spray device B (FF nasal spray) into each nostril QD in the morning for 28-day treatment period. |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Participants received one spray of placebo from nasal spray device A (placebo nasal spray) followed by one spray from nasal spray device B (placebo nasal spray) into each nostril QD in the morning for 28-day treatment period. |
| BG001 | FF 55 µg QD | Participants received one spray of FF 55 µg from nasal spray device A (FF nasal spray) followed by one spray from nasal spray device B (placebo nasal spray) into each nostril QD in the morning for 28-day treatment period. |
| BG002 | FF 110 µg QD | Participants received one spray of FF 110 µg from nasal spray device A (FF nasal spray) followed by one spray from nasal spray device B (FF nasal spray) into each nostril QD in the morning for 28-day treatment period. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
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| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| 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 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Mean Change From Baseline in Daily, Reflective Total Nasal Symptom Scores (rTNSS) Over the First 2 Weeks Treatment Period | TNSS is a composite score of the four components (nasal congestion, itching, rhinorrhea and sneezing) with a total score of 0 to 12. A higher score means a worse nasal symptom. The score of each component ranges from 0 (no symptom) to 3 (severe symptoms). Participants were instructed to provide scores in a reflective manner using their diary. The daily rTNSS was the average of the morning rTNSS and evening rTNSS assessments. The daily scores were averaged to calculate the overall/total score. The morning reflective assessment was performed prior to administering the morning dose. The evening reflective assessment was performed approximately 12 hours after dosing but before bedtime. Baseline scores obtained over "4 days prior to randomization" were average of the last 8 rTNSS assessments (4 AM assessments, 4 PM assessments) over the consecutive four 24-hours periods prior to randomization. Change from Baseline was defined as post-dose visit value minus Baseline value. | Intent-To-Treat (ITT) Population comprised of all randomized participants who received at least one dose of study treatment. | Posted | Least Squares Mean | Standard Error | Scores on a scale | Baseline and up to Week 2 |
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| Secondary | Number of Participants Showing Response to the Therapy After the First 2 Weeks Treatment on a 7-point Categorical Scale | Response was defined as effectiveness of study medication for relieving allergic rhinitis symptoms over the entire treatment period. Overall response to therapy was evaluated using the 7-point categorical scale ranging from 1 (significantly improved) to 7 (significantly worse). Number of participants showing response to therapy after the first 2 weeks have been presented. Only those participants with response to therapy over the entire treatment period were included in the analysis. | ITT Population | Posted | Number | Participants | Week 2 |
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| Secondary | Mean Change From Baseline of Intranasal Finding Score by Anterior Rhinoscopy at the First 2 Weeks | The nasal concha mucosa symptoms score was used to evaluate change in anterior rhinoscopy. It is a composite score of four components including swelling of inferior nasal concha mucosa, color of inferior nasal concha mucosa, watery secretion volume and description of rhinorrhea. Severity of each of the component was assessed using the scale ranging from 0 (no symptom) to 3 (severe). The 4 components were averaged to obtain a total score which ranges from 0 to 12 where a higher score means a worse nasal symptom. Baseline was defined as 4 days prior to randomization, including the morning symptom assessment on the randomization date. Change from Baseline was defined as post-dose visit value minus Baseline value. Only those participants with data available at the specified time points were included in the analysis. | ITT Population | Posted | Least Squares Mean | Standard Error | Scores on a scale | Baseline and up to Week 2 |
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| Secondary | Mean Change From Baseline Over the First 2 Weeks in the Daily, Reflective Total Ocular Symptoms Score (rTOSS) | TOSS is a composite score of the three components (eye itching and burning, eye watering and eye redness) with a total score of 0 to 9. Higher score means a worse symptom. The score of each component ranges from 0 (no symptom) to 3 (severe symptoms). The daily scores were averaged to calculate the overall/total score. Participants were instructed to provide scores and document their symptoms in a reflective manner twice daily using their diary at the same time of reflective nasal symptoms assessment. Baseline scores obtained over "4 days prior to randomization" were average of the last 8 rTNSS assessments (4 AM assessments, 4 PM assessments) over the consecutive four 24-hours periods prior to randomization. Change from Baseline was defined as post-dose visit value minus Baseline value | ITT Population | Posted | Least Squares Mean | Standard Error | Scores on a scale | Baseline and up to Week 2 |
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| Secondary | Mean Change From Baseline in Rescue Loratadine Use (Mean Rescue-free Days) Over the First 2 Weeks Treatment Period | Loratadine was provided as a rescue medication to use if needed throughout the study treatment period. Participants were asked to document loratadine rescue medication use on the daily treatment diary. Baseline was defined as 4 days prior to randomization, including the morning symptom assessment on the randomization date. Change from Baseline was defined as post-dose visit value minus Baseline value. | ITT Population | Posted | Least Squares Mean | Standard Error | Days | Baseline and up to Week 2 |
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| Secondary | Mean Change From Baseline in Daily rTNSS Over the 4 Weeks Treatment Period | TNSS is a composite score of the four components (nasal congestion, itching, rhinorrhea and sneezing) with a total score of 0 to 12. A higher score means a worse nasal symptom. The score of each component ranges from 0 (no symptom) to 3 (severe symptoms). Participants were instructed to provide scores in a reflective manner using their diary. The daily rTNSS was the average of the morning rTNSS and evening rTNSS assessments. The daily scores were averaged to calculate the overall/total score. The morning reflective assessment was performed prior to administering the morning dose. The evening reflective assessment was performed approximately 12 hours after dosing but before bedtime. Baseline scores obtained over "4 days prior to randomization" were average of the last 8 rTNSS assessments (4 AM assessments, 4 PM assessments) over the consecutive four 24-hours periods prior to randomization. Change from Baseline was defined as post-dose visit value minus Baseline value. | ITT Population | Posted | Least Squares Mean | Standard Error | Scores on a scale | Baseline and up to Week 4 |
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| Secondary | Number of Participants Showing Response to the Therapy After 4 Weeks Treatment on a 7-point Categorical Scale | Response was defined as effectiveness of study medication for relieving allergic rhinitis symptoms over the entire treatment period. Overall response to therapy was evaluated using the 7-point categorical scale ranging from 1 (significantly improved) to 7 (significantly worse). Number of participants showing response to therapy after the first 4 weeks have been presented. Only those participants with response to therapy over the entire treatment period were included in the analysis. | ITT Population | Posted | Number | Participants | Week 4 |
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| Secondary | Mean Change From Baseline of Intranasal Finding Score by Anterior Rhinoscopy at the First 4 Weeks | The nasal concha mucosa symptoms score was used to evaluate change in anterior rhinoscopy. It is a composite score of four components including swelling of inferior nasal concha mucosa, color of inferior nasal concha mucosa, watery secretion volume and description of rhinorrhea. Severity of each of the component was assessed using the scale ranging from 0 (no symptom) to 3 (severe). The 4 components were averaged to obtain a total score which ranges from 0 to 12 where a higher score means a worse nasal symptom. Baseline was defined as 4 days prior to randomization, including the morning symptom assessment on the randomization date. Change from Baseline was defined as post-dose visit value minus Baseline value. Only those participants with data available at the specified time points were included in the analysis. | ITT Population | Posted | Least Squares Mean | Standard Error | Scores on a scale | Baseline and up to Week 4 |
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| Secondary | Mean Change From Baseline in the Daily rTOSS Over the 4 Weeks Treatment Period | TOSS is a composite score of the three components (eye itching and burning, eye watering and eye redness) with a total score of 0 to 9. Higher score means a worse symptom. The score of each component ranges from 0 (no symptom) to 3 (severe symptoms). The daily scores were averaged to calculate the overall/total score. Participants were instructed to provide scores and document their symptoms in a reflective manner twice daily using their diary at the same time of reflective nasal symptoms assessment. Baseline scores obtained over "4 days prior to randomization" were average of the last 8 rTNSS assessments (4 AM assessments, 4 PM assessments) over the consecutive four 24-hours periods prior to randomization. Change from Baseline was defined as post-dose visit value minus Baseline value. | ITT Population | Posted | Least Squares Mean | Standard Error | Scores on a scale | Baseline and up to Week 4 |
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| Secondary | Mean Change From Baseline in Rescue Loratadine Use (Mean Rescue-free Days) Over the First 4 Weeks Treatment Period | Loratadine was provided as a rescue medication to use if needed throughout the study treatment period. Participants were asked to document loratadine rescue medication use on the daily treatment diary. Baseline was defined as 4 days prior to randomization, including the morning symptom assessment on the randomization date. Change from Baseline was defined as post-dose visit value minus Baseline value. | ITT Population | Posted | Least Squares Mean | Standard Error | Days | Baseline and up to Week 4 |
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| Secondary | Number of Participants With Serious Adverse Events (SAEs) and Non-SAEs During the Treatment Period | An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability, is a congenital anomaly/birth defect, other situations and is associated with liver injury or impaired liver function. | ITT Population | Posted | Number | Participants | Up to Week 4 |
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| Secondary | Number of Participants With Clinical Chemistry Values Outside the Normal Range | Blood samples were collected from participants at indicated time points to evaluate clinical chemistry values outside normal range. The clinical chemistry parameters including alanine aminotransferase (ALT), albumin, alkaline phosphatase (ALP), aspartate aminotransferase (AST), calcium, creatinine, direct bilirubin, glucose, potassium, sodium, total bilirubin, total protein and blood urea nitrogen (BUN) with values outside normal range is presented. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). | ITT Population | Posted | Number | Participants | Week 4 |
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| Secondary | Number of Participants With Hematology Values Outside Normal Range | Blood samples were collected from participants at indicated time points to evaluate hematology values outside normal range. The hematology parameters including basophils, eosinophils, hematocrit, hemoglobin, lymphocytes, mean corpuscular hemoglobin (MCH), mean corpuscular volume (MCV), monocytes, platelet, red blood cells (RBC), total neutrophils, white blood cells (WBC) with values outside normal range is presented. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles). | ITT Population | Posted | Number | Participants | Week 4 |
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| Secondary | Number of Participants With Urinalysis Values Outside Normal Range | Urine parameters including urine specific gravity and urine potential of hydrogen (pH) with values outside normal range is presented. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles). | ITT Population | Posted | Number | Participants | Week 4 |
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| Secondary | Number of Participants With Change From Baseline in Nasal Examination | A detailed nasal examination of the mucosa, septum, secretions, nasal patency, size of any polyps and ulcers was performed at specific time points. Number of participants with improved or worsened conditions are presented. Improved condition was defined as increase in number of patencies and Worsened condition was defined as decrease in number of patencies, from Baseline to Week 4. The Baseline value for a nasal examination was the most recent recorded value for Week 4 before dosing on Day 1. Change from Baseline was defined as post-dose visit value minus Baseline value. | ITT Population | Posted | Number | Participants | Baseline and Week 4 |
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| Secondary | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Vital signs including SBP and DBP were measured in a semi-supine position after 5 minutes rest. The most recent recorded value for Week 4 before dosing on Day 1 was considered as Baseline value. Change from Baseline was defined as post-dose visit value minus Baseline value. Only those participants with data available for the specified time point were analyzed. | ITT Population | Posted | Mean | Standard Deviation | Millimeter of mercury (mmHg) | Baseline and Week 4 |
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| Secondary | Change From Baseline in Heart Rate | Vital signs including heart rate were measured in a semi-supine position after 5 minutes rest. The most recent recorded value for Week 4 before dosing on Day 1 was considered as Baseline value. Change from Baseline was defined as post-dose visit value minus Baseline value. Only those participants with data available for the specified time point were analyzed. | ITT Population | Posted | Mean | Standard Deviation | Beats per minute | Baseline and Week 4 |
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| Secondary | Change From Baseline in Temperature | Vital signs including temperature were measured in a semi-supine position after 5 minutes rest. The most recent recorded value for Week 4 before dosing on Day 1 was considered as Baseline value. Change from Baseline was defined as post-dose visit value minus Baseline value. Only those participants with data available for the specified time point were analyzed. | ITT Population | Posted | Mean | Standard Deviation | Degree Celsius | Baseline and Week 4 |
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| Secondary | Change From Baseline in Respiration Rate | Vital signs including respiration rate were measured in a semi-supine position after 5 minutes rest. The most recent recorded value for Week 4 before dosing on Day 1 was considered as Baseline value. Change from Baseline was defined as post-dose visit value minus Baseline value. Only those participants with data available for the specified time point were analyzed. | ITT Population | Posted | Mean | Standard Deviation | Breaths per minute | Baseline and Week 4 |
|
On-therapy SAEs and non-SAEs are presented from the start of study treatment up to Week 4
On-therapy SAEs and non-SAEs are reported for the ITT Population.
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 | Placebo | Participants received one spray of placebo from nasal spray device A (placebo nasal spray) followed by one spray from nasal spray device B (placebo nasal spray) into each nostril QD in the morning for 28-day treatment period. | 0 | 120 | 0 | 120 | 51 | 120 |
| EG001 | FF 55 µg QD | Participants received one spray of FF 55 µg from nasal spray device A (FF nasal spray) followed by one spray from nasal spray device B (placebo nasal spray) into each nostril QD in the morning for 28-day treatment period. | 0 | 119 | 0 | 119 | 52 | 119 |
| EG002 | FF 110 µg QD | Participants received one spray of FF 110 µg from nasal spray device A (FF nasal spray) followed by one spray from nasal spray device B (FF nasal spray) into each nostril QD in the morning for 28-day treatment period. | 0 | 119 | 1 | 119 | 65 | 119 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Tonsillitis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper respiratory tract infection | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Otitis media acute | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Hordeolum | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Otitis media | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Furuncle | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Impetigo | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Myringitis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Otitis externa | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Rubella | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Tracheitis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Nasal mucosal erosion | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Nasal dryness | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Pharyngeal inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Sputum discoloured | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Dental caries | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Urticaria papular | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| White blood cell count increased | Investigations | MedDRA 20.1 | Systematic Assessment |
| |
| Blood uric acid increased | Investigations | MedDRA 20.1 | Systematic Assessment |
| |
| Neutrophil percentage increased | Investigations | MedDRA 20.1 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 20.1 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 20.1 | Systematic Assessment |
| |
| Eosinophil count increased | Investigations | MedDRA 20.1 | Systematic Assessment |
| |
| Urine output decreased | Investigations | MedDRA 20.1 | Systematic Assessment |
| |
| Urobilinogen urine increased | Investigations | MedDRA 20.1 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 20.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Systemic inflammatory response syndrome | General disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Thirst | General disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Lymphadenitis | Blood and lymphatic system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Leukocytosis | Blood and lymphatic system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Conjunctival hyperaemia | Eye disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Erythema of eyelid | Eye disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Eye pruritus | Eye disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Eschar | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
| |
| Heat stroke | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
| |
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Sinus bradycardia | Cardiac disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Balanoposthitis | Reproductive system and breast disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Allergy to arthropod bite | Immune system disorders | MedDRA 20.1 | 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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 | GSKClinicalSupportHD@gsk.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 22, 2018 | Mar 8, 2018 | SAP_001.pdf |
| ID | Term |
|---|---|
| D012220 | Rhinitis |
| D065631 | Rhinitis, Allergic |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
Not provided
Not provided
| Male |
|
| ANCOVA |
| <0.001 |
| Mean Difference (Final Values) |
| -1.32 |
| 2-Sided |
| 95 |
| -1.77 |
| -0.87 |
LS mean difference between placebo and FF 110 µg QD has been presented using ANCOVA model adjusted for treatment, Baseline value, gender, age and type of Allergic Rhinitis. |
| Other |
|
|
|
| OG002 | FF 110 µg QD | Participants received one spray of FF 110 µg from nasal spray device A (FF nasal spray) followed by one spray from nasal spray device B (FF nasal spray) into each nostril QD in the morning for 28-day treatment period. |
|
|
|
| OG002 | FF 110 µg QD | Participants received one spray of FF 110 µg from nasal spray device A (FF nasal spray) followed by one spray from nasal spray device B (FF nasal spray) into each nostril QD in the morning for 28-day treatment period. |
|
|
|
|
|
|
| OG002 | FF 110 µg QD | Participants received one spray of FF 110 µg from nasal spray device A (FF nasal spray) followed by one spray from nasal spray device B (FF nasal spray) into each nostril QD in the morning for 28-day treatment period. |
|
|
|
|
|
|
| OG002 | FF 110 µg QD | Participants received one spray of FF 110 µg from nasal spray device A (FF nasal spray) followed by one spray from nasal spray device B (FF nasal spray) into each nostril QD in the morning for 28-day treatment period. |
|
|
|
| OG002 | FF 110 µg QD | Participants received one spray of FF 110 µg from nasal spray device A (FF nasal spray) followed by one spray from nasal spray device B (FF nasal spray) into each nostril QD in the morning for 28-day treatment period. |
|
|
|
|
|
|
Participants received one spray of FF 110 µg from nasal spray device A (FF nasal spray) followed by one spray from nasal spray device B (FF nasal spray) into each nostril QD in the morning for 28-day treatment period.
|
|
Participants received one spray of FF 110 µg from nasal spray device A (FF nasal spray) followed by one spray from nasal spray device B (FF nasal spray) into each nostril QD in the morning for 28-day treatment period.
|
|
Participants received one spray of FF 110 µg from nasal spray device A (FF nasal spray) followed by one spray from nasal spray device B (FF nasal spray) into each nostril QD in the morning for 28-day treatment period.
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
Participants received one spray of FF 110 µg from nasal spray device A (FF nasal spray) followed by one spray from nasal spray device B (FF nasal spray) into each nostril QD in the morning for 28-day treatment period.
|
|
|
|
|
|
|
|
|
|