Rhinitis, Allergic, Perennial
Conditions
Brief summary
Efficacy and safety of GW685698X (55 µg/day, q.d.) nasal spray over a period of 2 weeks in Japanese paediatric subjects ages 6 to \< 15 years with perennial allergic rhinitis will be evaluated compared with placebo.
Interventions
DRUGFluticasone furoate
55 mcg/day, intranasal, 2 weeks
DRUGPlacebo
Placebo, intranasal, 2 weeks
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Years to 14 Years
Healthy volunteers
No
Inclusion criteria
* Informed Consent * 6 to \<15 years of age, male or eligible female (females of childbearing potential must commit to consistent and correct use of an acceptable method of birth control), outpatient * Diagnosis of perennial allergic rhinitis: A positive test response to house dust and/or dust mites on serum antigen-specific IgE antibody test at Visit 1. One year or more clinical history of perennial allergic rhinitis. A positive test result on nasal eosinophil count at Visit 1/1A. * Either subject's parent/guardian who signed ICF or subject is able to complete assessments on the patient diary through the study. * ALT \< 2xULN; alkaline phosphatase and bilirubin \<= 1.5xULN * Average of 3TNSS is \>= 4.0 in the last consecutive 4 days prior to Visit 2. * Completion of the patient diary on \>= 3 days of the last consecutive 4 days prior to Visit 2
Exclusion criteria
* Has a seasonal pollen as an allergen * A nose disorder that could affect the assessment of the study medication or eye or nose surgery (within 3 months prior to Visit 1) * Bacterial or viral infection of upper respiratory tract or eye * Concurrent disease/abnormalities: Clinically significant uncontrolled disease * Known hypersensitivity to corticosteroids or any excipients in the investigational product * Has recent participation in a study and/or exposure to an investigational study drug within 3 months prior to Visit 1 * Use of the following medication and/or its combination drug within the specified time: Anti-IgE (Within 6 months prior to Visit 1), Immunosuppressive medications or Systemic corticosteroids (Within 8 weeks prior to Visit 1), Topical corticosteroids (Within 4 weeks prior to Visit 1), Immunotherapy or nonspecific allassotherapy which was initiated, discontinued or changed its dose within 4 weeks prior to Visit 1 * Affiliation with Investigator's Site: Relative or employee * History of alcohol or drug abuse, children in care or in the opinion of the investigator (sub-investigator), inappropriate to be enrolled in the study. * Average of 3TNSS is \>= 8.0 in the last consecutive 4 days prior to Visit 2. * Bacterial or viral infection of upper respiratory tract or eye during the screening period.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline in the 3 Total Nasal Symptom Score (3TNSS) Over the Entire Treatment Period | Baseline through the entire treatment period (2 weeks) | The 3TNSS is the sum of the 3 individual symptom scores for sneezing, rhinorrhea, and nasal congestion. Each symptom is scored on a scale from 0 to 3; the range of sums for the 3TNSS is 0 to 9. The symptoms were evaluated using a scale of 0, 1, 2, or 3; a larger score indicates more severe symptoms. The participant's parent/guardian who signed the informed consent form (ICF) or the participant themself scored nasal symptoms every day during the screening period and the treatment period. The Baseline value is defined as the average 3TNSS over the last 4 consecutive days prior to Visit 2 (start of the treatment period). For the entire assessment period, a mean score for each participant was calculated using available diary data from the assessment periods, taking the average of non-missing data during the period. Change from Baseline was calculated as the mean score for the entire treatment period minus the score at Baseline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Percent Change From Baseline in 3TNSS Over the Entire Treatment Period, at Week 1, and at Week 2 | Baseline through the entire treatment period (2 weeks), Week 1, and Week 2 | The 3TNSS is the sum of the 3 individual symptom scores for sneezing, rhinorrhea, and nasal congestion. Each symptom is scored on a scale from 0 to 3; the range of sums for the 3TNSS is 0 to 9. The symptoms were evaluated using a scale of 0, 1, 2, or 3; a larger score indicates more severe symptoms. The participant's parent/guardian who signed the ICF or the participant themself scored nasal symptoms every day during the screening period and the treatment period. The Baseline value is defined as the average 3TNSS over the last 4 consecutive days prior to Visit 2 (start of the treatment period). For the entire treatment period (Weeks 1 and 2), Week 1, and Week 2, a mean score for each participant was calculated using available diary data from the assessment periods, taking the average of non-missing data during the period. Percent change from Baseline=(mean score at the post-Baseline assessment minus the score at Baseline) divided by the Baseline value \* 100. |
| Mean Change From Baseline in 3TNSS at the Indicated Days | Baseline; Days 1 through 14 | The 3TNSS is the sum of the 3 individual symptom scores for sneezing, rhinorrhea, and nasal congestion. Each symptom is scored on a scale from 0 to 3; the range of sums for the 3TNSS is 0 to 9. The symptoms were evaluated using a scale of 0, 1, 2, or 3; a larger score indicates more severe symptoms. The participant's parent/guardian who signed the ICF or the participant themself scored nasal symptoms every day during the screening period and the treatment period. The Baseline value is defined as the average 3TNSS over the last 4 consecutive days prior to Visit 2 (start of the treatment period). Change from Baseline was calculated as the mean score at the indicated day minus the score at Baseline. |
| Mean Change From Baseline in the 4 Total Nasal Symptom Score (4TNSS) Over the Entire Treatment Period, at Week 1, and at Week 2 | Baseline through the entire treatment period (2 weeks), Week 1, and Week 2 | The 4TNSS is the sum of the 4 individual symptom scores for sneezing, rhinorrhea, nasal congestion, and nasal itching. Each symptom is scored on a scale from 0 to 3; the range of sums for the 4TNSS is 0 to 12. The symptoms were evaluated using a scale of 0, 1, 2, or 3; a larger score indicates more severe symptoms. The participant's parent/guardian who signed the ICF or the participant themself scored nasal symptoms every day during the screening period and the treatment period. The Baseline value is defined as the average of the 4TNSS in the last 4 consecutive days prior to Visit 2 (start of the treatment period). A mean score for each participant was calculated using available diary data from the assessment periods, taking the average of non-missing data during the period. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. |
| Mean Percent Change From Baseline in the 4TNSS Over the Entire Treatment Period, at Week 1, and at Week 2 | Baseline through the entire treatment period (2 weeks), Week 1, and Week 2 | The 4TNSS is the sum of the 4 individual symptom scores for sneezing, rhinorrhea, nasal congestion, and nasal itching. Each symptom is scored on a scale from 0 to 3; the range of sums for the 4TNSS is 0 to 12. The symptoms were evaluated using a scale of 0, 1, 2, or 3; a larger score indicates more severe symptoms. The participant's parent/guardian who signed the ICF or the participant themself scored nasal symptoms every day during the screening period and the treatment period. The Baseline value is defined as the average 4TNSS over the last 4 consecutive days prior to Visit 2 (start of the treatment period). For the entire treatment period (Weeks 1 and 2), Week 1, and Week 2, a mean score for each participant was calculated using available diary data from the assessment periods, taking the average of non-missing data during the period. Percent change from Baseline=(mean score at the post-Baseline assessment minus the score at Baseline) divided by the Baseline value \* 100. |
| Mean Change From Baseline in Rhinorrhea, Nasal Congestion, Sneezing, and Nasal Itching Over the Entire Treatment Period (ETP), at Week 1, and at Week 2 | Baseline through the entire treatment period (2 weeks), Week 1, and Week 2 | Four individual symptoms (sneezing, rhinorrhea, nasal congestion, and nasal itching) were scored on a scale from 0 to 3 using a scale of 0, 1, 2, or 3; a larger score indicates more severe symptoms. The participant's parent/guardian who signed the ICF or the participant themself scored nasal symptoms every day during the screening period and the treatment period. The Baseline value is defined as the average of the symptom scores in the last 4 consecutive days prior to Visit 2 (start of the treatment period). A mean score for each participant was calculated using available diary data from the assessment periods, taking the average of non-missing data during the period. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. |
| Mean Change From Baseline in the Total Ocular Symptom Score (TOSS) Over the Entire Treatment Period, at Week 1, and at Week 2 | Baseline through the entire treatment period (2 weeks), Week 1, and Week 2 | Symptoms of eye itching, tearing, and redness were scored by the participant's parent/guardian who signed the ICF or the participant themself using a scale of 0, 1, 2, or 3 (a larger score indicates more severe symptoms) and were recorded in the participant's diary. The TOSS is the sum of all three symtpom scores and ranges from 0 to 9. The mean of the Baseline period is defined as the mean score of 4 consecutive days prior to Visit 2 (start of the treatment period). The mean of each assessment period is defined as the mean score of the entire treatment period (Weeks 1 and 2), Week 1, and Week 2. For each assessment period, a mean score for each participant was calculated using available diary data from the assessment periods, taking the average of non-missing data during the period. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. |
| Mean Change From Baseline (BL) in the Total Ocular Symptom Score (TOSS) for the Baseline TOSS >0 Over the Entire Treatment Period, at Week 1, and at Week 2 | Baseline through the entire treatment period (2 weeks), Week 1, and Week 2 | Symptoms of eye itching, tearing, and redness were scored by the participant's parent/guardian who signed the ICF or the participant themself using a scale of 0, 1, 2, or 3 (a larger score indicates more severe symptoms) and were recorded in the participant's diary. The TOSS is the sum of all three symtpom scores and ranges from 0 to 9. The mean of the Baseline period is defined as the mean score of 4 consecutive days prior to Visit 2 (start of the treatment period). The mean of each assessment period is defined as the mean score of the entire treatment period (Weeks 1 and 2), Week 1, and Week 2. For each assessment period, a mean score for each participant was calculated using available diary data from the assessment periods, taking the average of non-missing data during the period. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. |
| Mean Change From Baseline in 3TNSS at Week 1 and Week 2 | Baseline; Week 1 and Week 2 | The 3TNSS is the sum of the 3 individual symptom scores for sneezing, rhinorrhea, and nasal congestion. Each symptom is scored on a scale from 0 to 3; the range of sums for the 3TNSS is 0 to 9. The symptoms were evaluated using a scale of 0, 1, 2, or 3; a larger score indicates more severe symptoms. The participant's parent/guardian who signed the ICF or the participant themself scored nasal symptoms every day during the screening period and the treatment period. The Baseline value is defined as the average 3TNSS over the last 4 consecutive days prior to Visit 2 (start of the treatment period). For Week 1 and Week 2, a mean score for each participant was calculated using available diary data from the assessment periods, taking the average of non-missing data during the period. Change from Baseline was calculated as the mean score at Week 1 and Week 2 minus the score at Baseline. |
| Mean Percent Change From Baseline (BL) in the TOSS for the Baseline TOSS >0 Over the Entire Treatment Period, at Week 1, and at Week 2 | Baseline through the entire treatment period (2 weeks), Week 1, and Week 2 | Symptoms of eye itching, tearing, and redness were scored by the participant's (par.) parent/guardian who signed the ICF or the par. themself using a scale of 0, 1, 2, or 3 (a larger score indicates more severe symptoms) and were recorded in the par.'s diary. The TOSS is the sum of all 3 symptom scores and ranges from 0 to 9. The mean of the BL period is defined as the mean score of 4 consecutive days prior to Visit 2 (start of the treatment period). The mean of each assessment period is defined as the mean score of the entire treatment period (Weeks 1 and 2), Week 1, and Week 2. For each assessment period, a mean score for each par. was calculated using available diary data from the assessment periods, taking the average of non-missing data during the period. Percent change from BL=(mean score at post-BL assessment minus score at BL) divided by the BL value \* 100. |
| Mean Change From Baseline in the Individual Ocular Symptom Scores (Eye Itching, Tearing, and Redness) Over the Entire Treatment Period, at Week 1, and at Week 2 | Baseline through the entire treatment period (2 weeks), Week 1, and Week 2 | Symptoms of eye itching, tearing, and redness were scored by the participant's parent/guardian who signed the ICF or the participant themself using a scale of 0, 1, 2, or 3 (a larger score indicates more severe symptoms) and were recorded in the participant's diary. The mean of the Baseline period is defined as the mean score of 4 consecutive days prior to Visit 2 (start of the treatment period). The mean of each assessment period is defined as the mean score of the entire treatment period (Weeks 1 and 2), Week 1, and Week 2. For each assessment period, a mean score for each participant was calculated using available diary data from the assessment periods, taking the average of non-missing data during the period. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. |
| Mean Change From Baseline in the Score of Troubles With Daily Life Over the Entire Treatment Period, at Week 1, and at Week 2 | Baseline through the entire treatment period (2 weeks), Week 1, and Week 2 | The participant's parent/guardian who signed the ICF or the participant themself scored the participant's troubles with daily life once daily using the following scale: 0, None; 1, Few troubles; 2, Intermediate between 3 and 1; or 3, Painful and complicating daily life. The mean of the Baseline period is defined as the mean score of 4 consecutive days prior to Visit 2 (start of the treatment period). The mean of each assessment period is defined as the mean score of the entire treatment period (Weeks 1 and 2), Week 1, and Week 2. For each assessment period, a mean score for each participant was calculated using available diary data from the assessment periods, taking the average of non-missing data during the period. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. |
| Number of Participants With the Indicated Scores for Rhinoscopy Findings (Swelling of Inferior Turbinate Mucosa, Color of Inferior Turbinate Mucosa, Quantity of Nasal Discharge, and Quality of Nasal Discharge) at Baseline, Week 1, and Week 2/EW | Baseline, Week 1, and Week 2/Early Withdrawal (EW) | Rhinoscopy was assessed by the investigator by scoring swelling of inferior turbinate mucosa (SOITM) scored as 0 (none), 1 (possible to see center of the middle turbinate), 2 (between 3 and 1), or 3 (impossible to see middle turbinate); color of inferior turbinate mucosa (COITM) scored as 0 (normal), 1 (pink), 2 (red), or 3 (pale); quantity of nasal discharge (QTND) scored as 0 (none), 1 (small amount adhered), 2 (between 3 and 1), or 3 (filled); and quality of nasal discharge (QLND) scored as 0 (none), 1 (pyoid), 2 (viscous), or 3 (watery). |
| Number of Participants With the Indicated Overall Response to Therapy, as Assessed by the Investigator | Week 2/EW | The investigator evaluated the participant's overall response to therapy (defined as improvement in the symptoms of allergic rhinitis) compared with Visit 2 (start of the treatment period), using the following 7-point categorical scale: 1=significantly improved, 2=moderately improved, 3=mildly improved, 4=no change, 5=mildly worse, 6=moderately worse, and 7=significantly worse. |
| Number of Participants With the Indicated Overall Response to Therapy, as Assessed by the Participant's Parent/Guardian or the Participant | Week 2/EW | The participant's parent/guardian who signed the ICF or the participant themself evaluated the participant's overall response to therapy (defined as improvement in the symptoms of allergic rhinitis) compared with Visit 2 (start of the treatment period), using the following 7-point categorical scale: 1=significantly improved, 2=moderately improved, 3=mildly improved, 4=no change, 5=mildly worse, 6=moderately worse, and 7=significantly worse. |
| Mean Percent Change From Baseline (BL) in the TOSS Over the Entire Treatment Period, at Week 1, and at Week 2 | Baseline through the entire treatment period (2 weeks), Week 1, and Week 2 | Symptoms of eye itching, tearing, and redness were scored by the participant's (par.) parent/guardian who signed the ICF or the par. themself using a scale of 0, 1, 2, or 3 (a larger score indicates more severe symptoms) and were recorded in the par.'s diary. The TOSS is the sum of all 3 symptom scores and ranges from 0 to 9. The mean of the BL period is defined as the mean score of 4 consecutive days prior to Visit 2 (start of the treatment period). The mean of each assessment period is defined as the mean score of the entire treatment period (Weeks 1 and 2), Week 1, and Week 2. For each assessment period, a mean score for each par. was calculated using available diary data from the assessment periods, taking the average of non-missing data during the period. Percent change from BL=(mean score at post-BL assessment minus score at BL) divided by the BL value \* 100. Par. with a BL TOSS of 0 were not analyzed because percent change from BL could not be calculated. |
Countries
Japan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Fluticasone Furoate 55 µg Per Day Fluticasone furoate nasal spray (55 micrograms \[µg\] per day) was administered as one spray into each nostril (27.5 μg per spray) once daily in the morning for 2 weeks. | 131 |
| Placebo Matching placebo nasal spray was administered as one spray into each nostril once daily in the morning for 2 weeks. | 130 |
| Total | 261 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Protocol-defined Stopping Criteria Met | 0 | 2 |
Baseline characteristics
| Characteristic | Fluticasone Furoate 55 µg Per Day | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 10.0 Years STANDARD_DEVIATION 2.32 | 10.1 Years STANDARD_DEVIATION 2.22 | 10.1 Years STANDARD_DEVIATION 2.26 |
| Gender Female | 46 Participants | 51 Participants | 97 Participants |
| Gender Male | 85 Participants | 79 Participants | 164 Participants |
| Race/Ethnicity, Customized Asian - Japanese Heritage | 131 participants | 130 participants | 261 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 23 / 131 | 25 / 130 |
| serious Total, serious adverse events | 0 / 131 | 0 / 130 |
Outcome results
Primary
Mean Change From Baseline in the 3 Total Nasal Symptom Score (3TNSS) Over the Entire Treatment Period
The 3TNSS is the sum of the 3 individual symptom scores for sneezing, rhinorrhea, and nasal congestion. Each symptom is scored on a scale from 0 to 3; the range of sums for the 3TNSS is 0 to 9. The symptoms were evaluated using a scale of 0, 1, 2, or 3; a larger score indicates more severe symptoms. The participant's parent/guardian who signed the informed consent form (ICF) or the participant themself scored nasal symptoms every day during the screening period and the treatment period. The Baseline value is defined as the average 3TNSS over the last 4 consecutive days prior to Visit 2 (start of the treatment period). For the entire assessment period, a mean score for each participant was calculated using available diary data from the assessment periods, taking the average of non-missing data during the period. Change from Baseline was calculated as the mean score for the entire treatment period minus the score at Baseline.
Time frame: Baseline through the entire treatment period (2 weeks)
Population: Full Analysis Set (FAS): all participants meeting the primary criteria for enrollment, without any major good clinical practice (GCP) deviation, who received at least one dose of the assigned treatment and had diary assessment for 3TNSS after receiving a dose of study medication
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Fluticasone Furoate 55 µg Per Day | Mean Change From Baseline in the 3 Total Nasal Symptom Score (3TNSS) Over the Entire Treatment Period | -1.98 Scores on a scale | Standard Error 0.12 |
| Placebo | Mean Change From Baseline in the 3 Total Nasal Symptom Score (3TNSS) Over the Entire Treatment Period | -0.89 Scores on a scale | Standard Error 0.12 |
p-value: <0.00195% CI: [-1.41, -0.76]ANCOVA
Secondary
Mean Change From Baseline (BL) in the Total Ocular Symptom Score (TOSS) for the Baseline TOSS >0 Over the Entire Treatment Period, at Week 1, and at Week 2
Symptoms of eye itching, tearing, and redness were scored by the participant's parent/guardian who signed the ICF or the participant themself using a scale of 0, 1, 2, or 3 (a larger score indicates more severe symptoms) and were recorded in the participant's diary. The TOSS is the sum of all three symtpom scores and ranges from 0 to 9. The mean of the Baseline period is defined as the mean score of 4 consecutive days prior to Visit 2 (start of the treatment period). The mean of each assessment period is defined as the mean score of the entire treatment period (Weeks 1 and 2), Week 1, and Week 2. For each assessment period, a mean score for each participant was calculated using available diary data from the assessment periods, taking the average of non-missing data during the period. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Time frame: Baseline through the entire treatment period (2 weeks), Week 1, and Week 2
Population: FAS. Only those participants with BL TOSS \>0 who were available for assessment at both BL and the indicated assessment period were analyzed. Participants were analyzed for the entire treatment period if they had an assessment on any day during Week 1 and Week 2. Analysis was based on an ANCOVA with a model adjusting for Treatment, BL, Age, and Sex.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Fluticasone Furoate 55 µg Per Day | Mean Change From Baseline (BL) in the Total Ocular Symptom Score (TOSS) for the Baseline TOSS >0 Over the Entire Treatment Period, at Week 1, and at Week 2 | Entire Treatment Period, n=99, 92 | -0.77 Scores on a scale | Standard Error 0.11 |
| Fluticasone Furoate 55 µg Per Day | Mean Change From Baseline (BL) in the Total Ocular Symptom Score (TOSS) for the Baseline TOSS >0 Over the Entire Treatment Period, at Week 1, and at Week 2 | Week 1, n=99, 92 | -0.56 Scores on a scale | Standard Error 0.11 |
| Fluticasone Furoate 55 µg Per Day | Mean Change From Baseline (BL) in the Total Ocular Symptom Score (TOSS) for the Baseline TOSS >0 Over the Entire Treatment Period, at Week 1, and at Week 2 | Week 2, n= 99, 90 | -0.99 Scores on a scale | Standard Error 0.13 |
| Placebo | Mean Change From Baseline (BL) in the Total Ocular Symptom Score (TOSS) for the Baseline TOSS >0 Over the Entire Treatment Period, at Week 1, and at Week 2 | Entire Treatment Period, n=99, 92 | -0.47 Scores on a scale | Standard Error 0.11 |
| Placebo | Mean Change From Baseline (BL) in the Total Ocular Symptom Score (TOSS) for the Baseline TOSS >0 Over the Entire Treatment Period, at Week 1, and at Week 2 | Week 1, n=99, 92 | -0.35 Scores on a scale | Standard Error 0.11 |
| Placebo | Mean Change From Baseline (BL) in the Total Ocular Symptom Score (TOSS) for the Baseline TOSS >0 Over the Entire Treatment Period, at Week 1, and at Week 2 | Week 2, n= 99, 90 | -0.56 Scores on a scale | Standard Error 0.13 |
Secondary
Mean Change From Baseline in 3TNSS at the Indicated Days
The 3TNSS is the sum of the 3 individual symptom scores for sneezing, rhinorrhea, and nasal congestion. Each symptom is scored on a scale from 0 to 3; the range of sums for the 3TNSS is 0 to 9. The symptoms were evaluated using a scale of 0, 1, 2, or 3; a larger score indicates more severe symptoms. The participant's parent/guardian who signed the ICF or the participant themself scored nasal symptoms every day during the screening period and the treatment period. The Baseline value is defined as the average 3TNSS over the last 4 consecutive days prior to Visit 2 (start of the treatment period). Change from Baseline was calculated as the mean score at the indicated day minus the score at Baseline.
Time frame: Baseline; Days 1 through 14
Population: FAS. Change from Baseline was analyzed for only those participants who were available for assessment at both Baseline and the indicated study day (Days 1 through 14). The analysis was based on an ANCOVA with a model adjusting for Treatment, Baseline, Age, and Sex.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Fluticasone Furoate 55 µg Per Day | Mean Change From Baseline in 3TNSS at the Indicated Days | Day 2, n=131, 130 | -1.33 Scores on a scale | Standard Error 0.14 |
| Fluticasone Furoate 55 µg Per Day | Mean Change From Baseline in 3TNSS at the Indicated Days | Day 1, n=130, 130 | -0.71 Scores on a scale | Standard Error 0.13 |
| Fluticasone Furoate 55 µg Per Day | Mean Change From Baseline in 3TNSS at the Indicated Days | Day 3, n=131, 130 | -1.53 Scores on a scale | Standard Error 0.15 |
| Fluticasone Furoate 55 µg Per Day | Mean Change From Baseline in 3TNSS at the Indicated Days | Day 4, n=131, 130 | -1.69 Scores on a scale | Standard Error 0.15 |
| Fluticasone Furoate 55 µg Per Day | Mean Change From Baseline in 3TNSS at the Indicated Days | Day 5, n=131, 130 | -1.89 Scores on a scale | Standard Error 0.16 |
| Fluticasone Furoate 55 µg Per Day | Mean Change From Baseline in 3TNSS at the Indicated Days | Day 6, n=131, 130 | -1.95 Scores on a scale | Standard Error 0.16 |
| Fluticasone Furoate 55 µg Per Day | Mean Change From Baseline in 3TNSS at the Indicated Days | Day 7, n=131, 130 | -2.05 Scores on a scale | Standard Error 0.16 |
| Fluticasone Furoate 55 µg Per Day | Mean Change From Baseline in 3TNSS at the Indicated Days | Day 8, n=131, 128 | -2.14 Scores on a scale | Standard Error 0.16 |
| Fluticasone Furoate 55 µg Per Day | Mean Change From Baseline in 3TNSS at the Indicated Days | Day 9, n=131, 128 | -2.29 Scores on a scale | Standard Error 0.16 |
| Fluticasone Furoate 55 µg Per Day | Mean Change From Baseline in 3TNSS at the Indicated Days | Day 10, n=131, 128 | -2.32 Scores on a scale | Standard Error 0.16 |
| Fluticasone Furoate 55 µg Per Day | Mean Change From Baseline in 3TNSS at the Indicated Days | Day 11, n=131, 128 | -2.36 Scores on a scale | Standard Error 0.16 |
| Fluticasone Furoate 55 µg Per Day | Mean Change From Baseline in 3TNSS at the Indicated Days | Day 12, n=131, 128 | -2.54 Scores on a scale | Standard Error 0.15 |
| Fluticasone Furoate 55 µg Per Day | Mean Change From Baseline in 3TNSS at the Indicated Days | Day 13, n=122, 123 | -2.47 Scores on a scale | Standard Error 0.16 |
| Fluticasone Furoate 55 µg Per Day | Mean Change From Baseline in 3TNSS at the Indicated Days | Day 14, n=105, 115 | -2.65 Scores on a scale | Standard Error 0.17 |
| Placebo | Mean Change From Baseline in 3TNSS at the Indicated Days | Day 11, n=131, 128 | -1.19 Scores on a scale | Standard Error 0.16 |
| Placebo | Mean Change From Baseline in 3TNSS at the Indicated Days | Day 8, n=131, 128 | -1.05 Scores on a scale | Standard Error 0.16 |
| Placebo | Mean Change From Baseline in 3TNSS at the Indicated Days | Day 1, n=130, 130 | -0.52 Scores on a scale | Standard Error 0.12 |
| Placebo | Mean Change From Baseline in 3TNSS at the Indicated Days | Day 2, n=131, 130 | -0.41 Scores on a scale | Standard Error 0.14 |
| Placebo | Mean Change From Baseline in 3TNSS at the Indicated Days | Day 13, n=122, 123 | -1.20 Scores on a scale | Standard Error 0.16 |
| Placebo | Mean Change From Baseline in 3TNSS at the Indicated Days | Day 3, n=131, 130 | -0.61 Scores on a scale | Standard Error 0.15 |
| Placebo | Mean Change From Baseline in 3TNSS at the Indicated Days | Day 9, n=131, 128 | -1.07 Scores on a scale | Standard Error 0.16 |
| Placebo | Mean Change From Baseline in 3TNSS at the Indicated Days | Day 4, n=131, 130 | -0.77 Scores on a scale | Standard Error 0.15 |
| Placebo | Mean Change From Baseline in 3TNSS at the Indicated Days | Day 12, n=131, 128 | -1.21 Scores on a scale | Standard Error 0.15 |
| Placebo | Mean Change From Baseline in 3TNSS at the Indicated Days | Day 5, n=131, 130 | -0.77 Scores on a scale | Standard Error 0.16 |
| Placebo | Mean Change From Baseline in 3TNSS at the Indicated Days | Day 10, n=131, 128 | -1.01 Scores on a scale | Standard Error 0.16 |
| Placebo | Mean Change From Baseline in 3TNSS at the Indicated Days | Day 6, n=131, 130 | -0.97 Scores on a scale | Standard Error 0.16 |
| Placebo | Mean Change From Baseline in 3TNSS at the Indicated Days | Day 14, n=105, 115 | -0.93 Scores on a scale | Standard Error 0.16 |
| Placebo | Mean Change From Baseline in 3TNSS at the Indicated Days | Day 7, n=131, 130 | -0.87 Scores on a scale | Standard Error 0.16 |
Secondary
Mean Change From Baseline in 3TNSS at Week 1 and Week 2
The 3TNSS is the sum of the 3 individual symptom scores for sneezing, rhinorrhea, and nasal congestion. Each symptom is scored on a scale from 0 to 3; the range of sums for the 3TNSS is 0 to 9. The symptoms were evaluated using a scale of 0, 1, 2, or 3; a larger score indicates more severe symptoms. The participant's parent/guardian who signed the ICF or the participant themself scored nasal symptoms every day during the screening period and the treatment period. The Baseline value is defined as the average 3TNSS over the last 4 consecutive days prior to Visit 2 (start of the treatment period). For Week 1 and Week 2, a mean score for each participant was calculated using available diary data from the assessment periods, taking the average of non-missing data during the period. Change from Baseline was calculated as the mean score at Week 1 and Week 2 minus the score at Baseline.
Time frame: Baseline; Week 1 and Week 2
Population: FAS. Change from Baseline was analyzed for only those participants who were available for assessment at both Baseline and the indicated assessment period. The analysis was based on ANCOVA with a model adjusting for Treatment, Baseline, Age, and Sex.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Fluticasone Furoate 55 µg Per Day | Mean Change From Baseline in 3TNSS at Week 1 and Week 2 | Week 1, n=131, 130 | -1.60 Scores on a scale | Standard Error 0.12 |
| Fluticasone Furoate 55 µg Per Day | Mean Change From Baseline in 3TNSS at Week 1 and Week 2 | Week 2, n=131, 128 | -2.38 Scores on a scale | Standard Error 0.13 |
| Placebo | Mean Change From Baseline in 3TNSS at Week 1 and Week 2 | Week 1, n=131, 130 | -0.70 Scores on a scale | Standard Error 0.12 |
| Placebo | Mean Change From Baseline in 3TNSS at Week 1 and Week 2 | Week 2, n=131, 128 | -1.10 Scores on a scale | Standard Error 0.13 |
Secondary
Mean Change From Baseline in Rhinorrhea, Nasal Congestion, Sneezing, and Nasal Itching Over the Entire Treatment Period (ETP), at Week 1, and at Week 2
Four individual symptoms (sneezing, rhinorrhea, nasal congestion, and nasal itching) were scored on a scale from 0 to 3 using a scale of 0, 1, 2, or 3; a larger score indicates more severe symptoms. The participant's parent/guardian who signed the ICF or the participant themself scored nasal symptoms every day during the screening period and the treatment period. The Baseline value is defined as the average of the symptom scores in the last 4 consecutive days prior to Visit 2 (start of the treatment period). A mean score for each participant was calculated using available diary data from the assessment periods, taking the average of non-missing data during the period. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Time frame: Baseline through the entire treatment period (2 weeks), Week 1, and Week 2
Population: FAS. Only those participants who were available for assessment at both Baseline and the indicated assessment period were analyzed. Participants were analyzed for the entire treatment period if they had an assessment on any day during Week 1 and Week 2. The analysis was based on an ANCOVA with a model adjusting for Treatment, Baseline, Age, and Sex.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Fluticasone Furoate 55 µg Per Day | Mean Change From Baseline in Rhinorrhea, Nasal Congestion, Sneezing, and Nasal Itching Over the Entire Treatment Period (ETP), at Week 1, and at Week 2 | Rhinorrhea, ETP, n=131, 130 | -0.69 Scores on a scale | Standard Error 0.05 |
| Fluticasone Furoate 55 µg Per Day | Mean Change From Baseline in Rhinorrhea, Nasal Congestion, Sneezing, and Nasal Itching Over the Entire Treatment Period (ETP), at Week 1, and at Week 2 | Rhinorrhea, Week 1, n=131, 130 | -0.55 Scores on a scale | Standard Error 0.05 |
| Fluticasone Furoate 55 µg Per Day | Mean Change From Baseline in Rhinorrhea, Nasal Congestion, Sneezing, and Nasal Itching Over the Entire Treatment Period (ETP), at Week 1, and at Week 2 | Rhinorrhea, Week 2, n=131, 128 | -0.85 Scores on a scale | Standard Error 0.06 |
| Fluticasone Furoate 55 µg Per Day | Mean Change From Baseline in Rhinorrhea, Nasal Congestion, Sneezing, and Nasal Itching Over the Entire Treatment Period (ETP), at Week 1, and at Week 2 | Nasal congestion, ETP, n=131, 130 | -0.70 Scores on a scale | Standard Error 0.05 |
| Fluticasone Furoate 55 µg Per Day | Mean Change From Baseline in Rhinorrhea, Nasal Congestion, Sneezing, and Nasal Itching Over the Entire Treatment Period (ETP), at Week 1, and at Week 2 | Nasal congestion, Week 1, n=131, 130 | -0.56 Scores on a scale | Standard Error 0.05 |
| Fluticasone Furoate 55 µg Per Day | Mean Change From Baseline in Rhinorrhea, Nasal Congestion, Sneezing, and Nasal Itching Over the Entire Treatment Period (ETP), at Week 1, and at Week 2 | Nasal congestion, Week 2, n=131, 128 | -0.84 Scores on a scale | Standard Error 0.05 |
| Fluticasone Furoate 55 µg Per Day | Mean Change From Baseline in Rhinorrhea, Nasal Congestion, Sneezing, and Nasal Itching Over the Entire Treatment Period (ETP), at Week 1, and at Week 2 | Sneezing, ETP, n=131, 130 | -0.60 Scores on a scale | Standard Error 0.04 |
| Fluticasone Furoate 55 µg Per Day | Mean Change From Baseline in Rhinorrhea, Nasal Congestion, Sneezing, and Nasal Itching Over the Entire Treatment Period (ETP), at Week 1, and at Week 2 | Sneezing, Week 1, n=131, 130 | -0.50 Scores on a scale | Standard Error 0.04 |
| Fluticasone Furoate 55 µg Per Day | Mean Change From Baseline in Rhinorrhea, Nasal Congestion, Sneezing, and Nasal Itching Over the Entire Treatment Period (ETP), at Week 1, and at Week 2 | Sneezing, Week 2, n= 131, 128 | -0.71 Scores on a scale | Standard Error 0.05 |
| Fluticasone Furoate 55 µg Per Day | Mean Change From Baseline in Rhinorrhea, Nasal Congestion, Sneezing, and Nasal Itching Over the Entire Treatment Period (ETP), at Week 1, and at Week 2 | Nasal itching, ETP, n=131, 130 | -0.41 Scores on a scale | Standard Error 0.04 |
| Fluticasone Furoate 55 µg Per Day | Mean Change From Baseline in Rhinorrhea, Nasal Congestion, Sneezing, and Nasal Itching Over the Entire Treatment Period (ETP), at Week 1, and at Week 2 | Nasal itching, Week 1, n=131, 130 | -0.33 Scores on a scale | Standard Error 0.05 |
| Fluticasone Furoate 55 µg Per Day | Mean Change From Baseline in Rhinorrhea, Nasal Congestion, Sneezing, and Nasal Itching Over the Entire Treatment Period (ETP), at Week 1, and at Week 2 | Nasal itching, Week 2, n= 131, 128 | -0.49 Scores on a scale | Standard Error 0.05 |
| Placebo | Mean Change From Baseline in Rhinorrhea, Nasal Congestion, Sneezing, and Nasal Itching Over the Entire Treatment Period (ETP), at Week 1, and at Week 2 | Nasal itching, Week 1, n=131, 130 | -0.04 Scores on a scale | Standard Error 0.05 |
| Placebo | Mean Change From Baseline in Rhinorrhea, Nasal Congestion, Sneezing, and Nasal Itching Over the Entire Treatment Period (ETP), at Week 1, and at Week 2 | Rhinorrhea, ETP, n=131, 130 | -0.31 Scores on a scale | Standard Error 0.05 |
| Placebo | Mean Change From Baseline in Rhinorrhea, Nasal Congestion, Sneezing, and Nasal Itching Over the Entire Treatment Period (ETP), at Week 1, and at Week 2 | Sneezing, ETP, n=131, 130 | -0.21 Scores on a scale | Standard Error 0.04 |
| Placebo | Mean Change From Baseline in Rhinorrhea, Nasal Congestion, Sneezing, and Nasal Itching Over the Entire Treatment Period (ETP), at Week 1, and at Week 2 | Rhinorrhea, Week 1, n=131, 130 | -0.23 Scores on a scale | Standard Error 0.05 |
| Placebo | Mean Change From Baseline in Rhinorrhea, Nasal Congestion, Sneezing, and Nasal Itching Over the Entire Treatment Period (ETP), at Week 1, and at Week 2 | Nasal itching, ETP, n=131, 130 | -0.12 Scores on a scale | Standard Error 0.04 |
| Placebo | Mean Change From Baseline in Rhinorrhea, Nasal Congestion, Sneezing, and Nasal Itching Over the Entire Treatment Period (ETP), at Week 1, and at Week 2 | Rhinorrhea, Week 2, n=131, 128 | -0.40 Scores on a scale | Standard Error 0.06 |
| Placebo | Mean Change From Baseline in Rhinorrhea, Nasal Congestion, Sneezing, and Nasal Itching Over the Entire Treatment Period (ETP), at Week 1, and at Week 2 | Sneezing, Week 1, n=131, 130 | -0.16 Scores on a scale | Standard Error 0.04 |
| Placebo | Mean Change From Baseline in Rhinorrhea, Nasal Congestion, Sneezing, and Nasal Itching Over the Entire Treatment Period (ETP), at Week 1, and at Week 2 | Nasal congestion, ETP, n=131, 130 | -0.36 Scores on a scale | Standard Error 0.05 |
| Placebo | Mean Change From Baseline in Rhinorrhea, Nasal Congestion, Sneezing, and Nasal Itching Over the Entire Treatment Period (ETP), at Week 1, and at Week 2 | Nasal itching, Week 2, n= 131, 128 | -0.19 Scores on a scale | Standard Error 0.05 |
| Placebo | Mean Change From Baseline in Rhinorrhea, Nasal Congestion, Sneezing, and Nasal Itching Over the Entire Treatment Period (ETP), at Week 1, and at Week 2 | Nasal congestion, Week 1, n=131, 130 | -0.29 Scores on a scale | Standard Error 0.05 |
| Placebo | Mean Change From Baseline in Rhinorrhea, Nasal Congestion, Sneezing, and Nasal Itching Over the Entire Treatment Period (ETP), at Week 1, and at Week 2 | Sneezing, Week 2, n= 131, 128 | -0.27 Scores on a scale | Standard Error 0.05 |
| Placebo | Mean Change From Baseline in Rhinorrhea, Nasal Congestion, Sneezing, and Nasal Itching Over the Entire Treatment Period (ETP), at Week 1, and at Week 2 | Nasal congestion, Week 2, n=131, 128 | -0.43 Scores on a scale | Standard Error 0.05 |
Secondary
Mean Change From Baseline in the 4 Total Nasal Symptom Score (4TNSS) Over the Entire Treatment Period, at Week 1, and at Week 2
The 4TNSS is the sum of the 4 individual symptom scores for sneezing, rhinorrhea, nasal congestion, and nasal itching. Each symptom is scored on a scale from 0 to 3; the range of sums for the 4TNSS is 0 to 12. The symptoms were evaluated using a scale of 0, 1, 2, or 3; a larger score indicates more severe symptoms. The participant's parent/guardian who signed the ICF or the participant themself scored nasal symptoms every day during the screening period and the treatment period. The Baseline value is defined as the average of the 4TNSS in the last 4 consecutive days prior to Visit 2 (start of the treatment period). A mean score for each participant was calculated using available diary data from the assessment periods, taking the average of non-missing data during the period. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Time frame: Baseline through the entire treatment period (2 weeks), Week 1, and Week 2
Population: FAS. Only those participants who were available for assessment at both Baseline and the indicated assessment period were analyzed. Participants were analyzed for the entire treatment period if they had an assessment on any day during Week 1 and Week 2. The analysis was based on an ANCOVA with a model adjusting for Treatment, Baseline, Age, and Sex.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Fluticasone Furoate 55 µg Per Day | Mean Change From Baseline in the 4 Total Nasal Symptom Score (4TNSS) Over the Entire Treatment Period, at Week 1, and at Week 2 | Entire Treatment Period, n=131, 130 | -2.40 Scores on a scale | Standard Error 0.15 |
| Fluticasone Furoate 55 µg Per Day | Mean Change From Baseline in the 4 Total Nasal Symptom Score (4TNSS) Over the Entire Treatment Period, at Week 1, and at Week 2 | Week 1, n=131, 130 | -1.94 Scores on a scale | Standard Error 0.15 |
| Fluticasone Furoate 55 µg Per Day | Mean Change From Baseline in the 4 Total Nasal Symptom Score (4TNSS) Over the Entire Treatment Period, at Week 1, and at Week 2 | Week 2, n= 131, 128 | -2.89 Scores on a scale | Standard Error 0.16 |
| Placebo | Mean Change From Baseline in the 4 Total Nasal Symptom Score (4TNSS) Over the Entire Treatment Period, at Week 1, and at Week 2 | Entire Treatment Period, n=131, 130 | -1.01 Scores on a scale | Standard Error 0.15 |
| Placebo | Mean Change From Baseline in the 4 Total Nasal Symptom Score (4TNSS) Over the Entire Treatment Period, at Week 1, and at Week 2 | Week 1, n=131, 130 | -0.74 Scores on a scale | Standard Error 0.15 |
| Placebo | Mean Change From Baseline in the 4 Total Nasal Symptom Score (4TNSS) Over the Entire Treatment Period, at Week 1, and at Week 2 | Week 2, n= 131, 128 | -1.29 Scores on a scale | Standard Error 0.16 |
Secondary
Mean Change From Baseline in the Individual Ocular Symptom Scores (Eye Itching, Tearing, and Redness) Over the Entire Treatment Period, at Week 1, and at Week 2
Symptoms of eye itching, tearing, and redness were scored by the participant's parent/guardian who signed the ICF or the participant themself using a scale of 0, 1, 2, or 3 (a larger score indicates more severe symptoms) and were recorded in the participant's diary. The mean of the Baseline period is defined as the mean score of 4 consecutive days prior to Visit 2 (start of the treatment period). The mean of each assessment period is defined as the mean score of the entire treatment period (Weeks 1 and 2), Week 1, and Week 2. For each assessment period, a mean score for each participant was calculated using available diary data from the assessment periods, taking the average of non-missing data during the period. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Time frame: Baseline through the entire treatment period (2 weeks), Week 1, and Week 2
Population: FAS. Only those participants who were available for assessment at both Baseline and the indicated assessment period were analyzed. Participants were analyzed for the entire treatment period if they had an assessment on any day during Week 1 and Week 2. The analysis was based on an ANCOVA with a model adjusting for Treatment, Baseline, Age, and Sex.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Fluticasone Furoate 55 µg Per Day | Mean Change From Baseline in the Individual Ocular Symptom Scores (Eye Itching, Tearing, and Redness) Over the Entire Treatment Period, at Week 1, and at Week 2 | Eye itching, Week 1, n=131, 130 | -0.15 Scores on a scale | Standard Error 0.04 |
| Fluticasone Furoate 55 µg Per Day | Mean Change From Baseline in the Individual Ocular Symptom Scores (Eye Itching, Tearing, and Redness) Over the Entire Treatment Period, at Week 1, and at Week 2 | Tearing, Week 2, n=131, 128 | -0.11 Scores on a scale | Standard Error 0.03 |
| Fluticasone Furoate 55 µg Per Day | Mean Change From Baseline in the Individual Ocular Symptom Scores (Eye Itching, Tearing, and Redness) Over the Entire Treatment Period, at Week 1, and at Week 2 | Tearing, Entire Treatment Period, n=131, 130 | -0.10 Scores on a scale | Standard Error 0.03 |
| Fluticasone Furoate 55 µg Per Day | Mean Change From Baseline in the Individual Ocular Symptom Scores (Eye Itching, Tearing, and Redness) Over the Entire Treatment Period, at Week 1, and at Week 2 | Redness, Entire Treatment Period, n=131, 130 | -0.11 Scores on a scale | Standard Error 0.03 |
| Fluticasone Furoate 55 µg Per Day | Mean Change From Baseline in the Individual Ocular Symptom Scores (Eye Itching, Tearing, and Redness) Over the Entire Treatment Period, at Week 1, and at Week 2 | Eye itching Week 2, n=131, 128 | -0.34 Scores on a scale | Standard Error 0.05 |
| Fluticasone Furoate 55 µg Per Day | Mean Change From Baseline in the Individual Ocular Symptom Scores (Eye Itching, Tearing, and Redness) Over the Entire Treatment Period, at Week 1, and at Week 2 | Redness, Week 1, n=131, 130 | -0.07 Scores on a scale | Standard Error 0.03 |
| Fluticasone Furoate 55 µg Per Day | Mean Change From Baseline in the Individual Ocular Symptom Scores (Eye Itching, Tearing, and Redness) Over the Entire Treatment Period, at Week 1, and at Week 2 | Tearing, Week 1, n=131, 130 | -0.09 Scores on a scale | Standard Error 0.03 |
| Fluticasone Furoate 55 µg Per Day | Mean Change From Baseline in the Individual Ocular Symptom Scores (Eye Itching, Tearing, and Redness) Over the Entire Treatment Period, at Week 1, and at Week 2 | Redness, Week 2, n=130, 128 | -0.16 Scores on a scale | Standard Error 0.04 |
| Fluticasone Furoate 55 µg Per Day | Mean Change From Baseline in the Individual Ocular Symptom Scores (Eye Itching, Tearing, and Redness) Over the Entire Treatment Period, at Week 1, and at Week 2 | Eye itching, Entire Treatment Period, n=131, 130 | -0.24 Scores on a scale | Standard Error 0.04 |
| Placebo | Mean Change From Baseline in the Individual Ocular Symptom Scores (Eye Itching, Tearing, and Redness) Over the Entire Treatment Period, at Week 1, and at Week 2 | Redness, Week 2, n=130, 128 | -0.10 Scores on a scale | Standard Error 0.04 |
| Placebo | Mean Change From Baseline in the Individual Ocular Symptom Scores (Eye Itching, Tearing, and Redness) Over the Entire Treatment Period, at Week 1, and at Week 2 | Eye itching, Entire Treatment Period, n=131, 130 | -0.18 Scores on a scale | Standard Error 0.04 |
| Placebo | Mean Change From Baseline in the Individual Ocular Symptom Scores (Eye Itching, Tearing, and Redness) Over the Entire Treatment Period, at Week 1, and at Week 2 | Eye itching, Week 1, n=131, 130 | -0.13 Scores on a scale | Standard Error 0.04 |
| Placebo | Mean Change From Baseline in the Individual Ocular Symptom Scores (Eye Itching, Tearing, and Redness) Over the Entire Treatment Period, at Week 1, and at Week 2 | Eye itching Week 2, n=131, 128 | -0.23 Scores on a scale | Standard Error 0.05 |
| Placebo | Mean Change From Baseline in the Individual Ocular Symptom Scores (Eye Itching, Tearing, and Redness) Over the Entire Treatment Period, at Week 1, and at Week 2 | Tearing, Entire Treatment Period, n=131, 130 | -0.05 Scores on a scale | Standard Error 0.03 |
| Placebo | Mean Change From Baseline in the Individual Ocular Symptom Scores (Eye Itching, Tearing, and Redness) Over the Entire Treatment Period, at Week 1, and at Week 2 | Tearing, Week 1, n=131, 130 | -0.03 Scores on a scale | Standard Error 0.03 |
| Placebo | Mean Change From Baseline in the Individual Ocular Symptom Scores (Eye Itching, Tearing, and Redness) Over the Entire Treatment Period, at Week 1, and at Week 2 | Tearing, Week 2, n=131, 128 | -0.07 Scores on a scale | Standard Error 0.03 |
| Placebo | Mean Change From Baseline in the Individual Ocular Symptom Scores (Eye Itching, Tearing, and Redness) Over the Entire Treatment Period, at Week 1, and at Week 2 | Redness, Entire Treatment Period, n=131, 130 | -0.09 Scores on a scale | Standard Error 0.03 |
| Placebo | Mean Change From Baseline in the Individual Ocular Symptom Scores (Eye Itching, Tearing, and Redness) Over the Entire Treatment Period, at Week 1, and at Week 2 | Redness, Week 1, n=131, 130 | -0.07 Scores on a scale | Standard Error 0.03 |
Secondary
Mean Change From Baseline in the Score of Troubles With Daily Life Over the Entire Treatment Period, at Week 1, and at Week 2
The participant's parent/guardian who signed the ICF or the participant themself scored the participant's troubles with daily life once daily using the following scale: 0, None; 1, Few troubles; 2, Intermediate between 3 and 1; or 3, Painful and complicating daily life. The mean of the Baseline period is defined as the mean score of 4 consecutive days prior to Visit 2 (start of the treatment period). The mean of each assessment period is defined as the mean score of the entire treatment period (Weeks 1 and 2), Week 1, and Week 2. For each assessment period, a mean score for each participant was calculated using available diary data from the assessment periods, taking the average of non-missing data during the period. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Time frame: Baseline through the entire treatment period (2 weeks), Week 1, and Week 2
Population: FAS. Only those participants who were available for assessment at both Baseline and the indicated assessment period were analyzed. Participants were analyzed for the entire treatment period if they had an assessment on any day during Week 1 and Week 2. The analysis was based on an ANCOVA with a model adjusting for Treatment, Baseline, Age, and Sex.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Fluticasone Furoate 55 µg Per Day | Mean Change From Baseline in the Score of Troubles With Daily Life Over the Entire Treatment Period, at Week 1, and at Week 2 | Entire Treatment Period, n=131, 130 | -0.43 Scores on a scale | Standard Error 0.04 |
| Fluticasone Furoate 55 µg Per Day | Mean Change From Baseline in the Score of Troubles With Daily Life Over the Entire Treatment Period, at Week 1, and at Week 2 | Week 1, n=131, 130 | -0.33 Scores on a scale | Standard Error 0.04 |
| Fluticasone Furoate 55 µg Per Day | Mean Change From Baseline in the Score of Troubles With Daily Life Over the Entire Treatment Period, at Week 1, and at Week 2 | Week 2, n=131, 128 | -0.53 Scores on a scale | Standard Error 0.05 |
| Placebo | Mean Change From Baseline in the Score of Troubles With Daily Life Over the Entire Treatment Period, at Week 1, and at Week 2 | Entire Treatment Period, n=131, 130 | -0.13 Scores on a scale | Standard Error 0.04 |
| Placebo | Mean Change From Baseline in the Score of Troubles With Daily Life Over the Entire Treatment Period, at Week 1, and at Week 2 | Week 1, n=131, 130 | -0.10 Scores on a scale | Standard Error 0.04 |
| Placebo | Mean Change From Baseline in the Score of Troubles With Daily Life Over the Entire Treatment Period, at Week 1, and at Week 2 | Week 2, n=131, 128 | -0.16 Scores on a scale | Standard Error 0.05 |
Secondary
Mean Change From Baseline in the Total Ocular Symptom Score (TOSS) Over the Entire Treatment Period, at Week 1, and at Week 2
Symptoms of eye itching, tearing, and redness were scored by the participant's parent/guardian who signed the ICF or the participant themself using a scale of 0, 1, 2, or 3 (a larger score indicates more severe symptoms) and were recorded in the participant's diary. The TOSS is the sum of all three symtpom scores and ranges from 0 to 9. The mean of the Baseline period is defined as the mean score of 4 consecutive days prior to Visit 2 (start of the treatment period). The mean of each assessment period is defined as the mean score of the entire treatment period (Weeks 1 and 2), Week 1, and Week 2. For each assessment period, a mean score for each participant was calculated using available diary data from the assessment periods, taking the average of non-missing data during the period. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Time frame: Baseline through the entire treatment period (2 weeks), Week 1, and Week 2
Population: FAS. Only those participants who were available for assessment at both Baseline and the indicated assessment period were analyzed. Participants were analyzed for the entire treatment period if they had an assessment on any day during Week 1 and Week 2. The analysis was based on an ANCOVA with a model adjusting for Treatment, Baseline, Age, and Sex.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Fluticasone Furoate 55 µg Per Day | Mean Change From Baseline in the Total Ocular Symptom Score (TOSS) Over the Entire Treatment Period, at Week 1, and at Week 2 | Entire Treatment Period, n=131, 130 | -0.46 Scores on a scale | Standard Error 0.09 |
| Fluticasone Furoate 55 µg Per Day | Mean Change From Baseline in the Total Ocular Symptom Score (TOSS) Over the Entire Treatment Period, at Week 1, and at Week 2 | Week 1, n=131, 130 | -0.31 Scores on a scale | Standard Error 0.09 |
| Fluticasone Furoate 55 µg Per Day | Mean Change From Baseline in the Total Ocular Symptom Score (TOSS) Over the Entire Treatment Period, at Week 1, and at Week 2 | Week 2, n= 131, 128 | -0.61 Scores on a scale | Standard Error 0.1 |
| Placebo | Mean Change From Baseline in the Total Ocular Symptom Score (TOSS) Over the Entire Treatment Period, at Week 1, and at Week 2 | Week 2, n= 131, 128 | -0.39 Scores on a scale | Standard Error 0.1 |
| Placebo | Mean Change From Baseline in the Total Ocular Symptom Score (TOSS) Over the Entire Treatment Period, at Week 1, and at Week 2 | Entire Treatment Period, n=131, 130 | -0.32 Scores on a scale | Standard Error 0.09 |
| Placebo | Mean Change From Baseline in the Total Ocular Symptom Score (TOSS) Over the Entire Treatment Period, at Week 1, and at Week 2 | Week 1, n=131, 130 | -0.22 Scores on a scale | Standard Error 0.09 |
Secondary
Mean Percent Change From Baseline (BL) in the TOSS for the Baseline TOSS >0 Over the Entire Treatment Period, at Week 1, and at Week 2
Symptoms of eye itching, tearing, and redness were scored by the participant's (par.) parent/guardian who signed the ICF or the par. themself using a scale of 0, 1, 2, or 3 (a larger score indicates more severe symptoms) and were recorded in the par.'s diary. The TOSS is the sum of all 3 symptom scores and ranges from 0 to 9. The mean of the BL period is defined as the mean score of 4 consecutive days prior to Visit 2 (start of the treatment period). The mean of each assessment period is defined as the mean score of the entire treatment period (Weeks 1 and 2), Week 1, and Week 2. For each assessment period, a mean score for each par. was calculated using available diary data from the assessment periods, taking the average of non-missing data during the period. Percent change from BL=(mean score at post-BL assessment minus score at BL) divided by the BL value \* 100.
Time frame: Baseline through the entire treatment period (2 weeks), Week 1, and Week 2
Population: FAS. Only those participants with BL TOSS \>0 who were available for assessment at both BL and the indicated assessment period were analyzed. Participants were analyzed for the entire treatment period if they had an assessment on any day during Week 1 and Week 2. Analysis was based on an ANCOVA with a model adjusting for Treatment, BL, Age, and Sex.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Fluticasone Furoate 55 µg Per Day | Mean Percent Change From Baseline (BL) in the TOSS for the Baseline TOSS >0 Over the Entire Treatment Period, at Week 1, and at Week 2 | Entire Treatment Period, n=99, 92 | -20.97 Percent change | Standard Error 11.39 |
| Fluticasone Furoate 55 µg Per Day | Mean Percent Change From Baseline (BL) in the TOSS for the Baseline TOSS >0 Over the Entire Treatment Period, at Week 1, and at Week 2 | Week 1, n=99, 92 | -9.20 Percent change | Standard Error 10.9 |
| Fluticasone Furoate 55 µg Per Day | Mean Percent Change From Baseline (BL) in the TOSS for the Baseline TOSS >0 Over the Entire Treatment Period, at Week 1, and at Week 2 | Week 2, n=99, 90 | -33.52 Percent change | Standard Error 13.27 |
| Placebo | Mean Percent Change From Baseline (BL) in the TOSS for the Baseline TOSS >0 Over the Entire Treatment Period, at Week 1, and at Week 2 | Entire Treatment Period, n=99, 92 | 1.57 Percent change | Standard Error 11.64 |
| Placebo | Mean Percent Change From Baseline (BL) in the TOSS for the Baseline TOSS >0 Over the Entire Treatment Period, at Week 1, and at Week 2 | Week 1, n=99, 92 | 5.37 Percent change | Standard Error 11.14 |
| Placebo | Mean Percent Change From Baseline (BL) in the TOSS for the Baseline TOSS >0 Over the Entire Treatment Period, at Week 1, and at Week 2 | Week 2, n=99, 90 | -1.70 Percent change | Standard Error 13.69 |
Secondary
Mean Percent Change From Baseline (BL) in the TOSS Over the Entire Treatment Period, at Week 1, and at Week 2
Symptoms of eye itching, tearing, and redness were scored by the participant's (par.) parent/guardian who signed the ICF or the par. themself using a scale of 0, 1, 2, or 3 (a larger score indicates more severe symptoms) and were recorded in the par.'s diary. The TOSS is the sum of all 3 symptom scores and ranges from 0 to 9. The mean of the BL period is defined as the mean score of 4 consecutive days prior to Visit 2 (start of the treatment period). The mean of each assessment period is defined as the mean score of the entire treatment period (Weeks 1 and 2), Week 1, and Week 2. For each assessment period, a mean score for each par. was calculated using available diary data from the assessment periods, taking the average of non-missing data during the period. Percent change from BL=(mean score at post-BL assessment minus score at BL) divided by the BL value \* 100. Par. with a BL TOSS of 0 were not analyzed because percent change from BL could not be calculated.
Time frame: Baseline through the entire treatment period (2 weeks), Week 1, and Week 2
Population: FAS. Only those participants who were available for assessment at both Baseline and the indicated assessment period were analyzed. Participants were analyzed for the entire treatment period if they had an assessment on any day during Week 1 and Week 2. The analysis was based on an ANCOVA with a model adjusting for Treatment, Baseline, Age, and Sex.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Fluticasone Furoate 55 µg Per Day | Mean Percent Change From Baseline (BL) in the TOSS Over the Entire Treatment Period, at Week 1, and at Week 2 | Entire Treatment Period, n=99, 92 | -20.97 Percent change | Standard Error 11.39 |
| Fluticasone Furoate 55 µg Per Day | Mean Percent Change From Baseline (BL) in the TOSS Over the Entire Treatment Period, at Week 1, and at Week 2 | Week 1, n=99, 92 | -9.20 Percent change | Standard Error 10.9 |
| Fluticasone Furoate 55 µg Per Day | Mean Percent Change From Baseline (BL) in the TOSS Over the Entire Treatment Period, at Week 1, and at Week 2 | Week 2, n= 99, 90 | -33.52 Percent change | Standard Error 13.27 |
| Placebo | Mean Percent Change From Baseline (BL) in the TOSS Over the Entire Treatment Period, at Week 1, and at Week 2 | Entire Treatment Period, n=99, 92 | 1.57 Percent change | Standard Error 11.64 |
| Placebo | Mean Percent Change From Baseline (BL) in the TOSS Over the Entire Treatment Period, at Week 1, and at Week 2 | Week 1, n=99, 92 | 5.37 Percent change | Standard Error 11.14 |
| Placebo | Mean Percent Change From Baseline (BL) in the TOSS Over the Entire Treatment Period, at Week 1, and at Week 2 | Week 2, n= 99, 90 | -1.70 Percent change | Standard Error 13.69 |
Secondary
Mean Percent Change From Baseline in 3TNSS Over the Entire Treatment Period, at Week 1, and at Week 2
The 3TNSS is the sum of the 3 individual symptom scores for sneezing, rhinorrhea, and nasal congestion. Each symptom is scored on a scale from 0 to 3; the range of sums for the 3TNSS is 0 to 9. The symptoms were evaluated using a scale of 0, 1, 2, or 3; a larger score indicates more severe symptoms. The participant's parent/guardian who signed the ICF or the participant themself scored nasal symptoms every day during the screening period and the treatment period. The Baseline value is defined as the average 3TNSS over the last 4 consecutive days prior to Visit 2 (start of the treatment period). For the entire treatment period (Weeks 1 and 2), Week 1, and Week 2, a mean score for each participant was calculated using available diary data from the assessment periods, taking the average of non-missing data during the period. Percent change from Baseline=(mean score at the post-Baseline assessment minus the score at Baseline) divided by the Baseline value \* 100.
Time frame: Baseline through the entire treatment period (2 weeks), Week 1, and Week 2
Population: FAS. Only those participants who were available for assessment at both Baseline and the indicated assessment period were analyzed. Participants were analyzed for the entire treatment period if they had an assessment on any day during Week 1 and Week 2. The analysis was based on an ANCOVA with a model adjusting for Treatment, Baseline, Age, and Sex.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Fluticasone Furoate 55 µg Per Day | Mean Percent Change From Baseline in 3TNSS Over the Entire Treatment Period, at Week 1, and at Week 2 | Week 1, n=131, 130 | -31.96 Percent change | Standard Error 2.46 |
| Fluticasone Furoate 55 µg Per Day | Mean Percent Change From Baseline in 3TNSS Over the Entire Treatment Period, at Week 1, and at Week 2 | Week 2, n=131, 128 | -47.89 Percent change | Standard Error 2.7 |
| Fluticasone Furoate 55 µg Per Day | Mean Percent Change From Baseline in 3TNSS Over the Entire Treatment Period, at Week 1, and at Week 2 | Entire treatment period, n=131, 130 | -39.76 Percent change | Standard Error 2.38 |
| Placebo | Mean Percent Change From Baseline in 3TNSS Over the Entire Treatment Period, at Week 1, and at Week 2 | Week 1, n=131, 130 | -13.89 Percent change | Standard Error 2.44 |
| Placebo | Mean Percent Change From Baseline in 3TNSS Over the Entire Treatment Period, at Week 1, and at Week 2 | Week 2, n=131, 128 | -21.95 Percent change | Standard Error 2.7 |
| Placebo | Mean Percent Change From Baseline in 3TNSS Over the Entire Treatment Period, at Week 1, and at Week 2 | Entire treatment period, n=131, 130 | -17.74 Percent change | Standard Error 2.36 |
Secondary
Mean Percent Change From Baseline in the 4TNSS Over the Entire Treatment Period, at Week 1, and at Week 2
The 4TNSS is the sum of the 4 individual symptom scores for sneezing, rhinorrhea, nasal congestion, and nasal itching. Each symptom is scored on a scale from 0 to 3; the range of sums for the 4TNSS is 0 to 12. The symptoms were evaluated using a scale of 0, 1, 2, or 3; a larger score indicates more severe symptoms. The participant's parent/guardian who signed the ICF or the participant themself scored nasal symptoms every day during the screening period and the treatment period. The Baseline value is defined as the average 4TNSS over the last 4 consecutive days prior to Visit 2 (start of the treatment period). For the entire treatment period (Weeks 1 and 2), Week 1, and Week 2, a mean score for each participant was calculated using available diary data from the assessment periods, taking the average of non-missing data during the period. Percent change from Baseline=(mean score at the post-Baseline assessment minus the score at Baseline) divided by the Baseline value \* 100.
Time frame: Baseline through the entire treatment period (2 weeks), Week 1, and Week 2
Population: FAS. Only those participants who were available for assessment at both Baseline and the indicated assessment period were analyzed. Participants were analyzed for the entire treatment period if they had an assessment on any day during Week 1 and Week 2. The analysis was based on an ANCOVA with a model adjusting for Treatment, Baseline, Age, and Sex.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Fluticasone Furoate 55 µg Per Day | Mean Percent Change From Baseline in the 4TNSS Over the Entire Treatment Period, at Week 1, and at Week 2 | Entire Treatment Period, n=131, 130 | -40.42 Percent change | Standard Error 2.46 |
| Fluticasone Furoate 55 µg Per Day | Mean Percent Change From Baseline in the 4TNSS Over the Entire Treatment Period, at Week 1, and at Week 2 | Week 1, n=131, 130 | -32.55 Percent change | Standard Error 2.54 |
| Fluticasone Furoate 55 µg Per Day | Mean Percent Change From Baseline in the 4TNSS Over the Entire Treatment Period, at Week 1, and at Week 2 | Week 2, n= 131, 128 | -48.58 Percent change | Standard Error 2.78 |
| Placebo | Mean Percent Change From Baseline in the 4TNSS Over the Entire Treatment Period, at Week 1, and at Week 2 | Entire Treatment Period, n=131, 130 | -16.09 Percent change | Standard Error 2.44 |
| Placebo | Mean Percent Change From Baseline in the 4TNSS Over the Entire Treatment Period, at Week 1, and at Week 2 | Week 1, n=131, 130 | -11.54 Percent change | Standard Error 2.52 |
| Placebo | Mean Percent Change From Baseline in the 4TNSS Over the Entire Treatment Period, at Week 1, and at Week 2 | Week 2, n= 131, 128 | -20.92 Percent change | Standard Error 2.78 |
Secondary
Number of Participants With the Indicated Overall Response to Therapy, as Assessed by the Investigator
The investigator evaluated the participant's overall response to therapy (defined as improvement in the symptoms of allergic rhinitis) compared with Visit 2 (start of the treatment period), using the following 7-point categorical scale: 1=significantly improved, 2=moderately improved, 3=mildly improved, 4=no change, 5=mildly worse, 6=moderately worse, and 7=significantly worse.
Time frame: Week 2/EW
Population: FAS
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fluticasone Furoate 55 µg Per Day | Number of Participants With the Indicated Overall Response to Therapy, as Assessed by the Investigator | Mildly improved | 36 participants |
| Fluticasone Furoate 55 µg Per Day | Number of Participants With the Indicated Overall Response to Therapy, as Assessed by the Investigator | Mildly worse | 1 participants |
| Fluticasone Furoate 55 µg Per Day | Number of Participants With the Indicated Overall Response to Therapy, as Assessed by the Investigator | Moderately improved | 38 participants |
| Fluticasone Furoate 55 µg Per Day | Number of Participants With the Indicated Overall Response to Therapy, as Assessed by the Investigator | Moderately worse | 2 participants |
| Fluticasone Furoate 55 µg Per Day | Number of Participants With the Indicated Overall Response to Therapy, as Assessed by the Investigator | No change | 22 participants |
| Fluticasone Furoate 55 µg Per Day | Number of Participants With the Indicated Overall Response to Therapy, as Assessed by the Investigator | Significantly worse | 0 participants |
| Fluticasone Furoate 55 µg Per Day | Number of Participants With the Indicated Overall Response to Therapy, as Assessed by the Investigator | Significantly improved | 32 participants |
| Placebo | Number of Participants With the Indicated Overall Response to Therapy, as Assessed by the Investigator | Significantly worse | 1 participants |
| Placebo | Number of Participants With the Indicated Overall Response to Therapy, as Assessed by the Investigator | Significantly improved | 12 participants |
| Placebo | Number of Participants With the Indicated Overall Response to Therapy, as Assessed by the Investigator | Moderately improved | 25 participants |
| Placebo | Number of Participants With the Indicated Overall Response to Therapy, as Assessed by the Investigator | Mildly improved | 31 participants |
| Placebo | Number of Participants With the Indicated Overall Response to Therapy, as Assessed by the Investigator | No change | 54 participants |
| Placebo | Number of Participants With the Indicated Overall Response to Therapy, as Assessed by the Investigator | Mildly worse | 5 participants |
| Placebo | Number of Participants With the Indicated Overall Response to Therapy, as Assessed by the Investigator | Moderately worse | 2 participants |
Secondary
Number of Participants With the Indicated Overall Response to Therapy, as Assessed by the Participant's Parent/Guardian or the Participant
The participant's parent/guardian who signed the ICF or the participant themself evaluated the participant's overall response to therapy (defined as improvement in the symptoms of allergic rhinitis) compared with Visit 2 (start of the treatment period), using the following 7-point categorical scale: 1=significantly improved, 2=moderately improved, 3=mildly improved, 4=no change, 5=mildly worse, 6=moderately worse, and 7=significantly worse.
Time frame: Week 2/EW
Population: FAS
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fluticasone Furoate 55 µg Per Day | Number of Participants With the Indicated Overall Response to Therapy, as Assessed by the Participant's Parent/Guardian or the Participant | Mildly improved | 34 participants |
| Fluticasone Furoate 55 µg Per Day | Number of Participants With the Indicated Overall Response to Therapy, as Assessed by the Participant's Parent/Guardian or the Participant | Mildly worse | 0 participants |
| Fluticasone Furoate 55 µg Per Day | Number of Participants With the Indicated Overall Response to Therapy, as Assessed by the Participant's Parent/Guardian or the Participant | Moderately improved | 51 participants |
| Fluticasone Furoate 55 µg Per Day | Number of Participants With the Indicated Overall Response to Therapy, as Assessed by the Participant's Parent/Guardian or the Participant | Moderately worse | 0 participants |
| Fluticasone Furoate 55 µg Per Day | Number of Participants With the Indicated Overall Response to Therapy, as Assessed by the Participant's Parent/Guardian or the Participant | No change | 18 participants |
| Fluticasone Furoate 55 µg Per Day | Number of Participants With the Indicated Overall Response to Therapy, as Assessed by the Participant's Parent/Guardian or the Participant | Significantly worse | 0 participants |
| Fluticasone Furoate 55 µg Per Day | Number of Participants With the Indicated Overall Response to Therapy, as Assessed by the Participant's Parent/Guardian or the Participant | Significantly improved | 28 participants |
| Placebo | Number of Participants With the Indicated Overall Response to Therapy, as Assessed by the Participant's Parent/Guardian or the Participant | Significantly worse | 0 participants |
| Placebo | Number of Participants With the Indicated Overall Response to Therapy, as Assessed by the Participant's Parent/Guardian or the Participant | Significantly improved | 2 participants |
| Placebo | Number of Participants With the Indicated Overall Response to Therapy, as Assessed by the Participant's Parent/Guardian or the Participant | Moderately improved | 26 participants |
| Placebo | Number of Participants With the Indicated Overall Response to Therapy, as Assessed by the Participant's Parent/Guardian or the Participant | Mildly improved | 48 participants |
| Placebo | Number of Participants With the Indicated Overall Response to Therapy, as Assessed by the Participant's Parent/Guardian or the Participant | No change | 51 participants |
| Placebo | Number of Participants With the Indicated Overall Response to Therapy, as Assessed by the Participant's Parent/Guardian or the Participant | Mildly worse | 3 participants |
| Placebo | Number of Participants With the Indicated Overall Response to Therapy, as Assessed by the Participant's Parent/Guardian or the Participant | Moderately worse | 0 participants |
Secondary
Number of Participants With the Indicated Scores for Rhinoscopy Findings (Swelling of Inferior Turbinate Mucosa, Color of Inferior Turbinate Mucosa, Quantity of Nasal Discharge, and Quality of Nasal Discharge) at Baseline, Week 1, and Week 2/EW
Rhinoscopy was assessed by the investigator by scoring swelling of inferior turbinate mucosa (SOITM) scored as 0 (none), 1 (possible to see center of the middle turbinate), 2 (between 3 and 1), or 3 (impossible to see middle turbinate); color of inferior turbinate mucosa (COITM) scored as 0 (normal), 1 (pink), 2 (red), or 3 (pale); quantity of nasal discharge (QTND) scored as 0 (none), 1 (small amount adhered), 2 (between 3 and 1), or 3 (filled); and quality of nasal discharge (QLND) scored as 0 (none), 1 (pyoid), 2 (viscous), or 3 (watery).
Time frame: Baseline, Week 1, and Week 2/Early Withdrawal (EW)
Population: FAS. Participants who were withdrawn before Visit 3 (Week 1) were not included in the analysis for Week 1.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fluticasone Furoate 55 µg Per Day | Number of Participants With the Indicated Scores for Rhinoscopy Findings (Swelling of Inferior Turbinate Mucosa, Color of Inferior Turbinate Mucosa, Quantity of Nasal Discharge, and Quality of Nasal Discharge) at Baseline, Week 1, and Week 2/EW | QLND, Baseline, Score 1, n=131, 130 | 0 participants |
| Fluticasone Furoate 55 µg Per Day | Number of Participants With the Indicated Scores for Rhinoscopy Findings (Swelling of Inferior Turbinate Mucosa, Color of Inferior Turbinate Mucosa, Quantity of Nasal Discharge, and Quality of Nasal Discharge) at Baseline, Week 1, and Week 2/EW | QTND, Baseline, Score 1, n=131, 130 | 52 participants |
| Fluticasone Furoate 55 µg Per Day | Number of Participants With the Indicated Scores for Rhinoscopy Findings (Swelling of Inferior Turbinate Mucosa, Color of Inferior Turbinate Mucosa, Quantity of Nasal Discharge, and Quality of Nasal Discharge) at Baseline, Week 1, and Week 2/EW | QTND, Baseline, Score 2, n=131, 130 | 60 participants |
| Fluticasone Furoate 55 µg Per Day | Number of Participants With the Indicated Scores for Rhinoscopy Findings (Swelling of Inferior Turbinate Mucosa, Color of Inferior Turbinate Mucosa, Quantity of Nasal Discharge, and Quality of Nasal Discharge) at Baseline, Week 1, and Week 2/EW | QTND, Week 1, Score 0, n= 131, 128 | 38 participants |
| Fluticasone Furoate 55 µg Per Day | Number of Participants With the Indicated Scores for Rhinoscopy Findings (Swelling of Inferior Turbinate Mucosa, Color of Inferior Turbinate Mucosa, Quantity of Nasal Discharge, and Quality of Nasal Discharge) at Baseline, Week 1, and Week 2/EW | QTND, Week 1, Score 1, n= 131, 128 | 57 participants |
| Fluticasone Furoate 55 µg Per Day | Number of Participants With the Indicated Scores for Rhinoscopy Findings (Swelling of Inferior Turbinate Mucosa, Color of Inferior Turbinate Mucosa, Quantity of Nasal Discharge, and Quality of Nasal Discharge) at Baseline, Week 1, and Week 2/EW | QTND, Week 1, Score 2, n= 131, 128 | 32 participants |
| Fluticasone Furoate 55 µg Per Day | Number of Participants With the Indicated Scores for Rhinoscopy Findings (Swelling of Inferior Turbinate Mucosa, Color of Inferior Turbinate Mucosa, Quantity of Nasal Discharge, and Quality of Nasal Discharge) at Baseline, Week 1, and Week 2/EW | QTND, Week 1, Score 3, n= 131, 128 | 4 participants |
| Fluticasone Furoate 55 µg Per Day | Number of Participants With the Indicated Scores for Rhinoscopy Findings (Swelling of Inferior Turbinate Mucosa, Color of Inferior Turbinate Mucosa, Quantity of Nasal Discharge, and Quality of Nasal Discharge) at Baseline, Week 1, and Week 2/EW | QTND, Week 2/EW, Score 0, n=131, 130 | 63 participants |
| Fluticasone Furoate 55 µg Per Day | Number of Participants With the Indicated Scores for Rhinoscopy Findings (Swelling of Inferior Turbinate Mucosa, Color of Inferior Turbinate Mucosa, Quantity of Nasal Discharge, and Quality of Nasal Discharge) at Baseline, Week 1, and Week 2/EW | QTND, Week 2/EW, Score 1, n=131, 130 | 49 participants |
| Fluticasone Furoate 55 µg Per Day | Number of Participants With the Indicated Scores for Rhinoscopy Findings (Swelling of Inferior Turbinate Mucosa, Color of Inferior Turbinate Mucosa, Quantity of Nasal Discharge, and Quality of Nasal Discharge) at Baseline, Week 1, and Week 2/EW | QTND, Week 2/EW, Score 2, n=131, 130 | 18 participants |
| Fluticasone Furoate 55 µg Per Day | Number of Participants With the Indicated Scores for Rhinoscopy Findings (Swelling of Inferior Turbinate Mucosa, Color of Inferior Turbinate Mucosa, Quantity of Nasal Discharge, and Quality of Nasal Discharge) at Baseline, Week 1, and Week 2/EW | QTND, Week 2/EW, Score 3, n=131, 130 | 1 participants |
| Fluticasone Furoate 55 µg Per Day | Number of Participants With the Indicated Scores for Rhinoscopy Findings (Swelling of Inferior Turbinate Mucosa, Color of Inferior Turbinate Mucosa, Quantity of Nasal Discharge, and Quality of Nasal Discharge) at Baseline, Week 1, and Week 2/EW | QLND, Baseline, Score 0, n=131, 130 | 9 participants |
| Fluticasone Furoate 55 µg Per Day | Number of Participants With the Indicated Scores for Rhinoscopy Findings (Swelling of Inferior Turbinate Mucosa, Color of Inferior Turbinate Mucosa, Quantity of Nasal Discharge, and Quality of Nasal Discharge) at Baseline, Week 1, and Week 2/EW | QTND, Baseline, Score 3, n=131, 130 | 11 participants |
| Fluticasone Furoate 55 µg Per Day | Number of Participants With the Indicated Scores for Rhinoscopy Findings (Swelling of Inferior Turbinate Mucosa, Color of Inferior Turbinate Mucosa, Quantity of Nasal Discharge, and Quality of Nasal Discharge) at Baseline, Week 1, and Week 2/EW | QLND, Baseline, Score 2, n=131, 130 | 29 participants |
| Fluticasone Furoate 55 µg Per Day | Number of Participants With the Indicated Scores for Rhinoscopy Findings (Swelling of Inferior Turbinate Mucosa, Color of Inferior Turbinate Mucosa, Quantity of Nasal Discharge, and Quality of Nasal Discharge) at Baseline, Week 1, and Week 2/EW | QLND, Baseline, Score 3, n=131, 130 | 93 participants |
| Fluticasone Furoate 55 µg Per Day | Number of Participants With the Indicated Scores for Rhinoscopy Findings (Swelling of Inferior Turbinate Mucosa, Color of Inferior Turbinate Mucosa, Quantity of Nasal Discharge, and Quality of Nasal Discharge) at Baseline, Week 1, and Week 2/EW | QLND, Week 1, Score 0, n= 131, 128 | 39 participants |
| Fluticasone Furoate 55 µg Per Day | Number of Participants With the Indicated Scores for Rhinoscopy Findings (Swelling of Inferior Turbinate Mucosa, Color of Inferior Turbinate Mucosa, Quantity of Nasal Discharge, and Quality of Nasal Discharge) at Baseline, Week 1, and Week 2/EW | QLND, Week 1, Score 1, n= 131, 128 | 2 participants |
| Fluticasone Furoate 55 µg Per Day | Number of Participants With the Indicated Scores for Rhinoscopy Findings (Swelling of Inferior Turbinate Mucosa, Color of Inferior Turbinate Mucosa, Quantity of Nasal Discharge, and Quality of Nasal Discharge) at Baseline, Week 1, and Week 2/EW | QLND, Week 1, Score 2, n= 131, 128 | 24 participants |
| Fluticasone Furoate 55 µg Per Day | Number of Participants With the Indicated Scores for Rhinoscopy Findings (Swelling of Inferior Turbinate Mucosa, Color of Inferior Turbinate Mucosa, Quantity of Nasal Discharge, and Quality of Nasal Discharge) at Baseline, Week 1, and Week 2/EW | QLND, Week 1, Score 3, n= 131, 128 | 66 participants |
| Fluticasone Furoate 55 µg Per Day | Number of Participants With the Indicated Scores for Rhinoscopy Findings (Swelling of Inferior Turbinate Mucosa, Color of Inferior Turbinate Mucosa, Quantity of Nasal Discharge, and Quality of Nasal Discharge) at Baseline, Week 1, and Week 2/EW | QLND, Week 2/EW, Score 0, n=131, 130 | 62 participants |
| Fluticasone Furoate 55 µg Per Day | Number of Participants With the Indicated Scores for Rhinoscopy Findings (Swelling of Inferior Turbinate Mucosa, Color of Inferior Turbinate Mucosa, Quantity of Nasal Discharge, and Quality of Nasal Discharge) at Baseline, Week 1, and Week 2/EW | QLND, Week 2/EW, Score 1, n=131, 130 | 3 participants |
| Fluticasone Furoate 55 µg Per Day | Number of Participants With the Indicated Scores for Rhinoscopy Findings (Swelling of Inferior Turbinate Mucosa, Color of Inferior Turbinate Mucosa, Quantity of Nasal Discharge, and Quality of Nasal Discharge) at Baseline, Week 1, and Week 2/EW | QLND, Week 2/EW, Score 2, n=131, 130 | 26 participants |
| Fluticasone Furoate 55 µg Per Day | Number of Participants With the Indicated Scores for Rhinoscopy Findings (Swelling of Inferior Turbinate Mucosa, Color of Inferior Turbinate Mucosa, Quantity of Nasal Discharge, and Quality of Nasal Discharge) at Baseline, Week 1, and Week 2/EW | QLND, Week 2/EW, Score 3, n=131, 130 | 40 participants |
| Fluticasone Furoate 55 µg Per Day | Number of Participants With the Indicated Scores for Rhinoscopy Findings (Swelling of Inferior Turbinate Mucosa, Color of Inferior Turbinate Mucosa, Quantity of Nasal Discharge, and Quality of Nasal Discharge) at Baseline, Week 1, and Week 2/EW | SOITM, Baseline, Score 0, n=131, 130 | 2 participants |
| Fluticasone Furoate 55 µg Per Day | Number of Participants With the Indicated Scores for Rhinoscopy Findings (Swelling of Inferior Turbinate Mucosa, Color of Inferior Turbinate Mucosa, Quantity of Nasal Discharge, and Quality of Nasal Discharge) at Baseline, Week 1, and Week 2/EW | SOITM, Baseline, Score 1, n=131, 130 | 24 participants |
| Fluticasone Furoate 55 µg Per Day | Number of Participants With the Indicated Scores for Rhinoscopy Findings (Swelling of Inferior Turbinate Mucosa, Color of Inferior Turbinate Mucosa, Quantity of Nasal Discharge, and Quality of Nasal Discharge) at Baseline, Week 1, and Week 2/EW | SOITM, Baseline, Score 2, n=131, 130 | 54 participants |
| Fluticasone Furoate 55 µg Per Day | Number of Participants With the Indicated Scores for Rhinoscopy Findings (Swelling of Inferior Turbinate Mucosa, Color of Inferior Turbinate Mucosa, Quantity of Nasal Discharge, and Quality of Nasal Discharge) at Baseline, Week 1, and Week 2/EW | SOITM, Baseline, Score 3, n=131, 130 | 51 participants |
| Fluticasone Furoate 55 µg Per Day | Number of Participants With the Indicated Scores for Rhinoscopy Findings (Swelling of Inferior Turbinate Mucosa, Color of Inferior Turbinate Mucosa, Quantity of Nasal Discharge, and Quality of Nasal Discharge) at Baseline, Week 1, and Week 2/EW | SOITM, Week 1, Score 0, n=131, 128 | 9 participants |
| Fluticasone Furoate 55 µg Per Day | Number of Participants With the Indicated Scores for Rhinoscopy Findings (Swelling of Inferior Turbinate Mucosa, Color of Inferior Turbinate Mucosa, Quantity of Nasal Discharge, and Quality of Nasal Discharge) at Baseline, Week 1, and Week 2/EW | SOITM, Week 1, Score 1, n=131, 128 | 45 participants |
| Fluticasone Furoate 55 µg Per Day | Number of Participants With the Indicated Scores for Rhinoscopy Findings (Swelling of Inferior Turbinate Mucosa, Color of Inferior Turbinate Mucosa, Quantity of Nasal Discharge, and Quality of Nasal Discharge) at Baseline, Week 1, and Week 2/EW | SOITM, Week 1, Score 2, n=131, 128 | 53 participants |
| Fluticasone Furoate 55 µg Per Day | Number of Participants With the Indicated Scores for Rhinoscopy Findings (Swelling of Inferior Turbinate Mucosa, Color of Inferior Turbinate Mucosa, Quantity of Nasal Discharge, and Quality of Nasal Discharge) at Baseline, Week 1, and Week 2/EW | SOITM, Week 1, Score 3, n=131, 128 | 24 participants |
| Fluticasone Furoate 55 µg Per Day | Number of Participants With the Indicated Scores for Rhinoscopy Findings (Swelling of Inferior Turbinate Mucosa, Color of Inferior Turbinate Mucosa, Quantity of Nasal Discharge, and Quality of Nasal Discharge) at Baseline, Week 1, and Week 2/EW | SOITM, Week 2/EW, Score 0, n=131, 130 | 19 participants |
| Fluticasone Furoate 55 µg Per Day | Number of Participants With the Indicated Scores for Rhinoscopy Findings (Swelling of Inferior Turbinate Mucosa, Color of Inferior Turbinate Mucosa, Quantity of Nasal Discharge, and Quality of Nasal Discharge) at Baseline, Week 1, and Week 2/EW | SOITM, Week 2/EW, Score 1, n=131, 130 | 62 participants |
| Fluticasone Furoate 55 µg Per Day | Number of Participants With the Indicated Scores for Rhinoscopy Findings (Swelling of Inferior Turbinate Mucosa, Color of Inferior Turbinate Mucosa, Quantity of Nasal Discharge, and Quality of Nasal Discharge) at Baseline, Week 1, and Week 2/EW | SOITM, Week 2/EW, Score 2, n=131, 130 | 37 participants |
| Fluticasone Furoate 55 µg Per Day | Number of Participants With the Indicated Scores for Rhinoscopy Findings (Swelling of Inferior Turbinate Mucosa, Color of Inferior Turbinate Mucosa, Quantity of Nasal Discharge, and Quality of Nasal Discharge) at Baseline, Week 1, and Week 2/EW | SOITM, Week 2/EW, Score 3, n=131, 130 | 13 participants |
| Fluticasone Furoate 55 µg Per Day | Number of Participants With the Indicated Scores for Rhinoscopy Findings (Swelling of Inferior Turbinate Mucosa, Color of Inferior Turbinate Mucosa, Quantity of Nasal Discharge, and Quality of Nasal Discharge) at Baseline, Week 1, and Week 2/EW | COITM, Baseline, Score 0, n=131, 130 | 2 participants |
| Fluticasone Furoate 55 µg Per Day | Number of Participants With the Indicated Scores for Rhinoscopy Findings (Swelling of Inferior Turbinate Mucosa, Color of Inferior Turbinate Mucosa, Quantity of Nasal Discharge, and Quality of Nasal Discharge) at Baseline, Week 1, and Week 2/EW | COITM, Baseline, Score 1, n=131, 130 | 13 participants |
| Fluticasone Furoate 55 µg Per Day | Number of Participants With the Indicated Scores for Rhinoscopy Findings (Swelling of Inferior Turbinate Mucosa, Color of Inferior Turbinate Mucosa, Quantity of Nasal Discharge, and Quality of Nasal Discharge) at Baseline, Week 1, and Week 2/EW | COITM, Baseline, Score 2, n=131, 130 | 28 participants |
| Fluticasone Furoate 55 µg Per Day | Number of Participants With the Indicated Scores for Rhinoscopy Findings (Swelling of Inferior Turbinate Mucosa, Color of Inferior Turbinate Mucosa, Quantity of Nasal Discharge, and Quality of Nasal Discharge) at Baseline, Week 1, and Week 2/EW | COITM, Baseline, Score 3, n=131, 130 | 88 participants |
| Fluticasone Furoate 55 µg Per Day | Number of Participants With the Indicated Scores for Rhinoscopy Findings (Swelling of Inferior Turbinate Mucosa, Color of Inferior Turbinate Mucosa, Quantity of Nasal Discharge, and Quality of Nasal Discharge) at Baseline, Week 1, and Week 2/EW | COITM, Week 1, Score 0, n= 131, 128 | 5 participants |
| Fluticasone Furoate 55 µg Per Day | Number of Participants With the Indicated Scores for Rhinoscopy Findings (Swelling of Inferior Turbinate Mucosa, Color of Inferior Turbinate Mucosa, Quantity of Nasal Discharge, and Quality of Nasal Discharge) at Baseline, Week 1, and Week 2/EW | COITM, Week 1, Score 1, n= 131, 128 | 45 participants |
| Fluticasone Furoate 55 µg Per Day | Number of Participants With the Indicated Scores for Rhinoscopy Findings (Swelling of Inferior Turbinate Mucosa, Color of Inferior Turbinate Mucosa, Quantity of Nasal Discharge, and Quality of Nasal Discharge) at Baseline, Week 1, and Week 2/EW | COITM, Week 1, Score 2, n= 131, 128 | 23 participants |
| Fluticasone Furoate 55 µg Per Day | Number of Participants With the Indicated Scores for Rhinoscopy Findings (Swelling of Inferior Turbinate Mucosa, Color of Inferior Turbinate Mucosa, Quantity of Nasal Discharge, and Quality of Nasal Discharge) at Baseline, Week 1, and Week 2/EW | COITM, Week 1, Score 3, n= 131, 128 | 58 participants |
| Fluticasone Furoate 55 µg Per Day | Number of Participants With the Indicated Scores for Rhinoscopy Findings (Swelling of Inferior Turbinate Mucosa, Color of Inferior Turbinate Mucosa, Quantity of Nasal Discharge, and Quality of Nasal Discharge) at Baseline, Week 1, and Week 2/EW | COITM, Week 2/EW, Score 0, n=131, 130 | 7 participants |
| Fluticasone Furoate 55 µg Per Day | Number of Participants With the Indicated Scores for Rhinoscopy Findings (Swelling of Inferior Turbinate Mucosa, Color of Inferior Turbinate Mucosa, Quantity of Nasal Discharge, and Quality of Nasal Discharge) at Baseline, Week 1, and Week 2/EW | COITM, Week 2/EW, Score 1, n=131, 130 | 68 participants |
| Fluticasone Furoate 55 µg Per Day | Number of Participants With the Indicated Scores for Rhinoscopy Findings (Swelling of Inferior Turbinate Mucosa, Color of Inferior Turbinate Mucosa, Quantity of Nasal Discharge, and Quality of Nasal Discharge) at Baseline, Week 1, and Week 2/EW | COITM, Week 2/EW, Score 2, n=131, 130 | 17 participants |
| Fluticasone Furoate 55 µg Per Day | Number of Participants With the Indicated Scores for Rhinoscopy Findings (Swelling of Inferior Turbinate Mucosa, Color of Inferior Turbinate Mucosa, Quantity of Nasal Discharge, and Quality of Nasal Discharge) at Baseline, Week 1, and Week 2/EW | COITM, Week 2/EW, Score 3, n=131, 130 | 39 participants |
| Fluticasone Furoate 55 µg Per Day | Number of Participants With the Indicated Scores for Rhinoscopy Findings (Swelling of Inferior Turbinate Mucosa, Color of Inferior Turbinate Mucosa, Quantity of Nasal Discharge, and Quality of Nasal Discharge) at Baseline, Week 1, and Week 2/EW | QTND, Baseline, Score 0, n=131, 130 | 8 participants |
| Placebo | Number of Participants With the Indicated Scores for Rhinoscopy Findings (Swelling of Inferior Turbinate Mucosa, Color of Inferior Turbinate Mucosa, Quantity of Nasal Discharge, and Quality of Nasal Discharge) at Baseline, Week 1, and Week 2/EW | COITM, Week 2/EW, Score 3, n=131, 130 | 49 participants |
| Placebo | Number of Participants With the Indicated Scores for Rhinoscopy Findings (Swelling of Inferior Turbinate Mucosa, Color of Inferior Turbinate Mucosa, Quantity of Nasal Discharge, and Quality of Nasal Discharge) at Baseline, Week 1, and Week 2/EW | SOITM, Baseline, Score 1, n=131, 130 | 32 participants |
| Placebo | Number of Participants With the Indicated Scores for Rhinoscopy Findings (Swelling of Inferior Turbinate Mucosa, Color of Inferior Turbinate Mucosa, Quantity of Nasal Discharge, and Quality of Nasal Discharge) at Baseline, Week 1, and Week 2/EW | QTND, Baseline, Score 1, n=131, 130 | 53 participants |
| Placebo | Number of Participants With the Indicated Scores for Rhinoscopy Findings (Swelling of Inferior Turbinate Mucosa, Color of Inferior Turbinate Mucosa, Quantity of Nasal Discharge, and Quality of Nasal Discharge) at Baseline, Week 1, and Week 2/EW | COITM, Baseline, Score 1, n=131, 130 | 31 participants |
| Placebo | Number of Participants With the Indicated Scores for Rhinoscopy Findings (Swelling of Inferior Turbinate Mucosa, Color of Inferior Turbinate Mucosa, Quantity of Nasal Discharge, and Quality of Nasal Discharge) at Baseline, Week 1, and Week 2/EW | QTND, Baseline, Score 2, n=131, 130 | 63 participants |
| Placebo | Number of Participants With the Indicated Scores for Rhinoscopy Findings (Swelling of Inferior Turbinate Mucosa, Color of Inferior Turbinate Mucosa, Quantity of Nasal Discharge, and Quality of Nasal Discharge) at Baseline, Week 1, and Week 2/EW | QTND, Baseline, Score 3, n=131, 130 | 8 participants |
| Placebo | Number of Participants With the Indicated Scores for Rhinoscopy Findings (Swelling of Inferior Turbinate Mucosa, Color of Inferior Turbinate Mucosa, Quantity of Nasal Discharge, and Quality of Nasal Discharge) at Baseline, Week 1, and Week 2/EW | SOITM, Baseline, Score 2, n=131, 130 | 55 participants |
| Placebo | Number of Participants With the Indicated Scores for Rhinoscopy Findings (Swelling of Inferior Turbinate Mucosa, Color of Inferior Turbinate Mucosa, Quantity of Nasal Discharge, and Quality of Nasal Discharge) at Baseline, Week 1, and Week 2/EW | QTND, Week 1, Score 0, n= 131, 128 | 18 participants |
| Placebo | Number of Participants With the Indicated Scores for Rhinoscopy Findings (Swelling of Inferior Turbinate Mucosa, Color of Inferior Turbinate Mucosa, Quantity of Nasal Discharge, and Quality of Nasal Discharge) at Baseline, Week 1, and Week 2/EW | COITM, Week 1, Score 3, n= 131, 128 | 56 participants |
| Placebo | Number of Participants With the Indicated Scores for Rhinoscopy Findings (Swelling of Inferior Turbinate Mucosa, Color of Inferior Turbinate Mucosa, Quantity of Nasal Discharge, and Quality of Nasal Discharge) at Baseline, Week 1, and Week 2/EW | QTND, Week 1, Score 1, n= 131, 128 | 62 participants |
| Placebo | Number of Participants With the Indicated Scores for Rhinoscopy Findings (Swelling of Inferior Turbinate Mucosa, Color of Inferior Turbinate Mucosa, Quantity of Nasal Discharge, and Quality of Nasal Discharge) at Baseline, Week 1, and Week 2/EW | SOITM, Baseline, Score 3, n=131, 130 | 36 participants |
| Placebo | Number of Participants With the Indicated Scores for Rhinoscopy Findings (Swelling of Inferior Turbinate Mucosa, Color of Inferior Turbinate Mucosa, Quantity of Nasal Discharge, and Quality of Nasal Discharge) at Baseline, Week 1, and Week 2/EW | QTND, Week 1, Score 2, n= 131, 128 | 42 participants |
| Placebo | Number of Participants With the Indicated Scores for Rhinoscopy Findings (Swelling of Inferior Turbinate Mucosa, Color of Inferior Turbinate Mucosa, Quantity of Nasal Discharge, and Quality of Nasal Discharge) at Baseline, Week 1, and Week 2/EW | COITM, Baseline, Score 2, n=131, 130 | 29 participants |
| Placebo | Number of Participants With the Indicated Scores for Rhinoscopy Findings (Swelling of Inferior Turbinate Mucosa, Color of Inferior Turbinate Mucosa, Quantity of Nasal Discharge, and Quality of Nasal Discharge) at Baseline, Week 1, and Week 2/EW | QTND, Week 1, Score 3, n= 131, 128 | 6 participants |
| Placebo | Number of Participants With the Indicated Scores for Rhinoscopy Findings (Swelling of Inferior Turbinate Mucosa, Color of Inferior Turbinate Mucosa, Quantity of Nasal Discharge, and Quality of Nasal Discharge) at Baseline, Week 1, and Week 2/EW | SOITM, Week 1, Score 0, n=131, 128 | 5 participants |
| Placebo | Number of Participants With the Indicated Scores for Rhinoscopy Findings (Swelling of Inferior Turbinate Mucosa, Color of Inferior Turbinate Mucosa, Quantity of Nasal Discharge, and Quality of Nasal Discharge) at Baseline, Week 1, and Week 2/EW | QTND, Week 2/EW, Score 0, n=131, 130 | 37 participants |
| Placebo | Number of Participants With the Indicated Scores for Rhinoscopy Findings (Swelling of Inferior Turbinate Mucosa, Color of Inferior Turbinate Mucosa, Quantity of Nasal Discharge, and Quality of Nasal Discharge) at Baseline, Week 1, and Week 2/EW | COITM, Week 2/EW, Score 2, n=131, 130 | 20 participants |
| Placebo | Number of Participants With the Indicated Scores for Rhinoscopy Findings (Swelling of Inferior Turbinate Mucosa, Color of Inferior Turbinate Mucosa, Quantity of Nasal Discharge, and Quality of Nasal Discharge) at Baseline, Week 1, and Week 2/EW | QTND, Week 2/EW, Score 1, n=131, 130 | 57 participants |
| Placebo | Number of Participants With the Indicated Scores for Rhinoscopy Findings (Swelling of Inferior Turbinate Mucosa, Color of Inferior Turbinate Mucosa, Quantity of Nasal Discharge, and Quality of Nasal Discharge) at Baseline, Week 1, and Week 2/EW | SOITM, Week 1, Score 1, n=131, 128 | 55 participants |
| Placebo | Number of Participants With the Indicated Scores for Rhinoscopy Findings (Swelling of Inferior Turbinate Mucosa, Color of Inferior Turbinate Mucosa, Quantity of Nasal Discharge, and Quality of Nasal Discharge) at Baseline, Week 1, and Week 2/EW | QTND, Week 2/EW, Score 2, n=131, 130 | 31 participants |
| Placebo | Number of Participants With the Indicated Scores for Rhinoscopy Findings (Swelling of Inferior Turbinate Mucosa, Color of Inferior Turbinate Mucosa, Quantity of Nasal Discharge, and Quality of Nasal Discharge) at Baseline, Week 1, and Week 2/EW | COITM, Baseline, Score 3, n=131, 130 | 68 participants |
| Placebo | Number of Participants With the Indicated Scores for Rhinoscopy Findings (Swelling of Inferior Turbinate Mucosa, Color of Inferior Turbinate Mucosa, Quantity of Nasal Discharge, and Quality of Nasal Discharge) at Baseline, Week 1, and Week 2/EW | QTND, Week 2/EW, Score 3, n=131, 130 | 5 participants |
| Placebo | Number of Participants With the Indicated Scores for Rhinoscopy Findings (Swelling of Inferior Turbinate Mucosa, Color of Inferior Turbinate Mucosa, Quantity of Nasal Discharge, and Quality of Nasal Discharge) at Baseline, Week 1, and Week 2/EW | SOITM, Week 1, Score 2, n=131, 128 | 44 participants |
| Placebo | Number of Participants With the Indicated Scores for Rhinoscopy Findings (Swelling of Inferior Turbinate Mucosa, Color of Inferior Turbinate Mucosa, Quantity of Nasal Discharge, and Quality of Nasal Discharge) at Baseline, Week 1, and Week 2/EW | QLND, Baseline, Score 0, n=131, 130 | 6 participants |
| Placebo | Number of Participants With the Indicated Scores for Rhinoscopy Findings (Swelling of Inferior Turbinate Mucosa, Color of Inferior Turbinate Mucosa, Quantity of Nasal Discharge, and Quality of Nasal Discharge) at Baseline, Week 1, and Week 2/EW | COITM, Week 2/EW, Score 0, n=131, 130 | 10 participants |
| Placebo | Number of Participants With the Indicated Scores for Rhinoscopy Findings (Swelling of Inferior Turbinate Mucosa, Color of Inferior Turbinate Mucosa, Quantity of Nasal Discharge, and Quality of Nasal Discharge) at Baseline, Week 1, and Week 2/EW | QLND, Baseline, Score 1, n=131, 130 | 0 participants |
| Placebo | Number of Participants With the Indicated Scores for Rhinoscopy Findings (Swelling of Inferior Turbinate Mucosa, Color of Inferior Turbinate Mucosa, Quantity of Nasal Discharge, and Quality of Nasal Discharge) at Baseline, Week 1, and Week 2/EW | SOITM, Week 1, Score 3, n=131, 128 | 24 participants |
| Placebo | Number of Participants With the Indicated Scores for Rhinoscopy Findings (Swelling of Inferior Turbinate Mucosa, Color of Inferior Turbinate Mucosa, Quantity of Nasal Discharge, and Quality of Nasal Discharge) at Baseline, Week 1, and Week 2/EW | QLND, Baseline, Score 2, n=131, 130 | 27 participants |
| Placebo | Number of Participants With the Indicated Scores for Rhinoscopy Findings (Swelling of Inferior Turbinate Mucosa, Color of Inferior Turbinate Mucosa, Quantity of Nasal Discharge, and Quality of Nasal Discharge) at Baseline, Week 1, and Week 2/EW | COITM, Week 1, Score 0, n= 131, 128 | 2 participants |
| Placebo | Number of Participants With the Indicated Scores for Rhinoscopy Findings (Swelling of Inferior Turbinate Mucosa, Color of Inferior Turbinate Mucosa, Quantity of Nasal Discharge, and Quality of Nasal Discharge) at Baseline, Week 1, and Week 2/EW | QLND, Baseline, Score 3, n=131, 130 | 97 participants |
| Placebo | Number of Participants With the Indicated Scores for Rhinoscopy Findings (Swelling of Inferior Turbinate Mucosa, Color of Inferior Turbinate Mucosa, Quantity of Nasal Discharge, and Quality of Nasal Discharge) at Baseline, Week 1, and Week 2/EW | SOITM, Week 2/EW, Score 0, n=131, 130 | 19 participants |
| Placebo | Number of Participants With the Indicated Scores for Rhinoscopy Findings (Swelling of Inferior Turbinate Mucosa, Color of Inferior Turbinate Mucosa, Quantity of Nasal Discharge, and Quality of Nasal Discharge) at Baseline, Week 1, and Week 2/EW | QLND, Week 1, Score 0, n= 131, 128 | 18 participants |
| Placebo | Number of Participants With the Indicated Scores for Rhinoscopy Findings (Swelling of Inferior Turbinate Mucosa, Color of Inferior Turbinate Mucosa, Quantity of Nasal Discharge, and Quality of Nasal Discharge) at Baseline, Week 1, and Week 2/EW | QTND, Baseline, Score 0, n=131, 130 | 6 participants |
| Placebo | Number of Participants With the Indicated Scores for Rhinoscopy Findings (Swelling of Inferior Turbinate Mucosa, Color of Inferior Turbinate Mucosa, Quantity of Nasal Discharge, and Quality of Nasal Discharge) at Baseline, Week 1, and Week 2/EW | QLND, Week 1, Score 1, n= 131, 128 | 5 participants |
| Placebo | Number of Participants With the Indicated Scores for Rhinoscopy Findings (Swelling of Inferior Turbinate Mucosa, Color of Inferior Turbinate Mucosa, Quantity of Nasal Discharge, and Quality of Nasal Discharge) at Baseline, Week 1, and Week 2/EW | SOITM, Week 2/EW, Score 1, n=131, 130 | 45 participants |
| Placebo | Number of Participants With the Indicated Scores for Rhinoscopy Findings (Swelling of Inferior Turbinate Mucosa, Color of Inferior Turbinate Mucosa, Quantity of Nasal Discharge, and Quality of Nasal Discharge) at Baseline, Week 1, and Week 2/EW | QLND, Week 1, Score 2, n= 131, 128 | 27 participants |
| Placebo | Number of Participants With the Indicated Scores for Rhinoscopy Findings (Swelling of Inferior Turbinate Mucosa, Color of Inferior Turbinate Mucosa, Quantity of Nasal Discharge, and Quality of Nasal Discharge) at Baseline, Week 1, and Week 2/EW | COITM, Week 1, Score 1, n= 131, 128 | 43 participants |
| Placebo | Number of Participants With the Indicated Scores for Rhinoscopy Findings (Swelling of Inferior Turbinate Mucosa, Color of Inferior Turbinate Mucosa, Quantity of Nasal Discharge, and Quality of Nasal Discharge) at Baseline, Week 1, and Week 2/EW | QLND, Week 1, Score 3, n= 131, 128 | 78 participants |
| Placebo | Number of Participants With the Indicated Scores for Rhinoscopy Findings (Swelling of Inferior Turbinate Mucosa, Color of Inferior Turbinate Mucosa, Quantity of Nasal Discharge, and Quality of Nasal Discharge) at Baseline, Week 1, and Week 2/EW | SOITM, Week 2/EW, Score 2, n=131, 130 | 42 participants |
| Placebo | Number of Participants With the Indicated Scores for Rhinoscopy Findings (Swelling of Inferior Turbinate Mucosa, Color of Inferior Turbinate Mucosa, Quantity of Nasal Discharge, and Quality of Nasal Discharge) at Baseline, Week 1, and Week 2/EW | QLND, Week 2/EW, Score 0, n=131, 130 | 33 participants |
| Placebo | Number of Participants With the Indicated Scores for Rhinoscopy Findings (Swelling of Inferior Turbinate Mucosa, Color of Inferior Turbinate Mucosa, Quantity of Nasal Discharge, and Quality of Nasal Discharge) at Baseline, Week 1, and Week 2/EW | COITM, Week 2/EW, Score 1, n=131, 130 | 51 participants |
| Placebo | Number of Participants With the Indicated Scores for Rhinoscopy Findings (Swelling of Inferior Turbinate Mucosa, Color of Inferior Turbinate Mucosa, Quantity of Nasal Discharge, and Quality of Nasal Discharge) at Baseline, Week 1, and Week 2/EW | QLND, Week 2/EW, Score 1, n=131, 130 | 3 participants |
| Placebo | Number of Participants With the Indicated Scores for Rhinoscopy Findings (Swelling of Inferior Turbinate Mucosa, Color of Inferior Turbinate Mucosa, Quantity of Nasal Discharge, and Quality of Nasal Discharge) at Baseline, Week 1, and Week 2/EW | SOITM, Week 2/EW, Score 3, n=131, 130 | 24 participants |
| Placebo | Number of Participants With the Indicated Scores for Rhinoscopy Findings (Swelling of Inferior Turbinate Mucosa, Color of Inferior Turbinate Mucosa, Quantity of Nasal Discharge, and Quality of Nasal Discharge) at Baseline, Week 1, and Week 2/EW | QLND, Week 2/EW, Score 2, n=131, 130 | 29 participants |
| Placebo | Number of Participants With the Indicated Scores for Rhinoscopy Findings (Swelling of Inferior Turbinate Mucosa, Color of Inferior Turbinate Mucosa, Quantity of Nasal Discharge, and Quality of Nasal Discharge) at Baseline, Week 1, and Week 2/EW | COITM, Week 1, Score 2, n= 131, 128 | 27 participants |
| Placebo | Number of Participants With the Indicated Scores for Rhinoscopy Findings (Swelling of Inferior Turbinate Mucosa, Color of Inferior Turbinate Mucosa, Quantity of Nasal Discharge, and Quality of Nasal Discharge) at Baseline, Week 1, and Week 2/EW | QLND, Week 2/EW, Score 3, n=131, 130 | 65 participants |
| Placebo | Number of Participants With the Indicated Scores for Rhinoscopy Findings (Swelling of Inferior Turbinate Mucosa, Color of Inferior Turbinate Mucosa, Quantity of Nasal Discharge, and Quality of Nasal Discharge) at Baseline, Week 1, and Week 2/EW | COITM, Baseline, Score 0, n=131, 130 | 2 participants |
| Placebo | Number of Participants With the Indicated Scores for Rhinoscopy Findings (Swelling of Inferior Turbinate Mucosa, Color of Inferior Turbinate Mucosa, Quantity of Nasal Discharge, and Quality of Nasal Discharge) at Baseline, Week 1, and Week 2/EW | SOITM, Baseline, Score 0, n=131, 130 | 7 participants |