Rhinitis
Conditions
Brief summary
Safety of GW685698X (55 µg/day, q.d.) nasal spray over a period of 12 weeks in Japanese paediatric subjects ages 2 to \< 15 years with perennial allergic rhinitis will be evaluated. And secondarily, efficacy and systemic exposure of GW685698X (55 µg/day, q.d.) nasal spray over a period of 12 weeks in Japanese paediatric subjects ages 2 to \< 15 years with perennial allergic rhinitis will also be evaluated.
Interventions
DRUGFluticasone furoate
55 mcg/day, intranasal, 12 weeks
Sponsors
GlaxoSmithKline
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to 14 Years
Healthy volunteers
No
Inclusion criteria
* Informed Consent * 2 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. Six months 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 \>= 3.0 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. * Bacterial or viral infection of upper respiratory tract or eye during the screening period.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Any Non-serious Adverse Event (AE) and Any Serious Adverse Event (SAE) | From the start of study treatment (Visit 2) until follow-up contact (Visit 6) (up to 13 weeks) | An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, is an other important medical event, or is an event of possible drug-induced liver injury. Refer to the general AE/SAE module for a list of AEs (occurring at a frequency threshold \>=5%) and SAEs. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Hemoglobin at Week 4 and Week 12/Early Withdrawal | Baseline, Week 4, and Week 12/Early Withdrawal | Change from Baseline was calculated as the value at the post-Baseline time points minus the value at Baseline. |
| Change From Baseline in Platelet Count and White Blood Cell (WBC) Count at Week 4 and Week 12/Early Withdrawal | Baseline, Week 4, and Week 12/Early Withdrawal | Change from Baseline was calculated as the value at the post-Baseline time points minus the value at Baseline. |
| Change From Baseline in Red Blood Cell (RBC) Count at Week 4 and Week 12/Early Withdrawal | Baseline, Week 4, and Week 12/Early Withdrawal | Change from Baseline was calculated as the value at the post-Baseline time points minus the value at Baseline. |
| Change From Baseline in Hematocrit at Week 4 and Week 12/Early Withdrawal | Baseline, Week 4, and Week 12/Early Withdrawal | Change from Baseline was calculated as the value at the post-Baseline time points minus the value at Baseline. |
| Change From Baseline in Albumin and Total Protein at Week 4 and Week 12/Early Withdrawal | Baseline, Week 4, and Week 12/Early Withdrawal | Change from Baseline was calculated as the value at the post-Baseline time points minus the value at Baseline. |
| Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyltransferase (GGT) at Week 4 and Week 12/Early Withdrawal | Baseline, Week 4, and Week 12/Early Withdrawal | Change from Baseline was calculated as the value at the post-Baseline time points minus the value at Baseline. |
| Change From Baseline in Direct Bilirubin, Total Bilirubin, and Creatinine at Week 4 and Week 12/Early Withdrawal | Baseline, Week 4, and Week 12/Early Withdrawal | Change from Baseline was calculated as the value at the post-Baseline time points minus the value at Baseline. |
| Change From Baseline in Calcium, Chloride, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Week 4 and Week 12/Early Withdrawal | Baseline, Week 4, and Week 12/Early Withdrawal | Change from Baseline was calculated as the value at the post-Baseline time points minus the value at Baseline. |
| Mean Change From Baseline in the 3 Total Nasal Symptom Score (3TNSS) Over the Entire Treatment Period, Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12 | Baseline through the entire treatment period (12 weeks), Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12 | 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. |
| Mean Percent Change From Baseline in the 3 Total Nasal Symptom Score (3TNSS) Over the Entire Treatment Period, Week 1to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12 | Baseline through the entire treatment period (12 weeks), Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12 | 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. 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 (BL) in Daily Variation of the 3 Total Nasal Symptom Score (3TNSS) | Baseline, Day 1 to Day 84 | 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 BL 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 BL was calculated as the mean score for the entire treatment period minus the score at BL. Only those participants available at the indicated time points were assessed. |
| Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophil Count at Week 4 and Week 12/Early Withdrawal | Baseline, Week 4, and Week 12/Early Withdrawal | Change from Baseline was calculated as the value at the post-Baseline time points minus the value at Baseline. Basophils, eosinophils, lymphocytes, monocytes, and total neutrophil counts are measured as the percentage of cells in white blood cells. |
| Mean Percent Change From Baseline in the 4 Total Nasal Symptom Score (4TNSS) Over the Entire Treatment Period, Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12 | Baseline through the entire treatment period (12 weeks), Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12 | 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. 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 the Total Ocular Symptom Score (TOSS) Over the Entire Treatment Period, Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12 | Baseline through the entire treatment period (12 weeks), Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12 | 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 (12 weeks), Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12. 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 Percent Change From Baseline in the Total Ocular Symptom Score (TOSS) Over the Entire Treatment Period, Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12 | Baseline through the entire treatment period (12 weeks), Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12 | 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 (12 weeks), Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12. 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. 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 Sneezing, Rhinorrhea, Nasal Congestion, and Nasal Itching Over the Entire Treatment Period, Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12 | Baseline through the entire treatment period (12 weeks), Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12 | 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 Eye Itching, Tearing, and Redness Over the Entire Treatment Period, Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12 | Baseline through the entire treatment period (12 weeks), Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12 | Three individual symptoms (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 (12 weeks), Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12. 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, Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12 | Baseline through the entire treatment period (12 weeks), Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12 | 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, Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12. 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) | Baseline, Week 4, Week 8, and Week 12/early withdrawal | 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 12/early withdrawal | 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 12/early withdrawal | The participant's parent/guardian who signed the ICF or the participant himself/herself 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 Plasma Concentration of GW685698X for Participants Aged >=2 to <6 Years | Between 0.5 to 2 hours after final dosing at Week 12 (Visit 5) | Pharmacokinetic (PK) samples were collected to analyze the plasma concentration of GW685698X. |
| Number of Participants With the Indicated Plasma Concentration of GW685698X for Participants Aged >=6 to <15 Years | Between 0.5 to 2 hours after final dosing at Week 12 (Visit 5) | PK samples were collected to analyze the plasma concentration of GW685698X. |
| Mean Change From Baseline in the 4 Total Nasal Symptom Score (4TNSS) Over the Entire Treatment Period, Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12 | Baseline through the entire treatment period (12 weeks), Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12 | 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. |
Countries
Japan
Participant flow
Pre-assignment details
Participants who met the inclusion criteria at Visit 1/1A entered a Screening Period (Visit 1 to 2). Participants who met the eligibility criteria for randomization entered the Treatment Period (Visit 2 to 5), during which they received GW685698X 55 micrograms (µg) once daily (QD) for a period of 12 weeks.
Participants by arm
| Arm | Count |
|---|---|
| GW685698X 55 μg QD Participants received GW685698X nasal spray (55 micrograms \[µg\]) as one spray into each nostril (27.5 μg per spray) once daily (QD) in the morning for 12 weeks. | 61 |
| Total | 61 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Physician Decision | 1 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | GW685698X 55 μg QD |
|---|---|
| Age, Continuous | 8.0 Years STANDARD_DEVIATION 3.59 |
| Gender Female | 19 Participants |
| Gender Male | 42 Participants |
| Race/Ethnicity, Customized Asian - Japanese Heritage | 61 participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 23 / 61 |
| serious Total, serious adverse events | 0 / 61 |
Outcome results
Primary
Number of Participants With Any Non-serious Adverse Event (AE) and Any Serious Adverse Event (SAE)
An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, is an other important medical event, or is an event of possible drug-induced liver injury. Refer to the general AE/SAE module for a list of AEs (occurring at a frequency threshold \>=5%) and SAEs.
Time frame: From the start of study treatment (Visit 2) until follow-up contact (Visit 6) (up to 13 weeks)
Population: Safety Population: all participants who received at least one dose of medication
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GW685698X 55 μg QD | Number of Participants With Any Non-serious Adverse Event (AE) and Any Serious Adverse Event (SAE) | Any AE | 41 participants |
| GW685698X 55 μg QD | Number of Participants With Any Non-serious Adverse Event (AE) and Any Serious Adverse Event (SAE) | Any SAE | 0 participants |
Secondary
Change From Baseline in Albumin and Total Protein at Week 4 and Week 12/Early Withdrawal
Change from Baseline was calculated as the value at the post-Baseline time points minus the value at Baseline.
Time frame: Baseline, Week 4, and Week 12/Early Withdrawal
Population: Safety Population. Only those participants available at the indicated time points were assessed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GW685698X 55 μg QD | Change From Baseline in Albumin and Total Protein at Week 4 and Week 12/Early Withdrawal | Albumin, Week 4, n=60 | -1.4 grams/L | Standard Deviation 2.05 |
| GW685698X 55 μg QD | Change From Baseline in Albumin and Total Protein at Week 4 and Week 12/Early Withdrawal | Albumin, Week 12/early withdrawal, n=61 | -0.8 grams/L | Standard Deviation 1.93 |
| GW685698X 55 μg QD | Change From Baseline in Albumin and Total Protein at Week 4 and Week 12/Early Withdrawal | Total protein, Week 4, n=60 | -1.8 grams/L | Standard Deviation 3.41 |
| GW685698X 55 μg QD | Change From Baseline in Albumin and Total Protein at Week 4 and Week 12/Early Withdrawal | Total protein, Week 12/early withdrawal, n=61 | -0.9 grams/L | Standard Deviation 3.36 |
Secondary
Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyltransferase (GGT) at Week 4 and Week 12/Early Withdrawal
Change from Baseline was calculated as the value at the post-Baseline time points minus the value at Baseline.
Time frame: Baseline, Week 4, and Week 12/Early Withdrawal
Population: Safety Population. Only those participants available at the indicated time points were assessed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GW685698X 55 μg QD | Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyltransferase (GGT) at Week 4 and Week 12/Early Withdrawal | ALP, Week 4, n=60 | -49.9 International units (IU)/L | Standard Deviation 89.43 |
| GW685698X 55 μg QD | Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyltransferase (GGT) at Week 4 and Week 12/Early Withdrawal | ALP, Week 12/early withdrawal, n=61 | 88.5 International units (IU)/L | Standard Deviation 586.1 |
| GW685698X 55 μg QD | Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyltransferase (GGT) at Week 4 and Week 12/Early Withdrawal | ALT, Week 4, n=60 | 0.7 International units (IU)/L | Standard Deviation 4.19 |
| GW685698X 55 μg QD | Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyltransferase (GGT) at Week 4 and Week 12/Early Withdrawal | ALT, Week 12/early withdrawal, n=61 | 0.4 International units (IU)/L | Standard Deviation 4.72 |
| GW685698X 55 μg QD | Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyltransferase (GGT) at Week 4 and Week 12/Early Withdrawal | AST, Week 4, n=60 | -0.3 International units (IU)/L | Standard Deviation 3.45 |
| GW685698X 55 μg QD | Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyltransferase (GGT) at Week 4 and Week 12/Early Withdrawal | AST, Week 12/early withdrawal, n=61 | 0.2 International units (IU)/L | Standard Deviation 3.39 |
| GW685698X 55 μg QD | Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyltransferase (GGT) at Week 4 and Week 12/Early Withdrawal | GGT, Week 4, n=60 | -0.1 International units (IU)/L | Standard Deviation 1.63 |
| GW685698X 55 μg QD | Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyltransferase (GGT) at Week 4 and Week 12/Early Withdrawal | GGT, Week 12/early withdrawal, n=61 | 0.1 International units (IU)/L | Standard Deviation 1.95 |
Secondary
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophil Count at Week 4 and Week 12/Early Withdrawal
Change from Baseline was calculated as the value at the post-Baseline time points minus the value at Baseline. Basophils, eosinophils, lymphocytes, monocytes, and total neutrophil counts are measured as the percentage of cells in white blood cells.
Time frame: Baseline, Week 4, and Week 12/Early Withdrawal
Population: Safety Population. Only those participants available at the indicated time points were assessed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GW685698X 55 μg QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophil Count at Week 4 and Week 12/Early Withdrawal | Basophils, Week 4, n=60 | -0.08 Percentage of cells | Standard Deviation 0.353 |
| GW685698X 55 μg QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophil Count at Week 4 and Week 12/Early Withdrawal | Basophils, Week 12/early withdrawal, n=61 | -0.12 Percentage of cells | Standard Deviation 0.356 |
| GW685698X 55 μg QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophil Count at Week 4 and Week 12/Early Withdrawal | Eosinophils, Week 4, n=60 | -0.29 Percentage of cells | Standard Deviation 2.538 |
| GW685698X 55 μg QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophil Count at Week 4 and Week 12/Early Withdrawal | Eosinophils, Week 12/early withdrawal, n=61 | -1.38 Percentage of cells | Standard Deviation 2.991 |
| GW685698X 55 μg QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophil Count at Week 4 and Week 12/Early Withdrawal | Lymphocytes, Week 4, n=60 | -1.22 Percentage of cells | Standard Deviation 6.863 |
| GW685698X 55 μg QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophil Count at Week 4 and Week 12/Early Withdrawal | Lymphocytes, Week 12/early withdrawal, n=61 | -1.77 Percentage of cells | Standard Deviation 8.181 |
| GW685698X 55 μg QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophil Count at Week 4 and Week 12/Early Withdrawal | Monocytes, Week 4, n=60 | 0.24 Percentage of cells | Standard Deviation 1.604 |
| GW685698X 55 μg QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophil Count at Week 4 and Week 12/Early Withdrawal | Monocytes, Week 12/early withdrawal, n=61 | 0.26 Percentage of cells | Standard Deviation 1.714 |
| GW685698X 55 μg QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophil Count at Week 4 and Week 12/Early Withdrawal | Total Neutrophils, Week 4, n=60 | 1.36 Percentage of cells | Standard Deviation 8.355 |
| GW685698X 55 μg QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophil Count at Week 4 and Week 12/Early Withdrawal | Total Neutrophils, Week 12/early withdrawal, n=61 | 3.02 Percentage of cells | Standard Deviation 9.684 |
Secondary
Change From Baseline in Calcium, Chloride, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Week 4 and Week 12/Early Withdrawal
Change from Baseline was calculated as the value at the post-Baseline time points minus the value at Baseline.
Time frame: Baseline, Week 4, and Week 12/Early Withdrawal
Population: Safety Population. Only those participants available at the indicated time points were assessed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GW685698X 55 μg QD | Change From Baseline in Calcium, Chloride, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Week 4 and Week 12/Early Withdrawal | Calcium, Week 4, n=60 | -0.0541 Millimoles (mmol)/L | Standard Deviation 0.09085 |
| GW685698X 55 μg QD | Change From Baseline in Calcium, Chloride, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Week 4 and Week 12/Early Withdrawal | Calcium, Week 12/early withdrawal, n=61 | -0.0372 Millimoles (mmol)/L | Standard Deviation 0.0748 |
| GW685698X 55 μg QD | Change From Baseline in Calcium, Chloride, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Week 4 and Week 12/Early Withdrawal | Chloride, Week 4, n=60 | 1.3 Millimoles (mmol)/L | Standard Deviation 2.27 |
| GW685698X 55 μg QD | Change From Baseline in Calcium, Chloride, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Week 4 and Week 12/Early Withdrawal | Chloride, Week 12/early withdrawal, n=61 | 1.1 Millimoles (mmol)/L | Standard Deviation 2.04 |
| GW685698X 55 μg QD | Change From Baseline in Calcium, Chloride, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Week 4 and Week 12/Early Withdrawal | Potassium, Week 4, n=60 | -0.13 Millimoles (mmol)/L | Standard Deviation 0.378 |
| GW685698X 55 μg QD | Change From Baseline in Calcium, Chloride, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Week 4 and Week 12/Early Withdrawal | Potassium, Week 12/early withdrawal, n=61 | -0.06 Millimoles (mmol)/L | Standard Deviation 0.38 |
| GW685698X 55 μg QD | Change From Baseline in Calcium, Chloride, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Week 4 and Week 12/Early Withdrawal | Sodium, Week 4, n=60 | -0.4 Millimoles (mmol)/L | Standard Deviation 1.7 |
| GW685698X 55 μg QD | Change From Baseline in Calcium, Chloride, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Week 4 and Week 12/Early Withdrawal | Sodium, Week 12/early withdrawal, n=61 | -1.2 Millimoles (mmol)/L | Standard Deviation 1.58 |
| GW685698X 55 μg QD | Change From Baseline in Calcium, Chloride, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Week 4 and Week 12/Early Withdrawal | Urea/BUN, Week 4, n=60 | -0.4998 Millimoles (mmol)/L | Standard Deviation 1.12504 |
| GW685698X 55 μg QD | Change From Baseline in Calcium, Chloride, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Week 4 and Week 12/Early Withdrawal | Urea/BUN, Week 12/early withdrawal, n=61 | -0.0954 Millimoles (mmol)/L | Standard Deviation 1.18765 |
Secondary
Change From Baseline in Direct Bilirubin, Total Bilirubin, and Creatinine at Week 4 and Week 12/Early Withdrawal
Change from Baseline was calculated as the value at the post-Baseline time points minus the value at Baseline.
Time frame: Baseline, Week 4, and Week 12/Early Withdrawal
Population: Safety Population. Only those participants available at the indicated time points were assessed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GW685698X 55 μg QD | Change From Baseline in Direct Bilirubin, Total Bilirubin, and Creatinine at Week 4 and Week 12/Early Withdrawal | Direct bilirubin, Week 4, n=60 | 0.114 Micromoles (μmol)/L | Standard Deviation 0.9889 |
| GW685698X 55 μg QD | Change From Baseline in Direct Bilirubin, Total Bilirubin, and Creatinine at Week 4 and Week 12/Early Withdrawal | Direct bilirubin, Week 12/early withdrawal, n=61 | -0.028 Micromoles (μmol)/L | Standard Deviation 0.8545 |
| GW685698X 55 μg QD | Change From Baseline in Direct Bilirubin, Total Bilirubin, and Creatinine at Week 4 and Week 12/Early Withdrawal | Total bilirubin, Week 4, n=60 | 0.370 Micromoles (μmol)/L | Standard Deviation 2.2504 |
| GW685698X 55 μg QD | Change From Baseline in Direct Bilirubin, Total Bilirubin, and Creatinine at Week 4 and Week 12/Early Withdrawal | Total bilirubin, Week 12/early withdrawal, n=61 | -0.533 Micromoles (μmol)/L | Standard Deviation 2.2844 |
| GW685698X 55 μg QD | Change From Baseline in Direct Bilirubin, Total Bilirubin, and Creatinine at Week 4 and Week 12/Early Withdrawal | Creatinine, Week 4, n=60 | -1.6649 Micromoles (μmol)/L | Standard Deviation 5.21356 |
| GW685698X 55 μg QD | Change From Baseline in Direct Bilirubin, Total Bilirubin, and Creatinine at Week 4 and Week 12/Early Withdrawal | Creatinine, Week 12/early withdrawal, n=61 | -0.5797 Micromoles (μmol)/L | Standard Deviation 5.63473 |
Secondary
Change From Baseline in Hematocrit at Week 4 and Week 12/Early Withdrawal
Change from Baseline was calculated as the value at the post-Baseline time points minus the value at Baseline.
Time frame: Baseline, Week 4, and Week 12/Early Withdrawal
Population: Safety Population. Only those participants available at the indicated time points were assessed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GW685698X 55 μg QD | Change From Baseline in Hematocrit at Week 4 and Week 12/Early Withdrawal | Hematocrit, Week 4, n=60 | -0.0061 Proportion of RBCs in blood | Standard Deviation 0.01965 |
| GW685698X 55 μg QD | Change From Baseline in Hematocrit at Week 4 and Week 12/Early Withdrawal | Hematocrit, Week 12/early withdrawal, n=61 | -0.0062 Proportion of RBCs in blood | Standard Deviation 0.01824 |
Secondary
Change From Baseline in Hemoglobin at Week 4 and Week 12/Early Withdrawal
Change from Baseline was calculated as the value at the post-Baseline time points minus the value at Baseline.
Time frame: Baseline, Week 4, and Week 12/Early Withdrawal
Population: Safety Population. Only those participants available at the indicated time points were assessed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GW685698X 55 μg QD | Change From Baseline in Hemoglobin at Week 4 and Week 12/Early Withdrawal | Hemoglobin, Week 4, n=60 | -1.9 Grams per liter (grams/L) | Standard Deviation 7.34 |
| GW685698X 55 μg QD | Change From Baseline in Hemoglobin at Week 4 and Week 12/Early Withdrawal | Hemoglobin, Week 12/early withdrawal, n=61 | 0.1 Grams per liter (grams/L) | Standard Deviation 6.09 |
Secondary
Change From Baseline in Platelet Count and White Blood Cell (WBC) Count at Week 4 and Week 12/Early Withdrawal
Change from Baseline was calculated as the value at the post-Baseline time points minus the value at Baseline.
Time frame: Baseline, Week 4, and Week 12/Early Withdrawal
Population: Safety Population. Only those participants available at the indicated time points were assessed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GW685698X 55 μg QD | Change From Baseline in Platelet Count and White Blood Cell (WBC) Count at Week 4 and Week 12/Early Withdrawal | WBC count, Week 12/early withdrawal, n=61 | -0.00 giga (10^9) cells (GI)/L | Standard Deviation 2.092 |
| GW685698X 55 μg QD | Change From Baseline in Platelet Count and White Blood Cell (WBC) Count at Week 4 and Week 12/Early Withdrawal | Platelet count, Week 4, n=60 | -0.4 giga (10^9) cells (GI)/L | Standard Deviation 54.95 |
| GW685698X 55 μg QD | Change From Baseline in Platelet Count and White Blood Cell (WBC) Count at Week 4 and Week 12/Early Withdrawal | Platelet count, Week 12/early withdrawal, n=61 | -2.9 giga (10^9) cells (GI)/L | Standard Deviation 56.26 |
| GW685698X 55 μg QD | Change From Baseline in Platelet Count and White Blood Cell (WBC) Count at Week 4 and Week 12/Early Withdrawal | WBC count, Week 4, n=60 | -0.45 giga (10^9) cells (GI)/L | Standard Deviation 1.86 |
Secondary
Change From Baseline in Red Blood Cell (RBC) Count at Week 4 and Week 12/Early Withdrawal
Change from Baseline was calculated as the value at the post-Baseline time points minus the value at Baseline.
Time frame: Baseline, Week 4, and Week 12/Early Withdrawal
Population: Safety Population. Only those participants available at the indicated time points were assessed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GW685698X 55 μg QD | Change From Baseline in Red Blood Cell (RBC) Count at Week 4 and Week 12/Early Withdrawal | RBC count, Week 4, n=60 | -0.081 tera (10^12) cells (TI)/L | Standard Deviation 0.2386 |
| GW685698X 55 μg QD | Change From Baseline in Red Blood Cell (RBC) Count at Week 4 and Week 12/Early Withdrawal | RBC count, Week 12/early withdrawal, n=61 | -0.039 tera (10^12) cells (TI)/L | Standard Deviation 0.208 |
Secondary
Mean Change From Baseline (BL) in Daily Variation of the 3 Total Nasal Symptom Score (3TNSS)
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 BL 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 BL was calculated as the mean score for the entire treatment period minus the score at BL. Only those participants available at the indicated time points were assessed.
Time frame: Baseline, Day 1 to Day 84
Population: Full Analysis Set (FAS) Population: 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 | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GW685698X 55 μg QD | Mean Change From Baseline (BL) in Daily Variation of the 3 Total Nasal Symptom Score (3TNSS) | Day 79, n=59 | -1.9 Scores on a scale | Standard Deviation 2.35 |
| GW685698X 55 μg QD | Mean Change From Baseline (BL) in Daily Variation of the 3 Total Nasal Symptom Score (3TNSS) | Day 80, n=59 | -1.8 Scores on a scale | Standard Deviation 2.15 |
| GW685698X 55 μg QD | Mean Change From Baseline (BL) in Daily Variation of the 3 Total Nasal Symptom Score (3TNSS) | Day 81, n=50 | -1.9 Scores on a scale | Standard Deviation 2.25 |
| GW685698X 55 μg QD | Mean Change From Baseline (BL) in Daily Variation of the 3 Total Nasal Symptom Score (3TNSS) | Day 82, n=43 | -1.7 Scores on a scale | Standard Deviation 2.45 |
| GW685698X 55 μg QD | Mean Change From Baseline (BL) in Daily Variation of the 3 Total Nasal Symptom Score (3TNSS) | Day 83, n=39 | -1.2 Scores on a scale | Standard Deviation 2.55 |
| GW685698X 55 μg QD | Mean Change From Baseline (BL) in Daily Variation of the 3 Total Nasal Symptom Score (3TNSS) | Day 84, n=31 | -1.2 Scores on a scale | Standard Deviation 2.55 |
| GW685698X 55 μg QD | Mean Change From Baseline (BL) in Daily Variation of the 3 Total Nasal Symptom Score (3TNSS) | Day 1, n=61 | -0.5 Scores on a scale | Standard Deviation 1.81 |
| GW685698X 55 μg QD | Mean Change From Baseline (BL) in Daily Variation of the 3 Total Nasal Symptom Score (3TNSS) | Day 2, n=61 | -0.8 Scores on a scale | Standard Deviation 1.9 |
| GW685698X 55 μg QD | Mean Change From Baseline (BL) in Daily Variation of the 3 Total Nasal Symptom Score (3TNSS) | Day 3, n=61 | -0.9 Scores on a scale | Standard Deviation 1.64 |
| GW685698X 55 μg QD | Mean Change From Baseline (BL) in Daily Variation of the 3 Total Nasal Symptom Score (3TNSS) | Day 4, n=61 | -1.3 Scores on a scale | Standard Deviation 1.76 |
| GW685698X 55 μg QD | Mean Change From Baseline (BL) in Daily Variation of the 3 Total Nasal Symptom Score (3TNSS) | Day 5, n=61 | -1.4 Scores on a scale | Standard Deviation 1.75 |
| GW685698X 55 μg QD | Mean Change From Baseline (BL) in Daily Variation of the 3 Total Nasal Symptom Score (3TNSS) | Day 6, n=61 | -1.3 Scores on a scale | Standard Deviation 1.76 |
| GW685698X 55 μg QD | Mean Change From Baseline (BL) in Daily Variation of the 3 Total Nasal Symptom Score (3TNSS) | Day 7, n=61 | -1.6 Scores on a scale | Standard Deviation 1.83 |
| GW685698X 55 μg QD | Mean Change From Baseline (BL) in Daily Variation of the 3 Total Nasal Symptom Score (3TNSS) | Day 8, n=61 | -1.9 Scores on a scale | Standard Deviation 1.94 |
| GW685698X 55 μg QD | Mean Change From Baseline (BL) in Daily Variation of the 3 Total Nasal Symptom Score (3TNSS) | Day 9, n=61 | -1.9 Scores on a scale | Standard Deviation 2.12 |
| GW685698X 55 μg QD | Mean Change From Baseline (BL) in Daily Variation of the 3 Total Nasal Symptom Score (3TNSS) | Day 10, n=61 | -2.0 Scores on a scale | Standard Deviation 1.9 |
| GW685698X 55 μg QD | Mean Change From Baseline (BL) in Daily Variation of the 3 Total Nasal Symptom Score (3TNSS) | Day 11, n=61 | -1.8 Scores on a scale | Standard Deviation 2.18 |
| GW685698X 55 μg QD | Mean Change From Baseline (BL) in Daily Variation of the 3 Total Nasal Symptom Score (3TNSS) | Day 12, n=61 | -1.9 Scores on a scale | Standard Deviation 1.98 |
| GW685698X 55 μg QD | Mean Change From Baseline (BL) in Daily Variation of the 3 Total Nasal Symptom Score (3TNSS) | Day 13, n=61 | -2.3 Scores on a scale | Standard Deviation 2.12 |
| GW685698X 55 μg QD | Mean Change From Baseline (BL) in Daily Variation of the 3 Total Nasal Symptom Score (3TNSS) | Day 14, n=61 | -2.2 Scores on a scale | Standard Deviation 2.21 |
| GW685698X 55 μg QD | Mean Change From Baseline (BL) in Daily Variation of the 3 Total Nasal Symptom Score (3TNSS) | Day 15, n=61 | -2.5 Scores on a scale | Standard Deviation 2.12 |
| GW685698X 55 μg QD | Mean Change From Baseline (BL) in Daily Variation of the 3 Total Nasal Symptom Score (3TNSS) | Day 16, n=61 | -2.3 Scores on a scale | Standard Deviation 2.05 |
| GW685698X 55 μg QD | Mean Change From Baseline (BL) in Daily Variation of the 3 Total Nasal Symptom Score (3TNSS) | Day 17, n=61 | -2.4 Scores on a scale | Standard Deviation 2.01 |
| GW685698X 55 μg QD | Mean Change From Baseline (BL) in Daily Variation of the 3 Total Nasal Symptom Score (3TNSS) | Day 18, n=61 | -2.5 Scores on a scale | Standard Deviation 1.96 |
| GW685698X 55 μg QD | Mean Change From Baseline (BL) in Daily Variation of the 3 Total Nasal Symptom Score (3TNSS) | Day 19, n=61 | -2.6 Scores on a scale | Standard Deviation 2.01 |
| GW685698X 55 μg QD | Mean Change From Baseline (BL) in Daily Variation of the 3 Total Nasal Symptom Score (3TNSS) | Day 20, n=61 | -2.7 Scores on a scale | Standard Deviation 2 |
| GW685698X 55 μg QD | Mean Change From Baseline (BL) in Daily Variation of the 3 Total Nasal Symptom Score (3TNSS) | Day 21, n=61 | -2.5 Scores on a scale | Standard Deviation 2.08 |
| GW685698X 55 μg QD | Mean Change From Baseline (BL) in Daily Variation of the 3 Total Nasal Symptom Score (3TNSS) | Day 22, n=61 | -2.6 Scores on a scale | Standard Deviation 2.03 |
| GW685698X 55 μg QD | Mean Change From Baseline (BL) in Daily Variation of the 3 Total Nasal Symptom Score (3TNSS) | Day 23, n=61 | -2.4 Scores on a scale | Standard Deviation 2.04 |
| GW685698X 55 μg QD | Mean Change From Baseline (BL) in Daily Variation of the 3 Total Nasal Symptom Score (3TNSS) | Day 24, n=61 | -2.4 Scores on a scale | Standard Deviation 2.13 |
| GW685698X 55 μg QD | Mean Change From Baseline (BL) in Daily Variation of the 3 Total Nasal Symptom Score (3TNSS) | Day 25, n=61 | -2.5 Scores on a scale | Standard Deviation 1.91 |
| GW685698X 55 μg QD | Mean Change From Baseline (BL) in Daily Variation of the 3 Total Nasal Symptom Score (3TNSS) | Day 26, n=61 | -2.5 Scores on a scale | Standard Deviation 2.08 |
| GW685698X 55 μg QD | Mean Change From Baseline (BL) in Daily Variation of the 3 Total Nasal Symptom Score (3TNSS) | Day 27, n=61 | -2.5 Scores on a scale | Standard Deviation 1.97 |
| GW685698X 55 μg QD | Mean Change From Baseline (BL) in Daily Variation of the 3 Total Nasal Symptom Score (3TNSS) | Day 28, n=61 | -2.4 Scores on a scale | Standard Deviation 1.99 |
| GW685698X 55 μg QD | Mean Change From Baseline (BL) in Daily Variation of the 3 Total Nasal Symptom Score (3TNSS) | Day 29, n=60 | -2.4 Scores on a scale | Standard Deviation 1.81 |
| GW685698X 55 μg QD | Mean Change From Baseline (BL) in Daily Variation of the 3 Total Nasal Symptom Score (3TNSS) | Day 30, n=60 | -2.5 Scores on a scale | Standard Deviation 1.79 |
| GW685698X 55 μg QD | Mean Change From Baseline (BL) in Daily Variation of the 3 Total Nasal Symptom Score (3TNSS) | Day 31, n=60 | -2.6 Scores on a scale | Standard Deviation 1.9 |
| GW685698X 55 μg QD | Mean Change From Baseline (BL) in Daily Variation of the 3 Total Nasal Symptom Score (3TNSS) | Day 32, n=60 | -2.4 Scores on a scale | Standard Deviation 2.16 |
| GW685698X 55 μg QD | Mean Change From Baseline (BL) in Daily Variation of the 3 Total Nasal Symptom Score (3TNSS) | Day 33, n=60 | -2.5 Scores on a scale | Standard Deviation 1.99 |
| GW685698X 55 μg QD | Mean Change From Baseline (BL) in Daily Variation of the 3 Total Nasal Symptom Score (3TNSS) | Day 34, n=60 | -2.4 Scores on a scale | Standard Deviation 2.3 |
| GW685698X 55 μg QD | Mean Change From Baseline (BL) in Daily Variation of the 3 Total Nasal Symptom Score (3TNSS) | Day 35, n=60 | -2.4 Scores on a scale | Standard Deviation 2.43 |
| GW685698X 55 μg QD | Mean Change From Baseline (BL) in Daily Variation of the 3 Total Nasal Symptom Score (3TNSS) | Day 36, n=60 | -2.2 Scores on a scale | Standard Deviation 2.21 |
| GW685698X 55 μg QD | Mean Change From Baseline (BL) in Daily Variation of the 3 Total Nasal Symptom Score (3TNSS) | Day 37, n=60 | -2.4 Scores on a scale | Standard Deviation 2.23 |
| GW685698X 55 μg QD | Mean Change From Baseline (BL) in Daily Variation of the 3 Total Nasal Symptom Score (3TNSS) | Day 38, n=60 | -2.4 Scores on a scale | Standard Deviation 2.41 |
| GW685698X 55 μg QD | Mean Change From Baseline (BL) in Daily Variation of the 3 Total Nasal Symptom Score (3TNSS) | Day 39, n=60 | -2.2 Scores on a scale | Standard Deviation 2.3 |
| GW685698X 55 μg QD | Mean Change From Baseline (BL) in Daily Variation of the 3 Total Nasal Symptom Score (3TNSS) | Day 40, n=60 | -2.2 Scores on a scale | Standard Deviation 2.17 |
| GW685698X 55 μg QD | Mean Change From Baseline (BL) in Daily Variation of the 3 Total Nasal Symptom Score (3TNSS) | Day 41, n=60 | -2.3 Scores on a scale | Standard Deviation 1.85 |
| GW685698X 55 μg QD | Mean Change From Baseline (BL) in Daily Variation of the 3 Total Nasal Symptom Score (3TNSS) | Day 42, n=60 | -2.6 Scores on a scale | Standard Deviation 1.8 |
| GW685698X 55 μg QD | Mean Change From Baseline (BL) in Daily Variation of the 3 Total Nasal Symptom Score (3TNSS) | Day 43, n=60 | -2.4 Scores on a scale | Standard Deviation 2.2 |
| GW685698X 55 μg QD | Mean Change From Baseline (BL) in Daily Variation of the 3 Total Nasal Symptom Score (3TNSS) | Day 44, n=60 | -2.5 Scores on a scale | Standard Deviation 2.16 |
| GW685698X 55 μg QD | Mean Change From Baseline (BL) in Daily Variation of the 3 Total Nasal Symptom Score (3TNSS) | Day 45, n=60 | -2.2 Scores on a scale | Standard Deviation 2.24 |
| GW685698X 55 μg QD | Mean Change From Baseline (BL) in Daily Variation of the 3 Total Nasal Symptom Score (3TNSS) | Day 46, n=60 | -2.5 Scores on a scale | Standard Deviation 1.89 |
| GW685698X 55 μg QD | Mean Change From Baseline (BL) in Daily Variation of the 3 Total Nasal Symptom Score (3TNSS) | Day 47, n=60 | -2.5 Scores on a scale | Standard Deviation 2.07 |
| GW685698X 55 μg QD | Mean Change From Baseline (BL) in Daily Variation of the 3 Total Nasal Symptom Score (3TNSS) | Day 48, n=60 | -2.4 Scores on a scale | Standard Deviation 2.27 |
| GW685698X 55 μg QD | Mean Change From Baseline (BL) in Daily Variation of the 3 Total Nasal Symptom Score (3TNSS) | Day 49, n=60 | -2.4 Scores on a scale | Standard Deviation 2.15 |
| GW685698X 55 μg QD | Mean Change From Baseline (BL) in Daily Variation of the 3 Total Nasal Symptom Score (3TNSS) | Day 50, n=60 | -2.4 Scores on a scale | Standard Deviation 2.33 |
| GW685698X 55 μg QD | Mean Change From Baseline (BL) in Daily Variation of the 3 Total Nasal Symptom Score (3TNSS) | Day 51, n=60 | -2.4 Scores on a scale | Standard Deviation 2.34 |
| GW685698X 55 μg QD | Mean Change From Baseline (BL) in Daily Variation of the 3 Total Nasal Symptom Score (3TNSS) | Day 52, n=60 | -2.4 Scores on a scale | Standard Deviation 1.99 |
| GW685698X 55 μg QD | Mean Change From Baseline (BL) in Daily Variation of the 3 Total Nasal Symptom Score (3TNSS) | Day 53, n=60 | -2.5 Scores on a scale | Standard Deviation 1.9 |
| GW685698X 55 μg QD | Mean Change From Baseline (BL) in Daily Variation of the 3 Total Nasal Symptom Score (3TNSS) | Day 54, n=60 | -2.2 Scores on a scale | Standard Deviation 1.98 |
| GW685698X 55 μg QD | Mean Change From Baseline (BL) in Daily Variation of the 3 Total Nasal Symptom Score (3TNSS) | Day 55, n=60 | -2.2 Scores on a scale | Standard Deviation 2.11 |
| GW685698X 55 μg QD | Mean Change From Baseline (BL) in Daily Variation of the 3 Total Nasal Symptom Score (3TNSS) | Day 56, n=60 | -2.3 Scores on a scale | Standard Deviation 2.11 |
| GW685698X 55 μg QD | Mean Change From Baseline (BL) in Daily Variation of the 3 Total Nasal Symptom Score (3TNSS) | Day 57, n=60 | -2.4 Scores on a scale | Standard Deviation 1.94 |
| GW685698X 55 μg QD | Mean Change From Baseline (BL) in Daily Variation of the 3 Total Nasal Symptom Score (3TNSS) | Day 58, n=60 | -2.4 Scores on a scale | Standard Deviation 1.98 |
| GW685698X 55 μg QD | Mean Change From Baseline (BL) in Daily Variation of the 3 Total Nasal Symptom Score (3TNSS) | Day 59, n=60 | -2.6 Scores on a scale | Standard Deviation 2.09 |
| GW685698X 55 μg QD | Mean Change From Baseline (BL) in Daily Variation of the 3 Total Nasal Symptom Score (3TNSS) | Day 60, n=60 | -2.8 Scores on a scale | Standard Deviation 1.75 |
| GW685698X 55 μg QD | Mean Change From Baseline (BL) in Daily Variation of the 3 Total Nasal Symptom Score (3TNSS) | Day 61, n=60 | -2.5 Scores on a scale | Standard Deviation 1.78 |
| GW685698X 55 μg QD | Mean Change From Baseline (BL) in Daily Variation of the 3 Total Nasal Symptom Score (3TNSS) | Day 62, n=60 | -2.6 Scores on a scale | Standard Deviation 1.65 |
| GW685698X 55 μg QD | Mean Change From Baseline (BL) in Daily Variation of the 3 Total Nasal Symptom Score (3TNSS) | Day 63, n=60 | -2.7 Scores on a scale | Standard Deviation 1.77 |
| GW685698X 55 μg QD | Mean Change From Baseline (BL) in Daily Variation of the 3 Total Nasal Symptom Score (3TNSS) | Day 64, n=60 | -2.6 Scores on a scale | Standard Deviation 1.96 |
| GW685698X 55 μg QD | Mean Change From Baseline (BL) in Daily Variation of the 3 Total Nasal Symptom Score (3TNSS) | Day 65, n=60 | -2.5 Scores on a scale | Standard Deviation 2.07 |
| GW685698X 55 μg QD | Mean Change From Baseline (BL) in Daily Variation of the 3 Total Nasal Symptom Score (3TNSS) | Day 66, n=60 | -2.2 Scores on a scale | Standard Deviation 2.24 |
| GW685698X 55 μg QD | Mean Change From Baseline (BL) in Daily Variation of the 3 Total Nasal Symptom Score (3TNSS) | Day 67, n=60 | -2.4 Scores on a scale | Standard Deviation 2.1 |
| GW685698X 55 μg QD | Mean Change From Baseline (BL) in Daily Variation of the 3 Total Nasal Symptom Score (3TNSS) | Day 68, n=60 | -2.3 Scores on a scale | Standard Deviation 2.23 |
| GW685698X 55 μg QD | Mean Change From Baseline (BL) in Daily Variation of the 3 Total Nasal Symptom Score (3TNSS) | Day 69, n=60 | -2.4 Scores on a scale | Standard Deviation 1.96 |
| GW685698X 55 μg QD | Mean Change From Baseline (BL) in Daily Variation of the 3 Total Nasal Symptom Score (3TNSS) | Day 70, n=60 | -2.5 Scores on a scale | Standard Deviation 1.79 |
| GW685698X 55 μg QD | Mean Change From Baseline (BL) in Daily Variation of the 3 Total Nasal Symptom Score (3TNSS) | Day 71, n=60 | -2.4 Scores on a scale | Standard Deviation 1.99 |
| GW685698X 55 μg QD | Mean Change From Baseline (BL) in Daily Variation of the 3 Total Nasal Symptom Score (3TNSS) | Day 72, n=60 | -2.1 Scores on a scale | Standard Deviation 1.97 |
| GW685698X 55 μg QD | Mean Change From Baseline (BL) in Daily Variation of the 3 Total Nasal Symptom Score (3TNSS) | Day 73, n=60 | -2.0 Scores on a scale | Standard Deviation 2.17 |
| GW685698X 55 μg QD | Mean Change From Baseline (BL) in Daily Variation of the 3 Total Nasal Symptom Score (3TNSS) | Day 74, n=59 | -1.6 Scores on a scale | Standard Deviation 2.37 |
| GW685698X 55 μg QD | Mean Change From Baseline (BL) in Daily Variation of the 3 Total Nasal Symptom Score (3TNSS) | Day 75, n=59 | -1.8 Scores on a scale | Standard Deviation 2.34 |
| GW685698X 55 μg QD | Mean Change From Baseline (BL) in Daily Variation of the 3 Total Nasal Symptom Score (3TNSS) | Day 76, n=59 | -1.8 Scores on a scale | Standard Deviation 2.56 |
| GW685698X 55 μg QD | Mean Change From Baseline (BL) in Daily Variation of the 3 Total Nasal Symptom Score (3TNSS) | Day 77, n=59 | -2.1 Scores on a scale | Standard Deviation 2.59 |
| GW685698X 55 μg QD | Mean Change From Baseline (BL) in Daily Variation of the 3 Total Nasal Symptom Score (3TNSS) | Day 78, n=59 | -2.1 Scores on a scale | Standard Deviation 2.49 |
Secondary
Mean Change From Baseline in Eye Itching, Tearing, and Redness Over the Entire Treatment Period, Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12
Three individual symptoms (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 (12 weeks), Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12. 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 (12 weeks), Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12
Population: FAS Population. Only those participants available at the indicated time points were assessed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GW685698X 55 μg QD | Mean Change From Baseline in Eye Itching, Tearing, and Redness Over the Entire Treatment Period, Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12 | Eye Itching, Entire Treatment Period, n=61 | -0.2 Scores on a scale | Standard Deviation 0.57 |
| GW685698X 55 μg QD | Mean Change From Baseline in Eye Itching, Tearing, and Redness Over the Entire Treatment Period, Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12 | Eye Itching, Week 1 to 2, n=61 | -0.1 Scores on a scale | Standard Deviation 0.53 |
| GW685698X 55 μg QD | Mean Change From Baseline in Eye Itching, Tearing, and Redness Over the Entire Treatment Period, Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12 | Eye Itching, Week 3 to 4, n=61 | -0.1 Scores on a scale | Standard Deviation 0.61 |
| GW685698X 55 μg QD | Mean Change From Baseline in Eye Itching, Tearing, and Redness Over the Entire Treatment Period, Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12 | Eye Itching, Week 7 to 8, n=60 | -0.2 Scores on a scale | Standard Deviation 0.68 |
| GW685698X 55 μg QD | Mean Change From Baseline in Eye Itching, Tearing, and Redness Over the Entire Treatment Period, Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12 | Eye Itching, Week 11 to 12, n=60 | -0.2 Scores on a scale | Standard Deviation 0.59 |
| GW685698X 55 μg QD | Mean Change From Baseline in Eye Itching, Tearing, and Redness Over the Entire Treatment Period, Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12 | Tearing, Entire Treatment Period, n=61 | 0.0 Scores on a scale | Standard Deviation 0.25 |
| GW685698X 55 μg QD | Mean Change From Baseline in Eye Itching, Tearing, and Redness Over the Entire Treatment Period, Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12 | Tearing, Week 1 to 2, n=61 | 0.0 Scores on a scale | Standard Deviation 0.22 |
| GW685698X 55 μg QD | Mean Change From Baseline in Eye Itching, Tearing, and Redness Over the Entire Treatment Period, Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12 | Tearing, Week 3 to 4, n=61 | 0.0 Scores on a scale | Standard Deviation 0.29 |
| GW685698X 55 μg QD | Mean Change From Baseline in Eye Itching, Tearing, and Redness Over the Entire Treatment Period, Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12 | Tearing, Week 7 to 8, n=60 | 0.0 Scores on a scale | Standard Deviation 0.28 |
| GW685698X 55 μg QD | Mean Change From Baseline in Eye Itching, Tearing, and Redness Over the Entire Treatment Period, Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12 | Tearing, Week 11 to 12, n=60 | 0.0 Scores on a scale | Standard Deviation 0.26 |
| GW685698X 55 μg QD | Mean Change From Baseline in Eye Itching, Tearing, and Redness Over the Entire Treatment Period, Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12 | Redness, Entire Treatment Period, n=61 | -0.1 Scores on a scale | Standard Deviation 0.34 |
| GW685698X 55 μg QD | Mean Change From Baseline in Eye Itching, Tearing, and Redness Over the Entire Treatment Period, Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12 | Redness, Week 1 to 2, n=61 | -0.0 Scores on a scale | Standard Deviation 0.32 |
| GW685698X 55 μg QD | Mean Change From Baseline in Eye Itching, Tearing, and Redness Over the Entire Treatment Period, Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12 | Redness, Week 3 to 4, n=61 | -0.0 Scores on a scale | Standard Deviation 0.35 |
| GW685698X 55 μg QD | Mean Change From Baseline in Eye Itching, Tearing, and Redness Over the Entire Treatment Period, Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12 | Redness, Week 7 to 8, n=60 | -0.0 Scores on a scale | Standard Deviation 0.43 |
| GW685698X 55 μg QD | Mean Change From Baseline in Eye Itching, Tearing, and Redness Over the Entire Treatment Period, Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12 | Redness, Week 11 to 12, n=60 | -0.1 Scores on a scale | Standard Deviation 0.39 |
Secondary
Mean Change From Baseline in Sneezing, Rhinorrhea, Nasal Congestion, and Nasal Itching Over the Entire Treatment Period, Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12
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 (12 weeks), Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12
Population: FAS Population. Only those participants available at the indicated time points were assessed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GW685698X 55 μg QD | Mean Change From Baseline in Sneezing, Rhinorrhea, Nasal Congestion, and Nasal Itching Over the Entire Treatment Period, Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12 | Sneezing, Entire Treatment Period, n=61 | -0.7 Scores on a scale | Standard Deviation 0.74 |
| GW685698X 55 μg QD | Mean Change From Baseline in Sneezing, Rhinorrhea, Nasal Congestion, and Nasal Itching Over the Entire Treatment Period, Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12 | Sneezing, Week 1 to 2, n=61 | -0.5 Scores on a scale | Standard Deviation 0.67 |
| GW685698X 55 μg QD | Mean Change From Baseline in Sneezing, Rhinorrhea, Nasal Congestion, and Nasal Itching Over the Entire Treatment Period, Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12 | Sneezing, Week 3 to 4, n=61 | -0.8 Scores on a scale | Standard Deviation 0.75 |
| GW685698X 55 μg QD | Mean Change From Baseline in Sneezing, Rhinorrhea, Nasal Congestion, and Nasal Itching Over the Entire Treatment Period, Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12 | Sneezing, Week 7 to 8, n=60 | -0.7 Scores on a scale | Standard Deviation 0.81 |
| GW685698X 55 μg QD | Mean Change From Baseline in Sneezing, Rhinorrhea, Nasal Congestion, and Nasal Itching Over the Entire Treatment Period, Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12 | Sneezing, Week 11 to 12, n=60 | -0.6 Scores on a scale | Standard Deviation 0.88 |
| GW685698X 55 μg QD | Mean Change From Baseline in Sneezing, Rhinorrhea, Nasal Congestion, and Nasal Itching Over the Entire Treatment Period, Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12 | Rhinorrhea, Entire Treatment Period, n=61 | -0.8 Scores on a scale | Standard Deviation 0.65 |
| GW685698X 55 μg QD | Mean Change From Baseline in Sneezing, Rhinorrhea, Nasal Congestion, and Nasal Itching Over the Entire Treatment Period, Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12 | Rhinorrhea, Week 1 to 2, n=61 | -0.5 Scores on a scale | Standard Deviation 0.62 |
| GW685698X 55 μg QD | Mean Change From Baseline in Sneezing, Rhinorrhea, Nasal Congestion, and Nasal Itching Over the Entire Treatment Period, Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12 | Rhinorrhea, Week 3 to 4, n=61 | -0.9 Scores on a scale | Standard Deviation 0.76 |
| GW685698X 55 μg QD | Mean Change From Baseline in Sneezing, Rhinorrhea, Nasal Congestion, and Nasal Itching Over the Entire Treatment Period, Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12 | Rhinorrhea, Week 7 to 8, n=60 | -0.8 Scores on a scale | Standard Deviation 0.73 |
| GW685698X 55 μg QD | Mean Change From Baseline in Sneezing, Rhinorrhea, Nasal Congestion, and Nasal Itching Over the Entire Treatment Period, Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12 | Rhinorrhea, Week 11 to 12, n=60 | -0.7 Scores on a scale | Standard Deviation 0.85 |
| GW685698X 55 μg QD | Mean Change From Baseline in Sneezing, Rhinorrhea, Nasal Congestion, and Nasal Itching Over the Entire Treatment Period, Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12 | Nasal Congestion, Entire Treatment Period, n=61 | -0.8 Scores on a scale | Standard Deviation 0.66 |
| GW685698X 55 μg QD | Mean Change From Baseline in Sneezing, Rhinorrhea, Nasal Congestion, and Nasal Itching Over the Entire Treatment Period, Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12 | Nasal Congestion, Week 1 to 2, n=61 | -0.5 Scores on a scale | Standard Deviation 0.63 |
| GW685698X 55 μg QD | Mean Change From Baseline in Sneezing, Rhinorrhea, Nasal Congestion, and Nasal Itching Over the Entire Treatment Period, Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12 | Nasal Congestion, Week 3 to 4, n=61 | -0.9 Scores on a scale | Standard Deviation 0.76 |
| GW685698X 55 μg QD | Mean Change From Baseline in Sneezing, Rhinorrhea, Nasal Congestion, and Nasal Itching Over the Entire Treatment Period, Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12 | Nasal Congestion, Week 7 to 8, n=60 | -0.8 Scores on a scale | Standard Deviation 0.72 |
| GW685698X 55 μg QD | Mean Change From Baseline in Sneezing, Rhinorrhea, Nasal Congestion, and Nasal Itching Over the Entire Treatment Period, Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12 | Nasal Congestion, Week 11 to 12, n=60 | -0.7 Scores on a scale | Standard Deviation 0.85 |
| GW685698X 55 μg QD | Mean Change From Baseline in Sneezing, Rhinorrhea, Nasal Congestion, and Nasal Itching Over the Entire Treatment Period, Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12 | Nasal Itching, Entire Treatment Period, n=61 | -0.4 Scores on a scale | Standard Deviation 0.58 |
| GW685698X 55 μg QD | Mean Change From Baseline in Sneezing, Rhinorrhea, Nasal Congestion, and Nasal Itching Over the Entire Treatment Period, Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12 | Nasal Itching, Week 1 to 2, n=61 | -0.2 Scores on a scale | Standard Deviation 0.55 |
| GW685698X 55 μg QD | Mean Change From Baseline in Sneezing, Rhinorrhea, Nasal Congestion, and Nasal Itching Over the Entire Treatment Period, Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12 | Nasal Itching, Week 3 to 4, n=61 | -0.4 Scores on a scale | Standard Deviation 0.63 |
| GW685698X 55 μg QD | Mean Change From Baseline in Sneezing, Rhinorrhea, Nasal Congestion, and Nasal Itching Over the Entire Treatment Period, Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12 | Nasal Itching, Week 7 to 8, n=60 | -0.4 Scores on a scale | Standard Deviation 0.67 |
| GW685698X 55 μg QD | Mean Change From Baseline in Sneezing, Rhinorrhea, Nasal Congestion, and Nasal Itching Over the Entire Treatment Period, Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12 | Nasal Itching, Week 11 to 12, n=60 | -0.3 Scores on a scale | Standard Deviation 0.69 |
Secondary
Mean Change From Baseline in the 3 Total Nasal Symptom Score (3TNSS) Over the Entire Treatment Period, Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12
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 (12 weeks), Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12
Population: FAS Population. Only those participants available at the indicated time points were assessed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GW685698X 55 μg QD | Mean Change From Baseline in the 3 Total Nasal Symptom Score (3TNSS) Over the Entire Treatment Period, Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12 | Entire Treatment Period, n=61 | -2.2 Scores on a scale | Standard Deviation 1.65 |
| GW685698X 55 μg QD | Mean Change From Baseline in the 3 Total Nasal Symptom Score (3TNSS) Over the Entire Treatment Period, Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12 | Week 1 to 2, n=61 | -1.6 Scores on a scale | Standard Deviation 1.58 |
| GW685698X 55 μg QD | Mean Change From Baseline in the 3 Total Nasal Symptom Score (3TNSS) Over the Entire Treatment Period, Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12 | Week 3 to 4, n=61 | -2.5 Scores on a scale | Standard Deviation 1.84 |
| GW685698X 55 μg QD | Mean Change From Baseline in the 3 Total Nasal Symptom Score (3TNSS) Over the Entire Treatment Period, Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12 | Week 7 to 8, n=60 | -2.4 Scores on a scale | Standard Deviation 1.86 |
| GW685698X 55 μg QD | Mean Change From Baseline in the 3 Total Nasal Symptom Score (3TNSS) Over the Entire Treatment Period, Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12 | Week 11 to 12, n=60 | -2.0 Scores on a scale | Standard Deviation 2.07 |
Secondary
Mean Change From Baseline in the 4 Total Nasal Symptom Score (4TNSS) Over the Entire Treatment Period, Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12
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 (12 weeks), Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12
Population: FAS Population. Only those participants available at the indicated time points were assessed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GW685698X 55 μg QD | Mean Change From Baseline in the 4 Total Nasal Symptom Score (4TNSS) Over the Entire Treatment Period, Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12 | Scores on a scale | -2.6 Scores on a scale | Standard Deviation 2.01 |
| GW685698X 55 μg QD | Mean Change From Baseline in the 4 Total Nasal Symptom Score (4TNSS) Over the Entire Treatment Period, Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12 | Week 1 to 2 n=61 | -1.8 Scores on a scale | Standard Deviation 1.93 |
| GW685698X 55 μg QD | Mean Change From Baseline in the 4 Total Nasal Symptom Score (4TNSS) Over the Entire Treatment Period, Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12 | Week 3 to 4, n=61 | -2.9 Scores on a scale | Standard Deviation 2.26 |
| GW685698X 55 μg QD | Mean Change From Baseline in the 4 Total Nasal Symptom Score (4TNSS) Over the Entire Treatment Period, Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12 | Week 7 to 8, n=60 | -2.8 Scores on a scale | Standard Deviation 2.26 |
| GW685698X 55 μg QD | Mean Change From Baseline in the 4 Total Nasal Symptom Score (4TNSS) Over the Entire Treatment Period, Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12 | Week 11 to 12, n=60 | -2.3 Scores on a scale | Standard Deviation 2.5 |
Secondary
Mean Change From Baseline in the Score of Troubles With Daily Life Over the Entire Treatment Period, Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12
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, Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12. 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 (12 weeks), Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12
Population: FAS Population. Only those participants available at the indicated time points were assessed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GW685698X 55 μg QD | Mean Change From Baseline in the Score of Troubles With Daily Life Over the Entire Treatment Period, Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12 | Entire Treatment Period, n=61 | -0.5 Scores on a scale | Standard Deviation 0.61 |
| GW685698X 55 μg QD | Mean Change From Baseline in the Score of Troubles With Daily Life Over the Entire Treatment Period, Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12 | Week 1 to 2, n=61 | -0.3 Scores on a scale | Standard Deviation 0.52 |
| GW685698X 55 μg QD | Mean Change From Baseline in the Score of Troubles With Daily Life Over the Entire Treatment Period, Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12 | Week 3 to 4, n=61 | -0.5 Scores on a scale | Standard Deviation 0.65 |
| GW685698X 55 μg QD | Mean Change From Baseline in the Score of Troubles With Daily Life Over the Entire Treatment Period, Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12 | Week 7 to 8, n=60 | -0.6 Scores on a scale | Standard Deviation 0.72 |
| GW685698X 55 μg QD | Mean Change From Baseline in the Score of Troubles With Daily Life Over the Entire Treatment Period, Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12 | Week 11 to 12, n=60 | -0.4 Scores on a scale | Standard Deviation 0.75 |
Secondary
Mean Change From Baseline in the Total Ocular Symptom Score (TOSS) Over the Entire Treatment Period, Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12
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 (12 weeks), Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12. 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 (12 weeks), Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12
Population: FAS Population. Only those participants available at the indicated time points were assessed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GW685698X 55 μg QD | Mean Change From Baseline in the Total Ocular Symptom Score (TOSS) Over the Entire Treatment Period, Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12 | Entire Treatment Period, n=61 | -0.2 Scores on a scale | Standard Deviation 1 |
| GW685698X 55 μg QD | Mean Change From Baseline in the Total Ocular Symptom Score (TOSS) Over the Entire Treatment Period, Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12 | Week 1 to 2, n=61 | -0.1 Scores on a scale | Standard Deviation 0.88 |
| GW685698X 55 μg QD | Mean Change From Baseline in the Total Ocular Symptom Score (TOSS) Over the Entire Treatment Period, Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12 | Week 3 to 4, n=61 | -0.1 Scores on a scale | Standard Deviation 1.08 |
| GW685698X 55 μg QD | Mean Change From Baseline in the Total Ocular Symptom Score (TOSS) Over the Entire Treatment Period, Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12 | Week 7 to 8, n=60 | -0.2 Scores on a scale | Standard Deviation 1.2 |
| GW685698X 55 μg QD | Mean Change From Baseline in the Total Ocular Symptom Score (TOSS) Over the Entire Treatment Period, Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12 | Week 11 to 12, n=60 | -0.3 Scores on a scale | Standard Deviation 1.06 |
Secondary
Mean Percent Change From Baseline in the 3 Total Nasal Symptom Score (3TNSS) Over the Entire Treatment Period, Week 1to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12
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. 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 (12 weeks), Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12
Population: FAS Population. Only those participants available at the indicated time points were assessed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GW685698X 55 μg QD | Mean Percent Change From Baseline in the 3 Total Nasal Symptom Score (3TNSS) Over the Entire Treatment Period, Week 1to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12 | Entire Treatment Period, n=61 | -46.9 Percent change | Standard Deviation 33.25 |
| GW685698X 55 μg QD | Mean Percent Change From Baseline in the 3 Total Nasal Symptom Score (3TNSS) Over the Entire Treatment Period, Week 1to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12 | Week 1 to 2, n=61 | -31.6 Percent change | Standard Deviation 36.36 |
| GW685698X 55 μg QD | Mean Percent Change From Baseline in the 3 Total Nasal Symptom Score (3TNSS) Over the Entire Treatment Period, Week 1to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12 | Week 3 to 4, n=61 | -53.2 Percent change | Standard Deviation 36.81 |
| GW685698X 55 μg QD | Mean Percent Change From Baseline in the 3 Total Nasal Symptom Score (3TNSS) Over the Entire Treatment Period, Week 1to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12 | Week 7 to 8, n=60 | -50.9 Percent change | Standard Deviation 38 |
| GW685698X 55 μg QD | Mean Percent Change From Baseline in the 3 Total Nasal Symptom Score (3TNSS) Over the Entire Treatment Period, Week 1to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12 | Week 11 to 12, n=60 | -40.7 Percent change | Standard Deviation 41.58 |
Secondary
Mean Percent Change From Baseline in the 4 Total Nasal Symptom Score (4TNSS) Over the Entire Treatment Period, Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12
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. 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 (12 weeks), Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12
Population: FAS Population. Only those participants available at the indicated time points were assessed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GW685698X 55 μg QD | Mean Percent Change From Baseline in the 4 Total Nasal Symptom Score (4TNSS) Over the Entire Treatment Period, Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12 | Entire Treatment Period, n=61 | -47.1 Percent change | Standard Deviation 34.06 |
| GW685698X 55 μg QD | Mean Percent Change From Baseline in the 4 Total Nasal Symptom Score (4TNSS) Over the Entire Treatment Period, Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12 | Week 1 to 2, n=61 | -31.3 Percent change | Standard Deviation 38.42 |
| GW685698X 55 μg QD | Mean Percent Change From Baseline in the 4 Total Nasal Symptom Score (4TNSS) Over the Entire Treatment Period, Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12 | Week 3 to 4, n=61 | -52.8 Percent change | Standard Deviation 38.62 |
| GW685698X 55 μg QD | Mean Percent Change From Baseline in the 4 Total Nasal Symptom Score (4TNSS) Over the Entire Treatment Period, Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12 | Week 7 to 8, n=60 | -51.3 Percent change | Standard Deviation 38.9 |
| GW685698X 55 μg QD | Mean Percent Change From Baseline in the 4 Total Nasal Symptom Score (4TNSS) Over the Entire Treatment Period, Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12 | Week 11 to 12, n=60 | -42.0 Percent change | Standard Deviation 41.95 |
Secondary
Mean Percent Change From Baseline in the Total Ocular Symptom Score (TOSS) Over the Entire Treatment Period, Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12
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 (12 weeks), Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12. 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. 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 (12 weeks), Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12
Population: FAS Population. Only those participants available at the indicated time points were assessed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GW685698X 55 μg QD | Mean Percent Change From Baseline in the Total Ocular Symptom Score (TOSS) Over the Entire Treatment Period, Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12 | Entire Treatment Period, n=36 | 7.1 Percent change | Standard Deviation 180.6 |
| GW685698X 55 μg QD | Mean Percent Change From Baseline in the Total Ocular Symptom Score (TOSS) Over the Entire Treatment Period, Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12 | Week 1 to 2, n=36 | 4.6 Percent change | Standard Deviation 138.41 |
| GW685698X 55 μg QD | Mean Percent Change From Baseline in the Total Ocular Symptom Score (TOSS) Over the Entire Treatment Period, Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12 | Week 3 to 4, n=36 | 17.5 Percent change | Standard Deviation 214.79 |
| GW685698X 55 μg QD | Mean Percent Change From Baseline in the Total Ocular Symptom Score (TOSS) Over the Entire Treatment Period, Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12 | Week 7 to 8, n=35 | 29.0 Percent change | Standard Deviation 251.46 |
| GW685698X 55 μg QD | Mean Percent Change From Baseline in the Total Ocular Symptom Score (TOSS) Over the Entire Treatment Period, Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12 | Week 11 to 12, n=35 | -22.5 Percent change | Standard Deviation 163.35 |
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 12/early withdrawal
Population: FAS Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GW685698X 55 μg QD | Number of Participants With the Indicated Overall Response to Therapy, as Assessed by the Investigator | Significantly Improved | 25 participants |
| GW685698X 55 μg QD | Number of Participants With the Indicated Overall Response to Therapy, as Assessed by the Investigator | Moderately Improved | 28 participants |
| GW685698X 55 μg QD | Number of Participants With the Indicated Overall Response to Therapy, as Assessed by the Investigator | Mildly Improved | 3 participants |
| GW685698X 55 μg QD | Number of Participants With the Indicated Overall Response to Therapy, as Assessed by the Investigator | No Change | 5 participants |
| GW685698X 55 μg QD | Number of Participants With the Indicated Overall Response to Therapy, as Assessed by the Investigator | Mildly Worse | 0 participants |
| GW685698X 55 μg QD | Number of Participants With the Indicated Overall Response to Therapy, as Assessed by the Investigator | Moderately Worse | 0 participants |
| GW685698X 55 μg QD | Number of Participants With the Indicated Overall Response to Therapy, as Assessed by the Investigator | Significantly Worse | 0 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 himself/herself 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 12/early withdrawal
Population: FAS Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GW685698X 55 μg QD | Number of Participants With the Indicated Overall Response to Therapy, as Assessed by the Participant's Parent/Guardian or the Participant | Significantly Improved | 13 participants |
| GW685698X 55 μg QD | Number of Participants With the Indicated Overall Response to Therapy, as Assessed by the Participant's Parent/Guardian or the Participant | Moderately Improved | 31 participants |
| GW685698X 55 μg QD | Number of Participants With the Indicated Overall Response to Therapy, as Assessed by the Participant's Parent/Guardian or the Participant | Mildly Improved | 12 participants |
| GW685698X 55 μg QD | Number of Participants With the Indicated Overall Response to Therapy, as Assessed by the Participant's Parent/Guardian or the Participant | No Change | 4 participants |
| GW685698X 55 μg QD | Number of Participants With the Indicated Overall Response to Therapy, as Assessed by the Participant's Parent/Guardian or the Participant | Mildly Worse | 1 participants |
| GW685698X 55 μg QD | 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 |
| GW685698X 55 μg QD | 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 |
Secondary
Number of Participants With the Indicated Plasma Concentration of GW685698X for Participants Aged >=2 to <6 Years
Pharmacokinetic (PK) samples were collected to analyze the plasma concentration of GW685698X.
Time frame: Between 0.5 to 2 hours after final dosing at Week 12 (Visit 5)
Population: PK Concentration Population: all participants from whom a PK sample was obtained and analyzed. Only those participants aged \>=2 to \<6 years were assessed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GW685698X 55 μg QD | Number of Participants With the Indicated Plasma Concentration of GW685698X for Participants Aged >=2 to <6 Years | Not Quantifiable (<10 picograms/milliliter [pg/mL] | 17 participants |
| GW685698X 55 μg QD | Number of Participants With the Indicated Plasma Concentration of GW685698X for Participants Aged >=2 to <6 Years | >=10 to <20 pg/mL | 2 participants |
| GW685698X 55 μg QD | Number of Participants With the Indicated Plasma Concentration of GW685698X for Participants Aged >=2 to <6 Years | >=20 to <30 pg/mL | 0 participants |
| GW685698X 55 μg QD | Number of Participants With the Indicated Plasma Concentration of GW685698X for Participants Aged >=2 to <6 Years | >=30 pg/mL | 0 participants |
Secondary
Number of Participants With the Indicated Plasma Concentration of GW685698X for Participants Aged >=6 to <15 Years
PK samples were collected to analyze the plasma concentration of GW685698X.
Time frame: Between 0.5 to 2 hours after final dosing at Week 12 (Visit 5)
Population: PK Concentration Population. Only those participants aged \>=6 to \<15 years were assessed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GW685698X 55 μg QD | Number of Participants With the Indicated Plasma Concentration of GW685698X for Participants Aged >=6 to <15 Years | Not Quantifiable (<10 pg/mL) | 37 participants |
| GW685698X 55 μg QD | Number of Participants With the Indicated Plasma Concentration of GW685698X for Participants Aged >=6 to <15 Years | >=10 to <20 pg/mL | 2 participants |
| GW685698X 55 μg QD | Number of Participants With the Indicated Plasma Concentration of GW685698X for Participants Aged >=6 to <15 Years | >=20 to <30 pg/mL | 1 participants |
| GW685698X 55 μg QD | Number of Participants With the Indicated Plasma Concentration of GW685698X for Participants Aged >=6 to <15 Years | >=30 pg/mL | 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)
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 4, Week 8, and Week 12/early withdrawal
Population: FAS Population. Only those participants available at the indicated time points were assessed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GW685698X 55 μg QD | 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) | SOITM, Baseline, Score 0, n=61 | 3 participants |
| GW685698X 55 μg QD | 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) | SOITM, Baseline, Score 1, n=61 | 9 participants |
| GW685698X 55 μg QD | 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) | SOITM, Baseline, Score 2, n=61 | 35 participants |
| GW685698X 55 μg QD | 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) | SOITM, Baseline, Score 3, n=61 | 14 participants |
| GW685698X 55 μg QD | 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) | SOITM, Week 4, Score 0, n=60 | 15 participants |
| GW685698X 55 μg QD | 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) | SOITM, Week 4, Score 1, n=60 | 21 participants |
| GW685698X 55 μg QD | 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) | SOITM, Week 4, Score 2, n=60 | 23 participants |
| GW685698X 55 μg QD | 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) | SOITM, Week 4, Score 3, n=60 | 1 participants |
| GW685698X 55 μg QD | 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) | SOITM, Week 8, Score 0, n=60 | 17 participants |
| GW685698X 55 μg QD | 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) | SOITM, Week 8, Score 1, n=60 | 24 participants |
| GW685698X 55 μg QD | 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) | SOITM, Week 8, Score 2, n=60 | 19 participants |
| GW685698X 55 μg QD | 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) | SOITM, Week 8, Score 3, n=60 | 0 participants |
| GW685698X 55 μg QD | 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) | SOITM, Week 12/early withdrawal, Score 0, n=61 | 21 participants |
| GW685698X 55 μg QD | 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) | SOITM, Week 12/early withdrawal, Score 1, n=61 | 26 participants |
| GW685698X 55 μg QD | 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) | SOITM, Week 12/early withdrawal, Score 2, n=61 | 13 participants |
| GW685698X 55 μg QD | 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) | SOITM, Week 12/early withdrawal, Score 3, n=61 | 1 participants |
| GW685698X 55 μg QD | 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) | COITM, Baseline, Score 0, n=61 | 0 participants |
| GW685698X 55 μg QD | 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) | COITM, Baseline, Score 1, n=61 | 10 participants |
| GW685698X 55 μg QD | 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) | COITM, Baseline, Score 2, n=61 | 23 participants |
| GW685698X 55 μg QD | 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) | COITM, Baseline, Score 3, n=61 | 28 participants |
| GW685698X 55 μg QD | 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) | COITM, Week 4, Score 0, n=60 | 10 participants |
| GW685698X 55 μg QD | 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) | COITM, Week 4, Score 1, n=60 | 28 participants |
| GW685698X 55 μg QD | 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) | COITM, Week 4, Score 2, n=60 | 13 participants |
| GW685698X 55 μg QD | 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) | COITM, Week 4, Score 3, n=60 | 9 participants |
| GW685698X 55 μg QD | 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) | COITM, Week 8, Score 0, n=60 | 12 participants |
| GW685698X 55 μg QD | 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) | COITM, Week 8, Score 1, n=60 | 30 participants |
| GW685698X 55 μg QD | 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) | COITM, Week 8, Score 2, n=60 | 11 participants |
| GW685698X 55 μg QD | 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) | COITM, Week 8, Score 3, n=60 | 7 participants |
| GW685698X 55 μg QD | 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) | COITM, Week 12/early withdrawal, Score 0, n=61 | 19 participants |
| GW685698X 55 μg QD | 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) | COITM, Week 12/early withdrawal, Score 1, n=61 | 28 participants |
| GW685698X 55 μg QD | 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) | COITM, Week 12/early withdrawal, Score 2, n=61 | 10 participants |
| GW685698X 55 μg QD | 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) | COITM, Week 12/early withdrawal, Score 3, n=61 | 4 participants |
| GW685698X 55 μg QD | 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) | QTND, Baseline, Score 0, n=61 | 4 participants |
| GW685698X 55 μg QD | 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) | QTND, Baseline, Score 1, n=61 | 16 participants |
| GW685698X 55 μg QD | 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) | QTND, Baseline, Score 2, n=61 | 33 participants |
| GW685698X 55 μg QD | 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) | QTND, Baseline, Score 3, n=61 | 8 participants |
| GW685698X 55 μg QD | 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) | QTND, Week 4, Score 0, n=60 | 30 participants |
| GW685698X 55 μg QD | 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) | QTND, Week 4, Score 1, n=60 | 24 participants |
| GW685698X 55 μg QD | 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) | QTND, Week 4, Score 2, n=60 | 5 participants |
| GW685698X 55 μg QD | 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) | QTND, Week 4, Score 3, n=60 | 1 participants |
| GW685698X 55 μg QD | 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) | QTND, Week 8, Score 0, n=60 | 29 participants |
| GW685698X 55 μg QD | 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) | QTND, Week 8, Score 1, n=60 | 25 participants |
| GW685698X 55 μg QD | 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) | QTND, Week 8, Score 2, n=60 | 4 participants |
| GW685698X 55 μg QD | 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) | QTND, Week 8, Score 3, n=60 | 2 participants |
| GW685698X 55 μg QD | 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) | QTND, Week 12/early withdrawal, Score 0, n=61 | 34 participants |
| GW685698X 55 μg QD | 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) | QTND, Week 12/early withdrawal, Score 1, n=61 | 24 participants |
| GW685698X 55 μg QD | 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) | QTND, Week 12/early withdrawal, Score 2, n=61 | 3 participants |
| GW685698X 55 μg QD | 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) | QTND, Week 12/early withdrawal, Score 3, n=61 | 0 participants |
| GW685698X 55 μg QD | 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) | QLND, Baseline, Score 0, n=61 | 4 participants |
| GW685698X 55 μg QD | 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) | QLND, Baseline, Score 1, n=61 | 0 participants |
| GW685698X 55 μg QD | 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) | QLND, Baseline, Score 2, n=61 | 14 participants |
| GW685698X 55 μg QD | 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) | QLND, Baseline, Score 3, n=61 | 43 participants |
| GW685698X 55 μg QD | 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) | QLND, Week 4, Score 0, n=60 | 30 participants |
| GW685698X 55 μg QD | 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) | QLND, Week 4, Score 1, n=60 | 11 participants |
| GW685698X 55 μg QD | 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) | QLND, Week 4, Score 2, n=60 | 4 participants |
| GW685698X 55 μg QD | 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) | QLND, Week 4, Score 3, n=60 | 15 participants |
| GW685698X 55 μg QD | 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) | QLND, Week 8, Score 0, n=60 | 30 participants |
| GW685698X 55 μg QD | 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) | QLND, Week 8, Score 1, n=60 | 13 participants |
| GW685698X 55 μg QD | 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) | QLND, Week 8, Score 2, n=60 | 5 participants |
| GW685698X 55 μg QD | 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) | QLND, Week 8, Score 3, n=60 | 12 participants |
| GW685698X 55 μg QD | 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) | QLND, Week 12/early withdrawal, Score 0, n=61 | 32 participants |
| GW685698X 55 μg QD | 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) | QLND, Week 12/early withdrawal, Score 1, n=61 | 10 participants |
| GW685698X 55 μg QD | 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) | QLND, Week 12/early withdrawal, Score 2, n=61 | 7 participants |
| GW685698X 55 μg QD | 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) | QLND, Week 12/early withdrawal, Score 3, n=61 | 12 participants |