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Study Of Adults And Adolescents With Vasomotor Rhinitis

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ClinicalTrials.gov Identifier: NCT00117325
Recruitment Status : Completed
First Posted : July 6, 2005
Results First Posted : March 13, 2018
Last Update Posted : March 13, 2018
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Primary Purpose: Treatment
Condition Rhinitis, Vasomotor
Intervention Drug: GW685698X
Enrollment 352
Recruitment Details The actual dose delivered from the product was 27.5 micrograms (µg) /actuation, which is therefore proposed as the label claim rather than 25 µg/actuation. Based on this spray content assessment, the dose examined in this study was actually 110 µg rather than the 100 µg dose indicated in the protocol.
Pre-assignment Details Out of 901 participants screened, 549 participants were screen failures and hence were not randomized into the study. Out of 901 participants screened, 352 participants were randomized from 11 July 2005 to 16 January 2006.
Arm/Group Title Placebo Fluticasone Furoate 110 mcg QD
Hide Arm/Group Description Participants received placebo matching with GW685698X aqueous nasal spray 110 microgram (mcg) administered as two sprays from the device into each nostril once daily every morning up to 4 weeks. Participants received Fluticasone Furoate (GW 685698X) aqueous nasal spray 110 mcg administered as two sprays from the device into each nostril once daily every morning up to 4 weeks.
Period Title: Overall Study
Started 173 179
Completed 160 167
Not Completed 13 12
Reason Not Completed
Adverse Event             3             3
Lost to Follow-up             1             1
Protocol Violation             2             3
Withdrawal by Subject             3             2
Lack of Efficacy             1             0
Use of prohibited medicine             1             2
Early termination             1             1
Admisnitrative             1             0
Arm/Group Title Placebo Fluticasone Furoate 110 mcg QD Total
Hide Arm/Group Description Participants received placebo matching with GW685698X aqueous nasal spray 110 mcg administered as two sprays from the device into each nostril once daily every morning up to 4 weeks. Participants received GW685698X aqueous nasal spray 110 mcg administered as two sprays from the device into each nostril once daily every morning up to 4 weeks. Total of all reporting groups
Overall Number of Baseline Participants 173 179 352
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 173 participants 179 participants 352 participants
45.0  (14.66) 46.6  (16.77) 45.8  (15.77)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 173 participants 179 participants 352 participants
Female
122
  70.5%
125
  69.8%
247
  70.2%
Male
51
  29.5%
54
  30.2%
105
  29.8%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 173 participants 179 participants 352 participants
American Indian or Alaska Native
0
   0.0%
1
   0.6%
1
   0.3%
Asian
1
   0.6%
1
   0.6%
2
   0.6%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
6
   3.5%
4
   2.2%
10
   2.8%
White
163
  94.2%
169
  94.4%
332
  94.3%
More than one race
3
   1.7%
4
   2.2%
7
   2.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Mean Change From Baseline Over the Entire Treatment Period in Daily Reflective Total Nasal Symptom Score (rTNSS)
Hide Description The daily rTNSS was the average of the AM (morning) and PM (before bed time) rTNSS assessments. Each rTNSS assessment comprised the sum of the three nasal symptom scores for rhinorrhea, nasal congestion and postnasal drip where each symptom was scored on a scale of 0 (no symptoms) to 3 (severe symptoms).. The severity of symptoms was defined as 0: none-symptom was not present, 1: mild-sign/symptom was clearly present but minimal awareness; easily tolerated, 2: moderate-definite awareness of sign/symptom that was bothersome but tolerable, 3: severe (sign/symptom was hard to tolerate; causes interference with activities of daily living and/or sleeping. Change from Baseline was calculated as any post-Baseline value minus the Baseline value. Baseline visit was 4 days prior to randomization (Day 1).
Time Frame Baseline (4 days prior to randomization [Day 1]) and up to Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Due to irregularities found during a compliance audit, a reduced intent-to-treat (RITT) population was defined which excludes two participants from one of the investigative sites.
Arm/Group Title Placebo Fluticasone Furoate 110 mcg QD
Hide Arm/Group Description:
Participants received placebo matching with GW685698X aqueous nasal spray 110 mcg administered as two sprays from the device into each nostril once daily every morning up to 4 weeks.
Participants received GW685698X aqueous nasal spray 110 mcg administered as two sprays from the device into each nostril once daily every morning up to 4 weeks.
Overall Number of Participants Analyzed 170 176
Least Squares Mean (Standard Error)
Unit of Measure: Score on scale
-1.71  (0.16) -2.05  (0.15)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Fluticasone Furoate 110 mcg QD
Comments Placebo versus Fluticasone Furoate 110 mcg QD Week 1-4 analysis.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.050
Comments [Not Specified]
Method ANCOVA
Comments Analysis of covariance (ANCOVA) method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.335
Confidence Interval (2-Sided) 95%
-0.67 to 0.00
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Mean Change From Baseline Over the Entire Treatment Period in Morning (AM), Pre-dose, Instantaneous Total Nasal Symptom Scores (iTNSS)
Hide Description The AM, pre-dose, iTNSS is the sum of the 3 individual nasal symptom score assessments for rhinorrhea, nasal congestion and postnasal drip performed at the moment immediately prior to taking their dose where each symptom was scored on a scale of 0 to 3 (0= no symptoms, 3= severe symptoms). . The severity of symptoms was defined as 0: none-symptom was not present, 1: mild-sign/symptom was clearly present but minimal awareness; easily tolerated, 2: moderate-definite awareness of sign/symptom that was bothersome but tolerable, 3: severe (sign/symptom was hard to tolerate; causes interference with activities of daily living and/or sleeping. Change from baseline was calculated as endpoint value minus the baseline value. Baseline visit was 4 days prior to randomization (Day 1).
Time Frame Baseline (4 days prior to randomization [Day 1]) and up to Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Reduced ITT Population. Only those participants with data available at the indicated time points were analyzed.
Arm/Group Title Placebo Fluticasone Furoate 110 mcg QD
Hide Arm/Group Description:
Participants received placebo matching with GW685698X aqueous nasal spray 110 mcg administered as two sprays from the device into each nostril once daily every morning up to 4 weeks.
Participants received GW685698X aqueous nasal spray 110 mcg administered as two sprays from the device into each nostril once daily every morning up to 4 weeks.
Overall Number of Participants Analyzed 170 176
Least Squares Mean (Standard Error)
Unit of Measure: Score on scale
-1.48  (0.16) -1.87  (0.16)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Fluticasone Furoate 110 mcg QD
Comments Placebo versus Fluticasone Furoate 110 mcg QD Week 1-4 analysis.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.027
Comments Week 1-4
Method ANCOVA
Comments ANCOVA method was used adjusting for baseline iTNSS, country, age, and gender, in addition to treatment effect.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.393
Confidence Interval (2-Sided) 95%
-0.74 to -0.05
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Number of Participants With Overall Evaluation of Response to Therapy
Hide Description The overall evaluation of Response to Therapy was based on a 7-point categorical scale where the participants rated their perception of the change or lack of change in their VMR (Vasomotor rhinitis) symptoms at the end of the study. The 7 categories were: 1=significantly improved, 2=moderately improved, 3= mildly improved, 4= no change, 5= mildly worse, 6= moderately worse, and 7= significantly worse.
Time Frame Up to 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
RITT population. Only those participants with data available at the indicated time points were analyzed.
Arm/Group Title Placebo Fluticasone Furoate 110 mcg QD
Hide Arm/Group Description:
Participants received placebo matching with GW685698X aqueous nasal spray 110 mcg administered as two sprays from the device into each nostril once daily every morning up to 4 weeks.
Participants received GW685698X aqueous nasal spray 110 mcg administered as two sprays from the device into each nostril once daily every morning up to 4 weeks.
Overall Number of Participants Analyzed 168 176
Measure Type: Count of Participants
Unit of Measure: Participants
Significantly Improved
26
  15.5%
33
  18.8%
Moderately Improved
37
  22.0%
40
  22.7%
Mildly Improved
45
  26.8%
47
  26.7%
No Change
52
  31.0%
50
  28.4%
Mildly Worse
1
   0.6%
3
   1.7%
Moderately Worse
4
   2.4%
1
   0.6%
Significantly Worse
3
   1.8%
2
   1.1%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Fluticasone Furoate 110 mcg QD
Comments Placebo versus Fluticasone Furoate 110 mcg QD up to Week 4 analysis.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.184
Comments [Not Specified]
Method Regression, Logistic
Comments logistic regression adjusting for age, gender, investigator, and treatment.
Other Statistical Analysis Effectiveness of study medication for relieving non-allergic rhinitis symptoms over the entire treatment period (Total response) was analyzed.
4.Secondary Outcome
Title Mean Change From Baseline Over the Entire Treatment Period in AM Pre-dose rTNSS
Hide Description The rTNSS is a rating of the severity of symptoms over the previous 12 hours and is performed in the AM (AM rTNSS). . The severity of symptoms was defined as 0: none-symptom was not present, 1: mild-sign/symptom was clearly present but minimal awareness; easily tolerated, 2: moderate-definite awareness of sign/symptom that was bothersome but tolerable, 3: severe (sign/symptom was hard to tolerate; causes interference with activities of daily living and/or sleeping. The TNSS was the sum of the individual symptom scores for rhinorrhoea, nasal congestion and post-nasal drip which was scored on a scale of 0-3. Change from Baseline was calculated as post randomization value minus the Baseline value. Baseline visit was 4 days prior to randomization (Day 1).
Time Frame Baseline (4 days prior to randomization [Day 1]) and up to Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
RITT population. Only those participants with data available at the indicated time points were analyzed.
Arm/Group Title Placebo Fluticasone Furoate 110 mcg QD
Hide Arm/Group Description:
Participants received placebo matching with GW685698X aqueous nasal spray 110 mcg administered as two sprays from the device into each nostril once daily every morning up to 4 weeks.
Participants received GW685698X aqueous nasal spray 110 mcg administered as two sprays from the device into each nostril once daily every morning up to 4 weeks.
Overall Number of Participants Analyzed 170 176
Least Squares Mean (Standard Error)
Unit of Measure: Score on scale
-1.69  (0.16) -2.04  (0.16)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Fluticasone Furoate 110 mcg QD
Comments Placebo versus Fluticasone Furoate 110 mcg QD Week 1-4 analysis.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.051
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.348
Confidence Interval (2-Sided) 95%
-0.70 to 0.00
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Mean Change From Baseline Over the Entire Treatment Period in Evening (PM) rTNSS
Hide Description The TNSS was the sum of the individual symptom scores for rhinorrhoea, nasal congestion and post-nasal drip which was scored on a scale of 0-3. The severity of symptoms was defined as 0: none-symptom was not present, 1: mild-sign/symptom was clearly present but minimal awareness; easily tolerated, 2: moderate-definite awareness of sign/symptom that was bothersome but tolerable, 3: severe (sign/symptom was hard to tolerate; causes interference with activities of daily living and/or sleeping. The rTNSS is a rating of the severity of symptoms over the previous 12 hours and is performed in the PM (PM rTNSS). Change from Baseline was calculated as any post-Baseline value minus the Baseline value. Baseline visit was 4 days prior to randomization (Day 1).
Time Frame Baseline (4 days prior to randomization [Day 1]) and up to Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
RITT Population. Only those participants with data available at the indicated time points were analyzed.
Arm/Group Title Placebo Fluticasone Furoate 110 mcg QD
Hide Arm/Group Description:
Participants received placebo matching with GW685698X aqueous nasal spray 110 mcg administered as two sprays from the device into each nostril once daily every morning up to 4 weeks.
Participants received GW685698X aqueous nasal spray 110 mcg administered as two sprays from the device into each nostril once daily every morning up to 4 weeks.
Overall Number of Participants Analyzed 172 178
Least Squares Mean (Standard Error)
Unit of Measure: Score on scale
-1.77  (0.16) -2.07  (0.15)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Fluticasone Furoate 110 mcg QD
Comments Placebo versus Fluticasone Furoate 110 mcg QD up to Week 4 analysis
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.076
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.304
Confidence Interval (2-Sided) 95%
-0.64 to 0.03
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Mean Percent Change From Baseline Over the Entire Treatment Period in Daily rTNSS
Hide Description The daily rTNSS was the average of the AM (morning) and PM (before bed time) rTNSS assessments.The TNSS was the sum of the individual symptom scores for rhinorrhoea, nasal congestion and post-nasal drip which was scored on a scale of 0-3. The severity of symptoms was defined as 0: none-symptom was not present, 1: mild-sign/symptom was clearly present but minimal awareness; easily tolerated, 2: moderate-definite awareness of sign/symptom that was bothersome but tolerable, 3: severe (sign/symptom was hard to tolerate; causes interference with activities of daily living and/or sleeping. Change from Baseline was calculated as any post-Baseline value minus the Baseline value. Baseline visit was 4 days prior to randomization (Day 1).
Time Frame Baseline (4 days prior to randomization [Day 1]) and up to Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
RITT Population. Only those participants with data available at the indicated time points were analyzed.
Arm/Group Title Placebo Fluticasone Furoate 110 mcg QD
Hide Arm/Group Description:
Participants received placebo matching with GW685698X aqueous nasal spray 110 mcg administered as two sprays from the device into each nostril once daily every morning up to 4 weeks.
Participants received GW685698X aqueous nasal spray 110 mcg administered as two sprays from the device into each nostril once daily every morning up to 4 weeks.
Overall Number of Participants Analyzed 170 176
Least Squares Mean (Standard Error)
Unit of Measure: Percent change in score
-26.14  (2.45) -30.65  (2.40)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Fluticasone Furoate 110 mcg QD
Comments Placebo versus Fluticasone Furoate 110 mcg QD Week 1-4 analysis.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.093
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -4.510
Confidence Interval (2-Sided) 95%
-9.77 to 0.75
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Mean Percent Change From Baseline Over the Entire Treatment Period in AM, Pre-dose iTNSS
Hide Description The AM, pre-dose, iTNSS is the sum of the 3 individual nasal symptom score assessments for rhinorrhea, nasal congestion and postnasal drip performed at the moment immediately prior to taking their dose where each symptom was scored on a scale of 0 to 3. The severity of symptoms was defined as 0: none-symptom was not present, 1: mild-sign/symptom was clearly present but minimal awareness; easily tolerated, 2: moderate-definite awareness of sign/symptom that was bothersome but tolerable, 3: severe (sign/symptom was hard to tolerate; causes interference with activities of daily living and/or sleeping. Change from Baseline was calculated as any post-Baseline value minus the Baseline value. Baseline visit was 4 days prior to randomization (Day 1).
Time Frame Baseline (4 days prior to randomization [Day 1]) and up to Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
RITT Population. Only those participants with data available at the indicated time points were analyzed.
Arm/Group Title Placebo Fluticasone Furoate 110 mcg QD
Hide Arm/Group Description:
Participants received placebo matching with GW685698X aqueous nasal spray 110 mcg administered as two sprays from the device into each nostril once daily every morning up to 4 weeks.
Participants received GW685698X aqueous nasal spray 110 mcg administered as two sprays from the device into each nostril once daily every morning up to 4 weeks.
Overall Number of Participants Analyzed 170 176
Least Squares Mean (Standard Error)
Unit of Measure: Percent change in score
-21.09  (2.54) -27.46  (2.50)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Fluticasone Furoate 110 mcg QD
Comments Placebo versus Fluticasone Furoate 110 mcg QD Week 1-4 analysis.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.023
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA method was used adjusting for baseline iTNSS, country, age, and gender, in addition to treatment effect.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -6.372
Confidence Interval (2-Sided) 95%
-11.8 to -0.90
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Mean Change From Baseline Over the Entire Treatment Period in Individual Daily, Reflective Nasal Symptom Scores for Rhinorrhea, Nasal Congestion and Post-nasal Drip
Hide Description The TNSS was the sum of the individual symptom scores for rhinorrhoea, nasal congestion and post-nasal drip which was scored on a scale of 0-3. The severity of symptoms was defined as 0: none-symptom was not present, 1: mild-sign/symptom was clearly present but minimal awareness; easily tolerated, 2: moderate-definite awareness of sign/symptom that was bothersome but tolerable, 3: severe (sign/symptom was hard to tolerate; causes interference with activities of daily living and/or sleeping. The daily reflective nasal symptom scores was the average of the AM (morning) and PM (before bed time) rTNSS assessments. Each rTNSS assessment comprised the sum of the three nasal symptom. Change from Baseline was calculated as any post-Baseline value minus the Baseline value. Baseline visit was 4 days prior to randomization (Day 1).
Time Frame Baseline (4 days prior to randomization [Day 1]) and up to Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
RITT Population. Only those participants with data available at the specified time points were analyzed.
Arm/Group Title Placebo Fluticasone Furoate 110 mcg QD
Hide Arm/Group Description:
Participants received placebo matching with GW685698X aqueous nasal spray 110 mcg administered as two sprays from the device into each nostril once daily every morning up to 4 weeks.
Participants received GW685698X aqueous nasal spray 110 mcg administered as two sprays from the device into each nostril once daily every morning up to 4 weeks.
Overall Number of Participants Analyzed 172 178
Least Squares Mean (Standard Error)
Unit of Measure: Score on scale
Rhinorrhea Number Analyzed 170 participants 176 participants
-0.50  (0.06) -0.62  (0.06)
Nasal Congestion Number Analyzed 170 participants 176 participants
-0.68  (0.06) -0.81  (0.06)
Post-nasal Drip Number Analyzed 171 participants 176 participants
-0.51  (0.06) -0.61  (0.06)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Fluticasone Furoate 110 mcg QD
Comments Placebo versus Fluticasone Furoate 110 mcg QD for Rhinorrhea
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.061
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.118
Confidence Interval (2-Sided) 95%
-0.24 to 0.01
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Fluticasone Furoate 110 mcg QD
Comments Placebo versus Fluticasone Furoate 110 mcg QD for Nasal Congestion
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.061
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.124
Confidence Interval (2-Sided) 95%
-0.25 to 0.01
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Fluticasone Furoate 110 mcg QD
Comments Placebo versus Fluticasone Furoate 110 mcg QD for post-nasal drip
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.138
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.095
Confidence Interval (2-Sided) 95%
-0.22 to 0.03
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Mean Change From Baseline Over the Entire Treatment Period in Individual AM, Pre-dose, Instantaneous, Nasal Symptom Scores for Rhinorrhea, Nasal Congestion and Postnasal Drip
Hide Description The AM, pre-dose, instantaneous nasal symptom score is the sum of the 3 individual nasal symptom score assessments for rhinorrhea, nasal congestion and postnasal drip performed at the moment immediately prior to taking their dose where each symptom was scored on a scale of 0 to 3 (0= no symptoms, 3= severe symptoms). Change from Baseline was calculated as any post-Baseline value minus the Baseline value. Baseline visit was 4 days prior to randomization (Day 1).
Time Frame Baseline (4 days prior to randomization [Day 1]) and up to Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
RITT Population. Only those participants with data available at the specified time points were analyzed.
Arm/Group Title Placebo Fluticasone Furoate 110 mcg QD
Hide Arm/Group Description:
Participants received placebo matching with GW685698X aqueous nasal spray 110 mcg administered as two sprays from the device into each nostril once daily every morning up to 4 weeks.
Participants received GW685698X aqueous nasal spray 110 mcg administered as two sprays from the device into each nostril once daily every morning up to 4 weeks.
Overall Number of Participants Analyzed 172 178
Least Squares Mean (Standard Error)
Unit of Measure: Score on scale
Rhinorrhea Number Analyzed 170 participants 176 participants
-0.44  (0.06) -0.56  (0.06)
Nasal congestion Number Analyzed 170 participants 176 participants
-0.54  (0.06) -0.70  (0.06)
Post-nasal drip Number Analyzed 170 participants 176 participants
-0.48  (0.06) -0.60  (0.06)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Fluticasone Furoate 110 mcg QD
Comments Placebo versus Fluticasone Furoate 110 mcg QD for Rhinorrhea
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.087
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.113
Confidence Interval (2-Sided) 95%
-0.24 to 0.02
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Fluticasone Furoate 110 mcg QD
Comments Placebo versus Fluticasone Furoate 110 mcg QD for nasal congestion
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.015
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.164
Confidence Interval (2-Sided) 95%
-0.30 to -0.03
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Fluticasone Furoate 110 mcg QD
Comments Placebo versus Fluticasone Furoate 110 mcg QD for post-nasal drip
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.106
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.112
Confidence Interval (2-Sided) 95%
-0.25 to 0.02
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Mean Change From Baseline Over the Entire Treatment Period in Individual AM, Reflective Nasal Symptom Scores for Rhinorrhea, Nasal Congestion and Postnasal Drip
Hide Description The reflective nasal symptom score is a rating of the severity of symptoms over the previous 12 hours and is performed in the AM (AM rTNSS). Score assessments for rhinorrhea, nasal congestion and postnasal drip performed at the moment immediately prior to taking their dose where each symptom was scored on a scale of 0 to 3 (0= no symptoms, 3= severe symptoms). Change from Baseline was calculated as any post-Baseline value minus the Baseline value. Baseline visit was 4 days prior to randomization (Day 1).
Time Frame Baseline (4 days prior to randomization [Day 1]) and up to Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
RITT Population. Only those participants with data available at the specified time points were analyzed.
Arm/Group Title Placebo Fluticasone Furoate 110mcg QD
Hide Arm/Group Description:
Participants received placebo matching with GW685698X aqueous nasal spray 110 mcg administered as two sprays from the device into each nostril once daily every morning up to 4 weeks.
Participants received GW685698X aqueous nasal spray 110 mcg administered as two sprays from the device into each nostril once daily every morning up to 4 weeks.
Overall Number of Participants Analyzed 172 178
Least Squares Mean (Standard Error)
Unit of Measure: Score on scale
Rhinorrhea Number Analyzed 170 participants 176 participants
-0.48  (0.06) -0.61  (0.06)
Nasal congestion Number Analyzed 170 participants 176 participants
-0.65  (0.06) -0.78  (0.06)
Post-nasal drip Number Analyzed 170 participants 176 participants
-0.55  (0.06) -0.64  (0.06)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Fluticasone Furoate 110mcg QD
Comments Placebo versus Fluticasone Furoate 110 mcg QD for rhinorrhea
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.048
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.132
Confidence Interval (2-Sided) 95%
-0.26 to -0.00
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Fluticasone Furoate 110mcg QD
Comments Placebo versus Fluticasone Furoate 110 mcg QD for Nasal congestion
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.076
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.124
Confidence Interval (2-Sided) 95%
-0.26 to 0.01
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Fluticasone Furoate 110mcg QD
Comments Placebo versus Fluticasone Furoate 110 mcg for post-nasal drip
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.164
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.093
Confidence Interval (2-Sided) 95%
-0.22 to 0.04
Estimation Comments [Not Specified]
11.Secondary Outcome
Title Mean Change From Baseline Over the Entire Treatment Period in Individual PM, Reflective, Nasal Symptom Scores for Rhinorrhea, Nasal Congestion and Postnasal Drip
Hide Description The reflective nasal symptom score is a rating of the severity of symptoms over the previous 12 hours and was performed in the PM (PM rTNSS). Score assessments for rhinorrhea, nasal congestion and postnasal drip performed at the moment immediately prior to taking their dose where each symptom was scored on a scale of 0 to 3 (0= no symptoms, 3= severe symptoms). Change from Baseline was calculated as any post-Baseline value minus the Baseline value. Baseline visit was 4 days prior to randomization (Day 1).
Time Frame Baseline (4 days prior to randomization [Day 1]) and up to Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
RITT Population. Only those participants with data available at the specified time points were analyzed.
Arm/Group Title Placebo Fluticasone Furoate 110 mcg QD
Hide Arm/Group Description:
Participants received placebo matching with GW685698X aqueous nasal spray 110 mcg administered as two sprays from the device into each nostril once daily every morning up to 4 weeks.
Participants received GW685698X aqueous nasal spray 110 mcg administered as two sprays from the device into each nostril once daily every morning up to 4 weeks.
Overall Number of Participants Analyzed 172 178
Least Squares Mean (Standard Error)
Unit of Measure: Score on scale
Rhinorrhea Number Analyzed 170 participants 176 participants
-0.53  (0.06) -0.59  (0.06)
Nasal congestion Number Analyzed 170 participants 176 participants
-0.73  (0.06) -0.84  (0.06)
Post-nasal drip Number Analyzed 171 participants 176 participants
-0.49  (0.06) -0.59  (0.06)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Fluticasone Furoate 110 mcg QD
Comments Placebo versus Fluticasone Furoate 110 mcg QD for Rhinorrhea
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.136
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.096
Confidence Interval (2-Sided) 95%
-0.22 to 0.03
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Fluticasone Furoate 110 mcg QD
Comments Placebo versus Fluticasone Furoate 110 mcg QD for nasal congestion
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.100
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.111
Confidence Interval 95%
-0.24 to 0.02
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Fluticasone Furoate 110 mcg QD
Comments Placebo versus Fluticasone Furoate 110 mcg QD for post-nasal drip
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.100
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.111
Confidence Interval (2-Sided) 95%
-0.24 to 0.02
Estimation Comments [Not Specified]
12.Secondary Outcome
Title Mean Scores Changes From Baseline as a Function of Time
Hide Description The onset of treatment effect was assessed by the mean change from Baseline in AM iTNSS (Days 1 to 28), the mean change from Baseline in daily rTNSS (Days 1 to 28), and mean change from Baseline in AM rTNSS and PM rTNSS. The time to maximum effect was also evaluated by the mean change from Baseline in daily rTNSS for Days 1 to 28. Change from Baseline was calculated as any post-Baseline value minus the Baseline value. Baseline visit was 4 days prior to randomization (Day 1).
Time Frame Baseline (4 days prior to randomization [Day 1]) and Daily for 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
RITT population. Only those participants with data available at the specified time points were analyzed.
Arm/Group Title Placebo Fluticasone Furoate 110 mcg QD
Hide Arm/Group Description:
Participants received placebo matching with GW685698X aqueous nasal spray 110 mcg administered as two sprays from the device into each nostril once daily every morning up to 4 weeks.
Participants received GW685698X aqueous nasal spray 110 mcg administered as two sprays from the device into each nostril once daily every morning up to 4 weeks.
Overall Number of Participants Analyzed 172 178
Least Squares Mean (Standard Error)
Unit of Measure: Score on scale
AM iTNSS Day 1 Number Analyzed 165 participants 175 participants
-0.47  (0.16) -0.92  (0.16)
AM iTNSS Day 2 Number Analyzed 166 participants 173 participants
-0.69  (0.17) -1.01  (0.17)
AM iTNSS Day 3 Number Analyzed 167 participants 175 participants
-0.75  (0.18) -1.14  (0.18)
AM iTNSS Day 4 Number Analyzed 167 participants 173 participants
-0.96  (0.18) -1.22  (0.18)
AM iTNSS Day 5 Number Analyzed 165 participants 172 participants
-1.15  (0.20) -1.45  (0.19)
AM iTNSS Day 6 Number Analyzed 166 participants 174 participants
-1.01  (0.20) -1.59  (0.19)
AM iTNSS Day 7 Number Analyzed 166 participants 175 participants
-1.17  (0.20) -1.55  (0.19)
AM iTNSS Day 8 Number Analyzed 165 participants 170 participants
-1.38  (0.20) -1.61  (0.20)
AM iTNSS Day 9 Number Analyzed 163 participants 169 participants
-1.47  (0.20) -1.66  (0.20)
AM iTNSS Day 10 Number Analyzed 161 participants 169 participants
-1.31  (0.21) -1.78  (0.21)
AM iTNSS Day 11 Number Analyzed 160 participants 169 participants
-1.48  (0.22) -1.66  (0.21)
AMiTNSS Day 12 Number Analyzed 159 participants 168 participants
-1.52  (0.22) -1.86  (0.21)
AM iTNSS Day 13 Number Analyzed 158 participants 168 participants
-1.48  (0.22) -1.83  (0.21)
AM iTNSS Day 14 Number Analyzed 160 participants 165 participants
-1.72  (0.21) -1.95  (0.20)
AM iTNSS Day 15 Number Analyzed 163 participants 163 participants
-1.54  (0.21) -1.92  (0.21)
AM iTNSS Day 16 Number Analyzed 163 participants 165 participants
-1.56  (0.21) -1.99  (0.21)
AM iTNSS Day 17 Number Analyzed 161 participants 162 participants
-1.64  (0.22) -2.20  (0.22)
AM iTNSS Day 18 Number Analyzed 162 participants 164 participants
-1.75  (0.21) -2.21  (0.21)
AM iTNSS Day 19 Number Analyzed 162 participants 165 participants
-1.70  (0.21) -2.33  (0.21)
AM iTNSS Day 20 Number Analyzed 157 participants 165 participants
-1.89  (0.22) -2.11  (0.21)
AM iTNSS Day 21 Number Analyzed 158 participants 161 participants
-1.97  (0.22) -2.26  (0.22)
AM iTNSS Day 22 Number Analyzed 154 participants 164 participants
-1.73  (0.22) -2.32  (0.22)
AM iTNSS Day 23 Number Analyzed 157 participants 164 participants
-1.80  (0.23) -2.27  (0.22)
AM iTNSS Day 24 Number Analyzed 157 participants 165 participants
-1.93  (0.23) -2.40  (0.22)
AM iTNSS Day 25 Number Analyzed 156 participants 164 participants
-1.93  (0.22) -2.36  (0.22)
AM iTNSS Day 26 Number Analyzed 154 participants 160 participants
-2.10  (0.23) -2.68  (0.22)
AM iTNSS Day 27 Number Analyzed 144 participants 152 participants
-2.01  (0.23) -2.49  (0.22)
AM iTNSS Day 28 Number Analyzed 115 participants 122 participants
-1.96  (0.28) -2.62  (0.26)
rTNSS Day 1 Number Analyzed 167 participants 176 participants
-0.71  (0.16) -0.93  (0.15)
rTNSS Day 2 Number Analyzed 167 participants 176 participants
-0.91  (0.16) -1.17  (0.16)
rTNSS Day 3 Number Analyzed 167 participants 176 participants
-1.07  (0.17) -1.38  (0.16)
rTNSS Day 4 Number Analyzed 168 participants 175 participants
-1.15  (0.17) -1.43  (0.16)
rTNSS Day 5 Number Analyzed 168 participants 176 participants
-1.22  (0.17) -1.35  (0.17)
rTNSS Day 6 Number Analyzed 167 participants 176 participants
-1.21  (0.19) -1.51  (0.18)
rTNSS Day 7 Number Analyzed 168 participants 174 participants
-1.37  (0.19) -1.66  (0.18)
rTNSS Day 8 Number Analyzed 165 participants 171 participants
-1.58  (0.18) -1.82  (0.18)
rTNSS Day 9 Number Analyzed 165 participants 171 participants
-1.55  (0.20) -1.92  (0.19)
rTNSS Day 10 Number Analyzed 165 participants 171 participants
-1.60  (0.20) -2.06  (0.19)
rTNSS Day 11 Number Analyzed 162 participants 169 participants
-1.65  (0.20) -1.96  (0.20)
rTNSS Day 12 Number Analyzed 163 participants 168 participants
-1.81  (0.19) -2.14  (0.19)
rTNSS Day 13 Number Analyzed 162 participants 168 participants
-1.87  (0.20) -2.12  (0.20)
rTNSS Day 14 Number Analyzed 163 participants 166 participants
-1.83  (0.20) -2.17  (0.20)
rTNSS Day 15 Number Analyzed 163 participants 165 participants
-1.70  (0.20) -2.11  (0.20)
rTNSS Day 16 Number Analyzed 163 participants 166 participants
-1.82  (0.20) -2.38  (0.20)
rTNSS Day 17 Number Analyzed 163 participants 166 participants
-1.94  (0.21) -2.53  (0.20)
rTNSS Day 18 Number Analyzed 163 participants 165 participants
-2.21  (0.20) -2.51  (0.20)
rTNSS Day 19 Number Analyzed 162 participants 166 participants
-1.99  (0.20) -2.44  (0.20)
rTNSS Day 20 Number Analyzed 160 participants 166 participants
-2.16  (0.20) -2.47  (0.20)
rTNSS Day 21 Number Analyzed 159 participants 166 participants
-2.12  (0.21) -2.54  (0.20)
rTNSS Day 22 Number Analyzed 157 participants 165 participants
-2.01  (0.21) -2.47  (0.21)
rTNSS Day 23 Number Analyzed 159 participants 165 participants
-1.99  (0.21) -2.30  (0.20)
rTNSS Day 24 Number Analyzed 158 participants 165 participants
-2.12  (0.21) -2.60  (0.20)
rTNSS Day 25 Number Analyzed 158 participants 164 participants
-2.28  (0.22) -2.44  (0.21)
rTNSS Day 26 Number Analyzed 155 participants 163 participants
-2.25  (0.22) -2.57  (0.21)
rTNSS Day 27 Number Analyzed 149 participants 154 participants
-2.23  (0.22) -2.51  (0.21)
rTNSS Day 28 Number Analyzed 119 participants 127 participants
-1.93  (0.28) -2.58  (0.26)
AM rTNSS Day 1 Number Analyzed 165 participants 174 participants
-0.70  (0.18) -1.02  (0.17)
AM rTNSS Day 2 Number Analyzed 164 participants 174 participants
-0.97  (0.18) -1.20  (0.17)
AM rTNSS Day 3 Number Analyzed 167 participants 176 participants
-1.12  (0.18) -1.37  (0.18)
AM rTNSS Day 4 Number Analyzed 165 participants 175 participants
-1.11  (0.18) -1.45  (0.18)
AM rTNSS Day 5 Number Analyzed 165 participants 174 participants
-1.33  (0.19) -1.48  (0.18)
AM rTNSS Day 6 Number Analyzed 164 participants 174 participants
-1.30  (0.20) -1.59  (0.20)
AM rTNSS Day 7 Number Analyzed 157 participants 168 participants
-1.28  (0.21) -1.69  (0.20)
AM rTNSS Day 8 Number Analyzed 158 participants 170 participants
-1.74  (0.21) -1.85  (0.20)
AM rTNSS Day 9 Number Analyzed 160 participants 171 participants
-1.73  (0.21) -1.94  (0.21)
AM rTNSS Day 10 Number Analyzed 156 participants 167 participants
-1.65  (0.21) -2.10  (0.20)
AM rTNSS Day 11 Number Analyzed 160 participants 166 participants
-1.66  (0.21) -1.96  (0.20)
AM rTNSS Day 12 Number Analyzed 161 participants 167 participants
-1.82  (0.21) -2.05  (0.20)
AM rTNSS Day 13 Number Analyzed 156 participants 163 participants
-1.87  (0.22) -2.06  (0.21)
AM rTNSS Day 14 Number Analyzed 154 participants 162 participants
-1.84  (0.21) -2.14  (0.20)
AM rTNSS Day 15 Number Analyzed 156 participants 163 participants
-1.67  (0.22) -2.15  (0.21)
AM rTNSS Day 16 Number Analyzed 161 participants 164 participants
-1.75  (0.22) -2.37  (0.21)
AM rTNSS Day 17 Number Analyzed 161 participants 160 participants
-2.12  (0.22) -2.62  (0.22)
AM rTNSS Day 18 Number Analyzed 163 participants 165 participants
-2.22  (0.21) -2.48  (0.21)
AM rTNSS Day 19 Number Analyzed 159 participants 164 participants
-1.83  (0.22) -2.37  (0.21)
AM rTNSS Day 20 Number Analyzed 157 participants 161 participants
-2.18  (0.22) -2.42  (0.22)
AM rTNSS Day 21 Number Analyzed 152 participants 163 participants
-2.07  (0.22) -2.64  (0.22)
AM rTNSS Day 22 Number Analyzed 147 participants 164 participants
-2.02  (0.23) -2.44  (0.22)
AM rTNSS Day 23 Number Analyzed 158 participants 162 participants
-1.96  (0.23) -2.17  (0.22)
AM rTNSS Day 24 Number Analyzed 156 participants 164 participants
-2.03  (0.23) -2.57  (0.22)
AM rTNSS Day 25 Number Analyzed 158 participants 163 participants
-2.22  (0.23) -2.45  (0.22)
AM rTNSS Day 26 Number Analyzed 152 participants 157 participants
-2.19  (0.23) -2.59  (0.23)
AM rTNSS Day 27 Number Analyzed 145 participants 153 participants
-2.23  (0.23) -2.54  (0.23)
AM rTNSS Day 28 Number Analyzed 110 participants 118 participants
-1.82  (0.30) -2.55  (0.27)
PM rTNSS Day 1 Number Analyzed 144 participants 152 participants
-0.88  (0.20) -0.97  (0.19)
PM rTNSS Day 2 Number Analyzed 157 participants 172 participants
-0.91  (0.18) -1.19  (0.17)
PM rTNSS Day 3 Number Analyzed 159 participants 170 participants
-1.10  (0.19) -1.39  (0.19)
PM rTNSS Day 4 Number Analyzed 164 participants 169 participants
-1.17  (0.19) -1.42  (0.19)
PM rTNSS Day 5 Number Analyzed 164 participants 172 participants
-1.06  (0.19) -1.29  (0.18)
PM rTNSS Day 6 Number Analyzed 162 participants 171 participants
-1.13  (0.21) -1.42  (0.20)
PM rTNSS Day 7 Number Analyzed 164 participants 168 participants
-1.48  (0.20) -1.64  (0.20)
PM rTNSS Day 8 Number Analyzed 152 participants 153 participants
-1.34  (0.20) -1.73  (0.19)
PM rTNSS Day 9 Number Analyzed 158 participants 166 participants
-1.49  (0.21) -1.89  (0.20)
PM rTNSS Day 10 Number Analyzed 162 participants 162 participants
-1.58  (0.21) -2.07  (0.21)
PM rTNSS Day 11 Number Analyzed 157 participants 162 participants
-1.62  (0.22) -2.02  (0.22)
PM rTNSS Day 12 Number Analyzed 158 participants 158 participants
-1.86  (0.21) -2.29  (0.21)
PM rTNSS Day 13 Number Analyzed 151 participants 166 participants
-1.91  (0.22) -2.18  (0.21)
PM rTNSS Day 14 Number Analyzed 157 participants 159 participants
-1.85  (0.23) -2.15  (0.22)
PM rTNSS Day 15 Number Analyzed 146 participants 155 participants
-1.78  (0.22) -2.15  (0.21)
PM rTNSS Day 16 Number Analyzed 153 participants 164 participants
-1.84  (0.23) -2.33  (0.22)
PM rTNSS Day 17 Number Analyzed 159 participants 158 participants
-1.81  (0.22) -2.51  (0.22)
PM rTNSS Day 18 Number Analyzed 161 participants 157 participants
-2.22  (0.22) -2.54  (0.23)
PM rTNSS Day 19 Number Analyzed 156 participants 162 participants
-2.23  (0.21) -2.53  (0.21)
PM rTNSS Day 20 Number Analyzed 155 participants 162 participants
-2.17  (0.21) -2.52  (0.20)
PM rTNSS Day 21 Number Analyzed 152 participants 160 participants
-2.19  (0.23) -2.48  (0.22)
PM rTNSS Day 22 Number Analyzed 150 participants 151 participants
-2.03  (0.22) -2.53  (0.22)
PM rTNSS Day 23 Number Analyzed 150 participants 161 participants
-2.06  (0.23) -2.41  (0.22)
PM rTNSS Day 24 Number Analyzed 155 participants 161 participants
-2.25  (0.22) -2.64  (0.21)
PM rTNSS Day 25 Number Analyzed 153 participants 161 participants
-2.39  (0.23) -2.42  (0.22)
PM rTNSS Day 26 Number Analyzed 151 participants 161 participants
-2.31  (0.23) -2.54  (0.22)
PM rTNSS Day 27 Number Analyzed 147 participants 149 participants
-2.25  (0.23) -2.54  (0.22)
PM rTNSS Day 28 Number Analyzed 117 participants 125 participants
-2.07  (0.30) -2.68  (0.28)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Fluticasone Furoate 110 mcg QD
Comments Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 1
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.011
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.450
Confidence Interval (2-Sided) 95%
-0.80 to -0.10
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Fluticasone Furoate 110 mcg QD
Comments Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 2
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.089
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.325
Confidence Interval (2-Sided) 95%
-0.70 to 0.05
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Fluticasone Furoate 110 mcg QD
Comments Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 3
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.052
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.393
Confidence Interval (2-Sided) 95%
-0.79 to 0.00
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, Fluticasone Furoate 110 mcg QD
Comments Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 4
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.187
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.262
Confidence Interval (2-Sided) 95%
-0.65 to 0.13
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, Fluticasone Furoate 110 mcg QD
Comments Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 5
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.164
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.298
Confidence Interval (2-Sided) 95%
-0.72 to 0.12
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo, Fluticasone Furoate 110 mcg QD
Comments Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 6
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.008
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.573
Confidence Interval (2-Sided) 95%
-1.00 to -0.15
Estimation Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Placebo, Fluticasone Furoate 110 mcg QD
Comments Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 7
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.082
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.376
Confidence Interval (2-Sided) 95%
-0.80 to 0.05
Estimation Comments [Not Specified]
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Placebo, Fluticasone Furoate 110 mcg QD
Comments Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 8
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.296
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.231
Confidence Interval (2-Sided) 95%
-0.67 to 0.20
Estimation Comments [Not Specified]
Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Placebo, Fluticasone Furoate 110 mcg QD
Comments Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 9
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.383
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.191
Confidence Interval (2-Sided) 95%
-0.62 to 0.24
Estimation Comments [Not Specified]
Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Placebo, Fluticasone Furoate 110 mcg QD
Comments Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 10
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.048
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.464
Confidence Interval (2-Sided) 95%
-0.92 to -0.00
Estimation Comments [Not Specified]
Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Placebo, Fluticasone Furoate 110 mcg QD
Comments Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 11
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.469
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.172
Confidence Interval (2-Sided) 95%
-0.64 to 0.29
Estimation Comments [Not Specified]
Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection Placebo, Fluticasone Furoate 110 mcg QD
Comments Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 12
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.151
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.340
Confidence Interval (2-Sided) 95%
-0.80 to 0.12
Estimation Comments [Not Specified]
Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection Placebo, Fluticasone Furoate 110 mcg QD
Comments Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 13
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.145
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.344
Confidence Interval (2-Sided) 95%
-0.81 to 0.12
Estimation Comments [Not Specified]
Hide Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection Placebo, Fluticasone Furoate 110 mcg QD
Comments Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 14
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.297
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.235
Confidence Interval (2-Sided) 95%
-0.68 to 0.21
Estimation Comments [Not Specified]
Hide Statistical Analysis 15
Statistical Analysis Overview Comparison Group Selection Placebo, Fluticasone Furoate 110 mcg QD
Comments Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 15
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.094
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.380
Confidence Interval (2-Sided) 95%
-0.82 to 0.07
Estimation Comments [Not Specified]
Hide Statistical Analysis 16
Statistical Analysis Overview Comparison Group Selection Placebo, Fluticasone Furoate 110 mcg QD
Comments Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 16
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.064
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.430
Confidence Interval (2-Sided) 95%
-0.89 to 0.03
Estimation Comments [Not Specified]
Hide Statistical Analysis 17
Statistical Analysis Overview Comparison Group Selection Placebo, Fluticasone Furoate 110 mcg QD
Comments Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 17
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.019
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.563
Confidence Interval (2-Sided) 95%
-1.03 to -0.09
Estimation Comments [Not Specified]
Hide Statistical Analysis 18
Statistical Analysis Overview Comparison Group Selection Placebo, Fluticasone Furoate 110 mcg QD
Comments Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 18
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.044
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.457
Confidence Interval (2-Sided) 95%
-0.90 to -0.01
Estimation Comments [Not Specified]
Hide Statistical Analysis 19
Statistical Analysis Overview Comparison Group Selection Placebo, Fluticasone Furoate 110 mcg QD
Comments Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 19
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.007
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.633
Confidence Interval (2-Sided) 95%
-1.09 to -0.17
Estimation Comments [Not Specified]
Hide Statistical Analysis 20
Statistical Analysis Overview Comparison Group Selection Placebo, Fluticasone Furoate 110 mcg QD
Comments Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 20
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.348
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.222
Confidence Interval (2-Sided) 95%
-0.69 to 0.24
Estimation Comments [Not Specified]
Hide Statistical Analysis 21
Statistical Analysis Overview Comparison Group Selection Placebo, Fluticasone Furoate 110 mcg QD
Comments Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 21
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.243
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.281
Confidence Interval (2-Sided) 95%
-0.76 to 0.19
Estimation Comments [Not Specified]
Hide Statistical Analysis 22
Statistical Analysis Overview Comparison Group Selection Placebo, Fluticasone Furoate 110 mcg QD
Comments Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 22
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.014
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.595
Confidence Interval (2-Sided) 95%
-1.07 to -0.12
Estimation Comments [Not Specified]
Hide Statistical Analysis 23
Statistical Analysis Overview Comparison Group Selection Placebo, Fluticasone Furoate 110 mcg QD
Comments Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 23
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.055
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.474
Confidence Interval (2-Sided) 95%
-0.96 to 0.01
Estimation Comments [Not Specified]
Hide Statistical Analysis 24
Statistical Analysis Overview Comparison Group Selection Placebo, Fluticasone Furoate 110 mcg QD
Comments Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 24
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.062
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.464
Confidence Interval (2-Sided) 95%
-0.95 to 0.02
Estimation Comments [Not Specified]
Hide Statistical Analysis 25
Statistical Analysis Overview Comparison Group Selection Placebo, Fluticasone Furoate 110 mcg QD
Comments Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 25
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.079
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.430
Confidence Interval (2-Sided) 95%
-0.91 to 0.05
Estimation Comments [Not Specified]
Hide Statistical Analysis 26
Statistical Analysis Overview Comparison Group Selection Placebo, Fluticasone Furoate 110 mcg QD
Comments Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 26
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.019
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.576
Confidence Interval (2-Sided) 95%
-1.06 to -0.10
Estimation Comments [Not Specified]
Hide Statistical Analysis 27
Statistical Analysis Overview Comparison Group Selection Placebo, Fluticasone Furoate 110 mcg QD
Comments Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 27
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.056
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.480
Confidence Interval (2-Sided) 95%
-0.97 to 0.01
Estimation Comments [Not Specified]
Hide Statistical Analysis 28
Statistical Analysis Overview Comparison Group Selection Placebo, Fluticasone Furoate 110 mcg QD
Comments Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 28
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.018
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.659
Confidence Interval (2-Sided) 95%
-1.20 to -0.11
Estimation Comments [Not Specified]
Hide Statistical Analysis 29
Statistical Analysis Overview Comparison Group Selection Placebo, Fluticasone Furoate 110 mcg QD
Comments Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 1
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.194
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.222
Confidence Interval (2-Sided) 95%
-0.56 to 0.1
Estimation Comments [Not Specified]
Hide Statistical Analysis 30
Statistical Analysis Overview Comparison Group Selection Placebo, Fluticasone Furoate 110 mcg QD
Comments Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 2
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.134
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.263
Confidence Interval (2-Sided) 95%
-0.61 to 0.08
Estimation Comments [Not Specified]
Hide Statistical Analysis 31
Statistical Analysis Overview Comparison Group Selection Placebo, Fluticasone Furoate 110 mcg QD
Comments Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 3
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.091
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.310
Confidence Interval (2-Sided) 95%
-0.67 to 0.05
Estimation Comments [Not Specified]
Hide Statistical Analysis 32
Statistical Analysis Overview Comparison Group Selection Placebo, Fluticasone Furoate 110 mcg QD
Comments Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 4
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.131
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.278
Confidence Interval (2-Sided) 95%
-0.64 to 0.08
Estimation Comments [Not Specified]
Hide Statistical Analysis 33
Statistical Analysis Overview Comparison Group Selection Placebo, Fluticasone Furoate 110 mcg QD
Comments Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 5
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.483
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.130
Confidence Interval (2-Sided) 95%
-0.49 to 0.23
Estimation Comments [Not Specified]
Hide Statistical Analysis 34
Statistical Analysis Overview Comparison Group Selection Placebo, Fluticasone Furoate 110 mcg QD
Comments Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 6
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.137
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.301
Confidence Interval (2-Sided) 95%
-0.70 to 0.10
Estimation Comments [Not Specified]
Hide Statistical Analysis 35
Statistical Analysis Overview Comparison Group Selection Placebo, Fluticasone Furoate 110 mcg QD
Comments Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 7
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.142
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.297
Confidence Interval (2-Sided) 95%
-0.69 to 0.10
Estimation Comments [Not Specified]
Hide Statistical Analysis 36
Statistical Analysis Overview Comparison Group Selection Placebo, Fluticasone Furoate 110 mcg QD
Comments Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 8
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.220
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.245
Confidence Interval (2-Sided) 95%
-0.64 to 0.15
Estimation Comments [Not Specified]
Hide Statistical Analysis 37
Statistical Analysis Overview Comparison Group Selection Placebo, Fluticasone Furoate 110 mcg QD
Comments Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 9
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.081
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.373
Confidence Interval (2-Sided) 95%
-0.79 to 0.05
Estimation Comments [Not Specified]
Hide Statistical Analysis 38
Statistical Analysis Overview Comparison Group Selection Placebo, Fluticasone Furoate 110 mcg QD
Comments Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 10
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.034
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.453
Confidence Interval (2-Sided) 95%
-0.87 to -0.04
Estimation Comments [Not Specified]
Hide Statistical Analysis 39
Statistical Analysis Overview Comparison Group Selection Placebo, Fluticasone Furoate 110 mcg QD
Comments Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 11
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.150
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.314
Confidence Interval (2-Sided) 95%
-0.74 to 0.11
Estimation Comments [Not Specified]
Hide Statistical Analysis 40
Statistical Analysis Overview Comparison Group Selection Placebo, Fluticasone Furoate 110 mcg QD
Comments Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 12
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.111
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.333
Confidence Interval (2-Sided) 95%
-0.74 to 0.08
Estimation Comments [Not Specified]
Hide Statistical Analysis 41
Statistical Analysis Overview Comparison Group Selection Placebo, Fluticasone Furoate 110 mcg QD
Comments Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 13
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.261
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.250
Confidence Interval (2-Sided) 95%
-0.69 to 0.19
Estimation Comments [Not Specified]
Hide Statistical Analysis 42
Statistical Analysis Overview Comparison Group Selection Placebo, Fluticasone Furoate 110 mcg QD
Comments Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 14
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.123
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.342
Confidence Interval (2-Sided) 95%
-0.78 to 0.09
Estimation Comments [Not Specified]
Hide Statistical Analysis 43
Statistical Analysis Overview Comparison Group Selection Placebo, Fluticasone Furoate 110 mcg QD
Comments Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 15
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.056
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.415
Confidence Interval (2-Sided) 95%
-0.84 to 0.01
Estimation Comments [Not Specified]
Hide Statistical Analysis 44
Statistical Analysis Overview Comparison Group Selection Placebo, Fluticasone Furoate 110 mcg QD
Comments Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 16
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.011
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.566
Confidence Interval (2-Sided) 95%
-1.00 to -0.13
Estimation Comments [Not Specified]
Hide Statistical Analysis 45
Statistical Analysis Overview Comparison Group Selection Placebo, Fluticasone Furoate 110 mcg QD
Comments Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 17
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.009
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.590
Confidence Interval (2-Sided) 95%
-1.03 to -0.15
Estimation Comments [Not Specified]
Hide Statistical Analysis 46
Statistical Analysis Overview Comparison Group Selection Placebo, Fluticasone Furoate 110 mcg QD
Comments Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 18
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.175
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.301
Confidence Interval (2-Sided) 95%
-0.74 to 0.13
Estimation Comments [Not Specified]
Hide Statistical Analysis 47
Statistical Analysis Overview Comparison Group Selection Placebo, Fluticasone Furoate 110 mcg QD
Comments Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 19
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.039
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.449
Confidence Interval (2-Sided) 95%
-0.87 to -0.02
Estimation Comments [Not Specified]
Hide Statistical Analysis 48
Statistical Analysis Overview Comparison Group Selection Placebo, Fluticasone Furoate 110 mcg QD
Comments Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 20
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.152
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.315
Confidence Interval (2-Sided) 95%
-0.75 to 0.12
Estimation Comments [Not Specified]
Hide Statistical Analysis 49
Statistical Analysis Overview Comparison Group Selection Placebo, Fluticasone Furoate 110 mcg QD
Comments Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 21
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.063
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.424
Confidence Interval (2-Sided) 95%
-0.87 to 0.02
Estimation Comments [Not Specified]
Hide Statistical Analysis 50
Statistical Analysis Overview Comparison Group Selection Placebo, Fluticasone Furoate 110 mcg QD
Comments Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 22
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.044
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.454
Confidence Interval (2-Sided) 95%
-0.90 to -0.01
Estimation Comments [Not Specified]
Hide Statistical Analysis 51
Statistical Analysis Overview Comparison Group Selection Placebo, Fluticasone Furoate 110 mcg QD
Comments Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 23
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.179
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.312
Confidence Interval (2-Sided) 95%
-0.77 to 0.14
Estimation Comments [Not Specified]
Hide Statistical Analysis 52
Statistical Analysis Overview Comparison Group Selection Placebo, Fluticasone Furoate 110 mcg QD
Comments Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 24
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.034
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.479
Confidence Interval (2-Sided) 95%
-0.92 to -0.04
Estimation Comments [Not Specified]
Hide Statistical Analysis 53
Statistical Analysis Overview Comparison Group Selection Placebo, Fluticasone Furoate 110 mcg QD
Comments Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 25
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.505
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.157
Confidence Interval (2-Sided) 95%
-0.62 to 0.31
Estimation Comments [Not Specified]
Hide Statistical Analysis 54
Statistical Analysis Overview Comparison Group Selection Placebo, Fluticasone Furoate 110 mcg QD
Comments Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 26
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.186
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.317
Confidence Interval (2-Sided) 95%
-0.79 to 0.15
Estimation Comments [Not Specified]
Hide Statistical Analysis 55
Statistical Analysis Overview Comparison Group Selection Placebo, Fluticasone Furoate 110 mcg QD
Comments Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 27
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.234
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.283
Confidence Interval (2-Sided) 95%
-0.75 to 0.18
Estimation Comments [Not Specified]
Hide Statistical Analysis 56
Statistical Analysis Overview Comparison Group Selection Placebo, Fluticasone Furoate 110 mcg QD
Comments Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 28
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.017
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.645
Confidence Interval (2-Sided) 95%
-1.17 to -0.12
Estimation Comments [Not Specified]
Hide Statistical Analysis 57
Statistical Analysis Overview Comparison Group Selection Placebo, Fluticasone Furoate 110 mcg QD
Comments Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 1
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.095
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.320
Confidence Interval (2-Sided) 95%
-0.70 to 0.06
Estimation Comments [Not Specified]
Hide Statistical Analysis 58
Statistical Analysis Overview Comparison Group Selection Placebo, Fluticasone Furoate 110 mcg QD
Comments Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 2
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.236
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.231
Confidence Interval (2-Sided) 95%
-0.61 to 0.15
Estimation Comments [Not Specified]
Hide Statistical Analysis 59
Statistical Analysis Overview Comparison Group Selection Placebo, Fluticasone Furoate 110 mcg QD
Comments Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 3
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.205
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.255
Confidence Interval (2-Sided) 95%
-0.65 to 0.14
Estimation Comments [Not Specified]
Hide Statistical Analysis 60
Statistical Analysis Overview Comparison Group Selection Placebo, Fluticasone Furoate 110 mcg QD
Comments Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 4
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.084
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.343
Confidence Interval (2-Sided) 95%
-0.73 to 0.05
Estimation Comments [Not Specified]
Hide Statistical Analysis 61
Statistical Analysis Overview Comparison Group Selection Placebo, Fluticasone Furoate 110 mcg QD
Comments Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 5
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.475
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.146
Confidence Interval (2-Sided) 95%
-0.55 to 0.26
Estimation Comments [Not Specified]
Hide Statistical Analysis 62
Statistical Analysis Overview Comparison Group Selection Placebo, Fluticasone Furoate 110 mcg QD
Comments Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 6
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.178
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.296
Confidence Interval (2-Sided) 95%
-0.73 to 0.14
Estimation Comments [Not Specified]
Hide Statistical Analysis 63
Statistical Analysis Overview Comparison Group Selection Placebo, Fluticasone Furoate 110 mcg QD
Comments Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 7
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.071
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.406
Confidence Interval (2-Sided) 95%
-0.85 to 0.04
Estimation Comments [Not Specified]
Hide Statistical Analysis 64
Statistical Analysis Overview Comparison Group Selection Placebo, Fluticasone Furoate 110 mcg QD
Comments Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 8
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.621
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.111
Confidence Interval (2-Sided) 95%
-0.55 to 0.33
Estimation Comments [Not Specified]
Hide Statistical Analysis 65
Statistical Analysis Overview Comparison Group Selection Placebo, Fluticasone Furoate 110 mcg QD
Comments Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 9
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.372
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.206
Confidence Interval (2-Sided) 95%
-0.66 to 0.25
Estimation Comments [Not Specified]
Hide Statistical Analysis 66
Statistical Analysis Overview Comparison Group Selection Placebo, Fluticasone Furoate 110 mcg QD
Comments Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 10
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.046
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.452
Confidence Interval (2-Sided) 95%
-0.90 to -0.01
Estimation Comments [Not Specified]
Hide Statistical Analysis 67
Statistical Analysis Overview Comparison Group Selection Placebo, Fluticasone Furoate 110 mcg QD
Comments Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 11
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.183
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.302
Confidence Interval (2-Sided) 95%
-0.75 to 0.14
Estimation Comments [Not Specified]
Hide Statistical Analysis 68
Statistical Analysis Overview Comparison Group Selection Placebo, Fluticasone Furoate 110 mcg QD
Comments Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 12
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.320
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.226
Confidence Interval (2-Sided) 95%
-0.67 to 0.22
Estimation Comments [Not Specified]
Hide Statistical Analysis 69
Statistical Analysis Overview Comparison Group Selection Placebo, Fluticasone Furoate 110 mcg QD
Comments Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 13
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.431
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.188
Confidence Interval (2-Sided) 95%
-0.66 to 0.28
Estimation Comments [Not Specified]
Hide Statistical Analysis 70
Statistical Analysis Overview Comparison Group Selection Placebo, Fluticasone Furoate 110 mcg QD
Comments Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 14
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.191
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.299
Confidence Interval (2-Sided) 95%
-0.75 to 0.15
Estimation Comments [Not Specified]
Hide Statistical Analysis 71
Statistical Analysis Overview Comparison Group Selection Placebo, Fluticasone Furoate 110 mcg QD
Comments Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 15
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.043
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.475
Confidence Interval (2-Sided) 95%
-0.94 to -0.02
Estimation Comments [Not Specified]
Hide Statistical Analysis 72
Statistical Analysis Overview Comparison Group Selection Placebo, Fluticasone Furoate 110 mcg QD
Comments Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 16
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.009
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.619
Confidence Interval (2-Sided) 95%
-1.08 to -0.16
Estimation Comments [Not Specified]
Hide Statistical Analysis 73
Statistical Analysis Overview Comparison Group Selection Placebo, Fluticasone Furoate 110 mcg QD
Comments Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 17
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.040
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.495
Confidence Interval (2-Sided) 95%
-0.97 to -0.02
Estimation Comments [Not Specified]
Hide Statistical Analysis 74
Statistical Analysis Overview Comparison Group Selection Placebo, Fluticasone Furoate 110 mcg QD
Comments Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 18
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.249
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.262
Confidence Interval (2-Sided) 95%
-0.71 to 0.18
Estimation Comments [Not Specified]
Hide Statistical Analysis 75
Statistical Analysis Overview Comparison Group Selection Placebo, Fluticasone Furoate 110 mcg QD
Comments Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 19
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.023
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.536
Confidence Interval (2-Sided) 95%
-1.00 to -0.07
Estimation Comments [Not Specified]
Hide Statistical Analysis 76
Statistical Analysis Overview Comparison Group Selection Placebo, Fluticasone Furoate 110 mcg QD
Comments Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 20
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.321
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.240
Confidence Interval (2-Sided) 95%
-0.71 to 0.23
Estimation Comments [Not Specified]
Hide Statistical Analysis 77
Statistical Analysis Overview Comparison Group Selection Placebo, Fluticasone Furoate 110 mcg QD
Comments Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 21
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.019
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.568
Confidence Interval (2-Sided) 95%
-1.04 to -0.09
Estimation Comments [Not Specified]
Hide Statistical Analysis 78
Statistical Analysis Overview Comparison Group Selection Placebo, Fluticasone Furoate 110 mcg QD
Comments Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 22
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.092
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.419
Confidence Interval (2-Sided) 95%
-0.91 to 0.07
Estimation Comments [Not Specified]
Hide Statistical Analysis 79
Statistical Analysis Overview Comparison Group Selection Placebo, Fluticasone Furoate 110 mcg QD
Comments Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 23
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.404
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.206
Confidence Interval (2-Sided) 95%
-0.69 to 0.28
Estimation Comments [Not Specified]
Hide Statistical Analysis 80
Statistical Analysis Overview Comparison Group Selection Placebo, Fluticasone Furoate 110 mcg QD
Comments Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 24
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.027
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.546
Confidence Interval (2-Sided) 95%
-1.03 to -0.06
Estimation Comments [Not Specified]
Hide Statistical Analysis 81
Statistical Analysis Overview Comparison Group Selection Placebo, Fluticasone Furoate 110 mcg QD
Comments Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 25
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.357
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.227
Confidence Interval (2-Sided) 95%
-0.71 to 0.26
Estimation Comments [Not Specified]
Hide Statistical Analysis 82
Statistical Analysis Overview Comparison Group Selection Placebo, Fluticasone Furoate 110 mcg QD
Comments Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 26
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.114
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.403
Confidence Interval (2-Sided) 95%
-0.90 to 0.10
Estimation Comments [Not Specified]
Hide Statistical Analysis 83
Statistical Analysis Overview Comparison Group Selection Placebo, Fluticasone Furoate 110 mcg QD
Comments Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 27
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.228
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.307
Confidence Interval (2-Sided) 95%
-0.81 to 0.19
Estimation Comments [Not Specified]
Hide Statistical Analysis 84
Statistical Analysis Overview Comparison Group Selection Placebo, Fluticasone Furoate 110 mcg QD
Comments Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 28
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.012
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.725
Confidence Interval (2-Sided) 95%
-1.29 to -0.16
Estimation Comments [Not Specified]
Hide Statistical Analysis 85
Statistical Analysis Overview Comparison Group Selection Placebo, Fluticasone Furoate 110 mcg QD
Comments Placebo versus Fluticasone Furoate 110 mcg QD for PM rTNSS at Day 1
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.643
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.093
Confidence Interval (2-Sided) 95%
-0.49 to 0.30
Estimation Comments [Not Specified]
Hide Statistical Analysis 86
Statistical Analysis Overview Comparison Group Selection Placebo, Fluticasone Furoate 110 mcg QD
Comments Placebo versus Fluticasone Furoate 110 mcg QD for PM rTNSS at Day 2
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.150
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.
Method of Estimation Estimation Parameter Mean Difference (Net)