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Trial record 27 of 10796 for:    Placebo AND once

Once-Daily Investigational Nasal Spray In Adults And Adolescents With Perennial Allergic Rhinitis (PAR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00289198
Recruitment Status : Completed
First Posted : February 9, 2006
Results First Posted : April 13, 2018
Last Update Posted : April 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, Allergic, Perennial
Interventions Drug: FF
Drug: Placebo
Enrollment 301
Recruitment Details This study was conducted from 07 February 2006 till 23 June 2006 at 40 centers across the globe. A total of 288 participants with perennial allergic rhinitis (PAR) were planned to be enrolled.
Pre-assignment Details Following a 7 to 14 day screening period, participants who met randomisation criteria were randomised to 6 weeks of treatment with fluticasone furoate or placebo nasal spray once daily. A total of 302 participants were randomised, 151 in each of the treatment groups.
Arm/Group Title Placebo Fluticasone Furoate
Hide Arm/Group Description Eligible participants received aqueous nasal spray of matching Placebo once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug. Eligible participants received aqueous nasal spray of Fluticasone furoate 100 micrograms (mcg) once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray (27.5 mcg per spray) into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug.
Period Title: Overall Study
Started 151 151
Completed 120 121
Not Completed 31 30
Reason Not Completed
Adverse Event             0             2
Protocol Violation             2             1
Withdrawal by Subject             4             1
Lack of Efficacy             2             0
Other: Low compliance             0             1
Other: Physician's decision             0             1
Other: Unable to attend on schedule             2             1
Other: Miscalculation of the visit date             21             22
Other: Impossible to come on visit             0             1
Arm/Group Title Fluticasone Furoate Placebo Total
Hide Arm/Group Description Eligible participants received aqueous nasal spray of Fluticasone furoate 100 mcg once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug. Eligible participants received aqueous nasal spray of matching Placebo once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug. Total of all reporting groups
Overall Number of Baseline Participants 151 151 302
Hide Baseline Analysis Population Description
The ITT Population included all participants who were randomized and received at least one dose of the study drug.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 151 participants 151 participants 302 participants
37.1  (16.57) 37.2  (16.20) 37.1  (16.36)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 151 participants 151 participants 302 participants
Female
85
  56.3%
86
  57.0%
171
  56.6%
Male
66
  43.7%
65
  43.0%
131
  43.4%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 151 participants 151 participants 302 participants
African American/African Heritage 4 3 7
American Indian or Alaska Native 0 1 1
Asian - Central/South Asian Heritage 2 1 3
Asian - East Asian Heritage 1 1 2
Asian - South East Asian Heritage 6 4 10
Native Hawaiian or other Pacific Islander 3 0 3
White - Arabic/North African Heritage 0 1 1
White - White/Caucasian/European Heritage 135 139 274
Mixed Race 0 1 1
1.Primary Outcome
Title Mean Change From Baseline (Day 1) Over the Entire Treatment Period in Daily, Reflective Total Nasal Symptom Scores (rTNSS) Over 6 Weeks
Hide Description TNSS is the sum of symptom scores for rhinorrhea, nasal congestion, nasal itching, and sneezing (each scored on a scale of 0 [none] to 3 [severe]; total possible score of 0 to 12). The rTNSS is a rating of the severity of symptoms over the previous 12 hours and is performed in morning (AM) and evening (PM). Daily rTNSS is defined as average of the PM rTNSS and the AM rTNSS of the next day prior to AM dosing. The Baseline daily rTNSS is defined as the average of the daily rTNSS over 4 consecutive 24 hour periods prior to randomization plus randomization day AM assessment. Change from Baseline was calculated as average of the non-missing daily rTNSS minus Baseline daily rTNSS. Analysis was performed using analysis of covariance (ANCOVA), adjusting for Baseline daily rTNSS, country, age, and gender. The Intent To Treat (ITT) Population comprised of all randomized participants who received >=1 dose of study drug. Only those participants available at the specified time points were analyzed
Time Frame Baseline (Day 1) and up to Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. Data is presented for the participants available at the time of assessment.
Arm/Group Title Placebo Fluticasone Furoate
Hide Arm/Group Description:
Eligible participants received aqueous nasal spray of matching Placebo once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug.
Eligible participants received aqueous nasal spray of Fluticasone furoate 100 mcg once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug.
Overall Number of Participants Analyzed 150 151
Least Squares Mean (Standard Error)
Unit of Measure: Scores on a scale
-2.69  (0.18) -3.95  (0.18)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Fluticasone Furoate
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Change from Baseline (Day 1) in reflective total nasal symptom scores for Placebo versus that for fluticasone furoate
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.256
Confidence Interval (2-Sided) 95%
-1.73 to -0.78
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Mean Change From Baseline (Day 1) in AM, Pre-dose, Instantaneous Total Nasal Symptom (iTNSS) Scores Over the Entire Treatment Period
Hide Description The AM pre-dose iTNSS is the sum of the 4 individual nasal symptom score assessments for rhinorrhea, nasal congestion, nasal itching, and sneezing performed at the moment immediately prior to taking the daily dose; each individual symptom score ranged on a scale of 0 to 3 where 0 indicated healthy condition and 3 indicated severity of the symptoms. The total score ranged on a scale of 0 to 12 where 0 indicated healthy condition and 12 indicated worst condition of symptoms. Baseline iTNSS is defined as the average of the non-missing values for iTNSS during the Baseline period where the Baseline period included the randomization day and the 3 consecutive days prior to randomization. Change from Baseline was calculated as score over the entire treatment period minus Baseline value. Analysis was performed using ANCOVA, adjusting for Baseline value, country, age, and gender. Only those participants available at the specified time points were analyzed.
Time Frame Baseline (Day 1) and up to Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. Data is presented for the participants available at the time of assessment.
Arm/Group Title Placebo Fluticasone Furoate
Hide Arm/Group Description:
Eligible participants received aqueous nasal spray of matching Placebo once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug.
Eligible participants received aqueous nasal spray of Fluticasone furoate 100 mcg once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug.
Overall Number of Participants Analyzed 149 150
Least Squares Mean (Standard Error)
Unit of Measure: Scores on a scale
-2.36  (0.18) -3.82  (0.18)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Fluticasone Furoate
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Mean change from Baseline in AM pre-dose instantaneous TNSS over entire period for Placebo versus that for Fluticasone furoate
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.459
Confidence Interval (2-Sided) 95%
-1.93 to -0.99
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Number of Participants With Response to Therapy Over Entire Treatment Period
Hide Description Response to therapy is defined as the effectiveness of FF for relieving allergic rhinitis symptoms over the entire treatment period. Response was, evaluated at the end of the study (Week 6) using a 7-point categorical scale, categorized as: 1=significantly improved, 2=moderately improved, 3=mildly improved, 4=no change, 5=mildly worse, 6=moderately worse, 7=significantly worse. Analysis was performed using logistic regression to evaluate treatment effect, adjusting for age, gender, and country. Effectiveness of the study drug for relieving allergic rhinitis symptoms over the entire treatment period was compared with Placebo.
Time Frame Up to 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. Data is presented for the participants available at the time of assessment.
Arm/Group Title Placebo Fluticasone Furoate
Hide Arm/Group Description:
Eligible participants received aqueous nasal spray of matching Placebo once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug.
Eligible participants received aqueous nasal spray of Fluticasone furoate 100 mcg once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug.
Overall Number of Participants Analyzed 151 151
Measure Type: Number
Unit of Measure: Participants
Significantly Improved 21 56
Moderately Improved 38 37
Mildly Improved 37 31
No Change 45 20
Mildly Worse 5 2
Moderately Worse 3 3
Significantly Worse 2 2
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Fluticasone Furoate
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Regression, Logistic
Comments Based on logistic regression adjusting for age, gender and country
4.Secondary Outcome
Title Mean Change From Baseline (Day 1) in AM rTNSS Over the Entire Treatment Period
Hide Description TNSS is the sum of symptom scores for rhinorrhea, nasal congestion, nasal itching, and sneezing (each scored on a scale of 0 [none] to 3 [severe]; total possible score of 0 to 12). The AM rTNSS is a rating of the severity of symptoms performed in the morning prior to administering the dose of study drug and assesses how the participant felt during the night (preceding 12 hours). Baseline rTNSS is defined as the average of the non-missing values for rTNSS during the Baseline period where the Baseline period included the randomization day and the 3 consecutive days prior to randomization. Change from Baseline was calculated as score over the entire treatment period minus Baseline value. Analysis was performed using ANCOVA, adjusting for Baseline value, country, age, and gender. Only those participants available at the specified time points were analyzed.
Time Frame Baseline (Day 1) and up to 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. Data is presented for the participants available at the time of assessment.
Arm/Group Title Placebo Fluticasone Furoate
Hide Arm/Group Description:
Eligible participants received aqueous nasal spray of matching Placebo once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug.
Eligible participants received aqueous nasal spray of Fluticasone furoate 100 mcg once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug.
Overall Number of Participants Analyzed 149 150
Least Squares Mean (Standard Error)
Unit of Measure: Scores on a scale
-2.66  (0.17) -3.93  (0.17)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Fluticasone Furoate
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.274
Confidence Interval (2-Sided) 95%
-1.74 to -0.81
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Mean Change From Baseline (Day 1) in PM rTNSS Over the Entire Treatment Period
Hide Description TNSS is the sum of symptom scores for rhinorrhea, nasal congestion, nasal itching, and sneezing (each scored on a scale of 0 [none] to 3 [severe]; total possible score of 0 to 12). The PM rTNSS is a rating of the severity of symptoms performed approximately 12 hours after dosing and before bedtime and assesses how the participant felt during the day. Baseline rTNSS is defined as the average of the non-missing values for rTNSS during the Baseline period where the baseline period includes the 4 consecutive days prior to randomization. Change from Baseline was calculated as score over the entire treatment period minus Baseline value. Analysis was performed using ANCOVA, adjusting for Baseline value, country, age, and gender. Only those participants available at the specified time points were analyzed.
Time Frame Baseline (Day 1) and up to 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. Data is presented for the participants available at the time of assessment.
Arm/Group Title Placebo Fluticasone Furoate
Hide Arm/Group Description:
Eligible participants received aqueous nasal spray of matching Placebo once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug.
Eligible participants received aqueous nasal spray of Fluticasone furoate 100 mcg once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug.
Overall Number of Participants Analyzed 150 150
Least Squares Mean (Standard Error)
Unit of Measure: Scores on a scale
-2.73  (0.18) -4.02  (0.18)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Fluticasone Furoate
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.291
Confidence Interval (2-Sided) 95%
-1.77 to -0.81
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Mean Percent Change From Baseline (Day 1) in Daily rTNSS Over the Entire Treatment Period
Hide Description TNSS is the sum of symptom scores for rhinorrhea, nasal congestion, nasal itching, and sneezing (each scored on a scale of 0 [none] to 3 [severe]; total possible score of 0 to 12). The rTNSS is a rating of the severity of symptoms over the previous 12 hours and is performed in morning (AM) and evening (PM). Daily rTNSS is defined as average of the PM rTNSS and the AM rTNSS of the next day prior to AM dosing. The Baseline daily rTNSS is defined as the average of the daily rTNSS over 4 consecutive 24 hour periods prior to randomization plus randomization day AM assessment. Change from Baseline was calculated as average of the non-missing daily rTNSS minus Baseline daily rTNSS. Analysis was performed using analysis of covariance (ANCOVA), adjusting for Baseline daily rTNSS, country, age, and gender. The Intent To Treat (ITT) Population comprised of all randomized participants who received >=1 dose of study drug. Only those participants available at the specified time points were analyzed
Time Frame Baseline (Day 1) and up to 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. Data is presented for the participants available at the time of assessment.
Arm/Group Title Placebo Fluticasone Furoate
Hide Arm/Group Description:
Eligible participants received aqueous nasal spray of matching Placebo once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug.
Eligible participants received aqueous nasal spray of Fluticasone furoate 100 mcg once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug.
Overall Number of Participants Analyzed 150 151
Least Squares Mean (Standard Error)
Unit of Measure: Percent change
-30.23  (2.22) -44.35  (2.21)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Fluticasone Furoate
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -14.118
Confidence Interval (2-Sided) 95%
-20.03 to -8.21
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Mean Percent Change From Baseline (Day 1) in AM Pre-Dose iTNSS Over the Entire Treatment Period
Hide Description TNSS is the sum of symptom scores for rhinorrhea, nasal congestion, nasal itching, and sneezing (each scored on a scale of 0 [none] to 3 [severe]; total possible score of 0 to 12). The rTNSS is a rating of the severity of symptoms over the previous 12 hours and is performed in morning (AM) and evening (PM). Daily rTNSS is defined as average of the PM rTNSS and the AM rTNSS of the next day prior to AM dosing. The BL daily rTNSS is defined as the average of the daily rTNSS over 4 consecutive 24-hour periods prior to randomization plus randomization day AM assessment. Change from Baseline was calculated as average of the non-missing daily rTNSS minus Baseline daily rTNSS. Analysis was performed using ANCOVA, adjusting for BL daily rTNSS, country, age, and gender. Only those participants available at the specified time points were analyzed. Change from Baseline is the value at indicated time-point minus the baseline value*100.
Time Frame Baseline and up to 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. Data is presented for the participants available at the time of assessment.
Arm/Group Title Placebo Fluticasone Furoate
Hide Arm/Group Description:
Eligible participants received aqueous nasal spray of matching Placebo once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug.
Eligible participants received aqueous nasal spray of Fluticasone furoate 100 mcg once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug.
Overall Number of Participants Analyzed 149 150
Least Squares Mean (Standard Error)
Unit of Measure: Percent change
-24.67  (2.66) -44.70  (2.66)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Fluticasone Furoate
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -20.033
Confidence Interval (2-Sided) 95%
-27.13 to -12.94
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Mean Change From Baseline (Day 1) in Daily Reflective Individual Nasal Symptom Scores (rINSS) Over the Entire Treatment Period
Hide Description The individual nasal symptom scores (INSS) for rhinorrhea, nasal congestion, nasal itching and sneezing were assessed on a 4 point (0 [none] to 3 [severe]) categorical scale and larger score indicates severe symptoms. The INSS is a rating of the severity of symptoms over the previous 12 hours and is performed in AM and PM. Daily INSS is defined as average of the PM INSS and the AM INSS of the next day prior to AM dosing. The Baseline daily INSS is defined as the average of the daily INSS over 4 consecutive 24-hour periods prior to randomization plus randomization day AM assessment. Change from Baseline was calculated as average of the non-missing daily INSS minus Baseline daily INSS. Analysis was performed using ANCOVA, adjusting for Baseline value, country, age, and gender.
Time Frame Baseline (Day 1) and up to 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. Only those participants available at the time of assessment were analyzed.
Arm/Group Title Placebo Fluticasone Furoate
Hide Arm/Group Description:
Eligible participants received aqueous nasal spray of matching Placebo once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug.
Eligible participants received aqueous nasal spray of Fluticasone furoate 100 mcg once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug.
Overall Number of Participants Analyzed 150 151
Least Squares Mean (Standard Error)
Unit of Measure: Scores on a scale
Rhinorrhea -0.67  (0.05) -0.94  (0.05)
Nasal Congestion -0.69  (0.05) -0.97  (0.05)
Nasal Itching -0.65  (0.05) -0.98  (0.05)
Sneezing -0.68  (0.05) -1.07  (0.05)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Fluticasone Furoate
Comments Rhinorrhea score, Placebo vs Fluticasone furoate
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.277
Confidence Interval (2-Sided) 95%
-0.41 to -0.14
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Fluticasone Furoate
Comments Nasal Congestion, Placebo vs Fluticasone furoate
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.277
Confidence Interval (2-Sided) 95%
-0.42 to -0.14
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Fluticasone Furoate
Comments Nasal Itching, Placebo vs Fluticasone furoate
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.331
Confidence Interval (2-Sided) 95%
-0.47 to -0.20
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, Fluticasone Furoate
Comments Sneezing score, Placebo vs Fluticasone furoate
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.390
Confidence Interval (2-Sided) 95%
-0.52 to -0.27
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Mean Change From Baseline (Day 1) in AM Pre-dose Instantaneous Individual Nasal Symptom Score (iINSS) Over the Entire Treatment Period
Hide Description The iINSS score for rhinorrhea, nasal congestion, nasal itching and sneezing were assessed on a 4 point (0 [none] to 3 [severe]) categorical scale and larger score indicates severe symptoms. The AM pre-dose iINSS is a rating of the severity of symptoms performed at the moment immediately prior to dosing. Baseline iINSS is defined as the average of the non-missing values for iINSS during the Baseline period where the Baseline period included the randomization day and the 3 consecutive days prior to randomization. Change from Baseline was calculated as score over the entire treatment period minus Baseline value. Analysis was performed using ANCOVA, adjusting for Baseline value, country, age, and gender. Only those participants available at the specified time points were analyzed.
Time Frame Baseline (Day 1) and up to 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. Data is presented for the participants available at the time of assessment.
Arm/Group Title Placebo Fluticasone Furoate
Hide Arm/Group Description:
Eligible participants received aqueous nasal spray of matching Placebo once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug.
Eligible participants received aqueous nasal spray of Fluticasone furoate 100 mcg once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug.
Overall Number of Participants Analyzed 149 150
Least Squares Mean (Standard Error)
Unit of Measure: Scores on a scale
Rhinorrhea -0.57  (0.05) -0.93  (0.05)
Nasal Congestion -0.55  (0.05) -0.92  (0.05)
Nasal Itching -0.61  (0.05) -0.98  (0.05)
Sneezing -0.63  (0.05) -1.00  (0.05)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Fluticasone Furoate
Comments Rhinorrhea score, Placebo versus fluticasone furoate
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.357
Confidence Interval (2-Sided) 95%
-0.50 to -0.22
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Fluticasone Furoate
Comments Nasal Congestion score, Placebo versus fluticasone furoate
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.370
Confidence Interval (2-Sided) 95%
-0.51 to -0.23
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Fluticasone Furoate
Comments Nasal itching score, Placebo versus fluticasone furoate
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.372
Confidence Interval (2-Sided) 95%
-0.50 to -0.24
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, Fluticasone Furoate
Comments Sneezing score, Placebo versus fluticasone furoate
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.372
Confidence Interval (2-Sided) 95%
-0.50 to -0.24
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Mean Change From Baseline (Day 1) in AM rINSS Over the Entire Treatment
Hide Description INSS for rhinorrhea, nasal congestion, nasal itching and sneezing were assessed on a 4 point (0 [none] to 3 [severe]) categorical scale and larger score indicates severe symptoms. The AM rINSS is a rating of the severity of symptoms performed in the morning prior to administering the dose of study drug and assesses how the participant felt during the night (preceding 12 hours). Baseline rINSS is defined as the average of the non-missing values for rINSS during the Baseline period where the Baseline period included the randomization day and the 3 consecutive days prior to randomization. Change from Baseline was calculated as score over the entire treatment period minus Baseline value. Analysis was performed using ANCOVA, adjusting for Baseline value, country, age, and gender. Only those par. available at the specified time points were analyzed.
Time Frame Baseline (Day 1) and up to 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. Data is presented for the participants available at the time of assessment.
Arm/Group Title Placebo Fluticasone Furoate
Hide Arm/Group Description:
Eligible participants received aqueous nasal spray of matching Placebo once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug.
Eligible participants received aqueous nasal spray of Fluticasone furoate 100 mcg once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug.
Overall Number of Participants Analyzed 149 150
Least Squares Mean (Standard Error)
Unit of Measure: Scores on a scale
Rhinorrhea -0.67  (0.05) -0.95  (0.05)
Nasal Congestion -0.66  (0.05) -0.98  (0.05)
Nasal Itching -0.64  (0.05) -0.96  (0.05)
Sneezing -0.69  (0.05) -1.06  (0.05)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Fluticasone Furoate
Comments Rhinorrhea score,Placebo versus fluticasone furoate
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.281
Confidence Interval (2-Sided) 95%
-0.42 to -0.14
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Fluticasone Furoate
Comments Nasal Congestion score, Placebo versus fluticasone furoate
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.314
Confidence Interval (2-Sided) 95%
-0.45 to -0.17
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Fluticasone Furoate
Comments Nasal itching score, Placebo versus fluticasone furoate
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.324
Confidence Interval (2-Sided) 95%
-0.45 to -0.19
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, Fluticasone Furoate
Comments Sneezing score, Placebo versus fluticasone furoate
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.374
Confidence Interval (2-Sided) 95%
-0.50 to -0.25
Estimation Comments [Not Specified]
11.Secondary Outcome
Title Mean Change From Baseline (Day 1) in PM rINSS Over the Entire Treatment Period
Hide Description rINSS for rhinorrhea, nasal congestion, nasal itching and sneezing were assessed on a 4 point (0 [none] to 3 [severe]) categorical scale and larger score indicates severe symptoms. The PM rINSS is a rating of the severity of symptoms performed approximately 12 hours after dosing and before bedtime and assesses how the participant felt during the day. Baseline rINSS is defined as the average of the non-missing values for rINSS during the Baseline period where the Baseline period included the 4 consecutive days prior to randomization. Change from Baseline was calculated as score over the entire treatment period minus Baseline value. Analysis was performed using ANCOVA, adjusting for Baseline value, country, age, and gender. Only those par. available at the specified time points were analyzed.
Time Frame Baseline (Day 1) and up to 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title Placebo Fluticasone Furoate
Hide Arm/Group Description:
Eligible participants received aqueous nasal spray of matching Placebo once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug.
Eligible participants received aqueous nasal spray of Fluticasone furoate 100 micrograms (mcg) once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug.
Overall Number of Participants Analyzed 150 150
Least Squares Mean (Standard Error)
Unit of Measure: Scores on a scale
Rhinorrhea -0.66  (0.05) -0.96  (0.05)
Nasal Congestion -0.70  (0.05) -0.97  (0.05)
Nasal Itching -0.68  (0.05) -1.01  (0.05)
Sneezing -0.68  (0.05) -1.09  (0.05)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Fluticasone Furoate
Comments Rhinorrhea score, Placebo vs Fluticasone furoate
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.292
Confidence Interval 95%
-0.43 to -0.15
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Fluticasone Furoate
Comments Nasal Congestion score, Placebo vs Fluticasone furoate
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.264
Confidence Interval (2-Sided) 95%
-0.40 to -0.12
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Fluticasone Furoate
Comments Nasal Itching score, Placebo vs Fluticasone furoate
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.336
Confidence Interval (2-Sided) 95%
-0.48 to -0.20
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, Fluticasone Furoate
Comments Sneezing score, Placebo vs Fluticasone furoate
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.412
Confidence Interval (2-Sided) 95%
-0.54 to -0.28
Estimation Comments [Not Specified]
12.Secondary Outcome
Title Mean Change From Baseline (Day 1) in Daily Reflective Total Ocular Symptom Score (rTOSS) Over the Entire Treatment Period
Hide Description TOSS is defined as the sum of the 3 individual ocular symptom scores for itching/burning eyes, tearing/watering eyes, and eye redness, and ranges from 0 to 9. Each symptom is scored on a 4 point (0 [none] to 3 [severe]) categorical scale. The rTOSS is a rating of the severity of symptoms over the previous 12 hours and is performed in AM and PM. Daily rTOSS is defined as average of the PM rTOSS and the AM rTOSS of the next day prior to AM dosing. The BL daily rTOSS is defined as the average of the daily rTOSS over 4 consecutive 24-hour periods prior to randomization plus randomization day AM assessment. Change from BL was calculated as average of the non-missing daily rTOSS minus BL daily rTOSS. Analysis was performed using ANCOVA, adjusting for BL value, country, age, and gender. Only those participants available at the specified time points were analyzed.
Time Frame Baseline (Day 1) and up to 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. Data is presented for the participants available at the time of assessment.
Arm/Group Title Placebo Fluticasone Furoate
Hide Arm/Group Description:
Eligible participants received aqueous nasal spray of matching Placebo once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug.
Eligible participants received aqueous nasal spray of Fluticasone furoate 100 mcg once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug.
Overall Number of Participants Analyzed 150 151
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
-1.41  (0.13) -1.92  (0.13)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Fluticasone Furoate
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.004
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.506
Confidence Interval (2-Sided) 95%
-0.85 to -0.16
Estimation Comments [Not Specified]
13.Secondary Outcome
Title Mean Change From Baseline (Day 1) in AM Pre-dose Instantaneous TOSS (iTOSS) Over the Entire Treatment Period
Hide Description The TOSS score is defined as the sum of the 3 individual ocular symptom scores for itching/burning eyes, tearing/watering eyes, and eye redness, and ranges from 0 to 9. Each symptom is scored on a 4 point (0 [none] to 3 [severe]) categorical scale. The AM pre-dose iTOSS is a rating of the severity of symptoms performed at the moment immediately prior to dosing. Baseline iTOSS is defined as the average of the non-missing values for iTOSS during the Baseline period where the Baseline period included the randomization day and the 3 consecutive days prior to randomization. Change from Baseline was calculated as score over the entire treatment period minus Baseline value. Analysis was performed using ANCOVA, adjusting for Baseline value, country, age, and gender.
Time Frame Baseline (Day 1) and up to 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. Data is presented for the participants available at the time of assessment.
Arm/Group Title Placebo Fluticasone Furoate
Hide Arm/Group Description:
Eligible participants received aqueous nasal spray of matching Placebo once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug.
Eligible participants received aqueous nasal spray of Fluticasone furoate 100 mcg once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug.
Overall Number of Participants Analyzed 149 150
Least Squares Mean (Standard Error)
Unit of Measure: Scores on a scale
-1.26  (0.13) -1.76  (0.13)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Fluticasone Furoate
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.007
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.491
Confidence Interval 95%
-0.85 to -0.13
Estimation Comments [Not Specified]
14.Secondary Outcome
Title Mean Change From Baseline (Day 1) in AM rTOSS Over the Entire Treatment Period
Hide Description The TOSS score is defined as the sum of the 3 individual ocular symptom scores for itching/burning eyes, tearing/watering eyes, and eye redness, and ranges from 0 to 9. Each symptom is scored on a 4 point (0 [none] to 3 [severe]) categorical scale and larger score indicates more severe symptoms. The AM rTOSS is a rating of the severity of symptoms performed in the morning prior to administering the dose of study drug and assesses how the participant felt during the night (preceding 12 hours). Baseline rTOSS is defined as the average of the non-missing values for rTOSS during the Baseline period where the Baseline period includes the randomization day and the 3 consecutive days prior to randomization. Change from Baseline was calculated as score over the entire treatment period minus Baseline value. Analysis was performed using ANCOVA, adjusting for Baseline value, country, age, and gender. Only those participants available at the specified time points were analyzed
Time Frame Baseline (Day 1) and up to 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. Data is presented for the participants available at the time of assessment.
Arm/Group Title Placebo Fluticasone Furoate
Hide Arm/Group Description:
Eligible participants received aqueous nasal spray of matching Placebo once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug.
Eligible participants received aqueous nasal spray of Fluticasone furoate 100 mcg once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug.
Overall Number of Participants Analyzed 149 150
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
-1.39  (0.13) -1.92  (0.13)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Fluticasone Furoate
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.003
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.531
Confidence Interval (2-Sided) 95%
-0.88 to -0.19
Estimation Comments [Not Specified]
15.Secondary Outcome
Title Mean Change From Baseline (Day 1) in PM rTOSS Over the Entire Treatment Period
Hide Description The TOSS score is defined as the sum of the 3 individual ocular symptom scores for itching/burning eyes, tearing/watering eyes, and eye redness, and ranges from 0 to 9. Each symptom is scored on a 4 point (0 [none] to 3 [severe]) categorical scale. The PM rTOSS is a rating of the severity of symptoms performed approximately 12 hours after dosing and before bedtime and assesses how the participant felt during the day. Baseline rTOSS is defined as the average of the non-missing values for rTOSS during the Baseline period where the baseline period includes the 4 consecutive days prior to randomization. Change from Baseline was calculated as score over the entire treatment period minus Baseline value. Analysis was performed using ANCOVA, adjusting for Baseline value, country, age, and gender. Only those participants available at the specified time points were analyzed.
Time Frame Baseline (Day 1) and up to 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. Data is presented for the participants available at the time of assessment.
Arm/Group Title Placebo Fluticasone Furoate
Hide Arm/Group Description:
Eligible participants received aqueous nasal spray of matching Placebo once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug.
Eligible participants received aqueous nasal spray of Fluticasone furoate 100 mcg once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug.
Overall Number of Participants Analyzed 150 150
Least Squares Mean (Standard Error)
Unit of Measure: Scores on a scale
-1.44  (0.13) -1.93  (0.13)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Fluticasone Furoate
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.005
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.496
Confidence Interval (2-Sided) 95%
-0.84 to -0.15
Estimation Comments [Not Specified]
16.Secondary Outcome
Title Mean Change From Baseline (Day 1) in Daily Reflective Individual Ocular Symptom Scores (iIOSS) Over the Entire Treatment Period
Hide Description Individual ocular symptom scores (IOSS) for itching/burning eyes, tearing/watering eyes, and eye redness were assessed on a 4 point (0 [none]to 3 [severe]) categorical scale. The IOSS is a rating of the severity of symptoms over the previous 12 hours and is performed in AM and PM. Daily IOSS is defined as average of the PM IOSS and the AM IOSS of the next day prior to AM dosing. The BL daily IOSS is defined as the average of the daily IOSS over 4 consecutive 24-hour periods prior to randomization plus randomization day AM assessment. Change from BL was calculated as average of the non-missing daily IOSS minus BL daily IOSS. Analysis was performed using ANCOVA, adjusting for BL value, country, age, and gender.
Time Frame Baseline (Day 1) and up to 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. Data is presented for the participants available at the time of assessment.
Arm/Group Title Placebo Fluticasone Furoate
Hide Arm/Group Description:
Eligible participants received aqueous nasal spray of matching Placebo once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug.
Eligible participants received aqueous nasal spray of Fluticasone furoate 100 mcg once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug.
Overall Number of Participants Analyzed 150 151
Least Squares Mean (Standard Error)
Unit of Measure: Scores on a scale
Eye itching/burning -0.47  (0.05) -0.69  (0.05)
Eye tearing/watering -0.48  (0.05) -0.62  (0.05)
Eye redness -0.45  (0.04) -0.61  (0.04)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Fluticasone Furoate
Comments Eye itching/burning score, Placebo vs fluticasone furoate
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.216
Confidence Interval (2-Sided) 95%
-0.34 to -0.09
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Fluticasone Furoate
Comments Eye tearing/watering score, Placebo vs fluticasone furoate
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.028
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.137
Confidence Interval (2-Sided) 95%
-0.26 to -0.02
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Fluticasone Furoate
Comments Eye redness, Placebo vs fluticasone furoate
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.010
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.156
Confidence Interval (2-Sided) 95%
-0.27 to -0.04
Estimation Comments [Not Specified]
17.Secondary Outcome
Title Mean Change From Baseline (Day 1) in AM Pre-Dose Instantaneous Individual Ocular Symptom Score (iIOSS) Over the Entire Treatment Period
Hide Description IOSS for itching/burning eyes, tearing/watering eyes, and eye redness were assessed on a 4 point (0 [none]to 3 [severe]) categorical scale. The AM pre-dose iIOSS is a rating of the severity of symptoms performed at the moment immediately prior to dosing. Baseline iIOSS is defined as the average of the non-missing values for iIOSS during the Baseline period where the Baseline period includes the randomization day and the 3 consecutive days prior to randomization. Change from Baseline is calculated as the score over the entire treatment period minus the score at Baseline. Analysis was performed using ANCOVA, adjusting for Baseline value, country, age, and gender.
Time Frame Baseline (Day 1) and up to 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. Data is presented for the participants available at the time of assessment.
Arm/Group Title Placebo Fluticasone Furoate
Hide Arm/Group Description:
Eligible participants received aqueous nasal spray of matching Placebo once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug.
Eligible participants received aqueous nasal spray of Fluticasone furoate 100 mcg once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug.
Overall Number of Participants Analyzed 149 150
Least Squares Mean (Standard Error)
Unit of Measure: Scores on a scale
Eye itching/burning -0.39  (0.05) -0.6  (0.5)
Eye tearing/watering -0.43  (0.05) -0.59  (0.05)
Eye redness -0.45  (0.05) -0.56  (0.05)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Fluticasone Furoate
Comments Eye itching/burning score, Placebo vs fluticasone furoate
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.215
Confidence Interval (2-Sided) 95%
-0.35 to -0.08
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Fluticasone Furoate
Comments Eye tearing or watering, Placebo vs fluticasone furoate
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.016
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.161
Confidence Interval 95%
-0.29 to -0.03
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Fluticasone Furoate
Comments Eye redness score, Placebo vs fluticasone furoate
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.076
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.113
Confidence Interval (2-Sided) 95%
-0.24 to -0.01
Estimation Comments [Not Specified]
18.Secondary Outcome
Title Mean Change From Baseline (Day 1) in AM Reflective Individual Ocular Symptom Score (rIOSS) Over the Entire Treatment Period
Hide Description rIOSS for itching/burning eyes, tearing/watering eyes, and eye redness were assessed on a 4 point (0 [none]to 3 [severe]) categorical scale. The AM rIOSS is a rating of the severity of symptoms performed in the morning prior to administering the dose of study drug and assesses how the participant felt during the night (preceding 12 hours). Baseline rIOSS is defined as the average of the non-missing values for rIOSS during the Baseline period where the Baseline period includes the randomization day and the 3 consecutive days prior to randomization. Change from Baseline was calculated as score over the entire treatment period minus Baseline value. Analysis was performed using ANCOVA, adjusting for Baseline value, country, age, and gender.
Time Frame Baseline (Day 1) and up to 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. Data is presented for the participants available at the time of assessment.
Arm/Group Title Placebo Fluticasone Furoate
Hide Arm/Group Description:
Eligible participants received aqueous nasal spray of matching Placebo once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug.
Eligible participants received aqueous nasal spray of Fluticasone furoate 100 mcg once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug.
Overall Number of Participants Analyzed 149 150
Least Squares Mean (Standard Error)
Unit of Measure: Scores on a scale
Eye itching/burning -0.48  (0.05) -0.69  (0.05)
Eye tearing/watering -0.48  (0.05) -0.62  (0.05)
Eye redness -0.44  (0.05) -0.61  (0.05)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Fluticasone Furoate
Comments Eye itching/burning score, Placebo vs Fluticasone furoate
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.211
Confidence Interval (2-Sided) 95%
-0.34 to -0.08
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Fluticasone Furoate
Comments Eye tearing/watering, Placebo vs Fluticasone furoate
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.023
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.145
Confidence Interval (2-Sided) 95%
-0.27 to -0.02
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Fluticasone Furoate
Comments Eye Redness score, Placebo vs Fluticasone furoate
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.005
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.176
Confidence Interval (2-Sided) 95%
-0.30 to -0.05
Estimation Comments [Not Specified]
19.Secondary Outcome
Title Mean Change From Baseline (Day 1) in PM rIOSS Over the Entire Treatment Period
Hide Description IOSS for itching/burning eyes, tearing/watering eyes, and eye redness were assessed on a 4 point (0 [none]to 3 [severe]) categorical scale. The PM rIOSS is a rating of the severity of symptoms performed approximately 12 hours after dosing and before bedtime and assesses how the participant felt during the day. Baseline rIOSS is defined as the average of the non-missing values for rIOSS during the Baseline period where the baseline period includes the 4 consecutive days prior to randomization. Change from Baseline is calculated as the score over the entire treatment period minus the score at Baseline. Analysis was performed using ANCOVA, adjusting for Baseline value, country, age, and gender.
Time Frame Baseline (Day 1) and up to 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. Data is presented for the participants available at the time of assessment.
Arm/Group Title Placebo Fluticasone Furoate
Hide Arm/Group Description:
Eligible participants received aqueous nasal spray of matching Placebo once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug.
Eligible participants received aqueous nasal spray of Fluticasone furoate 100 mcg once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug.
Overall Number of Participants Analyzed 150 150
Least Squares Mean (Standard Error)
Unit of Measure: Scores on a scale
Eye itching/burning -0.47  (0.05) -0.69  (0.05)
Eye tearing/watering -0.49  (0.05) -0.62  (0.05)
Eye redness -0.47  (0.05) -0.61  (0.05)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Fluticasone Furoate
Comments Eye itching/burning, Placebo vs fluticasone furoate
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.223
Confidence Interval (2-Sided) 95%
-0.35 to -0.09
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Fluticasone Furoate
Comments Eye Tearing/Watering score, Placebo vs fluticasone furoate
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.040
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.130
Confidence Interval (2-Sided) 95%
-0.25 to -0.01
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Fluticasone Furoate
Comments Eye Redness score, Placebo vs fluticasone furoate
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.022
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.142
Confidence Interval (2-Sided) 95%
-0.26 to -0.02
Estimation Comments [Not Specified]
20.Secondary Outcome
Title Mean Change From Baseline (Day 1) in Daily Peak Nasal Inspiratory Flow (PNIF) Over the Entire Treatment Period
Hide Description PNIF is the tool for determining the extent of nasal airway obstruction. Participants used a portable hand-held inspiratory flow meter and face mask to measure and record PNIF. PNIF measurements was completed and recorded following assessment of allergy symptoms in the AM (prior to taking study medication), and 12 hours later in the PM (after recording allergy symptoms). Three measurements were taken and the highest measurement recorded on the electronic diary. Daily PNIF is defined as average of PM PNIF and AM PNIF of the next day prior to AM dosing. The Baseline is defined as average of the last 8 readings (4 AM and 4 PM) of PNIF measurement over the four 24-hour periods prior to randomization. Change from Baseline is calculated as the value over the entire treatment period minus the value at Baseline. Analysis was performed using ANCOVA, adjusting for BL value, country, age, and gender.
Time Frame Baseline (Day 1) and up to 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. Data is presented for the participants available at the time of assessment.
Arm/Group Title Placebo Fluticasone Furoate
Hide Arm/Group Description:
Eligible participants received aqueous nasal spray of matching Placebo once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug.
Eligible participants received aqueous nasal spray of Fluticasone furoate 100 mcg once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug.
Overall Number of Participants Analyzed 150 151
Least Squares Mean (Standard Error)
Unit of Measure: Liters per minute
17.35  (2.13) 25.72  (2.13)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Fluticasone Furoate
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.004
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 8.376
Confidence Interval (2-Sided) 95%
2.71 to 14.04
Estimation Comments [Not Specified]
21.Secondary Outcome
Title Mean Change From Baseline (Day 1) in AM PNIF Over the Entire Treatment Period
Hide Description PNIF is the tool for determining the extent of nasal airway obstruction. Participants used a portable hand-held inspiratory flow meter and face mask to measure and record PNIF. AM PNIF measurements was completed and recorded following assessment of allergy symptoms in the AM (prior to taking study medication). Three measurements were taken and the highest measurement recorded on the electronic diary. Baseline AM PNIF is defined as the average of the non-missing values for PNIF during the Baseline period where the Baseline period includes the randomization day and the 3 consecutive days prior to randomization. Change from Baseline is calculated as the value over the entire treatment period minus the value at Baseline. Analysis was performed using ANCOVA, adjusting for Baseline value, country, age, and gender.
Time Frame Baseline (Day 1) and up to 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. Data is presented for the participants available at the time of assessment.
Arm/Group Title Placebo Fluticasone Furoate
Hide Arm/Group Description:
Eligible participants received aqueous nasal spray of matching Placebo once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug.
Eligible participants received aqueous nasal spray of Fluticasone furoate 100 mcg once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug.
Overall Number of Participants Analyzed 149 150
Least Squares Mean (Standard Error)
Unit of Measure: Liters per minute
16.33  (2.16) 25.61  (2.17)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Fluticasone Furoate
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 9.280
Confidence Interval (2-Sided) 95%
3.52 to 15.04
Estimation Comments [Not Specified]
22.Secondary Outcome
Title Mean Change From Baseline (Day 1) in PM PNIF Over the Entire Treatment Period
Hide Description The PNIF score is the tool for determining the extent of nasal airway obstruction. Participants used a portable hand-held inspiratory flow meter and face mask to measure and record PNIF. PM PNIF measurements was completed and recorded after assessment of allergy symptoms in the PM (12 hours after study medication). Three measurements were taken on each occasion and the highest measurement recorded on the electronic diary. Baseline PM PNIF is defined as the average of the non-missing values for PNIF during the Baseline period where the Baseline period includes the 4 consecutive days prior to randomization. Change from baseline is calculated as the value over the entire treatment period minus the value at Baseline. Analysis was performed using ANCOVA, adjusting for Baseline value, country, age, and gender.
Time Frame Baseline (Day 1) and up to 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. Data is presented for the participants available at the time of assessment.
Arm/Group Title Placebo Fluticasone Furoate
Hide Arm/Group Description:
Eligible participants received aqueous nasal spray of matching Placebo once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug.
Eligible participants received aqueous nasal spray of Fluticasone furoate 100 mcg once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug.
Overall Number of Participants Analyzed 150 147
Least Squares Mean (Standard Error)
Unit of Measure: Liters per minute
18.51  (2.15) 26.15  (2.20)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Fluticasone Furoate
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.009
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 7.638
Confidence Interval (2-Sided) 95%
1.89 to 13.39
Estimation Comments [Not Specified]
Time Frame Serious adverse events (SAEs) and non-serious adverse events (nSAEs) were collected from the start of study treatment until follow-up period (Up to 48 days).
Adverse Event Reporting Description SAEs and non-serious AEs were reported for members of the ITT population that comprised of all participants who were randomised to treatment, and received at least one dose of study drug.
 
Arm/Group Title Placebo Fluticasone Furoate
Hide Arm/Group Description Eligible participants received aqueous nasal spray of matching Placebo once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug. Eligible participants received aqueous nasal spray of Fluticasone furoate 100 micrograms (mcg) once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug.
All-Cause Mortality
Placebo Fluticasone Furoate
Affected / at Risk (%) Affected / at Risk (%)
Total   0/151 (0.00%)   0/151 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Fluticasone Furoate
Affected / at Risk (%) Affected / at Risk (%)
Total   0/151 (0.00%)   1/151 (0.66%) 
Infections and infestations     
Acute sinusitis  1  0/151 (0.00%)  1/151 (0.66%) 
1
Term from vocabulary, MedDRA 9.0
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Placebo Fluticasone Furoate
Affected / at Risk (%) Affected / at Risk (%)
Total   66/151 (43.71%)   77/151 (50.99%) 
Blood and lymphatic system disorders     
Lymphadenopathy  1  1/151 (0.66%)  1/151 (0.66%) 
Anaemia  1  0/151 (0.00%)  1/151 (0.66%) 
Ear and labyrinth disorders     
Motion sickness  1  1/151 (0.66%)  0/151 (0.00%) 
Eye disorders     
Conjunctivitis  1  0/151 (0.00%)  2/151 (1.32%) 
Vision blurred  1  1/151 (0.66%)  1/151 (0.66%) 
Dry eye  1  0/151 (0.00%)  1/151 (0.66%) 
Eye pain  1  1/151 (0.66%)  0/151 (0.00%) 
Ocular hyperaemia  1  1/151 (0.66%)  0/151 (0.00%) 
Visual disturbance  1  1/151 (0.66%)  0/151 (0.00%) 
Gastrointestinal disorders     
Diarrhoea  1  2/151 (1.32%)  3/151 (1.99%) 
Nausea  1  1/151 (0.66%)  4/151 (2.65%) 
Dyspepsia  1  1/151 (0.66%)  2/151 (1.32%) 
Abdominal pain upper  1  0/151 (0.00%)  2/151 (1.32%) 
Dry mouth  1  1/151 (0.66%)  1/151 (0.66%) 
Abdominal distension  1  0/151 (0.00%)  1/151 (0.66%) 
Abdominal pain  1  0/151 (0.00%)  1/151 (0.66%) 
Constipation  1  0/151 (0.00%)  1/151 (0.66%) 
Oral soft tissue disorder  1  1/151 (0.66%)  0/151 (0.00%) 
Stomach discomfort  1  0/151 (0.00%)  1/151 (0.66%) 
General disorders     
Gastrooesophageal reflux disease  1  0/151 (0.00%)  1/151 (0.66%) 
Pyrexia  1  3/151 (1.99%)  2/151 (1.32%) 
Chest pain  1  1/151 (0.66%)  1/151 (0.66%) 
Fatigue  1  0/151 (0.00%)  2/151 (1.32%) 
Feeling hot  1  1/151 (0.66%)  1/151 (0.66%) 
Thirst  1  2/151 (1.32%)  0/151 (0.00%) 
Chills  1  1/151 (0.66%)  0/151 (0.00%) 
Oedema peripheral  1  1/151 (0.66%)  0/151 (0.00%) 
Pain  1  0/151 (0.00%)  1/151 (0.66%) 
Immune system disorders     
Food allergy  1  0/151 (0.00%)  1/151 (0.66%) 
Infections and infestations     
Nasopharyngitis  1  7/151 (4.64%)  9/151 (5.96%) 
Upper respiratory tract infection  1  6/151 (3.97%)  3/151 (1.99%) 
Influenza  1  2/151 (1.32%)  3/151 (1.99%) 
Viral infection  1  1/151 (0.66%)  3/151 (1.99%) 
Gastroenteritis viral  1  1/151 (0.66%)  1/151 (0.66%) 
Bronchitis  1  0/151 (0.00%)  1/151 (0.66%) 
Fungal infection  1  1/151 (0.66%)  0/151 (0.00%) 
Gastroenteritis  1  0/151 (0.00%)  1/151 (0.66%) 
Herpes simplex  1  1/151 (0.66%)  0/151 (0.00%) 
Nasal candidiasis  1  1/151 (0.66%)  0/151 (0.00%) 
Pharyngeal candidiasis  1  0/151 (0.00%)  1/151 (0.66%) 
Pharyngitis  1  0/151 (0.00%)  1/151 (0.66%) 
Purulent discharge  1  0/151 (0.00%)  1/151 (0.66%) 
Rhinovirus infection  1  1/151 (0.66%)  0/151 (0.00%) 
Sinusitis  1  1/151 (0.66%)  0/151 (0.00%) 
Injury, poisoning and procedural complications     
Procedural pain  1  1/151 (0.66%)  3/151 (1.99%) 
Contusion  1  1/151 (0.66%)  1/151 (0.66%) 
Arthropod bite  1  1/151 (0.66%)  0/151 (0.00%) 
Fall  1  0/151 (0.00%)  1/151 (0.66%) 
Joint sprain  1  1/151 (0.66%)  0/151 (0.00%) 
Ligament rupture  1  0/151 (0.00%)  1/151 (0.66%) 
Investigations     
Blood pressure increased  1  1/151 (0.66%)  0/151 (0.00%) 
Metabolism and nutrition disorders     
Anorexia  1  1/151 (0.66%)  0/151 (0.00%) 
Fluid retention  1  0/151 (0.00%)  1/151 (0.66%) 
Musculoskeletal and connective tissue disorders     
Muscle tightness  1  1/151 (0.66%)  2/151 (1.32%) 
Back pain  1  1/151 (0.66%)  1/151 (0.66%) 
Arthritis  1  0/151 (0.00%)  1/151 (0.66%) 
Bone cyst  1  0/151 (0.00%)  1/151 (0.66%) 
Muscle spasms  1  0/151 (0.00%)  1/151 (0.66%) 
Musculoskeletal stiffness  1  0/151 (0.00%)  1/151 (0.66%) 
Myalgia  1  1/151 (0.66%)  0/151 (0.00%) 
Neck pain  1  1/151 (0.66%)  0/151 (0.00%) 
Osteoarthritis  1  0/151 (0.00%)  1/151 (0.66%) 
Pain in extremity  1  1/151 (0.66%)  0/151 (0.00%) 
Synovial cyst  1  0/151 (0.00%)  1/151 (0.66%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Thyroid neoplasm  1  1/151 (0.66%)  0/151 (0.00%) 
Nervous system disorders     
Headache  1  29/151 (19.21%)  27/151 (17.88%) 
Dizziness  1  1/151 (0.66%)  4/151 (2.65%) 
Sinus headache  1  2/151 (1.32%)  1/151 (0.66%) 
Migraine  1  2/151 (1.32%)  0/151 (0.00%) 
Dysgeusia  1  1/151 (0.66%)  0/151 (0.00%) 
Hyperaesthesia  1  0/151 (0.00%)  1/151 (0.66%) 
Somnolence  1  0/151 (0.00%)  1/151 (0.66%) 
Tension headache  1  0/151 (0.00%)  1/151 (0.66%) 
Tremor  1  0/151 (0.00%)  1/151 (0.66%) 
Psychiatric disorders     
Anxiety  1  1/151 (0.66%)  1/151 (0.66%) 
Insomnia  1  0/151 (0.00%)  2/151 (1.32%) 
Depression  1  0/151 (0.00%)  1/151 (0.66%) 
Respiratory, thoracic and mediastinal disorders     
Epistaxis  1  6/151 (3.97%)  13/151 (8.61%) 
Pharyngolaryngeal pain  1  6/151 (3.97%)  13/151 (8.61%) 
Cough  1  5/151 (3.31%)  2/151 (1.32%) 
Nasal discomfort  1  3/151 (1.99%)  1/151 (0.66%) 
Nasal septum ulceration  1  0/151 (0.00%)  4/151 (2.65%) 
Nasal dryness  1  1/151 (0.66%)  2/151 (1.32%) 
Asthma  1  0/151 (0.00%)  2/151 (1.32%) 
Dry throat  1  0/151 (0.00%)  2/151 (1.32%) 
Nasal oedema  1  2/151 (1.32%)  0/151 (0.00%) 
Nasal ulcer  1  0/151 (0.00%)  2/151 (1.32%) 
Rhinorrhoea  1  0/151 (0.00%)  2/151 (1.32%) 
Dyspnoea  1  0/151 (0.00%)  1/151 (0.66%) 
Dyspnoea exertional  1  0/151 (0.00%)  1/151 (0.66%) 
Nasal polyps  1  1/151 (0.66%)  0/151 (0.00%) 
Postnasal drip  1  0/151 (0.00%)  1/151 (0.66%) 
Rhinalgia  1  1/151 (0.66%)  0/151 (0.00%) 
Throat irritation  1  0/151 (0.00%)  1/151 (0.66%) 
Wheezing  1  0/151 (0.00%)  1/151 (0.66%) 
Skin and subcutaneous tissue disorders     
Scab  1  1/151 (0.66%)  4/151 (2.65%) 
Rash  1  3/151 (1.99%)  0/151 (0.00%) 
Dermatitis allergic  1  0/151 (0.00%)  1/151 (0.66%) 
Onychoclasis  1  0/151 (0.00%)  1/151 (0.66%) 
Pain of skin  1  1/151 (0.66%)  0/151 (0.00%) 
Pruritus generalised  1  0/151 (0.00%)  1/151 (0.66%) 
Urticaria  1  1/151 (0.66%)  0/151 (0.00%) 
Vascular disorders     
Hypertension  1  0/151 (0.00%)  2/151 (1.32%) 
1
Term from vocabulary, MedDRA 9.0
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00289198     History of Changes
Other Study ID Numbers: FFR106080
First Submitted: February 8, 2006
First Posted: February 9, 2006
Results First Submitted: April 17, 2017
Results First Posted: April 13, 2018
Last Update Posted: April 13, 2018