The purpose of this study is to compare the effects (effectiveness and safety) of an intranasal corticosteroid (fluticasone furoate nasal spray \[FFNS\]), with a placebo nasal spray for the treatment of perennial (year-round) allergic rhinitis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
315
Fluticasone furoate nasal spray
Placebo
Mean Change From Baseline Over the Entire Treatment Period in Daily Reflective Total Nasal Symptom Scores (rTNSS)
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 (performed in the morning \[AM\] and evening \[PM\]) was a rating of the severity of symptoms over the previous 12 hours. The daily rTNSS was the average of the AM rTNSS and PM rTNSS assessments. Change from baseline is calculated as the score at the end of study minus the score at baseline.
Time frame: Daily; Baseline through End of Study (Week 4)
Mean Change From Baseline Over the Entire Treatment Period in Morning (AM), Pre-dose Instantaneous Total Nasal Symptom Score (iTNSS)
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 symptom is scored on a scale of 0 (none) to 3 (severe). Change from baseline is calculated as the score over the entire treatment period minus the score at baseline. TNSS: Total possible score ranges from 0 to 12.
Time frame: Daily; Baseline through End of Study (Week 4)
Mean Change From Baseline Over the Entire Treatment Period in Daily Reflective Total Ocular Symptom Scores (rTOSS)
The TOSS is equal to the sum of the three individual ocular symptom scores for eye itching/burning, eye tearing/watering, and eye redness, where each symptom is scored on a scale of 0 (none) to 3 (severe); total possible score of 0 to 9. Change from baseline is calculated as the score at the end of study minus the score at baseline.
Time frame: Daily; Baseline through End of Study (Week 4)
Total Nasal Symptoms: Mean Change From Baseline Over the Entire Treatment Period in AM rTNSS
TNSS = 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 (performed in the morning \[AM\] and evening \[PM\]) is a rating of the severity of symptoms over the previous 12 hours. Change from baseline is calculated as the score at the end of study minus the score at baseline.
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GSK Investigational Site
Baltimore, Maryland, United States
GSK Investigational Site
Wheaton, Maryland, United States
GSK Investigational Site
North Dartmouth, Massachusetts, United States
GSK Investigational Site
Minneapolis, Minnesota, United States
GSK Investigational Site
Plymouth, Minnesota, United States
GSK Investigational Site
St Louis, Missouri, United States
GSK Investigational Site
Lincoln, Nebraska, United States
GSK Investigational Site
Ocean City, New Jersey, United States
GSK Investigational Site
Canton, Ohio, United States
GSK Investigational Site
Providence, Rhode Island, United States
...and 27 more locations
Time frame: Daily; Baseline through End of Study (Week 4)
Total Nasal Symptoms: Mean Change From Baseline Over the Entire Treatment Period in PM rTNSS
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 (performed in the morning \[AM\] and evening \[PM\]) is a rating of the severity of symptoms over the previous 12 hours. Change from baseline is calculated as the score at the end of study minus the score at baseline.
Time frame: Daily; Baseline through End of Study (Week 4)
Total Nasal Symptoms: Mean Percent Change From Baseline Over the Entire Treatment Period in Daily rTNSS and AM, Pre-dose iTNSS
The rTNSS is a rating of the severity of symptoms over the previous 12 hours and was performed in the AM (AM rTNSS) and PM (PM rTNSS). AM, pre-dose iTNSS: 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 symptom is scored on a scale of 0 (none) to 3 (severe), with a total possible score range of 0 to 12. Change from baseline is calculated as the score at the end of study minus the score at baseline.
Time frame: Daily; Baseline through End of Study (Week 4)
Individual Nasal Symptoms: Mean Change From Baseline Over the Entire Treatment Period in Individual Daily Reflective Nasal Symptom Scores and AM, Pre-dose Instantaneous Nasal Symptom Scores for Rhinorrhea, Nasal Congestion, Nasal Itching, and Sneezing
The rTNSS is a rating of the severity of symptoms over the previous 12 hours and was performed in the AM (AM rTNSS) and PM (PM rTNSS). 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 immediately prior to taking the daily dose. Change from baseline is calculated as the score at the end of study minus the score at baseline. Each symptom is scored on a scale of 0 (none) to 3 (severe), with a total possible score of 0 to 12.
Time frame: Daily; Baseline through End of Study (Week 4)
Mean Change From Baseline Over the Entire Treatment Period in Both Individual AM Reflective and PM Reflective Nasal Symptom Scores for Rhinorrhea, Nasal Congestion, Nasal Itching, and Sneezing.
The rTNSS is a rating of the severity of symptoms over the previous 12 hours and was performed in the AM (AM rTNSS) and PM (PM rTNSS). Change from baseline is calculated as the score at the end of study minus the score at baseline. Each symptom is scored on a scale of 0 (none) to 3 (severe), with a total possible score of 0 to 12.
Time frame: Daily; Baseline through End of Study (Week 4)
Total Ocular Symptoms: Mean Change From Baseline Over the Entire Treatment Period in AM, Pre-dose Instantaneous Total Ocular Symptom Scores (iTOSS)
The AM, pre-dose iTOSS is the sum of the 3 individual ocular symptom scores for eyes itching/burning, eyes tearing/watering, and eye redness, performed immediately prior to taking the daily dose; each symptom is scored on a scale of 0 (none) to 3 (severe), with a total possible score of 0 to 9. Change from baseline is calculated as the score at the end of study minus the score at baseline.
Time frame: Daily; Baseline through End of Study (Week 4)
Total Ocular Symptoms: Mean Change From Baseline Over the Entire Treatment Period in Both the AM Reflective Total Ocular Symptom Scores (rTOSS) and PM rTOSS
The rTOSS is a rating of the severity of symptoms over the previous 12 hours and was performed in the AM (AM rTOSS) and PM (PM rTOSS). Change from baseline is calculated as the score at the end of study minus the score at baseline. Each symptom is scored on a scale of 0 (none) to 3 (severe), with a total possible score of 0 to 9.
Time frame: Daily; Baseline through End of Study (Week 4)
Total Ocular Symptoms: Mean Percent Change From Baseline Over the Entire Treatment Period in Both the Daily rTOSS and the AM, Pre-dose iTOSS
The rTOSS is a rating of the severity of symptoms over the previous 12 hours and was performed in the AM (AM rTOSS) and PM (PM rTOSS). AM, pre-dose iTOSS: sum of the 3 individual ocular symptom scores (scored on a scale of 0 \[none\] to 3 \[severe\], with a total possible score of 0 to 9) for eyes itching/burning, eyes tearing/watering, and eye redness, performed immediately prior to taking the daily dose. Change from baseline is calculated as the score at the end of study minus the score at baseline.
Time frame: Daily; Baseline through End of Study (Week 4)
Individual Ocular Symptoms: Mean Change From Baseline Over the Entire Treatment Period in Both the Individual, Daily Reflective and the AM, Pre-dose Instantaneous Ocular Symptom Scores for Eyes Itching/Burning, Eyes Tearing/Watering, and Eye Redness.
The rTOSS is a rating of the severity of symptoms over the previous 12 hrs. and was performed in the AM (AM rTOSS) and PM (PM rTOSS). The AM, pre-dose iTOSS is the sum of the 3 individual ocular symptom scores (scored on a scale of 0 \[none\] to 3 \[severe\], with a total possible score of 0 to 9) for eyes itching/burning, eyes tearing/watering, and eye redness, performed immediately prior to taking the daily dose. Change from baseline is calculated as the score at the end of study minus the score at baseline.
Time frame: Daily; Baseline through End of Study (Week 4)
Mean Change From Baseline Over the Entire Treatment Period in Both the Individual AM Reflective and PM Reflective Ocular Symptom Scores for Eyes Itching/Burning, Eyes Tearing/Watering, and Eye Redness
The rTOSS is a rating of the severity of symptoms over the previous 12 hrs. and was performed in the AM (AM rTOSS) and PM (PM rTOSS). Each symptom is scored on a scale of 0 (none) to 3 (severe), with a total possible score of 0 to 9. Change from baseline is calculated as the score at the end of study minus the score at baseline.
Time frame: Daily; Baseline through End of Study (Week 4)
Peak Nasal Inspiratory Flow (PNIF): Mean Change From Baseline in Daily, AM, and PM PNIF
PNIF: Objective measure of nasal airway flow obstruction.
Time frame: Daily; Baseline through End of Study (Week 4)
Mean Change From Baseline to Endpoint in the Rhinoconjunctivitis Quality of Life Questionnaire With Standardised Activities (RQLQ[S])
RQLQ(S) is a 28-item, self-administered, disease-specific (allergic rhinitis), quality of life instrument that assesses quality of life over a 1-week interval. Each question is scored from 0 (not impaired at all) to 6 (severely impaired), with higher scores indicating more impairment on quality of life. RQLQ(S): Possible score ranges from 0 to 6. Change from baseline is calculated as the score at the endpoint minus the score at baseline.
Time frame: Baseline and Week 4