Trial Outcomes & Findings for A Clinical Study To Test A Nasal Spray (Fluticasone Furoate Nasal Spray) For The Treatment Of Perennial (Year-round) Allergic Rhinitis (NCT NCT00609674)
NCT ID: NCT00609674
Last Updated: 2016-12-16
Results Overview
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.
COMPLETED
PHASE4
315 participants
Daily; Baseline through End of Study (Week 4)
2016-12-16
Participant Flow
Participant milestones
| Measure |
Placebo
Placebo nasal spray
|
Fluticasone Furoate 110 mcg
Once-daily fluticasone furoate (FF) nasal spray 110 mcg
|
|---|---|---|
|
Overall Study
STARTED
|
155
|
160
|
|
Overall Study
COMPLETED
|
148
|
153
|
|
Overall Study
NOT COMPLETED
|
7
|
7
|
Reasons for withdrawal
| Measure |
Placebo
Placebo nasal spray
|
Fluticasone Furoate 110 mcg
Once-daily fluticasone furoate (FF) nasal spray 110 mcg
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
1
|
|
Overall Study
Protocol Violation
|
3
|
5
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
Withdrew consent
|
2
|
1
|
Baseline Characteristics
A Clinical Study To Test A Nasal Spray (Fluticasone Furoate Nasal Spray) For The Treatment Of Perennial (Year-round) Allergic Rhinitis
Baseline characteristics by cohort
| Measure |
Placebo
n=155 Participants
Placebo nasal spray
|
Fluticasone Furoate 110 mcg
n=160 Participants
Once-daily fluticasone furoate (FF) nasal spray 110 mcg
|
Total
n=315 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
39.3 years
STANDARD_DEVIATION 15.06 • n=5 Participants
|
38.1 years
STANDARD_DEVIATION 14.18 • n=7 Participants
|
38.7 years
STANDARD_DEVIATION 14.61 • n=5 Participants
|
|
Gender
Female
|
45 Participants
n=5 Participants
|
57 Participants
n=7 Participants
|
102 Participants
n=5 Participants
|
|
Gender
Male
|
110 Participants
n=5 Participants
|
103 Participants
n=7 Participants
|
213 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
140 participants
n=5 Participants
|
149 participants
n=7 Participants
|
289 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African American/African Heritage
|
11 participants
n=5 Participants
|
3 participants
n=7 Participants
|
14 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian/Alaska Native
|
0 participants
n=5 Participants
|
2 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
4 participants
n=5 Participants
|
3 participants
n=7 Participants
|
7 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian/Other Pacific Islander
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African American/African Heritage & Asian & White
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian & White
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Daily; Baseline through End of Study (Week 4)Population: Intent-to-Treat (ITT) Population: all randomized subjects who received at least one dose of study drug
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.
Outcome measures
| Measure |
Placebo
n=155 Participants
Placebo nasal spray
|
Fluticasone Furoate 110 mcg
n=160 Participants
Once-daily fluticasone furoate (FF) nasal spray 110 mcg
|
|---|---|---|
|
Mean Change From Baseline Over the Entire Treatment Period in Daily Reflective Total Nasal Symptom Scores (rTNSS)
|
-2.45 Points on a scale
Standard Error 0.24
|
-3.19 Points on a scale
Standard Error 0.23
|
SECONDARY outcome
Timeframe: Daily; Baseline through End of Study (Week 4)Population: ITT Population
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.
Outcome measures
| Measure |
Placebo
n=155 Participants
Placebo nasal spray
|
Fluticasone Furoate 110 mcg
n=160 Participants
Once-daily fluticasone furoate (FF) nasal spray 110 mcg
|
|---|---|---|
|
Mean Change From Baseline Over the Entire Treatment Period in Morning (AM), Pre-dose Instantaneous Total Nasal Symptom Score (iTNSS)
|
-2.29 Points on a scale
Standard Error 0.25
|
-2.97 Points on a scale
Standard Error 0.24
|
SECONDARY outcome
Timeframe: Daily; Baseline through End of Study (Week 4)Population: ITT Population
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.
Outcome measures
| Measure |
Placebo
n=155 Participants
Placebo nasal spray
|
Fluticasone Furoate 110 mcg
n=160 Participants
Once-daily fluticasone furoate (FF) nasal spray 110 mcg
|
|---|---|---|
|
Mean Change From Baseline Over the Entire Treatment Period in Daily Reflective Total Ocular Symptom Scores (rTOSS)
|
-1.99 Points on a scale
Standard Error 0.20
|
-2.23 Points on a scale
Standard Error 0.19
|
SECONDARY outcome
Timeframe: Daily; Baseline through End of Study (Week 4)Population: ITT Population
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.
Outcome measures
| Measure |
Placebo
n=155 Participants
Placebo nasal spray
|
Fluticasone Furoate 110 mcg
n=160 Participants
Once-daily fluticasone furoate (FF) nasal spray 110 mcg
|
|---|---|---|
|
Total Nasal Symptoms: Mean Change From Baseline Over the Entire Treatment Period in AM rTNSS
|
-2.40 Points on a scale
Standard Error 0.24
|
-3.15 Points on a scale
Standard Error 0.23
|
SECONDARY outcome
Timeframe: Daily; Baseline through End of Study (Week 4)Population: ITT Population
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.
Outcome measures
| Measure |
Placebo
n=155 Participants
Placebo nasal spray
|
Fluticasone Furoate 110 mcg
n=160 Participants
Once-daily fluticasone furoate (FF) nasal spray 110 mcg
|
|---|---|---|
|
Total Nasal Symptoms: Mean Change From Baseline Over the Entire Treatment Period in PM rTNSS
|
-2.51 Points on a scale
Standard Error 0.25
|
-3.26 Points on a scale
Standard Error 0.24
|
SECONDARY outcome
Timeframe: Daily; Baseline through End of Study (Week 4)Population: ITT Population
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.
Outcome measures
| Measure |
Placebo
n=155 Participants
Placebo nasal spray
|
Fluticasone Furoate 110 mcg
n=160 Participants
Once-daily fluticasone furoate (FF) nasal spray 110 mcg
|
|---|---|---|
|
Total Nasal Symptoms: Mean Percent Change From Baseline Over the Entire Treatment Period in Daily rTNSS and AM, Pre-dose iTNSS
rTNSS
|
-26.39 percent change
Standard Error 2.69
|
-35.03 percent change
Standard Error 2.59
|
|
Total Nasal Symptoms: Mean Percent Change From Baseline Over the Entire Treatment Period in Daily rTNSS and AM, Pre-dose iTNSS
iTNSS
|
-24.87 percent change
Standard Error 2.89
|
-33.52 percent change
Standard Error 2.77
|
SECONDARY outcome
Timeframe: Daily; Baseline through End of Study (Week 4)Population: ITT Population
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.
Outcome measures
| Measure |
Placebo
n=155 Participants
Placebo nasal spray
|
Fluticasone Furoate 110 mcg
n=160 Participants
Once-daily fluticasone furoate (FF) nasal spray 110 mcg
|
|---|---|---|
|
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
rTNSS - rhinorrhea
|
-0.57 Points on a scale
Standard Error 0.07
|
-0.73 Points on a scale
Standard Error 0.06
|
|
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
rTNSS - nasal congestion
|
-0.63 Points on a scale
Standard Error 0.06
|
-0.80 Points on a scale
Standard Error 0.06
|
|
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
rTNSS - nasal itching
|
-0.63 Points on a scale
Standard Error 0.07
|
-0.82 Points on a scale
Standard Error 0.06
|
|
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
rTNSS - sneezing
|
-0.63 Points on a scale
Standard Error 0.07
|
-0.84 Points on a scale
Standard Error 0.06
|
|
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
iTNSS - rhinorrhea
|
-0.52 Points on a scale
Standard Error 0.07
|
-0.68 Points on a scale
Standard Error 0.07
|
|
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
iTNSS - nasal congestion
|
-0.51 Points on a scale
Standard Error 0.06
|
-0.71 Points on a scale
Standard Error 0.06
|
|
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
iTNSS - nasal itching
|
-0.66 Points on a scale
Standard Error 0.07
|
-0.81 Points on a scale
Standard Error 0.07
|
|
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
iTNSS - sneezing
|
-0.60 Points on a scale
Standard Error 0.07
|
-0.77 Points on a scale
Standard Error 0.07
|
SECONDARY outcome
Timeframe: Daily; Baseline through End of Study (Week 4)Population: ITT Population
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.
Outcome measures
| Measure |
Placebo
n=155 Participants
Placebo nasal spray
|
Fluticasone Furoate 110 mcg
n=160 Participants
Once-daily fluticasone furoate (FF) nasal spray 110 mcg
|
|---|---|---|
|
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.
AM reflective - rhinorrhea
|
-0.58 Points on a scale
Standard Error 0.07
|
-0.75 Points on a scale
Standard Error 0.06
|
|
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.
AM reflective - nasal congestion
|
-0.61 Points on a scale
Standard Error 0.06
|
-0.80 Points on a scale
Standard Error 0.06
|
|
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.
AM reflective - nasal itching
|
-0.62 Points on a scale
Standard Error 0.07
|
-0.80 Points on a scale
Standard Error 0.06
|
|
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.
AM reflective - sneezing
|
-0.61 Points on a scale
Standard Error 0.07
|
-0.81 Points on a scale
Standard Error 0.06
|
|
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.
PM reflective - rhinorrhea
|
-0.57 Points on a scale
Standard Error 0.07
|
-0.73 Points on a scale
Standard Error 0.07
|
|
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.
PM reflective - nasal congestion
|
-0.66 Points on a scale
Standard Error 0.06
|
-0.82 Points on a scale
Standard Error 0.06
|
|
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.
PM reflective - nasal itching
|
-0.64 Points on a scale
Standard Error 0.07
|
-0.85 Points on a scale
Standard Error 0.07
|
|
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.
PM reflective - sneezing
|
-0.65 Points on a scale
Standard Error 0.07
|
-0.87 Points on a scale
Standard Error 0.06
|
SECONDARY outcome
Timeframe: Daily; Baseline through End of Study (Week 4)Population: ITT Population
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.
Outcome measures
| Measure |
Placebo
n=155 Participants
Placebo nasal spray
|
Fluticasone Furoate 110 mcg
n=160 Participants
Once-daily fluticasone furoate (FF) nasal spray 110 mcg
|
|---|---|---|
|
Total Ocular Symptoms: Mean Change From Baseline Over the Entire Treatment Period in AM, Pre-dose Instantaneous Total Ocular Symptom Scores (iTOSS)
|
-1.80 Points on a scale
Standard Error 0.20
|
-1.97 Points on a scale
Standard Error 0.19
|
SECONDARY outcome
Timeframe: Daily; Baseline through End of Study (Week 4)Population: ITT Population
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.
Outcome measures
| Measure |
Placebo
n=155 Participants
Placebo nasal spray
|
Fluticasone Furoate 110 mcg
n=160 Participants
Once-daily fluticasone furoate (FF) nasal spray 110 mcg
|
|---|---|---|
|
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
AM rTOSS
|
-1.92 Points on a scale
Standard Error 0.20
|
-2.19 Points on a scale
Standard Error 0.19
|
|
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
PM rTOSS
|
-2.05 Points on a scale
Standard Error 0.20
|
-2.28 Points on a scale
Standard Error 0.19
|
SECONDARY outcome
Timeframe: Daily; Baseline through End of Study (Week 4)Population: ITT Population
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.
Outcome measures
| Measure |
Placebo
n=155 Participants
Placebo nasal spray
|
Fluticasone Furoate 110 mcg
n=160 Participants
Once-daily fluticasone furoate (FF) nasal spray 110 mcg
|
|---|---|---|
|
Total Ocular Symptoms: Mean Percent Change From Baseline Over the Entire Treatment Period in Both the Daily rTOSS and the AM, Pre-dose iTOSS
Daily rTOSS
|
-29.1 percent change
Standard Error 2.39
|
-32.1 percent change
Standard Error 2.44
|
|
Total Ocular Symptoms: Mean Percent Change From Baseline Over the Entire Treatment Period in Both the Daily rTOSS and the AM, Pre-dose iTOSS
AM, pre-dose iTOSS
|
-27.1 percent change
Standard Error 2.54
|
-29.7 percent change
Standard Error 2.55
|
SECONDARY outcome
Timeframe: Daily; Baseline through End of Study (Week 4)Population: ITT Population
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.
Outcome measures
| Measure |
Placebo
n=155 Participants
Placebo nasal spray
|
Fluticasone Furoate 110 mcg
n=160 Participants
Once-daily fluticasone furoate (FF) nasal spray 110 mcg
|
|---|---|---|
|
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.
Daily reflective - eye itching/burning
|
-0.64 Points on a scale
Standard Error 0.07
|
-0.75 Points on a scale
Standard Error 0.06
|
|
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.
Daily reflective - eye tearing/watering
|
-0.69 Points on a scale
Standard Error 0.07
|
-0.76 Points on a scale
Standard Error 0.06
|
|
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.
Daily reflective - eye redness
|
-0.65 Points on a scale
Standard Error 0.07
|
-0.72 Points on a scale
Standard Error 0.07
|
|
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.
AM, pre-dose iTOSS - eye itching/burning
|
-0.58 Points on a scale
Standard Error 0.07
|
-0.67 Points on a scale
Standard Error 0.07
|
|
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.
AM, pre-dose iTNSS - eye tearing/watering
|
-0.63 Points on a scale
Standard Error 0.07
|
-0.67 Points on a scale
Standard Error 0.07
|
|
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.
AM, pre-dose iTNSS - eye redness
|
-0.59 Points on a scale
Standard Error 0.07
|
-0.63 Points on a scale
Standard Error 0.07
|
SECONDARY outcome
Timeframe: Daily; Baseline through End of Study (Week 4)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.
Outcome measures
| Measure |
Placebo
n=155 Participants
Placebo nasal spray
|
Fluticasone Furoate 110 mcg
n=160 Participants
Once-daily fluticasone furoate (FF) nasal spray 110 mcg
|
|---|---|---|
|
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
AM reflective - eye itching/burning
|
-0.62 Points on a scale
Standard Error 0.07
|
-0.74 Points on a scale
Standard Error 0.07
|
|
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
AM reflective - eye tearing/watering
|
-0.66 Points on a scale
Standard Error 0.07
|
-0.74 Points on a scale
Standard Error 0.06
|
|
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
AM reflective - eye redness
|
-0.63 Points on a scale
Standard Error 0.07
|
-0.72 Points on a scale
Standard Error 0.07
|
|
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
PM reflective - eye itching/burning
|
-0.66 Points on a scale
Standard Error 0.07
|
-0.77 Points on a scale
Standard Error 0.07
|
|
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
PM reflective - eye tearing/watering
|
-0.72 Points on a scale
Standard Error 0.07
|
-0.79 Points on a scale
Standard Error 0.07
|
|
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
PM reflective - eye redness
|
-0.67 Points on a scale
Standard Error 0.07
|
-0.73 Points on a scale
Standard Error 0.07
|
SECONDARY outcome
Timeframe: Daily; Baseline through End of Study (Week 4)Population: ITT Population
PNIF: Objective measure of nasal airway flow obstruction.
Outcome measures
| Measure |
Placebo
n=155 Participants
Placebo nasal spray
|
Fluticasone Furoate 110 mcg
n=160 Participants
Once-daily fluticasone furoate (FF) nasal spray 110 mcg
|
|---|---|---|
|
Peak Nasal Inspiratory Flow (PNIF): Mean Change From Baseline in Daily, AM, and PM PNIF
PNIF: daily
|
13.52 Liters/minute
Standard Error 2.29
|
19.98 Liters/minute
Standard Error 2.20
|
|
Peak Nasal Inspiratory Flow (PNIF): Mean Change From Baseline in Daily, AM, and PM PNIF
PNIF: AM
|
13.15 Liters/minute
Standard Error 2.36
|
19.67 Liters/minute
Standard Error 2.27
|
|
Peak Nasal Inspiratory Flow (PNIF): Mean Change From Baseline in Daily, AM, and PM PNIF
PNIF: PM
|
13.88 Liters/minute
Standard Error 2.38
|
20.05 Liters/minute
Standard Error 2.28
|
SECONDARY outcome
Timeframe: Baseline and Week 4Population: ITT Population
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.
Outcome measures
| Measure |
Placebo
n=155 Participants
Placebo nasal spray
|
Fluticasone Furoate 110 mcg
n=160 Participants
Once-daily fluticasone furoate (FF) nasal spray 110 mcg
|
|---|---|---|
|
Mean Change From Baseline to Endpoint in the Rhinoconjunctivitis Quality of Life Questionnaire With Standardised Activities (RQLQ[S])
|
-1.22 Points on a scale
Standard Error 0.18
|
-1.76 Points on a scale
Standard Error 0.16
|
Adverse Events
Placebo
Fluticasone Furoate 110 mcg
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=155 participants at risk
Placebo nasal spray
|
Fluticasone Furoate 110 mcg
n=160 participants at risk
Once-daily fluticasone furoate (FF) nasal spray 110 mcg
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
8.4%
13/155
|
15.0%
24/160
|
|
Nervous system disorders
Headache
|
5.8%
9/155
|
5.0%
8/160
|
|
Infections and infestations
Nasopharyngitis
|
1.3%
2/155
|
5.0%
8/160
|
Additional Information
GSK Response Center
GlaxoSmithKline
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER