Rhinitis, Vasomotor
Conditions
Keywords
Vasomotor Rhinitis, VMR, nonallergic rhinitis, GW685698X
Brief summary
The primary objective of this study is to compare the efficacy and safety of GW685698X 100mcg once daily (QD) aqueous nasal spray with vehicle placebo nasal spray in adult and adolescent subjects (12 years of age and older) with vasomotor rhinitis (VMR).
Interventions
DRUGGW685698X
Aqueous Nasal Spray 100mcg
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Must be outpatients. * Diagnosis of VMR. * Literate in English or native language.
Exclusion criteria
* Significant concomitant medical condition. * Use corticosteroids or other allergy medications during the study. * Used tobacco products within the past year.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline Over the Entire Treatment Period in Daily Reflective Total Nasal Symptom Score (rTNSS) | Baseline (4 days prior to randomization [Day 1]) and up to Week 4 | The daily rTNSS was the average of the AM (morning) and PM (before bed time) rTNSS assessments. Each rTNSS assessment comprised the sum of the three nasal symptom scores for rhinorrhea, nasal congestion and postnasal drip where each symptom was scored on a scale of 0 (no symptoms) to 3 (severe symptoms).. The severity of symptoms was defined as 0: none-symptom was not present, 1: mild-sign/symptom was clearly present but minimal awareness; easily tolerated, 2: moderate-definite awareness of sign/symptom that was bothersome but tolerable, 3: severe (sign/symptom was hard to tolerate; causes interference with activities of daily living and/or sleeping. Change from Baseline was calculated as any post-Baseline value minus the Baseline value. Baseline visit was 4 days prior to randomization (Day 1). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Overall Evaluation of Response to Therapy | Up to 4 weeks | The overall evaluation of Response to Therapy was based on a 7-point categorical scale where the participants rated their perception of the change or lack of change in their VMR (Vasomotor rhinitis) symptoms at the end of the study. The 7 categories were: 1=significantly improved, 2=moderately improved, 3= mildly improved, 4= no change, 5= mildly worse, 6= moderately worse, and 7= significantly worse. |
| Mean Change From Baseline Over the Entire Treatment Period in AM Pre-dose rTNSS | Baseline (4 days prior to randomization [Day 1]) and up to Week 4 | The rTNSS is a rating of the severity of symptoms over the previous 12 hours and is performed in the AM (AM rTNSS). . The severity of symptoms was defined as 0: none-symptom was not present, 1: mild-sign/symptom was clearly present but minimal awareness; easily tolerated, 2: moderate-definite awareness of sign/symptom that was bothersome but tolerable, 3: severe (sign/symptom was hard to tolerate; causes interference with activities of daily living and/or sleeping. The TNSS was the sum of the individual symptom scores for rhinorrhoea, nasal congestion and post-nasal drip which was scored on a scale of 0-3. Change from Baseline was calculated as post randomization value minus the Baseline value. Baseline visit was 4 days prior to randomization (Day 1). |
| Mean Change From Baseline Over the Entire Treatment Period in Evening (PM) rTNSS | Baseline (4 days prior to randomization [Day 1]) and up to Week 4 | The TNSS was the sum of the individual symptom scores for rhinorrhoea, nasal congestion and post-nasal drip which was scored on a scale of 0-3. The severity of symptoms was defined as 0: none-symptom was not present, 1: mild-sign/symptom was clearly present but minimal awareness; easily tolerated, 2: moderate-definite awareness of sign/symptom that was bothersome but tolerable, 3: severe (sign/symptom was hard to tolerate; causes interference with activities of daily living and/or sleeping. The rTNSS is a rating of the severity of symptoms over the previous 12 hours and is performed in the PM (PM rTNSS). Change from Baseline was calculated as any post-Baseline value minus the Baseline value. Baseline visit was 4 days prior to randomization (Day 1). |
| Mean Percent Change From Baseline Over the Entire Treatment Period in Daily rTNSS | Baseline (4 days prior to randomization [Day 1]) and up to Week 4 | The daily rTNSS was the average of the AM (morning) and PM (before bed time) rTNSS assessments.The TNSS was the sum of the individual symptom scores for rhinorrhoea, nasal congestion and post-nasal drip which was scored on a scale of 0-3. The severity of symptoms was defined as 0: none-symptom was not present, 1: mild-sign/symptom was clearly present but minimal awareness; easily tolerated, 2: moderate-definite awareness of sign/symptom that was bothersome but tolerable, 3: severe (sign/symptom was hard to tolerate; causes interference with activities of daily living and/or sleeping. Change from Baseline was calculated as any post-Baseline value minus the Baseline value. Baseline visit was 4 days prior to randomization (Day 1). |
| Mean Percent Change From Baseline Over the Entire Treatment Period in AM, Pre-dose iTNSS | Baseline (4 days prior to randomization [Day 1]) and up to Week 4 | The AM, pre-dose, iTNSS is the sum of the 3 individual nasal symptom score assessments for rhinorrhea, nasal congestion and postnasal drip performed at the moment immediately prior to taking their dose where each symptom was scored on a scale of 0 to 3. The severity of symptoms was defined as 0: none-symptom was not present, 1: mild-sign/symptom was clearly present but minimal awareness; easily tolerated, 2: moderate-definite awareness of sign/symptom that was bothersome but tolerable, 3: severe (sign/symptom was hard to tolerate; causes interference with activities of daily living and/or sleeping. Change from Baseline was calculated as any post-Baseline value minus the Baseline value. Baseline visit was 4 days prior to randomization (Day 1). |
| Mean Change From Baseline Over the Entire Treatment Period in Morning (AM), Pre-dose, Instantaneous Total Nasal Symptom Scores (iTNSS) | Baseline (4 days prior to randomization [Day 1]) and up to Week 4 | The AM, pre-dose, iTNSS is the sum of the 3 individual nasal symptom score assessments for rhinorrhea, nasal congestion and postnasal drip performed at the moment immediately prior to taking their dose where each symptom was scored on a scale of 0 to 3 (0= no symptoms, 3= severe symptoms). . The severity of symptoms was defined as 0: none-symptom was not present, 1: mild-sign/symptom was clearly present but minimal awareness; easily tolerated, 2: moderate-definite awareness of sign/symptom that was bothersome but tolerable, 3: severe (sign/symptom was hard to tolerate; causes interference with activities of daily living and/or sleeping. Change from baseline was calculated as endpoint value minus the baseline value. Baseline visit was 4 days prior to randomization (Day 1). |
| Mean Change From Baseline Over the Entire Treatment Period in Individual AM, Pre-dose, Instantaneous, Nasal Symptom Scores for Rhinorrhea, Nasal Congestion and Postnasal Drip | Baseline (4 days prior to randomization [Day 1]) and up to Week 4 | The AM, pre-dose, instantaneous nasal symptom score is the sum of the 3 individual nasal symptom score assessments for rhinorrhea, nasal congestion and postnasal drip performed at the moment immediately prior to taking their dose where each symptom was scored on a scale of 0 to 3 (0= no symptoms, 3= severe symptoms). Change from Baseline was calculated as any post-Baseline value minus the Baseline value. Baseline visit was 4 days prior to randomization (Day 1). |
| Mean Change From Baseline Over the Entire Treatment Period in Individual AM, Reflective Nasal Symptom Scores for Rhinorrhea, Nasal Congestion and Postnasal Drip | Baseline (4 days prior to randomization [Day 1]) and up to Week 4 | The reflective nasal symptom score is a rating of the severity of symptoms over the previous 12 hours and is performed in the AM (AM rTNSS). Score assessments for rhinorrhea, nasal congestion and postnasal drip performed at the moment immediately prior to taking their dose where each symptom was scored on a scale of 0 to 3 (0= no symptoms, 3= severe symptoms). Change from Baseline was calculated as any post-Baseline value minus the Baseline value. Baseline visit was 4 days prior to randomization (Day 1). |
| Mean Change From Baseline Over the Entire Treatment Period in Individual PM, Reflective, Nasal Symptom Scores for Rhinorrhea, Nasal Congestion and Postnasal Drip | Baseline (4 days prior to randomization [Day 1]) and up to Week 4 | The reflective nasal symptom score is a rating of the severity of symptoms over the previous 12 hours and was performed in the PM (PM rTNSS). Score assessments for rhinorrhea, nasal congestion and postnasal drip performed at the moment immediately prior to taking their dose where each symptom was scored on a scale of 0 to 3 (0= no symptoms, 3= severe symptoms). Change from Baseline was calculated as any post-Baseline value minus the Baseline value. Baseline visit was 4 days prior to randomization (Day 1). |
| Mean Scores Changes From Baseline as a Function of Time | Baseline (4 days prior to randomization [Day 1]) and Daily for 28 days | The onset of treatment effect was assessed by the mean change from Baseline in AM iTNSS (Days 1 to 28), the mean change from Baseline in daily rTNSS (Days 1 to 28), and mean change from Baseline in AM rTNSS and PM rTNSS. The time to maximum effect was also evaluated by the mean change from Baseline in daily rTNSS for Days 1 to 28. Change from Baseline was calculated as any post-Baseline value minus the Baseline value. Baseline visit was 4 days prior to randomization (Day 1). |
| Mean Change From Baseline Over the Entire Treatment Period in Individual Daily, Reflective Nasal Symptom Scores for Rhinorrhea, Nasal Congestion and Post-nasal Drip | Baseline (4 days prior to randomization [Day 1]) and up to Week 4 | The TNSS was the sum of the individual symptom scores for rhinorrhoea, nasal congestion and post-nasal drip which was scored on a scale of 0-3. The severity of symptoms was defined as 0: none-symptom was not present, 1: mild-sign/symptom was clearly present but minimal awareness; easily tolerated, 2: moderate-definite awareness of sign/symptom that was bothersome but tolerable, 3: severe (sign/symptom was hard to tolerate; causes interference with activities of daily living and/or sleeping. The daily reflective nasal symptom scores was the average of the AM (morning) and PM (before bed time) rTNSS assessments. Each rTNSS assessment comprised the sum of the three nasal symptom. Change from Baseline was calculated as any post-Baseline value minus the Baseline value. Baseline visit was 4 days prior to randomization (Day 1). |
Countries
Canada, Czechia, Germany, Norway, Romania, United States
Participant flow
Recruitment details
The actual dose delivered from the product was 27.5 micrograms (µg) /actuation, which is therefore proposed as the label claim rather than 25 µg/actuation. Based on this spray content assessment, the dose examined in this study was actually 110 µg rather than the 100 µg dose indicated in the protocol.
Pre-assignment details
Out of 901 participants screened, 549 participants were screen failures and hence were not randomized into the study. Out of 901 participants screened, 352 participants were randomized from 11 July 2005 to 16 January 2006.
Participants by arm
| Arm | Count |
|---|---|
| Placebo Participants received placebo matching with GW685698X aqueous nasal spray 110 mcg administered as two sprays from the device into each nostril once daily every morning up to 4 weeks. | 173 |
| Fluticasone Furoate 110 mcg QD Participants received GW685698X aqueous nasal spray 110 mcg administered as two sprays from the device into each nostril once daily every morning up to 4 weeks. | 179 |
| Total | 352 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Admisnitrative | 1 | 0 |
| Overall Study | Adverse Event | 3 | 3 |
| Overall Study | Early termination | 1 | 1 |
| Overall Study | Lack of Efficacy | 1 | 0 |
| Overall Study | Lost to Follow-up | 1 | 1 |
| Overall Study | Protocol Violation | 2 | 3 |
| Overall Study | Use of prohibited medicine | 1 | 2 |
| Overall Study | Withdrawal by Subject | 3 | 2 |
Baseline characteristics
| Characteristic | Fluticasone Furoate 110 mcg QD | Total | Placebo |
|---|---|---|---|
| Age, Continuous | 46.6 Years STANDARD_DEVIATION 16.77 | 45.8 Years STANDARD_DEVIATION 15.77 | 45.0 Years STANDARD_DEVIATION 14.66 |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 10 Participants | 6 Participants |
| Race (NIH/OMB) More than one race | 4 Participants | 7 Participants | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 169 Participants | 332 Participants | 163 Participants |
| Sex: Female, Male Female | 125 Participants | 247 Participants | 122 Participants |
| Sex: Female, Male Male | 54 Participants | 105 Participants | 51 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 173 | 0 / 179 |
| other Total, other adverse events | 65 / 173 | 61 / 179 |
| serious Total, serious adverse events | 0 / 173 | 0 / 179 |
Outcome results
Primary
Mean Change From Baseline Over the Entire Treatment Period in Daily Reflective Total Nasal Symptom Score (rTNSS)
The daily rTNSS was the average of the AM (morning) and PM (before bed time) rTNSS assessments. Each rTNSS assessment comprised the sum of the three nasal symptom scores for rhinorrhea, nasal congestion and postnasal drip where each symptom was scored on a scale of 0 (no symptoms) to 3 (severe symptoms).. The severity of symptoms was defined as 0: none-symptom was not present, 1: mild-sign/symptom was clearly present but minimal awareness; easily tolerated, 2: moderate-definite awareness of sign/symptom that was bothersome but tolerable, 3: severe (sign/symptom was hard to tolerate; causes interference with activities of daily living and/or sleeping. Change from Baseline was calculated as any post-Baseline value minus the Baseline value. Baseline visit was 4 days prior to randomization (Day 1).
Time frame: Baseline (4 days prior to randomization [Day 1]) and up to Week 4
Population: Due to irregularities found during a compliance audit, a reduced intent-to-treat (RITT) population was defined which excludes two participants from one of the investigative sites.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Mean Change From Baseline Over the Entire Treatment Period in Daily Reflective Total Nasal Symptom Score (rTNSS) | -1.71 Score on scale | Standard Error 0.16 |
| Fluticasone Furoate 110 mcg QD | Mean Change From Baseline Over the Entire Treatment Period in Daily Reflective Total Nasal Symptom Score (rTNSS) | -2.05 Score on scale | Standard Error 0.15 |
Comparison: Placebo versus Fluticasone Furoate 110 mcg QD Week 1-4 analysis.p-value: 0.0595% CI: [-0.67, 0]ANCOVA
Secondary
Mean Change From Baseline Over the Entire Treatment Period in AM Pre-dose rTNSS
The rTNSS is a rating of the severity of symptoms over the previous 12 hours and is performed in the AM (AM rTNSS). . The severity of symptoms was defined as 0: none-symptom was not present, 1: mild-sign/symptom was clearly present but minimal awareness; easily tolerated, 2: moderate-definite awareness of sign/symptom that was bothersome but tolerable, 3: severe (sign/symptom was hard to tolerate; causes interference with activities of daily living and/or sleeping. The TNSS was the sum of the individual symptom scores for rhinorrhoea, nasal congestion and post-nasal drip which was scored on a scale of 0-3. Change from Baseline was calculated as post randomization value minus the Baseline value. Baseline visit was 4 days prior to randomization (Day 1).
Time frame: Baseline (4 days prior to randomization [Day 1]) and up to Week 4
Population: RITT population. Only those participants with data available at the indicated time points were analyzed.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Mean Change From Baseline Over the Entire Treatment Period in AM Pre-dose rTNSS | -1.69 Score on scale | Standard Error 0.16 |
| Fluticasone Furoate 110 mcg QD | Mean Change From Baseline Over the Entire Treatment Period in AM Pre-dose rTNSS | -2.04 Score on scale | Standard Error 0.16 |
Comparison: Placebo versus Fluticasone Furoate 110 mcg QD Week 1-4 analysis.p-value: 0.05195% CI: [-0.7, 0]ANCOVA
Secondary
Mean Change From Baseline Over the Entire Treatment Period in Evening (PM) rTNSS
The TNSS was the sum of the individual symptom scores for rhinorrhoea, nasal congestion and post-nasal drip which was scored on a scale of 0-3. The severity of symptoms was defined as 0: none-symptom was not present, 1: mild-sign/symptom was clearly present but minimal awareness; easily tolerated, 2: moderate-definite awareness of sign/symptom that was bothersome but tolerable, 3: severe (sign/symptom was hard to tolerate; causes interference with activities of daily living and/or sleeping. The rTNSS is a rating of the severity of symptoms over the previous 12 hours and is performed in the PM (PM rTNSS). Change from Baseline was calculated as any post-Baseline value minus the Baseline value. Baseline visit was 4 days prior to randomization (Day 1).
Time frame: Baseline (4 days prior to randomization [Day 1]) and up to Week 4
Population: RITT Population. Only those participants with data available at the indicated time points were analyzed.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Mean Change From Baseline Over the Entire Treatment Period in Evening (PM) rTNSS | -1.77 Score on scale | Standard Error 0.16 |
| Fluticasone Furoate 110 mcg QD | Mean Change From Baseline Over the Entire Treatment Period in Evening (PM) rTNSS | -2.07 Score on scale | Standard Error 0.15 |
Comparison: Placebo versus Fluticasone Furoate 110 mcg QD up to Week 4 analysisp-value: 0.07695% CI: [-0.64, 0.03]ANCOVA
Secondary
Mean Change From Baseline Over the Entire Treatment Period in Individual AM, Pre-dose, Instantaneous, Nasal Symptom Scores for Rhinorrhea, Nasal Congestion and Postnasal Drip
The AM, pre-dose, instantaneous nasal symptom score is the sum of the 3 individual nasal symptom score assessments for rhinorrhea, nasal congestion and postnasal drip performed at the moment immediately prior to taking their dose where each symptom was scored on a scale of 0 to 3 (0= no symptoms, 3= severe symptoms). Change from Baseline was calculated as any post-Baseline value minus the Baseline value. Baseline visit was 4 days prior to randomization (Day 1).
Time frame: Baseline (4 days prior to randomization [Day 1]) and up to Week 4
Population: RITT Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Mean Change From Baseline Over the Entire Treatment Period in Individual AM, Pre-dose, Instantaneous, Nasal Symptom Scores for Rhinorrhea, Nasal Congestion and Postnasal Drip | Nasal congestion | -0.54 Score on scale | Standard Error 0.06 |
| Placebo | Mean Change From Baseline Over the Entire Treatment Period in Individual AM, Pre-dose, Instantaneous, Nasal Symptom Scores for Rhinorrhea, Nasal Congestion and Postnasal Drip | Post-nasal drip | -0.48 Score on scale | Standard Error 0.06 |
| Placebo | Mean Change From Baseline Over the Entire Treatment Period in Individual AM, Pre-dose, Instantaneous, Nasal Symptom Scores for Rhinorrhea, Nasal Congestion and Postnasal Drip | Rhinorrhea | -0.44 Score on scale | Standard Error 0.06 |
| Fluticasone Furoate 110 mcg QD | Mean Change From Baseline Over the Entire Treatment Period in Individual AM, Pre-dose, Instantaneous, Nasal Symptom Scores for Rhinorrhea, Nasal Congestion and Postnasal Drip | Rhinorrhea | -0.56 Score on scale | Standard Error 0.06 |
| Fluticasone Furoate 110 mcg QD | Mean Change From Baseline Over the Entire Treatment Period in Individual AM, Pre-dose, Instantaneous, Nasal Symptom Scores for Rhinorrhea, Nasal Congestion and Postnasal Drip | Nasal congestion | -0.70 Score on scale | Standard Error 0.06 |
| Fluticasone Furoate 110 mcg QD | Mean Change From Baseline Over the Entire Treatment Period in Individual AM, Pre-dose, Instantaneous, Nasal Symptom Scores for Rhinorrhea, Nasal Congestion and Postnasal Drip | Post-nasal drip | -0.60 Score on scale | Standard Error 0.06 |
Comparison: Placebo versus Fluticasone Furoate 110 mcg QD for Rhinorrheap-value: 0.08795% CI: [-0.24, 0.02]ANCOVA
Comparison: Placebo versus Fluticasone Furoate 110 mcg QD for nasal congestionp-value: 0.01595% CI: [-0.3, -0.03]ANCOVA
Comparison: Placebo versus Fluticasone Furoate 110 mcg QD for post-nasal dripp-value: 0.10695% CI: [-0.25, 0.02]ANCOVA
Secondary
Mean Change From Baseline Over the Entire Treatment Period in Individual AM, Reflective Nasal Symptom Scores for Rhinorrhea, Nasal Congestion and Postnasal Drip
The reflective nasal symptom score is a rating of the severity of symptoms over the previous 12 hours and is performed in the AM (AM rTNSS). Score assessments for rhinorrhea, nasal congestion and postnasal drip performed at the moment immediately prior to taking their dose where each symptom was scored on a scale of 0 to 3 (0= no symptoms, 3= severe symptoms). Change from Baseline was calculated as any post-Baseline value minus the Baseline value. Baseline visit was 4 days prior to randomization (Day 1).
Time frame: Baseline (4 days prior to randomization [Day 1]) and up to Week 4
Population: RITT Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Mean Change From Baseline Over the Entire Treatment Period in Individual AM, Reflective Nasal Symptom Scores for Rhinorrhea, Nasal Congestion and Postnasal Drip | Rhinorrhea | -0.48 Score on scale | Standard Error 0.06 |
| Placebo | Mean Change From Baseline Over the Entire Treatment Period in Individual AM, Reflective Nasal Symptom Scores for Rhinorrhea, Nasal Congestion and Postnasal Drip | Nasal congestion | -0.65 Score on scale | Standard Error 0.06 |
| Placebo | Mean Change From Baseline Over the Entire Treatment Period in Individual AM, Reflective Nasal Symptom Scores for Rhinorrhea, Nasal Congestion and Postnasal Drip | Post-nasal drip | -0.55 Score on scale | Standard Error 0.06 |
| Fluticasone Furoate 110 mcg QD | Mean Change From Baseline Over the Entire Treatment Period in Individual AM, Reflective Nasal Symptom Scores for Rhinorrhea, Nasal Congestion and Postnasal Drip | Post-nasal drip | -0.64 Score on scale | Standard Error 0.06 |
| Fluticasone Furoate 110 mcg QD | Mean Change From Baseline Over the Entire Treatment Period in Individual AM, Reflective Nasal Symptom Scores for Rhinorrhea, Nasal Congestion and Postnasal Drip | Rhinorrhea | -0.61 Score on scale | Standard Error 0.06 |
| Fluticasone Furoate 110 mcg QD | Mean Change From Baseline Over the Entire Treatment Period in Individual AM, Reflective Nasal Symptom Scores for Rhinorrhea, Nasal Congestion and Postnasal Drip | Nasal congestion | -0.78 Score on scale | Standard Error 0.06 |
Comparison: Placebo versus Fluticasone Furoate 110 mcg QD for rhinorrheap-value: 0.04895% CI: [-0.26, 0]ANCOVA
Comparison: Placebo versus Fluticasone Furoate 110 mcg QD for Nasal congestionp-value: 0.07695% CI: [-0.26, 0.01]ANCOVA
Comparison: Placebo versus Fluticasone Furoate 110 mcg for post-nasal dripp-value: 0.16495% CI: [-0.22, 0.04]ANCOVA
Secondary
Mean Change From Baseline Over the Entire Treatment Period in Individual Daily, Reflective Nasal Symptom Scores for Rhinorrhea, Nasal Congestion and Post-nasal Drip
The TNSS was the sum of the individual symptom scores for rhinorrhoea, nasal congestion and post-nasal drip which was scored on a scale of 0-3. The severity of symptoms was defined as 0: none-symptom was not present, 1: mild-sign/symptom was clearly present but minimal awareness; easily tolerated, 2: moderate-definite awareness of sign/symptom that was bothersome but tolerable, 3: severe (sign/symptom was hard to tolerate; causes interference with activities of daily living and/or sleeping. The daily reflective nasal symptom scores was the average of the AM (morning) and PM (before bed time) rTNSS assessments. Each rTNSS assessment comprised the sum of the three nasal symptom. Change from Baseline was calculated as any post-Baseline value minus the Baseline value. Baseline visit was 4 days prior to randomization (Day 1).
Time frame: Baseline (4 days prior to randomization [Day 1]) and up to Week 4
Population: RITT Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Mean Change From Baseline Over the Entire Treatment Period in Individual Daily, Reflective Nasal Symptom Scores for Rhinorrhea, Nasal Congestion and Post-nasal Drip | Nasal Congestion | -0.68 Score on scale | Standard Error 0.06 |
| Placebo | Mean Change From Baseline Over the Entire Treatment Period in Individual Daily, Reflective Nasal Symptom Scores for Rhinorrhea, Nasal Congestion and Post-nasal Drip | Post-nasal Drip | -0.51 Score on scale | Standard Error 0.06 |
| Placebo | Mean Change From Baseline Over the Entire Treatment Period in Individual Daily, Reflective Nasal Symptom Scores for Rhinorrhea, Nasal Congestion and Post-nasal Drip | Rhinorrhea | -0.50 Score on scale | Standard Error 0.06 |
| Fluticasone Furoate 110 mcg QD | Mean Change From Baseline Over the Entire Treatment Period in Individual Daily, Reflective Nasal Symptom Scores for Rhinorrhea, Nasal Congestion and Post-nasal Drip | Rhinorrhea | -0.62 Score on scale | Standard Error 0.06 |
| Fluticasone Furoate 110 mcg QD | Mean Change From Baseline Over the Entire Treatment Period in Individual Daily, Reflective Nasal Symptom Scores for Rhinorrhea, Nasal Congestion and Post-nasal Drip | Nasal Congestion | -0.81 Score on scale | Standard Error 0.06 |
| Fluticasone Furoate 110 mcg QD | Mean Change From Baseline Over the Entire Treatment Period in Individual Daily, Reflective Nasal Symptom Scores for Rhinorrhea, Nasal Congestion and Post-nasal Drip | Post-nasal Drip | -0.61 Score on scale | Standard Error 0.06 |
Comparison: Placebo versus Fluticasone Furoate 110 mcg QD for Rhinorrheap-value: 0.06195% CI: [-0.24, 0.01]ANCOVA
Comparison: Placebo versus Fluticasone Furoate 110 mcg QD for Nasal Congestionp-value: 0.06195% CI: [-0.25, 0.01]ANCOVA
Comparison: Placebo versus Fluticasone Furoate 110 mcg QD for post-nasal dripp-value: 0.13895% CI: [-0.22, 0.03]ANCOVA
Secondary
Mean Change From Baseline Over the Entire Treatment Period in Individual PM, Reflective, Nasal Symptom Scores for Rhinorrhea, Nasal Congestion and Postnasal Drip
The reflective nasal symptom score is a rating of the severity of symptoms over the previous 12 hours and was performed in the PM (PM rTNSS). Score assessments for rhinorrhea, nasal congestion and postnasal drip performed at the moment immediately prior to taking their dose where each symptom was scored on a scale of 0 to 3 (0= no symptoms, 3= severe symptoms). Change from Baseline was calculated as any post-Baseline value minus the Baseline value. Baseline visit was 4 days prior to randomization (Day 1).
Time frame: Baseline (4 days prior to randomization [Day 1]) and up to Week 4
Population: RITT Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Mean Change From Baseline Over the Entire Treatment Period in Individual PM, Reflective, Nasal Symptom Scores for Rhinorrhea, Nasal Congestion and Postnasal Drip | Rhinorrhea | -0.53 Score on scale | Standard Error 0.06 |
| Placebo | Mean Change From Baseline Over the Entire Treatment Period in Individual PM, Reflective, Nasal Symptom Scores for Rhinorrhea, Nasal Congestion and Postnasal Drip | Nasal congestion | -0.73 Score on scale | Standard Error 0.06 |
| Placebo | Mean Change From Baseline Over the Entire Treatment Period in Individual PM, Reflective, Nasal Symptom Scores for Rhinorrhea, Nasal Congestion and Postnasal Drip | Post-nasal drip | -0.49 Score on scale | Standard Error 0.06 |
| Fluticasone Furoate 110 mcg QD | Mean Change From Baseline Over the Entire Treatment Period in Individual PM, Reflective, Nasal Symptom Scores for Rhinorrhea, Nasal Congestion and Postnasal Drip | Rhinorrhea | -0.59 Score on scale | Standard Error 0.06 |
| Fluticasone Furoate 110 mcg QD | Mean Change From Baseline Over the Entire Treatment Period in Individual PM, Reflective, Nasal Symptom Scores for Rhinorrhea, Nasal Congestion and Postnasal Drip | Nasal congestion | -0.84 Score on scale | Standard Error 0.06 |
| Fluticasone Furoate 110 mcg QD | Mean Change From Baseline Over the Entire Treatment Period in Individual PM, Reflective, Nasal Symptom Scores for Rhinorrhea, Nasal Congestion and Postnasal Drip | Post-nasal drip | -0.59 Score on scale | Standard Error 0.06 |
Comparison: Placebo versus Fluticasone Furoate 110 mcg QD for Rhinorrheap-value: 0.13695% CI: [-0.22, 0.03]ANCOVA
Comparison: Placebo versus Fluticasone Furoate 110 mcg QD for nasal congestionp-value: 0.195% CI: [-0.24, 0.02]ANCOVA
Comparison: Placebo versus Fluticasone Furoate 110 mcg QD for post-nasal dripp-value: 0.195% CI: [-0.24, 0.02]ANCOVA
Secondary
Mean Change From Baseline Over the Entire Treatment Period in Morning (AM), Pre-dose, Instantaneous Total Nasal Symptom Scores (iTNSS)
The AM, pre-dose, iTNSS is the sum of the 3 individual nasal symptom score assessments for rhinorrhea, nasal congestion and postnasal drip performed at the moment immediately prior to taking their dose where each symptom was scored on a scale of 0 to 3 (0= no symptoms, 3= severe symptoms). . The severity of symptoms was defined as 0: none-symptom was not present, 1: mild-sign/symptom was clearly present but minimal awareness; easily tolerated, 2: moderate-definite awareness of sign/symptom that was bothersome but tolerable, 3: severe (sign/symptom was hard to tolerate; causes interference with activities of daily living and/or sleeping. Change from baseline was calculated as endpoint value minus the baseline value. Baseline visit was 4 days prior to randomization (Day 1).
Time frame: Baseline (4 days prior to randomization [Day 1]) and up to Week 4
Population: Reduced ITT Population. Only those participants with data available at the indicated time points were analyzed.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Mean Change From Baseline Over the Entire Treatment Period in Morning (AM), Pre-dose, Instantaneous Total Nasal Symptom Scores (iTNSS) | -1.48 Score on scale | Standard Error 0.16 |
| Fluticasone Furoate 110 mcg QD | Mean Change From Baseline Over the Entire Treatment Period in Morning (AM), Pre-dose, Instantaneous Total Nasal Symptom Scores (iTNSS) | -1.87 Score on scale | Standard Error 0.16 |
Comparison: Placebo versus Fluticasone Furoate 110 mcg QD Week 1-4 analysis.p-value: 0.02795% CI: [-0.74, -0.05]ANCOVA
Secondary
Mean Percent Change From Baseline Over the Entire Treatment Period in AM, Pre-dose iTNSS
The AM, pre-dose, iTNSS is the sum of the 3 individual nasal symptom score assessments for rhinorrhea, nasal congestion and postnasal drip performed at the moment immediately prior to taking their dose where each symptom was scored on a scale of 0 to 3. The severity of symptoms was defined as 0: none-symptom was not present, 1: mild-sign/symptom was clearly present but minimal awareness; easily tolerated, 2: moderate-definite awareness of sign/symptom that was bothersome but tolerable, 3: severe (sign/symptom was hard to tolerate; causes interference with activities of daily living and/or sleeping. Change from Baseline was calculated as any post-Baseline value minus the Baseline value. Baseline visit was 4 days prior to randomization (Day 1).
Time frame: Baseline (4 days prior to randomization [Day 1]) and up to Week 4
Population: RITT Population. Only those participants with data available at the indicated time points were analyzed.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Mean Percent Change From Baseline Over the Entire Treatment Period in AM, Pre-dose iTNSS | -21.09 Percent change in score | Standard Error 2.54 |
| Fluticasone Furoate 110 mcg QD | Mean Percent Change From Baseline Over the Entire Treatment Period in AM, Pre-dose iTNSS | -27.46 Percent change in score | Standard Error 2.5 |
Comparison: Placebo versus Fluticasone Furoate 110 mcg QD Week 1-4 analysis.p-value: 0.02395% CI: [-11.8, -0.9]ANCOVA
Secondary
Mean Percent Change From Baseline Over the Entire Treatment Period in Daily rTNSS
The daily rTNSS was the average of the AM (morning) and PM (before bed time) rTNSS assessments.The TNSS was the sum of the individual symptom scores for rhinorrhoea, nasal congestion and post-nasal drip which was scored on a scale of 0-3. The severity of symptoms was defined as 0: none-symptom was not present, 1: mild-sign/symptom was clearly present but minimal awareness; easily tolerated, 2: moderate-definite awareness of sign/symptom that was bothersome but tolerable, 3: severe (sign/symptom was hard to tolerate; causes interference with activities of daily living and/or sleeping. Change from Baseline was calculated as any post-Baseline value minus the Baseline value. Baseline visit was 4 days prior to randomization (Day 1).
Time frame: Baseline (4 days prior to randomization [Day 1]) and up to Week 4
Population: RITT Population. Only those participants with data available at the indicated time points were analyzed.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Mean Percent Change From Baseline Over the Entire Treatment Period in Daily rTNSS | -26.14 Percent change in score | Standard Error 2.45 |
| Fluticasone Furoate 110 mcg QD | Mean Percent Change From Baseline Over the Entire Treatment Period in Daily rTNSS | -30.65 Percent change in score | Standard Error 2.4 |
Comparison: Placebo versus Fluticasone Furoate 110 mcg QD Week 1-4 analysis.p-value: 0.09395% CI: [-9.77, 0.75]ANCOVA
Secondary
Mean Scores Changes From Baseline as a Function of Time
The onset of treatment effect was assessed by the mean change from Baseline in AM iTNSS (Days 1 to 28), the mean change from Baseline in daily rTNSS (Days 1 to 28), and mean change from Baseline in AM rTNSS and PM rTNSS. The time to maximum effect was also evaluated by the mean change from Baseline in daily rTNSS for Days 1 to 28. Change from Baseline was calculated as any post-Baseline value minus the Baseline value. Baseline visit was 4 days prior to randomization (Day 1).
Time frame: Baseline (4 days prior to randomization [Day 1]) and Daily for 28 days
Population: RITT population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Mean Scores Changes From Baseline as a Function of Time | AM iTNSS Day 1 | -0.47 Score on scale | Standard Error 0.16 |
| Placebo | Mean Scores Changes From Baseline as a Function of Time | AM iTNSS Day 6 | -1.01 Score on scale | Standard Error 0.2 |
| Placebo | Mean Scores Changes From Baseline as a Function of Time | AM iTNSS Day 7 | -1.17 Score on scale | Standard Error 0.2 |
| Placebo | Mean Scores Changes From Baseline as a Function of Time | AM iTNSS Day 8 | -1.38 Score on scale | Standard Error 0.2 |
| Placebo | Mean Scores Changes From Baseline as a Function of Time | AM iTNSS Day 9 | -1.47 Score on scale | Standard Error 0.2 |
| Placebo | Mean Scores Changes From Baseline as a Function of Time | AM iTNSS Day 10 | -1.31 Score on scale | Standard Error 0.21 |
| Placebo | Mean Scores Changes From Baseline as a Function of Time | AM iTNSS Day 16 | -1.56 Score on scale | Standard Error 0.21 |
| Placebo | Mean Scores Changes From Baseline as a Function of Time | AM iTNSS Day 17 | -1.64 Score on scale | Standard Error 0.22 |
| Placebo | Mean Scores Changes From Baseline as a Function of Time | AM iTNSS Day 20 | -1.89 Score on scale | Standard Error 0.22 |
| Placebo | Mean Scores Changes From Baseline as a Function of Time | AM iTNSS Day 21 | -1.97 Score on scale | Standard Error 0.22 |
| Placebo | Mean Scores Changes From Baseline as a Function of Time | AM iTNSS Day 22 | -1.73 Score on scale | Standard Error 0.22 |
| Placebo | Mean Scores Changes From Baseline as a Function of Time | AM iTNSS Day 23 | -1.80 Score on scale | Standard Error 0.23 |
| Placebo | Mean Scores Changes From Baseline as a Function of Time | AM iTNSS Day 25 | -1.93 Score on scale | Standard Error 0.22 |
| Placebo | Mean Scores Changes From Baseline as a Function of Time | AM iTNSS Day 26 | -2.10 Score on scale | Standard Error 0.23 |
| Placebo | Mean Scores Changes From Baseline as a Function of Time | rTNSS Day 4 | -1.15 Score on scale | Standard Error 0.17 |
| Placebo | Mean Scores Changes From Baseline as a Function of Time | rTNSS Day 6 | -1.21 Score on scale | Standard Error 0.19 |
| Placebo | Mean Scores Changes From Baseline as a Function of Time | rTNSS Day 7 | -1.37 Score on scale | Standard Error 0.19 |
| Placebo | Mean Scores Changes From Baseline as a Function of Time | rTNSS Day 8 | -1.58 Score on scale | Standard Error 0.18 |
| Placebo | Mean Scores Changes From Baseline as a Function of Time | rTNSS Day 9 | -1.55 Score on scale | Standard Error 0.2 |
| Placebo | Mean Scores Changes From Baseline as a Function of Time | rTNSS Day 10 | -1.60 Score on scale | Standard Error 0.2 |
| Placebo | Mean Scores Changes From Baseline as a Function of Time | rTNSS Day 11 | -1.65 Score on scale | Standard Error 0.2 |
| Placebo | Mean Scores Changes From Baseline as a Function of Time | rTNSS Day 12 | -1.81 Score on scale | Standard Error 0.19 |
| Placebo | Mean Scores Changes From Baseline as a Function of Time | rTNSS Day 13 | -1.87 Score on scale | Standard Error 0.2 |
| Placebo | Mean Scores Changes From Baseline as a Function of Time | rTNSS Day 20 | -2.16 Score on scale | Standard Error 0.2 |
| Placebo | Mean Scores Changes From Baseline as a Function of Time | rTNSS Day 21 | -2.12 Score on scale | Standard Error 0.21 |
| Placebo | Mean Scores Changes From Baseline as a Function of Time | rTNSS Day 22 | -2.01 Score on scale | Standard Error 0.21 |
| Placebo | Mean Scores Changes From Baseline as a Function of Time | rTNSS Day 23 | -1.99 Score on scale | Standard Error 0.21 |
| Placebo | Mean Scores Changes From Baseline as a Function of Time | rTNSS Day 24 | -2.12 Score on scale | Standard Error 0.21 |
| Placebo | Mean Scores Changes From Baseline as a Function of Time | rTNSS Day 25 | -2.28 Score on scale | Standard Error 0.22 |
| Placebo | Mean Scores Changes From Baseline as a Function of Time | rTNSS Day 28 | -1.93 Score on scale | Standard Error 0.28 |
| Placebo | Mean Scores Changes From Baseline as a Function of Time | AM rTNSS Day 1 | -0.70 Score on scale | Standard Error 0.18 |
| Placebo | Mean Scores Changes From Baseline as a Function of Time | AM rTNSS Day 2 | -0.97 Score on scale | Standard Error 0.18 |
| Placebo | Mean Scores Changes From Baseline as a Function of Time | AM rTNSS Day 3 | -1.12 Score on scale | Standard Error 0.18 |
| Placebo | Mean Scores Changes From Baseline as a Function of Time | AM rTNSS Day 4 | -1.11 Score on scale | Standard Error 0.18 |
| Placebo | Mean Scores Changes From Baseline as a Function of Time | AM rTNSS Day 5 | -1.33 Score on scale | Standard Error 0.19 |
| Placebo | Mean Scores Changes From Baseline as a Function of Time | AM rTNSS Day 6 | -1.30 Score on scale | Standard Error 0.2 |
| Placebo | Mean Scores Changes From Baseline as a Function of Time | AM rTNSS Day 7 | -1.28 Score on scale | Standard Error 0.21 |
| Placebo | Mean Scores Changes From Baseline as a Function of Time | AM rTNSS Day 8 | -1.74 Score on scale | Standard Error 0.21 |
| Placebo | Mean Scores Changes From Baseline as a Function of Time | AM rTNSS Day 9 | -1.73 Score on scale | Standard Error 0.21 |
| Placebo | Mean Scores Changes From Baseline as a Function of Time | AM rTNSS Day 11 | -1.66 Score on scale | Standard Error 0.21 |
| Placebo | Mean Scores Changes From Baseline as a Function of Time | AM rTNSS Day 12 | -1.82 Score on scale | Standard Error 0.21 |
| Placebo | Mean Scores Changes From Baseline as a Function of Time | AM rTNSS Day 13 | -1.87 Score on scale | Standard Error 0.22 |
| Placebo | Mean Scores Changes From Baseline as a Function of Time | AM rTNSS Day 14 | -1.84 Score on scale | Standard Error 0.21 |
| Placebo | Mean Scores Changes From Baseline as a Function of Time | AM rTNSS Day 15 | -1.67 Score on scale | Standard Error 0.22 |
| Placebo | Mean Scores Changes From Baseline as a Function of Time | AM rTNSS Day 16 | -1.75 Score on scale | Standard Error 0.22 |
| Placebo | Mean Scores Changes From Baseline as a Function of Time | AM rTNSS Day 17 | -2.12 Score on scale | Standard Error 0.22 |
| Placebo | Mean Scores Changes From Baseline as a Function of Time | AM rTNSS Day 18 | -2.22 Score on scale | Standard Error 0.21 |
| Placebo | Mean Scores Changes From Baseline as a Function of Time | AM rTNSS Day 19 | -1.83 Score on scale | Standard Error 0.22 |
| Placebo | Mean Scores Changes From Baseline as a Function of Time | AM rTNSS Day 20 | -2.18 Score on scale | Standard Error 0.22 |
| Placebo | Mean Scores Changes From Baseline as a Function of Time | AM rTNSS Day 21 | -2.07 Score on scale | Standard Error 0.22 |
| Placebo | Mean Scores Changes From Baseline as a Function of Time | AM rTNSS Day 22 | -2.02 Score on scale | Standard Error 0.23 |
| Placebo | Mean Scores Changes From Baseline as a Function of Time | AM rTNSS Day 23 | -1.96 Score on scale | Standard Error 0.23 |
| Placebo | Mean Scores Changes From Baseline as a Function of Time | AM rTNSS Day 24 | -2.03 Score on scale | Standard Error 0.23 |
| Placebo | Mean Scores Changes From Baseline as a Function of Time | AM rTNSS Day 25 | -2.22 Score on scale | Standard Error 0.23 |
| Placebo | Mean Scores Changes From Baseline as a Function of Time | AM rTNSS Day 26 | -2.19 Score on scale | Standard Error 0.23 |
| Placebo | Mean Scores Changes From Baseline as a Function of Time | AM rTNSS Day 27 | -2.23 Score on scale | Standard Error 0.23 |
| Placebo | Mean Scores Changes From Baseline as a Function of Time | AM rTNSS Day 28 | -1.82 Score on scale | Standard Error 0.3 |
| Placebo | Mean Scores Changes From Baseline as a Function of Time | PM rTNSS Day 1 | -0.88 Score on scale | Standard Error 0.2 |
| Placebo | Mean Scores Changes From Baseline as a Function of Time | PM rTNSS Day 2 | -0.91 Score on scale | Standard Error 0.18 |
| Placebo | Mean Scores Changes From Baseline as a Function of Time | PM rTNSS Day 3 | -1.10 Score on scale | Standard Error 0.19 |
| Placebo | Mean Scores Changes From Baseline as a Function of Time | PM rTNSS Day 5 | -1.06 Score on scale | Standard Error 0.19 |
| Placebo | Mean Scores Changes From Baseline as a Function of Time | PM rTNSS Day 6 | -1.13 Score on scale | Standard Error 0.21 |
| Placebo | Mean Scores Changes From Baseline as a Function of Time | PM rTNSS Day 7 | -1.48 Score on scale | Standard Error 0.2 |
| Placebo | Mean Scores Changes From Baseline as a Function of Time | PM rTNSS Day 8 | -1.34 Score on scale | Standard Error 0.2 |
| Placebo | Mean Scores Changes From Baseline as a Function of Time | PM rTNSS Day 9 | -1.49 Score on scale | Standard Error 0.21 |
| Placebo | Mean Scores Changes From Baseline as a Function of Time | PM rTNSS Day 10 | -1.58 Score on scale | Standard Error 0.21 |
| Placebo | Mean Scores Changes From Baseline as a Function of Time | PM rTNSS Day 18 | -2.22 Score on scale | Standard Error 0.22 |
| Placebo | Mean Scores Changes From Baseline as a Function of Time | PM rTNSS Day 20 | -2.17 Score on scale | Standard Error 0.21 |
| Placebo | Mean Scores Changes From Baseline as a Function of Time | PM rTNSS Day 23 | -2.06 Score on scale | Standard Error 0.23 |
| Placebo | Mean Scores Changes From Baseline as a Function of Time | PM rTNSS Day 27 | -2.25 Score on scale | Standard Error 0.23 |
| Placebo | Mean Scores Changes From Baseline as a Function of Time | AM iTNSS Day 2 | -0.69 Score on scale | Standard Error 0.17 |
| Placebo | Mean Scores Changes From Baseline as a Function of Time | AM iTNSS Day 3 | -0.75 Score on scale | Standard Error 0.18 |
| Placebo | Mean Scores Changes From Baseline as a Function of Time | AM iTNSS Day 4 | -0.96 Score on scale | Standard Error 0.18 |
| Placebo | Mean Scores Changes From Baseline as a Function of Time | AM iTNSS Day 5 | -1.15 Score on scale | Standard Error 0.2 |
| Placebo | Mean Scores Changes From Baseline as a Function of Time | AM iTNSS Day 11 | -1.48 Score on scale | Standard Error 0.22 |
| Placebo | Mean Scores Changes From Baseline as a Function of Time | AMiTNSS Day 12 | -1.52 Score on scale | Standard Error 0.22 |
| Placebo | Mean Scores Changes From Baseline as a Function of Time | AM iTNSS Day 13 | -1.48 Score on scale | Standard Error 0.22 |
| Placebo | Mean Scores Changes From Baseline as a Function of Time | AM iTNSS Day 14 | -1.72 Score on scale | Standard Error 0.21 |
| Placebo | Mean Scores Changes From Baseline as a Function of Time | AM iTNSS Day 15 | -1.54 Score on scale | Standard Error 0.21 |
| Placebo | Mean Scores Changes From Baseline as a Function of Time | AM iTNSS Day 18 | -1.75 Score on scale | Standard Error 0.21 |
| Placebo | Mean Scores Changes From Baseline as a Function of Time | AM iTNSS Day 19 | -1.70 Score on scale | Standard Error 0.21 |
| Placebo | Mean Scores Changes From Baseline as a Function of Time | AM iTNSS Day 24 | -1.93 Score on scale | Standard Error 0.23 |
| Placebo | Mean Scores Changes From Baseline as a Function of Time | AM iTNSS Day 27 | -2.01 Score on scale | Standard Error 0.23 |
| Placebo | Mean Scores Changes From Baseline as a Function of Time | AM iTNSS Day 28 | -1.96 Score on scale | Standard Error 0.28 |
| Placebo | Mean Scores Changes From Baseline as a Function of Time | rTNSS Day 1 | -0.71 Score on scale | Standard Error 0.16 |
| Placebo | Mean Scores Changes From Baseline as a Function of Time | rTNSS Day 2 | -0.91 Score on scale | Standard Error 0.16 |
| Placebo | Mean Scores Changes From Baseline as a Function of Time | rTNSS Day 3 | -1.07 Score on scale | Standard Error 0.17 |
| Placebo | Mean Scores Changes From Baseline as a Function of Time | rTNSS Day 5 | -1.22 Score on scale | Standard Error 0.17 |
| Placebo | Mean Scores Changes From Baseline as a Function of Time | rTNSS Day 14 | -1.83 Score on scale | Standard Error 0.2 |
| Placebo | Mean Scores Changes From Baseline as a Function of Time | rTNSS Day 15 | -1.70 Score on scale | Standard Error 0.2 |
| Placebo | Mean Scores Changes From Baseline as a Function of Time | rTNSS Day 16 | -1.82 Score on scale | Standard Error 0.2 |
| Placebo | Mean Scores Changes From Baseline as a Function of Time | rTNSS Day 17 | -1.94 Score on scale | Standard Error 0.21 |
| Placebo | Mean Scores Changes From Baseline as a Function of Time | rTNSS Day 18 | -2.21 Score on scale | Standard Error 0.2 |
| Placebo | Mean Scores Changes From Baseline as a Function of Time | rTNSS Day 19 | -1.99 Score on scale | Standard Error 0.2 |
| Placebo | Mean Scores Changes From Baseline as a Function of Time | PM rTNSS Day 4 | -1.17 Score on scale | Standard Error 0.19 |
| Placebo | Mean Scores Changes From Baseline as a Function of Time | PM rTNSS Day 11 | -1.62 Score on scale | Standard Error 0.22 |
| Placebo | Mean Scores Changes From Baseline as a Function of Time | PM rTNSS Day 12 | -1.86 Score on scale | Standard Error 0.21 |
| Placebo | Mean Scores Changes From Baseline as a Function of Time | PM rTNSS Day 13 | -1.91 Score on scale | Standard Error 0.22 |
| Placebo | Mean Scores Changes From Baseline as a Function of Time | PM rTNSS Day 14 | -1.85 Score on scale | Standard Error 0.23 |
| Placebo | Mean Scores Changes From Baseline as a Function of Time | PM rTNSS Day 15 | -1.78 Score on scale | Standard Error 0.22 |
| Placebo | Mean Scores Changes From Baseline as a Function of Time | PM rTNSS Day 16 | -1.84 Score on scale | Standard Error 0.23 |
| Placebo | Mean Scores Changes From Baseline as a Function of Time | PM rTNSS Day 17 | -1.81 Score on scale | Standard Error 0.22 |
| Placebo | Mean Scores Changes From Baseline as a Function of Time | PM rTNSS Day 19 | -2.23 Score on scale | Standard Error 0.21 |
| Placebo | Mean Scores Changes From Baseline as a Function of Time | PM rTNSS Day 21 | -2.19 Score on scale | Standard Error 0.23 |
| Placebo | Mean Scores Changes From Baseline as a Function of Time | PM rTNSS Day 22 | -2.03 Score on scale | Standard Error 0.22 |
| Placebo | Mean Scores Changes From Baseline as a Function of Time | PM rTNSS Day 24 | -2.25 Score on scale | Standard Error 0.22 |
| Placebo | Mean Scores Changes From Baseline as a Function of Time | PM rTNSS Day 25 | -2.39 Score on scale | Standard Error 0.23 |
| Placebo | Mean Scores Changes From Baseline as a Function of Time | PM rTNSS Day 26 | -2.31 Score on scale | Standard Error 0.23 |
| Placebo | Mean Scores Changes From Baseline as a Function of Time | PM rTNSS Day 28 | -2.07 Score on scale | Standard Error 0.3 |
| Placebo | Mean Scores Changes From Baseline as a Function of Time | rTNSS Day 26 | -2.25 Score on scale | Standard Error 0.22 |
| Placebo | Mean Scores Changes From Baseline as a Function of Time | rTNSS Day 27 | -2.23 Score on scale | Standard Error 0.22 |
| Placebo | Mean Scores Changes From Baseline as a Function of Time | AM rTNSS Day 10 | -1.65 Score on scale | Standard Error 0.21 |
| Fluticasone Furoate 110 mcg QD | Mean Scores Changes From Baseline as a Function of Time | PM rTNSS Day 16 | -2.33 Score on scale | Standard Error 0.22 |
| Fluticasone Furoate 110 mcg QD | Mean Scores Changes From Baseline as a Function of Time | AM rTNSS Day 28 | -2.55 Score on scale | Standard Error 0.27 |
| Fluticasone Furoate 110 mcg QD | Mean Scores Changes From Baseline as a Function of Time | AM iTNSS Day 6 | -1.59 Score on scale | Standard Error 0.19 |
| Fluticasone Furoate 110 mcg QD | Mean Scores Changes From Baseline as a Function of Time | rTNSS Day 2 | -1.17 Score on scale | Standard Error 0.16 |
| Fluticasone Furoate 110 mcg QD | Mean Scores Changes From Baseline as a Function of Time | AM iTNSS Day 7 | -1.55 Score on scale | Standard Error 0.19 |
| Fluticasone Furoate 110 mcg QD | Mean Scores Changes From Baseline as a Function of Time | PM rTNSS Day 1 | -0.97 Score on scale | Standard Error 0.19 |
| Fluticasone Furoate 110 mcg QD | Mean Scores Changes From Baseline as a Function of Time | AM iTNSS Day 8 | -1.61 Score on scale | Standard Error 0.2 |
| Fluticasone Furoate 110 mcg QD | Mean Scores Changes From Baseline as a Function of Time | PM rTNSS Day 27 | -2.54 Score on scale | Standard Error 0.22 |
| Fluticasone Furoate 110 mcg QD | Mean Scores Changes From Baseline as a Function of Time | AM iTNSS Day 9 | -1.66 Score on scale | Standard Error 0.2 |
| Fluticasone Furoate 110 mcg QD | Mean Scores Changes From Baseline as a Function of Time | PM rTNSS Day 17 | -2.51 Score on scale | Standard Error 0.22 |
| Fluticasone Furoate 110 mcg QD | Mean Scores Changes From Baseline as a Function of Time | PM rTNSS Day 3 | -1.39 Score on scale | Standard Error 0.19 |
| Fluticasone Furoate 110 mcg QD | Mean Scores Changes From Baseline as a Function of Time | AM iTNSS Day 16 | -1.99 Score on scale | Standard Error 0.21 |
| Fluticasone Furoate 110 mcg QD | Mean Scores Changes From Baseline as a Function of Time | PM rTNSS Day 4 | -1.42 Score on scale | Standard Error 0.19 |
| Fluticasone Furoate 110 mcg QD | Mean Scores Changes From Baseline as a Function of Time | AM iTNSS Day 17 | -2.20 Score on scale | Standard Error 0.22 |
| Fluticasone Furoate 110 mcg QD | Mean Scores Changes From Baseline as a Function of Time | AM iTNSS Day 19 | -2.33 Score on scale | Standard Error 0.21 |
| Fluticasone Furoate 110 mcg QD | Mean Scores Changes From Baseline as a Function of Time | rTNSS Day 5 | -1.35 Score on scale | Standard Error 0.17 |
| Fluticasone Furoate 110 mcg QD | Mean Scores Changes From Baseline as a Function of Time | AM iTNSS Day 20 | -2.11 Score on scale | Standard Error 0.21 |
| Fluticasone Furoate 110 mcg QD | Mean Scores Changes From Baseline as a Function of Time | PM rTNSS Day 5 | -1.29 Score on scale | Standard Error 0.18 |
| Fluticasone Furoate 110 mcg QD | Mean Scores Changes From Baseline as a Function of Time | AM iTNSS Day 21 | -2.26 Score on scale | Standard Error 0.22 |
| Fluticasone Furoate 110 mcg QD | Mean Scores Changes From Baseline as a Function of Time | PM rTNSS Day 18 | -2.54 Score on scale | Standard Error 0.23 |
| Fluticasone Furoate 110 mcg QD | Mean Scores Changes From Baseline as a Function of Time | AM iTNSS Day 22 | -2.32 Score on scale | Standard Error 0.22 |
| Fluticasone Furoate 110 mcg QD | Mean Scores Changes From Baseline as a Function of Time | PM rTNSS Day 6 | -1.42 Score on scale | Standard Error 0.2 |
| Fluticasone Furoate 110 mcg QD | Mean Scores Changes From Baseline as a Function of Time | AM iTNSS Day 24 | -2.40 Score on scale | Standard Error 0.22 |
| Fluticasone Furoate 110 mcg QD | Mean Scores Changes From Baseline as a Function of Time | rTNSS Day 14 | -2.17 Score on scale | Standard Error 0.2 |
| Fluticasone Furoate 110 mcg QD | Mean Scores Changes From Baseline as a Function of Time | AM iTNSS Day 25 | -2.36 Score on scale | Standard Error 0.22 |
| Fluticasone Furoate 110 mcg QD | Mean Scores Changes From Baseline as a Function of Time | PM rTNSS Day 7 | -1.64 Score on scale | Standard Error 0.2 |
| Fluticasone Furoate 110 mcg QD | Mean Scores Changes From Baseline as a Function of Time | rTNSS Day 8 | -1.82 Score on scale | Standard Error 0.18 |
| Fluticasone Furoate 110 mcg QD | Mean Scores Changes From Baseline as a Function of Time | AM iTNSS Day 26 | -2.68 Score on scale | Standard Error 0.22 |
| Fluticasone Furoate 110 mcg QD | Mean Scores Changes From Baseline as a Function of Time | rTNSS Day 3 | -1.38 Score on scale | Standard Error 0.16 |
| Fluticasone Furoate 110 mcg QD | Mean Scores Changes From Baseline as a Function of Time | AM rTNSS Day 5 | -1.48 Score on scale | Standard Error 0.18 |
| Fluticasone Furoate 110 mcg QD | Mean Scores Changes From Baseline as a Function of Time | rTNSS Day 4 | -1.43 Score on scale | Standard Error 0.16 |
| Fluticasone Furoate 110 mcg QD | Mean Scores Changes From Baseline as a Function of Time | PM rTNSS Day 8 | -1.73 Score on scale | Standard Error 0.19 |
| Fluticasone Furoate 110 mcg QD | Mean Scores Changes From Baseline as a Function of Time | rTNSS Day 6 | -1.51 Score on scale | Standard Error 0.18 |
| Fluticasone Furoate 110 mcg QD | Mean Scores Changes From Baseline as a Function of Time | rTNSS Day 15 | -2.11 Score on scale | Standard Error 0.2 |
| Fluticasone Furoate 110 mcg QD | Mean Scores Changes From Baseline as a Function of Time | rTNSS Day 7 | -1.66 Score on scale | Standard Error 0.18 |
| Fluticasone Furoate 110 mcg QD | Mean Scores Changes From Baseline as a Function of Time | PM rTNSS Day 9 | -1.89 Score on scale | Standard Error 0.2 |
| Fluticasone Furoate 110 mcg QD | Mean Scores Changes From Baseline as a Function of Time | PM rTNSS Day 19 | -2.53 Score on scale | Standard Error 0.21 |
| Fluticasone Furoate 110 mcg QD | Mean Scores Changes From Baseline as a Function of Time | rTNSS Day 9 | -1.92 Score on scale | Standard Error 0.19 |
| Fluticasone Furoate 110 mcg QD | Mean Scores Changes From Baseline as a Function of Time | rTNSS Day 16 | -2.38 Score on scale | Standard Error 0.2 |
| Fluticasone Furoate 110 mcg QD | Mean Scores Changes From Baseline as a Function of Time | rTNSS Day 10 | -2.06 Score on scale | Standard Error 0.19 |
| Fluticasone Furoate 110 mcg QD | Mean Scores Changes From Baseline as a Function of Time | PM rTNSS Day 20 | -2.52 Score on scale | Standard Error 0.2 |
| Fluticasone Furoate 110 mcg QD | Mean Scores Changes From Baseline as a Function of Time | rTNSS Day 11 | -1.96 Score on scale | Standard Error 0.2 |
| Fluticasone Furoate 110 mcg QD | Mean Scores Changes From Baseline as a Function of Time | rTNSS Day 17 | -2.53 Score on scale | Standard Error 0.2 |
| Fluticasone Furoate 110 mcg QD | Mean Scores Changes From Baseline as a Function of Time | rTNSS Day 12 | -2.14 Score on scale | Standard Error 0.19 |
| Fluticasone Furoate 110 mcg QD | Mean Scores Changes From Baseline as a Function of Time | PM rTNSS Day 23 | -2.41 Score on scale | Standard Error 0.22 |
| Fluticasone Furoate 110 mcg QD | Mean Scores Changes From Baseline as a Function of Time | rTNSS Day 13 | -2.12 Score on scale | Standard Error 0.2 |
| Fluticasone Furoate 110 mcg QD | Mean Scores Changes From Baseline as a Function of Time | rTNSS Day 18 | -2.51 Score on scale | Standard Error 0.2 |
| Fluticasone Furoate 110 mcg QD | Mean Scores Changes From Baseline as a Function of Time | rTNSS Day 19 | -2.44 Score on scale | Standard Error 0.2 |
| Fluticasone Furoate 110 mcg QD | Mean Scores Changes From Baseline as a Function of Time | PM rTNSS Day 26 | -2.54 Score on scale | Standard Error 0.22 |
| Fluticasone Furoate 110 mcg QD | Mean Scores Changes From Baseline as a Function of Time | rTNSS Day 20 | -2.47 Score on scale | Standard Error 0.2 |
| Fluticasone Furoate 110 mcg QD | Mean Scores Changes From Baseline as a Function of Time | PM rTNSS Day 28 | -2.68 Score on scale | Standard Error 0.28 |
| Fluticasone Furoate 110 mcg QD | Mean Scores Changes From Baseline as a Function of Time | rTNSS Day 21 | -2.54 Score on scale | Standard Error 0.2 |
| Fluticasone Furoate 110 mcg QD | Mean Scores Changes From Baseline as a Function of Time | AM iTNSS Day 1 | -0.92 Score on scale | Standard Error 0.16 |
| Fluticasone Furoate 110 mcg QD | Mean Scores Changes From Baseline as a Function of Time | rTNSS Day 22 | -2.47 Score on scale | Standard Error 0.21 |
| Fluticasone Furoate 110 mcg QD | Mean Scores Changes From Baseline as a Function of Time | PM rTNSS Day 21 | -2.48 Score on scale | Standard Error 0.22 |
| Fluticasone Furoate 110 mcg QD | Mean Scores Changes From Baseline as a Function of Time | rTNSS Day 23 | -2.30 Score on scale | Standard Error 0.2 |
| Fluticasone Furoate 110 mcg QD | Mean Scores Changes From Baseline as a Function of Time | AM iTNSS Day 2 | -1.01 Score on scale | Standard Error 0.17 |
| Fluticasone Furoate 110 mcg QD | Mean Scores Changes From Baseline as a Function of Time | PM rTNSS Day 2 | -1.19 Score on scale | Standard Error 0.17 |
| Fluticasone Furoate 110 mcg QD | Mean Scores Changes From Baseline as a Function of Time | AM iTNSS Day 3 | -1.14 Score on scale | Standard Error 0.18 |
| Fluticasone Furoate 110 mcg QD | Mean Scores Changes From Baseline as a Function of Time | rTNSS Day 28 | -2.58 Score on scale | Standard Error 0.26 |
| Fluticasone Furoate 110 mcg QD | Mean Scores Changes From Baseline as a Function of Time | rTNSS Day 24 | -2.60 Score on scale | Standard Error 0.2 |
| Fluticasone Furoate 110 mcg QD | Mean Scores Changes From Baseline as a Function of Time | AM rTNSS Day 1 | -1.02 Score on scale | Standard Error 0.17 |
| Fluticasone Furoate 110 mcg QD | Mean Scores Changes From Baseline as a Function of Time | AM iTNSS Day 4 | -1.22 Score on scale | Standard Error 0.18 |
| Fluticasone Furoate 110 mcg QD | Mean Scores Changes From Baseline as a Function of Time | AM rTNSS Day 2 | -1.20 Score on scale | Standard Error 0.17 |
| Fluticasone Furoate 110 mcg QD | Mean Scores Changes From Baseline as a Function of Time | PM rTNSS Day 10 | -2.07 Score on scale | Standard Error 0.21 |
| Fluticasone Furoate 110 mcg QD | Mean Scores Changes From Baseline as a Function of Time | AM rTNSS Day 3 | -1.37 Score on scale | Standard Error 0.18 |
| Fluticasone Furoate 110 mcg QD | Mean Scores Changes From Baseline as a Function of Time | AM iTNSS Day 5 | -1.45 Score on scale | Standard Error 0.19 |
| Fluticasone Furoate 110 mcg QD | Mean Scores Changes From Baseline as a Function of Time | AM rTNSS Day 4 | -1.45 Score on scale | Standard Error 0.18 |
| Fluticasone Furoate 110 mcg QD | Mean Scores Changes From Baseline as a Function of Time | AM iTNSS Day 10 | -1.78 Score on scale | Standard Error 0.21 |
| Fluticasone Furoate 110 mcg QD | Mean Scores Changes From Baseline as a Function of Time | PM rTNSS Day 22 | -2.53 Score on scale | Standard Error 0.22 |
| Fluticasone Furoate 110 mcg QD | Mean Scores Changes From Baseline as a Function of Time | AM rTNSS Day 6 | -1.59 Score on scale | Standard Error 0.2 |
| Fluticasone Furoate 110 mcg QD | Mean Scores Changes From Baseline as a Function of Time | AM iTNSS Day 11 | -1.66 Score on scale | Standard Error 0.21 |
| Fluticasone Furoate 110 mcg QD | Mean Scores Changes From Baseline as a Function of Time | AM rTNSS Day 7 | -1.69 Score on scale | Standard Error 0.2 |
| Fluticasone Furoate 110 mcg QD | Mean Scores Changes From Baseline as a Function of Time | PM rTNSS Day 11 | -2.02 Score on scale | Standard Error 0.22 |
| Fluticasone Furoate 110 mcg QD | Mean Scores Changes From Baseline as a Function of Time | AM rTNSS Day 8 | -1.85 Score on scale | Standard Error 0.2 |
| Fluticasone Furoate 110 mcg QD | Mean Scores Changes From Baseline as a Function of Time | AMiTNSS Day 12 | -1.86 Score on scale | Standard Error 0.21 |
| Fluticasone Furoate 110 mcg QD | Mean Scores Changes From Baseline as a Function of Time | AM rTNSS Day 9 | -1.94 Score on scale | Standard Error 0.21 |
| Fluticasone Furoate 110 mcg QD | Mean Scores Changes From Baseline as a Function of Time | AM rTNSS Day 10 | -2.10 Score on scale | Standard Error 0.2 |
| Fluticasone Furoate 110 mcg QD | Mean Scores Changes From Baseline as a Function of Time | rTNSS Day 25 | -2.44 Score on scale | Standard Error 0.21 |
| Fluticasone Furoate 110 mcg QD | Mean Scores Changes From Baseline as a Function of Time | AM rTNSS Day 11 | -1.96 Score on scale | Standard Error 0.2 |
| Fluticasone Furoate 110 mcg QD | Mean Scores Changes From Baseline as a Function of Time | AM iTNSS Day 13 | -1.83 Score on scale | Standard Error 0.21 |
| Fluticasone Furoate 110 mcg QD | Mean Scores Changes From Baseline as a Function of Time | AM rTNSS Day 12 | -2.05 Score on scale | Standard Error 0.2 |
| Fluticasone Furoate 110 mcg QD | Mean Scores Changes From Baseline as a Function of Time | PM rTNSS Day 12 | -2.29 Score on scale | Standard Error 0.21 |
| Fluticasone Furoate 110 mcg QD | Mean Scores Changes From Baseline as a Function of Time | AM rTNSS Day 13 | -2.06 Score on scale | Standard Error 0.21 |
| Fluticasone Furoate 110 mcg QD | Mean Scores Changes From Baseline as a Function of Time | AM iTNSS Day 14 | -1.95 Score on scale | Standard Error 0.2 |
| Fluticasone Furoate 110 mcg QD | Mean Scores Changes From Baseline as a Function of Time | AM rTNSS Day 14 | -2.14 Score on scale | Standard Error 0.2 |
| Fluticasone Furoate 110 mcg QD | Mean Scores Changes From Baseline as a Function of Time | PM rTNSS Day 24 | -2.64 Score on scale | Standard Error 0.21 |
| Fluticasone Furoate 110 mcg QD | Mean Scores Changes From Baseline as a Function of Time | AM rTNSS Day 15 | -2.15 Score on scale | Standard Error 0.21 |
| Fluticasone Furoate 110 mcg QD | Mean Scores Changes From Baseline as a Function of Time | AM iTNSS Day 15 | -1.92 Score on scale | Standard Error 0.21 |
| Fluticasone Furoate 110 mcg QD | Mean Scores Changes From Baseline as a Function of Time | AM rTNSS Day 16 | -2.37 Score on scale | Standard Error 0.21 |
| Fluticasone Furoate 110 mcg QD | Mean Scores Changes From Baseline as a Function of Time | PM rTNSS Day 13 | -2.18 Score on scale | Standard Error 0.21 |
| Fluticasone Furoate 110 mcg QD | Mean Scores Changes From Baseline as a Function of Time | AM rTNSS Day 17 | -2.62 Score on scale | Standard Error 0.22 |
| Fluticasone Furoate 110 mcg QD | Mean Scores Changes From Baseline as a Function of Time | AM iTNSS Day 18 | -2.21 Score on scale | Standard Error 0.21 |
| Fluticasone Furoate 110 mcg QD | Mean Scores Changes From Baseline as a Function of Time | AM rTNSS Day 18 | -2.48 Score on scale | Standard Error 0.21 |
| Fluticasone Furoate 110 mcg QD | Mean Scores Changes From Baseline as a Function of Time | rTNSS Day 27 | -2.51 Score on scale | Standard Error 0.21 |
| Fluticasone Furoate 110 mcg QD | Mean Scores Changes From Baseline as a Function of Time | AM rTNSS Day 19 | -2.37 Score on scale | Standard Error 0.21 |
| Fluticasone Furoate 110 mcg QD | Mean Scores Changes From Baseline as a Function of Time | AM iTNSS Day 23 | -2.27 Score on scale | Standard Error 0.22 |
| Fluticasone Furoate 110 mcg QD | Mean Scores Changes From Baseline as a Function of Time | AM rTNSS Day 20 | -2.42 Score on scale | Standard Error 0.22 |
| Fluticasone Furoate 110 mcg QD | Mean Scores Changes From Baseline as a Function of Time | PM rTNSS Day 14 | -2.15 Score on scale | Standard Error 0.22 |
| Fluticasone Furoate 110 mcg QD | Mean Scores Changes From Baseline as a Function of Time | AM rTNSS Day 21 | -2.64 Score on scale | Standard Error 0.22 |
| Fluticasone Furoate 110 mcg QD | Mean Scores Changes From Baseline as a Function of Time | PM rTNSS Day 25 | -2.42 Score on scale | Standard Error 0.22 |
| Fluticasone Furoate 110 mcg QD | Mean Scores Changes From Baseline as a Function of Time | AM rTNSS Day 22 | -2.44 Score on scale | Standard Error 0.22 |
| Fluticasone Furoate 110 mcg QD | Mean Scores Changes From Baseline as a Function of Time | AM iTNSS Day 27 | -2.49 Score on scale | Standard Error 0.22 |
| Fluticasone Furoate 110 mcg QD | Mean Scores Changes From Baseline as a Function of Time | AM rTNSS Day 23 | -2.17 Score on scale | Standard Error 0.22 |
| Fluticasone Furoate 110 mcg QD | Mean Scores Changes From Baseline as a Function of Time | PM rTNSS Day 15 | -2.15 Score on scale | Standard Error 0.21 |
| Fluticasone Furoate 110 mcg QD | Mean Scores Changes From Baseline as a Function of Time | AM rTNSS Day 24 | -2.57 Score on scale | Standard Error 0.22 |
| Fluticasone Furoate 110 mcg QD | Mean Scores Changes From Baseline as a Function of Time | AM iTNSS Day 28 | -2.62 Score on scale | Standard Error 0.26 |
| Fluticasone Furoate 110 mcg QD | Mean Scores Changes From Baseline as a Function of Time | AM rTNSS Day 25 | -2.45 Score on scale | Standard Error 0.22 |
| Fluticasone Furoate 110 mcg QD | Mean Scores Changes From Baseline as a Function of Time | rTNSS Day 26 | -2.57 Score on scale | Standard Error 0.21 |
| Fluticasone Furoate 110 mcg QD | Mean Scores Changes From Baseline as a Function of Time | AM rTNSS Day 26 | -2.59 Score on scale | Standard Error 0.23 |
| Fluticasone Furoate 110 mcg QD | Mean Scores Changes From Baseline as a Function of Time | rTNSS Day 1 | -0.93 Score on scale | Standard Error 0.15 |
| Fluticasone Furoate 110 mcg QD | Mean Scores Changes From Baseline as a Function of Time | AM rTNSS Day 27 | -2.54 Score on scale | Standard Error 0.23 |
Comparison: Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 22p-value: 0.01495% CI: [-1.07, -0.12]ANCOVA
Comparison: Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 1p-value: 0.01195% CI: [-0.8, -0.1]ANCOVA
Comparison: Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 2p-value: 0.08995% CI: [-0.7, 0.05]ANCOVA
Comparison: Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 3p-value: 0.05295% CI: [-0.79, 0]ANCOVA
Comparison: Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 4p-value: 0.18795% CI: [-0.65, 0.13]ANCOVA
Comparison: Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 5p-value: 0.16495% CI: [-0.72, 0.12]ANCOVA
Comparison: Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 6p-value: 0.00895% CI: [-1, -0.15]ANCOVA
Comparison: Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 7p-value: 0.08295% CI: [-0.8, 0.05]ANCOVA
Comparison: Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 8p-value: 0.29695% CI: [-0.67, 0.2]ANCOVA
Comparison: Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 9p-value: 0.38395% CI: [-0.62, 0.24]ANCOVA
Comparison: Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 10p-value: 0.04895% CI: [-0.92, 0]ANCOVA
Comparison: Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 11p-value: 0.46995% CI: [-0.64, 0.29]ANCOVA
Comparison: Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 12p-value: 0.15195% CI: [-0.8, 0.12]ANCOVA
Comparison: Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 13p-value: 0.14595% CI: [-0.81, 0.12]ANCOVA
Comparison: Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 14p-value: 0.29795% CI: [-0.68, 0.21]ANCOVA
Comparison: Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 15p-value: 0.09495% CI: [-0.82, 0.07]ANCOVA
Comparison: Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 16p-value: 0.06495% CI: [-0.89, 0.03]ANCOVA
Comparison: Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 17p-value: 0.01995% CI: [-1.03, -0.09]ANCOVA
Comparison: Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 18p-value: 0.04495% CI: [-0.9, -0.01]ANCOVA
Comparison: Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 19p-value: 0.00795% CI: [-1.09, -0.17]ANCOVA
Comparison: Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 20p-value: 0.34895% CI: [-0.69, 0.24]ANCOVA
Comparison: Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 21p-value: 0.24395% CI: [-0.76, 0.19]ANCOVA
Comparison: Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 23p-value: 0.05595% CI: [-0.96, 0.01]ANCOVA
Comparison: Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 24p-value: 0.06295% CI: [-0.95, 0.02]ANCOVA
Comparison: Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 25p-value: 0.07995% CI: [-0.91, 0.05]ANCOVA
Comparison: Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 26p-value: 0.01995% CI: [-1.06, -0.1]ANCOVA
Comparison: Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 27p-value: 0.05695% CI: [-0.97, 0.01]ANCOVA
Comparison: Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 28p-value: 0.01895% CI: [-1.2, -0.11]ANCOVA
Comparison: Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 1p-value: 0.19495% CI: [-0.56, 0.1]ANCOVA
Comparison: Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 2p-value: 0.13495% CI: [-0.61, 0.08]ANCOVA
Comparison: Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 3p-value: 0.09195% CI: [-0.67, 0.05]ANCOVA
Comparison: Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 4p-value: 0.13195% CI: [-0.64, 0.08]ANCOVA
Comparison: Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 5p-value: 0.48395% CI: [-0.49, 0.23]ANCOVA
Comparison: Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 6p-value: 0.13795% CI: [-0.7, 0.1]ANCOVA
Comparison: Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 7p-value: 0.14295% CI: [-0.69, 0.1]ANCOVA
Comparison: Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 8p-value: 0.2295% CI: [-0.64, 0.15]ANCOVA
Comparison: Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 9p-value: 0.08195% CI: [-0.79, 0.05]ANCOVA
Comparison: Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 10p-value: 0.03495% CI: [-0.87, -0.04]ANCOVA
Comparison: Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 11p-value: 0.1595% CI: [-0.74, 0.11]ANCOVA
Comparison: Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 12p-value: 0.11195% CI: [-0.74, 0.08]ANCOVA
Comparison: Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 13p-value: 0.26195% CI: [-0.69, 0.19]ANCOVA
Comparison: Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 14p-value: 0.12395% CI: [-0.78, 0.09]ANCOVA
Comparison: Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 15p-value: 0.05695% CI: [-0.84, 0.01]ANCOVA
Comparison: Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 16p-value: 0.01195% CI: [-1, -0.13]ANCOVA
Comparison: Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 17p-value: 0.00995% CI: [-1.03, -0.15]ANCOVA
Comparison: Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 18p-value: 0.17595% CI: [-0.74, 0.13]ANCOVA
Comparison: Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 19p-value: 0.03995% CI: [-0.87, -0.02]ANCOVA
Comparison: Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 20p-value: 0.15295% CI: [-0.75, 0.12]ANCOVA
Comparison: Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 21p-value: 0.06395% CI: [-0.87, 0.02]ANCOVA
Comparison: Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 22p-value: 0.04495% CI: [-0.9, -0.01]ANCOVA
Comparison: Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 23p-value: 0.17995% CI: [-0.77, 0.14]ANCOVA
Comparison: Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 24p-value: 0.03495% CI: [-0.92, -0.04]ANCOVA
Comparison: Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 25p-value: 0.50595% CI: [-0.62, 0.31]ANCOVA
Comparison: Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 26p-value: 0.18695% CI: [-0.79, 0.15]ANCOVA
Comparison: Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 27p-value: 0.23495% CI: [-0.75, 0.18]ANCOVA
Comparison: Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 28p-value: 0.01795% CI: [-1.17, -0.12]ANCOVA
Comparison: Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 1p-value: 0.09595% CI: [-0.7, 0.06]ANCOVA
Comparison: Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 2p-value: 0.23695% CI: [-0.61, 0.15]ANCOVA
Comparison: Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 3p-value: 0.20595% CI: [-0.65, 0.14]ANCOVA
Comparison: Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 4p-value: 0.08495% CI: [-0.73, 0.05]ANCOVA
Comparison: Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 5p-value: 0.47595% CI: [-0.55, 0.26]ANCOVA
Comparison: Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 6p-value: 0.17895% CI: [-0.73, 0.14]ANCOVA
Comparison: Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 7p-value: 0.07195% CI: [-0.85, 0.04]ANCOVA
Comparison: Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 8p-value: 0.62195% CI: [-0.55, 0.33]ANCOVA
Comparison: Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 9p-value: 0.37295% CI: [-0.66, 0.25]ANCOVA
Comparison: Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 10p-value: 0.04695% CI: [-0.9, -0.01]ANCOVA
Comparison: Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 11p-value: 0.18395% CI: [-0.75, 0.14]ANCOVA
Comparison: Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 12p-value: 0.3295% CI: [-0.67, 0.22]ANCOVA
Comparison: Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 13p-value: 0.43195% CI: [-0.66, 0.28]ANCOVA
Comparison: Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 14p-value: 0.19195% CI: [-0.75, 0.15]ANCOVA
Comparison: Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 15p-value: 0.04395% CI: [-0.94, -0.02]ANCOVA
Comparison: Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 16p-value: 0.00995% CI: [-1.08, -0.16]ANCOVA
Comparison: Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 17p-value: 0.0495% CI: [-0.97, -0.02]ANCOVA
Comparison: Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 18p-value: 0.24995% CI: [-0.71, 0.18]ANCOVA
Comparison: Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 19p-value: 0.02395% CI: [-1, -0.07]ANCOVA
Comparison: Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 20p-value: 0.32195% CI: [-0.71, 0.23]ANCOVA
Comparison: Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 21p-value: 0.01995% CI: [-1.04, -0.09]ANCOVA
Comparison: Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 22p-value: 0.09295% CI: [-0.91, 0.07]ANCOVA
Comparison: Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 23p-value: 0.40495% CI: [-0.69, 0.28]ANCOVA
Comparison: Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 24p-value: 0.02795% CI: [-1.03, -0.06]ANCOVA
Comparison: Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 25p-value: 0.35795% CI: [-0.71, 0.26]ANCOVA
Comparison: Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 26p-value: 0.11495% CI: [-0.9, 0.1]ANCOVA
Comparison: Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 27p-value: 0.22895% CI: [-0.81, 0.19]ANCOVA
Comparison: Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 28p-value: 0.01295% CI: [-1.29, -0.16]ANCOVA
Comparison: Placebo versus Fluticasone Furoate 110 mcg QD for PM rTNSS at Day 1p-value: 0.64395% CI: [-0.49, 0.3]ANCOVA
Comparison: Placebo versus Fluticasone Furoate 110 mcg QD for PM rTNSS at Day 2p-value: 0.1595% CI: [-0.66, 0.1]ANCOVA
Comparison: Placebo versus Fluticasone Furoate 110 mcg QD for PM rTNSS at Day 3p-value: 0.16295% CI: [-0.7, 0.12]ANCOVA
Comparison: Placebo versus Fluticasone Furoate 110 mcg QD for PM rTNSS at Day 4p-value: 0.24295% CI: [-0.65, 0.17]ANCOVA
Comparison: Placebo versus Fluticasone Furoate 110 mcg QD for PM rTNSS at Day 5p-value: 0.27895% CI: [-0.63, 0.18]ANCOVA
Comparison: Placebo versus Fluticasone Furoate 110 mcg QD for PM rTNSS at Day 6p-value: 0.295% CI: [-0.71, 0.15]ANCOVA
Comparison: Placebo versus Fluticasone Furoate 110 mcg QD for PM rTNSS at Day 7p-value: 0.45695% CI: [-0.6, 0.27]ANCOVA
Comparison: Placebo versus Fluticasone Furoate 110 mcg QD for PM rTNSS at Day 8p-value: 0.07695% CI: [-0.81, 0.04]ANCOVA
Comparison: Placebo versus Fluticasone Furoate 110 mcg QD for PM rTNSS at Day 9p-value: 0.08495% CI: [-0.85, 0.05]ANCOVA
Comparison: Placebo versus Fluticasone Furoate 110 mcg QD for PM rTNSS at Day 10p-value: 0.0495% CI: [-0.94, -0.02]ANCOVA
Comparison: Placebo versus Fluticasone Furoate 110 mcg QD for PM rTNSS at Day 11p-value: 0.0995% CI: [-0.87, 0.06]ANCOVA
Comparison: Placebo versus Fluticasone Furoate 110 mcg QD for PM rTNSS at Day 12p-value: 0.0695% CI: [-0.88, 0.02]ANCOVA
Comparison: Placebo versus Fluticasone Furoate 110 mcg QD for PM rTNSS at Day 13p-value: 0.25295% CI: [-0.75, 0.2]ANCOVA
Comparison: Placebo versus Fluticasone Furoate 110 mcg QD for PM rTNSS at Day 14p-value: 0.22995% CI: [-0.79, 0.19]ANCOVA
Comparison: Placebo versus Fluticasone Furoate 110 mcg QD for PM rTNSS at Day 15p-value: 0.10995% CI: [-0.83, 0.08]ANCOVA
Comparison: Placebo versus Fluticasone Furoate 110 mcg QD for PM rTNSS at Day 1695% CI: [-0.96, -0.01]ANCOVA
Comparison: Placebo versus Fluticasone Furoate 110 mcg QD for PM rTNSS at Day 17p-value: 0.00395% CI: [-1.17, -0.23]ANCOVA
Comparison: Placebo versus Fluticasone Furoate 110 mcg QD for PM rTNSS at Day 18p-value: 0.18295% CI: [-0.81, 0.15]ANCOVA
Comparison: Placebo versus Fluticasone Furoate 110 mcg QD for PM rTNSS at Day 19p-value: 0.19495% CI: [-0.75, 0.15]ANCOVA
Comparison: Placebo versus Fluticasone Furoate 110 mcg QD for PM rTNSS at Day 20p-value: 0.12995% CI: [-0.8, 0.1]ANCOVA
Comparison: Placebo versus Fluticasone Furoate 110 mcg QD for PM rTNSS at Day 21p-value: 0.23295% CI: [-0.77, 0.19]ANCOVA
Comparison: Placebo versus Fluticasone Furoate 110 mcg QD for PM rTNSS at Day 22p-value: 0.04295% CI: [-0.98, -0.02]ANCOVA
Comparison: Placebo versus Fluticasone Furoate 110 mcg QD for PM rTNSS at Day 23p-value: 0.1595% CI: [-0.84, 0.13]ANCOVA
Comparison: Placebo versus Fluticasone Furoate 110 mcg QD for PM rTNSS at Day 24p-value: 0.0995% CI: [-0.86, 0.06]ANCOVA
Comparison: Placebo versus Fluticasone Furoate 110 mcg QD for PM rTNSS at Day 25p-value: 0.90995% CI: [-0.52, 0.46]ANCOVA
Comparison: Placebo versus Fluticasone Furoate 110 mcg QD for PM rTNSS at Day 26p-value: 0.35495% CI: [-0.73, 0.26]ANCOVA
Comparison: Placebo versus Fluticasone Furoate 110 mcg QD for PM rTNSS at Day 27p-value: 0.24595% CI: [-0.78, 0.2]ANCOVA
Comparison: Placebo versus Fluticasone Furoate 110 mcg QD for PM rTNSS at Day 28p-value: 0.03895% CI: [-1.17, -0.03]ANCOVA
Secondary
Number of Participants With Overall Evaluation of Response to Therapy
The overall evaluation of Response to Therapy was based on a 7-point categorical scale where the participants rated their perception of the change or lack of change in their VMR (Vasomotor rhinitis) symptoms at the end of the study. The 7 categories were: 1=significantly improved, 2=moderately improved, 3= mildly improved, 4= no change, 5= mildly worse, 6= moderately worse, and 7= significantly worse.
Time frame: Up to 4 weeks
Population: RITT population. Only those participants with data available at the indicated time points were analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants With Overall Evaluation of Response to Therapy | Moderately Worse | 4 Participants |
| Placebo | Number of Participants With Overall Evaluation of Response to Therapy | Moderately Improved | 37 Participants |
| Placebo | Number of Participants With Overall Evaluation of Response to Therapy | Mildly Improved | 45 Participants |
| Placebo | Number of Participants With Overall Evaluation of Response to Therapy | Significantly Worse | 3 Participants |
| Placebo | Number of Participants With Overall Evaluation of Response to Therapy | No Change | 52 Participants |
| Placebo | Number of Participants With Overall Evaluation of Response to Therapy | Mildly Worse | 1 Participants |
| Placebo | Number of Participants With Overall Evaluation of Response to Therapy | Significantly Improved | 26 Participants |
| Fluticasone Furoate 110 mcg QD | Number of Participants With Overall Evaluation of Response to Therapy | No Change | 50 Participants |
| Fluticasone Furoate 110 mcg QD | Number of Participants With Overall Evaluation of Response to Therapy | Significantly Improved | 33 Participants |
| Fluticasone Furoate 110 mcg QD | Number of Participants With Overall Evaluation of Response to Therapy | Significantly Worse | 2 Participants |
| Fluticasone Furoate 110 mcg QD | Number of Participants With Overall Evaluation of Response to Therapy | Moderately Improved | 40 Participants |
| Fluticasone Furoate 110 mcg QD | Number of Participants With Overall Evaluation of Response to Therapy | Mildly Worse | 3 Participants |
| Fluticasone Furoate 110 mcg QD | Number of Participants With Overall Evaluation of Response to Therapy | Mildly Improved | 47 Participants |
| Fluticasone Furoate 110 mcg QD | Number of Participants With Overall Evaluation of Response to Therapy | Moderately Worse | 1 Participants |
Comparison: Placebo versus Fluticasone Furoate 110 mcg QD up to Week 4 analysis.p-value: 0.184Regression, Logistic