Rhinitis, Allergic, Seasonal
Conditions
Keywords
once daily, mountain cedar, fexofenadine, allergic rhinitis, fluticasone furoate
Brief summary
The primary objective of this study is to compare the nighttime symptom relief of fluticasone furoate nasal spray and oral fexofenadine
Interventions
DRUGFluticasone furoate and fexofenadine
Fluticasone furoate and fexofenadine
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
* Informed consent. * Outpatient. * Females of child-bearing potential must use appropriate contraception. * Diagnosis of seasonal allergic rhinitis to mountain cedar. * Adequate exposure to allergen. * Able to comply with study procedures. * Literate.
Exclusion criteria
* Significant concomitant medical condition. * Use of corticosteroids, allergy medications, or other medication that affect allergic rhinitis * Positive pregnancy test. * Allergy to any component of the investigational product. * Tobacco use * Contact lens use * Has chickenpox or measles or recent exposure * Other clinical trial drug exposure in last 30 days * Affiliation with clinic site
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline Over the Two-week Treatment Period in Nighttime Symptoms Score (NSS) | Baseline (Day 1) and up to 2 Weeks | The NSS is a three-item questionnaire which assesses three aspects of allergic rhinitis symptoms at night which were rated using three 4-point scales, the sum of which comprises NSS. The total score ranged from 0 (best) to 9 (worst). The symptoms were: PM nasal congestion upon awakening (PMNCA) (0- None, 1- Mild, 2- Moderate, 3- Severe), difficulty in going to sleep due to nasal symptoms (DSNS) (0- Not at all, 1- Little, 2- Moderately, 3- Very), and nighttime awakenings due to nasal symptoms (NANS) (0- Not at all, 1- Once, 2- More than once, 3- I felt like I was awake all night). Each participant's Baseline NSS was defined as the average of the NSS calculated for the day of randomization and the three highest NSS scores calculated during the six days immediately prior to the day of randomization. Each participant's average change from Baseline NSS for Weeks 1-2 was the participant's average NSS over the treatment period minus the participant's Baseline NSS. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline Over the Two-week Treatment Period in Nighttime Reflective Total Nasal Symptom Scores (N-rTNSS) and Component Nasal Symptoms Score | Baseline (Day 1) and up to 2 Weeks | The nighttime reflective assessments were recorded each morning and assessed 4 nasal symptoms (rhinorrhea, nasal congestion, nasal itching, sneezing) at evening and night using a 4-point scale, 0- 'None' (symptom is not present), 1- 'Mild' (sign/symptom present; easily tolerated), 2- 'Moderate' (sign/symptom bothersome but tolerable), 3- 'Severe' (sign/symptom hard to tolerate; interference with activities of daily living). Scores of each of the 4 symptoms were summed for each participant to create a N-rTNSS for each day. The total score ranged from 0 (best) to 12 (worst). Each participant's Baseline total score was average of nighttime total symptom score on day of randomization and 3 highest scores calculated for 6 days immediately prior to day of randomization. Each participant's average change from Baseline nighttime total symptom score for Weeks 1-2 was the participant's average Nighttime total symptom score over the treatment period minus the participant's Baseline score. |
| Mean Change From Baseline Over the Two-week Treatment Period in D-rTNSS | Baseline (Day 1) and up to 2 Weeks | The Daytime reflective assessments were recorded each evening and assessed 4 nasal symptoms (rhinorrhea, nasal congestion, nasal itching, and sneezing) at evening and night using a 4-point scale, 0- 'None' (symptom is not present), 1- 'Mild' (sign/symptom present; easily tolerated), 2- 'Moderate' (sign/symptom bothersome but tolerable), 3- 'Severe' (sign/symptom hard to tolerate; interference with activities of daily living). The scores of each of the four Daytime symptoms were summed for each participant to create a D-rTNSS for each day. The total score ranged from 0 (best) to 12 (worst). Each participant's Baseline total symptom score was the average of the four highest total symptom score calculated for the seven days immediately prior to the day of randomization. Each participant's average change from Baseline Daytime total symptom score for Weeks 1-2 was the participant's average Daytime total symptom score over the treatment period minus the participants Baseline score. |
| Mean Change From Baseline Over the Two-week Treatment Period in 24-hour Reflective Total Nasal Symptom Scores (24-hour rTNSS) and Component Nasal Score | Baseline (Day 1) and up to 2 Weeks | Daily 24-hour rTNSS was calculated as the average of the corresponding N-rTNSS and D-rTNSS using a 4-point scale where, 0- 'None' (symptom is not present), 1- 'Mild' (sign/symptom present; easily tolerated), 2- 'Moderate' (sign/symptom bothersome but tolerable), 3- 'Severe' (sign/symptom hard to tolerate; interference with activities of daily living). The total score ranged from 0 (best) to 12 (worst). The 24-hour total symptom score for a Day is the average of the daytime total symptom score for that Day and the nighttime score for (D+1). If either component of a given date's 24-hour total symptom score was missing, then the 24-hour total symptom score itself were to be set to missing. Each participant's average change from Baseline 24-hour total symptom score for Weeks 1-2 was the participants average 24-hour total symptom score over the treatment period minus the participant's Baseline score. |
| Mean Change From Baseline Over the Two-week Treatment Period in Nighttime Reflective Total Ocular Symptom Scores (N-rTOSS) | Baseline (Day 1) and up to 2 Weeks | The nighttime reflective assessments were recorded each morning and assessed 3 ocular symptoms (tearing/watering, itching/burning, and redness) at evening and night using a 4-point scale, 0- 'None' (symptom is not present), 1- 'Mild' (sign/symptom present; easily tolerated), 2- 'Moderate' (sign/symptom bothersome but tolerable), 3- 'Severe' (sign/symptom hard to tolerate; interference with activities of daily living). Scores of each of 3 Nighttime symptoms were summed for each participant to create a N-rTOSS for each day. The total score ranged from 0 (best) to 9 (worst). Each participants Baseline total score was average of nighttime total symptom score on day of randomization and the 3 highest scores calculated for 6 days immediately prior to the day of randomization. Each participant's average change from Baseline nighttime total symptom score for Weeks 1-2 was the participant's average Nighttime total symptom score over treatment period minus the participant's Baseline score. |
| Mean Change From Baseline Over the Two-week Treatment Period in Daytime Reflective Total Ocular Symptom Scores (D-rTOSS) | Baseline (Day 1) and up to 2 Weeks | The Daytime reflective assessments were recorded each evening and assessed the 3 nasal symptoms (tearing/watering, itching/burning, and redness) at evening and night using a 4-point scale where, 0- 'None' (symptom is not present), 1- 'Mild' (sign/symptom present; easily tolerated), 2- 'Moderate' (sign/symptom bothersome but tolerable), 3- 'Severe' (sign/symptom hard to tolerate; interference with activities of daily living). The scores of each of the three Daytime symptoms were summed for each participant to create a D-rTOSS for each day. The total score ranged from 0 (best) to 9 (worst). Each participants Baseline total symptom score was the average of the four highest total symptom score calculated for the seven days immediately prior to the day of randomization. Each participant's average change from Baseline Daytime total symptom score for Weeks 1-2 was the participant's average Daytime total symptom score over the treatment period minus the participant's Baseline score. |
| Mean Change From Baseline Over the Two-week Treatment Period in 24-hour Reflective Total Ocular Symptom Scores (24-hour rTOSS) | Baseline (Day 1) and up to 2 Weeks | Daily 24-hour rTOSS was calculated as the average of the corresponding N-rTOSS and D-rTOSS using a 4-point scale, 0- 'None' (symptom is not present), 1- 'Mild' (sign/symptom present; easily tolerated), 2- 'Moderate' (sign/symptom bothersome but tolerable), 3- 'Severe' (sign/symptom hard to tolerate; interference with activities of daily living). The total score ranged from 0 (best) to 9 (worst). The 24-hour total symptom score for a Day is the average of the daytime total symptom score for that Day and the nighttime score for (D+1). If either component of a given date's 24-hour total symptom score was missing, then the 24-hour total symptom score itself was to be set to missing. Each participant's average change from Baseline 24-hour total symptom score for Weeks 1-2 was the participant's average 24-hour total symptom score over the treatment period minus the participant's Baseline score. Baseline is the 4 highest scores calculated for the 7 days prior to Day 1. |
| Mean Change From Baseline Over the Two-week Treatment Period in Pre-dose Instantaneous Total Nasal Symptom Score (Pre-dose iTNSS) and Pre-dose Instantaneous Total Ocular Symptom Scores (Pre-dose iTOSS) | Baseline (Day 1) and up to 2 Weeks | Participants were instructed to score and document their symptoms in an instantaneous manner on a diary card. The instantaneous rating was performed once daily just prior to administering their morning dose. The scores of each of the instantaneous nasal symptoms (nasal congestion, itching, rhinorrhea, and sneezing) and ocular symptoms (tearing/watering, itching/burning, and redness) were summed for each participant to create a iTNSS and iTOSS, respectively using a 4-point scale, 0- 'None' (symptom is not present), 1- 'Mild' (sign/symptom present; easily tolerated), 2- 'Moderate' (sign/symptom bothersome but tolerable), 3- 'Severe' (sign/symptom hard to tolerate; interference with activities of daily living). Total score ranged from 0 (best) to 12 (worst) for iTNSS and 0 (best) to 9 (worst) for iTOSS. Each participant's average change from Baseline iTNSS and iTOSS was participant's average iTNSS and iTOSS total score over the treatment period minus the participant's Baseline score. |
| Mean Change From Baseline Over the Two-week Treatment Period in Peak NasalIinspiratory Flow (PNIF) | Baseline (Day 1) and up to 2 Weeks | PNIF was measured by participants using an In-Check Nasal portable hand-held inspiratory flow meter and face mask. Participants recorded PNIF twice daily (in the morning prior to taking their study medication and in the evening). Three measurements were taken on each occasion and the highest measurement recorded on the electronic diary. Each participant's average change from Baseline PNIF was the participant's average PNIF over the treatment period minus the participant's baseline PNIF. |
| Mean Change From Baseline for Nocturnal Rhinoconjunctivitis Quality of Life Questionnaire (NRQLQ) | Baseline (Day 1) and Day 15 | The NRQLQ is a paper instrument administered on the day of randomization and at Visit 4/Early Withdrawal to assess nocturnal rhinitis-related quality of life. The NRQLQ is a 16-item, self-administered, disease-specific (allergic rhinitis), and quality of life instrument that measures the functional problems most troublesome to patients with nocturnal allergy symptoms over a one-week interval. Each question is scored from 0 to 6 with higher scores indicating more nocturnal impairment. Items are grouped into four domains: Sleep problems, Sleep time problems, Symptoms on waking in the morning and Practical problems. An overall score was calculated from the mean score of all items. Each participant's average change from Baseline NRQLQ score was the participant's average NRQLQ score over the treatment period minus the participant's baseline score. |
Countries
United States
Participant flow
Recruitment details
The study included 5-21 days of screening period followed by two weeks of treatment period and a Follow-up. Participants had to meet five symptom assessment criteria before randomization. Two of these were based on average Nasal Symptom Score assessment and three criteria's were based on the Daytime reflective Nasal Symptom Score (D-rTNSS).
Pre-assignment details
Total of 1360 participants were planned for enrollment so as to have 951 evaluable participants. A total of 1338 participants were screened and 936 were randomized.
Participants by arm
| Arm | Count |
|---|---|
| Placebo Participants received vehicle placebo nasal spray and oral placebo capsule each morning once daily for two weeks following pre-dose symptom assessment. | 313 |
| FFNS 110 mcg Participants received FFNS 110 mcg and oral placebo capsule each morning once daily for two weeks following pre-dose symptom assessment. | 312 |
| Fex 180 mg Participants received oral capsule (overencapsulated Fex 180 mg oral tablet) and vehicle placebo nasal spray each morning once daily for two weeks following pre-dose symptom assessment. | 311 |
| Total | 936 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 1 | 2 | 6 |
| Overall Study | Compliance less than 80 percent | 1 | 0 | 0 |
| Overall Study | In error, two study medications switched | 1 | 0 | 0 |
| Overall Study | Lack of Efficacy | 2 | 1 | 0 |
| Overall Study | Lost to Follow-up | 1 | 1 | 2 |
| Overall Study | Non-Compliance of diary | 2 | 0 | 1 |
| Overall Study | Noncompliance with study requirements | 1 | 1 | 1 |
| Overall Study | Participant could not swallow capsule | 0 | 0 | 1 |
| Overall Study | Participant could not tolerate symptoms | 0 | 0 | 1 |
| Overall Study | Participant ended study one day early | 1 | 0 | 0 |
| Overall Study | Participant moved eDiary,studymedication | 1 | 0 | 0 |
| Overall Study | Participant randomized(inadequate score) | 1 | 0 | 0 |
| Overall Study | Pregnancy | 2 | 0 | 0 |
| Overall Study | Protocol Violation | 6 | 9 | 10 |
| Overall Study | Randomized in error | 1 | 0 | 0 |
| Overall Study | Visit changed to EarlyWithdrawn Visit | 1 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 0 | 2 |
Baseline characteristics
| Characteristic | Placebo | FFNS 110 mcg | Fex 180 mg | Total |
|---|---|---|---|---|
| Age, Continuous | 37.8 Years STANDARD_DEVIATION 14.39 | 37.8 Years STANDARD_DEVIATION 13.95 | 39.6 Years STANDARD_DEVIATION 14.63 | 38.4 Years STANDARD_DEVIATION 14.34 |
| Race/Ethnicity, Customized African American/African Heritage | 22 Participants | 26 Participants | 9 Participants | 57 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 7 Participants | 5 Participants | 6 Participants | 18 Participants |
| Race/Ethnicity, Customized Asian - Central/South Asian Heritage | 3 Participants | 1 Participants | 1 Participants | 5 Participants |
| Race/Ethnicity, Customized Asian - East Asian Heritage | 1 Participants | 2 Participants | 0 Participants | 3 Participants |
| Race/Ethnicity, Customized Asian - Japanese Heritage | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Asian - South East Asian Heritage | 2 Participants | 1 Participants | 2 Participants | 5 Participants |
| Race/Ethnicity, Customized Mixed Race | 6 Participants | 7 Participants | 5 Participants | 18 Participants |
| Race/Ethnicity, Customized Native Hawaiian or other Pacific Islander | 2 Participants | 1 Participants | 2 Participants | 5 Participants |
| Race/Ethnicity, Customized White/Caucasian/European Heritage | 270 Participants | 268 Participants | 286 Participants | 824 Participants |
| Sex: Female, Male Female | 194 Participants | 209 Participants | 199 Participants | 602 Participants |
| Sex: Female, Male Male | 119 Participants | 103 Participants | 112 Participants | 334 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 313 | 0 / 312 | 0 / 311 |
| other Total, other adverse events | 11 / 313 | 12 / 312 | 10 / 311 |
| serious Total, serious adverse events | 0 / 313 | 0 / 312 | 1 / 311 |
Outcome results
Primary
Mean Change From Baseline Over the Two-week Treatment Period in Nighttime Symptoms Score (NSS)
The NSS is a three-item questionnaire which assesses three aspects of allergic rhinitis symptoms at night which were rated using three 4-point scales, the sum of which comprises NSS. The total score ranged from 0 (best) to 9 (worst). The symptoms were: PM nasal congestion upon awakening (PMNCA) (0- None, 1- Mild, 2- Moderate, 3- Severe), difficulty in going to sleep due to nasal symptoms (DSNS) (0- Not at all, 1- Little, 2- Moderately, 3- Very), and nighttime awakenings due to nasal symptoms (NANS) (0- Not at all, 1- Once, 2- More than once, 3- I felt like I was awake all night). Each participant's Baseline NSS was defined as the average of the NSS calculated for the day of randomization and the three highest NSS scores calculated during the six days immediately prior to the day of randomization. Each participant's average change from Baseline NSS for Weeks 1-2 was the participant's average NSS over the treatment period minus the participant's Baseline NSS.
Time frame: Baseline (Day 1) and up to 2 Weeks
Population: Intent-to-treat (ITT) population included all participants randomized to double-blind treatment. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Mean Change From Baseline Over the Two-week Treatment Period in Nighttime Symptoms Score (NSS) | NSS, Week 1-2 | -1.9 Scores on a scale | Standard Error 0.1 |
| Placebo | Mean Change From Baseline Over the Two-week Treatment Period in Nighttime Symptoms Score (NSS) | PMNCA, Week 1-2 | -0.6 Scores on a scale | Standard Error 0.03 |
| Placebo | Mean Change From Baseline Over the Two-week Treatment Period in Nighttime Symptoms Score (NSS) | NANS, Week 1-2 | -0.7 Scores on a scale | Standard Error 0.04 |
| Placebo | Mean Change From Baseline Over the Two-week Treatment Period in Nighttime Symptoms Score (NSS) | DSNS, Week 1-2 | -0.7 Scores on a scale | Standard Error 0.04 |
| FFNS 110 mcg | Mean Change From Baseline Over the Two-week Treatment Period in Nighttime Symptoms Score (NSS) | DSNS, Week 1-2 | -1.1 Scores on a scale | Standard Error 0.04 |
| FFNS 110 mcg | Mean Change From Baseline Over the Two-week Treatment Period in Nighttime Symptoms Score (NSS) | NSS, Week 1-2 | -2.9 Scores on a scale | Standard Error 0.1 |
| FFNS 110 mcg | Mean Change From Baseline Over the Two-week Treatment Period in Nighttime Symptoms Score (NSS) | NANS, Week 1-2 | -1.0 Scores on a scale | Standard Error 0.04 |
| FFNS 110 mcg | Mean Change From Baseline Over the Two-week Treatment Period in Nighttime Symptoms Score (NSS) | PMNCA, Week 1-2 | -0.9 Scores on a scale | Standard Error 0.03 |
| Fex 180 mg | Mean Change From Baseline Over the Two-week Treatment Period in Nighttime Symptoms Score (NSS) | DSNS, Week 1-2 | -0.8 Scores on a scale | Standard Error 0.04 |
| Fex 180 mg | Mean Change From Baseline Over the Two-week Treatment Period in Nighttime Symptoms Score (NSS) | PMNCA, Week 1-2 | -0.6 Scores on a scale | Standard Error 0.03 |
| Fex 180 mg | Mean Change From Baseline Over the Two-week Treatment Period in Nighttime Symptoms Score (NSS) | NANS, Week 1-2 | -0.7 Scores on a scale | Standard Error 0.03 |
| Fex 180 mg | Mean Change From Baseline Over the Two-week Treatment Period in Nighttime Symptoms Score (NSS) | NSS, Week 1-2 | -2.0 Scores on a scale | Standard Error 0.09 |
p-value: <0.00195% CI: [-1.2, -0.7]ANCOVA
p-value: <0.00195% CI: [-1.2, -0.7]ANCOVA
p-value: 0.81695% CI: [-0.3, 0.2]ANCOVA
Secondary
Mean Change From Baseline for Nocturnal Rhinoconjunctivitis Quality of Life Questionnaire (NRQLQ)
The NRQLQ is a paper instrument administered on the day of randomization and at Visit 4/Early Withdrawal to assess nocturnal rhinitis-related quality of life. The NRQLQ is a 16-item, self-administered, disease-specific (allergic rhinitis), and quality of life instrument that measures the functional problems most troublesome to patients with nocturnal allergy symptoms over a one-week interval. Each question is scored from 0 to 6 with higher scores indicating more nocturnal impairment. Items are grouped into four domains: Sleep problems, Sleep time problems, Symptoms on waking in the morning and Practical problems. An overall score was calculated from the mean score of all items. Each participant's average change from Baseline NRQLQ score was the participant's average NRQLQ score over the treatment period minus the participant's baseline score.
Time frame: Baseline (Day 1) and Day 15
Population: ITT Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Mean Change From Baseline for Nocturnal Rhinoconjunctivitis Quality of Life Questionnaire (NRQLQ) | Symptoms on waking | -1.4 Scores on a scale | Standard Error 0.09 |
| Placebo | Mean Change From Baseline for Nocturnal Rhinoconjunctivitis Quality of Life Questionnaire (NRQLQ) | Sleep time problems | -1.3 Scores on a scale | Standard Error 0.09 |
| Placebo | Mean Change From Baseline for Nocturnal Rhinoconjunctivitis Quality of Life Questionnaire (NRQLQ) | Overall score | -1.3 Scores on a scale | Standard Error 0.08 |
| Placebo | Mean Change From Baseline for Nocturnal Rhinoconjunctivitis Quality of Life Questionnaire (NRQLQ) | Sleep problems | -1.2 Scores on a scale | Standard Error 0.09 |
| Placebo | Mean Change From Baseline for Nocturnal Rhinoconjunctivitis Quality of Life Questionnaire (NRQLQ) | Practical problems | -1.2 Scores on a scale | Standard Error 0.09 |
| FFNS 110 mcg | Mean Change From Baseline for Nocturnal Rhinoconjunctivitis Quality of Life Questionnaire (NRQLQ) | Sleep time problems | -1.9 Scores on a scale | Standard Error 0.09 |
| FFNS 110 mcg | Mean Change From Baseline for Nocturnal Rhinoconjunctivitis Quality of Life Questionnaire (NRQLQ) | Overall score | -1.9 Scores on a scale | Standard Error 0.09 |
| FFNS 110 mcg | Mean Change From Baseline for Nocturnal Rhinoconjunctivitis Quality of Life Questionnaire (NRQLQ) | Sleep problems | -1.9 Scores on a scale | Standard Error 0.09 |
| FFNS 110 mcg | Mean Change From Baseline for Nocturnal Rhinoconjunctivitis Quality of Life Questionnaire (NRQLQ) | Symptoms on waking | -2 Scores on a scale | Standard Error 0.1 |
| FFNS 110 mcg | Mean Change From Baseline for Nocturnal Rhinoconjunctivitis Quality of Life Questionnaire (NRQLQ) | Practical problems | -1.9 Scores on a scale | Standard Error 0.1 |
| Fex 180 mg | Mean Change From Baseline for Nocturnal Rhinoconjunctivitis Quality of Life Questionnaire (NRQLQ) | Practical problems | -1.6 Scores on a scale | Standard Error 0.1 |
| Fex 180 mg | Mean Change From Baseline for Nocturnal Rhinoconjunctivitis Quality of Life Questionnaire (NRQLQ) | Symptoms on waking | -1.5 Scores on a scale | Standard Error 0.09 |
| Fex 180 mg | Mean Change From Baseline for Nocturnal Rhinoconjunctivitis Quality of Life Questionnaire (NRQLQ) | Overall score | -1.5 Scores on a scale | Standard Error 0.08 |
| Fex 180 mg | Mean Change From Baseline for Nocturnal Rhinoconjunctivitis Quality of Life Questionnaire (NRQLQ) | Sleep time problems | -1.5 Scores on a scale | Standard Error 0.09 |
| Fex 180 mg | Mean Change From Baseline for Nocturnal Rhinoconjunctivitis Quality of Life Questionnaire (NRQLQ) | Sleep problems | -1.5 Scores on a scale | Standard Error 0.09 |
p-value: <0.00195% CI: [-0.7, -0.3]ANCOVA
p-value: 0.20395% CI: [-0.4, 0.1]ANCOVA
p-value: <0.00195% CI: [-0.8, -0.4]ANCOVA
Secondary
Mean Change From Baseline Over the Two-week Treatment Period in 24-hour Reflective Total Nasal Symptom Scores (24-hour rTNSS) and Component Nasal Score
Daily 24-hour rTNSS was calculated as the average of the corresponding N-rTNSS and D-rTNSS using a 4-point scale where, 0- 'None' (symptom is not present), 1- 'Mild' (sign/symptom present; easily tolerated), 2- 'Moderate' (sign/symptom bothersome but tolerable), 3- 'Severe' (sign/symptom hard to tolerate; interference with activities of daily living). The total score ranged from 0 (best) to 12 (worst). The 24-hour total symptom score for a Day is the average of the daytime total symptom score for that Day and the nighttime score for (D+1). If either component of a given date's 24-hour total symptom score was missing, then the 24-hour total symptom score itself were to be set to missing. Each participant's average change from Baseline 24-hour total symptom score for Weeks 1-2 was the participants average 24-hour total symptom score over the treatment period minus the participant's Baseline score.
Time frame: Baseline (Day 1) and up to 2 Weeks
Population: ITT population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Mean Change From Baseline Over the Two-week Treatment Period in 24-hour Reflective Total Nasal Symptom Scores (24-hour rTNSS) and Component Nasal Score | Runny nose | -0.6 Scores on a scale | Standard Error 0.03 |
| Placebo | Mean Change From Baseline Over the Two-week Treatment Period in 24-hour Reflective Total Nasal Symptom Scores (24-hour rTNSS) and Component Nasal Score | Itchy nose | -0.7 Scores on a scale | Standard Error 0.04 |
| Placebo | Mean Change From Baseline Over the Two-week Treatment Period in 24-hour Reflective Total Nasal Symptom Scores (24-hour rTNSS) and Component Nasal Score | TNSS | -2.5 Scores on a scale | Standard Error 0.13 |
| Placebo | Mean Change From Baseline Over the Two-week Treatment Period in 24-hour Reflective Total Nasal Symptom Scores (24-hour rTNSS) and Component Nasal Score | Nasal congestion | -0.6 Scores on a scale | Standard Error 0.03 |
| Placebo | Mean Change From Baseline Over the Two-week Treatment Period in 24-hour Reflective Total Nasal Symptom Scores (24-hour rTNSS) and Component Nasal Score | Sneezing | -0.7 Scores on a scale | Standard Error 0.04 |
| FFNS 110 mcg | Mean Change From Baseline Over the Two-week Treatment Period in 24-hour Reflective Total Nasal Symptom Scores (24-hour rTNSS) and Component Nasal Score | Itchy nose | -0.9 Scores on a scale | Standard Error 0.04 |
| FFNS 110 mcg | Mean Change From Baseline Over the Two-week Treatment Period in 24-hour Reflective Total Nasal Symptom Scores (24-hour rTNSS) and Component Nasal Score | TNSS | -3.6 Scores on a scale | Standard Error 0.14 |
| FFNS 110 mcg | Mean Change From Baseline Over the Two-week Treatment Period in 24-hour Reflective Total Nasal Symptom Scores (24-hour rTNSS) and Component Nasal Score | Nasal congestion | -0.9 Scores on a scale | Standard Error 0.04 |
| FFNS 110 mcg | Mean Change From Baseline Over the Two-week Treatment Period in 24-hour Reflective Total Nasal Symptom Scores (24-hour rTNSS) and Component Nasal Score | Runny nose | -0.9 Scores on a scale | Standard Error 0.04 |
| FFNS 110 mcg | Mean Change From Baseline Over the Two-week Treatment Period in 24-hour Reflective Total Nasal Symptom Scores (24-hour rTNSS) and Component Nasal Score | Sneezing | -1.0 Scores on a scale | Standard Error 0.04 |
| Fex 180 mg | Mean Change From Baseline Over the Two-week Treatment Period in 24-hour Reflective Total Nasal Symptom Scores (24-hour rTNSS) and Component Nasal Score | Sneezing | -0.8 Scores on a scale | Standard Error 0.04 |
| Fex 180 mg | Mean Change From Baseline Over the Two-week Treatment Period in 24-hour Reflective Total Nasal Symptom Scores (24-hour rTNSS) and Component Nasal Score | Runny nose | -0.7 Scores on a scale | Standard Error 0.03 |
| Fex 180 mg | Mean Change From Baseline Over the Two-week Treatment Period in 24-hour Reflective Total Nasal Symptom Scores (24-hour rTNSS) and Component Nasal Score | TNSS | -2.8 Scores on a scale | Standard Error 0.13 |
| Fex 180 mg | Mean Change From Baseline Over the Two-week Treatment Period in 24-hour Reflective Total Nasal Symptom Scores (24-hour rTNSS) and Component Nasal Score | Itchy nose | -0.8 Scores on a scale | Standard Error 0.04 |
| Fex 180 mg | Mean Change From Baseline Over the Two-week Treatment Period in 24-hour Reflective Total Nasal Symptom Scores (24-hour rTNSS) and Component Nasal Score | Nasal congestion | -0.7 Scores on a scale | Standard Error 0.03 |
p-value: <0.00195% CI: [-1.6, -0.8]ANCOVA
p-value: <0.00195% CI: [-1.3, -0.6]ANCOVA
p-value: 0.13695% CI: [-0.6, 0.1]ANCOVA
Secondary
Mean Change From Baseline Over the Two-week Treatment Period in 24-hour Reflective Total Ocular Symptom Scores (24-hour rTOSS)
Daily 24-hour rTOSS was calculated as the average of the corresponding N-rTOSS and D-rTOSS using a 4-point scale, 0- 'None' (symptom is not present), 1- 'Mild' (sign/symptom present; easily tolerated), 2- 'Moderate' (sign/symptom bothersome but tolerable), 3- 'Severe' (sign/symptom hard to tolerate; interference with activities of daily living). The total score ranged from 0 (best) to 9 (worst). The 24-hour total symptom score for a Day is the average of the daytime total symptom score for that Day and the nighttime score for (D+1). If either component of a given date's 24-hour total symptom score was missing, then the 24-hour total symptom score itself was to be set to missing. Each participant's average change from Baseline 24-hour total symptom score for Weeks 1-2 was the participant's average 24-hour total symptom score over the treatment period minus the participant's Baseline score. Baseline is the 4 highest scores calculated for the 7 days prior to Day 1.
Time frame: Baseline (Day 1) and up to 2 Weeks
Population: ITT Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Mean Change From Baseline Over the Two-week Treatment Period in 24-hour Reflective Total Ocular Symptom Scores (24-hour rTOSS) | TOSS | -2.0 Scores on a scale | Standard Error 0.11 |
| Placebo | Mean Change From Baseline Over the Two-week Treatment Period in 24-hour Reflective Total Ocular Symptom Scores (24-hour rTOSS) | Eye tearing | -0.7 Scores on a scale | Standard Error 0.04 |
| Placebo | Mean Change From Baseline Over the Two-week Treatment Period in 24-hour Reflective Total Ocular Symptom Scores (24-hour rTOSS) | Eye itching | -0.7 Scores on a scale | Standard Error 0.04 |
| Placebo | Mean Change From Baseline Over the Two-week Treatment Period in 24-hour Reflective Total Ocular Symptom Scores (24-hour rTOSS) | Eye redness | -0.7 Scores on a scale | Standard Error 0.04 |
| FFNS 110 mcg | Mean Change From Baseline Over the Two-week Treatment Period in 24-hour Reflective Total Ocular Symptom Scores (24-hour rTOSS) | Eye redness | -0.8 Scores on a scale | Standard Error 0.04 |
| FFNS 110 mcg | Mean Change From Baseline Over the Two-week Treatment Period in 24-hour Reflective Total Ocular Symptom Scores (24-hour rTOSS) | TOSS | -2.5 Scores on a scale | Standard Error 0.11 |
| FFNS 110 mcg | Mean Change From Baseline Over the Two-week Treatment Period in 24-hour Reflective Total Ocular Symptom Scores (24-hour rTOSS) | Eye itching | -0.9 Scores on a scale | Standard Error 0.04 |
| FFNS 110 mcg | Mean Change From Baseline Over the Two-week Treatment Period in 24-hour Reflective Total Ocular Symptom Scores (24-hour rTOSS) | Eye tearing | -0.9 Scores on a scale | Standard Error 0.04 |
| Fex 180 mg | Mean Change From Baseline Over the Two-week Treatment Period in 24-hour Reflective Total Ocular Symptom Scores (24-hour rTOSS) | Eye redness | -0.7 Scores on a scale | Standard Error 0.04 |
| Fex 180 mg | Mean Change From Baseline Over the Two-week Treatment Period in 24-hour Reflective Total Ocular Symptom Scores (24-hour rTOSS) | Eye tearing | -0.8 Scores on a scale | Standard Error 0.04 |
| Fex 180 mg | Mean Change From Baseline Over the Two-week Treatment Period in 24-hour Reflective Total Ocular Symptom Scores (24-hour rTOSS) | Eye itching | -0.8 Scores on a scale | Standard Error 0.04 |
| Fex 180 mg | Mean Change From Baseline Over the Two-week Treatment Period in 24-hour Reflective Total Ocular Symptom Scores (24-hour rTOSS) | TOSS | -2.2 Scores on a scale | Standard Error 0.11 |
p-value: 0.00395% CI: [-0.7, -0.2]ANCOVA
p-value: 0.28695% CI: [-0.5, 0.1]ANCOVA
p-value: 0.10695% CI: [-0.6, 0]ANCOVA
Secondary
Mean Change From Baseline Over the Two-week Treatment Period in Daytime Reflective Total Ocular Symptom Scores (D-rTOSS)
The Daytime reflective assessments were recorded each evening and assessed the 3 nasal symptoms (tearing/watering, itching/burning, and redness) at evening and night using a 4-point scale where, 0- 'None' (symptom is not present), 1- 'Mild' (sign/symptom present; easily tolerated), 2- 'Moderate' (sign/symptom bothersome but tolerable), 3- 'Severe' (sign/symptom hard to tolerate; interference with activities of daily living). The scores of each of the three Daytime symptoms were summed for each participant to create a D-rTOSS for each day. The total score ranged from 0 (best) to 9 (worst). Each participants Baseline total symptom score was the average of the four highest total symptom score calculated for the seven days immediately prior to the day of randomization. Each participant's average change from Baseline Daytime total symptom score for Weeks 1-2 was the participant's average Daytime total symptom score over the treatment period minus the participant's Baseline score.
Time frame: Baseline (Day 1) and up to 2 Weeks
Population: ITT Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Mean Change From Baseline Over the Two-week Treatment Period in Daytime Reflective Total Ocular Symptom Scores (D-rTOSS) | TOSS | -2.2 Scores on a scale | Standard Error 0.11 |
| Placebo | Mean Change From Baseline Over the Two-week Treatment Period in Daytime Reflective Total Ocular Symptom Scores (D-rTOSS) | Eye tearing | -0.8 Scores on a scale | Standard Error 0.04 |
| Placebo | Mean Change From Baseline Over the Two-week Treatment Period in Daytime Reflective Total Ocular Symptom Scores (D-rTOSS) | Eye itching | -0.8 Scores on a scale | Standard Error 0.04 |
| Placebo | Mean Change From Baseline Over the Two-week Treatment Period in Daytime Reflective Total Ocular Symptom Scores (D-rTOSS) | Eye redness | -0.7 Scores on a scale | Standard Error 0.04 |
| FFNS 110 mcg | Mean Change From Baseline Over the Two-week Treatment Period in Daytime Reflective Total Ocular Symptom Scores (D-rTOSS) | Eye redness | -0.8 Scores on a scale | Standard Error 0.04 |
| FFNS 110 mcg | Mean Change From Baseline Over the Two-week Treatment Period in Daytime Reflective Total Ocular Symptom Scores (D-rTOSS) | TOSS | -2.6 Scores on a scale | Standard Error 0.11 |
| FFNS 110 mcg | Mean Change From Baseline Over the Two-week Treatment Period in Daytime Reflective Total Ocular Symptom Scores (D-rTOSS) | Eye itching | -0.9 Scores on a scale | Standard Error 0.04 |
| FFNS 110 mcg | Mean Change From Baseline Over the Two-week Treatment Period in Daytime Reflective Total Ocular Symptom Scores (D-rTOSS) | Eye tearing | -0.9 Scores on a scale | Standard Error 0.04 |
| Fex 180 mg | Mean Change From Baseline Over the Two-week Treatment Period in Daytime Reflective Total Ocular Symptom Scores (D-rTOSS) | Eye redness | -0.7 Scores on a scale | Standard Error 0.04 |
| Fex 180 mg | Mean Change From Baseline Over the Two-week Treatment Period in Daytime Reflective Total Ocular Symptom Scores (D-rTOSS) | Eye tearing | -0.8 Scores on a scale | Standard Error 0.04 |
| Fex 180 mg | Mean Change From Baseline Over the Two-week Treatment Period in Daytime Reflective Total Ocular Symptom Scores (D-rTOSS) | Eye itching | -0.9 Scores on a scale | Standard Error 0.04 |
| Fex 180 mg | Mean Change From Baseline Over the Two-week Treatment Period in Daytime Reflective Total Ocular Symptom Scores (D-rTOSS) | TOSS | -2.4 Scores on a scale | Standard Error 0.11 |
p-value: 0.00795% CI: [-0.7, -0.1]ANCOVA
p-value: 0.28695% CI: [-0.5, 0.1]ANCOVA
p-value: 0.10695% CI: [-0.5, 0.1]ANCOVA
Secondary
Mean Change From Baseline Over the Two-week Treatment Period in D-rTNSS
The Daytime reflective assessments were recorded each evening and assessed 4 nasal symptoms (rhinorrhea, nasal congestion, nasal itching, and sneezing) at evening and night using a 4-point scale, 0- 'None' (symptom is not present), 1- 'Mild' (sign/symptom present; easily tolerated), 2- 'Moderate' (sign/symptom bothersome but tolerable), 3- 'Severe' (sign/symptom hard to tolerate; interference with activities of daily living). The scores of each of the four Daytime symptoms were summed for each participant to create a D-rTNSS for each day. The total score ranged from 0 (best) to 12 (worst). Each participant's Baseline total symptom score was the average of the four highest total symptom score calculated for the seven days immediately prior to the day of randomization. Each participant's average change from Baseline Daytime total symptom score for Weeks 1-2 was the participant's average Daytime total symptom score over the treatment period minus the participants Baseline score.
Time frame: Baseline (Day 1) and up to 2 Weeks
Population: ITT population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Mean Change From Baseline Over the Two-week Treatment Period in D-rTNSS | Runny nose | -0.6 Scores on a scale | Standard Error 0.04 |
| Placebo | Mean Change From Baseline Over the Two-week Treatment Period in D-rTNSS | Itchy nose | -0.7 Scores on a scale | Standard Error 0.04 |
| Placebo | Mean Change From Baseline Over the Two-week Treatment Period in D-rTNSS | TNSS | -2.6 Scores on a scale | Standard Error 0.13 |
| Placebo | Mean Change From Baseline Over the Two-week Treatment Period in D-rTNSS | Nasal congestion | -0.7 Scores on a scale | Standard Error 0.04 |
| Placebo | Mean Change From Baseline Over the Two-week Treatment Period in D-rTNSS | Sneezing | -0.7 Scores on a scale | Standard Error 0.04 |
| FFNS 110 mcg | Mean Change From Baseline Over the Two-week Treatment Period in D-rTNSS | Itchy nose | -1.0 Scores on a scale | Standard Error 0.04 |
| FFNS 110 mcg | Mean Change From Baseline Over the Two-week Treatment Period in D-rTNSS | TNSS | -3.7 Scores on a scale | Standard Error 0.14 |
| FFNS 110 mcg | Mean Change From Baseline Over the Two-week Treatment Period in D-rTNSS | Nasal congestion | -0.9 Scores on a scale | Standard Error 0.04 |
| FFNS 110 mcg | Mean Change From Baseline Over the Two-week Treatment Period in D-rTNSS | Runny nose | -0.9 Scores on a scale | Standard Error 0.04 |
| FFNS 110 mcg | Mean Change From Baseline Over the Two-week Treatment Period in D-rTNSS | Sneezing | -1.1 Scores on a scale | Standard Error 0.04 |
| Fex 180 mg | Mean Change From Baseline Over the Two-week Treatment Period in D-rTNSS | Sneezing | -0.9 Scores on a scale | Standard Error 0.04 |
| Fex 180 mg | Mean Change From Baseline Over the Two-week Treatment Period in D-rTNSS | Runny nose | -0.7 Scores on a scale | Standard Error 0.03 |
| Fex 180 mg | Mean Change From Baseline Over the Two-week Treatment Period in D-rTNSS | TNSS | -3.0 Scores on a scale | Standard Error 0.13 |
| Fex 180 mg | Mean Change From Baseline Over the Two-week Treatment Period in D-rTNSS | Itchy nose | -0.8 Scores on a scale | Standard Error 0.04 |
| Fex 180 mg | Mean Change From Baseline Over the Two-week Treatment Period in D-rTNSS | Nasal congestion | -0.8 Scores on a scale | Standard Error 0.03 |
p-value: <0.00195% CI: [-1.5, -0.7]ANCOVA
p-value: <0.00195% CI: [-1.2, -0.4]ANCOVA
p-value: 0.13695% CI: [-0.7, 0.1]ANCOVA
Secondary
Mean Change From Baseline Over the Two-week Treatment Period in Nighttime Reflective Total Nasal Symptom Scores (N-rTNSS) and Component Nasal Symptoms Score
The nighttime reflective assessments were recorded each morning and assessed 4 nasal symptoms (rhinorrhea, nasal congestion, nasal itching, sneezing) at evening and night using a 4-point scale, 0- 'None' (symptom is not present), 1- 'Mild' (sign/symptom present; easily tolerated), 2- 'Moderate' (sign/symptom bothersome but tolerable), 3- 'Severe' (sign/symptom hard to tolerate; interference with activities of daily living). Scores of each of the 4 symptoms were summed for each participant to create a N-rTNSS for each day. The total score ranged from 0 (best) to 12 (worst). Each participant's Baseline total score was average of nighttime total symptom score on day of randomization and 3 highest scores calculated for 6 days immediately prior to day of randomization. Each participant's average change from Baseline nighttime total symptom score for Weeks 1-2 was the participant's average Nighttime total symptom score over the treatment period minus the participant's Baseline score.
Time frame: Baseline (Day 1) and up to 2 Weeks
Population: ITT population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Mean Change From Baseline Over the Two-week Treatment Period in Nighttime Reflective Total Nasal Symptom Scores (N-rTNSS) and Component Nasal Symptoms Score | Runny nose | -0.6 Scores on a scale | Standard Error 0.04 |
| Placebo | Mean Change From Baseline Over the Two-week Treatment Period in Nighttime Reflective Total Nasal Symptom Scores (N-rTNSS) and Component Nasal Symptoms Score | Itchy nose | -0.7 Scores on a scale | Standard Error 0.04 |
| Placebo | Mean Change From Baseline Over the Two-week Treatment Period in Nighttime Reflective Total Nasal Symptom Scores (N-rTNSS) and Component Nasal Symptoms Score | TNSS | -2.5 Scores on a scale | Standard Error 0.13 |
| Placebo | Mean Change From Baseline Over the Two-week Treatment Period in Nighttime Reflective Total Nasal Symptom Scores (N-rTNSS) and Component Nasal Symptoms Score | Nasal congestion | -0.6 Scores on a scale | Standard Error 0.03 |
| Placebo | Mean Change From Baseline Over the Two-week Treatment Period in Nighttime Reflective Total Nasal Symptom Scores (N-rTNSS) and Component Nasal Symptoms Score | Sneezing | -0.7 Scores on a scale | Standard Error 0.04 |
| FFNS 110 mcg | Mean Change From Baseline Over the Two-week Treatment Period in Nighttime Reflective Total Nasal Symptom Scores (N-rTNSS) and Component Nasal Symptoms Score | Itchy nose | -0.9 Scores on a scale | Standard Error 0.04 |
| FFNS 110 mcg | Mean Change From Baseline Over the Two-week Treatment Period in Nighttime Reflective Total Nasal Symptom Scores (N-rTNSS) and Component Nasal Symptoms Score | TNSS | -3.7 Scores on a scale | Standard Error 0.14 |
| FFNS 110 mcg | Mean Change From Baseline Over the Two-week Treatment Period in Nighttime Reflective Total Nasal Symptom Scores (N-rTNSS) and Component Nasal Symptoms Score | Nasal congestion | -0.9 Scores on a scale | Standard Error 0.04 |
| FFNS 110 mcg | Mean Change From Baseline Over the Two-week Treatment Period in Nighttime Reflective Total Nasal Symptom Scores (N-rTNSS) and Component Nasal Symptoms Score | Runny nose | -0.9 Scores on a scale | Standard Error 0.04 |
| FFNS 110 mcg | Mean Change From Baseline Over the Two-week Treatment Period in Nighttime Reflective Total Nasal Symptom Scores (N-rTNSS) and Component Nasal Symptoms Score | Sneezing | -1.0 Scores on a scale | Standard Error 0.04 |
| Fex 180 mg | Mean Change From Baseline Over the Two-week Treatment Period in Nighttime Reflective Total Nasal Symptom Scores (N-rTNSS) and Component Nasal Symptoms Score | Sneezing | -0.7 Scores on a scale | Standard Error 0.04 |
| Fex 180 mg | Mean Change From Baseline Over the Two-week Treatment Period in Nighttime Reflective Total Nasal Symptom Scores (N-rTNSS) and Component Nasal Symptoms Score | Runny nose | -0.7 Scores on a scale | Standard Error 0.03 |
| Fex 180 mg | Mean Change From Baseline Over the Two-week Treatment Period in Nighttime Reflective Total Nasal Symptom Scores (N-rTNSS) and Component Nasal Symptoms Score | TNSS | -2.7 Scores on a scale | Standard Error 0.13 |
| Fex 180 mg | Mean Change From Baseline Over the Two-week Treatment Period in Nighttime Reflective Total Nasal Symptom Scores (N-rTNSS) and Component Nasal Symptoms Score | Itchy nose | -0.7 Scores on a scale | Standard Error 0.04 |
| Fex 180 mg | Mean Change From Baseline Over the Two-week Treatment Period in Nighttime Reflective Total Nasal Symptom Scores (N-rTNSS) and Component Nasal Symptoms Score | Nasal congestion | -0.7 Scores on a scale | Standard Error 0.03 |
p-value: <0.00195% CI: [-1.6, -0.9]ANCOVA
p-value: <0.00195% CI: [-1.4, -0.7]ANCOVA
p-value: 0.13695% CI: [-0.6, 0.1]ANCOVA
Secondary
Mean Change From Baseline Over the Two-week Treatment Period in Nighttime Reflective Total Ocular Symptom Scores (N-rTOSS)
The nighttime reflective assessments were recorded each morning and assessed 3 ocular symptoms (tearing/watering, itching/burning, and redness) at evening and night using a 4-point scale, 0- 'None' (symptom is not present), 1- 'Mild' (sign/symptom present; easily tolerated), 2- 'Moderate' (sign/symptom bothersome but tolerable), 3- 'Severe' (sign/symptom hard to tolerate; interference with activities of daily living). Scores of each of 3 Nighttime symptoms were summed for each participant to create a N-rTOSS for each day. The total score ranged from 0 (best) to 9 (worst). Each participants Baseline total score was average of nighttime total symptom score on day of randomization and the 3 highest scores calculated for 6 days immediately prior to the day of randomization. Each participant's average change from Baseline nighttime total symptom score for Weeks 1-2 was the participant's average Nighttime total symptom score over treatment period minus the participant's Baseline score.
Time frame: Baseline (Day 1) and up to 2 Weeks
Population: ITT Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Mean Change From Baseline Over the Two-week Treatment Period in Nighttime Reflective Total Ocular Symptom Scores (N-rTOSS) | TOSS | -2 Scores on a scale | Standard Error 0.11 |
| Placebo | Mean Change From Baseline Over the Two-week Treatment Period in Nighttime Reflective Total Ocular Symptom Scores (N-rTOSS) | Eye tearing | -0.7 Scores on a scale | Standard Error 0.04 |
| Placebo | Mean Change From Baseline Over the Two-week Treatment Period in Nighttime Reflective Total Ocular Symptom Scores (N-rTOSS) | Eye itching | -0.7 Scores on a scale | Standard Error 0.04 |
| Placebo | Mean Change From Baseline Over the Two-week Treatment Period in Nighttime Reflective Total Ocular Symptom Scores (N-rTOSS) | Eye redness | -0.6 Scores on a scale | Standard Error 0.04 |
| FFNS 110 mcg | Mean Change From Baseline Over the Two-week Treatment Period in Nighttime Reflective Total Ocular Symptom Scores (N-rTOSS) | Eye redness | -0.8 Scores on a scale | Standard Error 0.04 |
| FFNS 110 mcg | Mean Change From Baseline Over the Two-week Treatment Period in Nighttime Reflective Total Ocular Symptom Scores (N-rTOSS) | TOSS | -2.5 Scores on a scale | Standard Error 0.11 |
| FFNS 110 mcg | Mean Change From Baseline Over the Two-week Treatment Period in Nighttime Reflective Total Ocular Symptom Scores (N-rTOSS) | Eye itching | -0.9 Scores on a scale | Standard Error 0.04 |
| FFNS 110 mcg | Mean Change From Baseline Over the Two-week Treatment Period in Nighttime Reflective Total Ocular Symptom Scores (N-rTOSS) | Eye tearing | -0.9 Scores on a scale | Standard Error 0.04 |
| Fex 180 mg | Mean Change From Baseline Over the Two-week Treatment Period in Nighttime Reflective Total Ocular Symptom Scores (N-rTOSS) | Eye redness | -0.7 Scores on a scale | Standard Error 0.04 |
| Fex 180 mg | Mean Change From Baseline Over the Two-week Treatment Period in Nighttime Reflective Total Ocular Symptom Scores (N-rTOSS) | Eye tearing | -0.8 Scores on a scale | Standard Error 0.04 |
| Fex 180 mg | Mean Change From Baseline Over the Two-week Treatment Period in Nighttime Reflective Total Ocular Symptom Scores (N-rTOSS) | Eye itching | -0.8 Scores on a scale | Standard Error 0.04 |
| Fex 180 mg | Mean Change From Baseline Over the Two-week Treatment Period in Nighttime Reflective Total Ocular Symptom Scores (N-rTOSS) | TOSS | -2.2 Scores on a scale | Standard Error 0.11 |
p-value: 0.00195% CI: [-0.8, -0.2]ANCOVA
p-value: 0.10695% CI: [-0.6, 0]ANCOVA
p-value: 0.28695% CI: [-0.5, 0.1]ANCOVA
Secondary
Mean Change From Baseline Over the Two-week Treatment Period in Peak NasalIinspiratory Flow (PNIF)
PNIF was measured by participants using an In-Check Nasal portable hand-held inspiratory flow meter and face mask. Participants recorded PNIF twice daily (in the morning prior to taking their study medication and in the evening). Three measurements were taken on each occasion and the highest measurement recorded on the electronic diary. Each participant's average change from Baseline PNIF was the participant's average PNIF over the treatment period minus the participant's baseline PNIF.
Time frame: Baseline (Day 1) and up to 2 Weeks
Population: ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Mean Change From Baseline Over the Two-week Treatment Period in Peak NasalIinspiratory Flow (PNIF) | Morning PNIF | 1.7 Liter(L)/minute (min) | Standard Error 0.99 |
| Placebo | Mean Change From Baseline Over the Two-week Treatment Period in Peak NasalIinspiratory Flow (PNIF) | Evening PNIF | 0.2 Liter(L)/minute (min) | Standard Error 1.12 |
| FFNS 110 mcg | Mean Change From Baseline Over the Two-week Treatment Period in Peak NasalIinspiratory Flow (PNIF) | Morning PNIF | 9.9 Liter(L)/minute (min) | Standard Error 1.28 |
| FFNS 110 mcg | Mean Change From Baseline Over the Two-week Treatment Period in Peak NasalIinspiratory Flow (PNIF) | Evening PNIF | 7.1 Liter(L)/minute (min) | Standard Error 1.31 |
| Fex 180 mg | Mean Change From Baseline Over the Two-week Treatment Period in Peak NasalIinspiratory Flow (PNIF) | Morning PNIF | 1.4 Liter(L)/minute (min) | Standard Error 1.18 |
| Fex 180 mg | Mean Change From Baseline Over the Two-week Treatment Period in Peak NasalIinspiratory Flow (PNIF) | Evening PNIF | 1.3 Liter(L)/minute (min) | Standard Error 1.23 |
Comparison: Morning assessmentp-value: <0.00195% CI: [5.7, 11.9]ANCOVA
Comparison: Morning assessmentp-value: <0.00195% CI: [5.3, 11.5]ANCOVA
Comparison: Morning assessmentp-value: 0.77995% CI: [-3.6, 2.7]ANCOVA
Comparison: Evening assessmentp-value: <0.00195% CI: [3.1, 9.6]ANCOVA
Comparison: Evening assessmentp-value: <0.00195% CI: [3.8, 10.3]ANCOVA
Comparison: Evening assessmentp-value: 0.66295% CI: [-2.5, 4]ANCOVA
Secondary
Mean Change From Baseline Over the Two-week Treatment Period in Pre-dose Instantaneous Total Nasal Symptom Score (Pre-dose iTNSS) and Pre-dose Instantaneous Total Ocular Symptom Scores (Pre-dose iTOSS)
Participants were instructed to score and document their symptoms in an instantaneous manner on a diary card. The instantaneous rating was performed once daily just prior to administering their morning dose. The scores of each of the instantaneous nasal symptoms (nasal congestion, itching, rhinorrhea, and sneezing) and ocular symptoms (tearing/watering, itching/burning, and redness) were summed for each participant to create a iTNSS and iTOSS, respectively using a 4-point scale, 0- 'None' (symptom is not present), 1- 'Mild' (sign/symptom present; easily tolerated), 2- 'Moderate' (sign/symptom bothersome but tolerable), 3- 'Severe' (sign/symptom hard to tolerate; interference with activities of daily living). Total score ranged from 0 (best) to 12 (worst) for iTNSS and 0 (best) to 9 (worst) for iTOSS. Each participant's average change from Baseline iTNSS and iTOSS was participant's average iTNSS and iTOSS total score over the treatment period minus the participant's Baseline score.
Time frame: Baseline (Day 1) and up to 2 Weeks
Population: ITT Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Mean Change From Baseline Over the Two-week Treatment Period in Pre-dose Instantaneous Total Nasal Symptom Score (Pre-dose iTNSS) and Pre-dose Instantaneous Total Ocular Symptom Scores (Pre-dose iTOSS) | Pre-dose iTNSS, Runny nose | -0.6 Score on a scale | Standard Error 0.04 |
| Placebo | Mean Change From Baseline Over the Two-week Treatment Period in Pre-dose Instantaneous Total Nasal Symptom Score (Pre-dose iTNSS) and Pre-dose Instantaneous Total Ocular Symptom Scores (Pre-dose iTOSS) | Pre-dose iTOSS, Eye redness | -0.6 Score on a scale | Standard Error 0.04 |
| Placebo | Mean Change From Baseline Over the Two-week Treatment Period in Pre-dose Instantaneous Total Nasal Symptom Score (Pre-dose iTNSS) and Pre-dose Instantaneous Total Ocular Symptom Scores (Pre-dose iTOSS) | TOSS | -1.9 Score on a scale | Standard Error 0.11 |
| Placebo | Mean Change From Baseline Over the Two-week Treatment Period in Pre-dose Instantaneous Total Nasal Symptom Score (Pre-dose iTNSS) and Pre-dose Instantaneous Total Ocular Symptom Scores (Pre-dose iTOSS) | Pre-dose iTNSS, Sneezing | -0.7 Score on a scale | Standard Error 0.04 |
| Placebo | Mean Change From Baseline Over the Two-week Treatment Period in Pre-dose Instantaneous Total Nasal Symptom Score (Pre-dose iTNSS) and Pre-dose Instantaneous Total Ocular Symptom Scores (Pre-dose iTOSS) | TNSS | -2.3 Score on a scale | Standard Error 0.13 |
| Placebo | Mean Change From Baseline Over the Two-week Treatment Period in Pre-dose Instantaneous Total Nasal Symptom Score (Pre-dose iTNSS) and Pre-dose Instantaneous Total Ocular Symptom Scores (Pre-dose iTOSS) | Pre-dose iTOSS, Eye itching | -0.7 Score on a scale | Standard Error 0.04 |
| Placebo | Mean Change From Baseline Over the Two-week Treatment Period in Pre-dose Instantaneous Total Nasal Symptom Score (Pre-dose iTNSS) and Pre-dose Instantaneous Total Ocular Symptom Scores (Pre-dose iTOSS) | Pre-dose iTNSS, Itchy nose | -0.7 Score on a scale | Standard Error 0.04 |
| Placebo | Mean Change From Baseline Over the Two-week Treatment Period in Pre-dose Instantaneous Total Nasal Symptom Score (Pre-dose iTNSS) and Pre-dose Instantaneous Total Ocular Symptom Scores (Pre-dose iTOSS) | Pre-dose iTNSS, Nasal congestion | -0.6 Score on a scale | Standard Error 0.03 |
| Placebo | Mean Change From Baseline Over the Two-week Treatment Period in Pre-dose Instantaneous Total Nasal Symptom Score (Pre-dose iTNSS) and Pre-dose Instantaneous Total Ocular Symptom Scores (Pre-dose iTOSS) | Pre-dose iTOSS, Eye tearing | -0.7 Score on a scale | Standard Error 0.04 |
| FFNS 110 mcg | Mean Change From Baseline Over the Two-week Treatment Period in Pre-dose Instantaneous Total Nasal Symptom Score (Pre-dose iTNSS) and Pre-dose Instantaneous Total Ocular Symptom Scores (Pre-dose iTOSS) | Pre-dose iTNSS, Sneezing | -1.0 Score on a scale | Standard Error 0.04 |
| FFNS 110 mcg | Mean Change From Baseline Over the Two-week Treatment Period in Pre-dose Instantaneous Total Nasal Symptom Score (Pre-dose iTNSS) and Pre-dose Instantaneous Total Ocular Symptom Scores (Pre-dose iTOSS) | TNSS | -3.6 Score on a scale | Standard Error 0.14 |
| FFNS 110 mcg | Mean Change From Baseline Over the Two-week Treatment Period in Pre-dose Instantaneous Total Nasal Symptom Score (Pre-dose iTNSS) and Pre-dose Instantaneous Total Ocular Symptom Scores (Pre-dose iTOSS) | Pre-dose iTNSS, Nasal congestion | -0.8 Score on a scale | Standard Error 0.03 |
| FFNS 110 mcg | Mean Change From Baseline Over the Two-week Treatment Period in Pre-dose Instantaneous Total Nasal Symptom Score (Pre-dose iTNSS) and Pre-dose Instantaneous Total Ocular Symptom Scores (Pre-dose iTOSS) | Pre-dose iTNSS, Itchy nose | -1.0 Score on a scale | Standard Error 0.04 |
| FFNS 110 mcg | Mean Change From Baseline Over the Two-week Treatment Period in Pre-dose Instantaneous Total Nasal Symptom Score (Pre-dose iTNSS) and Pre-dose Instantaneous Total Ocular Symptom Scores (Pre-dose iTOSS) | Pre-dose iTNSS, Runny nose | -0.9 Score on a scale | Standard Error 0.04 |
| FFNS 110 mcg | Mean Change From Baseline Over the Two-week Treatment Period in Pre-dose Instantaneous Total Nasal Symptom Score (Pre-dose iTNSS) and Pre-dose Instantaneous Total Ocular Symptom Scores (Pre-dose iTOSS) | TOSS | -2.4 Score on a scale | Standard Error 0.12 |
| FFNS 110 mcg | Mean Change From Baseline Over the Two-week Treatment Period in Pre-dose Instantaneous Total Nasal Symptom Score (Pre-dose iTNSS) and Pre-dose Instantaneous Total Ocular Symptom Scores (Pre-dose iTOSS) | Pre-dose iTOSS, Eye tearing | -0.9 Score on a scale | Standard Error 0.04 |
| FFNS 110 mcg | Mean Change From Baseline Over the Two-week Treatment Period in Pre-dose Instantaneous Total Nasal Symptom Score (Pre-dose iTNSS) and Pre-dose Instantaneous Total Ocular Symptom Scores (Pre-dose iTOSS) | Pre-dose iTOSS, Eye itching | -0.9 Score on a scale | Standard Error 0.04 |
| FFNS 110 mcg | Mean Change From Baseline Over the Two-week Treatment Period in Pre-dose Instantaneous Total Nasal Symptom Score (Pre-dose iTNSS) and Pre-dose Instantaneous Total Ocular Symptom Scores (Pre-dose iTOSS) | Pre-dose iTOSS, Eye redness | -0.8 Score on a scale | Standard Error 0.04 |
| Fex 180 mg | Mean Change From Baseline Over the Two-week Treatment Period in Pre-dose Instantaneous Total Nasal Symptom Score (Pre-dose iTNSS) and Pre-dose Instantaneous Total Ocular Symptom Scores (Pre-dose iTOSS) | Pre-dose iTNSS, Itchy nose | -0.7 Score on a scale | Standard Error 0.04 |
| Fex 180 mg | Mean Change From Baseline Over the Two-week Treatment Period in Pre-dose Instantaneous Total Nasal Symptom Score (Pre-dose iTNSS) and Pre-dose Instantaneous Total Ocular Symptom Scores (Pre-dose iTOSS) | TNSS | -2.6 Score on a scale | Standard Error 0.12 |
| Fex 180 mg | Mean Change From Baseline Over the Two-week Treatment Period in Pre-dose Instantaneous Total Nasal Symptom Score (Pre-dose iTNSS) and Pre-dose Instantaneous Total Ocular Symptom Scores (Pre-dose iTOSS) | Pre-dose iTOSS, Eye tearing | -0.8 Score on a scale | Standard Error 0.04 |
| Fex 180 mg | Mean Change From Baseline Over the Two-week Treatment Period in Pre-dose Instantaneous Total Nasal Symptom Score (Pre-dose iTNSS) and Pre-dose Instantaneous Total Ocular Symptom Scores (Pre-dose iTOSS) | Pre-dose iTNSS, Nasal congestion | -0.6 Score on a scale | Standard Error 0.03 |
| Fex 180 mg | Mean Change From Baseline Over the Two-week Treatment Period in Pre-dose Instantaneous Total Nasal Symptom Score (Pre-dose iTNSS) and Pre-dose Instantaneous Total Ocular Symptom Scores (Pre-dose iTOSS) | Pre-dose iTOSS, Eye redness | -0.7 Score on a scale | Standard Error 0.04 |
| Fex 180 mg | Mean Change From Baseline Over the Two-week Treatment Period in Pre-dose Instantaneous Total Nasal Symptom Score (Pre-dose iTNSS) and Pre-dose Instantaneous Total Ocular Symptom Scores (Pre-dose iTOSS) | Pre-dose iTNSS, Sneezing | -0.7 Score on a scale | Standard Error 0.04 |
| Fex 180 mg | Mean Change From Baseline Over the Two-week Treatment Period in Pre-dose Instantaneous Total Nasal Symptom Score (Pre-dose iTNSS) and Pre-dose Instantaneous Total Ocular Symptom Scores (Pre-dose iTOSS) | Pre-dose iTNSS, Runny nose | -0.6 Score on a scale | Standard Error 0.04 |
| Fex 180 mg | Mean Change From Baseline Over the Two-week Treatment Period in Pre-dose Instantaneous Total Nasal Symptom Score (Pre-dose iTNSS) and Pre-dose Instantaneous Total Ocular Symptom Scores (Pre-dose iTOSS) | Pre-dose iTOSS, Eye itching | -0.8 Score on a scale | Standard Error 0.04 |
| Fex 180 mg | Mean Change From Baseline Over the Two-week Treatment Period in Pre-dose Instantaneous Total Nasal Symptom Score (Pre-dose iTNSS) and Pre-dose Instantaneous Total Ocular Symptom Scores (Pre-dose iTOSS) | TOSS | -2.2 Score on a scale | Standard Error 0.1 |
Comparison: Pre-dose iTNSSp-value: <0.00195% CI: [-1.7, -1]ANCOVA
Comparison: Pre-dose iTNSSp-value: <0.00195% CI: [-1.4, -0.7]ANCOVA
Comparison: Pre-dose iTNSSp-value: 0.19395% CI: [-0.6, 0.1]ANCOVA
Comparison: Pre-dose iTOSSp-value: <0.00195% CI: [-0.8, -0.2]ANCOVA
Comparison: Pre-dose iTOSSp-value: 0.05895% CI: [-0.6, 0]ANCOVA
Comparison: Pre-dose iTOSSp-value: 0.1695% CI: [-0.5, 0]ANCOVA