A Phase 4 interventional study of Fluticasone furoate and fexofenadine in Rhinitis, Allergic, Seasonal, sponsored by GlaxoSmithKline. Completed at 6 sites in United States. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2018-03-07.
Sponsored by GlaxoSmithKline · Phase 4, Interventional, and Treatment
The primary objective of this study is to compare the nighttime symptom relief of fluticasone furoate nasal spray and oral fexofenadine
1,105 studies on the registry are indexed under Rhinitis; 65 are open to participants now.
This study's enrollment of 1,000 is above the median of 89 across 906 interventional studies indexed under Rhinitis.
Browse Rhinitis studies →GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.
Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion criteria:
Fluticasone furoate and fexofenadine
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
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
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
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
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
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
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
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
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
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
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).
| Milestone | Placebo | FFNS 110 Microgram (mcg) | Fex 180 Milligram (mg) |
|---|---|---|---|
| Started | 313 | 312 | 311 |
| Completed | 290 | 298 | 287 |
| Not completed | 23 | 14 | 24 |
| Withdrew: Visit changed to earlywithdrawn visit | 1 | 0 | 0 |
| Withdrew: Protocol violation | 6 | 9 | 10 |
| Withdrew: Participant randomized(inadequate score) | 1 | 0 | 0 |
| Withdrew: Compliance less than 80 percent | 1 | 0 | 0 |
| Withdrew: In error, two study medications switched | 1 | 0 | 0 |
| Withdrew: Lack of efficacy | 2 | 1 | 0 |
| Withdrew: Withdrawal by subject | 1 | 0 | 2 |
| Withdrew: Randomized in error | 1 | 0 | 0 |
| Withdrew: Participant could not tolerate symptoms | 0 | 0 | 1 |
| Withdrew: Participant could not swallow capsule | 0 | 0 | 1 |
| Withdrew: Pregnancy | 2 | 0 | 0 |
| Withdrew: Participant moved ediary,studymedication | 1 | 0 | 0 |
| Withdrew: Participant ended study one day early | 1 | 0 | 0 |
| Withdrew: Noncompliance with study requirements | 1 | 1 | 1 |
| Withdrew: Adverse event | 1 | 2 | 6 |
| Withdrew: Non-compliance of diary | 2 | 0 | 1 |
| Withdrew: Lost to follow-up | 1 | 1 | 2 |
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.
| Scores on a scale | Placebo | FFNS 110 mcg | Fex 180 mg |
|---|---|---|---|
| NSS, Week 1-2 | -1.9 ± 0.1 | -2.9 ± 0.1 | -2.0 ± 0.09 |
| PMNCA, Week 1-2 | -0.6 ± 0.03 | -0.9 ± 0.03 | -0.6 ± 0.03 |
| NANS, Week 1-2 | -0.7 ± 0.04 | -1.0 ± 0.04 | -0.7 ± 0.03 |
| DSNS, Week 1-2 | -0.7 ± 0.04 | -1.1 ± 0.04 | -0.8 ± 0.04 |
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.
| Scores on a scale | Placebo | FFNS 110 mcg | Fex 180 mg |
|---|---|---|---|
| TNSS | -2.5 ± 0.13 | -3.7 ± 0.14 | -2.7 ± 0.13 |
| Nasal congestion | -0.6 ± 0.03 | -0.9 ± 0.04 | -0.7 ± 0.03 |
| Itchy nose | -0.7 ± 0.04 | -0.9 ± 0.04 | -0.7 ± 0.04 |
| Runny nose | -0.6 ± 0.04 | -0.9 ± 0.04 | -0.7 ± 0.03 |
| Sneezing | -0.7 ± 0.04 | -1.0 ± 0.04 | -0.7 ± 0.04 |
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.
| Scores on a scale | Placebo | FFNS 110 mcg | Fex 180 mg |
|---|---|---|---|
| TNSS | -2.6 ± 0.13 | -3.7 ± 0.14 | -3.0 ± 0.13 |
| Nasal congestion | -0.7 ± 0.04 | -0.9 ± 0.04 | -0.8 ± 0.03 |
| Itchy nose | -0.7 ± 0.04 | -1.0 ± 0.04 | -0.8 ± 0.04 |
| Runny nose | -0.6 ± 0.04 | -0.9 ± 0.04 | -0.7 ± 0.03 |
| Sneezing | -0.7 ± 0.04 | -1.1 ± 0.04 | -0.9 ± 0.04 |
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.
| Scores on a scale | Placebo | FFNS 110 mcg | Fex 180 mg |
|---|---|---|---|
| TNSS | -2.5 ± 0.13 | -3.6 ± 0.14 | -2.8 ± 0.13 |
| Nasal congestion | -0.6 ± 0.03 | -0.9 ± 0.04 | -0.7 ± 0.03 |
| Itchy nose | -0.7 ± 0.04 | -0.9 ± 0.04 | -0.8 ± 0.04 |
| Runny nose | -0.6 ± 0.03 | -0.9 ± 0.04 | -0.7 ± 0.03 |
| Sneezing | -0.7 ± 0.04 | -1.0 ± 0.04 | -0.8 ± 0.04 |
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.
| Scores on a scale | Placebo | FFNS 110 mcg | Fex 180 mg |
|---|---|---|---|
| TOSS | -2 ± 0.11 | -2.5 ± 0.11 | -2.2 ± 0.11 |
| Eye tearing | -0.7 ± 0.04 | -0.9 ± 0.04 | -0.8 ± 0.04 |
| Eye itching | -0.7 ± 0.04 | -0.9 ± 0.04 | -0.8 ± 0.04 |
| Eye redness | -0.6 ± 0.04 | -0.8 ± 0.04 | -0.7 ± 0.04 |
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.
| Scores on a scale | Placebo | FFNS 110 mcg | Fex 180 mg |
|---|---|---|---|
| TOSS | -2.2 ± 0.11 | -2.6 ± 0.11 | -2.4 ± 0.11 |
| Eye tearing | -0.8 ± 0.04 | -0.9 ± 0.04 | -0.8 ± 0.04 |
| Eye itching | -0.8 ± 0.04 | -0.9 ± 0.04 | -0.9 ± 0.04 |
| Eye redness | -0.7 ± 0.04 | -0.8 ± 0.04 | -0.7 ± 0.04 |
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.
| Scores on a scale | Placebo | FFNS 110 mcg | Fex 180 mg |
|---|---|---|---|
| TOSS | -2.0 ± 0.11 | -2.5 ± 0.11 | -2.2 ± 0.11 |
| Eye tearing | -0.7 ± 0.04 | -0.9 ± 0.04 | -0.8 ± 0.04 |
| Eye itching | -0.7 ± 0.04 | -0.9 ± 0.04 | -0.8 ± 0.04 |
| Eye redness | -0.7 ± 0.04 | -0.8 ± 0.04 | -0.7 ± 0.04 |
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.
| Score on a scale | Placebo | FFNS 110 mcg | Fex 180 mg |
|---|---|---|---|
| TNSS | -2.3 ± 0.13 | -3.6 ± 0.14 | -2.6 ± 0.12 |
| Pre-dose iTNSS, Nasal congestion | -0.6 ± 0.03 | -0.8 ± 0.03 | -0.6 ± 0.03 |
| Pre-dose iTNSS, Itchy nose | -0.7 ± 0.04 | -1.0 ± 0.04 | -0.7 ± 0.04 |
| Pre-dose iTNSS, Runny nose | -0.6 ± 0.04 | -0.9 ± 0.04 | -0.6 ± 0.04 |
| Pre-dose iTNSS, Sneezing | -0.7 ± 0.04 | -1.0 ± 0.04 | -0.7 ± 0.04 |
| TOSS | -1.9 ± 0.11 | -2.4 ± 0.12 | -2.2 ± 0.1 |
| Pre-dose iTOSS, Eye tearing | -0.7 ± 0.04 | -0.9 ± 0.04 | -0.8 ± 0.04 |
| Pre-dose iTOSS, Eye itching | -0.7 ± 0.04 | -0.9 ± 0.04 | -0.8 ± 0.04 |
| Pre-dose iTOSS, Eye redness | -0.6 ± 0.04 | -0.8 ± 0.04 | -0.7 ± 0.04 |
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.
| Liter(L)/minute (min) | Placebo | FFNS 110 mcg | Fex 180 mg |
|---|---|---|---|
| Morning PNIF | 1.7 ± 0.99 | 9.9 ± 1.28 | 1.4 ± 1.18 |
| Evening PNIF | 0.2 ± 1.12 | 7.1 ± 1.31 | 1.3 ± 1.23 |
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.
| Scores on a scale | Placebo | FFNS 110 mcg | Fex 180 mg |
|---|---|---|---|
| Overall score | -1.3 ± 0.08 | -1.9 ± 0.09 | -1.5 ± 0.08 |
| Sleep problems | -1.2 ± 0.09 | -1.9 ± 0.09 | -1.5 ± 0.09 |
| Sleep time problems | -1.3 ± 0.09 | -1.9 ± 0.09 | -1.5 ± 0.09 |
| Symptoms on waking | -1.4 ± 0.09 | -2 ± 0.1 | -1.5 ± 0.09 |
| Practical problems | -1.2 ± 0.09 | -1.9 ± 0.1 | -1.6 ± 0.1 |
Collected over Adverse events (AEs) and Serious adverse events (SAEs) were collected from the time the first dose of study medication until the follow up contact (Up to Day 20). Non-serious events are listed at a 3% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo | 0/313 (0%) | 0/313 (0%) | 11/313 (3.5%) |
| FFNS 110 mcg | 0/312 (0%) | 0/312 (0%) | 12/312 (3.8%) |
| Fex 180 mg | 0/311 (0%) | 1/311 (0.3%) | 10/311 (3.2%) |
| Event | Placebo | FFNS 110 mcg | Fex 180 mg |
|---|---|---|---|
| CholecystitisHepatobiliary disorders | 0/313 | 0/312 | 1/311 |
| Event | Placebo | FFNS 110 mcg | Fex 180 mg |
|---|---|---|---|
| HeadacheNervous system disorders | 11/313 | 12/312 | 10/311 |
| Age, Continuous(Years) | Placebo | FFNS 110 mcg | Fex 180 mg | Total |
|---|---|---|---|---|
| Mean | 37.8 ± 14.39 | 37.8 ± 13.95 | 39.6 ± 14.63 | 38.4 ± 14.34 |
| Sex: Female, Male(Participants) | Placebo | FFNS 110 mcg | Fex 180 mg | Total |
|---|---|---|---|---|
| Female | 194 | 209 | 199 | 602 |
| Male | 119 | 103 | 112 | 334 |
| Race/Ethnicity, Customized(Participants) | Placebo | FFNS 110 mcg | Fex 180 mg | Total |
|---|---|---|---|---|
| African American/African Heritage | 22 | 26 | 9 | 57 |
| American Indian or Alaska Native | 7 | 5 | 6 | 18 |
| Asian - Central/South Asian Heritage | 3 | 1 | 1 | 5 |
| Asian - East Asian Heritage | 1 | 2 | 0 | 3 |
| Asian - Japanese Heritage | 0 | 1 | 0 | 1 |
| Asian - South East Asian Heritage | 2 | 1 | 2 | 5 |
| Native Hawaiian or other Pacific Islander | 2 | 1 | 2 | 5 |
| White/Caucasian/European Heritage | 270 | 268 | 286 | 824 |
| Mixed Race | 6 | 7 | 5 | 18 |
Plan to share: Yes — Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
GlaxoSmithKline