Fluticasone Furoate Nasal Spray Versus Oral Fexofenadine

Study Overview
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Brief Summary
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The primary objective of this study is to compare the nighttime symptom relief of fluticasone furoate nasal spray and oral fexofenadine

Official Title
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A Comparison of Fluticasone Furoate Nasal Spray Versus Oral Fexofenadine in the Treatment of Seasonal Allergic Rhinitis

Conditions
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Rhinitis, Allergic, Seasonal

Intervention / Treatment
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* Drug: Fluticasone furoate and fexofenadine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Fluticasone furoate and fexofenadine|Fluticasone furoate and fexofenadine|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline (Day 1) and up to 2 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | Baseline (Day 1) and Day 15 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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once daily, mountain cedar, fexofenadine, allergic rhinitis, fluticasone furoate