Fluticasone Furoate Nasal Spray Versus Oral Fexofenadine

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


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Informed consent Otherwise healthy outpatient with mountain cedar allergy Male or eligible female Females of childbearing potential must commit to the consistent and correct use of an acceptable method of birth control Age 12 years or older at Visit 2 Diagnosis of seasonal allergic rhinitis (SAR) to mountain cedar Adequate exposure to mountain cedar pollen Ability to comply with study procedures Literate Exclusion criteria: Significant concomitant medical conditions Use of intranasal corticosteroids within four weeks prior to Visit 1; use of inhaled, oral, intramuscular, intravenous, ocular, and/or dermatological corticosteroid (with the exception of hydrocortisone cream/ointment, 1% or less) within eight weeks prior to Visit 1. Use of other allergy medications within specific timeframes relative to Visit 1 Use of other medications that may affect allergic rhinitis or its symptoms Use of immunosuppressive medications eight weeks prior to screening and during the study Immunotherapy patients who are not stable on current dose Use of any medications that significantly alters the pharmacokinetics of fluticasone furoate or fexofenadine Allergy/Intolerance to corticosteroids, antihistamines, or any excipients in the two products Use of contact lenses Recent clinical trial/experimental medication experience within 30 days of Visit 1 Subject previously failed the 21-day screen period or failed to complete the treatment period Positive or inconclusive pregnancy test or female who is breastfeeding Employee or relative affiliation with investigational site Current tobacco use Active chickenpox or measles or exposure in the last 3 weeks

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
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: fluticasone furoate, fexofenadine|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Change From Baseline in the Nighttime Symptom Score (NSS) | Questions include: 1. Nasal congestion on awakening (Score: 0=none, 1=mild, 2=moderate, 3=severe); 2. Difficulty going to sleep (Score: 0=not at all, 1=little, 2=moderately, 3=very); 3. Nighttime awakenings (Score: 0=not at all, 1=once, 2=more than once, 3=felt like awake all night). The sum of the ratings for the three items comprises the NSS. | Baseline and Weeks 1-2 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Change From Baseline in Nighttime Reflective Total Nasal Symptom Score (N-rTNSS) | Subjects assessed four nasal symptoms (rhinorrhea, nasal congestion, nasal itching, and sneezing). The sum of the four nasal symptoms comprised the total nasal symptom score (TNSS). Reflective rating represented symptoms over preceding 12 hours. Scores: 0=symptoms not present, 1=mild severity, 2=moderate severity, 3=severe. | Baseline and Weeks 1-2 | 
| Mean Change From Baseline in Daytime Reflective Total Nasal Symptom Score (D-rTNSS) | Subjects assessed four nasal symptoms (rhinorrhea, nasal congestion, nasal itching, and sneezing). The sum of the four nasal symptoms comprised the total nasal symptom score (TNSS). Reflective rating represented symptoms over preceding 12 hours. Scores: 0=symptoms not present, 1=mild severity, 2=moderate severity, 3=severe. | Baseline and Weeks 1-2 | 
| Mean Change From Baseline in 24 Hour Reflective Total Nasal Symptom Score (24 Hour rTNSS) | Subjects assessed four nasal symptoms (rhinorrhea, nasal congestion, nasal itching, and sneezing). The sum of the four nasal symptoms comprised the total nasal symptom score (TNSS).Reflective rating represented symptoms over preceding 12 hours. Scores: 0=symptoms not present, 1=mild severity, 2=moderate severity, 3=severe. | Baseline and Weeks 1-2 | 
| Mean Change From Baseline in Nighttime Reflective Total Ocular Symptom Score (N-rTOSS) | Subjects assessed three ocular symptoms (itching/ burning eyes, tearing/watering eyes, and eye redness). The sum of the 3 ocular symptoms comprised the total ocular symptom score (TOSS). Reflective rating represented symptoms over preceding 12 hours. Scores: 0=symptoms not present, 1=mild severity, 2=moderate severity, 3=severe. | Baseline and Weeks 1-2 | 
| Mean Change From Baseline in Daytime Reflective Total Ocular Symptom Score (D-rTOSS) | Subjects assessed three ocular symptoms (itching/ burning eyes, tearing/watering eyes, and eye redness). The sum of the 3 ocular symptoms comprised the total ocular symptom score (TOSS). Reflective rating represented symptoms over preceding 12 hours. Scores: 0=symptoms not present, 1=mild severity, 2=moderate severity, 3=severe. | Baseline and Weeks 1-2 | 
| Mean Change From Baseline in 24 Hour Reflective Total Ocular Symptoms Score (rTOSS) | Subjects assessed three ocular symptoms (itching/ burning eyes, tearing/watering eyes, and eye redness). The sum of the 3 ocular symptoms comprised the total ocular symptom score (TOSS). Reflective rating represented symptoms over preceding 12 hours. Scores: 0=symptoms not present, 1=mild severity, 2=moderate severity, 3=severe. | Baseline and Weeks 1-2 | 
| Mean Change From Baseline in Pre-Dose Instantaneous Total Nasal Symptom Score (iTNSS) | Subjects assessed four nasal symptoms (rhinorrhea, nasal congestion, nasal itching, and sneezing). The sum of the four nasal symptoms comprised the total nasal symptom score (TNSS).Instantaneous rating represented symptoms at the time of the assessment. Scores: 0=symptoms not present, 1=mild severity, 2=moderate severity, 3=severe. | Baseline and Weeks 1-2 | 
| Mean Change From Baseline in Pre-Dose Instantaneous Total Ocular Symptom Score (iTOSS) | Subjects assessed three ocular symptoms (itching/ burning eyes, tearing/watering eyes, and eye redness). The sum of the four ocular symptoms comprised the total nasal symptom score (TOSS).Instantaneous rating represented symptoms at the time of the assessment. Scores: 0=symptoms not present, 1=mild severity, 2=moderate severity, 3=severe. | Baseline and Weeks 1-2 | 
| Mean Change From Baseline in Morning Peak Nasal Inspiratory Flow (PNIF) | Subjects used a portable hand-held inspiratory flow meter to measure and record PNIF in the morning prior to taking the study medication. Three measurements were taken and the highest measurement was recorded in the electronic diary. A positive change signifies improved nasal air flow. | Baseline and Weeks 1-2 | 
| Mean Change From Baseline in Evening Peak Nasal Inspiratory Flow (PNIF) | Subjects used a portable hand-held inspiratory flow meter to measure and record PNIF in the evening. Three measurements were taken and the highest measurement was recorded in the electronic diary. A positive change signifies improved nasal air flow. | Baseline and Weeks 1-2 | 
| Mean Change From Baseline at Day 15 for Nocturnal Rhinoconjunctivitis Quality of Life Questionnaire (NRQLQ) | Subjects completed the 16-item Nocturnal Rhinoconjunctivitis Quality of Life Questionnaire (NRQLQ)to assess nocturnal rhinitis-related quality of life. The NRQLQ measures the functional problems most troublesome to patients with nocturnal allergy symptoms. Each question scored from 0-6 with higher scores indicating more nocturnal impairment. | Baseline, Day 15 or if Early Withdrawal Day | 

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