A Comparison of Patients on AVAMYS ® Versus NASONEX (A Trade Mark of Schering Corporation) and FLIXONASE ® on Key Health Outcome Measures

Study Overview
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Brief Summary
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Previous publications have indicated that Allergic Rhinitis (AR) patients suffering from both ocular and nasal symptoms have a greater burden of illness and lower quality of life than patients suffering from nasal symptoms alone. Fluticasone furoate (FF) acts against both nasal and ocular symptoms. The purpose of this study was to evaluate the differences in symptom control (both perceptually and objectively) and resource use for patients with current seasonal AR.

Detailed Description
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Allergic rhinitis (AR) is a common inflammatory condition of the upper respiratory tract, nasal cavity and eyes affecting up to 20% of the population in the United States and Europe. The bothersome nature of AR symptoms can severely affect daily activities including ability to work and examination performance and impact on quality of life (QoL) and psychosocial well being. This study assesses the impact of Fluticasone furoate (FF) on the QoL of seasonal allergic rhinitis (SAR) patients, including the number of symptom-free days (SFD) and quality of life over the last 4 weeks, and compares this with other inhaled nasal steroids (INS): mometasone furate (MF) and fluticasone proprionate (FP). Selected physicians provide information including a range of demographic, symptom and treatment details for a number of their SAR patients. The patient themselves are then invited to provide details about their SAR including symptoms, the impact of AR upon their lifestyles, attitudes to treatment and completion of Health Related Quality of Life (HRQoL) instruments.

Official Title
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A Comparison of Patients on AVAMYS ® Versus NASONEX (A Trade Mark of Schering Corporation) and FLIXONASE ® on Key Health Outcome Measures

Conditions
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Rhinitis, Allergic, Perennial

Intervention / Treatment
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* Drug: Fluticasone furoate
* Drug: mometasone furoate
* Drug: fluticasone propionate


Participation Criteria
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Eligibility Criteria
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Patient Inclusion Criteria: Current Seasonal Allergic Rhinitis sufferer (based on physician judgement) Currently receiving prescribed INS treatment (no other treatment restrictions apply) Have consumed at least one full prescription on the specified INS treatment No comorbid Asthma or COPD diagnosis Informed Consent Exclusion Criteria: None specified
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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| FF<br>Cohort of patients receiving fluticasome furoate | Drug: Fluticasone furoate<br>* cohort of patients receiving fluticasone furate<br>* Other names: AVAMYS™;|
| MF<br>cohort of patients on mometasone furoate | Drug: mometasone furoate<br>* cohort receiving mometasone furoate<br>* Other names: NASONEX™;|
| FP<br>cohort of patients receiving fluticasone propionate | Drug: fluticasone propionate<br>* cohort of patients on fluticasone propionate<br>* Other names: FLIXONASE™;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the differences in Symtom Free Days (SFD) in patients receiving FF, MF or FP |  | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the differences in Quality of Life (mini-Rhinoconjunctivitis Quality of Life Questionnaire) in patients receiving FF, MF or FP |  | 4 weeks | 
| Evaluate the differences in the number of AR treatments used by patients receiving FF, MF or FP |  | 4 weeks | 
| Evaluate the differences in the number of non-prescribed treatments used by patients receiving FF, MF or FP |  | 4 weeks | 
| Evaluate the differences in the cost of non-prescribed treatments used by patients receiving FF, MF or FP |  | 4 weeks | 
| Evaluate the differences in the Pittsburgh Sleep Quality Index in patients receiving FF, MF or FP |  | 4 weeks | 
| Evaluate the differences in productivitiy (Work Productivity and Activity Impairment Questionnaire) of patients receiving FF, MF or FP |  | 4 weeks | 
| Evaluate the differences in number of work day lost by patients receiving FF, MF or FP |  | 4 weeks | 
| Evaluate the differences in the number of physician visits (as reported by patient and doctor) by patients receiving FF, MF or FP |  | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ocular symptoms, nasal symptoms, Allergic Rhinitis, Symptom Free Days, Quality of Life