Rhinocort Aqua Versus Placebo and Fluticasone Propionate

Study Overview
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Brief Summary
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The purpose of this study is to compare once daily treatment with Rhinocort against placebo and Fluticasone Propionate at reliving the nasal symptoms of seasonal allergic rhinitis.

Official Title
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A Multi-Center, Double-Blind, Randomized, Placebo-Controlled, Parallel-group, Phase IIIb Study to Assess the Efficacy, Safety & Product Attributes of Rhinocort Aqua(Budesonide) Versus Placebo and FluticasonePropionate as an Active Comparator in Patients 12yrs Age &Older With SeasonalAllergicRhinitis

Conditions
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Seasonal Allergic Rhinitis

Intervention / Treatment
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* Drug: Budesonide
* Drug: Fluticasone propionate
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: At least a 2 year documented history of seasonal allergic rhinitis who, in the opinion of the investigator, is a candidate for treatment with nasal steroids based on a history of either a)inadequate control of symptoms with antihistamines, decongestants and/or immunotherapy, or b) prior successful treatment with nasal steroids. A positive response to a skin prick test at Visit 1 or within the last 12 months for grass allergens that must be present in the subject's environment for the duration of the study. Exclusion Criteria: Primary or secondary adrenal insufficiency Nasal candidiasis, rhinitis medicamentosa, acute or chronic sinusitis, influenza, upper respiratory tract infection or structural abnormalities of the nose (e.g., septal deviation, nasal polyps) symptomatic enough to cause significant nasal obstruction as judged by the investigator. A diagnosis of asthma requiring treatment as specifies in the protocol.

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Budesonide | Drug: Budesonide<br> <br> * Other names: Rhinocort AQUA;|
| Active Comparator: 2<br>Fluticasone propionate | Drug: Fluticasone propionate<br> <br> * Other names: Flonase®;|
| Placebo Comparator: 3<br> | Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare once daily treatment with Rhinocort against placebo and at reliving the nasal symptoms of seasonal allergic rhinitis. |  | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare once daily treatment with Rhinocort against Fluticasone Propionate at reliving the nasal symptoms of seasonal allergic rhinitis. |  | 2 weeks | 
| To compare once daily treatment with placebo against Fluticasone Propionate at reliving the nasal symptoms of seasonal allergic rhinitis. |  | 2 weeks | 
| Safety assessment via adverse events and clinical measurements. |  | 2 & 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Seasonal allergic rhinitis, Nasal symptoms, Congestion, Rhinorrhea, Sneeze, budesonide, Rhinocort AQUA, Fluticasone propionate, Flonase