Clinical Study, Non Inferiority Between Noex® 32µg Versus Budecort Aqua® 32µg in Treatment of Alergic Rhinitis

Study Overview
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Brief Summary
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This study is to evaluate non inferiority of Eurofarma budesonide nasal spary x referral Astrazeneca budesonide. Half patients will receive Eurofarma medication and half patients will receive Astrazeneca medication. There is no placebo group.

Detailed Description
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Budesonide is a medicine already very used and registered about 20 years. Eurofarma has the intention to collect more data about safety and efficacy and present them to local authority. This study was draw to treat patients with persisntent rhinits moderate to severe in sites localted locally in Brasil.

Official Title
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Phase III, Multicenter, Randomized, Simple-blinded, Paralel Groups to Evaluate Non Inferiority of Noex® 32µg Versus Budecort Aqua® 32µg in Treatment of Alergic Persistent Rhinitis Moderate to Severe

Conditions
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Rhinitis, Allergic, Perennial

Intervention / Treatment
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* Drug: Budesonide


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 12. History of alergic persistent rhinitis moderate to severe at least 2 years. Proved alergic using PRICK or RAST test. Nasal symptoms (NIS) > 3 and nasal obstruction >1. Indication of nasal corticorteroids use.. Washout of nasal corticorteroids for 14 days. ICF. Exclusion Criteria: Other types of rhinitis; Asthma non controled Use of oral/injectable corticoids 30 days before screening. patients not eligible to complete diaries. patients with alergy to any substance of medicines. non controlled desease.

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 90 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Noex 32mcg<br>Noex/Budesonide 32mcg, 2 atomizations in each nostril by the morning and during the night, total of 256 mcg per day. Tretament of 28 days. | Drug: Budesonide<br>* Suspention to nasal use, 2 atomization in each nostril during the morning and at night.<br>* Other names: Budecort Aqua 32mcg;|
| Experimental: Budecort Aqua 32 mcg<br>Budecort Aqua/Budesonide 32mcg, 2 atomizations in each nostril by the morning and during the night, total of 256 mcg per day. Tretament of 28 days. | Drug: Budesonide<br>* Suspention to nasal use, 2 atomization in each nostril during the morning and at night.<br>* Other names: Budecort Aqua 32mcg;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Demonstrate non inferiority of Noex comparable with referral product Budecort Aqua in the treatment of rinithis moderate to severe during 4 weeks of treatment. | The questionnaire Nasal Index Score (NIS) will be used to check intensity of symptons and patient will answer this questionnaire daily at home. | 28 days |