Clinical Study, Non Inferiority Between Noex® 50µg Versus Busonid® 50µg in Treatment of Allergic Rhinitis

Eurofarma Laboratorios S.A.

Overview

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

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 persistent rhinitis moderate to severe in sites located locally in Brazil.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Conditions

Rhinitis, Allergic, Perennial

Interventions

Budesonid 50mcg (Noex)DRUG

Suspention to nasal use, 2 atomization in each nostril during the morning and at night.

Budesonid 50mcg (Busonid)DRUG

Suspention to nasal use, 2 atomization in each nostril during the morning and at night.

Eligibility

Sex: ALLMin age: 12 YearsMax age: 90 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Age ≥ 12 2. History of allergic persistent rhinitis moderate to severe at least 2 years 3. Proved allergic using PRICK or RAST test 4. Nasal symptoms (NIS) \> 3 and nasal obstruction \>1 5. Indication of nasal corticosteroids use 6. Washout of nasal corticosteroids for 14 days 7. ICF Exclusion Criteria: 1. Other types of rhinitis 2. Asthma non controlled 3. Use of oral/injectable corticoids 30 days before screening 4. patients not eligible to complete diaries 5. patients with allergy to any substance of medicines 6. non controlled disease

Locations (1)

Alexandra Dumont

Campinas, Brazil

Outcomes

Primary Outcomes

Demonstrate non inferiority of Noex using the questionnaire Nasal Index Score (NIS)

Using the questionnaire Nasal Index Score (NIS)

Time frame: 28 days

Data from ClinicalTrials.gov

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