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

Eurofarma Laboratorios S.A.

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Conditions

Rhinitis, Allergic, Perennial

Interventions

BudesonideDRUG

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

Locations (1)

Allergisa pesquisa dermato-cosmética ltda

Campinas, São Paulo, Brazil

Outcomes

Primary Outcomes

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.

Time frame: 28 days

Data from ClinicalTrials.gov

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