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Non-inferiority, Open-label, Multicenter and Randomized Clinical Trial About the Treatment of Mild to Moderate Persistent Allergic Rhinitis

2014-08-27 03:17:39 | BioPortfolio

Summary

To assess the efficacy of the study product Noex in the treatment of allergic rhinitis by means of the Nasal Index Score (NIS) after 4 weeks of treatment with the drug.

Description

Primary objective: To assess the efficacy of the study product Noex in the treatment of allergic rhinitis by means of the Nasal Index Score (NIS) after 4 weeks of treatment with the drug.

Secondary objectives: To determine the total NIS scale score after 12 weeks of treatment and the scores of the same scale individually for the symptoms of nasal obstruction, coryza, sneezing and nasal pruritus after 4 and 12 weeks of treatment, as well as to assess the safety of the study product according to the presence of adverse events.

Some eligibility criteria:

- NIS scale score > 4 points at the randomization visit

- Patients with persistent mild to moderate AR, according to the ARIA criteria with indication for use budesonide;

Study Design

Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Allergic Rhinitis

Intervention

Noex, Budecort Aqua

Location

IMA Brasil - Instituto de Pesquisa Clínica e Medicina Avançada
São Paulo
Brazil

Status

Recruiting

Source

Eurofarma Laboratorios Ltda

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:17:39-0400

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