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

Allergic Rhinitis Clinical Trial

Official title:
A Phase III, Non-inferiority, Open-label, Multicenter and Randomized Clinical Trial About the Treatment of Mild to Moderate Persistent Allergic Rhinitis in a Test Group Treated With Noex 32 mcg and a Reference Group Treated With Budecort Aqua® 32 mcg

Clinical Trial 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.

Clinical Trial 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, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01022047
Study type Interventional
Source Eurofarma Laboratorios S.A.
Contact
Status Completed
Phase Phase 3
Start date February 2010
Completion date December 2010
View Details
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