NCT01022047

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 280 (actual)
• Sponsor: Eurofarma Laboratorios S.A. · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Accepted

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.

Detailed 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;

Conditions

• Allergic Rhinitis

Interventions

Type	Name	Description
DRUG	Noex	The patients shall use the Noex drug only once a day (one application in each nostril) during the 12 weeks of treatment
DRUG	Budecort Aqua	The patients shall use the Budecort Aqua drug only once a day (one application in each nostril) during the 12 weeks of treatment.

Timeline

• Start date: 2010-02-01
• Primary completion: 2010-02-01
• Completion: 2010-12-01
• First posted: 2009-12-01
• Last updated: 2015-07-27

Locations

1 site across 1 country: Brazil