NCT02972866

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

Phase III, Multicenter, Randomized, Simple-blinded, Paralel Groups to Evaluate Non Inferiority of Noex® 32µg Versus Budecort Aqua® 32µg in Treatment of Alergic Persistent Rhinitis Moderate to Severe

• Status: Withdrawn
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Eurofarma Laboratorios S.A. · Industry
• Sex: All
• Age: 12 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Rhinitis, Allergic, Perennial

Interventions

Type	Name	Description
DRUG	Budesonide	Suspention to nasal use, 2 atomization in each nostril during the morning and at night.

Timeline

• Start date: 2016-06-01
• Primary completion: 2019-11-01
• Completion: 2019-11-01
• First posted: 2016-11-25
• Last updated: 2019-10-09

Locations

1 site across 1 country: Brazil