NCT02988778

Clinical Study, Non Inferiority Between Noex® 50µg Versus Busonid® 50µg in Treatment of Allergic Rhinitis

Phase III, Multicenter, Randomized, Simple-blinded, Parallel Groups to Evaluate Non Inferiority of Noex® 50µg Versus Busonid® 50µg in Treatment of Allergic 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• Status: Withdrawn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 spray 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 persistent rhinitis moderate to severe in sites located locally in Brazil.

Conditions

• Rhinitis, Allergic, Perennial

Interventions

Type	Name	Description
DRUG	Budesonid 50mcg (Noex)	Suspention to nasal use, 2 atomization in each nostril during the morning and at night.
DRUG	Budesonid 50mcg (Busonid)	Suspention to nasal use, 2 atomization in each nostril during the morning and at night.

Timeline

• Start date: 2019-10-08
• Primary completion: 2019-10-08
• Completion: 2019-10-08
• First posted: 2016-12-09
• Last updated: 2019-10-09

Locations

1 site across 1 country: Brazil