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

Phase 3

Withdrawn

• Conditions: Rhinitis, Allergic, Perennial
• Interventions: Drug: Budesonid 50mcg (Noex); Drug: Budesonid 50mcg (Busonid)

• Registration Number: NCT02988778
• Lead Sponsor: Eurofarma Laboratorios S.A.

Brief 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.

Study Timeline

• Study First Submitted: 2016-11-28
• Study First Submitted QC: 2016-12-08
• Study First Posted: 2016-12-09
• Status Verified: 2017-08
• Study Start: 2019-10-08
• Primary Completion: 2019-10-08
• Study Completion: 2019-10-08
• Last Update Submitted: 2019-10-08
• Last Update Posted: 2019-10-09

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Age ≥ 12
2. History of allergic persistent rhinitis moderate to severe at least 2 years
3. Proved allergic using PRICK or RAST test
4. Nasal symptoms (NIS) > 3 and nasal obstruction >1
5. Indication of nasal corticosteroids use
6. Washout of nasal corticosteroids for 14 days
7. ICF

Exclusion Criteria

1. Other types of rhinitis
2. Asthma non controlled
3. Use of oral/injectable corticoids 30 days before screening
4. patients not eligible to complete diaries
5. patients with allergy to any substance of medicines
6. non controlled disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Budesonid 50mcg (Noex)	Budesonid 50mcg (Noex)	Budesonid 50mcg (Noex), 2 atomizations in each nostril by the morning and during the night, total of 400 mcg per day. Treatment of 28 days.
Budesonid 50mcg (Busonid)	Budesonid 50mcg (Busonid)	Budesonid 50mcg (Busonid), 2 atomizations in each nostril by the morning and during the night, total of 400 mcg per day. Treatment of 28 days.

Primary Outcome Measures

Name	Time	Method
Demonstrate non inferiority of Noex using the questionnaire Nasal Index Score (NIS)	28 days	Using the questionnaire Nasal Index Score (NIS)

Trial Locations

Locations (1)

Alexandra Dumont; 🇧🇷 Campinas, Brazil