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

Phase 3

Withdrawn

• Conditions: Rhinitis, Allergic, Perennial
• Interventions: Drug: Budesonide

• Registration Number: NCT02972866
• Lead Sponsor: Eurofarma Laboratorios S.A.

Brief 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.

Study Timeline

• Study Start: 2016-06
• Study First Submitted: 2016-11-11
• Study First Submitted QC: 2016-11-21
• Study First Posted: 2016-11-25
• Status Verified: 2018-10
• Last Update Submitted: 2019-10-08
• Last Update Posted: 2019-10-09
• Primary Completion: 2019-11
• Study Completion: 2019-11

Recruitment & Eligibility

• Status: WITHDRAWN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

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Budecort Aqua 32 mcg	Budesonide	Budecort Aqua/Budesonide 32mcg, 2 atomizations in each nostril by the morning and during the night, total of 256 mcg per day. Tretament of 28 days.
Noex 32mcg	Budesonide	Noex/Budesonide 32mcg, 2 atomizations in each nostril by the morning and during the night, total of 256 mcg per day. Tretament of 28 days.

Primary Outcome Measures

Name	Time	Method
Demonstrate non inferiority of Noex comparable with referral product Budecort Aqua in the treatment of rinithis moderate to severe during 4 weeks of treatment.	28 days	The questionnaire Nasal Index Score (NIS) will be used to check intensity of symptons and patient will answer this questionnaire daily at home.

Trial Locations

Locations (1)

Allergisa pesquisa dermato-cosmética ltda; 🇧🇷 Campinas, São Paulo, Brazil