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

Rhinitis, Allergic, Perennial Clinical Trial

— RINEX32  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02972866
• Other study ID #: EF148
• Status: Withdrawn
• Phase: Phase 3
• Start date: June 2016
• Est. completion date: November 2019

Study information

• Verified date: October 2018
• Source: Eurofarma Laboratorios S.A.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 2019
• Est. primary completion date: November 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Rhinitis
• Rhinitis, Allergic
• Rhinitis, Allergic, Perennial

Intervention

Drug:
• Budesonide
Suspention to nasal use, 2 atomization in each nostril during the morning and at night.

Locations

Country	Name	City	State
Brazil	Allergisa pesquisa dermato-cosmética ltda	Campinas	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Eurofarma Laboratorios S.A.

Country where clinical trial is conducted

Brazil, 

Outcome

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