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

Rhinitis, Allergic, Perennial Clinical Trial

— RINEX50  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02988778
• Other study ID #: EF149
• Status: Withdrawn
• Phase: Phase 3
• Start date: October 8, 2019
• Est. completion date: October 8, 2019

Study information

• Verified date: August 2017
• 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 spray 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 persistent rhinitis moderate to severe in sites located locally in Brazil.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 8, 2019
• Est. primary completion date: October 8, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• Budesonid 50mcg (Noex)
Suspention to nasal use, 2 atomization in each nostril during the morning and at night.
• Budesonid 50mcg (Busonid)
Suspention to nasal use, 2 atomization in each nostril during the morning and at night.

Locations

Country	Name	City	State
Brazil	Alexandra Dumont	Campinas

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 using the questionnaire Nasal Index Score (NIS)	Using the questionnaire Nasal Index Score (NIS)	28 days