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Withdrawn

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02988778

Acronym

RINEX50

Enrollment

Registered

2016-12-09

Start date

2019-10-08

Completion date

2019-10-08

Last updated

2019-10-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rhinitis, Allergic, Perennial

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.

Interventions

DRUGBudesonid 50mcg (Noex)

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

DRUGBudesonid 50mcg (Busonid)

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Investigator)

Eligibility

Sex/Gender

ALL

Age

12 Years to 90 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Demonstrate non inferiority of Noex using the questionnaire Nasal Index Score (NIS)	28 days	Using the questionnaire Nasal Index Score (NIS)

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026