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

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

Status

Withdrawn

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02972866

Acronym

RINEX32

Enrollment

Registered

2016-11-25

Start date

2016-06-30

Completion date

2019-11-30

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 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.

Interventions

DRUGBudesonide

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 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.

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

Brazil

Outcome results

None listed

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