Clinical Study, Non Inferiority Between Noex® 32µg Versus Budecort Aqua® 32µg in Treatment of Alergic Rhinitis (RINEX32)

Eurofarma

Status and phase: Withdrawn; Phase 3

Conditions: Rhinitis, Allergic, Perennial

Treatments: Drug: Budesonide

Study type: Interventional

Funder types: Industry

Identifiers

NCT02972866

EF148

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 12 to 90 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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0 participants in 2 patient groups

Noex 32mcg

Experimental group

Description:

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.

Treatment:

Drug: Budesonide

Budecort Aqua 32 mcg

Experimental group

Description:

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.

Treatment:

Drug: Budesonide