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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-30

Study Completion Date

2019-11-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Rhinitis, Allergic, Perennial

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Noex 32mcg

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.

Group Type EXPERIMENTAL

Budesonide

Intervention Type DRUG

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

Budecort Aqua 32 mcg

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.

Group Type EXPERIMENTAL

Budesonide

Intervention Type DRUG

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

Interventions

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Budesonide

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

Intervention Type DRUG

Other Intervention Names

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Noex 32mcg Budecort Aqua 32mcg

Eligibility Criteria

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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.

Minimum Eligible Age

12 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No