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

Last updated: October 8, 2019
Sponsor: Eurofarma Laboratorios S.A.
Overall Status: Trial Not Available

Phase

3

Condition

Rhinitis, Allergic, Perennial

Common Cold

Nasal Obstruction

Treatment

N/A

Clinical Study ID

NCT02972866
EF148
  • Ages 12-90
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

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.

Study Design

Study Start date:
June 01, 2016
Estimated Completion Date:
November 30, 2019

Study 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.

Connect with a study center

  • Allergisa pesquisa dermato-cosmética ltda

    Campinas, São Paulo
    Brazil

    Site Not Available

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