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

Sponsor
Eurofarma Laboratorios S.A. (Industry)
Overall Status
Withdrawn
CT.gov ID
NCT02972866
Collaborator
(none)
0
Enrollment
1
Location
2
Arms
41
Anticipated Duration (Months)
0
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 3

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Investigator)
Primary Purpose:
Treatment
Official Title:
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
Anticipated Study Start Date :
Jun 1, 2016
Anticipated Primary Completion Date :
Nov 1, 2019
Anticipated Study Completion Date :
Nov 1, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

Drug: Budesonide
Suspention to nasal use, 2 atomization in each nostril during the morning and at night.
Other Names:
  • Noex 32mcg
  • Budecort Aqua 32mcg

    		•
    Experimental: 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.

    Drug: Budesonide
    Suspention to nasal use, 2 atomization in each nostril during the morning and at night.
    Other Names:
  • Noex 32mcg
  • Budecort Aqua 32mcg

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    12 Years to 90 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Allergisa pesquisa dermato-cosmética ltda Campinas São Paulo Brazil

    Sponsors and Collaborators

    • Eurofarma Laboratorios S.A.

    Investigators

    • Principal Investigator: Mauro Acir Crippa Junior, Allergisa Pesquisa Dermato-Cosmética Ltda

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Eurofarma Laboratorios S.A.
    ClinicalTrials.gov Identifier:
    NCT02972866
    Other Study ID Numbers:
    • EF148
    First Posted:
    Nov 25, 2016
    Last Update Posted:
    Oct 9, 2019
    Last Verified:
    Oct 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Rhinitis
    Rhinitis, Allergic
    Rhinitis, Allergic, Perennial
    Budesonide

    Study Results

    No Results Posted as of Oct 9, 2019