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

Primary Purpose

Rhinitis, Allergic, Perennial

Status
Withdrawn
Phase
Phase 3
Locations
Brazil
Study Type
Interventional
Intervention
Budesonide
Sponsored by
Eurofarma Laboratorios S.A.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rhinitis, Allergic, Perennial

Eligibility Criteria

12 Years - 90 Years (Child, Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Allergisa pesquisa dermato-cosmética ltda

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Noex 32mcg

Budecort Aqua 32 mcg

Arm 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.

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.

Outcomes

Primary Outcome Measures

Demonstrate non inferiority of Noex comparable with referral product Budecort Aqua in the treatment of rinithis moderate to severe during 4 weeks of treatment.
The questionnaire Nasal Index Score (NIS) will be used to check intensity of symptons and patient will answer this questionnaire daily at home.

Secondary Outcome Measures

Full Information

First Posted
November 11, 2016
Last Updated
October 8, 2019
Sponsor
Eurofarma Laboratorios S.A.
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1. Study Identification

Unique Protocol Identification Number
NCT02972866
Brief Title
Clinical Study, Non Inferiority Between Noex® 32µg Versus Budecort Aqua® 32µg in Treatment of Alergic Rhinitis
Acronym
RINEX32
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Withdrawn
Why Stopped
Regulatory strategy
Study Start Date
June 2016 (Anticipated)
Primary Completion Date
November 2019 (Anticipated)
Study Completion Date
November 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eurofarma Laboratorios S.A.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rhinitis, Allergic, Perennial

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Noex 32mcg
Arm Type
Experimental
Arm 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.
Arm Title
Budecort Aqua 32 mcg
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Budesonide
Other Intervention Name(s)
Noex 32mcg, Budecort Aqua 32mcg
Intervention Description
Suspention to nasal use, 2 atomization in each nostril during the morning and at night.
Primary Outcome Measure Information:
Title
Demonstrate non inferiority of Noex comparable with referral product Budecort Aqua in the treatment of rinithis moderate to severe during 4 weeks of treatment.
Description
The questionnaire Nasal Index Score (NIS) will be used to check intensity of symptons and patient will answer this questionnaire daily at home.
Time Frame
28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥ 12. History of alergic persistent rhinitis moderate to severe at least 2 years. Proved alergic using PRICK or RAST test. Nasal symptoms (NIS) > 3 and nasal obstruction >1. Indication of nasal corticorteroids use.. Washout of nasal corticorteroids for 14 days. ICF. Exclusion Criteria: Other types of rhinitis; Asthma non controled Use of oral/injectable corticoids 30 days before screening. patients not eligible to complete diaries. patients with alergy to any substance of medicines. non controlled desease.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mauro Acir Crippa Junior
Organizational Affiliation
Allergisa Pesquisa Dermato-Cosmética Ltda
Official's Role
Principal Investigator
Facility Information:
Facility Name
Allergisa pesquisa dermato-cosmética ltda
City
Campinas
State/Province
São Paulo
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
Undecided, but could be shared upon investigator's request.

Learn more about this trial

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

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