Back to resultsClinical Study, Non Inferiority Between Noex® 50µg Versus Busonid® 50µg in Treatment of Allergic Rhinitis (RINEX50)
Primary Purpose
Rhinitis, Allergic, Perennial
Status
Withdrawn
Phase
Phase 3
Locations
Brazil
Study Type
Interventional
Intervention
Budesonid 50mcg (Noex)
Budesonid 50mcg (Busonid)
Sponsored by
About this trial
This is an interventional treatment trial for Rhinitis, Allergic, Perennial
Eligibility Criteria
Inclusion Criteria:
- Age ≥ 12
- History of allergic persistent rhinitis moderate to severe at least 2 years
- Proved allergic using PRICK or RAST test
- Nasal symptoms (NIS) > 3 and nasal obstruction >1
- Indication of nasal corticosteroids use
- Washout of nasal corticosteroids for 14 days
- ICF
Exclusion Criteria:
- Other types of rhinitis
- Asthma non controlled
- Use of oral/injectable corticoids 30 days before screening
- patients not eligible to complete diaries
- patients with allergy to any substance of medicines
- non controlled disease
Sites / Locations
- Alexandra Dumont
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Budesonid 50mcg (Noex)
Budesonid 50mcg (Busonid)
Arm Description
Budesonid 50mcg (Noex), 2 atomizations in each nostril by the morning and during the night, total of 400 mcg per day. Treatment of 28 days.
Budesonid 50mcg (Busonid), 2 atomizations in each nostril by the morning and during the night, total of 400 mcg per day. Treatment of 28 days.
Outcomes
Primary Outcome Measures
Demonstrate non inferiority of Noex using the questionnaire Nasal Index Score (NIS)
Using the questionnaire Nasal Index Score (NIS)
Secondary Outcome Measures
Full Information
NCT ID
NCT02988778
First Posted
November 28, 2016
Last Updated
October 8, 2019
Sponsor
Eurofarma Laboratorios S.A.
1. Study Identification
Unique Protocol Identification Number
NCT02988778
Brief Title
Clinical Study, Non Inferiority Between Noex® 50µg Versus Busonid® 50µg in Treatment of Allergic Rhinitis
Acronym
RINEX50
Official Title
Phase III, Multicenter, Randomized, Simple-blinded, Parallel Groups to Evaluate Non Inferiority of Noex® 50µg Versus Busonid® 50µg in Treatment of Allergic Persistent Rhinitis Moderate to Severe
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Withdrawn
Why Stopped
regulatory strategy
Study Start Date
October 8, 2019 (Actual)
Primary Completion Date
October 8, 2019 (Actual)
Study Completion Date
October 8, 2019 (Actual)
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 spray 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 persistent rhinitis moderate to severe in sites located locally in Brazil.
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
Budesonid 50mcg (Noex)
Arm Type
Experimental
Arm Description
Budesonid 50mcg (Noex), 2 atomizations in each nostril by the morning and during the night, total of 400 mcg per day.
Treatment of 28 days.
Arm Title
Budesonid 50mcg (Busonid)
Arm Type
Active Comparator
Arm Description
Budesonid 50mcg (Busonid), 2 atomizations in each nostril by the morning and during the night, total of 400 mcg per day.
Treatment of 28 days.
Intervention Type
Drug
Intervention Name(s)
Budesonid 50mcg (Noex)
Intervention Description
Suspention to nasal use, 2 atomization in each nostril during the morning and at night.
Intervention Type
Drug
Intervention Name(s)
Budesonid 50mcg (Busonid)
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 using the questionnaire Nasal Index Score (NIS)
Description
Using the questionnaire Nasal Index Score (NIS)
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 allergic persistent rhinitis moderate to severe at least 2 years
Proved allergic using PRICK or RAST test
Nasal symptoms (NIS) > 3 and nasal obstruction >1
Indication of nasal corticosteroids use
Washout of nasal corticosteroids for 14 days
ICF
Exclusion Criteria:
Other types of rhinitis
Asthma non controlled
Use of oral/injectable corticoids 30 days before screening
patients not eligible to complete diaries
patients with allergy to any substance of medicines
non controlled disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mauro Acir Crippa Junior, MD
Organizational Affiliation
Allergisa Pesquisa Dermato-Cosmetica LTDA
Official's Role
Principal Investigator
Facility Information:
Facility Name
Alexandra Dumont
City
Campinas
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® 50µg Versus Busonid® 50µg in Treatment of Allergic Rhinitis
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