Study Stopped
regulatory strategy
Clinical Study, Non Inferiority Between Noex® 50µg Versus Busonid® 50µg in Treatment of Allergic Rhinitis
RINEX50
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
1 other identifier
interventional
N/A
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Oct 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 28, 2016
CompletedFirst Posted
Study publicly available on registry
December 9, 2016
CompletedStudy Start
First participant enrolled
October 8, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 8, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
October 8, 2019
CompletedOctober 9, 2019
August 1, 2017
Same day
November 28, 2016
October 8, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Demonstrate non inferiority of Noex using the questionnaire Nasal Index Score (NIS)
Using the questionnaire Nasal Index Score (NIS)
28 days
Study Arms (2)
Budesonid 50mcg (Noex)
EXPERIMENTALBudesonid 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)
ACTIVE COMPARATORBudesonid 50mcg (Busonid), 2 atomizations in each nostril by the morning and during the night, total of 400 mcg per day. Treatment of 28 days.
Interventions
Suspention to nasal use, 2 atomization in each nostril during the morning and at night.
Suspention to nasal use, 2 atomization in each nostril during the morning and at night.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Alexandra Dumont
Campinas, Brazil
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mauro Acir Crippa Junior, MD
Allergisa Pesquisa Dermato-Cosmetica LTDA
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 28, 2016
First Posted
December 9, 2016
Study Start
October 8, 2019
Primary Completion
October 8, 2019
Study Completion
October 8, 2019
Last Updated
October 9, 2019
Record last verified: 2017-08