Study Stopped
Regulatory strategy
Clinical Study, Non Inferiority Between Noex® 32µg Versus Budecort Aqua® 32µg in Treatment of Alergic Rhinitis
RINEX32
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
1 other identifier
interventional
N/A
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Jun 2016
Typical duration for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2016
CompletedFirst Submitted
Initial submission to the registry
November 11, 2016
CompletedFirst Posted
Study publicly available on registry
November 25, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2019
CompletedOctober 9, 2019
October 1, 2018
3.4 years
November 11, 2016
October 8, 2019
Conditions
Outcome Measures
Primary Outcomes (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.
The questionnaire Nasal Index Score (NIS) will be used to check intensity of symptons and patient will answer this questionnaire daily at home.
28 days
Study Arms (2)
Noex 32mcg
EXPERIMENTALNoex/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 32 mcg
EXPERIMENTALBudecort 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.
Interventions
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 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Allergisa pesquisa dermato-cosmética ltda
Campinas, São Paulo, Brazil
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mauro Acir Crippa Junior
Allergisa Pesquisa Dermato-Cosmética 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 11, 2016
First Posted
November 25, 2016
Study Start
June 1, 2016
Primary Completion
November 1, 2019
Study Completion
November 1, 2019
Last Updated
October 9, 2019
Record last verified: 2018-10