Clinical Study, Non Inferiority Between Noex® 50µg Versus Busonid® 50µg in Treatment of Allergic Rhinitis
NCT ID: NCT02988778
Last Updated: 2019-10-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE3
INTERVENTIONAL
2019-10-08
2019-10-08
Brief Summary
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Detailed Description
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This study was draw to treat patients with persistent rhinitis moderate to severe in sites located locally in Brazil.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Budesonid 50mcg (Noex)
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 (Noex)
Suspention to nasal use, 2 atomization in each nostril during the morning and at night.
Budesonid 50mcg (Busonid)
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.
Budesonid 50mcg (Busonid)
Suspention to nasal use, 2 atomization in each nostril during the morning and at night.
Interventions
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Budesonid 50mcg (Noex)
Suspention to nasal use, 2 atomization in each nostril during the morning and at night.
Budesonid 50mcg (Busonid)
Suspention to nasal use, 2 atomization in each nostril during the morning and at night.
Eligibility Criteria
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Inclusion Criteria
2. History of allergic persistent rhinitis moderate to severe at least 2 years
3. Proved allergic using PRICK or RAST test
4. Nasal symptoms (NIS) \> 3 and nasal obstruction \>1
5. Indication of nasal corticosteroids use
6. Washout of nasal corticosteroids for 14 days
7. ICF
Exclusion Criteria
2. Asthma non controlled
3. Use of oral/injectable corticoids 30 days before screening
4. patients not eligible to complete diaries
5. patients with allergy to any substance of medicines
6. non controlled disease
12 Years
90 Years
ALL
No
Sponsors
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Eurofarma Laboratorios S.A.
INDUSTRY
Responsible Party
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Principal Investigators
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Mauro Acir Crippa Junior, MD
Role: PRINCIPAL_INVESTIGATOR
Allergisa Pesquisa Dermato-Cosmetica LTDA
Locations
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Alexandra Dumont
Campinas, , Brazil
Countries
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Other Identifiers
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EF149
Identifier Type: -
Identifier Source: org_study_id
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