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To assess the efficacy of the study product Noex in the treatment of allergic rhinitis by means of the Nasal Index Score (NIS) after 4 weeks of treatment with the drug.
Primary objective: To assess the efficacy of the study product Noex in the treatment of allergic rhinitis by means of the Nasal Index Score (NIS) after 4 weeks of treatment with the drug.
Secondary objectives: To determine the total NIS scale score after 12 weeks of treatment and the scores of the same scale individually for the symptoms of nasal obstruction, coryza, sneezing and nasal pruritus after 4 and 12 weeks of treatment, as well as to assess the safety of the study product according to the presence of adverse events.
Some eligibility criteria:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Noex | Experimental | The patients shall use the NOEX drug only once a day (one application in each nostril) during the 12 weeks of treatment |
|
| Budecort Aqua | Active Comparator | The patients shall use the Budecort Aqua drug only once a day (one application in each nostril) during the 12 weeks of treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Noex | Drug | The patients shall use the Noex drug only once a day (one application in each nostril) during the 12 weeks of treatment |
|
| Measure | Description | Time Frame |
|---|---|---|
| The primary objective of the study is to evaluate the efficiency of Noex | 5 months |
| Measure | Description | Time Frame |
|---|---|---|
| The secondary objectives and endpoints of the study are to evaluate the safety of Noex®, according to the frequency of the adverse events. | 5 months |
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Inclusion Criteria:
Exclusion Criteria:
Patients using allergen-specific immunotherapy during the last year, as well as using anti-leukotrienes and anti-immunoglobulin E during the last month, or even patients using inhalant or oral corticosteroids after V0 will not be enrolled in the study.
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| Name | Affiliation | Role |
|---|---|---|
| Fabio Morato, M.D. | IMA Brasil - Instituto de Pesquisa Clínica e Medicina Avançada | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IMA Brasil - Instituto de Pesquisa Clínica e Medicina Avançada | São Paulo | Brazil |
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| ID | Term |
|---|---|
| D065631 | Rhinitis, Allergic |
| ID | Term |
|---|---|
| D012220 | Rhinitis |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D012130 | Respiratory Hypersensitivity |
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| Budecort Aqua | Drug | The patients shall use the Budecort Aqua drug only once a day (one application in each nostril) during the 12 weeks of treatment. |
|
| D010038 |
| Otorhinolaryngologic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |