Allergic Rhinitis
Conditions
Brief summary
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.
Detailed description
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: * NIS scale score \> 4 points at the randomization visit * Patients with persistent mild to moderate AR, according to the ARIA criteria with indication for use budesonide;
Interventions
DRUGNoex
The patients shall use the Noex drug only once a day (one application in each nostril) during the 12 weeks of treatment
DRUGBudecort Aqua
The patients shall use the Budecort Aqua drug only once a day (one application in each nostril) during the 12 weeks of treatment.
Sponsors
Eurofarma Laboratorios S.A.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Sign the informed consent form or - in case of patients younger than 18 years, the legal responsible must sign the consent; * ≥ 12 years old; * NIS scale score \> 4 points at the randomization visit * Patients with persistent mild to moderate AR, according to the ARIA criteria (see Appendix B), with indication for use budesonide; * Positive skin test for at least one relevant airborne agent; * AR symptoms for at least 2 years; * May undergo a washout period of at least 2 weeks (without using any oral, nasal or inhalant corticosteroid agent; see 6.4).
Exclusion criteria
* Patients with persistent severe allergic rhinitis; * Patients with severe co-morbidities (at the investigator's opinion); * Patients with moderate to severe persistent asthma; * Clinical history of infection of the airways 30 days before the study entry; * Patients with structural changes causing nasal obstruction, such as pronounced nasal septum deviation, nasal polyps or any other type of nasal malformation; * Pregnant women and patients planning to become pregnant during the study period or breastfeeding women; * Patients in need of other drugs to treat the allergic rhinitis, such as anti-immunoglobulin E, allergen-specific immunotherapy, anti-leukotrienes, systemic vasoconstrictors, oral corticosteroids and other inhalant corticosteroids. 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective of the study is to evaluate the efficiency of Noex | 5 months |
Secondary
| Measure | 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 |
Countries
Brazil
Outcome results
None listed