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: * 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;
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
280
The patients shall use the Noex drug only once a day (one application in each nostril) during the 12 weeks of treatment
The patients shall use the Budecort Aqua drug only once a day (one application in each nostril) during the 12 weeks of treatment.
IMA Brasil - Instituto de Pesquisa Clínica e Medicina Avançada
São Paulo, Brazil
The primary objective of the study is to evaluate the efficiency of Noex
Time frame: 5 months
The secondary objectives and endpoints of the study are to evaluate the safety of Noex®, according to the frequency of the adverse events.
Time frame: 5 months
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