The purpose of this study is to evaluate the efficacy and safety of DEP114 in the treatment of Moderate to Severe Persistent Allergic Rhinitis in children aged between 6 and 11 years.
* double-blind, superiority, parallel group trial. * Experiment duration: 05 days. * 03 visits (days 0, 5 and 28). * Efficacy will be evaluated for persistent allergic rhinitis based on Global improvement in nasal symptoms score * Adverse events evaluation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
318
DEP114 oral solution
Desloratadine oral solution
To demonstrate the superiority of DEP114 in relation to desloratadine 0.5 mg/mL in relieving the nasal symptoms of moderate to severe persistent allergic rhinitis in children, five days after starting treatment.
Global improvement in nasal symptoms (absolute variation in total nasal symptoms score obstruction, runny nose, itching and sneezing, where 0=no symptoms, 1=mild symptoms, 2=moderate symptoms and 3=severe symptoms) five days after the start of treatment.
Time frame: 5 days
To evaluate the effectiveness of DEP114 in relieving nasal symptoms of moderate to severe persistent allergic rhinitis in children, throughout the treatment.
Global improvement in nasal symptoms throughout treatment (absolute variation in the total score of nasal symptoms, where 0=no symptoms, 1=mild symptoms, 2=moderate symptoms and 3=severe symptoms) on days 1, 2, 3, 4 and 5. Improvement of nasal symptoms three days after the start of the treatment (proportion of participants with improvement in total nasal symptoms score, where 0=no symptoms, 1=mild symptoms, 2=moderate symptoms and 3=severe symptoms) three days after the start of treatment, with improvement in total nasal symptoms score change of at least 4 points on day 3 compared to at baseline).
Time frame: 1-5 days
Evaluate the efficacy of DEP114 to relieve nasal obstruction present in moderate to severe persistent allergic rhinitis in children through the treatment.
Improvement of nasal obstruction throughout treatment (absolute variation in total nasal symptoms score obstruction, where 0=no symptoms, 1=mild symptoms, 2=moderate symptoms and 3=severe symptoms) on days 1, 2, 3, 4 and 5.
Time frame: 1-5 days
Evaluate the efficacy of DEP114 to relieve coryza present in moderate to severe persistent allergic rhinitis in children, three and five days after the start of treatment.
Improvement of the runny nose three and five days after the start of the treatment (distribution of participants according to intensity of coryza at baseline, three and five days after the start of treatment).
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Time frame: 3 and 5 day
Evaluate the efficacy of DEP114 to relieve nasal itching present in moderate to severe persistent allergic rhinitis in children, three and five days after the start of treatment.
Improvement of nasal itching three and five days after the onset treatment (distribution of participants according to intensity of nasal itching at baseline, three and five days after starting treatment).
Time frame: 3 and 5 day
Evaluate the efficacy of DEP114 to relieve sneezing present in persistent allergic rhinitis moderate to severe in children, three and five days after the start of treatment.
Improvement in sneezing three and five days after the start of the treatment (distribution of participants according to intensity of sneezing at baseline, three and five days after starting treatment).
Time frame: 3 and 5 day
Evaluate the efficacy of DEP114 to relieve symptoms of moderate to severe persistent allergic rhinitis in children according to the perception of the person responsible for the participant.
Overall assessment of the treatment by the person responsible for the treatment participant five days after the start of treatment (distribution of participants according to a 5-point categorical scale, where 0=very bad, 1=bad, 2=neither good nor bad, 3=good, 4=very good).
Time frame: 5 day
Evaluate the efficacy of DEP114 to relieve symptoms of moderate to severe persistent allergic rhinitis in children according to the investigator's perception.
Overall assessment of treatment by the investigator five days after the start of treatment (distribution of participants according to a 5-point categorical scale, where 0=very bad 1=bad, 2=neither good nor bad, 3=good, 4=very good).
Time frame: 5 day