Allergic Rhinitis
Conditions
Brief summary
The purpose of this study is to evaluate the non-inferiority of the clinical efficacy of the mometasone nasal gel in the treatment of allergic rhinitis.
Interventions
The patient should administer 1 spray in each nostril once daily.
The patient should administer 1 spray in each nostril once daily.
Sponsors
EMS
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
6 Years to 11 Years
Healthy volunteers
No
Inclusion criteria
* Signed Consent of the patient; * Clinical diagnosis of moderate - severe persistent allergic rhinitis according to ARIA classification(Allergic Rhinitis and Its Impact on Asthma);
Exclusion criteria
* Patients with any clinically significant disease that in the investigator is opinion can´t participate in the study; * Patients with any laboratory finding or image finding that in the investigator is opinion can´t participate in the clinical trial; * Patients with history of hypersensitivity to any of the formula compounds; * Participation in clinical trial in the year prior to this study; * Pregnancy or risk of pregnancy and lactating patients; * Patients who were in use of drugs that can interfere with evaluation; * Decongestants dependent patients or patients receiving allergen specific immunotherapy; * Patients on treatment with monoamine oxidase inhibitors (MAOIs).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy of allergic rhinitis treatment based proportion of participants who show at least moderate relief. | 28 days |
Secondary
| Measure | Time frame |
|---|---|
| Safety will be evaluated by the adverse events occurrences | 28 days |
Outcome results
None listed