Clinical Evaluation of Safety and Efficacy of Pediatric Naridrin in Comparison to Afrin on the Improval of Nasal Congestion.

EMS1 site in 1 country292 target enrollmentJanuary 16, 2018

InterventionsNaridrin Afrin

Overview

The purpose of this study is to evaluate the efficacy of the Naridrin in improving nasal congestion.

Open label, randomized, multicenter clinical study. Maximal experiment duration: 2 days; 2 visits. Safety and efficacy evaluation

Registry

clinicaltrials.gov

Start Date

January 16, 2018

End Date

April 3, 2019

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Sponsor

EMS

Responsible Party

Sponsor

•Participants aged 10-17 years old with clinical symptoms of inflammatory of allergic nasal congestion in at least one nostril due to rhinitis or rhinopharyngitis (cold or flu);
•Signed Consent;
•Participants whose mother, father and / or legal guardian is in accordance with all study purposes and procedures;
•Participants with clinical symptoms of nasal congestion in at least one nostril diagnosed through the Glatzel mirror;
•Participants with minimal score of 2 points in the 0 to 3 scale (Moderate obstruction).

•Participation in clinical trial in the year prior to this study;
•Total obstruction of one of the nostrils by other etiologies that are not inflammatory or allergic;
•Infectious bacterial-disease (clinically diagnosed);
•Participants treated with antibiotic or possible antibiotic use due to another medical condition;
•Use of intranasal corticosteroids (7 days prior to the study) or systemic (15 days prior to the study), regarding the plasma half-life of the drug;
•Use of decongestants or antihistamine (intranasal or systemic) in the 03 days prior to the study;
•Use of inhaled drugs (except nasal moisturizers such as saline solution) or treatment with immunosuppressants in the week before the study;
•Participants with septum deviation grade II and III, nasal polyps, severe turbinate hypertrophy, adenoid hypertrophy, or other determining factors for nasal obstruction;
•History of hyperthyroidism or hypertension;
•History of hypersensitivity to the components of the study drugs;