Efficacy and Safety of Pediatric Drugs in Nasal Congestion

EMS

Status and phase

Completed

Phase 3

Conditions

Nasal Congestion

Treatments

Drug: Naridrin

Drug: Afrin

Study type

Interventional

Funder types

Industry

Identifiers

NMDEMS0214NA-III

Details and patient eligibility

About

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

Full description

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

Enrollment

292 patients

Sex

All

Ages

10 to 17 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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).

Exclusion criteria

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;
History of transphenoidal hypophysectomy or oronasal surgery with exposure of the dura-mater;
Exclusive mouth-breathers patients;
Participants in chronic drug treatment for allergies (eg vaccines for allergy, cromolyn);
History of alcohol and / or drug abuse 3 months prior to the study;
Smokers
Pregnancy or risk of pregnancy and lactating patients;
PAny clinical, laboratory that, in the judgment of the investigator, may interfere with the safety of research participants.