Efficacy and Safety of Pediatric Drugs in Nasal Congestion

• Status: Completed
• Trial end date: 2019-04-03
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: EMS
• Treatments: Maleic acid; Naphazoline; Oxymetazoline; Phenylephrine; Pyrilamine

Criteria

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.