Efficacy and Safety of Pediatric Drugs in Nasal Congestion

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

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

Study Overview

• Status: Completed
• Conditions: Nasal Congestion
• Intervention / Treatment: Drug: Naridrin; Drug: Afrin

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 292
• Phase: Phase 3

Contacts and Locations

Study Locations

• Brazil
  • SP
    • Santo André, SP, Brazil
      • Faculdade de Medicina do ABC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Naridrin; Naridrin: 2 drops in each nostril once daily as prescription	Drug: Naridrin; Naridrin® : 2 drops in each nostril once daily as prescription; Other Names: Naphazoline Hydrochloride; Mepyramine Maleate; Dexpanthenol
Active Comparator: 0.05 % Oxymetazoline Hydrochloride; 2 pumps in each nostril every 12 hours	Drug: Afrin; 2 pumps in each nostril every 12 hours.; Other Names: oxymetazoline hydrochloride

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Relief of Nasal Congestion	Relief of nasal congestion will be measured on a scale of 0 to 3 (0 = without congestion and 3 total congestion)	2 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Events	Safety of the drug will be assessed by observation of adverse events monitored for the type, frequency and intensity during the days of the follow-up. The evaluation of the heart frequency will also be a safety parameter.	2 days

Collaborators and Investigators

• Sponsor: EMS

Study record dates

Study Major Dates

• Study Start (Actual): January 16, 2018
• Primary Completion (Actual): August 3, 2018
• Study Completion (Actual): April 3, 2019

Study Registration Dates

• First Submitted: November 5, 2015
• First Submitted That Met QC Criteria: November 9, 2015
• First Posted (Estimate): November 10, 2015

Study Record Updates

• Last Update Posted (Actual): October 16, 2019
• Last Update Submitted That Met QC Criteria: October 14, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: nasal congestion
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Protective Agents; Adrenergic alpha-Agonists; Adrenergic Agonists; Cardiotonic Agents; Hypnotics and Sedatives; Respiratory System Agents; Anti-Allergic Agents; Sleep Aids, Pharmaceutical; Histamine H1 Antagonists; Histamine Antagonists; Histamine Agents; Sympathomimetics; Vasoconstrictor Agents; Mydriatics; Nasal Decongestants; Adrenergic alpha-1 Receptor Agonists; Phenylephrine; Oxymetazoline; Naphazoline; Pyrilamine
• Other Study ID Numbers: NMDEMS0214NA-III

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No