Efficacy and Safety of Pediatric Drugs in Nasal Congestion

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

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

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

Conditions
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Nasal Congestion

Intervention / Treatment
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* Drug: Naridrin
* Drug: Afrin


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Naridrin<br>Naridrin: 2 drops in each nostril once daily as prescription | Drug: Naridrin<br>* Naridrin® : 2 drops in each nostril once daily as prescription<br>* Other names: Dexpanthenol;|
| Active Comparator: 0.05 % Oxymetazoline Hydrochloride<br>2 pumps in each nostril every 12 hours | Drug: Afrin<br>* 2 pumps in each nostril every 12 hours.<br>* Other names: oxymetazoline hydrochloride;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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nasal congestion