Efficacy of Nasal Naphazoline Hydrocloride + Pheniramine Maleate + Panthenol Compared With Naphazoline Hydrocloride in the Symptomatic Control of Nasal Congestion and Nasopharyngeal

Study Overview
=================
Brief Summary
-----------------
The common cold is a major cause of nasal obstruction and reaches children and adults two or more times a year. At the moment, there is no cure for the common cold, and therefore the reduction of symptoms is the focus of the treatment. The study has parallel distribution design, with two equal groups, in which one group will be treated by a combination of naphazoline hydrocloride + pheniramine maleate + panthenol and the other will receive treatment with naphazoline hydrocloride.

Detailed Description
-----------------
STUDY DESIGN randomized,double blind, prospective, multicentric, parallel group, intent to treat trial Experiment duration: 3 days 2 visits (days 0 and 2) Evaluation of symptoms reduction Adverse events evaluation

Official Title
-----------------
A Randomized, Double-blind, Prospective, Multicentric, Superior Efficacy and Safety of Naphazoline Hydrocloride + Pheniramine Maleate + Panthenol Compared With Naphazoline Hydrocloride in the Symptomatic Control of Nasal Congestion and Nasopharyngeal Due to Colds or Other Upper Respiratory Allergies

Conditions
-----------------
Flu, Cold, Allergic Disorder of Respiratory System

Intervention / Treatment
-----------------
* Drug: naphazoline hydrocloride
* Drug: Naphazoline hydrocloride + Pheniramine Maleate + Panthenol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients must be able to understand the study procedures, agree to participate and give written consent. Patients aged over 18 years of both sexes; Patients with clinical signs of flu and colds or other upper respiratory allergies; Patients with early signs and symptoms with time of evolution not more than 72 hours. Exclusion Criteria: Patients treated with antibiotics Current treatment with immunosuppressants (eg.cyclosporine or methotrexate); Use of intranasal cromalin the week before inclusion; Use of decongestants or anti-histaminic (intranasal or systemic); Presence of any disease or anatomical abnormality that may difficult the data analysis ; Uncontrolled hypertension; Presence of respiratory symptoms for more than 14 days; History of abuse of drugs and alcohol; Presence of other concomitant pulmonary diseases; Hypersensitivity to any compound of investigational product

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test group<br>Naphazoline Hydrocloride (1.0mg) + Pheniramine Maleate (0.2mg) + Panthenol(5.0mg). 02 drops in each nostril every 12 hours for 3 days | Drug: Naphazoline hydrocloride + Pheniramine Maleate + Panthenol<br>* 02 drops into each nostril each 12 hours for 03 days<br>|
| Active Comparator: Comparator group<br>Naphazoline Hydrocloride (0.5mg) 02 drops in each nostril every 12 hours for 3 days | Drug: naphazoline hydrocloride<br>* 02 drops into each nostril, 04 times a day for 03 days<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of treatment in nasal congestion reduction based on Peak Flow Nasal Inspiratory (PFNI) assay | The individual response rate to the nasal congestion reduction is calculated by measuring the peak flow nasal inspiratory (PFNI) during the first and last visit. | 3 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety will be evaluated by the Adverse events occurence | Adverse events will be collected and followed in order to evaluate safety and tolerability | 3 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
nasal and nasopharyngeal congestion