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

EMS132 enrolled

Overview

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.

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

132

Conditions

Flu Cold Allergic Disorder of Respiratory System

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Patients must be able to understand the study procedures, agree to participate and give written consent. 2. Patients aged over 18 years of both sexes; 3. Patients with clinical signs of flu and colds or other upper respiratory allergies; 4. Patients with early signs and symptoms with time of evolution not more than 72 hours. Exclusion Criteria: 1. Patients treated with antibiotics 2. Current treatment with immunosuppressants (eg.cyclosporine or methotrexate); 3. Use of intranasal cromalin the week before inclusion; 4. Use of decongestants or anti-histaminic (intranasal or systemic); 5. Presence of any disease or anatomical abnormality that may difficult the data analysis ; 6. Uncontrolled hypertension; 7. Presence of respiratory symptoms for more than 14 days; 8. History of abuse of drugs and alcohol; 9. Presence of other concomitant pulmonary diseases; 10. Hypersensitivity to any compound of investigational product

Outcomes

Primary Outcomes

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.

Time frame: 3 days

Secondary Outcomes

Safety will be evaluated by the Adverse events occurence

Adverse events will be collected and followed in order to evaluate safety and tolerability

Time frame: 3 days