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

Phase 3

Completed

• Conditions: Flu; Cold; Allergic Disorder of Respiratory System
• Interventions: Drug: Naphazoline hydrocloride + Pheniramine Maleate + Panthenol; Drug: naphazoline hydrocloride

• Registration Number: NCT01533220
• Lead Sponsor: EMS

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

Study Timeline

• Study First Submitted: 2012-02-09
• Study First Submitted QC: 2012-02-10
• Study First Posted: 2012-02-15
• Study Start: 2013-01-01
• Primary Completion: 2013-08-31
• Study Completion: 2014-04-30
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-24
• Last Update Posted: 2019-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 132

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Test group	Naphazoline hydrocloride + Pheniramine Maleate + Panthenol	Naphazoline Hydrocloride (1.0mg) + Pheniramine Maleate (0.2mg) + Panthenol(5.0mg). 02 drops in each nostril every 12 hours for 3 days
Comparator group	naphazoline hydrocloride	Naphazoline Hydrocloride (0.5mg) 02 drops in each nostril every 12 hours for 3 days

Primary Outcome Measures

Name	Time	Method
Efficacy of treatment in nasal congestion reduction based on Peak Flow Nasal Inspiratory (PFNI) assay	3 days	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.

Secondary Outcome Measures

Name	Time	Method
Safety will be evaluated by the Adverse events occurence	3 days	Adverse events will be collected and followed in order to evaluate safety and tolerability