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

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

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 Overview

• Status: Completed
• Conditions: Flu; Cold; Allergic Disorder of Respiratory System
• Intervention / Treatment: Drug: Naphazoline hydrocloride + Pheniramine Maleate + Panthenol; Drug: 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 Type: Interventional
• Enrollment (Actual): 132
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Test group; 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; 02 drops into each nostril each 12 hours for 03 days
Active Comparator: Comparator group; Naphazoline Hydrocloride (0.5mg) 02 drops in each nostril every 12 hours for 3 days	Drug: naphazoline hydrocloride; 02 drops into each nostril, 04 times a day for 03 days

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

Collaborators and Investigators

• Sponsor: EMS

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2013
• Primary Completion (Actual): August 31, 2013
• Study Completion (Actual): April 30, 2014

Study Registration Dates

• First Submitted: February 9, 2012
• First Submitted That Met QC Criteria: February 10, 2012
• First Posted (Estimate): February 15, 2012

Study Record Updates

• Last Update Posted (Actual): January 25, 2019
• Last Update Submitted That Met QC Criteria: January 24, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: nasal and nasopharyngeal congestion
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Hypersensitivity; Respiration Disorders; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Adrenergic alpha-Agonists; Adrenergic Agonists; Dermatologic Agents; Respiratory System Agents; Anti-Allergic Agents; Histamine H1 Antagonists; Histamine Antagonists; Histamine Agents; Antipruritics; Vasoconstrictor Agents; Nasal Decongestants; Pheniramine; Naphazoline
• Other Study ID Numbers: NMPEMS1011

Drug and device information, study documents

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