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

Flu Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01533220
• Other study ID #: NMPEMS1011
• Status: Completed
• Phase: Phase 3
• Start date: January 1, 2013
• Est. completion date: April 30, 2014

Study information

• Verified date: January 2019
• Source: EMS
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 132
• Est. completion date: April 30, 2014
• Est. primary completion date: August 31, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Allergic Disorder of Respiratory System
• Cold
• Flu
• Hypersensitivity
• Respiration Disorders

Intervention

Drug:
• naphazoline hydrocloride
02 drops into each nostril, 04 times a day for 03 days
• Naphazoline hydrocloride + Pheniramine Maleate + Panthenol
02 drops into each nostril each 12 hours for 03 days

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
EMS

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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