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

• Sponsor: EMS (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01533220
• Collaborator: (none)
• Enrollment: 132
• Arms: 2
• Actual Duration (Months): 15.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Flu; Cold; Allergic Disorder of Respiratory System	Drug: naphazoline hydrocloride; Drug: Naphazoline hydrocloride + Pheniramine Maleate + Panthenol	Phase 3

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 Design

• Study Type: Interventional
• Actual Enrollment: 132 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Jan 1, 2013
• Actual Primary Completion Date: Aug 31, 2013
• Actual Study Completion Date: Apr 30, 2014

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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

1. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• EMS

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: EMS
• ClinicalTrials.gov Identifier: NCT01533220
• Other Study ID Numbers: NMPEMS1011
• First Posted: Feb 15, 2012
• Last Update Posted: Jan 25, 2019
• Last Verified: Jan 1, 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by EMS: nasal and nasopharyngeal congestion
• Additional relevant MeSH terms: Respiration Disorders; Hypersensitivity; Pheniramine; Naphazoline

Study Results

No Results Posted as of Jan 25, 2019