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

EMS

Status and phase: Completed; Phase 3

Conditions: Allergic Disorder of Respiratory System; Flu; Cold

Treatments: Drug: Naphazoline hydrocloride + Pheniramine Maleate + Panthenol; Drug: naphazoline hydrocloride

Study type: Interventional

Funder types: Industry

Identifiers

NCT01533220

NMPEMS1011

Details and patient eligibility

About

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.

Full 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

Enrollment: 132 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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132 participants in 2 patient groups

Test group

Experimental group

Description:

Naphazoline Hydrocloride (1.0mg) + Pheniramine Maleate (0.2mg) + Panthenol(5.0mg). 02 drops in each nostril every 12 hours for 3 days

Treatment:

Drug: Naphazoline hydrocloride + Pheniramine Maleate + Panthenol

Comparator group

Active Comparator group

Description:

Naphazoline Hydrocloride (0.5mg) 02 drops in each nostril every 12 hours for 3 days

Treatment:

Drug: naphazoline hydrocloride