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Completed

NCT Number: NCT01533220

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

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.

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Key information

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients must be able to understand the study procedures, agree to participate and give written consent.
  • Patients aged over 18 years of both sexes;
  • Patients with clinical signs of flu and colds or other upper respiratory allergies;
  • Patients with early signs and symptoms with time of evolution not more than 72 hours.

Exclusion criteria

  • Patients treated with antibiotics
  • Current treatment with immunosuppressants (eg.cyclosporine or methotrexate);
  • Use of intranasal cromalin the week before inclusion;
  • Use of decongestants or anti-histaminic (intranasal or systemic);
  • Presence of any disease or anatomical abnormality that may difficult the data analysis ;
  • Uncontrolled hypertension;
  • Presence of respiratory symptoms for more than 14 days;
  • History of abuse of drugs and alcohol;
  • Presence of other concomitant pulmonary diseases;
  • Hypersensitivity to any compound of investigational product

Treatment and study plan

naphazoline hydrocloride

Drug

02 drops into each nostril, 04 times a day for 03 days

Naphazoline hydrocloride + Pheniramine Maleate + Panthenol

Drug

02 drops into each nostril each 12 hours for 03 days

Primary outcomes

  1. Efficacy of treatment in nasal congestion reduction based on Peak Flow Nasal Inspiratory (PFNI) assay

    Time frame: 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 outcomes

  1. Safety will be evaluated by the Adverse events occurence

    Time frame: 3 days

    Adverse events will be collected and followed in order to evaluate safety and tolerability

Sponsors and collaborators

Lead sponsor

EMS

Industry

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2013
Study completion
2014
First posted
Feb 15, 2012
Registry last updated
Jan 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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