Efficacy of Nasal Naphazoline Hydrocloride + Pheniramine Maleate + Panthenol Compared With Naphazoline Hydrocloride in the Symptomatic Control of Nasal Congestion and Nasopharyngeal
This trial is active, not recruiting.
|Conditions||flu, cold, allergic disorder of respiratory system|
|Treatments||naphazoline hydrocloride, naphazoline hydrocloride + pheniramine maleate + panthenol|
|Start date||June 2013|
|End date||October 2013|
|Trial size||212 participants|
|Trial identifier||NCT01533220, NMPEMS1011|
The common cold is a major cause of nasal obstruction and reaches children and adults twice 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 treatment.
The study was designed to parallel distribution, with two equal groups, with one group will receive treatment with a combination of naphazoline hydrocloride + pheniramine maleate + panthenol and the other will receive treatment with naphazoline hydrocloride.
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
|Masking||double blind (subject, caregiver, investigator, outcomes assessor)|
Efficacy of treatment in nasal congestion reduction based on Peak Flow Nasal Inspiratory (PFNI) assay
time frame: Day 5
Safety will be evaluated by the Adverse events occurence
time frame: Day 5
Male or female participants at least 12 years old.
- Patients must be able to understand the study procedures, agree to participate and give written consent.
- Patients aged over 12 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 48 hours;
- Patients with good mental health;
- Negative urine pregnancy test
- 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
|Official title||A Randomized, Double-blind, Prospective, Monocentric, 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|
|Principal investigator||Marco César MD Santos, Jorge|
|Description||STUDY DESIGN - randomized,double blind, prospective,monocentric, parallel group, intent to treat trial - Experiment duration: 5 days - 4 visits (days 0,1,3 and 5) - Evaluation of symptoms reduction - Adverse events evaluation|
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