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

Launched by EMS · Feb 10, 2012

Keywords

ClinConnect Summary

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

Gender

ALL

Eligibility criteria

• 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