Efficacy of Nasal Naphazoline Hydrocloride + Pheniramine Maleate + Panthenol Compared With Naphazoline Hydrocloride in the Symptomatic Control of Nasal Congestion and Nasopharyngeal
Information source: EMS
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Flu; Cold; Allergic Disorder of Respiratory System
Intervention: naphazoline hydrocloride (Drug); Naphazoline hydrocloride + Pheniramine Maleate + Panthenol (Drug)
Phase: Phase 3
Status: Active, not recruiting
Sponsored by: EMS Official(s) and/or principal investigator(s): Marco César MD Santos, Jorge, Principal Investigator, Affiliation: IPO - PR
Summary
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.
Clinical Details
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
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Efficacy of treatment in nasal congestion reduction based on Peak Flow Nasal Inspiratory (PFNI) assay
Secondary outcome: Safety will be evaluated by the Adverse events occurence
Detailed 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
Eligibility
Minimum age: 12 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. Patients must be able to understand the study procedures, agree to participate and
give written consent.
2. Patients aged over 12 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 48 hours;
5. Patients with good mental health;
6. Negative urine pregnancy test
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
Locations and Contacts
Instituto Paranaense de Otorrinolaringologia, Curitiba, Parana 80620010, Brazil
Additional Information
Starting date: June 2013
Last updated: September 24, 2013
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