Back to resultsEfficacy of Nasal Naphazoline Hydrocloride + Pheniramine Maleate + Panthenol Compared With Naphazoline Hydrocloride in the Symptomatic Control of Nasal Congestion and Nasopharyngeal
Primary Purpose
Flu, Cold, Allergic Disorder of Respiratory System
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
naphazoline hydrocloride
Naphazoline hydrocloride + Pheniramine Maleate + Panthenol
Sponsored by
About this trial
This is an interventional treatment trial for Flu focused on measuring nasal and nasopharyngeal congestion
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Test group
Comparator group
Arm Description
Naphazoline Hydrocloride (1.0mg) + Pheniramine Maleate (0.2mg) + Panthenol(5.0mg). 02 drops in each nostril every 12 hours for 3 days
Naphazoline Hydrocloride (0.5mg) 02 drops in each nostril every 12 hours for 3 days
Outcomes
Primary Outcome Measures
Efficacy of treatment in nasal congestion reduction based on Peak Flow Nasal Inspiratory (PFNI) assay
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 Outcome Measures
Safety will be evaluated by the Adverse events occurence
Adverse events will be collected and followed in order to evaluate safety and tolerability
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01533220
Brief Title
Efficacy of Nasal Naphazoline Hydrocloride + Pheniramine Maleate + Panthenol Compared With Naphazoline Hydrocloride in the Symptomatic Control of Nasal Congestion and Nasopharyngeal
Official 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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
January 1, 2013 (Actual)
Primary Completion Date
August 31, 2013 (Actual)
Study Completion Date
April 30, 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
EMS
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
Detailed 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Flu, Cold, Allergic Disorder of Respiratory System
Keywords
nasal and nasopharyngeal congestion
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
132 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Test group
Arm Type
Experimental
Arm Description
Naphazoline Hydrocloride (1.0mg) + Pheniramine Maleate (0.2mg) + Panthenol(5.0mg).
02 drops in each nostril every 12 hours for 3 days
Arm Title
Comparator group
Arm Type
Active Comparator
Arm Description
Naphazoline Hydrocloride (0.5mg)
02 drops in each nostril every 12 hours for 3 days
Intervention Type
Drug
Intervention Name(s)
naphazoline hydrocloride
Intervention Description
02 drops into each nostril, 04 times a day for 03 days
Intervention Type
Drug
Intervention Name(s)
Naphazoline hydrocloride + Pheniramine Maleate + Panthenol
Intervention Description
02 drops into each nostril each 12 hours for 03 days
Primary Outcome Measure Information:
Title
Efficacy of treatment in nasal congestion reduction based on Peak Flow Nasal Inspiratory (PFNI) assay
Description
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.
Time Frame
3 days
Secondary Outcome Measure Information:
Title
Safety will be evaluated by the Adverse events occurence
Description
Adverse events will be collected and followed in order to evaluate safety and tolerability
Time Frame
3 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
12. IPD Sharing Statement
Learn more about this trial
Efficacy of Nasal Naphazoline Hydrocloride + Pheniramine Maleate + Panthenol Compared With Naphazoline Hydrocloride in the Symptomatic Control of Nasal Congestion and Nasopharyngeal
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