Allergic Disorder of Respiratory System, Cold, Flu
Conditions
Keywords
nasal and nasopharyngeal congestion
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
Interventions
DRUGNaphazoline hydrocloride + Pheniramine Maleate + Panthenol
02 drops into each nostril each 12 hours for 03 days
DRUGnaphazoline hydrocloride
02 drops into each nostril, 04 times a day for 03 days
Sponsors
EMS
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy of treatment in nasal congestion reduction based on Peak Flow Nasal Inspiratory (PFNI) assay | 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
| Measure | Time frame | Description |
|---|---|---|
| Safety will be evaluated by the Adverse events occurence | 3 days | Adverse events will be collected and followed in order to evaluate safety and tolerability |
Outcome results
None listed