Other specified diseases of the upper airways
Conditions
Interventions
A total of 190 participants of both sexes will be randomized into two groups of 95 individuals each.
At Visit 1, the principal investigator must obtain the written informed consent of each participant
Drug
Sponsors
CAEP - Centro Avançado de Estudos e Pesquisas
Synova Pesquisa Científica Ltda.
Eligibility
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Men or women between and including 18 and 65 years-old; women of childbearing age willing or able to use, at least, one highly effective contraceptive method throughout the study. In the context of this study, an effective method is defined as one that results in a low failure rate (i.e. less than 1% per year) when used consistently and correctly such as barrier methods, oral, injectables or implanted contraceptives, sexual abstinence or vasectomy of the partner; participants able to understand and perform all study procedures and instructions; participants who signed the Informed Consent Form (ICF) prior to any procedures regarding the study; participants diagnosed with moderate or severe nasal obstruction (i.e. at least number 5 of VAS - Visual Analogue Scale) due to cold or flu and who present symptoms within 24 to 48 hours after the onset of these symptoms.
Exclusion criteria
Exclusion criteria: Hypersensitivity to any of the components, including active ingredients, regarding the study medication; people that have used the study medication (Penetro) at previous time; total obstruction of one nostril by other etiologies that are not related to cold or flu, or for a period less than 24 hours and greater than 48 hours after the onset of symptoms; infectious processes of bacterial etiology (clinically diagnosed); participants on antibiotic treatment or being about to start an antibiotic therapy for another clinical condition; use of intranasal corticosteroid (7 days prior to the study) or systemic (15 days prior to the study), respecting the plasmatic half-life of the drug; use of intranasal or systemic decongestants or antihistamines in the 3 days prior to the study; participants taking inhaled or immunosuppressive drugs 7 days prior to the study; participants with nasal septum deviations (grades II and III), nasal polyps, pronounced hypertrophy of turbinates, hypertrophy of adenoids or other conditions determining nasal obstruction; use of a chronic oral respirator for 6 months or more before inclusion in the study; history of alcohol and/or drug abuse 3 months prior to the study, confirmed after a questioning done by the investigator; history of surgery in the 3 months prior to the study; being a smoker; female participants of childbearing age with a positive pregnancy test on the urine test; participation in a clinical study in the last 12 months; other diseases that, at the discretion of the principal investigator, may interfere with the results of the study; participants with known mental incapacity, language barriers or any incapacity that, at the discretion of the principal investigator, prevent the correct understanding of the Informed Consent Form (ICF) and study activities; known clinically significant systemic disease; pregnant or lactating women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation through the Visual Analogue Scale (VAS) of the degree of nasal congestion due to cold or flu after the administration of Penetro® or placebo. Comparison of the efficacy of Penetro® with regard to placebo in VAS-based nasal decongestion. | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluation of the clinical course of the study participants after being treated with Penetro® compared to placebo. ;Assessment of the safety through the collection of adverse events, serious adverse events and physical and laboratory examinations. | — |
Countries
Brazil
Contacts
Public ContactMichele Espíndola
Laboratório Daudt Oliveira Ltda.
Outcome results
None listed