Other specified diseases of the upper airways
Conditions
Interventions
Drug
A total of 200 participants of both sexes will be randomized into two groups of 100 individuals each. At Visit 1, the principal investigator must obtain the written assent of each participant, as well
Sponsors
Centro de Pesquisa Clínica São Lucas
Synova Pesquisa Científica Ltda.
Eligibility
Age
6 Years to 17 Years
Inclusion criteria
Inclusion criteria: Participants greater than or equal to 06 and less than or equal to 17 years of age; Participant with symptoms of moderate or severe nasal congestion (ie, reaching at least 5 VAS) lasting at least 24 hours and a maximum of 48 hours prior to inclusion; Negative urinary B-HCG test for female participants after menarche; Participants able to understand and perform all study procedures and instructions; Participants must have the Informed Assent Form and the Informed Consent Form prior to any procedures related to the study.
Exclusion criteria
Exclusion criteria: Hypersensitivity to the active ingredients of study medication; Have used the study drug (Penetro®) at some earlier time; Total obstruction of one nostril by other etiologies that are not cooled or influenza, or for a period less than 24 hours and greater than 48 hours after the onset of symptoms; Bacterial Infectious etiology (diagnosed clinically); Participants on antibiotic treatment or anticipation of antibiotic use for another clinical condition; Intranasal corticosteroid use (7 days before study) or systemic (15 days before study), respecting the plasma half-life of the drug; Use of decongestants or intranasal or systemic antihistamines in the 3 days prior to the study; Participants taking inhaled or immunosuppressive drugs 7 days before the start of the study; Participants with grade II and III septum diversion, nasal polyps, severe congenital hypertrophy, adenoid hypertrophy, or other conditions that determine nasal obstruction; Chronic oral respirator with history for 6 months or more prior to study inclusion; History of surgery in the 3 months prior to the study; Female participants with a positive pregnancy outcome through the urinary hCG test; Participation in a clinical trial in the past 12 months; Other diseases that, at the discretion of the researcher responsible, may interfere with the results of the study; Mental incapacity or linguistic barriers or incapacity that, in the discretion of the researcher responsible, prevent the adequate understanding of the information of the Term of the Free and Informed Assent and the Informed Consent Form and the activities of the study; Known clinically significant systemic disease.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation of the degree of nasal congestion, due to cold or flu, after the administration of Penetro® or placebo using the Visual Analogue Scale (VAS), which helps to assess the intensity of nasal congestion symptoms of the clinical trial participants. On this scale, the number "0" means total absence of symptoms and number "10", the maximum level of symptoms bearable by the participant. Comparison of the efficacy of Penetro® over placebo in nasal decongestion based on VAS results. | — |
Secondary
| Measure | Time frame |
|---|---|
| Expected endpoint 1 Evaluation of the clinical course of the study participants (nasal mucosa edema, nasal pruritus, sneezing, rhinorrhea, irritation and/or itching in the nose) after being treated with Penetro® compared to placebo.;Expected endpoint 2 Evaluation of the efficacy after drug administration compared to placebo considering the subgroups of participants aged 6 to 12 years-old and 13 to 17 years-old.;Expected endpoint 3 Collection of adverse events and serious adverse events ocurred after the signing of the Informed Consent Form/Child Assent Form; changes in clinical evaluation; changes in the evaluation of laboratory tests; changes in overall physical assessment. | — |
Countries
Brazil
Contacts
Public ContactMichele Espíndola
Laboratório Daudt Oliveira Ltda.
Outcome results
None listed