Evaluation of efficacy and safety of Penetro® solution for inhalation (eucalyptol, terpin monohydrate and menthol) over placebo in the treatment of acute nasal obstruction in 06-17 years-old children

INTERVENTION: 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 as the written informed consent of the participant. In the presence of the investigator or a delegated professional, the participant shall indicate in VAS (Visual Analogue Scale) the corresponding number of the degree of symptoms of nasal congestion of that moment, which, 0 (excellent) and 10 (very bad). The participants with a diagnosis of moderate or severe nasal obstruction (i.e., reaching, at least, VAS number 5) due to a cold or flu and who present the symptoms started in the period between 24 and 48 hours before this evaluation will continue in the study. The investigator shall confirm the medical history and any concomitant medication received by the participant within the last 7 days (or within the last 15 days for systemic corticosteroid), perform laboratory tests, as well as performing a physical examination, including oroscopy and otoscopy, as well as checking vital signs. For female participants of childbearing age, a urine sample must be collected for pregnancy test of human chorionic gonadotrophin. After the participant complied with all procedures, the investigator will allocate them randomly in two study groups: Penetro® Group or Placebo Group. At Visit 1, at the Clinical Research Center, the first inhalation will be performed with the medication corresponding to the group in which the participant was allocated. According to the randomization list, a professional will distribute the study drug to the participants, Penetro® or placebo together with a plastic funnel, so that the participant can continue the administration at home every 8 hours (or so 1 hour) from the first inhalation. The participant will also receive a diary, which shall be completed at home in accordance with the general orientations of a trained professional for the s Drug Expectorants CONDITION: J00‐J99 Nasal Obstruction Other disorders of nose and nasal sinuses Other specified diseases of the upper airways; nasal obstruction ; Other disorders of nose and nasal sinuses ; Nasal Obstruction PRIMARY OUTCOME: 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 OUTCOME: 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. 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.