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 adults

Phase 3

Not yet recruiting

• Conditions: Other specified diseases of the upper airways; nasal obstruction; C08.460.525

• Registration Number: RBR-8zzfzn
• Lead Sponsor: CAEP - Centro Avançado de Estudos e Pesquisas

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-04-02
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Not yet recruiting
• Sex: Not specified
• Target Recruitment: Not specified

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

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.

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Evaluation of the clinical course of the study participants after being treated with Penetro® compared to placebo.<br>;Assessment of the safety through the collection of adverse events, serious adverse events and physical and laboratory examinations.