Prospective Multicenter Clinical Investigation Evaluating the Performance and Safety of Gilbert Laboratories' Decongestant Seawater Spray Pocket Valve Enriched With Essential Oils

What this Trial Is About

The trial investigates the safety and performance of a decongestant seawater spray pocket valve enriched with essential oils, developed by Gilbert Laboratories. It focuses on patients aged 12 years and older who have acute rhinitis with nasal obstruction caused by infections like colds or rhinosinusitis, as well as non-infectious allergic rhinitis. The study aims to assess how well the spray works to relieve nasal obstruction over an 8-day period. Participants will use the seawater spray enriched with essential oils, with some receiving peak nasal flow measurements before and after the first use and on Day 3, while others will not have these measurements. The study includes two groups: major patients with nasal flow measurements and minor patients without these measurements. The spray use and monitoring will continue for about one week. During the study, participants will complete questionnaires daily to report symptoms such as nasal obstruction, nasal cavity freshness, secretion thinning, irritation relief, and itching relief. Researchers will monitor the speed of symptom relief, patient satisfaction, ease of device use, and overall symptom severity. Safety will be tracked through reported adverse events during the 7-day use period, and quality of life improvements will also be evaluated.

Safety and Performance Assessment of the Decongestant Seawater Spray Pocket Valve Enriched With Essential Oils in Patients With Acute Rhinitis Associated With Nasal Obstruction: "DEVALPO"