Prospective Multicenter Clinical Investigation to Evaluate the Performance and Safety of the Mechanical Decongestant Seawater Spray Enriched With Essential Oils from Laboratoires Gilbert in Acute Rhinitis Patients

What this Trial Is About

Researchers are evaluating the performance and safety of a mechanical decongestant seawater spray enriched with essential oils from Laboratoires Gilbert in people aged 12 and older who have acute rhinitis with nasal obstruction. The study focuses on how this spray works over a 7-day period to relieve symptoms associated with infections like rhynopharyngitis and rhinosinusitis, as well as non-infectious allergic rhinitis. Participants will use the seawater spray daily during the 7-day study period. The main measure is the spray's effectiveness after 3 days of use. Additional evaluations include effects immediately after the first use and throughout the study on symptoms such as nasal obstruction, secretion thinning, nasal cavity cleansing, irritation relief, and itching. Researchers will also assess patient satisfaction, quality of life improvements, ease of use, and any side effects or device issues. During the study, participants will complete questionnaires to report their symptom changes and feelings about the spray each day. They will be monitored for adverse events and any device problems. The study lasts for a total of 7 days, with assessments at the beginning, during, and at the end of the treatment period to evaluate overall symptom severity and patient experience.

Performance and Safety Assessment of the Mechanical Decongestant Seawater Spray Enriched With Essential Oils From Laboratoires Gilbert in Patient With Acute Rhinitis Associated With Nasal Obstruction