Real-world Study to Assess Effectiveness of Seawater Nasal Sprays on Sinonasal Symptoms

What this Trial Is About

Researchers are evaluating four different isotonic and hypertonic seawater-based nasal sprays in real-life settings for their effectiveness, safety, usage, tolerance, and user satisfaction. The study focuses on infants, children, adults, and pregnant or breastfeeding women who have acute or chronic sinonasal conditions such as upper respiratory tract infections, allergic rhinitis, chronic rhinosinusitis, bronchiolitis, COVID-19, and post-surgery nasal issues. The investigation aims to understand how these devices perform when used as intended across various patient groups. Participants will use one of four CE-marked nasal spray devices according to their specific indications and target populations. The sprays include Respimer® Hygiene-Prevention for babies, kids, and adults, Respimer® Decongestion for babies from two months old and older, and Phytosun arôms® Hypertonic nasal wash for children six years and older and adults. Usage instructions vary by product, ranging from 1 to 6 sprays per nostril daily, with different frequencies for treatment and prevention purposes. The study period covers up to three months to assess both short-term and longer-term effects. During the study, participants or their parents will complete online questionnaires and follow healthcare providers' advice on nasal wash techniques. Researchers will monitor nasal symptom changes, including intensity and frequency, improvement in nasal breathing, quality of life, and satisfaction with the sprays. Effectiveness will be evaluated from day 0 to day 5 for acute conditions and up to day 14 for chronic issues, extending to three months for seasonal symptom management. Safety, tolerance, and usage patterns will also be recorded throughout the study.

Assessement of Effectiveness of Seawater Nasal Sprays on Sinonasal Symptoms