Chitosan-based (Captomucil® complex) medical device nasal spray for relieving symptoms in patients with rhinitis: a primary care study

Abstract

BACKGROUND: Rhinitis is a common disease characterized by typical symptoms, including itching, sneezing, rhinorrhea, and nasal obstruction. A medical device has been developed. This medical device is a nasal spray formulated and produced with a patented manufacturing process and contains a natural complex based on chitosan. Chitosan reduces mucus overproduction and improves its rheological characteristics. METHODS: The present study investigated the medical device’s efficacy and safety in patients with nasal symptoms due to rhinitis and visited in a primary care setting. Nasal symptoms were assessed by a four-point scale (0-3), and the sum of all symptom scores was also calculated (TNSS). Patients took two sprays/nostril once a day per two weeks. Patients were visited at baseline, after one and two weeks. Fifty-one patients (22 males and 29 females, mean age 44 years) completed the study. RESULTS: The medical device with chitosan significantly reduced each symptom and the TNSS (P<0.05 after one week and P<0.001 after two weeks). In addition, the treatment was safe and well tolerated. CONCLUSIONS: In conclusion, this study showed that a medical device with chitosan, intranasally administered per two weeks, reduced the perceived severity of nasal symptoms during rhinitis.