Real-World Safety and Performance of Saline Nasal Spray Products for Nasal Cleansing and Reducing Obstruction of the Nasal Cavity  

作　　者：Mathieu M. Albasser Gary Smith Mariane Ballerini Fernandes Nisha Patel Petr Novak Martina Hagen Mathieu M. Albasser;Gary Smith;Mariane Ballerini Fernandes;Nisha Patel;Petr Novak;Martina Hagen(GSK Consumer Healthcare SARL, a Haleon company, Nyon, Switzerland;Haleon, Weybridge, Surrey, UK;GSK, Kingston upon Thames, London, UK;Haleon, Prague, Czech Republic)

机构地区：[1]GSK Consumer Healthcare SARL, a Haleon company, Nyon, Switzerland [2]Haleon, Weybridge, Surrey, UK [3]GSK, Kingston upon Thames, London, UK [4]Haleon, Prague, Czech Republic

出　　处：《Open Journal of Respiratory Diseases》2023年第4期65-79,共15页呼吸病期刊（英文）

摘　　要：Background and Objectives: Three post-marketing clinical follow-up studies were performed in Europe to confirm the safety and performance of four nonprescription, nasal cleansing medical devices: Otrivin Sea Water (OSW) pressurized spray, OSW with aloe vera (OSWAV), Otrisal 0.74% NaCl Metered-Dose Spray (MDS), and Prorhinel spray. Material and Methods: Observational, single-arm, retrospective studies consisting of a single online questionnaire were performed between July 2021 and December 2021. Eligible participants were adults who used the device or supervised use of the device in a participant under 18 years of age within 6 months of completing the questionnaire. Demographics, safety, and device performance were assessed. Results: Based on questionnaires submitted on OSW (n = 556), OSWAV (n = 555), Otrisal MDS (n = 555), and Prorhinel (n = 555), proportions of users who reported safety events were 1.8% for OSW, 2.3% for OSWAV, 1.4% for Otrisal MDS, and 2.0% for Prorhinel. Proportions of users who indicated they were satisfied or very satisfied with device performance ranged from 72.0% - 89.0% across all devices. Device performance for all products was also supported for additional preventative and symptomatic uses through exploratory analyses. Conclusions and Significance: These data confirm device safety and performance of OSW, OSWAV, Otrisal MDS, and Prorhinel for their intended uses.Background and Objectives: Three post-marketing clinical follow-up studies were performed in Europe to confirm the safety and performance of four nonprescription, nasal cleansing medical devices: Otrivin Sea Water (OSW) pressurized spray, OSW with aloe vera (OSWAV), Otrisal 0.74% NaCl Metered-Dose Spray (MDS), and Prorhinel spray. Material and Methods: Observational, single-arm, retrospective studies consisting of a single online questionnaire were performed between July 2021 and December 2021. Eligible participants were adults who used the device or supervised use of the device in a participant under 18 years of age within 6 months of completing the questionnaire. Demographics, safety, and device performance were assessed. Results: Based on questionnaires submitted on OSW (n = 556), OSWAV (n = 555), Otrisal MDS (n = 555), and Prorhinel (n = 555), proportions of users who reported safety events were 1.8% for OSW, 2.3% for OSWAV, 1.4% for Otrisal MDS, and 2.0% for Prorhinel. Proportions of users who indicated they were satisfied or very satisfied with device performance ranged from 72.0% - 89.0% across all devices. Device performance for all products was also supported for additional preventative and symptomatic uses through exploratory analyses. Conclusions and Significance: These data confirm device safety and performance of OSW, OSWAV, Otrisal MDS, and Prorhinel for their intended uses.

关 键 词：Saline Solution Sodium Chloride Common Cold Allergens Postmarketing Product Surveillance 

分 类 号：R55[医药卫生—血液循环系统疾病]