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.
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)
