Safety and Performance of Narhinel 0.9% Sodium Chloride Monodose and Otrisal 0.74% Sodium Chloride Monodose Nasal Saline Solutions and Nasal Aspirators in Real-World Settings: Postmarket Clinical Follow-up Study Results.

Background: Blocked or stuffy nose is a common and bothersome symptom of colds, particularly for young children who are unable to clear their noses on their own. Nasal saline solutions and nasal aspirators are designed to gently cleanse and remove blocking nasal secretions. Objective: To assess the safety and performance of 2 monodose isotonic saline solutions (Narhinel 0.9% and Otrisal 0.74% sodium chloride; GSK Consumer Healthcare SARL, a Haleon company, Nyon, Switzerland) and 2 nasal aspirators with disposable hard- and soft-nozzle refills used as a standalone or combination treatment. Methods: We conducted 2 observational, online questionnaire-based, postmarket clinical follow-up studies in Europeans who had used any of the devices ≥1 time in the past 6 months. Coprimary objectives were to confirm the safety and performance of the saline solutions (Narhinel and Otrisal, Study 1) and nasal aspirators (with hard- and soft-nozzle refills, Study 2). Safety was assessed via the proportion of patients reporting adverse events and/or device malfunctions while using the devices within the previous 6 months, and performance was assessed by satisfaction rated on a 5-point scale, with "satisfied" and "very satisfied" being the highest performance ratings. Results: A total of 1136 (Study 1) and 1237 (Study 2) questionnaires were initiated by volunteer participants. Less than 2% of participants reported adverse events for any evaluated product in the previous 6 months. Most participants were "satisfied" or "very satisfied" with the devices for their intended use, with 78% to 91% of participants in the Narhinel arm, 73%-94% in the Otrisal arm, 71% to 95% in the soft-nozzle arm, and 71% to 80% in the hard-nozzle arm giving these ratings. Conclusions: These data support the safety and performance of 2 monodose saline solutions (Narhinel and Otrisal) for nasal cleansing, nasal moisturization, and/or loosening nasal secretions, and of nasal aspirators (with hard- and soft-nozzle refills) for clearing a blocked nose and removing nasal secretions.

Pneumococcal Colonization in Healthy Adult Research Participants in the Conjugate Vaccine Era, United Kingdom, 2010-2017.

Pneumococcal colonization is rarely studied in adults, except as part of family surveys. We report the outcomes of colonization screening in healthy adults (all were nonsmokers without major comorbidities or contact with children aged <5 years) who had volunteered to take part in clinical research. Using nasal wash culture, we detected colonization in 6.5% of volunteers (52 of 795). Serotype 3 was the commonest serotype (10 of 52 isolates). The majority of the remaining serotypes (35 of 52 isolates) were nonvaccine serotypes, but we also identified persistent circulation of serotypes 19A and 19F. Resistance to at least 1 of 6 antibiotics tested was found in 8 of 52 isolates.

A pilot study on the efficacy of nasal rinsing during ablution in reducing acute respiratory tract infection (ARI) among male Hajj pilgrims.

OBJECTIVE: This study aimed to assess the effectiveness of nasal rinsing during ablution in reducing acute respiratory tract infection among male Hajj pilgrims. METHODS: A quasi-experimental trial study was conducted to compare the effectiveness of nasal rinsing between two groups. The intervention group was instructed to perform nasal rinsing during ablution, while the control group was not asked to do nasal rinsing. Both groups were provided progress diaries to record the symptoms of respiratory tract infection, including cough, rhinorrhoea, nasal blockage, fever, and sore throat, as well as thick phlegm, shortness of breath, epistaxis, and changes in sense of smell. The groups were also instructed to record any visits to clinics for their symptoms throughout their stay in Makkah for the Hajj ritual. RESULTS: The study showed that nasal rinsing significantly reduced the symptoms of cough, rhinorrhoea, and nasal blockage. The intervention group had an increased number of visits to healthcare facilities for treatment, when compared to those of the control group. There were no significant differences in the groups regarding the symptoms of fever and sore throat. CONCLUSION: Nasal rinsing can be included as part of intervention methods that include vaccination and the use of a face mask. Nasal rinsing can be easily practiced by the pilgrims, since it is a Sunnah act in ablution, which is an integral element of Muslims' daily life.

Poly-ε-caprolactone/Chitosan and Chitosan Particles: Two Recombinant Antigen Delivery Systems for Intranasal Vaccination.

Several evidences converge on the idea that among the mucosal administration routes, the nasal mucosa is the most attractive site for the delivery of vaccines. Mucoadhesive particulate adjuvants should be able to increase the residence time of antigens in nasal cavity in order to increase their probability of being taken up by nasopharynx-associated lymphoid tissue (NALT) cells and subsequently to initiate the innate and adaptive immune response. Focusing on chitosan, a mucoadhesive biopolymer, we describe in this chapter a method to prepare antigen loaded chitosan nanoparticles and a second method to prepare antigen loaded poly-ε-caprolactone/chitosan nanoparticles. Additionally the methodology for the assessment of mucoadhesivity of the delivery system is also described. The two critical procedures in mice intranasal immunization experiments include challenges in the intranasal administration itself due to the small mouse nose, and the other is related with the collection of mucosal secretions to assess the sIgA. The techniques are difficult to perform without advanced training. Therefore, protocols followed in our laboratory, as well as some tips, are described in this chapter.

Influence of Nasal Washing with Bidouguan Perfusate on Nasal Mucosal Cytokines of Nasal Polyp Patients After Operation / 广州中医药大学学报

Objective To observe the influence of nasal washing with Bidouguan Perfusate (BP) on nasal mucosal cytokines of nasal polyp patients after operation. Methods Thirty-nine nasal polyp patients were randomized into BP group ( N=18) and normal saline group ( N=21). All patients received operation for nasal polyp and postoperative comprehensive treatment, and additionally, BP group was given washing with BP and normal saline group was washed with 0.9%normal saline for 3 months. The scores of SNOT-20 and Lund-Kennedy were observed for the evaluation of therapeutic effect. Enzyme-linked immunosorbent assay ( ELISA) was used for detection of interleukin 5 (IL-5), interleukin 8 (IL-8), interleukin 10 (IL-10), interferon gamma (IFN-γ), granulocyte-macrophage colony-stimulating factor (GM-CSF), tumor necrosis factor alpha (TNF-α) in nasal mucosa before operation and 3 months after operation. Results ( 1) SNOT-20 and Lund-Kennedy scores were decreased after operation ( P 0.05). ( 2) The expression levels of IL-5, IL-8, IL-10, IFN-γ, TNF-αand GM-CSF in the nasal mucosa were decreased in both groups 3 months after operation (P0.05). Conclusion Nasal washing with BP has similar effect to normal saline on improving the quality of life and nasal mucosal histology 3 months after operation, but BP has better effect on regulating nasal mucosal IL-5, IL-8, IL-10 and IFN-γ.