Nasal Spray In Treatment Research Articles

Estimating the benefit of esketamine nasal spray versus real-world treatment on patient-reported functional remission: results from the ICEBERG study.

Treatment resistant depression (TRD) affects approximately 10-30% of patients with major depressive disorder, and most patients with TRD do not respond to real-world treatments (RWT). Treatment with esketamine nasal spray (NS) plus a selective serotonin or serotonin norepinephrine reuptake inhibitor (SSRI/SNRI) has significant long-term clinical benefit over RWT in patients with TRD. However, the impact on patient-reported function remains to be determined. The ICEBERG analysis was an indirect treatment comparison performed using data from two studies of patients with TRD: SUSTAIN-2 (esketamine NS; NCT02497287) and the European Observational TRD Cohort (EOTC; RWT; NCT03373253; clinicaltrials.gov). Here, patient-reported functional remission, assessed using the Sheehan Disability Scale (SDS), was defined as SDS ≤6 at Month 6. Analyses were conducted using propensity score re-weighting and multivariable models based on 18 covariates. At Month 6, the probability of functional remission in esketamine NS-treated patients from SUSTAIN-2 (n=512) was 25.6% (95% confidence interval [CI] 21.8-29.4), while the adjusted probability for RWT patients from the EOTC (n=184) was 11.5% (95% CI 6.9-16.1; relative risk: 2.226 [95% CI 1.451-3.416]; p=0.0003). In the total combined population (N=696), patients who did not achieve clinical response or remission had a low probability of achieving functional remission (5.84% and 8.76%, respectively). However, for patients who did achieve clinical response or remission, the probability of achieving functional remission was greater (43.38% and 54.15%, respectively), although many still did not achieve this status. For patients with TRD, esketamine NS had a significant functional benefit versus RWT after 6 months of treatment. Irrespective of treatment, achievement of clinical response or remission was insufficient to attain functional remission. Nevertheless, clinical remission increased the likelihood of achieving functional remission, further supporting an important role for clinical remission in for the path towards functional recovery.

Modified painless wheat-grain blistering moxibustion for allergic rhinitis of lung deficiency and cold attacking: a randomized controlled trial

To observe the clinical efficacy of modified painless wheat-grain blistering moxibustion for allergic rhinitis (AR) of lung deficiency and cold attacking, and to explore its effects on serum immunoglobulin E (IgE) and interleukin-10 (IL-10). Ninety-eight patients of perennial AR with lung deficiency and cold attacking were randomly divided into an observation group (49 cases, 2 dropped out) and a control group (49 cases, 2 dropped out). The control group received mometasone furoate nasal spray treatment. The observation group received modified painless wheat-grain blistering moxibustion at bilateral Feishu (BL 13), Gaohuang (BL 43), Zusanli (ST 36), and Shenzhu (GV 12) in addition to the control group's treatment. Moxibustion at Shenzhu (GV 12) was applied once every other day, 3 grains each time, forming moxibustion sores after about one week. After sores formed, moxibustion was applied once every other 2 days. For Feishu (BL 13), Gaohuang (BL 43), and Zusanli (ST 36), moxibustion was applied on one side first, every other day, 3 grains each time, until sores formed, then on the other side, alternating sides in a cycle. Both groups were treated for 4 weeks. The total nasal symptoms score (TNSS), nasal symptom visual analogue scale (VAS), and rhinoconjunctivitis quality of life questionnaire (RQLQ) scores were observed before and after treatment, and after 4 and 12 weeks of treatment completion (follow-ups). Serum IgE and IL-10 levels were measured before and after treatment, and treatment efficacy and recurrence rates at follow-ups were recorded. Compared before treatment, TNSS, VAS, and RQLQ scores in both groups were reduced after treatment and at follow-ups (P<0.05), and these scores in the observation group were lower than those in the control group (P<0.05). Except for TNSS scores in the control group at the follow-ups, and in the observation group at the 4-week follow-up, all scores at follow-ups in both groups were higher than those after treatment (P<0.05). Compared before treatment, serum IgE levels in both groups were decreased (P<0.05), and serum IL-10 levels were increased (P<0.05) after treatment. The observation group had lower serum IgE levels and higher IL-10 levels than the control group (P<0.05). The total effective rate in the observation group was 93.6% (44/47), higher than 74.5% (35/47) in the control group (P<0.05). The recurrence rates after 4 and 12 weeks of treatment completion in the observation group were lower than those in the control group (4.5% [2/44] vs 22.9% [8/35], 9.1% [4/44] vs 40.0% [14/35], P<0.05). On the basis of mometasone furoate nasal spray, modified painless wheat-grain blistering moxibustion could improve clinical symptoms in patients of AR with lung deficiency and cold attacking, and provide more sustained long-term efficacy, possibly through the regulation of serum IgE and IL-10 levels.

Efficiency of Oral Steroids and Steroidal Nasal Spray in Treatment of Chronic Rhinosinusitis: A Comparative Study

ABSTRACT Objective: To assess how well steroidal nasal sprays and oral steroids work for treating CRS. Methods: Two hundred patients with CRS were included in a randomized controlled experiment. The patients were split into two groups: Group B received steroidal nasal sprays (fluticasone propionate 110 mcg/day in each nostril for 12 weeks) and Group A received oral steroids (prednisolone 30 mg/day for 14 days, followed by tapering over 7 days). The “Sino-Nasal Outcome Test (SNOT-22)” was used to quantify improvement in symptoms, the “Rhinosinusitis Disability Index (RSDI)” was used to measure quality of life, and the recurrence rate was measured at the 6-month follow-up. Results: At 12 weeks, SNOT-22 and RSDI scores significantly improved with both oral steroids and steroidal nasal sprays (P &lt; 0.05). At the 6-month follow-up, however, oral steroids had a greater recurrence rate (25% vs. 12%, P = 0.02) when compared to steroidal nasal sprays. The two groups’ adverse effects were similar and of low severity. Conclusion: In conclusion, nasal sprays containing steroids seem to be a safer and more successful option than oral steroids for treating CRS, making them worthy of being used as the first line of treatment.

Barriers to Esketamine Nasal Spray Treatment Among Adults With Treatment-Resistant Depression.

Barriers to Esketamine Nasal Spray Treatment Among Adults With Treatment-Resistant Depression.

How adults with treatment resistant depression experience their first esketamine nasal spray treatment? Preliminary results from a French qualitative study

IntroductionSpravato® (esketamine nasal spray- ENS) is a new adjunctive drug for Treatment Resistant Depression (TRD), i.e. patients with major depressive disorder that failed to adequately respond despite the use of two different antidepressants. In France, a real world non-interventional post-commercialization cohort study is being conducted aiming to describe the conditions of use of the esketamine, and to observe the outcomes.ObjectivesTo in-depth explore the lived experience of first administered ENS treatment among adults with TRD, we are conducting an ancillary qualitative study.MethodsThis qualitative study uses the IPSE approach (Sibeoni et al. BMC Medical Research Methodology 20.1(2020):1-21) and has been conducted in four French psychiatric departments. Design was based on the recruitment of patients through the Cohort study, all interviewed twice, the first time 3 to 5 weeks after the first administration of ENS, and the second time around 6 months after, whether treatment has been continued or not. Data analysis follows the IPSE analytic procedure and is conducted in two stages: three individual researchers carry out independent work and the group collectively pools data. These preliminary results are based on the sole analysis of the first interviews conducted from July 2022 to July 2023.ResultsEighteen participants with moderate to severe TRD, including 13 women, were interviewed and two axes of experience have been produced: (1) the overwhelming experiences of the treatment, perceived differently depending on patients, as a dissociative experience, both inside – described as a trip- and outside of them; (2) A discordant treatment experience with both solitude and relational support from medical team.ConclusionsThese results highlight the need to better prepare the patients for the initiation of the treatment and to take into consideration the settings in which the treatment is administered, as well as the importance of the support received from the nursing staff.Disclosure of InterestE. Manolios Grant / Research support from: have recieved financial support to conduct the study, J. Mathé Grant / Research support from: have recieved financial support to conduct the study, J. Sibeoni Grant / Research support from: have recieved financial support to conduct the study, M. Rotharmel Consultant of: Janssen, B. Astruc Consultant of: Janssen, B. Falissard Consultant of: Janssen, L. Mekaoui Consultant of: Janssen, A. Laurin Consultant of: Janssen, E. Gaudre-Wattinne Employee of: Janssen Cilag, J. Dupin Employee of: Janssen Cilag, A. Revah-Levy Grant / Research support from: have recieved financial support to conduct the study

Niclosamide: A career builder

My contribution to honoring Professor Kinam Park celebrates and resonates with his scholarly career in drug delivery, his commitment to encouraging the next generation(s), and his efforts to keep us focused on clinically effective formulations. To do this I take as my example, niclosamide, a small molecule protonophore that, uniquely, can “target” all cell membranes, both plasma and organelle. As such, it acts upstream of many cell pathways and so has the potential to affect many of the essential events that a cell, and particularly a diseased cell or other entities like a virus, use to stay alive and prosper. Literature shows that it has so far been discovered to positively influence (at least): cancer, bacterial and viral infection, metabolic diseases such as Type II diabetes, NASH and NAFLD, artery constriction, endometriosis, neuropathic pain, rheumatoid arthritis, sclerodermatous graft-versus-host disease, systemic sclerosis, Parkinson's, and COPD. With such a fundamental action and broad-spectrum activity, I believe that studying niclosamide in all its manifestations, discovering if and to what extent it can contribute positively to disease control (and also where it can't), formulating it as effective therapeutics, and testing them in preclinical and clinical trials is a career builder for our next generation(s).The article is divided into two parts: Part I introduces niclosamide and other proton shunts mainly in cancer and viral infections and reviews an exponentially growing literature with some concepts and physicochemical properties that lead to its proton shunt mechanism. Part II focuses on repurposing by reformulation of niclosamide. I give two examples of “carrier-free formulations”, — one for cancer (as a prodrug therapeutic of niclosamide stearate for i.v. and other administration routes, exemplified by our recent work on Osteosarcoma in mice and canine patients), and the other as a niclosamide solution formulation (that could provide the basis for a preventative nasal spray and early treatment option for COVID19 and other respiratory virus infections).My goal is to excite and enthuse, encourage, and motivate all involved in the drug development and testing process in academia, institutes, and industry, to learn more about this interesting molecule and others like it. To enable such endeavors, I give many proposed ideas throughout the document, that have been stimulated and inspired by gaps in the literature, urgent needs in disease, and new studies arising from our own work. The hope is that, by reading through this document and studying the suggested topics and references, the drug delivery and development community will continue our lineage and benefit from our legacy to achieve niclosamide's potential as an effective contributor to the treatment and control of many diseases and conditions.

Rapid Rescue Treatment with Diazepam Nasal Spray Leads to Faster Seizure Cluster Termination in Epilepsy: An Exploratory Post Hoc Cohort Analysis.

Although prompt treatment of status epilepticus is standard of care, the effect of timing of rescue therapy administration for seizure clusters in epilepsy remains unknown. Seizure clusters are a rare but clinically important condition, and benzodiazepines are the cornerstone rescue therapy for seizure clusters in epilepsy. We characterized temporal patterns from a large dataset of treated seizure clusters in the safety study of diazepam nasal spray. This post hoc analysis used timing data of treated seizure clusters recorded by care partners and patients in seizure diaries during a 1-year safety study. Data analysis used time from seizure start to administration of diazepam. From 4466 observations, 3225 had data meeting criteria for analysis. Overall, median times from seizure start to dose administration, dose administration to seizure termination, and total seizure duration were 2, 3, and 7min, respectively. In seizure clusters treated in < 5min (median 1.0min), median time from dose to seizure termination was 2.0min, and median total seizure duration was 4.0min. Among seizure clusters treated in ≥ 5min (median 10.0min), median time to seizure termination was 10.0min, and median total seizure duration was 23.0min. Previously published safety results reported that over a mean participation of 1.5years, 82.2% of patients had ≥ 1 treatment-emergent adverse events (TEAEs) irrespective of relationship to treatment, including 30.7% with serious TEAEs; 18.4% had TEAEs deemed at least possibly related to the study drug, none of which were serious. There were no events of cardiorespiratory depression. Echoing the importance of early use of benzodiazepines in status epilepticus, the findings from this exploratory analysis of patients with refractory epilepsy and frequent seizure clusters identify a potential benefit of early diazepam nasal spray treatment leading to faster seizure resolution within the seizure cluster. Trial Registration Information: ClinicalTrials.gov identifier NCT02721069 ( https://clinicaltrials.gov/ct2/show/NCT02721069 ).

Indirect adjusted comparison of 6-month clinical outcomes between esketamine nasal spray and other real-world polypharmacy treatment strategies for treatment resistant depression: results from the ICEBERG study.

The efficacy of esketamine nasal spray (NS) as a rapid-acting agent for treatment resistant depression (TRD) was demonstrated in comparisons with placebo, when both were given in addition to a newly initiated selective serotonin reuptake inhibitor (SSRI)/serotonin norepinephrine reuptake inhibitor (SNRI). How esketamine NS compares with commonly used real-world (RW) polypharmacy treatment strategies is not known. ICEBERG was an adjusted indirect treatment comparison that analysed data from SUSTAIN-2 (NCT02497287; clinicaltrials.gov), a long-term, open-label study of esketamine NS plus SSRI/SNRI, and the European Observational TRD Cohort (EOTC; NCT03373253; clinicaltrials.gov), an observational study of routine clinical practice. Data were compared between patients receiving esketamine NS (SUSTAIN-2) and those from the EOTC treated with polypharmacy treatment strategies, either combination or augmentation. Analyses were adjusted for potential confounders, using rescaled average treatment effect among treated estimates. Threshold analyses were conducted to assess potential impact of unmeasured confounders on the robustness of analyses where esketamine NS was found to be significantly superior. Sensitivity analyses were used to understand the impact of analysis method selection and data handling. Esketamine NS treatment resulted in a higher probability of 6-month response (49.7% [95% confidence interval (CI) 45.6-53.9]) and remission (33.6% [95% CI 29.7-37.6]) versus RW polypharmacy (26.8% [95% CI 21.0-32.5] and 19.4%, [95% CI 14.2-24.6], respectively). Relative risk calculations showed esketamine NS was 1.859 (95% CI 1.474-2.345; p < 0.0001) times as likely to result in response and 1.735 (1.297-2.322; p = 0.0002) times as likely to result in remission versus RW polypharmacy at 6 months. Threshold and extensive sensitivity analyses supported that analyses of esketamine NS superiority were robust. ICEBERG supports esketamine NS being superior to current RW individualized polypharmacy strategies, including augmentation, with benefits extending beyond acute use, to improved chance of 6-month response and remission. While unobserved confounding factors may certainly impact results of an indirect comparison, threshold analysis supported a low likelihood of this affecting the conclusions.To view an animated summary of this publication, please click on the Supplementary video.

Probiotic and intra-nasal oxytocin combination therapy on autonomic function and gut-brain axis signaling in young children and teens with autism spectrum disorder

Autonomic dysfunction has been widely studied in individuals with autism spectral disorder (ASD); however, the autonomic response to probiotic and oxytocin (OT) combination intervention has not yet been explored. We conducted the present study that includes 35 individuals with ASD aged 3–20 years to explore autonomic responses to daily Lactobacillus plantarum probiotic supplementation and OT nasal spray treatment both alone and in combination. We identified significant improvements in autonomic indices from subjects receiving combination treatment relative to those receiving placebo. Parameters that were observed to improve following combination treatment are time domain metrics of heart rate variability (HRV), including the root mean square of successive differences between normal heartbeats (RMSSD), standard deviation of normal-to-normal R–R intervals (SDNN), and proportion of the number of pairs of adjacent NN intervals that differ by more than 50ms (pNN50, p < 0.05). Furthermore, individuals that received either probiotics or OT alone demonstrated fewer changes in RMSSD, pNN50, and SDNN. Several parameters that demonstrated significant improvements in combination therapy were found to be correlated with baseline levels of OT (LF power: r = −0.86, p = 0.024; mean HR: r = 0.89, p = 0.012). Additionally, Social Responsiveness Scale (SRS) raw total scores (mean HR, r = 0.86, p = 0.024) and Aberrant Behavior Checklist (ABC) raw total scores (mean HR r = 0.94, p = 0.017) were correlated with mean heart rate (HR) and HRV-derived parameters. These results provide further evidence of synergy of probiotic and OT combination and help us gain a better understanding of the role of the gut-brain axis in ASD phenotypes and pathogenesis.

Cost-effectiveness analysis of Biyuan Tongqiao Granules combined with Triamcinolone Acetonide Nasal Spray in treatment of chronic rhinosinusitis

This study aims to evaluate the effectiveness and economic efficiency of Biyuan Tongqiao Granules combined with Triamcinolone Acetonide Nasal Spray in the treatment of chronic rhinosinusitis(CRS). The randomized controlled trial(RCT) of Biyuan Tongqiao Granules combined with Triamcinolone Acetonide Nasal Spray in the treatment of CRS was searched against EMbase, PubMed, Cochrane Library, CNKI, VIP, SinoMed, and Wanfang. The efficacy, nasal mucociliary transport time, and safety of the therapy above in the treatment of CRS were analyzed with single-group rate and Meta-analysis, and the economy and sensitivity were evaluated from the perspective of payer. A total of 9 RCTs were included, including 1 145 patients. Meta-analysis showed that compared with Triamcinolone Acetonide Nasal Spray alone, Biyuan Tongqiao Granules combined with Triamcinolone Acetonide Nasal Spray in the treatment of CRS patients increased the effective rate(RR=1.17, 95%CI[1.11, 1.24], P&lt;0.000 01) and shortened the nasal mucociliary transport time(MD=-3.32, 95%CI[-5.86,-0.78], P=0.01), there was no significant difference in the incidence of adverse reactions between the two groups. The incremental cost-effectiveness analysis showed that the treatment costs of the control group and the observation group were 44.15 yuan and 1 044.96 yuan, respectively. In the Biyuan Tongqiao Granules combined with Triamcinolone Acetonide Nasal Spray treatment group, 75.48 yuan was spent to improve the effective rate of CRS by 1%. The one-way sensitivity analysis indicated the days of treatment, the RR of Biyuan Tongqiao Granules combined with Triamcinolone Acetonide Nasal Spray, the price of unit preparation of Biyuan Tongqiao Granules, and the effective rate of Triamcinolone Acetonide Nasal Spray alone had great influence on the incremental cost-effectiveness ratio. In conclusion, Biyuan Tongqiao Granules combined with Triamcinolone Acetonide Nasal Spray improves the therapeutic effect on CRS. The probabilistic sensitivity analysis showed that when the willingness to pay was greater than 7 920 yuan(less than 0.1 of GDP per capita 8 098 yuan), the combined therapy was economically superior to the control. Due to the limited number of articles published, it is necessary to carry out a real-world clinical trial of Biyuan Tongqiao Gra-nules and Triamcinolone Acetonide Nasal Spray in the treatment of CRS, so as to compare the cost-effectiveness of Biyuan Tongqiao Granules and Triamcinolone Acetonide Nasal Spray.

Effects of oral prednisolone and fluticasone nasal spray in the management of chronic rhinosinusitis with polyposis: A prospective observational study

To study the effects of combination therapy with oral prednisolone and topical fluticasone propionate nasal spray in patients with Chronic Rhinosinusitis with Nasal Polyposis (CRSwNP). To study the improvement in symptom scores, Endoscopic and CT scores before and after treatment with combination therapy.This prospective observational study was conducted on 50 patients attending the Outpatient Department of Otorhinolaryngology, J.L.N Hospital and Research Centre, Bhilai (Chhattisgarh), India over a period of 6 months from February 2020 to July 2020. Patients with symptoms of CRSwNP persisting for more than 12 weeks were thoroughly examined clinically along with Nasal endoscopy and Computed Tomography scan of Nose and Paranasal sinuses (CT PNS) and pre-treatment Visual Analog Scale (VAS), Lund &amp; Mackay Scores for Endoscopic and CT findings were noted. Patients were treated with combination therapy of oral prednisolone and fluticasone propionate nasal spray and post treatment scores were noted using similar scales during the follow up visits and the results were statistically analysed.Total mean age of patients suffering from CRSwNP in our study was 47.3 ± 12.58. Males were affected more by CRSwNP than females (76% vs 24%). At the end of 3 months from baseline 48 patients (96%) showed a reduction in nasal discharge, 47 patients (94%) showed a reduction in nasal obstruction, 25 patients (50%) showed improvement in facial pain and 17 patients (34%) showed improvement in hyposmia. Overall post treatment Visual Analog Symptom (VAS) score improved in 42 patients (84%), Nasal endoscopy (Lund - Mackay scoring) improved in 43 patients (86%) and Radiological CT PNS &amp; Nose (Lund - Mackay Scoring) improved in 33 patients (66%).We found that combined therapy with oral prednisolone and fluticasone propionate nasal spray for 3 weeks is very effective in reducing the symptoms of chronic rhinosinusitis along with decrease in nasal secretions, edema and polyp size.

Esketamine nasal spray for major depressive disorder with acute suicidal ideation or behavior: description of treatment access, utilization, and claims-based outcomes in the United States

AimsTo describe real-world esketamine nasal spray access and use as well as healthcare resource use (HRU) and costs among adults with evidence of major depressive disorder (MDD) with suicidal ideation or behavior (MDSI).MethodsAdults with ≥1 claim for esketamine nasal spray and evidence of MDSI 12 months before/on the date of esketamine initiation (index date) were selected from Clarivate’s Real World Data product (01/2016–03/2021). Patients initiated esketamine on/after 03/05/2019 (esketamine approval for treatment-resistant depression; later approved for MDSI on 08/05/2020) were included in the overall cohort. Esketamine access (measured as approved/abandoned/rejected claims) and use were described post-index; HRU and healthcare costs (2021 USD) were described over 6 months pre- and post-index.ResultsAmong 269 patients in the overall cohort with esketamine pharmacy claims, 46.8% had the first pharmacy claim approved, 38.7% had it rejected, and 14.5% abandoned their claim; 169 patients were initiated on esketamine in the overall cohort (mean age 40.9 years, 62.1% female); 45.0% had ≥8 esketamine treatment sessions (recommended per label) with a mean [median] of 85.0 [58.5] days from index to 8th session (per label 28 days). Among 115 patients with ≥6 months of data post-index, in the 6-month pre- and post-index, respectively, 37.4 and 19.1% had all-cause inpatient admissions, 42.6 and 33.9% had emergency department visits, 92.2 and 81.7% had outpatient visits; mean ± standard deviation all-cause monthly total healthcare costs were $8,371±$15,792 and $6,486±$7,614, respectively.LimitationsThis was a descriptive claims-based analysis; no formal statistical comparisons were performed due to limited sample size as data covered up to 24 months of esketamine use in the US clinical setting.ConclusionsNearly half of patients experience access issues with first esketamine nasal spray treatment session. All-cause HRU and healthcare costs trend lower in the 6 months after relative to 6 months before esketamine initiation.

Aqueous Nasal Spray in Treatment of Rhinitis and Rhinosinusitis: Adverse Event Focusing on Epistaxis

Aqueous Nasal Spray in Treatment of Rhinitis and Rhinosinusitis: Adverse Event Focusing on Epistaxis

Eustachian Tube Dysfunction in Children with Adenoid Hypertrophy: The Effect of Intranasal Azelastine-Fluticasone Spray Treatment on Middle Ear Ventilation and Adenoid Tissue.

Eustachian tube dysfunction (ETD) is frequent in children with adenoid hypertrophy (AH). Although the most common treatment of AH is surgical removal of adenoid tissue, numerous studies have reported the efficacy of intranasal steroids. The effects of the intranasal steroid and azelastine combination on AH and ETD have not been reported before. In this study, we tried to determine the effects of 3-month intranasal Azelastine-Fluticasone dipropionate combination (Aze-Flu) treatment in children with ETD and AH. 100 children who had open mouth sleep, snoring, and sleep apnea and were diagnosed with AH and ETD participated in this study. The mean age was 7.73 ± 2.37 (4-14 years). The rates of adenoid tissue hypertrophy and choanal occlusion were evaluated using a rigid pediatric nasal endoscope and reassessed after 3 months of Aze-Flu nasal spray treatment. The function of the Eustachian tube (ET) was evaluated before and after medical treatment using the Eustachian tube score, the Eustachian dysfunction test-7 (ETS-7) and tubomanometry (TMM). The results were evaluated in 100 patients with AH and ETD. The adenoid tissue to choana rate was 82% before treatment and decreased to 37% after treatment. The ETS-7 test score was 6.36 before treatment and increased to 9.72 at the end of 3 months. Both the regression of the adenoid tissue and the improvement in the Eustachian function scores were statistically significant (p < 0.05). AH significantly increases the frequency of ETD. In this study, it was observed that Aze-Flu treatment was significantly effective in both regression of the adenoid tissue and Eustachian tube dysfunction. We believe that it can be applied as an initial therapy in children with AH and associated ETD.

SARS-CoV-2 accelerated clearance using a novel nitric oxide nasal spray (NONS) treatment: A randomized trial.

BackgroundAdditional outpatient therapies which are readily accessible will be essential to reduce COVID-19 illness progression in high risk individuals. Especially as the virus continues to mutate with greater transmissibility despite increased global vaccination.MethodsA randomized, double-blind, multicentre, parallel group, placebo-controlled phase III clinical trial evaluated the ability of nitric oxide (NO) to rapidly eradicate nasal SARS-CoV-2 RNA. Adults (18–70 years) with mild symptomatic COVID-19 were randomized, confirmed by laboratory SARS-CoV-2 reverse transcription polymerase chain reaction (RT-PCR) nasal swab. Randomisation was 1:1, NONS (N = 153) vs placebo (N = 153). NO generated by a nasal spray (NONS) was self-administered six times daily as two sprays per nostril (0⋅45 mL of solution/dose) for seven days. Patients at high risk of illness progression, defined as unvaccinated, ≥ 45 years of age or having comorbidities, were the primary analysis population.FindingsOverall, mean SARS-CoV-2 RNA concentrations (6·96 log10 copies/mL in the NONS group and 7·16 log10 copies/mL in the placebo group) were comparable at baseline. Primary endpoint mean treatment difference SARS-CoV-2 RNA change from baseline to the end of treatment (EOT) was -0·52 copies/mL (SE 0·202, 95% CI -0·92 to -0·12; p = 0·010) with NONS compared to placebo. Secondary endpoint assessments demonstrated a greater proportion of patients receiving NONS (82·8%) cleared SARS-CoV-2 (RT-PCR negative) by EOT compared to placebo (66·7%, p = 0·046), with no virus RNA detected a median of four days earlier compared to placebo (three vs seven days; p = 0·044).InterpretationUse of NONS in patients recently infected with SARS-CoV-2 accelerates nasal virus clearance.FundingFunding provided by Glenmark Pharmaceuticals Limited. Study medication provided by SaNOtize.

Effect of Local Corticosteroid Administration on CD8+CD25+Foxp3+ Tregs in Neutrophilic CRSwNP

Introduction: CD8⁺CD25⁺Foxp3⁺ regulatory T cells (Tregs) play an important role in human’s immune tolerance. The study was aimed to assess the influence of budesonide nasal spray on CD8⁺CD25⁺Foxp3⁺ Tregs and to evaluate their cellular functions in neutrophilic chronic rhinosinusitis with nasal polyps (CRSwNPs). Methods: Fifteen patients with neutrophilic CRSwNPs were enrolled and received physiological saline or budesonide nasal spray treatment (Saline or Budesonide group) for 3 months. Nasal tissue samples were obtained from normal subjects or those patients and cultured in vitro. CD8⁺CD25⁺Foxp3⁺ Tregs were separated from normal or NP tissues and also cultured in vitro. Then interleukin (IL)-10 and its mRNA were evaluated in the above cell cultures. The cells were applied into NP cultures. Finally, myeloperoxidase (MPO), interferon (IFN)-γ, IL-1β, and tumor necrosis factor (TNF)-α were assessed in the tissue cultures. Results: CD8⁺CD25⁺Foxp3⁺ Tregs decreased in NP tissues. Budesonide administration did not enhance the percentage of these cells in polypoid tissues. IL-10 and its mRNA were increased in the above cell cultures from NPs. However, there were no statistical differences between the two treatments in the IL-10 expression. Additionally, levels of MPO, IFN-γ, IL-1β, and TNF-α were totally elevated in NP tissue cultures and reduced after the administration of CD8⁺CD25⁺Foxp3⁺ Tregs. However, there were no significant differences in concentrations of these mediators between these two groups of the CD8⁺CD25⁺Foxp3⁺ Tregs treatment in vitro. Conclusion: The findings indicate that CD8⁺CD25⁺Foxp3⁺ Tregs might regulate the neutrophilic inflammation, and budesonide nasal spray therapy could not ameliorate the inflammation in neutrophilic CRSwNPs.

Sublingual spray treatment of vitamin B12 deficiency in children

Objective: Vitamin B12 deficiency can lead to serious health problems both in children and adult. Intramuscular injection therapy is applied as the gold standard in the treatment of vitamin B12 deficiency. There are also oral, nasal, and sublingual spray treatment methods. In this study, we aimed to show the efficacy of sublingual spray treatment of vitamin B12 deficiency in children. Materials and Methods: Forty-five pediatric patients (25 boys, 20 girls), aged 9-36 months with serum cobalamin concentrations less than 200 pg/mL, were treated with sublingual vitamin B12 (methylcobalamin) spray. All patients were treated for four months by giving 500 μg oral spray daily for the first week, every other day for the next one week, two days a week for the next two weeks and then once a week for four months. Vitamin B12 levels were checked after four months. Results: Post-treatment vitamin B12 values were significantly higher than pre-treatment values (p<0.001). Vitamin B12 levels increased from 161.58±32.98 pg/mL to 427.44±148.58 pg/mL. After the treatment, the vitamin B12 level of all patients was found to be >200 pg/mL, except for only two patients. Vitamin B12 levels returned to normal in 96% of the patients with a sublingual spray treatment. Conclusions: Data from this study indicate that sublingual vitamin B12(methylcobalamin) spray (500μg) for four months is effective for treatment of children with vitamin B12 deficiency. Sublingual spray that is easier and more practical to use can be preferred for children with vitamin B12 deficiency instead of parenteral and oral vitamin B12 therapy.

Efficacy and safety of fluticasone propionate nasal spray in treatment ofadenoidal hypertrophic snoring in children

This study investigatedthe efficacy and safety offluticasone propionate nasal spray in treatment of adenoidal hypertrophic snoring in children.Fifty-six children with adenoidal hypertrophic snoring were enrolled. According to adenoidal-nasopharyngeal ratio (ANR) in lateral nasal X-ray examination,the children were assigned in moderategroup (23 cases) and severegroup (33 cases).The fluticasone propionate nasal spray was used for all patientsfor 4 weeks.In 56 patients, after treatment, compared with before treatment, the snoring, sleep apneaand nasal obstruction scores in moderategroupand the nasal obstruction score in severegroupwere significantly decreased,respectively (P < 0.05).The decreases of snoring, sleep apnea, mouth breathing and nasal obstruction scores after treatment in moderate group were significantly higher than those in severe group, respectively (P <0.001).After treatment, in 18 patients with ateral nasal X-ray examination,the adenoid size was obviously reduced, and the nasopharynx airway was obviously enlarged. The meanANRdropped from 0.76±0.10 to 0.72±0.09(P <0.001).Duringtreatment, only 2 of 56 patients were reported with intranasal dryness and occasional epistaxis, which were self-healed without treatment.Fluticasone propionate nasal spray is effective and safe for treatment of children’s snoring caused by adenoidal hypertrophy.

A COMPARATIVE STUDY TO ASSESS THE EFFICACY OF HYDROXYPROPYLMETHYLCELLULOSE POWDER OVER STEROID SPRAY IN TREATMENT OF ALLERGIC RHINITIS IN THE DEPTT. OF ENT AND HEAD & NECK SURGERY, SILCHAR MEDICAL COLLEGE & HOSPITAL

Objective: To assess the efficacy of Hydroxypropylmethylcellulose powder over steroid nasal spray in treatment of allergic rhinitis. Methods: A prospective study of 60 patients suffering from allergic rhinitis was conducted in the ENT and Head &amp; Neck surgery Department, Silchar medical College and Hospital from April 2018 to August 2018.The study subjects were divided into two groups A and B. Group A was treated with oral antihistaminic and steroid nasal spray, while group B was treated with oral antihistaminics and HYDROXYPROPYLMETHYLCELLULOSE powder nasal spray for 4 weeks. The treatment outcomes were evaluated after 14 days and 28 days from the beginning of treatment, by assessing relief of symptom on a five point scale. Results: There was almost similar score in both the groups ranging between score 3 and 4(i.e., relief of nasal obstruction and sneezing) after 14 days of treatment (62% vs 64%). But after 28 days there was significantly better improvement score of group B study subjects over group A in score 5 (i.e., complete relief from symptoms (83.3% vs. 66.6% ).In both the groups, mild sedation at the beginning of the treatment was reported in some patients, which is a well known side effect of antihistaminics. Conclusion: The result obtained comparing both the groups indicated high efficacy of hydroxypropylmethylcellulose powder over steroid nasal spray in the treatment of allergic rhinitis.

Acute migraine anesthetic nasal spray treatment during the COVID-19 pandemic (1779)

Acute migraine anesthetic nasal spray treatment during the COVID-19 pandemic (1779)