Triamcinolone Acetonide in the Treatment of Perennial Allergic Rhinitis: A post hoc Efficacy Analysis of a Phase III Study Performed in Russia.

INTRODUCTION: Allergic rhinitis (AR) is a disease which affects >24% of the population in Russia. Triamcinolone acetonide (TAA) is a corticosteroid used for treating AR. This post hoc analysis assesses the efficacy of intranasal TAA in improving perennial AR (PAR) symptom scores over 4 weeks. METHODS: NASANIF (NCT03317015) was a double-blind, parallel-group, multicenter, prospective, non-inferiority, phase III clinical trial in which patients with PAR were randomized (1:1) to receive TAA or fluticasone propionate (FP) over 4 weeks. Our post hoc analysis evaluates weekly change in PAR symptoms using the reflective Total Nasal Symptom Score (rTNSS), overall and for individual symptoms (sneezing, nasal itching, rhinorrhoea, and nasal obstruction). Proportion of patients and time to achieve a ≥50 or ≥75% reduction in rTNSS were assessed. For rTNSS endpoints, a linear mixed-model methodology was used; for time-to-event endpoints, cumulative incidence functions were estimated using the Kaplan-Meier method, in the per-protocol population. RESULTS: Of 260 patients, 128 each completed the study and were randomized to receive TAA or FP. From baseline to week 4, the changes in total rTNSS were -7.78 (95% CI: -8.1701 to -7.3967; p < 0.001) and -7.52 (-7.9053 to -7.1320; p < 0.001) for TAA and FP, respectively. Individual symptoms improved significantly from baseline. The proportion of patients achieving ≥50 and ≥75% reductions in total rTNSS was 88.0 and 67.2%, respectively in the TAA group. No significant differences were observed between the TAA and FP in any analyses. CONCLUSIONS: TAA produced effective and prolonged improvement of PAR symptoms over a 4-week treatment period.

Nasal cytology can predict clinical efficacy of subcutaneous immunotherapy in intermittent allergic rhinitis.

Introduction: Allergen immunotherapy (AIT) is the only disease-modifying treatment option available for patients with IgE-mediated allergic rhinitis. The identification of specific biomarkers, which may predict response to AIT, is currently an active field of research in the aspect of recommended personalization of medicine. Aim: To assess the changes in rhinological parameters in intermittent allergic rhinitis (IAR) patients resulting from subcutaneous immunotherapy (SCIT). Material and methods: Forty-two patients (female: 19; 45%) with IAR qualified for subcutaneous immunotherapy were enrolled in this study. Fourteen (33.3%) patients were desensitized with grass pollen allergen extracts, 12 (28.6%) with tree pollen allergen extracts, and 16 (38.1%) with grass and tree pollen allergen extracts. The patients were evaluated before AIT during the pollen season and in the next pollen season after introduction of subcutaneous immunotherapy. On both occasions, determination of total nasal symptom score (TNSS), rhinomanometry and nasal cytology were performed. Results: All examined parameters significantly improved after one course of allergen immunotherapy: the percentage of eosinophils in nasal mucosa, TNSS and nasal resistance decreased, whereas the nasal flow rate increased. The decrease in percentage of nasal eosinophils significantly correlated with improvement in TNSS (rs = 0.39, p < 0.05) and was the highest in the subgroup sensitive to grass pollen (44.5 (40-52)). Conclusions: The rhinological assessment confirmed high effectiveness of SCIT in intermittent allergic rhinitis. A high percentage of eosinophils in nasal cytology before subcutaneous immunotherapy can predict its clinical efficacy for intermittent allergic rhinitis, especially in grass pollen allergy.

MP-AzeFlu in Moderate-to-Severe Allergic Rhinitis: A Literature Review.

Allergic rhinitis (AR) is prevalent, and many patients present with moderate-to-severe symptomatic disease. The majority of patients are not satisfied with their AR treatment, despite the use of concurrent medications. These gaps underscore the need for treatment with more effective options for moderate-to-severe AR. The authors' objective was to review systematically the efficacy and safety of MP-AzeFlu for the treatment of AR. The primary outcomes studied were nasal, ocular, and total symptoms. Other outcomes included time to onset and of AR control, quality of life, and safety. Searches of PubMed and Cochrane databases were conducted on May 14, 2020, with no date restrictions, to identify publications reporting data on MP-AzeFlu. Clinical studies of any phase were included. Studies were excluded if they were not in English, were review articles, did not discuss the safety and efficacy of MP-AzeFlu for AR symptoms. Treatment of AR with MP-AzeFlu results in effective, sustained relief of nasal and ocular symptoms, and faster onset and time to control compared with intranasal azelastine or fluticasone propionate. Long-term use of MP-AzeFlu was safe, with benefits in children, adults, and adults aged ≥65 years. Other treatment options, including fluticasone propionate and azelastine alone or the combination of intranasal corticosteroids and oral antihistamine, do not provide the same level of efficacy as MP-AzeFlu in terms of rapid and sustained relief of the entire AR symptom complex. Furthermore, MP-AzeFlu significantly improves patient quality of life. MP-AzeFlu is a currently available combination that may satisfy all these patient needs and expectations.

Nasal allergen challenge and environmental exposure chamber challenge: A randomized trial comparing clinical and biological responses to cat allergen.

BACKGROUND: The direct-instillation nasal allergen challenge (NAC) and the environmental exposure chamber (EEC) are 2 methods of conducting controlled allergen provocations. The clinical and biological comparability of these methods has not been thoroughly investigated. OBJECTIVE: We sought to compare clinical and immunologic responses to cat allergen in NAC versus EEC. METHODS: Twenty-four participants were randomized to receive either NAC followed by a 2-day challenge in an EEC or a 2-day challenge in an EEC followed by NAC. Challenges were separated by 28-day washout periods. We measured total nasal symptom scores, peak nasal inspiratory flow, nasal (0-8 hours) and serum cytokines, serum antibodies, peripheral blood antigen-specific T lymphocytes, and gene expression in nasal scrapings. The primary outcome was the total nasal symptom score area under the curve for the first 3 hours after allergen exposure in NAC or after initiation of exposure in EEC. RESULTS: Both challenges increased IL-5 and IL-13 in nasal fluids and serum and resulted in altered nasal cell expression of gene modules related to mucosal biology and transcriptional regulation. Changes in gene modules, more so than cytokine measurements, showed significant associations with total nasal symptom score and peak nasal inspiratory flow. Overall, EEC exposure generated larger responses and more early terminations compared with NAC. Although the 2 challenges did not correlate in symptom magnitude or temporality, striking correlations were observed in cytokine levels. CONCLUSIONS: Although clinical outcomes of NAC and EEC were temporally different and nonequivalent in magnitude, immunologic responses were similar. Selection of a particular allergen challenge method should depend on considerations of study objectives and cost.

Gut microbial characteristics of adult patients with allergy rhinitis.

BACKGROUND: Although recent studies have indicated that intestinal microbiota dweller are involved in the pathogenesis of allergy rhinitis (AR), the influence of gut microbiota on AR adult has not been fully elucidated yet. Hence, we carried out this study to uncover the distinctive bacterial taxa that differentiate allergy rhinitis patients from healthy individuals. Feces samples from thirty three AR patients and thirty one healthy individuals were analyzed by 16S rRNA gene sequencing. RESULTS: Results showed that the bacterial diversity in AR group was significantly higher than that of the non-AR group. Bacterial communities between AR and non-AR group were significantly differentiated as revealed by Principal coordinates analysis (PCoA) and the variation within non-AR were higher than that of the counterpart. Firmicutes, Fusobacteria, Actinobacteria, Cyanobacteria and Chloroflexi were the significantly differed phyla taxa and the top significantly distinguished bacterial genus included Prevotella_9, Phascolarctobacterium, Roseburia, Megamonas, Alistipes, Lachnoclostridium and Fusobacterium. The higher network complexity in AR group were dominated by taxa belonging to Firmicutes. The predicted function, alpha linolenic acid metabolism and bacterial invasion of epithelial cells pathway were higher in non-AR group while gonadotropin-releasing hormone (GnRH) signaling pathway, Fc γ-R mediated phagocytosis and endocytosis were higher in AR patients. Although the bacterial diversity between moderate and severe AR patients showed no significant difference, the significant correlation between featured genus and total nasal symptom score or rhinoconjunctivitis quality of life questionnaire, such as Butyricicoccus and Eisenbergiella, revealed the potential to intervene the AR status by means of gut microbiota. CONCLUSIONS: In conclusion, patients with allergy rhinitis had distinguished gut microbiota characteritics in comparison with healthy controls. The results suggest that gut microbiota might play crucial roles in influencing the course and different symptoms of AR. Trial registration ChiCTR, ChiCTR1900028613. Registered 29 December 2019, https://www.chictr.org.cn/showproj.aspx?proj=47650 .

Triamcinolone Acetonide versus Fluticasone Propionate in the Treatment of Perennial Allergic Rhinitis: A Randomized, Parallel-Group Trial.

BACKGROUND: Intranasal sprays are recommended as targeted therapy for allergic rhinitis (AR). Triamcinolone acetonide is a nasal corticosteroid preparation indicated for the treatment of seasonal and perennial AR (PAR) in different countries worldwide. OBJECTIVES: In order to determine the efficacy of triamcinolone acetonide in the treatment of PAR, the non-inferiority of triamcinolone acetonide to fluticasone propionate was assessed in Russian adults. METHODS: In this randomized, double-blind, parallel-group, multicenter, prospective, non-inferiority, phase III clinical trial, a total of 260 patients with persistent PAR were randomized to receive either triamcinolone acetonide or fluticasone propionate nasal sprays for 4 weeks. The efficacy in symptom control was evaluated using the reflective total nasal symptom score (rTNSS) from baseline (day 0) to day 28. Safety was assessed through the reporting of adverse events. RESULTS: The rTNSS mean values decreased from baseline to the end of study treatment (day 28) in both groups: -8.2 ± 3.0 in the triamcinolone acetonide arm versus -8.0 ± 2.8 in the fluticasone propionate arm. The mean difference between the groups (triamcinolone acetonide - fluticasone propionate) for rTNSS change from baseline was -0.2 (95% confidence interval -0.89 to 0.54), with an upper confidence limit of 0.54, which is lower than the non-inferiority margin of 0.8. Triamcinolone acetonide was well tolerated, with no difference in adverse event occurrence compared with fluticasone propionate. CONCLUSIONS: Triamcinolone acetonide proved to be non-inferior to fluticasone propionate in adult patients with PAR; both treatments decreased rTNSS values and showed a good safety profile.

Efficacy and safety of rupatadine in Japanese patients with seasonal allergic rhinitis: A double-blind, randomized, multicenter, placebo-controlled clinical trial.

BACKGROUND: Rupatadine is a novel non-sedating second-generation H1-antihistamine with antiplatelet-activating factor activity, first marketed in Spain in 2003. It is used for treating allergic rhinitis in more than 80 countries. This study investigated its efficacy and safety in Japanese patients with seasonal allergic rhinitis (SAR). METHODS: This was a randomized, placebo-controlled, double-blind study conducted at 4 medical institutions in Japan (JapicCTI-152785). Adolescent and adult SAR outpatients aged 12-64 years entered a 1-week placebo run-in period. After eligibility was confirmed, patients orally received placebo, rupatadine 10 mg, or 20 mg once daily for 2 weeks. The primary endpoint was a change from baseline to second week of treatment in total 4 nasal symptom score (T4NSS). RESULTS: Nine hundred patients were randomly assigned to placebo, rupatadine 10 mg, or rupatadine 20 mg (302, 298, and 300 patients, respectively). The least squares mean difference in the primary endpoint between rupatadine and placebo was -1.085 for 10 mg, and -1.415 for 20 mg (analysis of covariance, both P < 0.001). The rates of adverse events were 6.6%, 14.1%, and 15.0% for placebo, rupatadine 10 mg, and rupatadine 20 mg, respectively. Somnolence was most frequently reported: 7.0% for rupatadine 10 mg and 7.3% for rupatadine 20 mg. No serious adverse drug reactions were observed, and no adverse events resulted in premature discontinuation. CONCLUSIONS: Rupatadine 10 and 20 mg were significantly superior to placebo in improving nasal and ocular symptoms of SAR, and were well tolerated.

Efficacy and safety of bilastine in Japanese patients with perennial allergic rhinitis: A multicenter, randomized, double-blind, placebo-controlled, parallel-group phase III study.

BACKGROUND: Bilastine, a novel non-sedating second-generation H1 antihistamine, has been approved in most European countries since 2010. This study aimed to evaluate the superiority of bilastine over placebo in Japanese patients with perennial allergic rhinitis (PAR). METHODS: This randomized, double-blind, placebo-controlled, parallel-group, phase III study (trial registration number JapicCTI-142600) evaluated the effect of a 2-week treatment period with bilastine (20 mg once daily), fexofenadine (60 mg twice daily), or a matched placebo (double dummy) in patients with PAR. All patients were instructed to record individual nasal and ocular symptoms in diaries daily. The primary endpoint was the mean change in total nasal symptom scores (TNSS) from baseline to Week 2 (Days 10-13). RESULTS: A total of 765 patients were randomly allocated to receive bilastine, fexofenadine, or placebo (256, 254, and 255 patients, respectively). The mean change in TNSS from baseline at Week 2 was significantly decreased by bilastine (-0.98) compared to placebo (-0.63, P = 0.023). Bilastine and fexofenadine showed no significant difference in the primary endpoint. However, the mean change in TNSS from baseline on Day 1 was more significantly decreased by bilastine (-0.99) than by placebo (-0.28, P < 0.001) or fexofenadine (-0.62, P = 0.032). The active drugs also improved instantaneous TNSS 1 h after the first and before the second drug administration on Day 1 (P < 0.05). The study drugs were well tolerated. CONCLUSIONS: After 2-week treatment period, bilastine 20 mg once daily was effective and tolerable in Japanese patients with PAR, and exhibited a rapid onset of action.

Preventive effect of nasal filters on allergic rhinitis: A randomized, double-blind, placebo-controlled crossover park study.

BACKGROUND: A recently reported small, out-of-season environmental exposure unit study found nasal filters to be efficacious in preventing seasonal allergic rhinitis (AR). However, nasal filters still need to show efficacy in a natural setting in a regular pollen season. OBJECTIVE: We sought to evaluate the efficacy of nasal filters (Rhinix; Rhinix ApS, Aarhus, Denmark) for the prevention of symptoms related to seasonal AR. METHODS: The trial was a single-center, randomized (1:1), double-blind, placebo-controlled crossover clinical trial (NCT02108574) conducted over 2 days in the main grass pollen season in June 2014 in Aarhus, Denmark, on 65 adults with proven grass allergy. A total nasal symptom score (TNSS) consisting of blocked nose, runny nose, nasal itching, and sneezing was used to evaluate symptoms. The difference in daily∑ TNSS (the sum of 13 ratings) was the primary outcome measure. The difference in maximum TNSS (highest score, 13 ratings) was also evaluated. RESULTS: The nasal filters significantly reduced daily∑ TNSSs (P = .03) and maximum TNSSs (P = .03) compared with placebo. Median relative reductions were 40% for daily∑ TNSSs (P = .02), 43% for maximum TNSSs (P = .004), 83% for daily∑ sneezing (P = .001), 75% for daily∑ watery eyes (P = .02), and 53% for daily∑ runny nose (P = .005) when compared with placebo. The nasal filters were well tolerated, and no serious adverse events were recorded. CONCLUSION: Statistically significant and clinically relevant reductions were achieved for the primary outcome measure of daily∑ TNSS, for maximum TNSS and for a subset of individual symptoms. The results support the preventive role of nasal filters for managing seasonal AR.

Efficacy of the oral chemoattractant receptor homologous molecule on TH2 cells antagonist BI 671800 in patients with seasonal allergic rhinitis.

BACKGROUND: The inflammatory response in patients with seasonal allergic rhinitis (SAR) is partly mediated by the prostaglandin D2 receptor chemoattractant receptor homologous molecule on T(H)2 cells (CRTH2). OBJECTIVE: We sought to investigate the efficacy and safety of the oral CRTH2 antagonist BI 671800 (50, 200, and 400 mg twice daily), fluticasone propionate nasal spray (200 µg once daily), or oral montelukast (10 mg once daily) administered for 2 weeks in patients with SAR. METHODS: In this randomized, double-blind, placebo-controlled, partial-crossover study, participants aged 18 to 65 years with a positive skin prick test to Dactylis glomerata pollen were exposed to out-of-season allergen in the environmental challenge chamber for 6 hours. The primary efficacy variable was the total nasal symptom score assessed as the area under the curve (AUC)(0-6h). RESULTS: In total, 146 patients (63.7% male; mean age, 36.1 years) were randomized. The adjusted mean total nasal symptom score AUC(0-6h) was significantly reduced versus placebo with 200 mg of BI 671800 (absolute difference, -0.85; percentage difference, -17%; P = .0026), montelukast (absolute difference, -0.74; percentage difference, -15%; P = .0115), and fluticasone propionate (absolute difference, -1.64; percentage difference, -33%; P < .0001). Compared with placebo, BI 671800 significantly reduced nasal eosinophil values (P < .05 for all doses), significantly inhibited nasal inflammatory cytokine levels (IL-4 and eotaxin, P < .05; 200 mg twice daily), and induced a dose-related reduction in ex vivo prostaglandin D2-mediated eosinophil shape change. CONCLUSION: Two hundred milligrams of BI 671800 twice daily demonstrated efficacy in treating SAR symptoms induced by environmental challenge chamber allergen exposure and had a favorable safety profile.

A proof-of-concept study of the effect of a novel H3-receptor antagonist in allergen-induced nasal congestion.

BACKGROUND: H1-receptor inverse agonists are used effectively for treating several symptoms of allergic rhinitis, including nasal itching, rhinorrhea, and sneezing, although most agents are not very effective in treating nasal congestion. OBJECTIVE: This study evaluated the relative efficacy of a novel selective H3-receptor antagonist, JNJ-39220675, in preventing nasal congestion induced by exposing participants with ragweed allergy to ragweed allergen in an environmental exposure chamber model. METHODS: In this single-dose, patient-blind, double-dummy, placebo- and active-controlled, phase IIa cross-over study, 53 participants were randomized to JNJ-39220675 plus placebo, placebo plus pseudoephedrine, or only placebo. The primary efficacy assessment was change in nasal patency assessed by measuring the minimal cross-sectional area of the nasal cavity by using acoustic rhinometry. Secondary assessment included total nasal symptom scores (TNSSs) over the 8-hour environmental exposure chamber exposure period. RESULTS: Smaller decreases in minimal cross-sectional area were observed after JNJ-39220675 (least square mean difference, -0.126; P = .06) and pseudoephedrine (least square mean difference, -0.195; P = .004) treatment compared with placebo. The means for the baseline-adjusted area under the curve of TNSSs were significantly smaller for JNJ-39220675 (P = .0003) and pseudoephedrine (P = .04) versus placebo. JNJ-39220675 was significantly effective in treating all 4 individual symptoms (P ≤ .05 for all scores) compared with placebo, whereas pseudoephedrine only showed a trend for improvement in individual symptom scores of the TNSS. Insomnia was the most frequent adverse event (17.3%) associated with JNJ-39220675 treatment. CONCLUSION: Prophylactic treatment with the H3-antagonist JNJ-39220675 relieved allergen-induced nasal congestion by using standard nasal symptom scoring; however, in contrast to pseudoephedrine, it only showed a trend for increasing nasal patency by using objective measures.

The Effect of Levagen+ (Palmitoylethanolamide) Supplementation on Symptoms of Allergic Rhinitis-A Double-Blind Placebo-Controlled Trial.

BACKGROUND: Allergic rhinitis (AR) is an inflammatory, symptomatic disorder stimulated by antigen-specific immunoglobulin E inflammation in response to allergens. Current treatments include the use of corticosteroids and antihistamines to reduce inflammation by preventing histamine release. Palmitoylethanolamide (PEA) is reported to be an alternative treatment, shown to downregulate mast cell activation and increase the synthesis of endocannabinoid 2-Arachidonoylglycerol to reduce histamine and the symptoms of AR. METHOD: A double-blind, randomised, placebo-controlled clinical trial in which 108 participants presenting with seasonal AR were supplemented with either 350 mg of PEA (Levagen+) or a placebo daily for two weeks. Symptom scores were recorded using the reflective total nasal symptom score (rTNSS) twice a day (morning and evening) for the two weeks, and blood was taken at baseline and week 2. RESULTS: 101 participants completed the study with no baseline group differences. No significant difference was seen between groups for allergy symptoms scores (rTNSS) throughout the 14 days of treatment. A sub-group analysis of participants scoring over four (mild-to-moderate) on the total rTNSS at baseline showed that Levagen+ significantly reduced scores compared to the placebo group. Only 36 participants had full sets of blood taken due to COVID-19. The pathology results showed a significant difference in change from baseline between groups. The Levagen+ group had a significant decrease from baseline in histamine, IL-4, IL-8, IL-10, and TNF-α. The placebo group only had a reduction in IL-4. CONCLUSION: The results of this study show that Levagen+ can alleviate AR symptoms, resulting in a reduction in histamine and inflammatory markers.

Improvement in Nasal Symptoms of Chronic Rhinitis after Cryoablation of the Posterior Nasal Nerve.

Objective: To determine the efficacy of posterior nasal nerve (PNN) cryoablation for improving the symptoms of chronic rhinitis. Study Design: Retrospective cohort study. Setting: A private practice. Methods: This study evaluated medication usage and adverse effects of in-office PNN cryoablation with a handheld device in patients > 18 years with chronic (>6 months) allergic or nonallergic rhinitis for whom medical management failed. The total nasal symptom score (TNSS) and mini rhinoconjunctivitis quality of life questionnaire (mRQLQ) scores were compared before and after treatment. Results: This study included 127 patients with a mean age of 52.4 ± 16.9 years; 60.6% of patients were female and 49.6% had allergic rhinitis. Mean symptom scores decreased from 5.94 (95% confidence interval [CI], 5.51-6.43) to 3.44 (95% CI, 2.97-3.81, P < .001) after the procedure, with clinically important decreases in 75 (59.1%) patients. For patients with baseline TNSS values of ≥4, 63.5% (66/104) had a clinically important decrease, whereas only 39.1% (9/23) of those with the lower baseline did (P = .04). Mean mRQLQ scores also decreased from 2.51 (95% CI, 2.29-2.72) to 1.28 (95% CI, 1.20-1.47, P < .001) after the procedure. Seventy-eight of 273 (28.6%) medications were discontinued after the procedure. Adverse effects occurred in 18.1% (23/127) of patients with headache as the most common. Conclusion: PNN cryoablation improves nasal symptoms and quality of life in patients with chronic rhinitis. Patients with a higher baseline TNSS are more likely to experience significant symptomatic improvement.

Association of Sinonasal Computed Tomography Scores to Patient-Reported Outcome Measures: A Systematic Review and Meta-analysis.

OBJECTIVE: To perform a systematic review of proposed sinus computed tomography (CT) scoring systems and determine their association with patient-reported outcome measures (PROMs). DATA SOURCES: PubMed, CINAHL, Scopus, and Cochrane Library. REVIEW METHODS: A systematic search was conducted following the PRISMA guidelines (Preferred Reporting Items for Systematic Reviews and Meta-analyses) for studies describing CT scores and PROMs in patients with chronic rhinosinusitis. RESULTS: A total of 144 studies were included. Out of 20,741 patients, 53.6% were male and 55.5% had nasal polyposis. A meta-analysis of correlations revealed a moderate correlation between Lund-McKay (LM) and the 22-item Sinonasal Outcome Test (SNOT-22; r = 0.434, P < .001) and a weaker correlation between LM and the 20-item Sinonasal Outcome Test (SNOT-20; r = 0.257, P = .039). Meta-regression also revealed a weak association between LM and SNOT-20 (n = 25 studies) but no significant associations between Zinreich score and SNOT-22 or LM scores and PROMs, including SNOT-22 (n = 94 studies), Rhinosinusitis Disability Index (n = 25), nasal obstruction visual analog scale (n = 15), Chronic Sinusitis Survey (n = 12), Total Nasal Symptom Score (n = 4), Total Symptom Score (n = 3), and 12-Item Short Form Health Survey (n = 3). CONCLUSION: There is essentially little association between radiologic grade and PROMs. CT grading systems with improved clinical utility are needed.

[Evaluation of subjective scale in allergen nasal provocation test].

Objective:To compare the clinical value of visual analogue scale （VAS）, Lebel scale and total nasal symptom scores （TNSS） in evaluating nasal allergen provocation test （NAPT）. Methods:A total of 151 patients suspected of allergic rhinitis admitted to the Department of Otolaryngology-Head and Neck Surgery of our hospital from April 2020 to September 2020 were included, of which 76 were positive for house dust mites and 75 were negative for allergens. Nasal airway resistance（NAR） was measured by active anterior nasal manometry. Nasal symptoms were evaluated by VAS, Lebel and TNSS. House dust mite allergen was used for NAPT by spray method. An increase≥40% in NAR was used as the gold standard for objective evaluation of NAPT. ROC curves of VAS, Lebel and TNSS were drawn to compare the evaluation effectiveness of different subjective evaluation methods, and the optimal critical point of each ROC curve was obtained. Results:With NAR increased by ≥40% as the gold standard, the area under ROC curve of VAS was 0.884, and the sensitivity and specificity were 97.75% and 80.65%, respectively. The area under ROC curve of Lebel was 0.773, and the sensitivity and specificity were 68.54% and 75.81%, respectively. The area under ROC curve of TNSS was 0.792, and the sensitivity and specificity were 68.54% and 79.03%, respectively. There was no significant difference between Lebel and TNSS（P>0.05）. The VAS differed significantly from Lebel and TNSS（P<0.05）. The Kappa values of VAS, Lebel, TNSS and NAR were 0.803, 0.432 and 0.459, respectively. Conclusion:The VAS, Lebel, TNSS subjective scale and NAR are consistent in evaluating the efficacy of NAPT, with the VAS assessment showing highest consistency with NAR. As objective assessment instruments are not widely used in China, subjective assessment method could be adopted to evaluate the efficacy of NAPT in clinical practice, and VAS scale is recommended as a priority.

Comparative efficacy and acceptability of licensed dose intranasal corticosteroids for moderate-to-severe allergic rhinitis: a systematic review and network meta-analysis.

No evidence shows that one intranasal corticosteroid (INCS) is better than another for treating moderate-to-severe allergic rhinitis (AR). This network meta-analysis assessed the comparative efficacy and acceptability of licensed dose aqueous INCSs. PubMed/MEDLINE, Scopus, EMBASE, and the Cochrane Central Register of Controlled Trials were searched until 31 March 2022. Eligible studies included randomized controlled trials comparing INCSs with placebo or other types of INCSs in patients with moderate-to-severe allergic rhinitis. Two reviewers independently screened and extracted data following the Preferred Reporting Items in Systematic Reviews and Meta-analysis guideline. A random-effects model was used for data pooling. Continuous outcomes were expressed as standardized mean difference (SMD). The primary outcomes were the efficacy in improving total nasal symptom score (TNSS) and treatment acceptability (the study dropout). We included 26 studies, 13 with 5,134 seasonal AR patients and 13 with 4,393 perennial AR patients. Most placebo-controlled studies had a moderate quality of evidence. In seasonal AR, mometasone furoate (MF) was ranked the highest efficacy, followed by fluticasone furoate (FF), ciclesonide (CIC), fluticasone propionate and triamcinolone acetonide (TAA) (SMD -0.47, 95% CI: -0.63 to -0.31; -0.46, 95% CI: -0.59 to -0.33; -0.44, 95% CI: -0.75 to -0.13; -0.42, 95% CI: -0.67 to -0.17 and -0.41, 95% CI: -0.81 to -0.00), In perennial AR, budesonide was ranked the highest efficacy, followed by FF, TAA, CIC, and MF (SMD -0.43, 95% CI: -0.75 to -0.11; -0.36, 95% CI: -0.53 to -0.19; -0.32, 95% CI: -0.54 to -0.10; -0.29, 95% CI: -0.48 to -0.11; and -0.28, 95% CI: -0.55 to -0.01). The acceptability of all included INCSs was not inferior to the placebo. According to our indirect comparison, some INCSs have superior efficacy to others with moderate quality of evidence in most placebo-controlled studies for treating moderate-to-severe AR.

Expression and diagnostic value of miR-142-5p and miR-155-5p in the serum of children with allergic rhinitis.

BACKGROUND: Recent studies have demonstrated that microRNAs (miRNAs) play an essential role in the regulation of allergic rhinitis (AR), but the underlying mechanism is still unclear. OBJECTIVE: This case-control study aimed to measure the expression levels of serum miRNAs in children with AR, to evaluate their potential as diagnostic markers, and investigate the association between miRNAs and IL-4, total nasal symptom score (TNSS), and specific IgE (Artemisia). METHODS: Twenty allergic rhinitis patients and 20 healthy controls were included. The expression levels of serum miR-18a-5p, miR-142-5p, miR-155-5p, and miR-3687 were measured using quantitative real-time polymerase chain reaction. Serum cytokine levels were measured using IL-4 enzyme-linked immunosorbent assay kits. Nasal symptoms were assessed using the TNSS. A receiver operating characteristic (ROC) curve was used to test the diagnostic ability of the study parameters. RESULTS: The AR case group had a higher serum expression of miR-142-5p, miR-155-5p, and IL-4 than did the control group. However, there were no significant differences in the serum miR-18a-5p and miR-3687 expression levels between the two groups. We found that serum miR-142-5p and miR-155-5p levels were positively correlated with the expression of specific IgE (Artemisia). TNSS did not correlate with miR-142-5p or miR-155-5p levels. In addition, no significant correlation was identified between miR-142-5p and IL-4 expression, whereas miR-155-5p was positively correlated with IL-4 expression. The receiver operating characteristic curve did not look promising. The AUC was around 0.7 and it was not high enough for diagnostic tool. CONCLUSION: The expression levels of serum miR-142-5p and miR-155-5p were upregulated in children with AR; however, they were insufficient as diagnostic tools for AR. MiR-155-5p may be involved in T helper type 2 cell-mediated immune response.

Is Posterior Nasal Nerve Neurectomy Really a Ray of Hope for the Patients of Allergic Rhinitis.

Allergic rhinitis significantly affects the quality of life, it contributes to missed or unproductive time at school or work, disturbed sleep pattern and day time somnolence. Rhinitis is defined clinically as having two or more symptoms of anterior or posterior rhinorrhoea, sneezing, nasal blockage and/or itching of the nose during two or more consecutive days for more than 1 h on most days (International rhinitis management working group, 1994). Allergic rhinitis is diagnosed when these symptoms are caused by allergen exposure leading to an IgE mediated reaction. Nerve irritation causes sneezing and itching, the loss of mucosal integrity causes causes rhinorrhoea and the vascular engrogment leads to nasal blockage. Medical modalities are symptomatically effective in mild cases, with temporary relief and addressable adverse effects. Prolonged treatment with allergy immunotherapy causes a sustainable financial burden while remaining inaccessible at smaller towns. Posterior nasal nerve neurectomy is short, easy and effective alternative. The basic procedure is to selectively cut nerve bundles at the level of the sphenopalatine foramen (SPF) with a trans nasal approach. By denervating the nasal mucosa one renders it unresponsive to any sorts of allergen or allergic reaction. The aim of the study was to evaluate the outcome of posterior nasal nerve neurectomy in cases of severe allergic rhinitis by assessing its impact on the total nasal symptom score. The study is a hospital based prospective study, conducted on 15 patients who presented to the ENT department of Mahatma Gandhi Hospital from march 2021 to October 2021 (6 months) suffering from allergic rhinitis and did not show any satisfactory improvement even after 1 year of medical treatment. Adult patients in the age group of 20-45 yrs. diagnosed with allergic rhinitis were enrolled into the study after obtaining a due written consent. These included patients having 2 or more symptoms of allergic rhinitis and refractoriness to medical therapy for > 1 year along with significantly affected quality of life and elevated IgE level. Patients with drug induced & hormonal causes of rhinitis, chronic rhinosinusitis and any anatomical feature which precipitates to rhinitis such as deviated nasal septum, hypertrophied turbinates, blocked osteomeatal unit, polypoidal nasal mucosa and sinonasal polyposis were excluded from the study. During our study period from march 2021-September 2021, 15 patients were enrolled in the study. All the patients were followed up at 2nd and 6th month postoperatively. Amongst these patients, there were 11 females (73.34%) and 4 were male (26.67%)The mean age of patients was 35.2 years. Subjective nasal symptoms of all 15 patients improved over the period of 6 months. The mean TNSS improved from 12.067 preoperatively to 8.66 at the end of 2nd month, i.e., 23.1% improvement. By the end of the 6th postoperative month there was a consistent reduction in the tnss, which further reduced to a mean of 3.4 (70.2% reduction) indicating a further improvement in symptoms with time. With the advancement & popularity of endoscopic sinus surgery in the past decade, endoscopic resection of the posterior nasal nerve is emerging as a safe and less invasive technique with long standing results. Medical treatment usually provides mild and symptomatic relief with long duration of treatment period. Thus, PNN is safer, economical & easier alternative to current trend of treatment of allergic rhinitis, proving to be highly efficient in cases of intractable allergic rhinitis.

Comparison of the Effects of Azelastine and Fluticasone Nasal Sprays in the Treatment of Allergic Rhinitis.

Allergic rhinitis is a highly prevalent, allergen-induced disease. Intranasal corticosteroids are currently the first-line therapy for these patients. It is uncertain whether intranasal antihistamines have comparable efficacy. This study compares effects of Azelastine and Fluticasone nasal spray in patients with allergic rhinitis. Prospective comparative study including 240 patients with allergic rhinitis was conducted with 120 each in fluticasone and azelastine group. Nasal sprays were given for period of three months along with an oral antihistamine. Follow up was done after three months. Pre and post treatment symptom assessment were done using Total nasal symptom score. The median TNSS in pre and post treatment of group A (fluticasone) is 10(4) and 1(3) which shows statistical significance with p value < 0.001. Median TNSS in pre and post treatment of group B (azelastine) is 9(4) and 1(2) which shows statistical significance with p value < 0.001. The median TNSS in pre and post treatment value between Group A and B shows no statistically significant difference between two groups with p value 0.56 and 0.06 respectively. Intranasal azelastine and fluticasone had comparable efficacy in symptom control in patients with allergic rhinitis. Azelastine due to its lesser side effects, can be safely used in children, patients with glaucoma and cataract. Azelastine may be considered as a safer replacement to fluticasone for long term use in patients with allergic rhinitis. A larger multicentric study with a bigger sample size may be required to confirm the efficacy and safety profile of azelastine nasal spray.

Airway Nitric Oxide in Children with HDM-Induced Allergic Rhinitis.

BACKGROUND: Rhinitis is a common problem in children. Airway nitric oxide (NO) was proposed to represent eosinophilic inflammation. OBJECTIVES: To evaluate airway NO level in children with house dust mite (HDM)-induced allergic rhinitis. METHODS: Children aged 5 to 18 years old with moderate-severe persistent rhinitis and positive result for the HDM nasal provocation test (NPT) was enrolled. The nasal symptoms evaluated by total nasal symptom score (TNSS) and visual analog scale (VAS) were recorded. Skin prick test (SPT) to common aeroallergens, fractional exhaled nitric oxide (FeNO), nasal nitric oxide (nNO), and blood test for specific IgE (sIgE) to HDM was measured. Rhinitis severity was categorized as severe if the VAS score > 7. RESULTS: Forty-eight children with HDM-induced allergic rhinitis with the mean age of 9.3 ± 2.4 years were enrolled. nNO levels and VAS score were significantly correlated (R = 0.398, P = .005). Children with severe rhinitis had significantly higher nNO levels than moderate rhinitis (1652.05 vs 941.30 parts per billion [ppb], P = .002), while there was no difference in FeNO level. ROC curve analysis demonstrated the cut-off value of nNO at 1350 ppb (AUC 0.764, 95% CI: 0.616-0.911, P = .002) for detecting severe HDM-induced allergic rhinitis with the sensitivity of 78% and the specificity of 71%. The level of FeNO in children who had HDM mean wheal diameter (MWD) > 8 mm was significantly higher than those with HDM MWD of 3 to 8 mm and those with a negative test (39.7 vs 14.3 vs 14.4 ppb; P = .006, respectively). Children who had sIgE to HDM < 0.35 KUA/L had significantly lower FeNO than those with sIgE to HDM 0.35 to 50 KUA/L and >50 KUA/L (9.5 vs 19.7 vs 40.4 ppb; P = .029, respectively). CONCLUSIONS: Cut-off value for the diagnosis of severe HDM-induced chronic rhinitis was proposed. Rhinitis children who had a higher degree of HDM sensitization had a higher level of FeNO.