Nasal Symptom Score Research Articles

The efficacy and safety of standardized dust mite allergen subcutaneous immunotherapy in children with allergic rhinitis during treatment

Objective: To evaluate the efficacy and safety of standardized dust mite allergen subcutaneous immunotherapy (SCIT) in children with allergic rhinitis (AR) during treatment. Methods: A total of 283 children with AR diagnosed with definite dust mite allergy and completed 2 to 3 years of SCIT who attended the Department of Otorhinolaryngology Head and Neck Surgery, Xiangya Hospital, Central South University, from August 2019 to October 2021 were included, including 205 males and 78 females, with a mean age of 10.8 years. The total nasal symptoms score (TNSS), symptom medication score (SMS), rhinoconjunctivitis quality of life questionnaire (RQLQ) and visual analogue scale (VAS) before and after 2 to 3 years' treatment were recorded, and the differences before and after treatment were compared. Adverse reactions during SCIT were recorded to evaluate its safety. SPSS 22.0 software was used for statistical analysis. Results: The overall effectiveness rate during SCIT in 283 children with AR was 89.4% (253/283). Compared with baseline, all symptom scores, medication scores and quality of life scores were significantly lower after 2 to 3 years of SCIT (all P<0.05). Further group comparisons showed positive efficacy in patients with different clinical characteristics, including age, gender, smoking status, family history of AR, symptom severity, mono-or poly-allergy, and second immunization, with no statistically significant differences between groups (all P>0.05). A total of 12 735 injections were administered during the SCIT, and a total of 213 (1.67%) injections of local adverse reactions occurred, mainly in the initial treatment phase, and the diameter of the local air mass was mostly 5 to 20 mm; 71 (0.56%) injections of systemic adverse reactions occurred, mainly in the initial treatment phase, and most of them were grade 1 reactions with no serious systemic adverse reaction such as shock. Conclusion: Standardized dust mite SCIT has a good safety profile and definite efficacy in treating AR children with different clinical characteristics. It can significantly improve all symptoms, reduce the use of symptomatic drugs and improve their quality of life.

Impact of the Allergic Therapeutic Adherence in Children with Allergic Rhinitis and ADHD: A Pilot Study.

Allergic rhinitis (AR) is the most common chronic allergic disease in children. Several studies have shown an association between attention deficit hyperactivity disorder (ADHD) and allergies, especially AR. Patients with ADHD usually have poor therapeutic adherence, and untreated AR symptoms may worsen the quality of life of patients. The aim of our study was to analyse therapeutic adherence in patients with ADHD and AR and estimate the impact of the adherence on ADHD symptoms. Total Nasal Symptoms Score (TNSS), Paediatric or Adolescent Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ 6-12 years; ARQLQ 13-17 years), Swanson, Nolan, and Pelham version IV scale (SNAP-IV), and Medication Assessment Questionnaire (MGL MAQ) were recorded. In the AR-ADHD group, a positive correlation between TNSS and SNAP-IV subscales was found: worse AR symptoms were related to a negative effect on ADHD scores. AR-ADHD patients with better ADHD therapeutic adherence showed higher AR symptoms and higher oppositional defiant disorder scores in the SNAP-IV questionnaire. Our results suggest that better adherence to AR therapy (oral antihistamines and/or intranasal corticosteroids, INCS) is associated with a reduction in inattention symptoms in children with ADHD. This data could prove to be fundamental for the psychic outcome of these patients.

Efficacy and safety of self-administered acupressure on symptoms, quality of life and nasal mucosal function in patients with perennial allergic rhinitis: study protocol for a randomized controlled exploratory trial

IntroductionAllergic rhinitis is a global health problem that can potentially be managed through acupressure. Our clinical observations have identified Allergic Rhinitis Acupressure Therapeutic (ARAT) as a novel acupressure treatment acting on specific acupoints, which may enhance the effectiveness of acupressure. Therefore, we propose a three-arm randomized controlled trial will be conducted to investigate the efficacy and safety of ARAT for perennial allergic rhinitis (PAR).Methods/designIn this trial, eligible 111 participants diagnosed with PAR will be randomly assigned to one of three groups: the ARAT group, the non-specific acupoints group, or the blank control group. The primary outcome will be the change in the total nasal symptom score, and the secondary outcomes will include: 1) changes in the scores of the standard version of Rhinoconjunctivitis Quality of Life Questionnaire (RQLQs); 2) acoustic rhinometry and anterior rhinomanometry; 3) changes in the scores of relief medication usage; 4) incidence of adverse events. Additionally, we will measure and compare the changes in cytokine levels (IL-5, IL-13, IFN-γ, and TSLP) in nasal secretions.The RQLQs and primary outcomes will be assessed at the beginning, middle, and end stages of the treatment period, with monthly follow-ups conducted over a total of three months. The secondary outcomes and biomarkers in nasal secretions will be measured at the beginning and end of the treatment period. Any adverse events or need for rescue medication will be carefully noted and recorded.DiscussionThis study may produce a new acupressure treatment prescription that is easy to learn, more targeted, and adaptable. This trial represents the first clinical investigation comparing ARAT treatment for PAR with the non-specific acupoints group and blank control group. Our data is expected to provide evidence demonstrating the safety and efficacy of ARAT for PAR patients, while also exploring the functional mechanism underlying ARAT treatment, moreover, the results offer valuable insights for healthcare professionals in managing PAR symptoms.Trial registrationChinese Clinical Trial Registry, ChiCTR2300072292. Registered on June 08, 2023.

Sodium Chloride versus Lactose as a Carrier for House Dust Mite Allergen in Allergen Chamber Studies: A Clinical Study to Assess Noninferiority

Introduction: In the Fraunhofer allergen challenge chamber (ACC), a standardized, universal, good manufacturing practice-conforming technology using a spray dried solution of lactose (L) and allergen extract has been established. In this study, we investigated the noninferiority of hypertonic sodium chloride (S) versus L as a carrier for house dust mite (HDM) allergen to simplify manufacturing, reduce costs, and allow for wider use. Methods: Using a participant-blinded, sham exposure-controlled, single-arm, sequential intervention study, we challenged adults with HDM allergic rhinitis five times in the ACC. Participants were first exposed to S, L, and clean air (block 1), followed by S + HDM and L + HDM (block 2). Primary endpoints were mean total nasal symptom score (TNSS) and mean nasal secretion weight. Results: 19 participants were enrolled in the study (10 females; mean age 32 years [22–49], 4 with mild allergic asthma). The safety profile of S + HDM and L + HDM was similar; eight participants experienced mild procedure-related adverse events including tiredness, cough, and dyspnea. Due to dropouts, 13 participants completed the study and were evaluated. Mean TNSS and nasal secretion were as follows: S 0.98, 0.28 g; L 1.1, 0.20 g; clean air 1.1, 0.23 g; S + HDM 5.7, 4.8 g; L + HDM 5.1, 5.1 g. Separate block 1/block 2 MANOVAs with TNSS and nasal secretion as dependent variables revealed no significant differences between the carriers, neither alone and compared with clean air (p = 0.2059, Wilk’s λ = 0.78) nor combined with HDM (p = 0.3474, Wilk’s λ = 0.89). Noninferiority of S was established using a meta-analysis-based minimal clinical important difference of −0.55: mean TNSS difference between S + HDM and L + HDM was 0.62 (90% CI: −0.51 to 1.74). Conclusion: S as an HDM carrier was safe and well tolerated. It was noninferior to L which makes it an adequate and easy-to-use carrier substitute.

A Clinical Study to Assess the Efficacy and Safety of MP-AzeFlu Nasal Spray in Comparison to Commercially Available Azelastine Hydrochloride and Fluticasone Propionate Nasal Sprays in Chinese Volunteers with Allergic Rhinitis.

The objective of the present study was to evaluate the efficacy and safety of MP-AzeFlu nasal spray in comparison to commercially available azelastine hydrochloride and fluticasone propionate sprays in Chinese patients with moderate-to-severe allergic rhinitis (AR). We conducted a 14-day multicenter, randomized, double-blind, active controlled prospective clinical study in adult and adolescent patients with AR, who had moderate-to-severe symptoms. The primary efficacy endpoint was the change from baseline in combined 12-h reflective total nasal symptom score (rTNSS) (morning [AM] + afternoon [PM]). The safety profile of the study medications was assessed through the recording, reporting, and analysis of baseline medical conditions, adverse events (AEs), vital signs, and focused nasal examination. Three hundred patients per treatment group were randomized, which led to a total sample size estimation of 900 patients. MP-AzeFlu group showed significantly higher symptom reduction for the entire 2-week treatment period in rTNSS when compared with the AZE group (LS mean difference: -1.96; 95% CI: - 2.53, - 1.39; p < 0.0001), or the FLU group (LS mean difference: -0.98; 95% CI: - 1.55, - 0.41; p = 0.0007). The results of adult RQLQ showed improvement in QoL in all treatment groups. Except for dysgeusia (bitter taste) that was reported by more patients (13 [4.3%]) in the MP-AzeFlu group, the incidence of all other TEAEs in the MP-AzeFlu group was comparable or even lower than in other treatment groups. MP-AzeFlu, when administered as one spray per nostril twice daily for 14days, alleviated AR symptoms in Chinese patients with moderate-to-severe AR. Clinicaltrials.gov; NCT03599791, Registered June 29, 2018, retrospectively registered, https://clinicaltrials.gov/ct2/show/NCT03599791 .

Glucocorticoid-Induced Transcript 1(GLCCI1) SNP rs37937 Is Associated With the Risk of Developing Allergic Rhinitis and the Response to Intranasal Corticosteroids in a Chinese Han Population.

Evidence has shown that glucocorticoid-induced transcript 1 (GLCCI1) single nucleotide polymorphism (SNP) rs37937 is associated with asthma. The objective of this study was to investigate whether the GLCCI1 SNP rs37937 is a risk factor for allergic rhinitis (AR) in a Chinese Han population. A total of 220 individuals including 109 AR patients and 111 healthy subjects were included. The genotyping of GLCCI1 rs37973 was performed by the SNaPshot method. The correlations of rs37973 polymorphism, AR risk, and clinical characteristics were further analyzed, as well as the treatment response to intranasal corticosteroids (INCS) in AR patients of different genotypes. Three GLCCI1 rs37973 SNP genotypes were identified in both AR patients and healthy subjects. Significant association between rs37973 polymorphism and AR under allele model, dominant model, heterozygote model, and homozygote model were shown. The A allele frequency of SNP rs37973 in AR was significantly higher than that in controls. The serum total immunoglobulin E (IgE) in AR patients of AA genotype was significantly higher than in patients of GA and GG genotype, and the serum total IgE in GA genotype was significantly higher than in GG genotype. Interestingly, after 4 weeks of INCS treatment for AR patients, the improvement of the nasal itching score, sneezing score, runny nose score, total nasal symptom score, and visual analog scale score of the GG genotype were worse than the AA or GA genotype. The GLCCI1 rs37937 polymorphism is associated with the risk of developing AR and the response to INCS treatment in the Chinese Han population.

Effect of Chronic Rhinitis Treatment in Children with Attention-Deficit/Hyperactivity Disorder.

The purpose of this study is to examine the effect of chronic rhinitis treatment on attention-deficit/hyperactivity disorder (ADHD) symptoms in children with ADHD. Children and adolescents with ADHD were screened for chronic rhinitis symptoms. Participants with positive chronic rhinitis screening underwent the skin prick test and received rhinitis treatment for 3 months. All participants were evaluated using the parent's and teacher's Vanderbilt ADHD rating scales, total nasal symptom score, and Quality of Life Questionnaire (OSA-18) for pediatric obstructive sleep apnea at pretreatment and posttreatment. Overall, 140 children and adolescents with ADHD were enrolled and screened for chronic rhinitis. Fifty-four children and adolescents with positive screening results underwent the skin prick test and received rhinitis treatment. After 3 months of treatment, inattentive, hyperactive/impulsive, and total ADHD symptom scores were significantly decreased as reported by parents ( p = 0.031 to <0.001) and teachers ( p = 0.001 to <0.001) compared with those before treatment. A subgroup analysis also showed improvement in ADHD symptoms as reported by parents and teachers in the allergic and nonallergic rhinitis groups. Pearson's correlation coefficient analyses showed positive correlations between improvement in the ADHD symptom scores reported by parents and improvement in the quality of life related to sleep problems from the OSA-18 questionnaire (r = 0.377-0.387). Treating chronic rhinitis can improve ADHD symptoms in children and adolescents with ADHD. Pediatricians should be aware of and treat chronic rhinitis to maximize ADHD symptom control.

Lower serum 15-HETE level predicts nasal ILC2 accumulation during COX-1 inhibition in AERD

Aspirin-exacerbated respiratory disease (AERD) is associated with high levels of cysteinyl leukotrienes, prostaglandin D2, and low levels of prostaglandin E2. Further, 15-hydroxyeicosatetraenoic acid (15-HETE) levels may have predictive value in therapeutic outcomes of aspirin desensitization. Accumulation of nasal group 2 innate lymphoid cells (ILC2s) has been demonstrated during COX-1 inhibition in AERD, although the relationships between tissue ILC2 accumulation, reaction symptom severity, and novel lipid biomarkers are unknown. We sought to determine whether novel lipid mediators are predictive of nasal ILC2 accumulation and symptom scores during COX-1 inhibitor challenge in patients with AERD. Blood and nasal scraping samples from patients with AERD were collected at baseline and COX-1 inhibitor reaction and then processed for flow cytometry for nasal ILC2s and serum for lipidomic analysis. Eight patients with AERD who were undergoing aspirin desensitization were recruited. Of the 161 eicosanoids tested, 42 serum mediators were detected. Baseline levels of 15-HETE were negatively correlated with the change in numbers of airway ILC2s (r= -0.6667; P= .0428). Docosahexaenoic acid epoxygenase metabolite 19,20-dihydroxy-4Z,7Z,10Z,13Z,16Z-docosapentaenoic acid (19,20-diHDPA) was positively correlated with both changes in airway ILC2s (r= 0.7143; P= .0305) and clinical symptom scores (r= 0.5000; P= .0081). Low levels of baseline 15-HETE predicted a greater accumulation of airway ILC2s in patients with AERD who were receiving COX-1 inhibition. Further, increases in the cytochrome P pathway metabolite 19,20-dihydroxy-4Z,7Z,10Z,13Z,16Z-docosapentaenoic acid (19,20-diHDPA) were associated with increased symptoms and nasal ILC2 accumulation. Future studies to assess how these mediators might control ILC2s may improve the understanding of AERD pathogenesis.

Postnasal drip and chronic cough in patients with chronic rhinitis treated with temperature-controlled radiofrequency neurolysis.

To evaluate the contribution of postnasal drip (PND) and chronic cough (CC) to symptoms of patients with chronic rhinitis treated with temperature-controlled radiofrequency (TCRF) neurolysis of the posterior nasal nerve (PNN), and correlate PND and CC scores with components of the reflective total nasal symptom score (rTNSS). Pooled data from three prospective studies: two single-arm studies and the index active treatment arm of a randomized controlled trial. Adult patients with baseline rTNSS ≥6 were treated with TCRF neurolysis at nonoverlapping regions of the PNN. PND and CC symptoms were evaluated on a 0 (none) to 3 (severe) scale. Data from 228 patients (57.9% women, 42.1% men) were included. The mean baseline rTNSS was 8.1 (95% confidence interval [CI], 7.8-8.3), which decreased to 3.2 (95% CI, 2.9-3.5) at 6 months. At baseline, 97.4% of patients had PND and 80.3% had CC. Median baseline PND and CC symptom scores were 3 (interquartile range [IQR], 2-3) and 2 (IQR, 1-2), respectively. At 6 months, this decreased to 1 (IQR, 0-2) and 0 (IQR, 0-1), respectively, showing significant improvement from baseline (both p<0.001). Spearman correlation coefficients with components of rTNSS (rhinorrhea, congestion, itching, sneezing) were 0.16 to 0.22 for CC and 0.19 to 0.46 for PND, indicating only a weak to moderate correlation. PND and CC contribute to the symptomatology of chronic rhinitis and are significantly improved after TCRF neurolysis of the PNN. The inclusion of PND and CC symptoms in a chronic rhinitis assessment instrument could provide important additional information for the characterization of the disease state and outcomes after any therapeutic treatment.

Radiofrequency Neurolysis of the Posterior Nasal Nerve: A Systematic Review and Meta-Analysis.

Temperature-controlled radiofrequency neurolysis of the posterior nasal nerve (PNN) has been approved for use since 2020. This review synthesized the published data to assess its efficacy for treatment of chronic rhinitis. Pubmed/Medline, Embase, Scopus, Web of Science. A systematic search was conducted with no restrictions on publication years in April 2023. RCTs and prospective investigations that reported the reflective Total Nasal Symptom Score (rTNSS) outcome of radiofrequency neurolysis as a single procedure in chronic rhinitis patients were included. Pooled estimates for change in rTNSS from baseline at 3 months and responder rates (≥30% reduction in baseline rTNSS) at 3 and 6 months were obtained. Other outcomes, such as postnasal drip and cough scores, quality of life (QoL) measures, and adverse events were included for qualitative review. Five studies were included in the systematic review, of which four were included in the meta-analysis. A total of 284 participants underwent treatment. The pooled change in rTNSS score at 3 months was -4.28 (95% CI, -5.10 to -3.46). The pooled responder rate at 3 months was 77.11% (95% CI, 68.21%-86.01%) and at 6 months 80.80% (95% CI, 70.85%-90.76%). Postnasal drip and cough scores and QoL also improved significantly at follow up. A total of 36 adverse events were reported in 21 (7.4%) patients. The findings from this review suggest that temperature-controlled radiofrequency neurolysis of the PNN is effective at treating chronic rhinitis symptoms and that it has an overall favorable safety profile. Laryngoscope, 134:507-516, 2024.

Comparative clinical assessment of mometasone furoate-azelastine hydrochloride intranasal spray (Ryaltris AZ®) with fluticasone furoate-azelastine hydrochloride intranasal spray in patients with allergic rhinitis in India

Background: Allergic rhinitis is a type of IgE-mediated hypersensitivity reaction. ARIA recommends a combination of intranasal corticosteroid and intranasal antihistamine as first-line treatment for allergic rhinitis in moderate to severe AR. The current study aimed to compare the effectiveness and safety of Mometasone furoate-Azelastine hydrochloride Nasal Spray and Fluticasone furoate-Azelastine hydrochloride Nasal Spray for the treatment of allergic rhinitis in India. Methods: A multicentric, comparative study was carried out across 30 ENT clinics in India. From September to November 2022, medical records were scrutinised for information such as medical history, symptoms, treatment details, clinical results, and adverse events. The mean change in total nasal and non-nasal symptom scores from baseline to the end of treatment was used to assess effectiveness. Results: 235 received mometasone furoate-azelastine hydrochloride intranasal spray and 221 received Fluticasone furoate-Azelastine hydrochloride (FF-Az) Intranasal Spray. The mean change from the baseline TNSS score at day 14 in the MF-AZ and FF-Az groups was -6.89 (±3.32) and -6.82 (±3.20) respectively, with no significant difference (p=0.81) between the two. Bitterness and nasal irritation was significantly higher in the FF-Az group. There was no hospitalization, SAE, or treatment discontinuation due to AEs among patients in either group. Conclusions: The study found that intranasal mometasone-azelastine and fluticasone furoate-azelastine sprays were equally effective in relieving nasal and non-nasal symptoms by days 7 and 14, respectively. However, patients in the fluticasone furoate-azelastine group reported more bitter taste and nasal irritation.

Long-term treatment outcomes in refractory rhinitis medicamentosa managed with nasal surgery.

Limited treatment options exist for refractory Rhinitis Medicamentosa (RM). The role of surgery after failed medical management is not well defined. Mucosal contact points and restricted airflow often perpetuate decongestant use. This study assessed the long-term outcomes of nasal surgery in patients with refractory RM. A prospective cohort study of refractory RM treated with nasal surgery was performed with ≥12months follow-up. Refractory RM was defined as nasal decongestant use once per day continuously for ≥4weeks despite medical therapy. Patients with concomitant sinus disease and nonrhinitis conditions were excluded. Sinonasal Outcome Test (SNOT22), Nasal Symptom Score (NSS), and nasal medication use were assessed. Patients who ceased decongestants were compared with ongoing users. A total of 56 patients (age 48.4 [5.0] years, 50% female) were assessed. Median follow-up was 3.4(1.6-6.2) years. Total cessation of decongestants was achieved in 91.1%, while 5.4% had intermittent use, and 3.6% reported daily use. Ongoing users had higher odds of concomitant asthma (40.0% vs. 3.9%; odds ratio [OR], 16.33 [1.7-159.75]; p=0.036), reduced symptom improvement (ΔSNOT22, -4.6 [15.7] vs. 27.1 [17], p=0.009 and ΔNSS, -1.0 [4.2] vs. -6.6 [5.1], p=0.025), and greater ongoing use of nasal corticosteroid (60.0% vs. 5.9%; OR 24.0 [2.8-203.1]) and saline sprays (40% vs. 3.9%; OR 16.3 [1.7-159.8]) but showed no difference in allergy status (OR, 0.7[0.1-7.1]), previous surgery (OR, 1.0[0.1-10.2]), gastroesophageal reflux (OR 1.0[0.1-10.2], or underlying anxiety/depression (OR 6.1[0.8-45.9]) compared with those who ceased. Surgically re-establishing a nasal airway was associated with long-term decongestant cessation and symptom improvement in medically refractory RM.

Nasal and blood transcriptomic pathways underpinning the clinical response to grass pollen immunotherapy

Allergen immunotherapy (AIT) is a well-established disease-modifying therapy for allergic rhinitis, yet the fundamental mechanisms underlying its clinical effect remain inadequately understood. Gauging Response in Allergic Rhinitis to Sublingual and Subcutaneous Immunotherapy was a randomized, double-blind, placebo-controlled trial of individuals allergic to timothy grass who received 2 years of placebo (n= 30), subcutaneous immunotherapy (SCIT) (n= 27), or sublingual immunotherapy (SLIT) (n= 27) and were then followed for 1 additional year. We used yearly biospecimens from the Gauging Response in Allergic Rhinitis to Sublingual and Subcutaneous Immunotherapy study to identify molecular mechanisms of response. We used longitudinal transcriptomic profiling of nasal brush and PBMC samples after allergen provocation to uncover airway and systemic expression pathways mediating responsiveness to AIT. ClinicalTrials.gov Identifier: NCT01335139, EudraCT Number: 2010-023536-16. SCIT and SLIT demonstrated similar changes in gene module expression over time. In nasal samples, alterations included downregulation of pathways of mucus hypersecretion, leukocyte migration/activation, and endoplasmic reticulum stress (log2 fold changes -0.133 to -0.640, false discovery rates [FDRs] <0.05). We observed upregulation of modules related to epithelial development, junction formation, and lipid metabolism (log2 fold changes 0.104 to 0.393, FDRs <0.05). In PBMCs, modules related to cellular stress response and type 2 cytokine signaling were reduced by immunotherapy (log2 fold changes -0.611 to -0.828, FDRs <0.05). Expression of these modules was also significantly associated with both Total Nasal Symptom Score and peak nasal inspiratory flow, indicating important links between treatment, module expression, and allergen response. Our results identify specific molecular responses of the nasal airway impacting barrier function, leukocyte migration activation, and mucus secretion that are affected by both SCIT and SLIT, offering potential targets to guide novel strategies for AIT.

Clinical effectiveness of decoction form of herbal medicine in primary care treatment of allergic rhinitis: A retrospective cohort study

BackgroundThe decoction form of herbal medicine (D-HM) is mainly prescribed to patients with allergic rhinitis (AR) in Korean Medicine (KM) clinics in the Republic of Korea; however, it is difficult to conduct clinical trials of D-HM due to regulatory issues. This study investigated the clinical safety and effectiveness of D-HM combination therapy for the treatment of AR by analyzing the AR outpatient data from 17 KM clinics. MethodsThis retrospective cohort study included patients who visited KM clinics for AR treatment from January 1, 2021, to March 31, 2022. Cases were collated using structured case report forms and divided into the D-HM with KM usual care group (D-HM group) and the KM usual care group (UC group). Since D-HM therapy could not be randomly assigned to the study population, we used optimal propensity score (PS) matching to investigate the effectiveness and safety of D-HM combination therapy in the treatment of AR. ResultsData from 228 patients were collected. After PS matching, 144 patients were finally analyzed. The total nasal symptom score (TNSS) and mini-rhinoconjunctivitis quality of life questionnaire (mini-RQLQ) were significantly improved in the D-HM group compared with those in the UC group (TNSS: p=0.02; mini-RQLQ: p=0.04). Four patients in the D-HM group experienced minor adverse events that were mild and resolved within 15 days. ConclusionsD-HM combination therapy may be beneficial in the management of symptoms and rhinitis-associated quality of life and potentially useful in clinical practice. However, randomized placebo-controlled clinical trials are required to confirm their effectiveness. Study registrationThis study has been registered at Clinical Research Information Service (KCT0007242).

Birch-induced allergic rhinitis: Results of exposure during nasal allergen challenge, environmental chamber, and pollen season

BackgroundPollen variation can affect field study data quality. Nasal allergen challenge (NAC) is considered the gold standard for evaluating allergic rhinitis, while environmental exposure chambers (EECs) are mainly used in phase 2 drug development studies. We aimed to study birch-induced allergic rhinitis under 3 different conditions. MethodsThis study included 30 participants allergic to birch pollen, based on birch skin prick test, specific immunoglobulin E (IgE), and positive NAC. Participants were exposed to placebo twice, followed by 2 consecutive 4-h birch airborne exposures, repeated on 2 occasions to evaluate reproducibility and priming effect. Nasal response was defined as total corrected nasal symptom score (ΔTNSS) ≥ 5 during NAC and EEC. The primary end-point was to measure TNSS during the last 2 h of first allergen exposure. TNSS was also analyzed during natural exposure. ResultsThe dose most commonly yielding positive TNSS during NAC was 175.2 ng/200 μL. Eighteen participants experienced ΔTNSS ≥5 during the last 2 h of the first exposure, whereas 21 had positive responses at all 4 exposures. Mean ΔTNSS was 1 with placebo versus 6 with birch. Exposures were reproducible, with no observed priming effect. Airborne Bet v 1 was 25 ng/m3, while the pollen measurement was 279/m3 during pollen season. TNSS reached 5 in 67.9% of participants during peak pollen season. ConclusionEEC outcomes were similar to those obtained with NAC and natural exposure, suggesting the usefulness of EEC in allergic rhinitis studies. The primary end-point was reached, as 60% of participants experienced nasal responses.

Efficacy and immunological changes of sublingual immunotherapy in pediatric allergic rhinitis

BackgroundAllergen-specific immunotherapy, including subcutaneous immunotherapy (SCIT) and sublingual immunotherapy (SLIT), improves the disease progression of allergic rhinitis (AR). SCIT and SLIT exhibit similar efficacy, but SLIT has less systemic reactions. However, few studies have investigated the underlying mechanisms of SLIT treatment. In this study, we explored the efficacy of SLIT under different treatment durations and immunological changes. MethodsThis retrospective study was conducted from August 2017 to August 2022 in our hospital. A total of 314 children who underwent SLIT were divided into the following groups based on their treatment duration: the 1 year group (6 months–1 year), the 2 years group (1–2 years), and the 3 years group (2–3 years). The treatment efficacy was confirmed using a combined symptom and medication score (SMS). Multiple serum cytokines were measured using Luminex. Various immune cells in PBMCs were determined using flow cytometry. ResultsThe total nasal symptom score (TNSS), rescue medication score (RMS), and SMS of the 3 years group was significantly different from those of the 1 years and 2 years groups. At the end of the 2 years following cessation of SLIT, the following results were observed in the 3 years group: 1) the TNSS, RMS, and SMS had significantly improved, 2) the serum IL-10, TGF-beta, and IL-35 levels had increased significantly, and 3) the percentages of regulatory T cell, regulatory B cell, and follicular regulatory T cell increased significantly. ConclusionOur results suggest that 3 years of SLIT is necessary for long-term effects and continued immunological changes.

Barrier-forming, drug-free nasal spray reduces allergic symptoms induced by house dust mite allergen.

House Dust Mite (HDM) is the most common indoor allergen triggering allergic symptoms. First-line pharmacotherapy treatment is recommended in international guidelines, while the avoidance of allergens represents a still unmet guideline principle. AM-301 is a new non-pharmacological nasal spray that creates a protective gel-like barrier on the nasal mucosa, preventing the contact with the allergens. This randomized, open-label, 3-period crossover study assessed the efficacy and safety of AM-301. The objective was to determine whether AM-301 reduces allergic rhinitis (AR) symptoms in patients exposed to HDM allergens. Adults with confirmed Perennial Allergic Rhinitis (PAR; n=37) were exposed to HDM allergen in a controlled Allergen Exposure Chamber before and during a treatment course of AM-301 (in six different sequences) within 3weeks (A: One spray AM-301 per nostril/B: Two sprays AM-301 per nostril/C: no treatment). For the primary efficacy analysis, data from the total nasal symptom score (TNSS) were pooled from treatment A+B (D) and analyzed with Analysis of Covariance Model. As secondary endpoints, single time points, visits and symptoms were analyzed. The primary endpoint (overall change in TNSS from baseline over all three visits) showed significant results (p=0.0085). A comparable alleviation of all four symptoms (itchy nose, nasal congestion, runny nose, sneezing) by the protective layer started to emerge after 40min and lasted up to 180min (end of challenge). AM-301 resulted to be safe and well-tolerated. AM-301 significantly reduced HDM-related allergic symptoms in a standardized allergen challenge. Protection was observed to last up to 180min.

Evaluation of disease control after SARS-CoV-2 infection or vaccination in patients with NSAID-exacerbated airway disease.

Background: There are insufficient data on changes in disease control after severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) infection or vaccination in patients with nonsteroidal anti-inflammatory drug exacerbated respiratory disease (N-ERD). Objective: This study aimed to investigate the history of coronavirus disease 2019 (COVID-19) in patients with N-ERD, determine whether they experienced exacerbations of asthma or rhinitis after COVID-19, and evaluate their postvaccination asthma and rhinitis control data. Methods: The demographic characteristics of patients with N-ERD and whether they had had symptoms of asthma, changes in nasal symptom scores Sino-nasal outcome test (SNOT-22), Asthma Control Test (ACT) within 1 month after SARS-CoV-2 vaccination or infection were recorded. The prevalence of COVID-19 in patients with N-ERD and in healthy controls was estimated. Results: A total of 103 patients with N-ERD and 100 healthy controls were included in the study. Thirty seven of the patients (35.9%) and 65 of the controls (65%) had a history of COVID-19. There were no significant differences in changes in the ACT and SNOT-22 scores after SARS-CoV-2 vaccination (p = 0.999). Although, the change in ACT score after infection was significant (p = 0.017; r = 0.39), there was no significant change in level of asthma control (p < 0.001). Conclusion: The history of COVID-19 was less frequent in the N-ERD group. There was no deterioration in asthma and rhinitis controls after SARS-CoV-2 vaccination. Although a significant decrease was observed in the ACT scores after COVID-19, there was no deterioration in the level of asthma control.

The effect of nose clip on exercise-induced bronchoconstriction in adolescents.

Oral breathing is considered to increase hyper-responsiveness of the airways. Data on the need for nose clip (NC) during exercise challenge test (ECT) in children and adolescents is scarce. Ouraim was to evaluate the role of NC during ECT in children and adolescents. A prospective, cohort study; children referred for ECT were evaluated on two separate visits, with and without a NC. Demographic, clinical data and measurements of lung functions were recorded. Allergy and asthma control were evaluated by Total Nasal Symptoms Score (TNSS) and Asthma Control Test (ACT) questionnaires. Sixty children and adolescents (mean age 16.7 ± 1.1 years, 38% Female,) performed ECT with NC and 48 (80%) completed visit 2 (ECT without NC), 8.7 ± 7.9 days after visit 1. Following exercise, 29/48 patients (60.4%) with NC had a decline of ≥12% in forced expiratory volume in the first second (FEV1 ) (positive ECT) compared to only 16/48 (33.3%) positive tests without NC (p = 0.0008). Test result was changed in 14 patients from positive ECT (with NC) to negative ECT (no NC) and in only one patient from negative to positive. The use of NC resulted in greater FEV1 decline (median 16.3% predicted, IQR 6.0-19.1% predicted vs. median 4.5% predicted, IQR 1.6-18.4% predicted, p = 0.0001), and better FEV1 increase after bronchodil at or inhalation compared to ECT without NC. Higher TNSS scores did not predict higher probability to positive ECT. The use of NC during ECT increases detection rate of exercise induced bronchoconstriction during ECT in the pediatric population. These findings strengthen the recommendation of nasal blockage during ECT in children and adolescents.

Observation of the long-term clinical efficacy of "Fuyang Guben" acupuncture-moxibustion therapy on perennial allergic rhinitis and its effects on the total IgE and IL-4 in the serum

To investigate the long-term clinical efficacy and safety of "Fuyang Guben" (supporting yang and consolidating root) acupuncture-moxibustion therapy on perennial allergic rhinitis (PAR), and to explore its functioning mechanism. The patients with PAR were randomly divided into acupuncture + western medicine group (n=30) and western medicine group (n=30). In the western medicine group, fluticasone propionate nasal spray was administered, one spray in each nostril in one treatment, once a day, for 6 weeks. On the basis of the western medicine group, fuyangguben acupuncture-moxibustion therapy was supplemented. Acupuncture was applied to Shangxing (GV23), Yintang (GV24+), and bilateral Yingxiang (LI20), Shangyingxiang (EX-HN8), Sibai (ST2), Hegu (LI4) and Chize (LU5); warm needling was applied at Dazhui (GV14). The patients of this group received 30 min of acupuncture-moxibustion therapy 3 times weekly during the first 4 weeks and twice a week in the last 2 weeks, totally for 6 weeks. Before treatment, after treatment, in week 10, 18 and 30 of follow-up visits, the reflective total nasal symptom score (rTNSS), the total non-nasal symptom score (TNNSS), the total ophthalmic symptom score (TOSS), and the score of the rhinitis quality of life (RQLQ) scale were compared in the patients of the two groups separately. Using ELISA, the serum concentrations of total immunoglobulin E (IgE) and interleukin-4 (IL-4) were detected before and after treatment. After treatment, the rTNSS, TNNSS, TOSS, as well as RQLQ score were lower in comparison with those before treatment in each group (P<0.05).The rTNSS, TNNSS, TOSS and the score of RQLQ in the week 10, 18 and 30 of follow-up visits were reduced when compared with those before treatment in each group (P<0.05), and these scores in the acupuncture + western medicine group were remarkably lower than those of the western medicine group (P<0.05). After treatment, the serum contents of total IgE and IL-4 were significantly decreased when compared with those before treatment in the acupuncture + western medicine group (P<0.05), and these indicators in the acupuncture + western medicine group were lower than those of the western medicine group (P<0.05). On the base of treatment with fluticasone propionate nasal spray, "Fuyang Guben" acupuncture-moxibustion therapy is safe and effective on PAR, presenting a remarkably long-term efficacy. The functioning mechanism may be related to the down-regulation of total IgE and IL-4 in serum.