Rhinoconjunctivitis Quality Of Life Questionnaire Research Articles

Efficacy comparison and safety analysis of subcutaneous specific immunotherapy with standardized house dust mite allergen in patients with single and multiple allergic rhinitis

Efficacy comparison and safety analysis of subcutaneous specific immunotherapy with standardized house dust mite allergen in patients with single and multiple allergic rhinitis

Efficacy and safety of Sanfeng Tongqiao Diwan in patients with allergic rhinitis: a single-arm clinical trial in China.

BackgroundTraditional Chinese medicine (TCM) has a long history and its own characteristics in the treatment of allergic rhinitis. In this study, the efficacy and safety of patients with allergic rhinitis treated with Sanfeng Tongqiao Diwan were observed to support the clinical medication of patients with allergic rhinitis.MethodsA total of 61 patients with allergic rhinitis aged 12–70 years from the First Affiliated Hospital of Guangzhou Medical University were included in this study. All the patients were treated with Sanfeng Tongqiao Diwan for a period of 7 days. Return visits were carried out 24 hours after the first medication, the 4th day of medication, and the 7th day of medication, during which the efficacy and safety were assessed.ResultsThe effective rates of Sanfeng Tongqiao Diwan at 24 hours, 4 days, and 7 days were 49.2%, 60.7%, and 65.6%, respectively. Comparing the severity of various symptoms after treatment to baseline, significant differences were found in nasal secretion (2.95±0.67 vs. 2.26±1.30, P<0.001), stuffy nose (5.66±2.95 vs. 3.34±2.57, P<0.001), mucosa congestion (7.08±1.82 vs. 4.23±2.28, P<0.001), running nose (5.21±1.81 vs. 2.90±1.89, P<0.001), and sneezing (3.00±0 vs. 1.92±1.45, P<0.001). The full symptom scores showed progressive decline during treatment, measuring 20.21±5.13 at baseline and 12.02±6.47 at 7 days (P<0.001). Compared to the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) score of 64.61±30.27 at baseline, statistical significance (P<0.001) was found at 24 hours, 4 days, and 7 days, measuring 43.11±28.01, 40.74±28.6, and 39.97±40.48, respectively. The incidence rate of adverse events (AEs) was 3.3% (2/61), with no serious AEs.ConclusionsIn this study, the use of Sanfeng Tongqiao Diwan is effective in the treatment of allergic rhinitis patients, especially in patients with severe symptoms. Although the treatment system of TCM is different from that of Western medicine, the application of TCM will provide a new direction for the treatment of chronic diseases. Follow-up studies with an increased sample size are required for verification.

Effects of repeated oral intake of a quercetin-containing supplement on allergic reaction: a randomized, placebo-controlled, double-blind parallel-group study.

The present study aimed to investigate the effects of a 4-week repeated oral intake of a quercetin-containing supplement on allergen-induced reactions and relative subjective symptoms in Japanese adults who complained of discomfort in the eyes and nose. A randomized, placebo-controlled, double-blind parallel-group study was conducted on 66 subjects (22-78 years old) with allergic symptoms of pollinosis. The subjects were given the test product (200 mg quercetin) or the control product (vehicle) daily for 4 weeks. The Japanese Rhino-conjunctivitis Quality of Life Questionnaire (JRQLQ) scores and other tests were examined in each subject before and after starting the product intake. A new food-grade bioavailable formulation of quercetin, Quercetin phytosome®, was used. At 1:4 weeks after the start of the supplement intake, several scores of JRQLQ, including allergic symptoms, such as eye itching, sneezing, nasal discharge, and sleep disorder, were significantly improved in the quercetin-containing supplement group compared with the placebo group. Furthermore, the quality of life of these subjects significantly improved based on the original questionnaire and visual analog scale. Minor notable adverse effects were noted throughout the study. The results indicated that oral intake of quercetin-containing supplements might effectively reduce some allergy symptoms derived from pollinosis.

Effectiveness and safety of dupilumab in patients with chronic rhinosinusitis with nasal polyps and associated comorbidities: a multicentric prospective study in real life

BackgroundBiologics are currently one of the main treatment options for a number of diseases. The IgG4 monoclonal antibody dupilumab targets the Interleukin-4 receptor alpha chain, thus preventing the biological effects of the cytokines IL-4 and IL-13, that are essential for the Th2 response. Several controlled trials showed that dupilumab is effective and safe in patients with atopic dermatitis (AD), severe asthma and chronic rhinosinusitis with nasal polyps (CRSwNP), thus resulting in approval by regulatory agencies. Aim of the study was to evaluate the efficacy and safety of dupilumab in adult patients with CRSwNP stratified by common overlapping comorbid conditions.MethodsWe performed a multicenter, observational, prospective study enrolling adult patients with severe CRSwNP who had started dupilumab treatment in the context of standard care from January 2021 to October 2021. Data were collected from twentynine Italian secondary care centers for allergy and clinical immunology, all of which were part of the Italian Society of Allergy, Asthma and Clinical Immunology (SIAAIC). A number of efficacy parameters were used. Patient data were compared using the Wilcoxon test for paired data. All statistical analyses were performed with SPSS version 20 (IBM, Armonk, NY, USA).ResultsIn total, 82 patients with nasal polyposis were identified. A significant improvement was detected for all the applied efficacy parameters, i.e. 22-item Sino-Nasal Outcome Test (SNOT-22) and bilateral endoscopic nasal polyp score (NPS) scores for CRSwNP, Rhinitis Control Scoring System (RCSS) and Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) scores for allergic perennial rhinitis, Forced Expiratory Volume in the 1st second (FEV1) and Asthma Quality of Life Questionnaire (AQLQ) scores for asthma, Eczema Area and Severity Index (EASI) and Dermatology Life Quality Index (DLQI) scores for AD. A non-significant improvement was also obtained in the Urticaria Activity Score over 7 days (UAS7) for chronic spontaneous urticaria. Treatment with dupilumab was well tolerated.ConclusionsThese data suggest that dupilumab treatment in patients suffering from CRSwNP and associated comorbidities may be suitable. Such outcome, although confirmation by trials is warranted, suggests the possibility to treat different disorders with a single therapy, with favorable effects especially under the cost-effectiveness aspect.

The Efficacy and Safety of Probiotics for Allergic Rhinitis: A Systematic Review and Meta-Analysis.

BackgroundProbiotics have proven beneficial in a number of immune-mediated and allergic diseases. Several human studies have evaluated the efficacy and safety of probiotics in allergic rhinitis; however, evidence for their use has yet to be firmly established.ObjectiveWe undertook a systematic review and meta-analysis aiming to address the effect and safety of probiotics on allergic rhinitis.MethodsWe systematically searched databases [MEDLINE (PubMed), Embase, and the Cochrane Central Register of Controlled Trials] from inception until June 1, 2021. Qualified literature was selected according to inclusion and exclusion criteria, the data were extracted, and a systematic review and meta-analysis was conducted.ResultsTwenty-eight studies were included. The results showed that probiotics significantly relieved allergic rhinitis symptoms (standardized mean difference [SMD], −0.29, 95% confidence interval (CI) [−0.44, −0.13]; p = 0.0003, I 2 = 89%), decreased Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) scores compared with the control group (SMD, −0.64, 95% CI [−0.79, −0.49], p < 0.00001, I 2 = 97%), and increased T helper cell 1(Th1)/Th2 ratio (mean difference [MD], −2.47, 95% CI [−3.27, −1.68], p < 0.00001, I 2 = 72%). There was no significant change in overall or specific IgE levels between probiotic-treated and placebo-treated subjects (SMD, 0.09, 95% CI [−0.16, 0.34], I 2 = 0%, and SMD, −0.03, 95% CI [−0.18, 0.13], p = 0.72, I 2 = 0%, respectively).ConclusionsTo sum up, probiotic supplement seems to be effective in ameliorating allergic rhinitis symptoms and improving the quality of life, but there is high heterogeneity in some results after subgroup analysis and clinicians should be cautious when recommending probiotics in treating allergic rhinitis.Systematic Review Registration https://www.crd.york.ac.uk/PROSPERO/, PROSPERO (CRD42021242645).

Acupuncture for allergic rhinitis: a systematic review and meta-analysis

BackgroundIn this study, we attempted to assess the efficacy and safety of acupuncture for allergic rhinitis (AR), and to test the robustness of the estimated effects.MethodsThe Cochrane methodology standard was followed to conduct this systematic review. Randomized controlled trials (RCTs) comparing acupuncture with other therapies for AR were included. Furthermore, trial sequential analysis was conducted to test the robustness of pooled results. Thirty trials with 4413 participants were included.ResultsAcupuncture improved the nasal symptoms on Total Nasal Symptom Score (TNSS) and quality of life measured by Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) in adults with AR, compared to acupuncture with no intervention. Acupuncture was also shown to be more effective than sham acupuncture for nasal symptom (RQLQ subscale, n = 489, MD − 0.60, 95% CI − 1.16 to − 0.04) and quality of life (RQLQ, n = 248, − 8.47 95% CI − 14.91, − 2.03). No clear difference was observed between acupuncture and cetirizine or loratadine. Interestingly, trial sequential analysis (TSA) failed to confirm the aforementioned results. The effect of acupuncture for children/adolescents with AR remains unclear due to insufficient data. The performance bias and attrition bias are serious in most studies that were included. Selection bias may also have affected the quality of the evidence.ConclusionAcupuncture may have an advantage over no intervention and sham acupuncture in improving nasal symptoms and quality of life for adults with AR. The effect of acupuncture and cetirizine or loratadine for AR may be similar. Additional trials are necessary to confirm these results.

Effectiveness and safety of electric heating moxibustion for perennial allergic rhinitis: A pilot, randomized, assessor-blind trial

BackgroundThe prevalence of allergic rhinitis (AR), an inflammatory disease, is gradually increasing. Studies have reported that moxibustion is effective for treating AR. Electric heating moxibustion (EM) was developed to offer adaptable heat stimulation without the generation of smoke. ObjectivesThe objective of this study was to examine the possibility of EM in treating perennial allergic rhinitis (PAR) and to assess the feasibility of using this technique on a larger scale by comparing EM with acupuncture (AC). DesignA randomized pilot study was conducted on 40 patients with PAR. Patients were randomly assigned to one of two treatment groups: EM or AC. The primary outcome measure was the change in the total nasal symptom score (TNSS) between before and after treatment. The secondary outcome measures were the changes in the rhinoconjunctivitis quality of life questionnaire (RQLQ), nasal endoscopy index for pattern identification, pattern identification questionnaire for AR, total serum immunoglobulin E (IgE), eosinophil count, and adverse effects (AEs). ResultsThe results showed a statistically significant improvement in mean TNSS and RQLQ scores in both groups (p < 0.05), but no significant difference between the two groups. However, mean changes in itching and sneezing TNSS were significantly higher in the AC group. There was no significant difference in total serum IgE or eosinophil count before versus after treatment, nor was there any significant difference of three pattern subgroups between the two groups in the mean TNSS change. While the AC group reported two treatment-related AEs, there were no treatment-related AEs in the EM group. ConclusionThis trial provides evidence that EM isa safe alternative treatment for patients with PAR. Trial registrationClinicalTrials.gov, NCT03342105. Registered on 14 November 2017.

Efficacy and Safety of Lactobacillus reuteri CCFM1040 in Allergic Rhinitis and Asthma: A Randomized, Placebo-Controlled Trial.

The coexistence of allergic rhinitis (AR) and asthma reinforces the concept of “one airway, one disease,” which has prompted the exploration for a single intervention to treat both diseases. Lactobacillus reuteri CCFM1040 (CCFM1040) was found to be an inhibitor of the common pathogenesis of AR and asthma in our previous studies. This study presented a randomized, placebo-controlled trial to investigate the clinical effects of CCFM1040 on both diseases. The total symptom score (TSS), the quality of life (QoL), and the modulation in the gut microbiota of patients with AR, the Asthma Control and Test (ACT) of patients with asthma, and the safety of both AR and asthma were measured. In patients with AR, CCFM1040 numerically decreased TSS, Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ), 3 nasal scores in TSS (nasal congestion, watery eyes, and rhinorrhea), and sleep and significantly improved (P = 0.014) non-nose/eye symptoms. The ACT score was numerically increased in patients with asthma (from partially controlled to well-controlled). Significant microbial (from class level to genus level) and metabolic differences (P < 0.05) were found in patients with AR. No adverse reactions were observed. No effect on the blood and urine routine indexes. CCFM1040 has a potential benefit on both diseases. Further studies based on these findings will help to optimize the management of AR and asthma.

Intralymphatic immunotherapy with one or two allergens renders similar clinical response in patients with allergic rhinitis due to birch and grass pollen.

IntroductionThere is a need for a fast, efficient and safe way to induce tolerance in patients with severe allergic rhinitis. Intralymphatic immune therapy has been shown to be effective.MethodsPatients with severe birch and timothy allergy were randomized and received three doses of 0.1 ml of birch and 5‐grass allergen extracts (10,000 SQ units/ml, ALK‐Abelló), or birch and placebo or 5‐grass and placebo by ultrasound‐guided injections into inguinal lymph nodes at monthly intervals. Rhinoconjunctivitis total symptom score, medication score and rhinoconjunctivitis quality of life questionnaire were evaluated before treatment and after each birch and grass pollen season during three subsequent years. Circulating proportions of T helper subsets and allergen‐induced cytokine and chemokine production were analysed by flow cytometry and Luminex.ResultsThe three groups reported fewer symptoms, lower use of medication and improved quality of life during the birch and grass pollen seasons each year after treatment at an almost similar rate independently of treatment with one or two allergens. Mild local pain was the most common adverse event. IgE levels to birch decreased, whereas birch‐induced IL‐10 secretion increased in all three groups. IgG4 levels to birch and timothy and skin prick test reactivity remained mainly unchanged. Conjunctival challenge tests with timothy extract showed a higher threshold for allergen. In all three groups, regulatory T cell frequencies were increased 3 years after treatment.ConclusionsIntralymphatic immunotherapy with one or two allergens in patients with grass and birch pollen allergy was safe, effective and may be associated with bystander immune modulatory responses. Clinical Trial Registration: EudraCT (2013‐004726‐28).

Endoscopic posterior nasal neurectomy for the treatment of allergic rhinitis: anatomy and analysis of clinical efficacy

Objective: To propose total posterior nasal neurectomy with transection of sphenopalatine neurovascular bundle from anatomy for the treatment of allergic rhinitis, and to explore its clinical application. Methods: Two fresh cadaveric heads (4 sides) were dissected through endoscopic transnasal middle meatus approach at Otorhinolaryngology Anatomy Laboratory of China-Japan Friendship Hospital. The structures of the craniofacial bone related to the surgical approach were observed. Twelve patients with allergic rhinitis who treated in Department of Otorhinolaryngology, China-Japan Friendship Hospital from Feb. 1 2019 to Jun. 10 2021 were selected. All the patients were treated by posterior nasal neurotomy with the technique of complete transection of sphenopalatine neurovascular bundle and followed up for 1 year after sugery. During the follow-up, 2 patients were lost. The other 10 patients included 4 males and 6 females, aging from 29 to 69 years. Visual Analogue Scale (VAS) and Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) were used to evaluate the effect of the surgery. SPSS 25.0 software was used for statistical analysis. Results: Important anatomic landmarks of transnasal middle meatus approach were obtained during anatomy, such as ethmoid crest, sphenopalatine foramen/notch, palatine orbital process and sphenopalatine process. The postoperative VAS scores of nose, eye, pharynx, ear and whole body and total VAS scores were significantly lower than those before operation, with statistically significant difference (nose 2.50±1.70 vs 6.47±2.17, eyes 1.15±0.89 vs 3.60±2.57, pharynx 1.30±1.36 vs 4.25±3.64, ear 1.10±1.03 vs 2.67±2.00, whole body 1.08±1.24 vs 3.60±1.17, total 7.13±4.31 vs 20.58±9.05, all P<0.05). The postoperative RQLQ scores of sleep, nose, eyes, practical problems, emotion, activity and the total RQLQ scores of patients were significantly lower than those before operation, with statistically significant difference (sleep 0.80±0.69 vs 2.93±1.33, nose 1.38±1.18 vs 3.93±1.50, eyes 0.58±0.66 vs 1.80±1.25, practical problems 1.10±1.22 vs 3.03±1.84, emotion 1.00±1.81 vs 2.58±2.00, activity 2.77±2.93 vs 6.00±1.85, total 8.99±8.92 vs 22.42±8.69, all P<0.05). There was no significant difference in preoperative and postoperative scores of non-nasal/ocular symptoms (1.37±1.60 vs 2.16±1.12, P=0.166). There was no other complication except 2 cases with short-term postoperative numbness. Conclusions: Total posterior nasal neurectomy with transection of sphenopalatine neurovascular bundle is a safe, effective and feasible method for the treatment of intractable allergic rhinitis, and its long-term efficacy needs further observation.

A Meta-Analysis of Probiotics for the Treatment of Allergic Airway Diseases in Children and Adolescents.

Allergic airway disease is a chronic airway allergic inflammatory disease including allergic rhinitis (AR) and allergic asthma which is common in children and adolescents. Recently the probiotics has been becoming a supplementary or alternative therapy to allergic diseases, however the effect of them has not been clearly established. The purpose of the present meta-analysis was to evaluate the effectiveness of probiotics on allergic airway disease including AR and allergic asthma in children and adolescents. We performed a comprehensive search on PubMed, Cochrane Library, EMBASE for relevant publications from 1 Jan 2000 to 1 July 2021. Physical examinations, Pediatric Rhinoconjunctivitis Quality of Life Questionnaires (PRQLQs), Total Nasal Symptom Score (TNSS), Nasal or Eye Symptom Score (NSS or ESS), serum allergen-specific IgE, and eosinophil were used as evaluating indicators for AR and allergic asthma in children and adolescents. The meta-analysis was performed using Review Manager (RevMan, Version 5.3). 15 randomized controlled trials (RCTs) with a total of 1388 participants were included for the meta-analysis. Among them, 729 patients treated with probiotics served as the probiotics group, and 659 patients with placebo as control group. Significantly greater reduction in PRQLQs from baseline to endpoint (SMD = -2.57, 95% CI [ - 4.66, -0.48] P < 0.01), NSS (SMD = -1.43, 95% CI [ - 1.63, - 1.23], P < 0.01) and ESS (total MD = -1.67, 95% CI [ - 1.79, - 1.55], P < 0.01) were observed in probiotics group compared to control group. Probiotics have no significant effect to serum IgE and eosinophils (P > 0.01). The results of this meta-analysis indicated that probiotics treatment may reduce PRQLQs, NSS, ESS in patients with allergic airway disease. More research involving the mechanism of probiotics are needed to clarify the role of probiotics in AR and allergic asthma in children and adolescents.

Intranasal low-level laser therapy versus acupuncture treatment for allergic rhinitis: A randomized, noninferiority trial

IntroductionIntranasal low-level laser therapy (LLLT) has already proven its immunosuppressive effects on allergic rhinitis (AR) in experimental studies; however, there is a dearth of clinical evidence supporting its effects in treating AR. The aim of this study was to assess the safety and effectiveness of intranasal LLLT in the treatment of AR compared with acupuncture. MethodsA total of 80 patients with AR participated and were randomly assigned to the intranasal LLLT or acupuncture treatment (AT) group. They were given each treatment for 20 min 3 times a week for 4 weeks. ResultsBoth groups improved the total nasal symptom score (TNSS), rhinoconjunctivitis quality of life questionnaire (RQLQ) score, and nasal endoscopy index in patients with AR after 4 weeks of treatment, and these effects extended 4 weeks after the end of treatment. Intranasal LLLT was noninferior to AT in regard to the TNSS. The estimated outcome difference between baseline and the 5th week was −0.38 points (upper 97.5% confidence limit 1.06 points), which was within the noninferiority margin of 2 points. The effect size of the TNSS at the 5th week was 0.19, which was close to Cohen's small effect size. There were no significant differences between two groups regarding the RQLQ, nasal endoscopy index, total serum immunoglobulin E level or absolute eosinophil count. ConclusionThis study showed that intranasal LLLT is noninferior compared to AT in terms of the TNSS; thus, it may be used as an alternative or adjunctive treatment option for relieving symptoms of AR. Trial registrationThis study was registered at the Korean National Clinical Trial Registry, Clinical Research Information Service (KCT0004079).

Dupilumab Improves Asthma Control, and Allergic Rhinitis-Related Health-Related Quality of Life in Children With Uncontrolled Persistent Asthma With Comorbid Allergic Rhinitis

Children with asthma frequently have comorbid allergic rhinitis (AR). Dupilumab, a fully human monoclonal antibody, blocks the shared receptor component for interleukin (IL)-4/13, key and central drivers of type 2 (T2) inflammation in multiple diseases. VOYAGE, a 52-week, randomized, double-blind, placebo-controlled, phase 3 study (NCT02948959), evaluated dupilumab efficacy and safety in children aged 6–11 years with uncontrolled persistent asthma. We assessed the impact of dupilumab on asthma control (interviewer-administered 7-Item Asthma Control Questionnaire [ACQ-7-IA]) and AR-related health-related quality of life (HRQoL) (interviewer-administered Pediatric Rhinoconjunctivitis Quality of Life Questionnaire [PRQLQ-IA]) in children with a T2 inflammatory asthma phenotype (baseline blood eosinophils ≥150 cells/μL or FeNO ≥20 ppb), and co-existing AR.

Endotyping Seasonal Allergic Rhinitis in Children: A Cluster Analysis.

BackgroundSeasonal Allergic Rhinitis (SAR) is a heterogeneous inflammatory disease. We hypothesized that a cluster analysis based on the evaluation of cytokines in nasal lavage (NL) could characterize distinctive SAR endotypes in children.MethodsThis cross-sectional study enrolled 88 children with SAR. Detailed medical history was obtained by well-trained physicians. Quality of life and sleep quality were assessed through standardized questionnaires [Pediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ) and Pittsburgh Sleep Quality Index (PSQI) respectively]. Children were grouped through K-means clustering using Interleukin (IL)-5, IL-17, IL-23, and Interferon (INF)-γ in NL.ResultsOut of the 88 patients enrolled, 80 were included in the cluster analysis, which revealed three SAR endotypes. Cluster 1 showed lower levels of IL-5 and IL-17 and intermediate levels of IL-23 and IFN-γ; Cluster 2 had higher levels of IL-5 and intermediate levels of IL-17, IL-23, and IFN-γ; Cluster 3 showed higher levels of IL-17, IL-23, and IFN-γ and intermediate levels of IL-5. Cluster 1 showed intermediate values of nasal pH and nasal nitric oxide (nNO), and a lower percentage of neutrophils at nasal cytology than Clusters 2 and 3. Cluster 2 had a lower level of nasal pH, a higher nNO, higher scores in the ocular domain of PRQLQ, and worse sleep quality than Clusters 1 and 3. Cluster 3 showed a higher percentage of neutrophils at nasal cytology than Clusters 1 and 2.ConclusionsOur study identified three endotypes based on the evaluation of cytokines in NL, highlighting that childhood SAR is characterized by heterogeneous inflammatory cytokines.

Determining the minimal important differences in the RQLQ score with grass and tree allergy immunotherapy versus placebo in adults with moderate-to-severe allergy.

BackgroundPollen from grasses and trees can trigger allergic rhinitis (AR), where the symptoms and associated consequences can negatively affect quality of life (QoL). The Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) is frequently used in clinical trials of AR to assess QoL. To help interpret RQLQ data, the minimal important difference (MID) can be used to assess whether a mean difference in QoL between treatment groups is clinically meaningful. In seasonal allergy, an MID differs according to the allergen, pollen exposure, symptom severity, patient age and treatment; the same MID cannot be applied to all scenarios.MethodsUsing data from four Phase III clinical trials of SQ sublingual immunotherapy‐tablets in adults with moderate‐to‐severe allergy, between‐group MIDs were derived for the RQLQ in grass pollen allergy (during the peak [n = 501] and entire [n = 514] pollen seasons), and in tree pollen allergy (during the birch [n = 516] and tree [n = 518] pollen seasons), using anchor‐based methodology, supported by distribution‐based methods.ResultsFor grass pollen allergy, anchor‐based derived between‐group MIDs were 0.22 for the entire pollen season (n = 343) and 0.10 for the peak pollen season (n = 335). For tree pollen allergy, anchor‐based derived between‐group MIDs were 0.26 for the tree pollen season (n = 306) and 0.16 for the birch pollen season (n = 305) (representative of peak season). Distribution‐based derived MIDs were supportive of the anchor‐based values.ConclusionsThis analysis has derived between‐group MIDs specific to the trial populations evaluated and to the conditions under which the data were obtained, and highlights the need for a range of MIDs to reflect the unique nature of seasonal allergic disease.

Conception and Clinical Efficacy of an Osmotic, Polymeric, Stable Nasal Filmogen Barrier for Preventive Treatment of Allergen and Pollution Induced Rhinitis and Respiratory Symptoms

Background: Pollution induced allergic rhinitis and respiratory symptoms is becoming a major health problem in the world for which still there is no safe and preventive treatment. Objectives: Conceive and evaluate the allergen preventive properties and clinical efficacy of an osmotic, polymeric, stable filmogen spray, called PCNS. Materials and Methods: Amb A 1 (ragweed), Der P 1 and 2 (dust mite), Bet v 1 (birch), Alt a 1 (Alternaria, fungus), and Fel d 1 (cat dander) allergens were exposed at a concentration of 5µg/ml (20 µl per tube) on the polymeric test product film (120 and 240µl layer) and the allergens crossing the barrier were quantified in the agar gel beneath the film. 0.40% HPMC and PBS solutions, tested identically, served as controls. Clinical efficacy of PCNS nasal spray was evaluated in patients suffering from allergic rhinitis and/or respiratory symptoms (29 in test product v/s 15 in saline controls) for 22 days. Nasal, ocular, respiratory symptoms and Rhino conjunctivitis Quality of Life Questionnaire (RQLQ) were measured. Statistical analyses: The normality of the populations was determined by the Shapiro-Wilk test, then statistical analysis was performed by two-tailed Student’s test for comparisons between two groups and the two-way ANOVA followed by the post hoc Bonferroni’s test for comparisons of multiple groups. p&lt;0.05 was considered statistically significant. The analyses were performed with the software GraphPad Prism (version 8.4.2, La Jolla, USA). NS indicates not significant. Results: PCNS polymeric spray blocked the diffusion of all the allergens while 0.40% HPMC was able to prevent diffusion of only Alt a 1 and Fel d 1 allergens. Mean reflective total nasal symptom scores (rTNSS), reflective total ocular symptom score (rTOSS), and respiratory symptoms including effect on wheezing, cough, dyspnea, and chest tightness were moderately improved in the control saline group, but the improvements were nearly twice better in the PCNS group. RQLQ was improved by 23% in saline spray v/s 46% PCNS group. 4/15 patients in saline group v/s 1/29 in PCNS group required rescue medication during the study. PCNS was highly effective in reducing allergen and pollution induced respiratory symptoms. Conclusion: a polymeric, osmotic, and stable nasal barrier against pollutants and allergens represents an innovative approach against pollution induced respiratory symptoms.

Changes in olfaction & quality of life following standard medical therapy in patients with intermittent & persistent allergic rhinitis.

Allergic rhinitis (AR) is an inflammatory disease prevalent worldwide which can affect both olfaction and quality of life (QoL). The objective of the present study was to assess olfaction and QoL changes in patients with AR before and after medical therapy. Adult participants (>18 yr) with AR were recruited for this study. These patients prospectively underwent olfaction testing using the modified Connecticut Chemosensory Clinical Research Centre Test and QoL assessment using Rhinoconjunctivitis QoL Questionnaire (RQLQ) before and after standard medical therapy with topical steroids and/antihistaminics. Of the 150 patients recruited, 72 per cent had intermittent AR. The symptom of hyposmia was present in 34 patients (22.7%) and was more prevalent in patients with moderate-to-severe type of AR (P<0.001). However, olfaction testing revealed hyposmia/anosmia in 44 patients (29.3%). Mean composite olfaction scores were significantly higher in patients with mild AR compared to moderate/severe AR (P=0.026). The pre-therapy mean composite olfaction score in the 34 patients with olfaction disturbances was 3.1 standard deviation (±1.06 SD). Following therapy, the mean composite olfaction score rose to 4.3 (±1.34 SD) and this change was found to be significant (P<0.001). Mean pre-therapy RQLQ scores were 2.87 (0.06-5.33) overall. Significant improvement was also found in RQLQ scores following therapy (P<0.001). Mean RQLQ scores were significantly lower in those with moderate-to-severe AR (P<0.001) as well as those with intermittent AR (P=0.004). Nine patients had persistently high RQLQ scores after medical therapy. Both olfaction and QoL showed significant improvement after medical therapy in Indian adults with AR. In those patients who do not improve, other causes must be sought for the persistent symptoms.

Daily intake of Citrus jabara fruit peel powder (Japanese Patent No. 5,323,127) improves allergy-like symptoms: A randomized double-blind parallel-group comparative study

Citrus jabara (CJ) is a rare citrus fruit that used to grow naturally only in the southern part of the Kii Peninsula in Japan. Human intervention studies with oral intake of CJ fruit have shown its anti-allergic effects, but the testing method was a pre-post comparison study. In this study, we conducted a randomized, double-blind, parallel-group interventional study to evaluate the volume-dependent effects of oral intake of CJ fruit peel powder (Japanese Patent No. 5,323,127) on nasal and eye allergy-like symptoms. Ninety healthy adults were allocated to three groups and given test foods containing 1,000, 500, and 0 mg of CJ peel powder, with one packet per day for 4 weeks. After excluding those who dropped out or deviated from the study protocol, 73 were included in the efficacy analysis and 86 in the safety analysis. The high-dose group (1,000 mg/day) was significantly lower than the placebo group in the scores of “nasal and eye symptoms” at week 4, and “blocked nose” at weeks 2 and 4 in the evaluation of question I of Japanese Rhino-conjunctivitis Quality of Life Questionnaire (JRQLQ No. 1). The changes in scores (difference from the pre-observation period) on the Nasal and Eye Symptom Questionnaire showed a dose-dependent reduction in rhinorrhea. In the safety evaluation, there were no significant differences in examinations of physiology, hematology, and blood biochemistry between the groups, and no adverse events attributable to the test foods were observed. These results suggest that intake of CJ peel powder can alleviate allergy-like symptoms.

A Comparative Study of Fluticasone Alone and Fluticasone with Azelastine Nasal Spray in Patients with Allergic Rhinitis

In India, 20-30% of the population suffers from allergic rhinitis. Its prevalence increasing over the past many years and often adversely affects the quality of life. Little importance is given to allergic rhinitis and patients fail to correlate the ill-health to symptoms of allergic rhinitis in India. Studies have shown that patients with allergic rhinitis adversely affect the behavior, work performance, and lifestyle of patients. Hence this study was undertaken to compare the efficacy of fluticasone alone and in combination with azelastine. A total of 60 patients were randomly assigned into two groups (30 patients each), where the first group received fluticasone and the other group received fluticasone + azelastine. Drugs were administered as nasal spray and improvement were assessed using Total Nasal Symptom Score (TNSS) and Quality of life was assessed using Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) at baseline and at 2 weeks. Descriptive statistics and student’s t-test was used to analyze data. Both the groups had statistical improvement in TNSS and RQLQ scores when compared to baseline within the groups (p &lt; 0.0001). Comparison of overall TNSS between the groups was statistically significant (p &lt; 0.001), though total RQLQ scores were insignificant (&lt; 0.02) when compared between two groups. It was observed that both drugs were safe and efficacious. By these results, we conclude that the combination therapy showed better improvement in TNSS when compared to fluticasone alone. Azelastine due to antihistaminic properties and fluticasone anti-inflammatory effect showed synergistic anti-inflammatory effect and improvement in quality of life

Mepolizumab Is an Effective Option in Severe Eosinophilic Asthma Regardless of Baseline Features: Single-Center Real-Life Data

Background: Mepolizumab has been approved as a treatment option for severe eosinophilic asthma (SEA) patients in our country. We aimed to evaluate the clinical and functional efficacy of mepolizumab in this group of patients in real life as well as the response rates to mepolizumab and the possible factors affecting the response. Methods: The study was a retrospective chart review of patients with SEA treated with mepolizumab. The data were collected at baseline, and at the 6th and 12th month. Results: A total of 62 patients (41F/21M) with a mean age of 44.41 ± 13.24 years were included in the study. They had poor symptom control with a mean asthma control test (ACT) score of 16.61 ± 5.59, frequent exacerbations with a mean of 3.4 ± 3.7 in the previous 12 months, and 80.6% required daily oral corticosteroid (OCS) with a median dosage of 8 mg/day as methylprednisolone. The ACT score increased to 22.47 ± 3.18 and 22.03 ± 4.31, respectively, and blood eosinophil count decreased from 1,146/μL to 89/μL and 85/μL at the 6th and 12th month, respectively. The mean FEV1 at baseline was 2.102 L there was an increase of 0.373 L at 6th month and 0.596 L at 12th month. The percentage of regular users of OCS decreased to 66.0% at 6th month with a median dosage of 4 mg and 52.6% at 12th month with a median dosage of 2 mg. Mepolizumab reduced the rate of exacerbations compared with the previous year from a mean of 3.40 to 0.15 at 6th month and 0.36 at 12th month. There was a significant improvement in Asthma Quality of Life Questionnaire (AQLQ), Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ), and Sino-nasal Outcome Test (SNOT-22) scores at both of time points. The rate of responders and super-responders at 6th month was 60% and 28%, respectively, and consequently, the overall response rate was 88%. At the 12th month, the super-responder rate increased to 44.7% as well as the overall response to 89.4%. The only difference between the nonresponders, responders, and super-responders at the 6th and 12th month was whether regular daily OCS was used pre-mepolizumab. All nonresponders at both 6th and 12th month were using OCS regularly, whereas most of super-responder used the OCS only during exacerbations. Conclusion: Mepolizumab effectively reduced asthma exacerbations, steroid requirement, blood eosinophil counts and improved asthma control, pulmonary function, sinonasal symptoms and quality of life. Our data suggest that mepolizumab would be effective in selected patients in real-life settings.