{"title":"Phase II multicenter clinical trial of hypoallergenic 1BS-18 Hokushin bread oral immunotherapy for wheat-dependent exercise-induced anaphylaxis.","authors":"Kunie Kohno, Yuko Chinuki, Akiko Sugiyama, Reiko Kishikawa, Mayumi Okamoto, Michihiro Hide, Yoshiko Oda, Atsushi Fukunaga, Ritsuro Suzuki, Eishin Morita","doi":"10.5415/apallergy.0000000000000180","DOIUrl":"10.5415/apallergy.0000000000000180","url":null,"abstract":"<p><strong>Background: </strong>Therapies for desensitizing wheat-dependent exercise-induced anaphylaxis (WDEIA), a severe allergic response to wheat ingestion and exercise, remain unestablished. This study aimed to investigate whether continuous ingestion of hypoallergenic 1BS-18 Hokushin bread, which lacks the <i>Gli-B1</i> locus encoding the ω5-gliadin allergen, could achieve desensitization in adult patients with WDEIA sensitized to ω5-gliadin.</p><p><strong>Methods: </strong>Sixteen adult patients diagnosed with WDEIA participated in this study. Each patient was administered a safety dose of bread made from 1BS-18 Hokushin wheat, a hypoallergenic wheat that defects the <i>Gli-B1</i> locus responsible for encoding the ω5-gliadin allergen, over a 12-week period. The safe dose for each individual was determined through a stepwise increase in bread intake and monitored to prevent allergic reactions. Desensitization efficacy was evaluated by measuring basophil activation rates and serum allergen-specific IgE levels specific to wheat proteins using the basophil activation test and ImmunoCAP serum testing.</p><p><strong>Results: </strong>Fourteen of the 16 patients (87.5%) successfully completed the 12-week regimen of 1BS-18 Hokushin bread, with 2 patients (12.5%) discontinuing due to allergic reactions associated with the bread. Evaluation of basophil activation rates and serum allergen-specific IgE levels indicated no significant desensitization effects in any patient.</p><p><strong>Conclusions: </strong>Approximately 80% of patients with WDEIA were able to safely consume 1BS-18 Hokushin bread at least up to 60 g per day for 12 weeks without severe adverse reactions. However, this regimen did not achieve desensitization, suggesting that further studies may be necessary to explore alternative dosing, duration, or combinations with adjunct therapies for effective desensitization in patients with WDEIA.</p>","PeriodicalId":8488,"journal":{"name":"Asia Pacific Allergy","volume":"15 2","pages":"67-73"},"PeriodicalIF":2.1,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12289074/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144726915","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Asia Pacific AllergyPub Date : 2025-06-01Epub Date: 2025-03-17DOI: 10.5415/apallergy.0000000000000192
Ji-Yoon Oh, Chae Eun Lee, Seo Young Kim, Hyunkyoung Kim, Yu Ri Kang, Ji-Hyang Lee, Woo-Jung Song, Hyouk-Soo Kwon, You Sook Cho, Tae-Bum Kim
{"title":"Serum neuropilin-1 level may predict airway remodeling based on age and smoking status in asthma.","authors":"Ji-Yoon Oh, Chae Eun Lee, Seo Young Kim, Hyunkyoung Kim, Yu Ri Kang, Ji-Hyang Lee, Woo-Jung Song, Hyouk-Soo Kwon, You Sook Cho, Tae-Bum Kim","doi":"10.5415/apallergy.0000000000000192","DOIUrl":"10.5415/apallergy.0000000000000192","url":null,"abstract":"<p><strong>Background: </strong>Airway remodeling in asthma is induced by the production of vascular endothelial growth factor, and this process is mediated by neuropilin-1 (NRP-1).</p><p><strong>Objective: </strong>To investigate the association between the serum level of NRP-1 and clinical characteristics in asthma.</p><p><strong>Methods: </strong>We measured the serum level of NRP-1 and performed subgroup analysis of NRP-1 according to the clinical characteristics of 421 asthma patients registered in the Cohort for Reality and Evolution of Adult Asthma in Korea.</p><p><strong>Results: </strong>The serum level of NRP-1 was significantly higher in the group under 65 years of age than in the group over 65 years of age (1628.36 ± 589.51 vs 1416.75 ± 671.42; <i>P</i> < 0.001). Current smokers and ex-smokers had a significantly higher serum NRP-1 level compared with that of never smokers (1647.16 ± 572.34 vs 1528.5 ± 579.37; <i>P</i> = 0.041). Medium- and high-inhaled corticosteroid users had a higher serum NRP-1 level compared with that of low-inhaled corticosteroid users (1589.87 ± 591.7 vs 1436.12 ± 419.21; <i>P</i> = 0.049). The serum NRP-1 level was significantly higher in the group with a forced vital capacity (FVC) of 70% or higher than in the group with an FVC of 70% or lower. In univariate analysis, age was a factor influencing serum NRP-1 with a negative correlation (coefficient=-260.90; <i>P</i> < 0.001). Ex-smokers and current smokers were factors influencing serum NRP-1 with a positive correlation (coefficient = 118.66; <i>P</i> = 0.0412). An FVC of 70% or higher was a factor affecting serum NRP-1 with a positive correlation (coefficient = 173.86; <i>P</i> = 0.0224). Multivariable analysis revealed that age (coefficient = -233.53; <i>P</i> < 0.001) and smoking history (coefficient = -122.4; <i>P</i> = 0.0358) were significant variables affecting serum NRP-1.</p><p><strong>Conclusion: </strong>Serum NRP-1 level was high in asthma patients with a younger age and smoking history, suggesting its potential as a clinical marker for predicting early-stage airway remodeling based on the age and smoking status.</p>","PeriodicalId":8488,"journal":{"name":"Asia Pacific Allergy","volume":"15 2","pages":"63-66"},"PeriodicalIF":2.1,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12289087/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144726917","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Intensive bronchial dilation test: A modified method for evaluating airway reversibility.","authors":"Yujuan Yang, Ningbo Tang, Yuemei Sun, Liping Liu, Jianwei Wang, Pengyi Yu, Jiayu Cao, Yu Zhang, Xicheng Song","doi":"10.5415/apallergy.0000000000000178","DOIUrl":"10.5415/apallergy.0000000000000178","url":null,"abstract":"<p><strong>Background: </strong>A negative bronchial dilatation test (BDT) does not fully reflect the status of airway irreversibility in patients with severe obstructive or mixed ventilation dysfunction due to severe bronchospasm, mucus blockage, or insensitivity to bronchodilators, which will directly affect the subsequent diagnosis and treatment of those patients.</p><p><strong>Objective: </strong>We retrospectively examined the feasibility of using the \"intensive bronchial dilation test\" (IBDT) for excluding false-negative BDT.</p><p><strong>Methods: </strong>We retrospectively analyzed the clinical data of 82 patients with severe obstructive or mixed ventilation dysfunction in the Allergy department of Yantai Yuhuangding Hospital of Qingdao University. After the BDT, they all inhaled the triple atomized drugs (2 mg salbutamol, 1 mg budesonide, and 0.25 mg ipratropium) every 20 minutes in one hour and the lung function test was performed 15 minutes later, which was named as IBDT. All patients received another lung function test after 2 to 4 weeks of regular anti-inflammatory treatment. We compared the improvement of lung function indexes and the proportion of patients with reversible airway obstruction between BDT, IBDT, and 2 to 4 weeks of treatment groups.</p><p><strong>Results: </strong>The lung function indexes were significantly improved after the IBDT than those after the BDT (all <i>P</i> values < 0.01) and the number of patients with reversible airway obstruction significantly increased from 31 to 61 after the IBDT (<i>P</i> < 0.001), but the proportion of patients with reversible airway obstruction after the IBDT did not differ from that of patients with reversible airway obstruction after 2 to 4 weeks of treatment. The accuracy and sensitivity of the IBDT in evaluating airway reversibility reached 91.46% and 89.71%, respectively, both of which were significantly higher than for the BDT (54.88% and 45.59%, respectively).</p><p><strong>Conclusion: </strong>Our finding suggests that IBDT can more accurately and rapidly evaluate airway reversibility in patients with severe obstructive or mixed ventilation dysfunction when compared to BDT.</p>","PeriodicalId":8488,"journal":{"name":"Asia Pacific Allergy","volume":"15 2","pages":"45-48"},"PeriodicalIF":2.1,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12289092/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144726914","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Asia Pacific AllergyPub Date : 2025-06-01Epub Date: 2025-03-17DOI: 10.5415/apallergy.0000000000000201
Yoshinori Morita, Karin Tsuchiya, Kazuyuki Sogawa, Naoki Shimojo
{"title":"Garlic allergy in an infant: Identification of alliin lyase 1 and 2 as causative allergens.","authors":"Yoshinori Morita, Karin Tsuchiya, Kazuyuki Sogawa, Naoki Shimojo","doi":"10.5415/apallergy.0000000000000201","DOIUrl":"10.5415/apallergy.0000000000000201","url":null,"abstract":"<p><p>Garlic allergy is rare and is infrequently reported as a food allergy. This report details the case of a 13-month-old girl who developed an allergy to garlic. The consumption of a stew containing undercooked garlic triggered her allergic reaction. Blood tests revealed a garlic-specific IgE level of 10.3 kUA/L. In addition, in the skin prick test, a 4 × 4 mm, 2 × 2 mm, and 1 × 1 mm wheal was induced by raw garlic, garlic heated for 5 min, and garlic heated for 10 min, respectively. She had a known history of egg allergy. The foods consumed at the time did not contain eggs and included all other foods she had previously tolerated, except garlic. Therefore, we diagnosed her with a garlic allergy. We performed western blotting and mass spectrometric analysis and identified alliin lyase 1 and alliin lyase 2 as the major allergens. We further confirmed that the patient's sera reacted with recombinant alliin lyase 1 and 2. To our knowledge, this is the first report to accurately demonstrate the involvement of alliin lyase 1 and alliin lyase 2 in a patient with garlic allergy. Moreover, it highlights the differences in reactivity to garlic heated for different durations. In patients with garlic allergy, reactivity to heating time should be examined with skin prick tests.</p>","PeriodicalId":8488,"journal":{"name":"Asia Pacific Allergy","volume":"15 2","pages":"118-120"},"PeriodicalIF":2.1,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12289072/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144726891","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"The association of environmental house dust mite allergens and crustacean allergy: The Japan Environment and Children's Study (JECS).","authors":"Reiji Kojima, Ryoji Shinohara, Megumi Kushima, Hideki Yui, Sanae Otawa, Sayaka Horiuchi, Kunio Miyake, Hiroshi Yokomichi, Yuka Akiyama, Tadao Ooka, Zentaro Yamagata","doi":"10.5415/apallergy.0000000000000169","DOIUrl":"10.5415/apallergy.0000000000000169","url":null,"abstract":"<p><strong>Background: </strong>The higher crustacean allergy prevalence in Asia than in Western regions may be due to a shrimp-mite cross-reaction. A high environmental house dust mite prevalence may lead to increased house dust mite sensitization and thereby increase the prevalence of crustacean allergy.</p><p><strong>Objective: </strong>To determine the association between environmental house dust mite allergens and crustacean allergy in Japanese preschool children.</p><p><strong>Methods: </strong>We used data from 4,242 mother-infant dyads who participated in the subcohort study of the Japan Environment and Children's Study, a prospective birth cohort study. A logistic regression model was used to analyze the association between house dust mite allergens in dust at 18 months and 3 years of age and crustacean allergy at the age of 4 years.</p><p><strong>Results: </strong>The crustacean allergy prevalence was 0.4%. Greater house dust mite exposure at 18 months of age was associated with a higher prevalence of crustacean allergy, although this association was not statistically significant. However, there was no positive association between house dust mite exposure at 3 years of age and crustacean allergy.</p><p><strong>Conclusions: </strong>No association between house dust mite allergen exposure in infancy and the risk of crustacean allergy at preschool age was apparent. Follow-up studies, including investigation of tropomyosin sensitization in schoolchildren, are required.</p>","PeriodicalId":8488,"journal":{"name":"Asia Pacific Allergy","volume":"15 2","pages":"57-62"},"PeriodicalIF":2.1,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12289099/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144726918","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Asia Pacific AllergyPub Date : 2025-03-01Epub Date: 2025-01-13DOI: 10.5415/apallergy.0000000000000174
Menglin Wang, Yuan Zhang, Jingyun Li, Chengshuo Wang, Luo Zhang
{"title":"Stapokibart (CM310) in patients with uncontrolled seasonal allergic rhinitis (PHECDA): Rationale and design of a multicentre, randomized, double-blind, placebo-controlled study.","authors":"Menglin Wang, Yuan Zhang, Jingyun Li, Chengshuo Wang, Luo Zhang","doi":"10.5415/apallergy.0000000000000174","DOIUrl":"10.5415/apallergy.0000000000000174","url":null,"abstract":"<p><strong>Background: </strong>Seasonal allergic rhinitis (SAR) is a global health issue, and the current standard of care (SoC) has limited effectiveness in controlling the disease. There is a need for innovative treatments to better manage uncontrolled SAR and advance beyond the uniform SoC, and biologics targeting type 2 inflammation driving allergic rhinitis is promising.</p><p><strong>Objective: </strong>To evaluate the efficacy and safety of Stapokibart, a humanized monoclonal antibody targeting interleukin-4 receptor subunit alpha, as an add-on therapy in patients with uncontrolled SAR.</p><p><strong>Methods: </strong>The PHECDA is a multicenter, randomized, double-blind, placebo-controlled, phase 3 clinical study designed to evaluate the efficacy and safety of Stapokibart in treating uncontrolled SAR in adults. Conducted across 18 centers in China during the pollen season, the study plans to recruit 108 adult patients with moderate to severe nasal symptoms despite receiving SoC during the previous seasonal pollen period, along with a 1-week run-in period and a baseline blood eosinophil count of at least 300 cells·μL<sup>-1</sup>. The study consists of a screening/run-in period (1 week), treatment period (4 weeks), and follow-up period (8 weeks). In addition to SoC, which includes mometasone furoate nasal spray and loratadine, participants are randomly assigned using a centralized interactive-web-response-system to receive either subcutaneous Stapokibart 600 (loading dose)-300 mg or a placebo every 2 weeks for 4 weeks. The primary endpoint of the study is the mean change from baseline in the daily reflective total nasal symptom score over the first 2 weeks of treatment. Subjects who have been administered at least 1 dose of the investigational drug will be included in the assessments of both efficacy and safety.</p><p><strong>Results: </strong>This article outlines the methodology utilized in a multicenter trial studying Stapokibar for seasonal allergic rhinitis, with expectations to discuss its significant effects in subsequent analyses based on trial outcomes.</p><p><strong>Conclusion: </strong>The PHECDA study is for the first time to provide insight into the efficacy and safety of a seasonal add-on Stapokibart for patients with uncontrolled SAR during pollen exposure.</p><p><strong>Trial registration: </strong>NCT05908032.</p>","PeriodicalId":8488,"journal":{"name":"Asia Pacific Allergy","volume":"15 1","pages":"15-20"},"PeriodicalIF":1.6,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11882218/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143571837","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Asia Pacific AllergyPub Date : 2025-03-01Epub Date: 2025-01-13DOI: 10.5415/apallergy.0000000000000173
Anmar Al-Taie
{"title":"A systematic review for improper application of nasal spray in allergic rhinitis: A proposed role of community pharmacist for patient education and counseling in practical setting.","authors":"Anmar Al-Taie","doi":"10.5415/apallergy.0000000000000173","DOIUrl":"10.5415/apallergy.0000000000000173","url":null,"abstract":"<p><p>The application of nasal spray is encountered with technique errors, which can lead to decreased therapeutic response and treatment failure. Community pharmacists can play a pivotal role in providing appropriate knowledge and counseling services for the proper and effective use of these topical drugs. The aim of this systematic review was to assess the most important aspects of application technique errors and the impact of community pharmacist-led interventions on the provision of patient education and counseling regarding the application of these topical preparations in clinical practice. Preferred reporting items for systematic review and meta-analysis (PRISMA) criteria were used to set up a systematic search through different databases, including Scopus, Web of Science, and PubMed. A total of 10 articles were included in this study. Nearly three-quarters of the publications discussed improper technique, poor knowledge about installation technique, and poor adherence. Only 2 studies discussed pharmacist intervention, which comprised individualized brief education and training on the correct use of the nasal spray. The study highlights that there are many different aspects of application errors encountered by patients while using nasal spray. The study also highlights that there is a dearth of involvement of community pharmacists and pharmacist-led interventions for proper technique and application of these topical preparations.</p>","PeriodicalId":8488,"journal":{"name":"Asia Pacific Allergy","volume":"15 1","pages":"29-35"},"PeriodicalIF":1.6,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11882221/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143571857","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"A retrospective analysis of factors influencing response to omalizumab treatment in Indian patients with antihistamine refractory chronic spontaneous urticaria.","authors":"Thammannagowda Prarthana, Hitaishi Mehta, Anuradha Bishnoi, Davinder Parsad, Muthu Sendhil Kumaran","doi":"10.5415/apallergy.0000000000000184","DOIUrl":"10.5415/apallergy.0000000000000184","url":null,"abstract":"<p><strong>Background: </strong>Chronic spontaneous urticaria (CSU) presents as a persistent and distressing condition, with varying treatment responses. Omalizumab, a monoclonal anti-IgE antibody, has shown efficacy in managing antihistamine (AH<sub>1</sub>)-refractory CSU, but its varied response patterns and associated factors remain understudied, particularly in India.</p><p><strong>Methods: </strong>We conducted a retrospective study involving 81 antihistamine-resistant CSU patients treated with omalizumab at a tertiary care center in Northern India between 2018 and 2023. Baseline characteristics, treatment response, and adverse effects were analyzed. Patients were categorized into various response groups based on treatment timelines and biomarker correlations.</p><p><strong>Results: </strong>We observed 65% achieved symptom cessation (group 1) following a single omalizumab dose, while 21% responded between second and third doses (group 2). A subset (7.4%) necessitated increased dosing frequency (group 3) for symptom control. Additionally, 6.2% showed persistent symptoms despite increased dosing frequency (group 4), exhibiting distinctive biomarker profiles indicative of an autoimmune endotype. Notably, 27.1% experienced exacerbations during treatment, emphasizing the need for tailored management approaches and response expectations.</p><p><strong>Conclusion: </strong>Omalizumab demonstrated remarkable efficacy in the treatment of AH<sub>1</sub>-refractory CSU, with a good safety profile. This study highlights the complexity of treatment response to omalizumab and the potential utility of biomarkers in guiding personalized therapeutic strategies. Further research into biomarker-based endotypes is warranted to optimize CSU management.</p>","PeriodicalId":8488,"journal":{"name":"Asia Pacific Allergy","volume":"15 1","pages":"21-28"},"PeriodicalIF":1.6,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11882220/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143571814","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Efficacy and safety of azelastine hydrochloride and fluticasone propionate nasal spray in treating allergic rhinitis: A randomized controlled trial.","authors":"Xinling Han, Chengshuo Wang, Qinna Zhang, Bing Guan, Hua Zhang, Yafeng Yu, Jinyong Tang, Xiaoping Gao, Juan Meng, Chao Li, Huifang Zhou, Xinsheng Huang, Haiyun Shi, Tao Bian, Guohua Hu, Qingshan Jiang, Huabin Li, Lingbo Li, Xianhua Li, Chang Lin, Dingrong Liu, Jixiang Liu, Huaan Ma, Guolin Tan, Lijia Wan, Jiao Xia, Shuifang Xiao, Jinghua Xie, Zhimin Xing, Shenhong Qu, Changqing Zhao, Li Zhu, Yuan Zhang, Luo Zhang","doi":"10.5415/apallergy.0000000000000161","DOIUrl":"10.5415/apallergy.0000000000000161","url":null,"abstract":"<p><strong>Background: </strong>MP-AzeFlu (Dymista; Meda Pharma GmbH & Co., KG), a formulation combining azelastine hydrochloride and fluticasone propionate in a single spray, is superior to fluticasone propionate alone in relieving symptoms and improving the quality of life of patients with allergic rhinitis.</p><p><strong>Objectives: </strong>In this study, we evaluated whether the effect of AzeFlu, a generic drug manufactured from China, is equivalent to that of MP-AzeFlu.</p><p><strong>Methods: </strong>In total, 679 patients were recruited for a multicentre, randomized, double-blind, original drug-controlled, and parallel-group clinical trial. Overall, 339 and 340 patients were administered with AzeFlu and MP-AzeFlu, respectively. Efficacy was assessed by changes in the reflective total nasal symptom score, the area under the curve of reflective total nasal symptom score changes over time, changes from baseline in individual nasal symptom scores, and the Rhinoconjunctivitis Quality of Life Questionnaire. In addition, a safety evaluation was simultaneously performed.</p><p><strong>Results: </strong>AzeFlu and MP-AzeFlu reduced the reflective total nasal symptom score from baseline (AzeFlu -6.7 [standard deviation, 2.59]; MP-AzeFlu -6.7 [standard deviation, 2.76]; <i>P</i> = 0.905) and improved nasal symptoms and quality of life (AzeFlu -62.3 [standard deviation, 33.59]; MP-AzeFlu -64.7 [standard deviation, 33.73]; <i>P</i> = 0.394) in patients with allergic rhinitis. Significant differences were not observed between groups.</p><p><strong>Conclusion: </strong>AzeFlu showed effects equivalent to those of MP-AzeFlu in this clinical trial and may benefit Chinese patients with allergic rhinitis.<b>Registration number:</b> CTR20190189 (chinadrugtrials.org.cn/index.html).</p>","PeriodicalId":8488,"journal":{"name":"Asia Pacific Allergy","volume":"15 1","pages":"7-14"},"PeriodicalIF":1.6,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11882219/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143571876","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}