Pub Date : 2024-02-08eCollection Date: 2024-01-01DOI: 10.2147/JAA.S425101
Theresa W Guilbert, Kevin R Murphy, Eckard Hamelmann, Kristie R Ross, Atul Gupta, Alessandro Fiocchi, Changming Xia, Rebecca Gall, Olivier Ledanois, Amr Radwan, Juby A Jacob-Nara, Paul J Rowe, Yamo Deniz
Background: Severe, uncontrolled asthma and asthma exacerbations in children are associated with abnormal lung function and airway development, and increased risk of chronic obstructive lung disease in adulthood. The rationale for this post hoc analysis was to explore the relationship between changes in asthma exacerbation rates and lung function in children treated with dupilumab.
Methods: This post hoc analysis included children aged 6 to 11 years with uncontrolled, moderate-to-severe type 2 asthma (blood eosinophils ≥150 cells/μL or fractional exhaled nitric oxide ≥20 ppb) who received dupilumab or placebo in the phase 3 LIBERTY ASTHMA VOYAGE study (NCT02948959). Endpoints were the proportion of patients achieving clinically meaningful improvements (≥5% or ≥10%) in pre-bronchodilator percent-predicted forced expiratory volume in 1 second (ppFEV1) by Week 12, annualized severe asthma exacerbation rates from Week 12-52, and mean change from baseline in ppFEV1 to Week 12.
Results: At Week 12 of VOYAGE, 141/236 (60%) of children treated with dupilumab and 57/114 (50%) of children receiving placebo showed improvements of ≥5% in ppFEV1; 106/236 (45%) children receiving dupilumab and 36/114 (32%) receiving placebo achieved improvements in ppFEV1 ≥10%. During the Week 12-52 treatment period, dupilumab vs placebo significantly reduced severe exacerbation rates in all subgroups by 52-60% (all P<0.05). Dupilumab treatment resulted in rapid and sustained improvements in ppFEV1 (Week 12 least squares mean difference [95% CI] vs placebo: 3.54 [0.30, 6.78] percentage points; P=0.03) in children who achieved improvements of ≥5%.
Conclusion: Dupilumab vs placebo significantly improved pre-bronchodilator ppFEV1, with a higher proportion of patients achieving a clinically meaningful response at Week 12. Dupilumab also significantly reduced severe exacerbation rates, independent of pre-bronchodilator ppFEV1 response at Week 12.
{"title":"Impact of Lung Function on Asthma Exacerbation Rates in Children Treated with Dupilumab: The VOYAGE Study.","authors":"Theresa W Guilbert, Kevin R Murphy, Eckard Hamelmann, Kristie R Ross, Atul Gupta, Alessandro Fiocchi, Changming Xia, Rebecca Gall, Olivier Ledanois, Amr Radwan, Juby A Jacob-Nara, Paul J Rowe, Yamo Deniz","doi":"10.2147/JAA.S425101","DOIUrl":"10.2147/JAA.S425101","url":null,"abstract":"<p><strong>Background: </strong>Severe, uncontrolled asthma and asthma exacerbations in children are associated with abnormal lung function and airway development, and increased risk of chronic obstructive lung disease in adulthood. The rationale for this post hoc analysis was to explore the relationship between changes in asthma exacerbation rates and lung function in children treated with dupilumab.</p><p><strong>Methods: </strong>This post hoc analysis included children aged 6 to 11 years with uncontrolled, moderate-to-severe type 2 asthma (blood eosinophils ≥150 cells/μL or fractional exhaled nitric oxide ≥20 ppb) who received dupilumab or placebo in the phase 3 LIBERTY ASTHMA VOYAGE study (NCT02948959). Endpoints were the proportion of patients achieving clinically meaningful improvements (≥5% or ≥10%) in pre-bronchodilator percent-predicted forced expiratory volume in 1 second (ppFEV<sub>1</sub>) by Week 12, annualized severe asthma exacerbation rates from Week 12-52, and mean change from baseline in ppFEV<sub>1</sub> to Week 12.</p><p><strong>Results: </strong>At Week 12 of VOYAGE, 141/236 (60%) of children treated with dupilumab and 57/114 (50%) of children receiving placebo showed improvements of ≥5% in ppFEV<sub>1</sub>; 106/236 (45%) children receiving dupilumab and 36/114 (32%) receiving placebo achieved improvements in ppFEV<sub>1</sub> ≥10%. During the Week 12-52 treatment period, dupilumab vs placebo significantly reduced severe exacerbation rates in all subgroups by 52-60% (all <i>P</i><0.05). Dupilumab treatment resulted in rapid and sustained improvements in ppFEV<sub>1</sub> (Week 12 least squares mean difference [95% CI] vs placebo: 3.54 [0.30, 6.78] percentage points; <i>P</i>=0.03) in children who achieved improvements of ≥5%.</p><p><strong>Conclusion: </strong>Dupilumab vs placebo significantly improved pre-bronchodilator ppFEV<sub>1</sub>, with a higher proportion of patients achieving a clinically meaningful response at Week 12. Dupilumab also significantly reduced severe exacerbation rates, independent of pre-bronchodilator ppFEV<sub>1</sub> response at Week 12.</p><p><strong>Trial registration: </strong>NCT02948959.</p>","PeriodicalId":15079,"journal":{"name":"Journal of Asthma and Allergy","volume":"17 ","pages":"81-87"},"PeriodicalIF":3.2,"publicationDate":"2024-02-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10860392/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139722749","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Marie Chevereau-Choquet, Benjamin Thoreau, Camille Taillé, Sylvain Marchand-Adam, Hugues Morel, Laurent Plantier, Laurent Portel
Purpose: Severe asthma affects 5 to 10% of asthmatics and accounts for a large part of asthma-related morbidity and costs. The determinants of asthma severity are poorly understood. We tested the hypothesis that asthma severity was associated with 1) atopy and allergy and 2) markers associated with environmental exposure. Patients and Methods: Data from the FASE-CPHG study, a cross-sectional, observational, multicenter investigation, were analyzed to identify markers associated with asthma severity. Asthma severity was gauged using the ASSESS score, encompassing symptom control, exacerbations, FEV1 and therapeutic load. Bivariate and multivariate analyses were used to identify patient characteristics associated with the ASSESS score. Results: The analysis involved 948 patients, with 592 women, of which 447 patients (47%) had severe asthma. Among these, 491 patients (52%) had at least one positive aeroallergen skin prick test and 525 (55%) had at least one allergic disease among atopic dermatitis, chronic rhinitis and food allergy. The mean±SD ASSESS score was 11.2± 3.4. Characteristics associated with a higher ASSESS score were female sex, secondary or lower education, unemployed occupational status, smoking, work-aggravated asthma and urban housing. There was no association between the ASSESS score and allergic diseases, aeroallergen-specific skin prick tests and IgEs, or blood eosinophil counts. Conclusion: While atopy and allergy were frequent among asthmatics, neither was associated with asthma severity. Modifiable environmental factors such as smoking, urban housing and work-aggravated asthma were independently associated with asthma severity.
{"title":"Smoking, Urban Housing and Work-Aggravated Asthma are Associated with Asthma Severity in a Cross-Sectional Observational Study","authors":"Marie Chevereau-Choquet, Benjamin Thoreau, Camille Taillé, Sylvain Marchand-Adam, Hugues Morel, Laurent Plantier, Laurent Portel","doi":"10.2147/jaa.s424546","DOIUrl":"https://doi.org/10.2147/jaa.s424546","url":null,"abstract":"<strong>Purpose:</strong> Severe asthma affects 5 to 10% of asthmatics and accounts for a large part of asthma-related morbidity and costs. The determinants of asthma severity are poorly understood. We tested the hypothesis that asthma severity was associated with 1) atopy and allergy and 2) markers associated with environmental exposure.<br/><strong>Patients and Methods:</strong> Data from the FASE-CPHG study, a cross-sectional, observational, multicenter investigation, were analyzed to identify markers associated with asthma severity. Asthma severity was gauged using the ASSESS score, encompassing symptom control, exacerbations, FEV1 and therapeutic load. Bivariate and multivariate analyses were used to identify patient characteristics associated with the ASSESS score.<br/><strong>Results:</strong> The analysis involved 948 patients, with 592 women, of which 447 patients (47%) had severe asthma. Among these, 491 patients (52%) had at least one positive aeroallergen skin prick test and 525 (55%) had at least one allergic disease among atopic dermatitis, chronic rhinitis and food allergy. The mean±SD ASSESS score was 11.2± 3.4. Characteristics associated with a higher ASSESS score were female sex, secondary or lower education, unemployed occupational status, smoking, work-aggravated asthma and urban housing. There was no association between the ASSESS score and allergic diseases, aeroallergen-specific skin prick tests and IgEs, or blood eosinophil counts.<br/><strong>Conclusion:</strong> While atopy and allergy were frequent among asthmatics, neither was associated with asthma severity. Modifiable environmental factors such as smoking, urban housing and work-aggravated asthma were independently associated with asthma severity.<br/><br/><strong>Keywords:</strong> allergy, ASSESS, asthma, environment, severity<br/>","PeriodicalId":15079,"journal":{"name":"Journal of Asthma and Allergy","volume":"1 1","pages":""},"PeriodicalIF":3.2,"publicationDate":"2024-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139657981","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Introduction: This study aimed to demonstrate whether benralizumab maintained the safety and effectiveness profiles established in randomized controlled trials among all patients with severe uncontrolled asthma initially prescribed benralizumab in the real-world setting in Japan. Methods: This was a prospective, observational, multicenter post-marketing study (ClinicalTrial.gov, NCT03588546). The safety and tolerability of benralizumab over 1 year were assessed by the incidence of adverse events (AEs), serious AEs, adverse drug reactions (ADRs), and serious ADRs. Patient background characteristics indicating a more frequent onset of ADRs with benralizumab were explored. The main effectiveness assessment was the change in Asthma Control Questionnaire-5 (ACQ-5) score from baseline. Patients with baseline ACQ-5 scores ≥ 1.5 were defined as having severe uncontrolled asthma. Results: In total, 632 patients were evaluated for safety and 274 for effectiveness; 139 patients were included in the severe uncontrolled asthma subgroup. ADRs were reported in 12.7% and serious AEs in 13.0% of patients. Serious infections occurred in 3.8%, serious hypersensitivity in 0.3%, and malignancy in 0.3% of patients. No helminthic infections occurred. In the effectiveness population, benralizumab improved the mean (standard deviation [95% confidence interval]) ACQ-5 score by − 1.16 (1.40 [− 1.36, − 0.96]) from baseline; forced expiratory volume in 1 second by 0.151 (0.440 [0.09, 0.21]) L; and Mini-Asthma Quality of Life questionnaire score by 1.16 (1.29 [0.94, 1.38]) at the last observation. The annual asthma exacerbation rate was 0.42. A greater ACQ-5 score improvement was observed among patients with eosinophilic asthma characteristics. Conclusion: No new safety concerns were raised, and patients experienced benefits consistent with previous studies of benralizumab, thus supporting the use of benralizumab for the add-on maintenance treatment of patients with eosinophilic severe uncontrolled asthma.
Keywords: benralizumab, severe uncontrolled asthma, anti-interleukin-5 receptor α monoclonal antibody, eosinophils, exacerbation, asthma control, quality of life
{"title":"Real-World Safety and Effectiveness of Benralizumab in Japanese Patients with Severe Asthma: A Multicenter Prospective Observational Study","authors":"Masao Yamaguchi, Yoshihiro Nishimura, Yuko Takumi, Nobuya Hayashi, Kei Sakamoto, Yuji Tohda","doi":"10.2147/jaa.s432695","DOIUrl":"https://doi.org/10.2147/jaa.s432695","url":null,"abstract":"<strong>Introduction:</strong> This study aimed to demonstrate whether benralizumab maintained the safety and effectiveness profiles established in randomized controlled trials among all patients with severe uncontrolled asthma initially prescribed benralizumab in the real-world setting in Japan.<br/><strong>Methods:</strong> This was a prospective, observational, multicenter post-marketing study (ClinicalTrial.gov, NCT03588546). The safety and tolerability of benralizumab over 1 year were assessed by the incidence of adverse events (AEs), serious AEs, adverse drug reactions (ADRs), and serious ADRs. Patient background characteristics indicating a more frequent onset of ADRs with benralizumab were explored. The main effectiveness assessment was the change in Asthma Control Questionnaire-5 (ACQ-5) score from baseline. Patients with baseline ACQ-5 scores ≥ 1.5 were defined as having severe uncontrolled asthma.<br/><strong>Results:</strong> In total, 632 patients were evaluated for safety and 274 for effectiveness; 139 patients were included in the severe uncontrolled asthma subgroup. ADRs were reported in 12.7% and serious AEs in 13.0% of patients. Serious infections occurred in 3.8%, serious hypersensitivity in 0.3%, and malignancy in 0.3% of patients. No helminthic infections occurred. In the effectiveness population, benralizumab improved the mean (standard deviation [95% confidence interval]) ACQ-5 score by − 1.16 (1.40 [− 1.36, − 0.96]) from baseline; forced expiratory volume in 1 second by 0.151 (0.440 [0.09, 0.21]) L; and Mini-Asthma Quality of Life questionnaire score by 1.16 (1.29 [0.94, 1.38]) at the last observation. The annual asthma exacerbation rate was 0.42. A greater ACQ-5 score improvement was observed among patients with eosinophilic asthma characteristics.<br/><strong>Conclusion:</strong> No new safety concerns were raised, and patients experienced benefits consistent with previous studies of benralizumab, thus supporting the use of benralizumab for the add-on maintenance treatment of patients with eosinophilic severe uncontrolled asthma.<br/><br/><strong>Keywords:</strong> benralizumab, severe uncontrolled asthma, anti-interleukin-5 receptor α monoclonal antibody, eosinophils, exacerbation, asthma control, quality of life<br/>","PeriodicalId":15079,"journal":{"name":"Journal of Asthma and Allergy","volume":"199 1","pages":""},"PeriodicalIF":3.2,"publicationDate":"2024-01-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139510290","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Purpose: It is still unclear whether considering abnormal spirometry as a marker for disease control can help physicians adjust asthma controllers in children because of the scarcity of pediatric studies. We aimed to investigate the prevalence of abnormal spirometry in a selected pediatric asthmatic population and its effect on longitudinal outcomes. Patients and Methods: This retrospective cohort study was conducted at the Songklanagarind Hospital, Thailand. Children with asthma aged < 18 years were recruited for review if they attended the clinic and underwent acceptable spirometry with bronchodilator responsiveness (BDR) tests after receiving asthma treatment for at least 3 months between January 2011 and June 2022. Differences in baseline characteristics, atopic factors, asthma treatment, and outcomes were analyzed between the normal and abnormal spirometry groups over a 12-month post-spirometry period. Results: The mean age of the 203 enrolled patients was 10.9 ± 2.6 years. Abnormal spirometry, defined as airflow limitation or the presence of BDR, was observed in 58.1% of patients. No significant differences were observed in baseline characteristics, atopic factors, asthma treatment, or outcomes between the normal and abnormal spirometry groups. Further analysis of 107 patients with abnormal spirometry with symptom control revealed that physicians adjusted the asthma controller based on spirometry and symptoms in 84 and 23 patients, respectively. There was no significant difference in the loss of disease control over the 12-month post-spirometry period between the two groups. Conclusion: Abnormal spirometry was found in 58.1% of treated school-aged patients with asthma. Abnormal spirometry results were not associated with poor asthma outcomes during the 12-month follow-up. Both symptom-based and spirometry-based adjustments of asthma controllers resulted in comparable symptom control over a 12-month follow-up period in the selected population.
Keywords: pulmonary function test, lung function test, childhood asthma, bronchodilator responsiveness
{"title":"A Longitudinal Study of a Selected Pediatric Asthmatic Population with Normal and Abnormal Spirometry at Baseline: An Emphasis on Treatment Outcomes","authors":"Sornsiri Yimlamai, Kanokpan Ruangnapa, Wanaporn Anuntaseree, Kantara Saelim, Pharsai Prasertsan, Kantisa Sirianansopa","doi":"10.2147/jaa.s432648","DOIUrl":"https://doi.org/10.2147/jaa.s432648","url":null,"abstract":"<strong>Purpose:</strong> It is still unclear whether considering abnormal spirometry as a marker for disease control can help physicians adjust asthma controllers in children because of the scarcity of pediatric studies. We aimed to investigate the prevalence of abnormal spirometry in a selected pediatric asthmatic population and its effect on longitudinal outcomes.<br/><strong>Patients and Methods:</strong> This retrospective cohort study was conducted at the Songklanagarind Hospital, Thailand. Children with asthma aged < 18 years were recruited for review if they attended the clinic and underwent acceptable spirometry with bronchodilator responsiveness (BDR) tests after receiving asthma treatment for at least 3 months between January 2011 and June 2022. Differences in baseline characteristics, atopic factors, asthma treatment, and outcomes were analyzed between the normal and abnormal spirometry groups over a 12-month post-spirometry period.<br/><strong>Results:</strong> The mean age of the 203 enrolled patients was 10.9 ± 2.6 years. Abnormal spirometry, defined as airflow limitation or the presence of BDR, was observed in 58.1% of patients. No significant differences were observed in baseline characteristics, atopic factors, asthma treatment, or outcomes between the normal and abnormal spirometry groups. Further analysis of 107 patients with abnormal spirometry with symptom control revealed that physicians adjusted the asthma controller based on spirometry and symptoms in 84 and 23 patients, respectively. There was no significant difference in the loss of disease control over the 12-month post-spirometry period between the two groups.<br/><strong>Conclusion:</strong> Abnormal spirometry was found in 58.1% of treated school-aged patients with asthma. Abnormal spirometry results were not associated with poor asthma outcomes during the 12-month follow-up. Both symptom-based and spirometry-based adjustments of asthma controllers resulted in comparable symptom control over a 12-month follow-up period in the selected population.<br/><br/><strong>Keywords:</strong> pulmonary function test, lung function test, childhood asthma, bronchodilator responsiveness<br/>","PeriodicalId":15079,"journal":{"name":"Journal of Asthma and Allergy","volume":"1 1","pages":""},"PeriodicalIF":3.2,"publicationDate":"2024-01-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139506389","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Gassem Gohal, Abuobaida Yassin, Hussam Darraj, Anwar Darraj, Rawan Maghrabi, Yumna Barakat Abutalib, Sarah Talebi, Amani Ahmed Mutaen, Sulaiman Hamdi
Background: The prevalence of asthma among children has been on the rise worldwide, leading to significant morbidity and mortality. Our study was conducted to determine the prevalence of asthma and its related risk factors among school-age children in the Jazan Region, Saudi Arabia. Materials and Method: The study was a cross-sectional prospective study that used Phase I ISAAC protocol and was conducted from March to June 2023. The sample size was calculated to be 1600 among school-age children in the Jazan Region Saudi Arabia. This study complies with the Declaration of Helsinki. Data was analyzed using SPSS version 23.0, Descriptive statistics were calculated for study variables, and appropriate tests of significance were performed to determine statistical significance. Results: The total study population was 1368 the majority of them, 96.6% (n=1321), were Saudi nationals, and most of them lived in rural areas (70.6%, n=966). The prevalence of life-long wheezing, wheezing in the last 12 months, and exercise-induced wheezing was 28.0%, 29.2%, and 30.9%, respectively. Risk factors such as having indoor plants, having a pet, and a smoker in the household were reported by 48.0%, 24.6%, and 36.4% of participants, respectively. Living near an industrial area was determined as a risk factor in 98 (7.2%) of the children. Asthma-related symptoms were strongly correlated with all risk factors based on the chi-square test, and some risk factors based on multivariate linear regression. Conclusion: The prevalence of asthma among children in the Jazan Region is higher than previously reported, and the reported risk factors are significantly correlated with symptoms of asthma.
{"title":"Prevalence and Risk Factors of Childhood Asthma in Jazan Region, Saudi Arabia","authors":"Gassem Gohal, Abuobaida Yassin, Hussam Darraj, Anwar Darraj, Rawan Maghrabi, Yumna Barakat Abutalib, Sarah Talebi, Amani Ahmed Mutaen, Sulaiman Hamdi","doi":"10.2147/jaa.s443759","DOIUrl":"https://doi.org/10.2147/jaa.s443759","url":null,"abstract":"<strong>Background:</strong> The prevalence of asthma among children has been on the rise worldwide, leading to significant morbidity and mortality. Our study was conducted to determine the prevalence of asthma and its related risk factors among school-age children in the Jazan Region, Saudi Arabia.<br/><strong>Materials and Method:</strong> The study was a cross-sectional prospective study that used Phase I ISAAC protocol and was conducted from March to June 2023. The sample size was calculated to be 1600 among school-age children in the Jazan Region Saudi Arabia. This study complies with the Declaration of Helsinki. Data was analyzed using SPSS version 23.0, Descriptive statistics were calculated for study variables, and appropriate tests of significance were performed to determine statistical significance.<br/><strong>Results:</strong> The total study population was 1368 the majority of them, 96.6% (n=1321), were Saudi nationals, and most of them lived in rural areas (70.6%, n=966). The prevalence of life-long wheezing, wheezing in the last 12 months, and exercise-induced wheezing was 28.0%, 29.2%, and 30.9%, respectively. Risk factors such as having indoor plants, having a pet, and a smoker in the household were reported by 48.0%, 24.6%, and 36.4% of participants, respectively. Living near an industrial area was determined as a risk factor in 98 (7.2%) of the children. Asthma-related symptoms were strongly correlated with all risk factors based on the chi-square test, and some risk factors based on multivariate linear regression.<br/><strong>Conclusion:</strong> The prevalence of asthma among children in the Jazan Region is higher than previously reported, and the reported risk factors are significantly correlated with symptoms of asthma.<br/><br/>","PeriodicalId":15079,"journal":{"name":"Journal of Asthma and Allergy","volume":"13 1","pages":""},"PeriodicalIF":3.2,"publicationDate":"2024-01-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139506251","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Nicole MD van der Burg, Carl Ekelund, Leif H Bjermer, David Aronsson, Jaro Ankerst, Ellen Tufvesson
Background: Bronchodilator responsiveness (BDR) in asthma involves both the central and peripheral airways but is primarily relieved with beta-2-agonists and evaluated by spirometry. To date, antimuscarinics can be added as a reliever medication in more severe asthma. We hypothesize that combining both short-acting beta-2 agonist (SABA) and short-acting muscarinic antagonist (SAMA) could also improve the responsiveness in mild-moderate asthma. Therefore, we aimed to compare the direct effects of inhaling SABA alone, SAMA alone or combining both SABA and SAMA on the central and peripheral airways in asthma. Methods: Twenty-three patients with mild-moderate BDR in asthma performed dynamic spirometry and impulse oscillometry before (baseline) and multiple timepoints within an hour after inhalation of SABA (salbutamol), SAMA (ipratropium bromide), or both SABA and SAMA at three different visits. Results: The use of SAMA alone did not show any improvement compared to the use of SABA alone. Inhalation of SABA+SAMA, however, averaged either similar or better BDR than SABA alone in FEV1, MMEF, FVC, R5, R20 and R5-R20. Inhaling SABA+SAMA reached a stable BDR in more patients within 0– 10 minutes and also reached the FEV1 (Δ%)> 12% faster (3.5 minutes) than inhaling SABA alone (5.1 minutes). Inhaling SABA+SAMA was significantly better than SAMA alone in FEV1 (p = 0.015), MMEF (p = 0.0059) and R20 (p = 0.0049). Using these three variables highlighted a subgroup (30%, including more males) of patients that were more responsive to inhaling SABA+SAMA than SABA alone. Conclusion: Overall, combining SAMA with SABA was faster and more consistent at increasing the lung function than SABA alone or SAMA alone, and the additive effect was best captured by incorporating peripheral-related variables. Therefore, SAMA should be considered as an add-on reliever for mild-moderate patients with BDR in asthma.
背景：哮喘的支气管扩张剂反应性（BDR）涉及中枢和外周气道，但主要通过β-2-激动剂缓解，并通过肺活量测定进行评估。迄今为止，抗心律失常药可作为缓解药物用于较严重的哮喘。我们假设，将短效β-2 受体激动剂（SABA）和短效毒蕈碱拮抗剂（SAMA）结合使用，也能改善轻中度哮喘患者的反应性。因此，我们旨在比较单独吸入 SABA、单独吸入 SAMA 或同时吸入 SABA 和 SAMA 对哮喘患者中枢和外周气道的直接影响：23名轻中度BDR哮喘患者在三次不同的就诊中分别在吸入SABA（沙丁胺醇）、SAMA（异丙托溴铵）或同时吸入SABA和SAMA前（基线）和吸入后一小时内的多个时间点进行了动态肺活量测定和脉冲振荡测定：结果：与单独使用 SABA 相比，单独使用 SAMA 没有任何改善。然而，吸入 SABA+SAMA 在 FEV1、MMEF、FVC、R5、R20 和 R5-R20 方面的平均 BDR 与单用 SABA 相似或更好。吸入 SABA+SAMA 可使更多患者在 0-10 分钟内达到稳定的 BDR，而且达到 FEV1 (Δ%)> 的速度（3.5 分钟）比单独吸入 SABA（5.1 分钟）快 12%。在 FEV1（p = 0.015）、MMEF（p = 0.0059）和 R20（p = 0.0049）方面，吸入 SABA+SAMA 明显优于单独吸入 SAMA。使用这三个变量突出显示了一个亚组（30%，包括更多男性）患者对吸入 SABA+SAMA 比单独吸入 SABA 更敏感：总的来说，与单独使用 SABA 或单独使用 SAMA 相比，将 SAMA 与 SABA 结合使用能更快且更稳定地提高肺功能。因此，应考虑将 SAMA 作为轻中度哮喘 BDR 患者的附加缓解药物。
{"title":"Bronchodilator Responsiveness Measured by Spirometry and Impulse Oscillometry in Patients with Asthma After Short Acting Antimuscarinic and/or Beta-2-Agonists Inhalation","authors":"Nicole MD van der Burg, Carl Ekelund, Leif H Bjermer, David Aronsson, Jaro Ankerst, Ellen Tufvesson","doi":"10.2147/jaa.s442217","DOIUrl":"https://doi.org/10.2147/jaa.s442217","url":null,"abstract":"<strong>Background:</strong> Bronchodilator responsiveness (BDR) in asthma involves both the central and peripheral airways but is primarily relieved with beta-2-agonists and evaluated by spirometry. To date, antimuscarinics can be added as a reliever medication in more severe asthma. We hypothesize that combining both short-acting beta-2 agonist (SABA) and short-acting muscarinic antagonist (SAMA) could also improve the responsiveness in mild-moderate asthma. Therefore, we aimed to compare the direct effects of inhaling SABA alone, SAMA alone or combining both SABA and SAMA on the central and peripheral airways in asthma.<br/><strong>Methods:</strong> Twenty-three patients with mild-moderate BDR in asthma performed dynamic spirometry and impulse oscillometry before (baseline) and multiple timepoints within an hour after inhalation of SABA (salbutamol), SAMA (ipratropium bromide), or both SABA and SAMA at three different visits.<br/><strong>Results:</strong> The use of SAMA alone did not show any improvement compared to the use of SABA alone. Inhalation of SABA+SAMA, however, averaged either similar or better BDR than SABA alone in FEV<sub>1</sub>, MMEF, FVC, R5, R20 and R5-R20. Inhaling SABA+SAMA reached a stable BDR in more patients within 0– 10 minutes and also reached the FEV<sub>1</sub> (Δ%)> 12% faster (3.5 minutes) than inhaling SABA alone (5.1 minutes). Inhaling SABA+SAMA was significantly better than SAMA alone in FEV<sub>1</sub> (<em>p</em> = 0.015), MMEF (<em>p</em> = 0.0059) and R20 (<em>p</em> = 0.0049). Using these three variables highlighted a subgroup (30%, including more males) of patients that were more responsive to inhaling SABA+SAMA than SABA alone.<br/><strong>Conclusion:</strong> Overall, combining SAMA with SABA was faster and more consistent at increasing the lung function than SABA alone or SAMA alone, and the additive effect was best captured by incorporating peripheral-related variables. Therefore, SAMA should be considered as an add-on reliever for mild-moderate patients with BDR in asthma.<br/><br/>","PeriodicalId":15079,"journal":{"name":"Journal of Asthma and Allergy","volume":"11 1","pages":""},"PeriodicalIF":3.2,"publicationDate":"2024-01-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139499522","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Purpose: Japanese guidelines recommend that patients with uncontrolled asthma be referred by non-specialists to specialists (allergists and/or pulmonologists). This study investigated the reality of clinical practice in asthma patients referred to specialists in Japan. Patients and Methods: This was a retrospective, observational cohort study of asthma patients in a health insurance claim database (Cross Fact) referred from facilities with non-specialists to those with specialists from January 2016 to December 2018. The referred asthma patients were defined as patients with ≥ 4 inhaled corticosteroid (ICS)-containing prescriptions during a 1-year baseline period, with an asthma diagnosis, and who had visited a facility with specialists. Asthma exacerbation, maintenance treatment, laboratory tests, and medical procedures before and after referral were analyzed. Results: Data for 2135 patients were extracted, of which 420 with referral codes were analyzed. The proportion of patients with asthma exacerbations was 50.2% (95% confidence interval [CI]: 45.4– 55.1%) before referral and 37.4% (95% CI: 32.7– 42.2%) after, a significant decrease (P< 0.001; McNemar test). The proportions of patients prescribed ICS alone, long-acting beta-agonists (LABA), and ICS/LABA were lower after referral than before, but the proportions of patients prescribed long-acting muscarinic antagonists (LAMA), ICS/LABA/LAMA, and biologics increased after referral. More asthma-related laboratory tests were performed after referral, and spirometry incidence increased from 16.4% before referral to 51.4% after referral. Conclusion: This study shows a decrease in asthma exacerbations, change in asthma treatments, and increase in laboratory tests after referral to a specialist, suggesting that referrals to specialists lead to better management of asthma.
{"title":"A Retrospective Claims Database Study to Clarify Treatment Reality of Asthma Patients Before and After Referral to a Specialist","authors":"Soichiro Hozawa, Keita Ono, Naoyuki Makita, Hitomi Uchimura, Yoshifumi Arita, Takehiro Hirai, Naoki Tashiro","doi":"10.2147/jaa.s437944","DOIUrl":"https://doi.org/10.2147/jaa.s437944","url":null,"abstract":"<strong>Purpose:</strong> Japanese guidelines recommend that patients with uncontrolled asthma be referred by non-specialists to specialists (allergists and/or pulmonologists). This study investigated the reality of clinical practice in asthma patients referred to specialists in Japan.<br/><strong>Patients and Methods:</strong> This was a retrospective, observational cohort study of asthma patients in a health insurance claim database (Cross Fact) referred from facilities with non-specialists to those with specialists from January 2016 to December 2018. The referred asthma patients were defined as patients with ≥ 4 inhaled corticosteroid (ICS)-containing prescriptions during a 1-year baseline period, with an asthma diagnosis, and who had visited a facility with specialists. Asthma exacerbation, maintenance treatment, laboratory tests, and medical procedures before and after referral were analyzed.<br/><strong>Results:</strong> Data for 2135 patients were extracted, of which 420 with referral codes were analyzed. The proportion of patients with asthma exacerbations was 50.2% (95% confidence interval [CI]: 45.4– 55.1%) before referral and 37.4% (95% CI: 32.7– 42.2%) after, a significant decrease (P< 0.001; McNemar test). The proportions of patients prescribed ICS alone, long-acting beta-agonists (LABA), and ICS/LABA were lower after referral than before, but the proportions of patients prescribed long-acting muscarinic antagonists (LAMA), ICS/LABA/LAMA, and biologics increased after referral. More asthma-related laboratory tests were performed after referral, and spirometry incidence increased from 16.4% before referral to 51.4% after referral.<br/><strong>Conclusion:</strong> This study shows a decrease in asthma exacerbations, change in asthma treatments, and increase in laboratory tests after referral to a specialist, suggesting that referrals to specialists lead to better management of asthma.<br/><br/><strong>Keywords:</strong> asthma, database, referral, specialist, symptom exacerbation<br/>","PeriodicalId":15079,"journal":{"name":"Journal of Asthma and Allergy","volume":"6 1","pages":""},"PeriodicalIF":3.2,"publicationDate":"2024-01-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139499493","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Mark Gurnell, Amr Radwan, Claus Bachert, Njira Lugogo, Seong H Cho, Scott Nash, Haixin Zhang, Asif H Khan, Juby A Jacob-Nara, Paul J Rowe, Yamo Deniz
<strong>Purpose:</strong> Dupilumab significantly reduced the requirement for systemic corticosteroids (SCS) in patients with severe chronic rhinosinusitis with nasal polyps (CRSwNP). Patients with CRSwNP and coexisting asthma typically have a higher disease burden and have more difficulty in managing disease. Here, we report an analysis of asthma outcomes and SCS use in patients with CRSwNP and coexisting asthma.<br/><strong>Patients and Methods:</strong> This was a post hoc analysis of the randomized, placebo-controlled SINUS-24 and SINUS-52 studies (NCT02912468/NCT02898454) in patients with severe CRSwNP and coexisting asthma (patient self-reported) from the pooled intention-to-treat population randomized to dupilumab 300 mg every 2 weeks or placebo. On-treatment SCS use was estimated using Kaplan–Meier analysis. Forced expiratory volume in 1 s (FEV<sub>1</sub>), percent predicted FEV<sub>1</sub>, and the 6-item Asthma Control Questionnaire (ACQ-6) were assessed at baseline and Week 24 (pooled SINUS-24/52) in patients with/without history of asthma exacerbation or prior SCS use.<br/><strong>Results:</strong> Of 337 patients with coexisting asthma, 88 (26%) required on-treatment SCS use. The requirement for on-treatment SCS use for any reason was significantly lower with dupilumab (20/167 patients; 12%) vs placebo (68/170; 40%); hazard ratio (95% confidence interval) 0.248 (0.150– 0.409); <em>p</em> < 0.0001. The most frequent reasons for SCS use were nasal polyps (dupilumab 3% and placebo 27%) and asthma (2% and 9%, respectively). FEV<sub>1</sub>, percent predicted FEV<sub>1</sub>, and ACQ-6 were all significantly improved at Week 24 with dupilumab vs placebo irrespective of history of asthma exacerbation or prior SCS use (all <em>p</em> < 0.01).<br/><strong>Conclusion:</strong> Dupilumab significantly reduced the requirement for SCS and improved asthma outcomes irrespective of history of asthma exacerbation or prior SCS use vs placebo in patients with CRSwNP and coexisting asthma, demonstrating concomitant reduction of SCS use and asthma disease burden in these patients.<br/><br/><strong>Plain Language Summary:</strong> Chronic rhinosinusitis with nasal polyps (CRSwNP) and asthma are type 2 inflammatory conditions that often coexist. Patients with both CRSwNP and asthma generally have worse symptoms that are more difficult to treat. Their standard treatment is topical (inhaled/intranasal) corticosteroids, but where this is ineffective, systemic corticosteroids, also called SCS, are used. SCS are effective at reducing nasal polyp size and improving symptoms, but this effect often does not last, and many patients experience side effects when SCS are used for a long time. Dupilumab, a drug that targets type 2 inflammation, is approved for treating both uncontrolled CRSwNP and moderate-to-severe asthma. Here, we investigate whether dupilumab changes how often patients with CRSwNP and asthma need to use SCS and its effect on their asthma. We
{"title":"Dupilumab Reduces Asthma Disease Burden and Recurrent SCS Use in Patients with CRSwNP and Coexisting Asthma","authors":"Mark Gurnell, Amr Radwan, Claus Bachert, Njira Lugogo, Seong H Cho, Scott Nash, Haixin Zhang, Asif H Khan, Juby A Jacob-Nara, Paul J Rowe, Yamo Deniz","doi":"10.2147/jaa.s420140","DOIUrl":"https://doi.org/10.2147/jaa.s420140","url":null,"abstract":"<strong>Purpose:</strong> Dupilumab significantly reduced the requirement for systemic corticosteroids (SCS) in patients with severe chronic rhinosinusitis with nasal polyps (CRSwNP). Patients with CRSwNP and coexisting asthma typically have a higher disease burden and have more difficulty in managing disease. Here, we report an analysis of asthma outcomes and SCS use in patients with CRSwNP and coexisting asthma.<br/><strong>Patients and Methods:</strong> This was a post hoc analysis of the randomized, placebo-controlled SINUS-24 and SINUS-52 studies (NCT02912468/NCT02898454) in patients with severe CRSwNP and coexisting asthma (patient self-reported) from the pooled intention-to-treat population randomized to dupilumab 300 mg every 2 weeks or placebo. On-treatment SCS use was estimated using Kaplan–Meier analysis. Forced expiratory volume in 1 s (FEV<sub>1</sub>), percent predicted FEV<sub>1</sub>, and the 6-item Asthma Control Questionnaire (ACQ-6) were assessed at baseline and Week 24 (pooled SINUS-24/52) in patients with/without history of asthma exacerbation or prior SCS use.<br/><strong>Results:</strong> Of 337 patients with coexisting asthma, 88 (26%) required on-treatment SCS use. The requirement for on-treatment SCS use for any reason was significantly lower with dupilumab (20/167 patients; 12%) vs placebo (68/170; 40%); hazard ratio (95% confidence interval) 0.248 (0.150– 0.409); <em>p</em> < 0.0001. The most frequent reasons for SCS use were nasal polyps (dupilumab 3% and placebo 27%) and asthma (2% and 9%, respectively). FEV<sub>1</sub>, percent predicted FEV<sub>1</sub>, and ACQ-6 were all significantly improved at Week 24 with dupilumab vs placebo irrespective of history of asthma exacerbation or prior SCS use (all <em>p</em> < 0.01).<br/><strong>Conclusion:</strong> Dupilumab significantly reduced the requirement for SCS and improved asthma outcomes irrespective of history of asthma exacerbation or prior SCS use vs placebo in patients with CRSwNP and coexisting asthma, demonstrating concomitant reduction of SCS use and asthma disease burden in these patients.<br/><br/><strong>Plain Language Summary:</strong> Chronic rhinosinusitis with nasal polyps (CRSwNP) and asthma are type 2 inflammatory conditions that often coexist. Patients with both CRSwNP and asthma generally have worse symptoms that are more difficult to treat. Their standard treatment is topical (inhaled/intranasal) corticosteroids, but where this is ineffective, systemic corticosteroids, also called SCS, are used. SCS are effective at reducing nasal polyp size and improving symptoms, but this effect often does not last, and many patients experience side effects when SCS are used for a long time. Dupilumab, a drug that targets type 2 inflammation, is approved for treating both uncontrolled CRSwNP and moderate-to-severe asthma. Here, we investigate whether dupilumab changes how often patients with CRSwNP and asthma need to use SCS and its effect on their asthma. We","PeriodicalId":15079,"journal":{"name":"Journal of Asthma and Allergy","volume":"21 1","pages":""},"PeriodicalIF":3.2,"publicationDate":"2024-01-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139476682","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Purpose: This study aims to explore the complicated decision-making dilemma and challenges confronted by parents of children suffering from severe asthma within the Pediatric Intensive Care Unit (PICU) when participating in the development of their children’s discharge care plans. Patients and Methods: Employing a phenomenological methodology, a purposive sampling was performed to engage with 17 parents who participated in in-depth and semi-structured interviews between October 2022 and February 2023. The transcripts of these interviews were transcribed into textual data, which was then subjected to Colaizzi’s seven-step analysis for meticulous coding and comprehensive thematic elucidation. Results: The comprehensive analysis of the factors involved in the intricate decision-making dilemmas faced by parents of children with severe asthma during the process of crafting discharge care plans in the PICU revealed five themes and eight sub-themes: 1) Complexity of asthma-related information; 2) Insufficient provision of comprehensive decision-making support; 3) Encountering negative emotions and wavering confidence; 4) Navigating realistic constraints impacting both parents and HCPs; 5) Balancing the advantages and disadvantages of various plans. Conclusion: Parents of children with severe asthma in the PICU encounter intricate and multifaceted decision-making dilemmas while engaging in the formulation of discharge care plans. These complexities significantly dampen their decision-making enthusiasm and introduce potential risks to the children’s prognosis and recovery. In the future, it is imperative to leverage the guidance provided by healthcare professionals (HCPs) in the decision-making process, develop tailored decision support tools specifically designed for the formulation of discharge care plans for children with severe asthma in the PICU.
Keywords: severe asthma, parents, discharge care plan, decision-making dilemma, phenomenological study
{"title":"Factors Involved in Decision-Making Dilemmas Faced by Parents of Children with Severe Asthma in PICU During the Development of Discharge Care Plans: A Phenomenological Study","authors":"Guimei Fan, Mo Yi, Xiangmin Qiu, Jinfang Zhao","doi":"10.2147/jaa.s438318","DOIUrl":"https://doi.org/10.2147/jaa.s438318","url":null,"abstract":"<strong>Purpose:</strong> This study aims to explore the complicated decision-making dilemma and challenges confronted by parents of children suffering from severe asthma within the Pediatric Intensive Care Unit (PICU) when participating in the development of their children’s discharge care plans.<br/><strong>Patients and Methods:</strong> Employing a phenomenological methodology, a purposive sampling was performed to engage with 17 parents who participated in in-depth and semi-structured interviews between October 2022 and February 2023. The transcripts of these interviews were transcribed into textual data, which was then subjected to Colaizzi’s seven-step analysis for meticulous coding and comprehensive thematic elucidation.<br/><strong>Results:</strong> The comprehensive analysis of the factors involved in the intricate decision-making dilemmas faced by parents of children with severe asthma during the process of crafting discharge care plans in the PICU revealed five themes and eight sub-themes: 1) Complexity of asthma-related information; 2) Insufficient provision of comprehensive decision-making support; 3) Encountering negative emotions and wavering confidence; 4) Navigating realistic constraints impacting both parents and HCPs; 5) Balancing the advantages and disadvantages of various plans.<br/><strong>Conclusion:</strong> Parents of children with severe asthma in the PICU encounter intricate and multifaceted decision-making dilemmas while engaging in the formulation of discharge care plans. These complexities significantly dampen their decision-making enthusiasm and introduce potential risks to the children’s prognosis and recovery. In the future, it is imperative to leverage the guidance provided by healthcare professionals (HCPs) in the decision-making process, develop tailored decision support tools specifically designed for the formulation of discharge care plans for children with severe asthma in the PICU.<br/><br/><strong>Keywords:</strong> severe asthma, parents, discharge care plan, decision-making dilemma, phenomenological study<br/>","PeriodicalId":15079,"journal":{"name":"Journal of Asthma and Allergy","volume":"71 1","pages":""},"PeriodicalIF":3.2,"publicationDate":"2023-12-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139055395","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Muhammad Ifham Hanif, Bagus Muhammad Ihsan, Mentari Maratus Sholihah
Letter for the article Domestic Parasitic Infections in Patients with Asthma and Eosinophilia in Germany – Three Cases with Learnings in the Era of Anti- IL5 Treatments
致信《德国哮喘和嗜酸性粒细胞增多症患者的国内寄生虫感染– 抗IL5治疗时代的三个案例启示》一文
{"title":"Domestic Parasitic Infections in Patients with Asthma and Eosinophilia in Germany – Three Cases with Learnings in the Era of Anti-IL5 Treatments [Letter]","authors":"Muhammad Ifham Hanif, Bagus Muhammad Ihsan, Mentari Maratus Sholihah","doi":"10.2147/jaa.s454276","DOIUrl":"https://doi.org/10.2147/jaa.s454276","url":null,"abstract":"Letter for the article Domestic Parasitic Infections in Patients with Asthma and Eosinophilia in Germany – Three Cases with Learnings in the Era of Anti- IL5 Treatments","PeriodicalId":15079,"journal":{"name":"Journal of Asthma and Allergy","volume":"16 1","pages":""},"PeriodicalIF":3.2,"publicationDate":"2023-12-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139029040","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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