Asthma Control Questionnaire Score Research Articles

Achieving clinical remission in asthma with mepolizumab: a subanalysis on vitamin D as a predictor of response

Objective Mepolizumab, an anti-IL-5 monoclonal antibody, has shown promise in reducing exacerbations and steroid dependency in severe eosinophilic asthma. This study aims to evaluate the effectiveness of mepolizumab in achieving clinical remission in asthma over 12 months and explore Vitamin D levels as a predictor of response. Method We assessed Asthma Control Questionnaire (ACQ) scores, spirometry, number of exacerbations, oral corticosteroid (OCS) use, and inhaled corticosteroid (ICS) use in 32 patients, observing significant clinical improvements. Data were collected 1 year prior to starting mepolizumab and one year after starting mepolizumab. Nasal polyps were not seen in all the patients, and computed tomography of para-nasal sinuses are not available for all the patients, so nasal polyps status are not evaluated to avoid any bias. Result Our results indicate that 12 patients achieved clinical remission after starting mepolizumab, with a strong correlation between higher Vitamin D levels and positive treatment outcomes. This suggests that optimizing Vitamin D levels could enhance the response to mepolizumab in asthma patients, and help in achieving better asthma control. Conclusion Mepolizumab is an effective treatment for severe eosinophilic asthma, significantly improving clinical outcomes and reducing corticosteroid use. This study highlights the importance of Vitamin D as a predictor of response to mepolizumab, suggesting that higher Vitamin D levels may enhance treatment efficacy.

The triple radiologic asthma phenotype is associated with worse disease control

BackgroundEfforts have been made to combine radiographical biomarkers such as bronchiectasis or bronchial wall thickness (BWT) to identify asthma sub-phenotypes and their clinical implications. ObjectiveTo assess whether a composite triple radiological phenotype measured by high resolution computed tomography comprising BWT, mucus plug score (MPS) and mediastinal lymph node (MLN) size might provide a better insight into sub-phenotypes in persistent asthma. MethodsOne hundred and twelve patients with moderate-to-severe asthma were included in this retrospective observational study. A binary method was used to classify patients according to median values for: pooled MLN≥3.6mm; BWT as pooled wall area ≥50% of the total airway area; and MPS≥1 where a mucus plug was considered positive if complete bronchial obstruction was imaged more than 2 cm from a pleural surface. ResultsPatients with the triple imaging phenotype exhibited significantly worse asthma control questionnaire scores exceeding minimal clinical important difference, a higher prevalence of concomitant chronic rhinosinusitis with nasal polyposis and a greater total IgE level. ConclusionWe have demonstrated an association between poorer symptom control and the triple radiological asthma phenotype.

Long-term Safety and Efficacy of Dupilumab in Patients With Uncontrolled, Moderate-to-Severe Asthma Recruited From Korean Centers: A Subgroup Analysis of the Phase 3 LIBERTY ASTHMA TRAVERSE Trial.

Long-term data are limited on the safety and efficacy of dupilumab in patients with uncontrolled, moderate-to-severe asthma from Korea. The current subgroup analysis was designed to evaluate the long-term safety and efficacy of dupilumab in patients enrolled from Korean centers in the parent studies (phase 2b and QUEST) and who participated in the TRAVERSE open-label extension (OLE) study. TRAVERSE was a global, multicenter, OLE study that assessed the safety and efficacy of dupilumab 300 mg every 2 weeks for up to 96 weeks in patients (n = 2,282) with uncontrolled, moderate-to-severe asthma who completed prior dupilumab asthma clinical trials. The primary outcome was the incidence of any treatment-emergent adverse events (TEAEs); the secondary outcomes included annualized severe exacerbation rate, pre-bronchodilator forced expiratory volume in 1 second (pre-BD FEV1), and 5-item Asthma Control Questionnaire (ACQ-5) score. Safety outcomes were consistent with the parent studies and the overall TRAVERSE population; out of 74 patients, 70 experienced ≥ 1 TEAE, and 6 (8.1%) discontinued because of adverse events. During the treatment period, the unadjusted annualized severe exacerbation rate was low (0.470). Improvement in pre-BD FEV1 was seen as early as Week 2 with a mean change from the parent study baseline (PSBL), standard deviation (SD) of 0.42 L (0.47), which was sustained until Week 96. Mean change from PSBL (SD) in ACQ-5 score was -1.32 (0.76) at Week 48. This subgroup analysis of TRAVERSE showed the long-term safety and efficacy of dupilumab in patients with uncontrolled, moderate-to-severe asthma enrolled from Korean centers. ClinicalTrials.gov Identifier: NCT02134028.

Bronchodilator effect of oral doxofylline and procaterol in asthma: A randomized crossover study

Background Oral bronchodilators may be used as an adjunctive treatment, especially in patients with uncontrolled asthma or poor inhaler technique. This study aimed to determine the differences in asthma symptoms and bronchodilator effect between oral doxofylline and oral procaterol in adults with asthma. Methods A crossover randomized controlled trial was conducted. Asthmatic patients aged 18 years or older with stable inhaled corticosteroids and long-acting beta2-agonists (ICS/LABA) treatment were included. Each patient received 2 weeks of treatment with either doxofylline or procaterol followed by a 1-week washout period and 2 weeks of treatment with the other drug. Asthma symptoms were assessed using the Asthma Control Questionnaire-5 (ACQ-5) scores, pulmonary function was assessed by spirometry with bronchodilator testing, and adverse events were recorded. Results A total of 21 patients were randomly allocated to either the doxofylline or procaterol groups. The mean age of the patients was 53.0±14.8 years. ACQ-5 scores were 1.4±1.1. After two weeks of treatment, the ACQ-5 scores and all pulmonary function parameters were not significantly different between the two groups (P>0.05). However, significant improvements in ACQ-5 scores were found in both groups (mean change: -0.381± 0.740, P=0.029 and -0.476± 0.873, P=0.021 for the doxofylline and procaterol groups, respectively). None of the patients experienced asthma exacerbations. Conclusions Doxofylline and procaterol can improve asthma symptoms, although they cannot enhance lung function. These oral bronchodilators might be used as an add-on therapy in asthmatic patients with persistent symptoms despite treatment with an ICS/LABA combination.

Efficacy and safety of subcutaneous immunotherapy combined with omalizumab in children with dust mite-induced asthma

Objective To evaluate the benefits of combining omalizumab with specific immunotherapy (SCIT) in the treatment of children with bronchial asthma. Methods In this study, 83 children with asthma were treated at the Allergy Department of Qingdao University from January 2019 to February 2020. Participants were divided into three groups: SCIT, combination (omalizumab + SCIT), and control (standard asthma medications). We assessed Asthma Control Questionnaire (ACQ) scores, Visual Analogue Scale (VAS) scores, and lung function at baseline, 24 wk, and 48 wk. Additionally, asthma medication scores were compared at 24 and 48 wk. Adverse reactions were monitored in both the SCIT and combination groups. Results The combination group demonstrated lower ACQ scores at both 24 and 48 wk, and improved VAS scores at 48 wk compared to the other groups. Additionally, lung function parameters (FEV1 and FEF50) showed significant improvement in the combination group. Reduced asthma medication scores were noted in the combination group at 24 and 48 wk. Local adverse reactions were fewer in the combination group, and no systemic adverse reactions were reported. Conclusion Combining omalizumab with SCIT provides quicker asthma control, lowers medication requirements, and enhances lung function with fewer adverse effects, making it a safe and effective treatment for children with bronchial asthma.

Exploring Clinical Remission in Moderate Asthma - Perspectives from Asia, the Middle East, and South America.

Clinical remission is a relatively new concept in asthma but recent research initiatives suggest it could be an ambitious and achievable therapeutic target for patients with asthma. In this modified Delphi study (comprising two online surveys, completed either side of a virtual scientific workshop), the opinions of a panel of respiratory physicians were evaluated to summarize perspective statements on key therapeutic outcomes and criteria for on-treatment clinical remission in patients with moderate asthma. An agreement threshold was pre-defined as agreement by ≥ 75% of participants. Surveys 1 and 2 were completed by 20 and 18 participants, respectively. Most participants (95%) agreed with the concept of clinical remission in moderate asthma and that this should be a desirable treatment goal (90%). Based on a composite measure of 4-6 desirable therapeutic outcomes, current understanding of clinical remission was considered as 12months with no exacerbations, no oral corticosteroids, no daytime or night-time asthma symptoms (Asthma Control Test score ≥ 20 or Asthma Control Questionnaire score ≤ 0.75), stable lung function, and no treatment-related adverse events. No agreement was reached on the role of relievers in defining therapeutic outcomes or on the wider use of biomarkers and airway hyperresponsiveness for defining asthma remission in clinical practice. In line with recent consensus statements from the United States and Europe, there was a high level of agreement on the elements of clinical remission among a panel of respiratory physicians from Asia, the Middle East, and South America. Extension of the concept of clinical remission to patients with moderate asthma was considered aligned with the potential of clinical remission as a goal of therapy.

The outcome of posterior nasal nerve/vidian nerve neurectomy during FESS on patients of nasal polyposis associated with bronchial asthma

BackgroundWorldwide, bronchial asthma, allergic rhinitis, and chronic rhinosinusitis are highly prevalent conditions, and numerous researches have shown how they affect one another. Still, reports about surgical treatments remain limited.AimTo investigate the role of functional endoscopic sinus surgery (FESS) with posterior nasal nerve/vidian neurectomy, as a surgical protocol in the management of chronic rhinosinusitis with nasal polyposis (CRSwNP), and its effect on bronchial asthma (BA) patients’ quality of life and pulmonary function tests.MethodsThis study was a prospective observational study that involved 25 patients with BA and CRSwNP who underwent full-house FESS with bilateral posterior nasal nerve or vidian neurectomy in the Otorhinolaryngology-Head and Neck Surgery Department and were evaluated in the Chest Department, Zagazig University, from May 2022 to December 2023. All included patients were subjected to pre- and post-operative respiratory assessments including spirometry, Asthma Control Questionnaire (ACQ), and Asthma Quality of Life Questionnaire (AQLQ). Also, all patients were subjected to pre- and post-operative nasal assessment including visual analog scale (VAS), nasal endoscopic evaluation, and routine CT paranasal sinus.ResultsThis study included 25 patients (11 men and 14 women; age range 18–57 years; mean ± SD of age 33.24 ± 11.3 years). There were statistically significant increases as regards forced vital capacity and forced expiratory volume in 1 s according to preoperative, 3 months, and 6 months postoperative values. As regards ACQ, AQLQ, and VAS scores, there were highly statistically significant improvements according to preoperative, 3 months, and 6 months postoperative follow-up scores. Asthma medication step-down was successful in 52% of patients after 6 months of follow-up.ConclusionsThe quality of life, pulmonary function, and nasal symptoms of people with bronchial asthma combined with CRSwNP can both be alleviated after posterior nasal nerve/vidian neurectomy beside FESS.

Clinical remission maintained and improved over time in patients with severe asthma treated with omalizumab

Background Clinical remission has recently been proposed as a possible treatment goal even in severe asthma. In this real-world study, we aimed to assess the achievement rate and predictive factors of clinical remission using omalizumab in patients with severe asthma. Methods This retrospective observational study included patients with severe asthma initiated with omalizumab therapy and recruited from the asthma clinic of the Akdeniz University Hospital, Turkey. Clinical remission was defined as patients who received no oral corticosteroid (OCS) therapy; showed no exacerbations; showed an asthma control questionnaire score of ≤ 1, asthma control test (ACT) of ≥ 20, or both and, FEV1 of ≥ 80% predicted. Results A total of 58 patients were included in the study, with an average age of 56.4 ± 13.6 years. The mean duration of asthma was 23.5 ± 11.8 years and the mean duration of omalizumab treatment was 80.05 ± 35.04 months. Clinical remission rates were 25.9% in the first and second year, 34.0% in the third year, 34.1% in the fourth year and 47.4% in the fifth year. Pre-omalizumab ACT, FEV1 (%) and OCS use were significantly higher in patients with clinical remission at 1 year. Logistic regression analyses showed that none of the factors predicted clinical remission. Conclusion Omalizumab has the potential to induce disease remission in a significant proportion of people with severe asthma, and this is maintained and improved over time.

Efficacy of benralizumab in severe eosinophilic asthma: results of a real clinical practice prospective study BEST in Russia

The study of the efficacy of biological therapy in patients with severe bronchial asthma in real world settings is a relevant task since observational research programs allow answering questions that fall out of focus with a strict selection of patients in RCT. Multicenter studies are prioritized because they allow combining and systematizing additional previously undescribed data in a wider population.The aim of the BEST study (Real World Evidence of Benralizumab in Eosinophilic Severe AsThma in Russia) was to confirm the clinical effectiveness of benralizumab regarding change of disease control and quality of life (QoL) level associated with respiratory status in patients with eosinophilic phenotype of uncontrolled severe asthma in real clinical practice in Russia.Methods. An open-label non-randomised multicenter study was conducted involving 59 adult patients with severe eosinophilic asthma. Benralizumab was prescribed according to indications used in routine practice in addition to maintenance therapy. The duration of follow-up was 56 weeks. Disease control level was assessed using the Asthma Control Questionnaire-5 (ACQ-5), and QoL associated with respiratory status was assessed using the St. George’s Respiratory Questionnaire (SGRQ). Patients’ Global Impression of Change (PGIC) and Patients’ Global Impression of Severity (PGIS) were used for subjective assessments of the well-being of patients. The frequency of exacerbations, usage of systemic corticosteroids (SCS), and functional parameters were also evaluated.Results. The use of benralizumab led to a clinically significant improvement in ACQ-5 and SGRQ scores, a significant decrease in the frequency of exacerbations and a significant increase in pre- and post-bronchodilation FEV1 and FVC. There was an improvement in the well-being of patients according to the PGIC and PGIS scales. The SCS dose did not change. The therapeutic effect of benralizumab occurred quickly and persisted throughout the whole study, demonstrating the most significant changes in effectiveness values by the 56th week of treatment.Conclusion. The use of benralizumab in real clinical practice significantly improved the control of severe eosinophilic asthma and QoL of patients and was associated with a favorable safety profile.

Validity study of the Japanese version of the Nijmegen Questionnaire for verifying dysfunctional breathing in Japanese asthma patients

Dysfunctional breathing (DB) is a clinical condition characterized by irregular breathing patterns presenting a sensation of dyspnea and a feeling of chest tightness. DB is a known comorbidity of asthma that is difficult to control, leading to poor quality of life, so early diagnosis and therapeutic intervention are essential to improve the clinical condition of asthma. The Nijmegen Questionnaire (NQ), developed to screen for DB and translated into various languages, is used worldwide. However, a Japanese NQ (JNQ) is unavailable, so DB has not been clinically verified in people with asthma in Japan. This study aimed to prepare a JNQ, verify its reliability and validity, and demonstrate its clinical benefits in asthma treatment. The JNQ was prepared by back-translating the NQ with the author's consent. The answers to self-administered questionnaires, including the JNQ, Asthma Control Test (ACT), Asthma Control Questionnaire (ACQ), Mini Asthma Quality of Life Questionnaire (Mini-AQLQ), and Patient Health Questionnaire 9 (PHQ-9), were obtained with the consent of 68 people with asthma (average age ± SD, 52.04± 12.43 years) who visited Nihon University Itabashi Hospital. The reliability of the JNQ was analyzed by the Cronbach alpha coefficient. Acomparative test was conducted for each questionnaire (ACT, ACQ, Mini-AQLQ, PHQ-9), considering a JNQ score of 23 as the cutoff value. Patients with a score of 23 or more were assigned to the DB group, whereas patients with a score of less than 23 were assigned to the non-DB group. We analyzed the correlation between the JNQ and each questionnaire. The JNQ showed sufficient reliability (Cronbach alpha= 0.875). Correlation analysis between the JNQ score and each questionnaire revealed negative correlations with the ACT score (r= 0.262) and Mini-AQLQ score (r= -0.453) and positive correlations with the ACQ score (r= 0.337) and PHQ-9 score (r= 0.539). All of these correlations were statistically significant. As a result of the comparative test, the DB and non-DB groups showed a significant difference in Mini-AQLQ (P= .023) and PHQ-9 (P= .003) scores. No significant difference was observed between ACT (P= .294) and ACQ (P= .177) scores. The JNQ validates DB in Japanese people with asthma and reflects the deterioration of asthma control, decreased quality of life, and depression. Using the JNQ, early diagnosis and therapeutic intervention (eg, breathing exercises and a psychosomatic approach) for DB in people with asthma may help suppress the severity of asthma in Japan.

Benralizumab in Severe Eosinophilic Asthma and Chronic Rhinosinusitis with Nasal Polyps: The Real-World, Multi-Country RANS Observational Study.

Real-world evidence of benralizumab effectiveness on nasal polyps (NP) and asthma outcomes in patients with severe eosinophilic asthma (SEA) and comorbid chronic rhinosinusitis with NP are limited. The objective of this study was to assess NP and asthma outcomes in benralizumab-treated patients with SEA and comorbid NP in a real-world setting. RANS was a retrospective, multi-country observational study (ClinicalTrials.gov: NCT05180357) using medical chart reviews of adults with SEA and comorbid NP. Total NP Score (NPS), SinoNasal Outcome Test-22 (SNOT-22) total score, annualized exacerbation rate (AER), and 6-item Asthma Control Questionnaire (ACQ-6) and Asthma Control Test (ACT) scores during the 12 months pre-index (baseline) and post-index (follow-up) were measured. Clinically meaningful improvement from baseline following treatment, in terms of total NPS (≥1-point reduction), SNOT-22 total (≥8.9-point reduction), ACQ-6 (≥0.5-point reduction) or ACT (≥3-point increase) scores, were reported. A total of 233 patients were included. Baseline mean (standard deviation [SD]) NPS and SNOT-22 total scores were 3.8 (2.4) and 47.5 (22.6), respectively. The mean change (95% confidence interval [CI]) from baseline was -1.2 (-1.7, -0.6) for NPS, and -19.8 (-23.6, -15.9) for SNOT-22. The AER (95% CI) was 1.2 (0.96, 1.41) at baseline and 0.2 (0.13, 0.28) at follow-up. Mean (SD) ACQ-6 and ACT scores were 1.6 (1.3) and 15.0 (5.2) at baseline and 0.8 (1.0) and 22.0 (3.9) at follow-up, respectively. The proportion of patients who achieved clinically meaningful improvements in NPS, SNOT-22 total, ACQ-6, and ACT scores was 49.1%, 67.6%, 56.6%, and 81.1%, respectively. In this real-world study, improvements in NP and asthma outcomes in patients with SEA and comorbid NP were observed during the 12 months following benralizumab initiation.

Suboptimal Response to Biologics in Severe Asthma—A Marker of Humoral Immunodeficiencies

BackgroundAsthmatic patients with antibody deficiencies (AD) have more severe disease and higher risk of exacerbations. No data exists about the efficacy of biologics in severe asthma (SA) patients with AD.The objective of this study was to evaluate the efficacy of biologics in SA patients with and without AD. MethodsA case-control real-life study was conducted including 68 patients divided in two groups: group 1 with SA-AD and group 2 with SA. ResultsTreatment by biologics for 6 months was effective to decrease the number of exacerbations, hospitalizations, and emergency department (ED) visits, to improve the Asthma Control Questionnaire (ACQ) score and proved a systemic corticosteroid sparing effect. Despite benefits, the number of exacerbations, hospitalizations, and ED visits, the mean ACQ score, and the cumulative dose of systemic corticosteroids remain higher in group 1 vs 2, with lower lung function parameters. The rates of responses were inferior in group 1 vs 2 with a decrease by ≥50% of exacerbation rate in 76% vs 97% of patients (p=.006), no hospitalization in 44% vs 91% of patients (p<.001), no ED visit 56% vs 82% of patients (p=.018), significant improvement of ACQ score by ≥0.5 in 68% vs 100% of patients (p<.001), and increase of forced expiratory volume in the first second by >10% in 32% vs 65% of patients (p=.007). ConclusionDespite evident benefits, SA patients with AD have suboptimal responses to biologics compared to those immunocompetent. A multidisciplinary approach is necessary to optimize the management of these patients in practice.

Evidence for 2 clusters among patients with noneosinophilic asthma

BackgroundAlthough asthma is often seen as an eosinophilic disease associated with atopy, patients with noneosinophilic asthma represent a substantial part of the population with asthma. ObjectiveTo apply an unsupervised clustering method in a cohort of 588 patients with noneosinophilic asthma (sputum eosinophils < 3%) recruited from an asthma clinic of a secondary care center. MethodsOur cluster analysis of the whole cohort identified 2 subgroups as cluster 1 (n = 417) and cluster 2 (n = 171). ResultsCluster 1 comprised a predominantly female group with late disease onset, a low proportion of atopy (24%), and a substantial smoking history (53%). In this cluster, treatment burden was low (<50% of inhaled corticosteroid users); asthma control and quality of life were poor, with median Asthma Control Test, Asthma Control Questionnaire, and Asthma Quality of Life scores of 16, 1.7, and 4.5, respectively, whereas lung function was preserved with a median postbronchodilation forced expiratory volume in 1 second of 93% predicted. Cluster 2 was a predominantly male group, almost exclusively comprising patients with atopy (99%) with early disease onset and a moderate treatment burden (median inhaled corticosteroids dose 800 µg/d equivalent beclomethasone). In cluster 2, asthma was partially controlled, with median Asthma Control Test and Asthma Control Questionnaire scores reaching 18 and 1.3, respectively, and lung function well preserved with a median postbronchodilation of 95% predicted. Although systemic and airway neutrophilic inflammation was the dominant pattern in cluster 1, cluster 2 essentially comprised paucigranulocytic asthma with moderately elevated fraction exhaled nitric oxide. ConclusionNoneosinophilic asthma splits into 2 clusters distinguishing by disease onset, atopic status, smoking history, systemic and airway inflammation, and disease control and quality of life.

Super-responder and clinical remission in patients with asthma on treatment with single biologic therapy or cycling therapy using dupilumab in a real-world setting.

Regarding the therapeutic target in asthma, super-responder status (SR) is a status without systemic corticosteroids. Recently, clinical remission (CR), being a status of prolonged absence of asthma symptoms without systemic corticosteroids and/or normal pulmonary function, has gained attention as a new therapeutic target in asthma. Here, we examined the percentage and features of asthma patients on treatment with dupilumab showing SR and CR. 49 asthma patients used subcutaneous dupilumab for >1 year between April 2019 and November 2022. The status of SR and CR for 1 year was evaluated. Patients without any maintenance oral corticosteroids and exacerbations requiring systemic corticosteroids were classified as SR. CR was defined using three definitions based on changes in asthma symptoms and pulmonary function in addition to achieving SR for 1 year: CR without pulmonary function criteria (CR w/o F), fulfilment of asthma symptom improvement (asthma control questionnaire score <0.75 or asthma control test score ≥23); and CR-70 or CR-80, pulmonary function improvement (%forced expiratory volume in 1 second ≥70% or ≥80%) in addition to achieving CR w/o F, respectively. 38 (77.6%), 22 (44.9%), 13 (26.5%), 12 (24.5%) of patients had SR, CR w/o F, CR-70, and CR-80, respectively. Severe eosinophilic chronic rhinosinusitis was significantly more found in patients with SR and CR based on all three definitions than in those without. This study identified the percentage and features of patients on treatment with dupilumab showing SR and CR in a real-world setting. The outcome beyond CR on biologic treatment should be clarified.

Effect of Individual Patient Characteristics and Treatment Choices on Reliever Medication Use in Moderate-Severe Asthma: A Poisson Analysis of Randomised Clinical Trials.

Even though increased use of reliever medication, including short-acting beta agonists (SABA), provides an indirect measure of symptom worsening, there have been limited efforts to assess how different patterns of reliever use correlate with symptom control and future risk of exacerbations. Here, we evaluate the effect of individual baseline characteristics on reliever use in patients with moderate-severe asthma on regular maintenance therapy with fluticasone propionate (FP) or combination therapy with fluticasone propionate/salmeterol (FP/SAL) or budesonide/formoterol (BUD/FOR). A drug-disease model describing the number of 24-h puffs and overnight occasions was developed with data from five clinical studies (N = 6212). The model was implemented using a nonlinear mixed effects approach and a Poisson function, considering clinical and demographic baseline characteristics. Goodness of fit and model predictive performance were assessed. Heatmaps were created to summarise the effect of concurrent baseline factors on reliever utilisation. The final model accurately described individual patterns of reliever use, which is significantly increased with time since diagnosis, smoking, higher Asthma Control Questionnaire (ACQ-5) score and higher body mass index (BMI) at baseline. Whilst the number of puffs decreases slowly after an initial drop relative to the start of treatment, exacerbating patients utilise significantly more reliever than those who do not exacerbate. The mean effect of FP/SAL (median dose: 250/50μg BID) on reliever use was slightly higher than that of BUD/FOR (median dose: 160/4.5μg BID), i.e. a 75.3% vs 69.3% reduction in reliever use, respectively. The availability of individual-level patient data in conjunction with a parametric approach enabled the characterisation of interindividual differences in the patterns of reliever use in patients with moderate-severe asthma. Taken together, individual demographic and clinical characteristics, as well as exacerbation history, can be considered an indicator of the degree of asthma control. High SABA reliever use suggests suboptimal clinical management of patients on maintenance therapy.

Effectiveness of fruit and vegetable consumption with asthmatic symptoms and episodes: A systematic review

Introduction: Asthma is a chronic disease, so it is essential to adhere to good treatment and follow the recommendations appropriatel, Objective: to determine the effectiveness of recommending the consumption of fruits and vegetables (FV) on the reduction of asthma attacks, including Asthma Control Questionnaire (ACQ) and Interleukin-6 (IL-6) scores, Methods: The search was performed in the electronic databases: Pubmed, Web of Science, Scopus and Cochrane Library. Studies were included that applied at least one intervention or recommendation for FV consumption in patients with asthma, airway inflammation and other associated problems. Two independent reviewers assessed the selected studies and measured risk of bias. Relevant information was summarized and combined with random effect meta-analysis (DerSimonian-Laird). RevMan 5,4 was applied. Finally, the degree of recommendation was evaluated with GRADE-pro, Results: Three randomized clinical trials (RCTs) totaling 197 subjects were identified. A decrease in asthma symptoms was observed according to the ACQ, but not statistically significant (-0,20; 95 % CI: -0.59, 0,19). Furthermore, interleukin-6 also did not present significance 0,20 (95 % CI: -0,06, 0,46). The nature of the design of the meta-analyzed studies allows a high and moderate degree of recommendation to be scored, respectively. The findings in general suggest that FV intake can generate favorable changes in asthma and its prevention. However, this study failed to demonstrate this statistically, Conclusion: It is necessary that more RCTs be carried out to increase the power of the evidence and update the available information

Low Serum IL-18 Levels May Predict the Effectiveness of Dupilumab in Severe Asthma.

Objective Dupilumab, a monoclonal antibody specific for the human interleukin (IL)-4 receptor α, is used to treat severe asthma, especially in patients with elevated blood eosinophil counts and fractional exhaled nitric oxide (FeNO). The therapeutic response to dupilumab is highly variable. In this study, we explored new serum biomarkers to accurately predict the effect of dupilumab and examine the effect of dupilumab based on changes in the clinical parameters and cytokine levels. Methods Seventeen patients with severe asthma treated with dupilumab were enrolled. Responders, defined as those with a >0.5-point decrease in the Asthma Control Questionnaire (ACQ) score after 6 months of treatment, were included. Results There were 10 responders and 7 non-responders. Serum type 2 cytokines were equivalent between responders and non-responders; the baseline serum IL-18 level was significantly lower in responders than in non-responders (responders, 194.9±51.0 pg/mL; non-responders, 323.4±122.7 pg/mL, p=0.013). The cut-off value of IL-18 at 230.5 pg/mL could be used to distinguish non-responders from responders (sensitivity 71.4, specificity 80.0, p=0.032). Conclusion A low baseline serum IL-18 level may be a useful predictor of an unfavorable response to dupilumab in terms of the ACQ-6.

Effect of Buteyko breathing technique on clinical and functional parameters in adult patients with asthma: a randomized, controlled study

BackgroundThe established therapy of asthma might be supported by additional non-pharmaceutical measures, such as the Buteyko breathing technique (BBT); however, the available data are mixed. To clarify the effects of BBT in patients with asthma, we investigated whether it led to clinical improvements with correlation to functional parameters.MethodsUsing a randomized, controlled design, we studied two groups (n = 30 each) of patients with asthma under either BBT or usual therapy (UT) w/o BBT over a period of 3 months. The primary outcome comprised the voluntary control pause (CP) after 3 months, secondary outcomes an additional breathhold parameter, forced expiratory volume in 1 s (FEV1), capnovolumetry, exhaled nitric oxide (FeNO), Asthma Control Questionnaire (ACQ) and Nijmegen Questionnaire (NQ), and the use of medication (β2-agonists; inhaled corticosteroids, ICS).ResultsCP showed significant time-by-group interaction [F(1,58.09) = 28.70, p < 0.001] as well as main effects for study group [F(1,58.27) = 5.91, p = 0.018] and time [F(1,58.36) = 17.67, p < 0.001]. ACQ and NQ scores were significantly (p < 0.05 each) improved with BBT. This was associated with reductions in the use of β2-agonists and ICS (p < 0.05 each) by about 20% each. None of these effects occurred in the UT group. While FEV1 and the slopes of the capnovolumetric expiratory phases 2 and 3 did not significantly change, the capnovolumetric threshold volume at tidal breathing increased (p < 0.05) with BBT by about 10 mL or 10%, compared to baseline, suggesting a larger volume of the central airways. No significant changes were seen for FeNO.ConclusionsBBT was clinically effective, as indicated by the fact that the improvement in symptom scores and the small increase in bronchial volume occurred despite the significant reduction of respiratory pharmacotherapy. As the self-controlled Buteyko breathing therapy was well-accepted by the participants, it could be considered as supporting tool in asthma therapy being worth of wider attention in clinical practice.Trial registration Retrospectively registered on 10 March 2017 at ClinicalTrials.gov (NCT03098849).

Real-World Safety and Effectiveness of Benralizumab in Japanese Patients with Severe Asthma: A Multicenter Prospective Observational Study.

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. 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. 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. 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.

Characteristics and outcomes of patients enrolled in the Connect 360 benralizumab patient support programme in the UK: a retrospective cohort study

BackgroundPatient support programmes (PSPs) allow patients with chronic diseases to receive treatment and support at home. This study describes the Connect 360 PSP delivery and impact on patient-reported outcomes, satisfaction...