mini-AQLQ Scores Research Articles

Real-world clinical remission of severe asthma with benralizumab in Spanish adults with severe asthma

Objective Patients with severe eosinophilic asthma experience high risk of exacerbations and reduced quality of life. Benralizumab, a monoclonal antibody binding to IL-5 receptor α subunit, is an approved drug for its treatment. The objective was to describe clinical remission after benralizumab prescription in routine clinical practice. Methods Retrospective multicenter study with data from four hospitals in Valencian Community (Spain) with asthma units between 2019 and 2020. Data was gathered at baseline and after 12 months. We considered clinical remission after 1 year if the patient remained without exacerbations and use of systemic corticosteroids and with good clinical control and normal lung function. Results Data from 139 patients was gathered. At the 12-month follow-up, 44.1% were in clinical remission, since 84.0%, 77.5%, 51.0% and 95.5% of patients did not experience exacerbations, had total asthma control test score of ≥20, prebronchodilator FEV1 of ≥80% and did not use systemic corticosteroids. A significant reduction of long-acting muscarinic antagonists (p = 0.0001), leukotriene receptor antagonists (p = 0.0326), oral corticosteroids (p < 0.0001) and short-acting beta agonists (p = 0.0499) was observed. Baseline factors with greatest individual influence on clinical remission were employment situation, tobacco use, comorbidity number, eosinophil value, number of exacerbations, FEV1, emergency visit number, and ACT, MiniAQLQ and TAI scores. Final analysis of multiple logistic regression indicated that having baseline FEV1 value below 80% increases remission chance 9.7 times a year compared to FEV1 >80%. Conclusion Clinical remission after treatment with benralizumab is achievable in a high percentage of patients with severe asthma eosinophilia not controlled in real life.

Assessing the validity and reliability of the Arabic versions of Mini Asthma Quality of life questionnaire and Asthma Control Test in adult patients with asthma: A factor analysis study

Background and objectiveAsthma is a common disease that has a significant influence on patients’ quality of life. Although Arabic tools for assessing symptom control and quality of life in individuals with asthma are available, no sufficient studies have evaluated the validity of these tools. Therefore, the aim of the current study was to validate the Arabic version of these tools. MethodsExploratory Factor Analysis (EFA) and Confirmatory Factor Analysis (CFA) were conducted on the Arabic versions of the Asthma Control Test (ACT) and Mini Asthma Quality of Life Questionnaire (Mini AQLQ). ResultsA total of 314 participants (70.1 % females) were enrolled in the current study. The mean age of the participants was 51.47 (±16.37). EFA suggested a three-factor model for Mini AQLQ and a one-factor model for ACT, which was confirmed by CFA analyses. High correlations were found between spirometric values and ACT and Mini AQLQ scores, indicating good concurrent validity. The area under the curve produced by the Roc curve was 0.861 (p < 0.001), and the most suitable cut-off point was 4.741. ConclusionAll analyses conducted showed that the Arabic versions of both Mini AQLQ and ACT are reliable and valid and can be administered to adults with asthma. The application of these validated instruments will improve the management and diagnosis of asthma in Arab countries.

Factors associated with poor health-related quality of life among patients with asthma: A hospital-based study from Jordan

&lt;b&gt;Purpose&lt;/b&gt;: Exploring the factors that are associated with diminished health-related quality of life (HRQOL) in patients with asthma is essential to reach the optimal HRQOL. This study aim to assess HRQOL and its associated factors in patients with asthma in Jordan.&lt;br /&gt; &lt;b&gt;Methods&lt;/b&gt;: This cross-sectional study was conducted on patients with asthma attending King Abdullah University Hospital and Jordan University Hospital in Jordan. In addition to socio-demographic variables, the study survey included mini asthma quality of life questionnaire (mini AQLQ) to measure HRQOL and asthma control test (ACT) to assess the degree of asthma control in asthmatic patients. Binary logistic regression was used to build a model of the independent predictors of poor HRQOL in the study participants.&lt;br /&gt; &lt;b&gt;Results&lt;/b&gt;: Of the 314 participating patients, 70.1% were females, with a mean age of 51.47±16.37 years. 61.1% of the participants had low HRQOL, with a total mean mini AQLQ score of 4.30±1.30. Results revealed that advanced age (OR=0.961; 95% CI: 0.936-0.986; p&amp;lt;0.05) and lack of daily exercise (OR=0.233; 95% CI: 0.085-0.637; p&amp;lt;0.01) were significant predictors of poor HRQOL in patients with asthma, while better controlled disease, manifested by higher ACT score was associated with better HRQOL in these patients (OR=1.499; 95% CI: 1.344-1.672; p&amp;lt;0.01).&lt;br /&gt; &lt;b&gt;Conclusions&lt;/b&gt;: HRQOL represents an area for improvement in patients with asthma. The current study provides insight on the factors associated with poor HRQOL. Future interventions and asthma management programs should focus on improving asthma control and encouraging physical activity, particularly for older patients, with the aim of improving HRQOL among patients with asthma.

The ATLAS ASMA Study: Assessing the Impact of Asthma on Patients' Life - The Spanish Patients' Perspective.

ATLAS ASMA described the psychosocial impact of asthma on patients' daily life from patients' perspectives (in terms of impaired personal and intimate relationships, sleep quality, leisure time, daily activities, and others) in Spain. Secondary objective includes description of time since diagnosis, expectations, and satisfaction of patients about disease, treatment and medical assistance received, adherence to treatment, perceived control of asthma, and health-related quality of life. This was a cross-sectional, observational study, based on a self-administered online survey for adult patients (≥18 years) with asthma. Patients with asthma diagnosis of any type and severity who voluntarily participated in the survey through a web link were included consecutively. In the present manuscript, only adult patients' data are included. A total of 132 adults with asthma were included. Moderate/severe asthma constituted 59.1% of the patients (females 71.2%). Overall, most relevant areas affected due to asthma were leisure activities (67.0%) and the quality/quantity of sleep (52.3%). Moderate/severe patients perceived some degree of impairment in work, school, or at home due asthma more frequently vs mild patients (55.2% vs 10.9%). Poorly controlled asthma (ACT≤19) was reported in 41 (70.7%) and 10 (21.7%) moderate/severe and mild patients (p<0.000), respectively. Mild patients obtained higher mean (SD) Mini-AQLQ score than moderate/severe asthma patients (5.6 [1.0] vs 4.3 [1.1], p<0.000), likewise higher significant results for every individual dimension. Most patients cited little limitation to intense efforts (20.5%). Half of the patients mentioned needing more information about asthma. Topics those patients like to have more information were difficulties that may can have and legal topics (78.6%), asthma evolution (78.6%), secondary effects or issues related to the treatment (61.9%) and legal topics (61.9%). The study reported important insights on psychosocial impact of asthma on patients' daily life from patients' perspectives along with health determinants in asthma-related health outcomes, sociodemographic and psychosocial factors.

Relationship Between Asthma Control as Measured by the Asthma Impairment and Risk Questionnaire (AIRQ) and Patient Perception of Disease Status, Health-Related Quality of Life, and Treatment Adherence.

Critical asthma outcomes highlighted in clinical guidelines include asthma-related quality of life, asthma exacerbations, and asthma control. An easy-to-implement measure of asthma control that assesses both symptom impairment and exacerbation risk and reflects the impact of asthma on patients' lives is lacking. Hence, the objective of this study was to assess the Asthma Impairment and Risk Questionnaire (AIRQ®) construct validity relative to patient self-perception of asthma status and validated disease-specific patient-reported outcome (PRO) measures. Baseline data were analyzed from patients (aged ≥ 12 years) with asthma participating in a 12-month observational study assessing the ability of AIRQ to predict exacerbations. At entry, patients completed a sociodemographic questionnaire, AIRQ, 3 questions addressing self-perceived asthma status, Saint George's Respiratory Questionnaire (SGRQ), mini-Asthma Quality of Life Questionnaire (AQLQ), and Adult Asthma Adherence Questionnaire (AAAQ). Descriptive statistics were calculated for demographic and clinical characteristics. AIRQ construct validity was evaluated by assessing correlations between total AIRQ score and patient self-assessments, SGRQ, mini-AQLQ, and AAAQ scores. Comparisons of SGRQ, mini-AQLQ, and AAAQ total and component/domain scores by AIRQ control category were performed using general linear models and Scheffe's post hoc adjustments for pairwise comparisons. A total of 1112 patients were enrolled: 70% female, 78% White, mean (standard deviation) age 43.9 (19.5) years. There were highly significant correlations between AIRQ score and patient self-perception of overall control (r = 0.69; p < 0.001), total SGRQ (r = 0.74, p < 0.001), and mini-AQLQ (r = -0.78, p < 0.001) scores. As AIRQ control category worsened, so did total and domain SGRQ, mini-AQLQ, and AAAQ impediment-to-inhaled-corticosteroid-adherence scores (all pairwise comparisons p < 0.001). Findings demonstrate the construct validity of AIRQ relative to patient self-perception of asthma status, disease-specific PRO measures, and treatment adherence barriers. AIRQ can be a useful instrument to raise awareness of the unrecognized impacts of asthma on patients' lives.

Effectiveness and quality of life in asthmatic patients treated with budesonide/formoterol via Elpenhaler® device in primary care. The “SKIRON” real world study

Aim: Inhaled corticosteroid (ICS)/long-acting β2 agonist (LABA) combination therapy is used for the effective control of asthma. Aim of this study was to collect data on the effectiveness, safety, quality of life, and patient satisfaction from a fixed dose combination of budesonide/formoterol administered with the Elpenhaler® device following 3-months’ treatment.Methods: A 3-month real-life, multicentre, one-arm, prospective observational study (SKIRON study-NCT03055793) was conducted, using the following questionnaires: Asthma Control Questionnaire (ACQ-6) for asthma control assessment, MiniAQLQ questionnaire for QoL assessment, and Feeling of Satisfaction with Inhaler questionnaire (FSI-10) for patients’ satisfaction with the inhaler device. Comorbidities and safety data were also recorded during the study.Results: We enrolled 1,174 asthmatic patients following standard clinical practice in primary care from 126 sites in urban and rural areas of Greece. The majority of patients (71.5%) had at least one comorbidity. A statistically significant improvement in the ACQ-6 score was noted at 3 months compared to the baseline evaluation (mean ± SD 2.19 ± 0.97 at baseline vs. 0.55 ± 0.56 at 3 months; mean change −1.64 (95%CI −1.69, −1.57), p < 0.0001). MiniAQLQ score was statistically and clinically significantly improved, compared to baseline, (4.55 ± 1.04 at baseline vs. 6.37 ± 0.64 at 3 months; mean change 1.82 (95%CI 1.75, 1.87), p < 0.0001). The mean FSI-10 score of 44.2 ± 5.4 indicated patient satisfaction and ease-of-use of the Elpenhaler® device.Conclusions: In this large real-world study of inadequately-controlled asthma patients in primary care settings, the treatment with budesonide/formoterol FDC with the Elpenhaler® device was associated with significant improvement in patients’ asthma control and quality of life.

The value of home monitoring of exhaled nitric oxide and mobile pulmonary function in the management of asthma

Objective: To investigate the application value of household dynamic monitoring of exhaled nitric oxide (FeNO) and pulmonary ventilation function in daily management of asthma. Methods: A total of 22 untreated patients with uncontrolled asthma who visited the Respiratory Disease Clinic of China-Japan Friendship Hospital from October 2019 to December 2020 were enrolled. Demographic characteristics, asthma history, comorbidities, asthma control test (ACT), and mini-asthma quality of life questionnaire (mini-AQLQ) were collected through face-to-face surveys. FeNO, pulmonary ventilation function, sputum eosinophil ratio and blood eosinophil count before treatment were collected through medical records. During the treatment of inhaled corticosteroids (ICS), the subjects were monitored at home for 4 weeks by FeNO analyzer and mobile electronic vital capacity at fixed time in the morning and evening. After the treatment, the above indicators were measured again to evaluate the treatment effect. Diurnal and dynamic changes of FeNO and pulmonary ventilation function monitored at home during treatment were analyzed. Results: The age of the subjects was (40±14) years, and 14 cases were female. After 4 weeks of ICS treatment, ACT score, mini-AQLQ score, forced expiratory volume at 1 second (FEV1, L) and FEV1/forced vital capacity (FVC, %) were 23±2, 5.49±1.04, 2.89±0.60 and 72.2±7.8, respectively, higher than before treatment [16±4, 4.06±0.95, 2.47±0.76 and 66.4±14.3, respectively]. FeNO [ppb (part per billion)], sputum eosinophil percentage (%) and blood eosinophil levels (×106/L) [M (Q1, Q3)] were 27 (18, 47), 2.8 (1.0, 14.0) and 255 (188, 280), respectively, lower than before treatment [80 (56, 117), 25.8 (15.0, 59.6) and 380 (283, 658)] (all P values<0.05). The level of FeNO in the morning was higher than that in the evening 2 weeks before routine monitoring (P=0.028), and no statistical difference was found in pulmonary ventilation function between day and night (P>0.05). The curve fitting of daily monitoring of FeNO and lung ventilation function showed that FeNO and lung ventilation function were gradually improved, and the effective time of treatment determined by FeNO was 3.5 (3.0, 5.3) d, which was earlier than all lung ventilation function indicators (all P values<0.05). The maximum action time of FeNO was (14.5±2.2) d, which was earlier than that of FEV1 (20.7±2.8) d (all P values<0.05), but there was no statistically difference between the maximum effect time determined by other lung ventilation function indicators (all P values>0.05). Conclusion: Household dynamic daily monitoring of FeNO and pulmonary ventilation function can be used to assess the response to ICS treatment, with FeNO being the more sensitive indicator.

Impact of asthma control on quality of life in an outpatient setting in Brazil

Introduction The goal of asthma therapy is asthma control. As a chronic disease, asthma may cause considerable physical, emotional and social restrictions impacting quality of life. The aim of this study was to analyze control of asthma symptoms in an outpatient setting in Brazil and its impact on quality of life. Methods A pilot cross-sectional study was performed in two public centers in the metropolitan region of São Paulo, Brazil. Control of asthma symptoms was assessed according to GINA guidelines, and quality of life was analyzed by the Mini Quality of Life Questionnaire (mini-AQLQ). Results A total of 47 adult patients with asthma were analyzed. Asthma was controlled in 8 patients (17.0%), partially controlled in 26 patients (55.3%) and uncontrolled in 13 patients (27.7%). Patients with controlled asthma showed better mini-AQLQ scores (4.99 ± 1.10) as compared to those with partly controlled (3.66 ± 1.10) and uncontrolled asthma (2.59 ± 0.64; p < 0.001 for both). Most patients (85.1%) were taking inhaled corticosteroids (ICS) and long-acting bronchodilators (LABA) as controller treatment. Conclusions Better asthma control had a positive impact on Health-Related Quality of Life (HRQoL) contributing to a better disease management. Few patients reached full asthma control in our specialty ambulatory center, suggesting further initiatives are required to improve the quality of asthma care in Brazil.

Influence of vitamin D supplementation on the quality of life of asthma patients: Findings from ACVID randomised clinical trial

Published data on vitamin D and the quality of life of asthma patients are scarce and disparate. The ACVID clinical trial, published in 2020, showed the efficacy of calcifediol in improving asthma control in asthma patients with vitamin D deficiency. Data on vitamin D and quality of life measured by the Mini-AQLQ questionnaire were analysed: supplemented patients showed improved quality of life compared with a placebo group, and the initial mini-AQLQ scores were improved for both groups.

Clinical Determinants of Successful Omalizumab Therapy in Severe Allergic Asthma Patients: 4-Year-Long, Real-Life Observation.

IntroductionOmalizumab is a high-cost therapy recommended for the treatment of severe allergic asthma.ObjectiveTo find clinical parameters that are related to the sustained response to omalizumab.Patients and MethodsThis retrospective, real-life, 4-year follow-up was provided in Poland between March 2013 and May 2019. The success of omalizumab was assessed based on composed subjective and objective criteria. Simple/multiple regression analyses were performed to search for predictors of the response to omalizumab.ResultsA total of 989 severe allergic asthma patients were referred for omalizumab therapy, of whom 854 patients were considered eligible for treatment. At weeks 16 and 52, omalizumab was successful in 84% and 91% of patients, respectively. Treatment effectiveness was maintained up to the 4-year follow-up. Four predictors of the response to omalizumab were found at week 16 and two at week 52. The results at week 16 may be used as predictors of success at week 52 based on the model including baseline FEV1% and change in ACQ-7 and miniAQLQ score at week 16: the area under the ROC curve equals 0.746 [95% CI: 0.672–0.820].ConclusionOmalizumab therapy is very effective, with this efficacy sustained after 4 years of treatment. Success of the therapy can be predicted from the baseline FEV1% and clinical improvement (based on ACQ-7 and miniAQLQ scores) at week 16.

Assessment of Asthma Control and Quality of Life among Asthmatic Patients Attending Armed Forces Referral and Teaching Hospital, Addis Ababa, Ethiopia.

Background The primary goal of asthma management is to achieve good asthma control. However, poor patient-physician communication, unavailability of appropriate medications, and lack of long-term goals have made asthma control difficult in developing countries. Poor assessment of asthma control and quality of life is a major cause of suboptimal asthma treatment worldwide, and information regarding this issue is scanty in developing countries like Ethiopia. This study thus attempted to assess the level of asthma control and quality of life in asthmatic patients attending Armed Forces Referral and Teaching Hospital. Methods A cross-sectional study comprising 184 physician-diagnosed asthmatic patients was conducted using interview, chart review, and prescription assessment. Asthma control was assessed using Asthma Control Test, while asthma quality of life was assessed using Mini-Asthma Quality of Life Questionnaire (mini-AQLQ). Spearman's rank correlation analysis was performed to understand the relationship between mean mini-AQLQ score and asthma control. Receiver operating characteristic curve analysis was performed to establish cut-off values for mini-AQLQ. Results Asthma was uncontrolled in 67.9% subjects. There was a strong correlation between asthma control and quality of life (rs = 0.772; P < 0.01). A cut-off value for the quality of life was established at 4.97. Majority of the patients were taking two or three antiasthmatic drugs. Oral tablet and inhaler short-acting beta agonists (SABA) were the frequently combined drugs. Uncontrolled asthma was associated with middle-aged adults (adjusted odds ratio (AOR) = 6.31; 95% CI: 2.06, 19.3; P = 0.001), male gender (AOR = 0.38; 95% CI: 0.15, 0.98; P = 0.044), married (AOR = 0.24; 95% CI: 0.08, 0.78; P = 0.017), comorbidities (AOR = 0.23; 95% CI: 0.09, 0.61; P = 0.003), and oral SABA use (AOR = 0.22; 95% CI: 0.09, 0.59; P = 0.003). Male gender (AOR = 0.36; 95% CI: 0.16, 0.84; P = 0.018), intermittent asthma (AOR = 0.18; 95% CI: 0.04, 0.86; P = 0.032), use of oral corticosteroids (AOR = 0.22; 95% CI: 0.06, 0.73; P = 0.013), and SABA (AOR = 0.39; 95% CI: 0.17, 0.89; P = 0.026) were found to have a significant association with poor asthma-related quality of life. Conclusion The findings collectively indicate asthma remains poorly controlled in a large proportion of asthma patients in the study setting. Moreover, quality of life appears to be directly related to asthma control. Healthcare providers should therefore focus on asthma education with an integrated treatment plan to improve asthma control and quality of life.

Effects of bronchial thermoplasty on airway remodeling, asthma control and quality of life in patients with severe asthma

Objective: To investigate the effects of bronchial thermoplasty (BT) on airway remodeling, asthma control and quality of life in patients with severe asthma. Methods: From January to September 2019, 11 patients with severe asthma were recruited from China Japan Friendship Hospital to receive BT treatment. The treatment was performed over three sessions separated by 3-week intervals. The right lower lobe, the left lower lobe and the bilateral upper lobes were treated respectively. In this study, patients' self-control method was used. The timepoint before the first BT treatment was defined as pre-treatment group, and the timepoint before the third treatment was defined as post-treatment group. Histological staining was used to detect the airway remodeling of the left lower lobe in two groups, including the mass of airway smooth muscle (ASM) and collagen in airway wall, and the thickness of basement membrane. The cell classification of bronchoalveolar lavage fluid (BALF) from the left lower lobe and peripheral blood, total serum IgE, asthma control test (ACT), mini asthma quality of life questionnaire (miniAQLQ) and the forced expiratory volume in 1 second expressed as percent predicted (FEV(1)%pred) were evaluated in the two groups. The correlation was analyzed between airway remodeling and asthma control and quality of life. Results: Effects of BT in post-treatment group, compared with pre-treatment group: the mass of ASM and collagen in airway wall was significantly decreased [(9.8±2.5)% vs (25.8±7.7)%, (12.9±4.0)% vs (17.4±5.6)%] (both P<0.05), while basement membrane thickness was not significantly different (P>0.05); the percentage of eosinophils in BALF and peripheral blood, and total serum IgE were not significantly different (all P>0.05); ACT score and miniAQLQ score were significantly increased [(23.1±1.8) vs (13.8±6.2) points, (5.3±1.3) vs (3.6±1.5) points] (both P<0.05), while FEV(1)% pred was not statistically different (P>0.05). The mass of ASM was negatively correlated with ACT score (r=-0.712), miniAQLQ score (r=-0.557) and FEV(1)%pred (r=-0.477), while the mass of collagen was negatively correlated with ACT score (r=-0.549) and miniAQLQ score (r=-0.639) (all P<0.05). Conclusion: BT treatment could improve airway remodeling, asthma control and quality of life in patients with severe asthma; besides, the reduction of remodeling is related to the improvements of asthma control and quality of life.

Exploring the relationship between generalised anxiety/depression scales and asthma-specific quality of life/control questionnaires in a specialist asthma clinic

Introduction Psychological issues are common in patients with chronic disabling diseases such as asthma. National guidance recommends that specialist asthma clinic attendees should complete questionnaires screening for psychological comorbidities. However, completing these in addition to asthma specific questionnaires can be burdensome. In order to investigate whether anxiety and depression questionnaires can be used in a targeted manner, this study investigates the correlation between the respective scores. We hypothesize that there is correlation between asthma-specific and anxiety/depression questionnaire scores. Methods Three-hundred individuals with poorly controlled asthma attending a specialist clinic were asked to complete Asthma Control Questionnaire (ACQ), mini-Asthma Quality of Life Questionnaire (mini-AQLQ), Generalized Anxiety Disorder (GAD-7) and Patient Health Questionnaires (PHQ-9). A Pearson correlation coefficient was generated and area under ROC and confusion matrices were used to assess correlation. Results 49% and 47% of patients completing the GAD-7 or PHQ-9 questionnaires, respectively had scores above the screening level for co-morbid anxiety and depression. Additional questionnaires were often incomplete (GAD-7 = 150 and PHQ-9 = 140). GAD-7 and PHQ-9 correlated with ACQ and mini-AQLQ (all p = <0.001, r values 0.53–0.65). Asthma-specific questionnaire scores were predictive of GAD-7 and PHQ-9 scores (AUCs of 0.78 to 0.84). 75% of patients with a mini-AQLQ score of <3 met the threshold GAD-7 and PHQ-9 score of 10. Conclusions ACQ and mini-AQLQ correlate with GAD-7 and PHQ-9 amongst specialist asthma clinic attendees. A mini-AQLQ >3 suggests patients are unlikely to have anxiety or depression. These findings could be used to identify patients requiring formal screening for psychological co-morbidity.

Impact of allergies on health-related quality of life in patients with asthma

Objective: To estimate the health-related quality of life (HRQoL) and health utilities among asthma patients with and without comorbid allergies in a managed care population.Methods: This was a retrospective analysis of patient survey responses and pharmacy claims from the Observational Study of Asthma Control and Outcomes (OSACO). Patients ≥12 years-old with persistent asthma received four identical surveys between April-2011 and December-2012. The presence of allergy was identified by a positive response to a survey question about hay fever/seasonal allergies and ≥1 diagnosis-related ICD-9-CM code(s) for allergic conditions. HRQoL instruments included generic utility (EQ-5D-3L [including VAS]), asthma-specific utility (AQL-5D) and asthma-specific health status (Mini Asthma Quality of Life Questionnaire [MiniAQLQ]). Median regression was used for utility scores and Least Squares regression for MiniAQLQ, adjusting for sociodemographic characteristics and smoking.Results: Of the 2681 asthmatics who completed the first survey in the OSACO study, 971 had comorbid allergies. After adjusting for covariates, asthma patients with comorbid allergies had significantly lower MiniAQLQ scores than patients without allergies (−0.489 [95% CI −0.570, −0.409]; p < 0.01), with the greatest decrement/impairment observed for the environmental stimuli domain (−0.729 [95% CI −0.844, −0.613]; p < 0.01). Utility scores were also statistically significantly lower for asthma patients with comorbid allergies compared to those without allergies (EQ-5D, −0.031 [95% CI −0.047, −0.015]; AQL-5D, −0.036 [95% CI −0.042, −0.029]; p < 0.01 each).Conclusions: The presence of allergies with persistent asthma is associated with a significant deleterious impact on several different measures of HRQoL.

The Impact of Bronchial Thermoplasty on Asthma-Related Quality of Life and Controller Medication Use

Background: Despite an improved understanding of the pathophysiology of asthma, severe asthma sufferers continue to experience a poor quality of life (QOL). Bronchial thermoplasty (BT) utilizes thermal energy to reduce airway smooth muscle. In industry-sponsored trials, BT improves QOL and reduces severe exacerbations; however, the impact of BT on asthma-related QOL and medication use in non-industry-sponsored trials is less clear. Objective: The aim of this study was to determine the impact of BT on asthma QOL measures (mini-AQLQ) and asthma controller medication use during the year following treatment with BT. Methods: We performed a prospective study of the impact of BT in 25 patients with severe persistent asthma. Our primary outcome was change in asthma-related QOL score (mini-AQLQ) 1 year after BT treatment. Our secondary outcome was change in asthma medication use 1 year after BT. Results: BT led to an improvement in mini-AQLQ score from a baseline of 3.6 ± 0.3 before therapy to 5.6 ± 0.3 1 year after the final BT procedure. Overall, 88% percent of patients showed a clinically significant improvement in mini-AQLQ at 1 year. Patients treated with BT showed a reduction in the use of montelukast and omalizumab 1 year after BT. Conclusion: In patients with severe persistent asthma and low asthma-related QOL scores, BT leads to an improvement in asthma-related QOL and a decrease in asthma medication use when measured 1 year after the final BT treatment.

A Multicenter, Observational, Prospective Study of the Effectiveness of Switching from Budesonide/Formoterol Turbuhaler® to Budesonide/Formoterol Easyhaler®.

IntroductionIn real-life practice, asthma remains poorly controlled, with a considerable burden on patients’ quality of life. Budesonide/formoterol (B/F) Easyhaler® has demonstrated similar dose consistency, therapeutic equivalence, and equivalent bronchodilator efficacy to B/F Turbuhaler®, but no real-life comparisons are yet available in patients switching from B/F Turbuhaler® to B/F Easyhaler®.MethodsThe primary objective of this real-life, non-interventional, observational study was to show non-inferiority of asthma control when adult patients in Swedish primary care with persistent asthma switched from B/F Turbuhaler® to B/F Easyhaler®. At visit 1, baseline demographic and endpoint data were recorded, and eligible patients switched to B/F Easyhaler®. The study comprised a control visit (visit 2) and a concluding examination (visit 3) after 12 weeks. Asthma control was assessed using the Asthma Control Test (ACT). The mini-Asthma Quality of Life Questionnaire (AQLQ) and lung function test were performed, and participants and investigators answered questionnaires about ease-of-use and teaching.ResultsA total of 117 patients were enrolled in the on-treatment population; 81 (64.8%) were female. At visit 3, B/F Easyhaler® demonstrated non-inferiority to B/F Turbuhaler®; the mean difference in change from baseline ACT was statistically significant (18.9 vs. 20.7, respectively; p < 0.0001) and met the non-inferiority criteria of B/F Easyhaler® being greater than − 1.5 points versus the reference product. Asthma was well controlled in 62 (53.0%) patients at baseline, increasing to 83 patients (70.9%) at visit 3. Patients experienced statistically significant improvements in mini-AQLQ score after B/F Easyhaler® treatment and lung function remained stable across the treatment period. B/F Easyhaler® was easy to learn and prepare for use.ConclusionThis real-life, non-interventional, non-inferiority study in adults with persist asthma demonstrates equivalent or better disease control when patients switch from B/F Turbuhaler® to B/F Easyhaler®. A further study with direct comparison between treatments could add to the understanding of inhaler switch.FundingOrion Corporation, Orion Pharma.Electronic supplementary materialThe online version of this article (10.1007/s12325-019-00940-7) contains supplementary material, which is available to authorized users.

Asthma control and quality of life in a real-life setting: a cross-sectional study of adult asthma patients in Japan (ACQUIRE-2)

Objective: The level of asthma control in adult asthma patients receiving treatment in clinical practice from allergy and/or respiratory specialists in Japan remains unclear. We conducted the ACQUIRE-2 study (NCT02640742) to evaluate level of asthma control, asthma symptoms, health-related quality of life (HR-QoL), and reliever medication use in this setting. Methods: This observational study was undertaken between December 2015 and June 2016 in 58 medical institutions across Japan. We enrolled outpatients aged ≥20 years diagnosed with asthma for ≥1 year who were being managed by specialists. Criteria to evaluate the level of asthma control were based on modified definitions of the Asthma Prevention and Management Guideline 2015, Japan (JGL 2015) and Global Initiative for Asthma (GINA) 2012. Asthma symptoms, HR-QoL, and reliever medication use were also evaluated. Results: Of 1250 enrolled patients, 1175 were analyzed, 62.9% of whom were women. Mean (± standard deviation) age and duration of asthma were 59.7 ± 14.5 years and 16.9 ± 14.0 years, respectively. Using JGL 2015-based criteria, 24.4%, 69.2%, and 6.5% of patients had well-controlled, insufficiently-controlled, and poorly-controlled asthma, respectively. Using GINA-based criteria, 35.1%, 49.8%, and 15.1% of patients had controlled, partly controlled, and uncontrolled asthma, respectively. Daytime and nighttime asthma symptoms were experienced by 51.5% and 44.9% of patients, respectively. The mean MiniAQLQ score was 5.8 ± 1.0 (7-point scale). Conclusions: Asthma was not well-controlled in the majority of patients in this study. To achieve better asthma control, improvements in symptom monitoring and management may be required.Trial registration: ClinicalTrials.gov identifier: NCT02640742.

Development of a questionnaire to evaluate asthma control in Japanese asthma patients

BackgroundThe asthma control questionnaires used in Japan are Japanese translations of those developed outside Japan, and have some limitations; a questionnaire designed to optimally evaluate asthma control levels for Japanese may be necessary. The present study was conducted to validate the Japan Asthma Control Survey (JACS) questionnaire in Japanese asthma patients. MethodsA total of 226 adult patients with mild to severe persistent asthma were enrolled and responded to the JACS questionnaire, asthma control questionnaire (ACQ), and Mini asthma quality of life questionnaire (Mini AQLQ) at Weeks 0 and 4. The reliability, validity, and sensitivity/responsiveness of the JACS questionnaire were evaluated. ResultsThe intra-class correlation coefficients (ICCs) were within the range of 0.55–0.75 for all JACS scores, indicating moderate/substantial reproducibility. For internal consistency, Cronbach's alpha coefficients ranged from 0.76 to 0.92 in total and subscale scores, which were greater than the lower limit of internal consistency. As for factor validity, the cumulative contribution ratio of four main factors was 0.66. For criterion-related validity, the correlation coefficients between the JACS total score and ACQ5, ACQ6, and Mini AQLQ scores were −0.78, −0.78, and 0.77, respectively, showing a significant correlation (p < 0.0001). ConclusionsThe JACS questionnaire was validated in terms of reliability and validity. It will be necessary to evaluate the therapeutic efficacy measured by the JACS questionnaire and calculate cutoff values for the asthma control status in a higher number of patients. Clinical Trial registrationUMIN000016589

Long-term effect of weight loss induced by bariatric surgery on asthma control and health related quality of life in asthmatic patients with severe obesity: A pilot study

BackgroundThe weight loss induced by bariatric surgery (BS) improves asthma clinical control evaluated usually after a short time. The long-term effects of weight loss attained by BS on asthma control and health related-quality of life (HRQoL) in patients affected by asthma and obesity are not known. ObjectiveTo investigate the five-year effect of weight reduction induced by BS on asthma control, quality of life and pulmonary functional parameters in severely obese intermittent or mild-to-moderate asthmatic patients. MethodsTwenty-six consecutive severe obese subjects with previous diagnosis of asthma with indication for laparoscopic adjustable gastric banding (LAGB) were enrolled into the study. Fifteen of them agreed to undertake the surgery (treatment group, TG) while the remaining eleven non-operated patients represented the control group (CG). Body mass index (BMI), Asthma Control Test (ACT), Mini Asthma Quality of Life Questionnaire (mini-AQLQ) and spirometric parameters were evaluated at baseline and after one and five years from surgery. ResultsMean BMI of TG significantly decreased at one and five years after the surgery, while it remained unchanged in CG. After surgery, both the overall ACT and the mini-AQLQ score significantly improved in TG after one year, persisting improved after 5-years (p < 0.001), while these outcomes remained unchanged in CG. As compared with the pre-surgery values, the percentage of predicted FEV1 and FVC significantly increased at five-year follow-up from surgery in TG, while it remained unchanged in CG. ConclusionsIn severe obese asthmatic patients, the significant improvement of asthma control test and HRQoL, observed one year after LAGB, persists five years after surgery.

Asthma quality of life and control after sinus surgery in patients with chronic rhinosinusitis.

Patients with chronic rhinosinusitis (CRS) often have comorbid asthma. Prior studies have not examined the impact of CRS or endoscopic sinus surgery (ESS) upon asthma quality of life (QOL) and asthma control using validated outcome metrics. Patients with CRS, both with and without polyps, and comorbid asthma completed the Mini Asthma QOL Questionnaire (miniAQLQ) and Asthma Control Test (ACT) at baseline and 6 months postoperatively as part of a multi-institutional, prospective study. Baseline metrics were available on 86 patients. Patients undergoing ESS reported improved miniAQLQ [0.5 (SD ±1.1), 95% CI: 0.2-0.7; P = 0.002] and ACT scores [1.3 (±4.1), 95% CI: 0.2-2.4; P = 0.025]. Uncontrolled baseline asthma (ACT < 20) was present in 51% of patients undergoing ESS. In uncontrolled patients, ESS resulted in a minimal clinically important difference 57% of the time for miniAQLQ scores (≥0.5 points) and 50% of the time for ACT scores (≥3.0 points). After adjustment with linear regression, baseline miniAQLQ scores were worse in patients with comorbid allergy (P = 0.045) and chronic obstructive pulmonary disease (COPD; P = 0.015). Adjusted baseline ACT scores were worse in patients with COPD (P = 0.004). Covariates associated with changes in miniAQLQ scores after ESS were pre-operative corticosteroid dependency (P = 0.011) and change in total SNOT-22 score (P = 0.010). Covariate associated with significantly less improvement in ACT scores was obstructive sleep apnea (P = 0.016). Patients with CRS often present with uncontrolled asthma, and ESS improves both miniAQLQ and ACT. Approximately half of patients with uncontrolled asthma improve after ESS, yet there are few CRS-specific factors associated with asthma QOL or control or ESS outcomes.