Asthma Quality Of Life Questionnaire Research Articles

Assessment of the health related quality of life in children with asthma in a tertiary hospital in North Central, Nigeria.

Introductionasthma is a chronic inflammatory disorder of the airways with over 339 million people affected worldwide. Asthma can impair the quality of life (QoL) in its various bio-psycho-social domains causing poor concentration, poor school performance and impaired daily activities. This study assessed the QoL in asthmatic children aged 7- 17 years.Methodsa descriptive cross-sectional study of 46 children with asthma. Relevant bio-data and medical history were documented and the QoL assessment was carried out using the paediatric asthma quality of life questionnaire. Asthma severity and asthma control were defined based on the global initiative for asthma protocol. The data was analysed with IBM SPSS version 22.Resultsthe mean age was 12.4 ± 3.3 years, with a male to female ratio of 1: 1.9. About 61% of the study population were moderately impaired in their QoL and 41.3% had uncontrolled asthma. The mean QoL score was 5.80 with the activity domain and the emotion domain having the lowest mean scores (5.78 ± 1.0 and 5.91 ± 1.2 respectively). There was a significant association between QoL and age, asthma severity, asthma control and social class (p< 0.05) but not Gender. The logistic regression did not identify any of these factors as being predictors of QoL in the children. Conclusion: the study participants had moderately impaired QoL with the 7-10 year-olds more severely affected. The activity and emotion domains are more impaired. Therefore in addition to providing medical intervention, the treatment of children with asthma should include psychological support and counselling.

Subgroup Analysis of a Randomized Trial of the Effects of Positive Messaging on Patient-Reported Outcomes with Asthma - Effect of Obesity.

Asthma in obese patients represents a specific phenotype that is associated with increased symptoms, more frequent and severe exacerbations, reduced responsiveness to treatment, and decreased quality of life. Marketing and placebos have been shown to alter subjective responses to interventions in both asthma and obesity. We evaluated obesity as a potential treatment effect modifier of the effects enhanced drug messaging or placebos on subjective asthma outcomes. We conducted a secondary analysis of a multicenter, randomized clinical trial that studied the effect of messaging and placebos on asthma outcomes. A total of 601 participants were randomized (1:1:1:1:1) to one of 5 groups: enhanced messaging with montelukast or placebo, neutral messaging with montelukast or placebo, or usual care and followed for 4 weeks after randomization. We compared baseline characteristics by obesity status for 600 participants with data on body weight. Obesity was evaluated as an effect modifier for enhanced messaging (versus neutral messaging) and on placebo effects (versus usual care) in 362 participants assigned to a placebo group or usual care for three asthma questionnaires: Asthma Control Questionnaire, Asthma Quality of Life Questionnaire and Asthma Symptoms Utility Index. Overall, 227 (37%) of participants were obese. Obese participants were older (mean age 41 vs 34), more likely female (82% vs 67%) and self-identified as Black (44% vs 25%) than non-obese participants. As previously published, enhanced messaging was associated with improvements in patient-reported asthma scores, but there was no evidence for a placebo effect. Obesity status did not influence the message effects nor did it modify responses to placebo. Obesity has been shown to be an important factor associated with asthma outcomes and an effect modifier of drug treatment effects. We conducted a post hoc, subgroup analysis of data from a multicenter randomized trial of enhanced messaging and placebo associated with drug treatment on asthma outcomes. Our findings suggest that observed differences in treatment effects between obese and non-obese patients sometimes seen in trials of asthma treatments are unlikely to be due to different "placebo" effects of treatment and may reflect differential physiologic effects of active agents.

Application of Orem’s Self-Care Deficit Nursing Theory on Self-Efficacy and Quality of Life Among Patients with Bronchial Asthma: Randomized Controlled Study

Background: Asthma is a serious public health problem and a major cause of disability. Asthma is a chronicinflammatory disorder of the lungs that can lead to structural and functional changes, resulting in bronchialhyper responsiveness and airflow obstruction. Achieving optimal asthma control relies upon the patient’sbehavior factors namely treatment compliance and self-monitoring using peak flow meter and that may beinfluenced by monitoring the self-efficacy and quality of life, these ingredients turn the behavior into the desiredoutcome, significantly predicts the quality of life. Reducing asthma related expenses and less hospitalizations andemergency department visit with bronchial asthma is essential. The present study aimed to determine the effect ofself-monitoring behaviors based on Orem’s nursing theory on the quality of life and self-efficacy in patients withbronchial asthma.Methods: This randomized controlled trial study was conducted in Outpatient department, Tertiary carehospital, Chennai. 250 patients were selected using random sampling and divided equally into two control andexperimental groups based on random allocation number generated by computer. A teaching program basedon Orem’s nursing theory and according to the needs of patients was conducted in the experimental group. Datawere collected before, immediately after one month, and third and 6th month the intervention using Asthma Selfefficacyand Asthma Quality of Life Questionnaires. Data were analyzed using SPSS 21; Chi-square test, Mean-Whitney, Wilcoxon signed Rank test and KruskalWalli’s Test were used to analyze the data.Results: The mean score of the self-efficacy in the experimental group was significantly higher than the controlgroup six months after the intervention (56.31±4.82 vs. 58.30±5.83; P=0.0001). However, this difference was notsignificant immediately after the intervention (58.23±2.32 vs. 55.86±4.321, P=0.01). The mean scores of quality oflife were not significantly different from those of the control group immediately after (104.96±6.32 vs. 66.43±6.21,P=0.001) and six months after the intervention (130.48±12.432 vs. 78.82±4.34, P=0.0001).&#x0D; Conclusion: The results showed that emphasizing self-care based on Orem’s theory can improve the quality oflife of patients with bronchial asthma. Therefore, it is recommended that nurses in outpatient care of patients withbronchial asthma should apply this theory.

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

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

The Role of Education, Monitoring, and Symptom Perception in Internet-Based Self-management Among Adolescents With Asthma: Secondary Analysis of a Randomized Controlled Trial.

BackgroundInternet-based self-management programs improve asthma control and the asthma-related quality of life in adults and adolescents. The components of self-management programs include education and the web-based self-monitoring of symptoms; the latter requires adequate perception in order to timely adjust lifestyle or medication or to contact a care provider.ObjectiveWe aimed to test the hypothesis that adherence to education and web-based monitoring and adequate symptom perception are important determinants for the improvement of asthma control in self-management programs.MethodsWe conducted a subgroup analysis of the intervention group of a randomized controlled trial, which included adolescents who participated in the internet-based self-management arm. We assessed the impacts that attendance in education sessions, the frequency of web-based monitoring, and the level of perception had on changes in asthma control (Asthma Control Questionnaire [ACQ]) and asthma-related quality of life (Pediatric Asthma Quality of Life Questionnaire) from baseline to 12 months after intervention.ResultsAdolescents who attended education sessions had significant and clinically relevant improvements in asthma control (ACQ score difference: −0.6; P=.03) and exhibited a nonsignificant trend of improvement in asthma-related quality of life (Pediatric Asthma Quality of Life Questionnaire score difference: −0.45; P=.15) when compared to those who did not adhere to education. Frequent monitoring alone did not improve asthma control (P=.07) and quality of life (P=.44) significantly, but its combination with education did result in improved ACQ scores (difference: −0.88; P=.02). There were no significant differences in outcomes between normoperceivers and hypoperceivers.ConclusionsEducation, especially in combination with frequent web-based monitoring, is an important determinant for the 1-year outcomes of asthma control in internet-based self-management programs for adolescents with partly controlled and uncontrolled asthma; however, we could not establish the effect of symptom perception. This study provides important knowledge on the effects of asthma education and monitoring in daily life.

Long-term Effectiveness of a Peer-Led Asthma Self-management Program on Asthma Outcomes in Adolescents Living in Urban Areas

Long-term effectiveness of a peer-led asthma self-management program in improving asthma outcomes in adolescents living in urban areas has not been established.To determine the long-term effects of a peer-led program on asthma control, quality of life, and asthma management among predominantly racial and ethnic minority adolescents living in urban areas.A parallel-group, randomized clinical trial was conducted in 2015 to 2019 in 3 metropolitan cities in the US: Buffalo, New York; Baltimore, Maryland; and Memphis, Tennessee. Adolescents aged 12 to 17 years old with persistent asthma were recruited mainly through clinical practices and schools. Participants were followed-up for 15 months after the intervention. Double-blinding was achieved for baseline. Data analysis was performed from June 2019 to June 2020.The intervention group received a peer-led asthma self-management program; the control group received the identical program led by adult health care professionals. Peer leaders made follow-up contacts every other month for 12 months.The primary outcome was quality of life measured by the Pediatric Asthma Quality of Life Questionnaire, which consists of 3 subscales that measure symptoms (10 items), activity limitations (5 items), and emotional functioning (8 items) in the past 2 weeks. Each item was measured on a 7-point scale, with higher mean scores indicating better quality of life. Secondary measures included the Asthma Control Questionnaire and an asthma self-management index capturing steps to prevent and manage symptoms, self-efficacy, and lung function.Of 395 eligible adolescents, 35 refused, 38 did not show or were lost to contact, and 2 withdrew before randomization; 320 adolescents participated (mean [SD] age, 14.3 [1.71] years), including 168 boys (52.5%), 251 Black or African American adolescents (78.4%), and 232 adolescents (72.5%) with public health insurance. Of 320 enrolled, 303 were included in the longitudinal analysis. Response rates were 80% or higher at all time points. The peer-led group had greater improvement in outcomes than the adult-led group, with adjusted mean differences (AMDs) between baseline and 15 months of 0.75 vs 0.37 for quality of life (between-group AMD, 0.38; 95% CI, 0.07 to 0.63) and -0.59 vs -0.31 for asthma control (between-group AMD, -0.28; 95% CI, -0.51 to -0.01). Outcomes were not affected by bimonthly contact doses.In this randomized clinical trial, a peer-led asthma self-management education was more effective than an adult-led program in improving asthma outcomes, with the improvements sustained for up to 15 months. These findings suggest that a peer-led asthma self-management program should be considered in addressing the disproportionate asthma burden in racial and ethnic minority adolescents living in urban communities.ClinicalTrials.gov Identifier: NCT02293499.

Quality of life and asthma control in pregnant women with asthma

BackgroundAsthma is the most commonly occurring respiratory illness during pregnancy. Associations with complications of pregnancy and adverse perinatal outcome have been established. However, little is known about quality of life (QoL) in pregnant women with asthma and how it relates to asthma control particularly for Iran.ObjectiveTo determine the relationship between asthma related QoL and asthma control and severity.MethodsWe conducted a prospective study in pregnant women with asthma. We used the Asthma Control Questionnaire and the Asthma Quality of Life Questionnaire (AQLQ) and the guidelines of the Global Initiative for Asthma for assessment of asthma severity.ResultsAmong 1603 pregnant women, 34 were diagnosed with asthma. Of these 13 had intermittent, 10 mild, 8 moderate and 3 severe persistent asthma. There was a significant decrease of QoL with poorer asthma control (p = 0.014). This decline could be due to limitations of activity in those with poorer asthma control, which is underlined by the significant decline of QoL with increasing asthma severity (p = 0.024).ConclusionAlthough the majority of pregnant women with asthma had a favorable score in AQLQ, reduced QoL was related to increased asthma severity and poor asthma control. This underlines the importance of controlling asthma during pregnancy not only for the prevention of adverse pregnancy outcomes but also for the preservation of QoL.

Bronchial Thermoplasty Global Registry (BTGR): 2-year results

ObjectivesBronchial thermoplasty (BT) is a device-based treatment for subjects ≥18 years with severe asthma not well controlled with inhaled corticosteroids and long-acting beta-agonists. The Bronchial Thermoplasty Global Registry (BTGR) collected...

Real-world study in severe eosinophilic asthma patients refractory to anti-IL5 biological agents treated with benralizumab in Spain (ORBE study)

BackgroundBenralizumab, a monoclonal antibody targeting the human interleukin-5 (IL-5) receptor (IL-5R), was used before marketing authorisation in Spain in a real world setting as part of an early-access programme (EAP) to treat patients with severe eosinophilic asthma with prior insufficient response or intolerance to anti-IL5 treatment (mepolizumab or reslizumab). The objective of this study is to describe the patient profile candidate for treatment and to assess benralizumab effectiveness.MethodsThis is an observational, retrospective, multicentre study in severe eosinophilic asthma patients refractory to other biological agents targeting the IL-5 pathway. Baseline characteristics included closest data, from the previous 12 months, to benralizumab treatment onset (index date). Patients were followed until the last treatment dosage while EAP was active (March to December 2018). Effectiveness was evaluated versus baseline, in patients who received at least three doses, with asthma control test (ACT), Mini Asthma Quality of Life Questionnaire (MiniAQLQ), annual severe exacerbation rate, oral corticosteroids treatment (OCS) and asthma-related healthcare resources utilization.ResultsTwenty-seven patients treated with benralizumab were included in the analysis. Effectiveness was assessed in 19 patients. Both questionnaires showed clinically meaningful differences, i.e. ACT score ≥ 3 and MiniAQLQ score ≥ 0.5, compared with baseline [mean (SD), 3.3 (6.8) and 1.2 (1.9), respectively]. Patients treated with OCS decreased during follow-up from 88.9% (n = 24/27) at baseline to 78.9% (n = 15/19) and 31.6% (n = 6/19) had an OCS dose reduction ≥ 50%. The difference in annual severe exacerbation rate during follow-up showed a significant reduction vs. baseline (2.12 per patient-year, 95% CI 0.99–3.24, p = 0.002). The differences in annual rate of non-scheduled primary care and specialist visits during follow-up indicated a significant decrease [2.28 per patient-year (95% CI 1.55–3.01; p < 0.001) and 1.47 per patient-year (95% CI 0.65–2.30; p = 0.004), respectively], as well as the difference in annual rate of number of emergency department visits [1.18 per patient-year (95% CI 0.51–1.85; p = 0.007)].ConclusionsThese results suggest that severe eosinophilic asthma patients receiving benralizumab, presented clinically meaningful improvement in asthma control and asthma-related QoL as well as OCS dose reduction. Results also aim to significant reductions in annual severe exacerbation rates, non-scheduled primary care and specialist visits, and emergency department visits rates.

Macrolides versus placebo for chronic asthma.

Macrolides versus placebo for chronic asthma.

Clinical therapeutic effect on bronchial asthma by the observation of skin reaction after acupoint application based on chronic disease management platform of asthma

To compare the therapeutic effect on bronchial asthma between presence of skin reaction and the absence of skin reaction after acupoint application. Sixty-one patients with bronchial asthma were treated with acupoint application during the hottest periods of summer ("dog days"). The acupoints included Dingchuan (EX-B 1), Feishu (BL 13), Xinshu (BL 15), Pishu (BL 20) and Shenshu (BL 23). The treatment was given once every 7 days, with the herbal plaster remained for 6 h each time, and 4 treatments were required totally. According to the local skin reaction after acupoint application, a skin reaction group (30 cases, 2 cases dropped off) and a non-skin reaction group (31 cases) were divided. Separately, before treatment and 1 year after treatment, using chronic disease management platform of asthma, the number of asthma attacks, the score of asthma control test (ACT) and the score of asthma quality of life questionnaire (AQLQ) were recorded online. Besides, the therapeutic effect was observed in the two groups 1 year after treatment. One year after treatment, the number of asthma attacks was reduced as compared with that before treatment in the patients of either group (P<0.001), the score of ACT and each domain in AQLQ, i.e. activity limitation, asthma symptoms, psychological state, reactions to stimuli and self-health care as well as the total scores of AQLQ were all increased as compared with those before treatment (P<0.001). The number of asthma attacks in the skin reaction group was less than the non-skin reaction group (P<0.05), the score of ACT and each domain of AQLQ and the total scores of AQLQ were all higher than the non-skin reaction group successively (P<0.05, P<0.01). The total effective rate was 82.1% (23/28) in the skin reaction group, better than 67.7% (21/31) in the non-skin reaction group (P<0.05). In treatment of acupoint application for bronchial asthma, the clinical therapeutic effect is better in the patients with local skin reaction after acupoint application. The chronic disease management platform of asthma is convenient for online evaluation.

LEVEL ASSESSMENT OF CONTROL OF BRONCHIAL ASTHMA IN ADOLESCENTS

Introduction. The problem of controlling bronchial asthma in adolescents remains relevant, and its monitoring is more difficult than in other age categories, since during the period of long-term remission the disease can be accompanied by signs of bronchial hyperreactivity to nonspecific irritants, and pulmonary ventilation disorders can have a «latent» character, persisting much longer than the clinical symptoms of the disease, which leads to tactical errors in determining the level of bronchial asthma control and is a risk factor for its progression. Aim: to develop a method for assessing the level of bronchial asthma control in adolescents, when there are no clinical, anamnestic and functional signs of insufficient control of asthma, by using a quality of life questionnaire and an additional bronchodilatory test. Materials and methods. The study included 43 adolescents with mild (41.9 %) and moderate (58.1 %) controlled bronchial asthma. To identify cases of «latent» bronchospasm, a bronchodilatory test with salbutamol was performed and the increase in forced expiratory volume in 1 second (FEV1) was calculated. In the case of an increase in FEV1 ≥ 12.0 %, the presence of «latent» bronchospasm was confirmed. If the increase in FEV1 turned out to be &lt; 12.0 %, a questionnaire was performed using the Pediatric Asthma Quality of Life Questionnaire (PAQLQ) and if the value of the integral indicator of the overall quality of life PAQLQ ≤ 6.5 points, an additional bronchodilator test with a combined bronchodilator (fenoterol / ipratropium bromide). Results. The absence of changes in the initial levels of spirometric parameters was found in all 43 patients (FEV1 &gt; 80.0 %). When carrying out a bronchodilatory test with salbatamol, 7 patients (16.3 %) with a positive response (increase in FEV1 ≥ 12.0 %) were identified, which indicated cases of «latent» bronchospasm and partial control of asthma, and 36 people (83.7 %) with a negative answer (increase in FEV1 &lt; 12.0 %). Among 36 patients with an increase in FEV1 &lt; 12.0 % in the test with salbutamol applied the PAQLQ questionnaire and identified 24 people or 66.7 % with an overall quality of life of ≤ 6.5 points, which reflected the negative impact of adolescents asthma on the quality of life and lack of complete asthma control. This was confirmed in 7 out of 24 people (29.2 %) in an additional bronchodilatory test with a combined bronchodilator, in which they gave a positive response (increase in FEV1 ≥ 12.0 %; r = -0.4, p = 0.02). The reasons for the decrease in the overall quality of life of ≤ 6.5 points in the remaining 17 adolescents were due to psychoemotional states or vegetative-vascular dysfunction, and not to the latent course of «latent» bronchospasm. As a result, among 43 adolescents, 14 patients or 32.6 % with «latent» bronchospasm were found. At the same time, the relative risk of a positive patient response to a bronchodilator test with a combined bronchodilator was 2.1 times higher than during a bronchodilator test with salbutamol (OR = 2.1, 95 % CI 1.1–7.0). Conclusions. Conducting bronchodilatory tests with bronchodilators of various pharmacological groups and questioning patients using the PAQLQ questionnaire on the quality of life makes it possible to establish cases of «latent» bronchospasm even with a negative response to salbutamol, when there are no clinical and anamnestic signs of insufficient asthma control and the FEV1 index exceeds 80.0 % of proper values. Keywords: adolescents, bronchial asthma, control, bronchospasm.

A multicenter study on the safety and efficacy of bronchial thermoplasty in adults with severe asthma.

Background and Aim:Bronchial thermoplasty (BT) is a treatment option for patients with severe asthma. BT involves controlled delivery of radiofrequency energy using a bronchoscopic catheter, thereby reducing bronchial hyperreactivity. Herein, we describe our experience on the safety and efficacy of BT in severe asthma.Methods:This was a retrospective multicenter study of subjects who underwent BT at four centers across India.Results:We included 36 subjects (mean ± standard deviation [SD] age, 50.9 ± 11.5 years, women [69.44%]) undergoing 105 BT treatment sessions. All the subjects met the American Thoracic Society/European Respiratory Society criteria for severe asthma, 22.2% were requiring oral maintenance glucocorticoids. The mean ± SD baseline %predicted forced expiratory volume in one second (FEV1) was 62.07 ± 18.54. The median interquartile range (IQR) annual asthma exacerbation rate in the year preceding BT was 3.5 (1–10). We encountered intraprocedural complications in 7 (6.7%) sessions. An exacerbation of asthma following BT occurred in 6 (5.7%) procedures. We observed a significant improvement in the asthma control test and the asthma control questionnaire scores following BT. The quality of life (asthma quality of life questionnaire) also significantly improved. We noted a significant reduction in the number of exacerbations following BT (median [IQR], 3 [1–10] per year pre-BT versus 0.5 [0–3] per year post-BT, P < 0.001). No significant change occurred in the %predicted FEV1 following BT.Conclusion:BT is a feasible treatment option in patients with severe asthma. More extensive studies are required to establish the efficacy of BT in real-life settings.

Measuring respiratory symptoms in moderate/severe asthma: evaluation of a respiratory symptom tool, the E-RS\xae: COPD in asthma populations

BackgroundSymptom constructs included in the Evaluating Respiratory Symptoms in Chronic Obstructive Pulmonary Disease (E-RS®: COPD) tool may be relevant to patients with asthma. The purpose of this study was to evaluate content validity and psychometric performance of the E-RS: COPD in moderate/severe asthma patients.MethodsContent validity of the E-RS: COPD was evaluated in patients with moderate/severe asthma using concept elicitation and cognitive debriefing interviews. Secondary analyses using data from two clinical trials in patients with moderate/severe asthma evaluated the factor structure of the E-RS: COPD plus two supplementary items (wheeze; shortness of breath with strenuous physical activity) and assessed psychometric properties of the tool, which will be referred to as E-RS®: Asthma when used in asthma populations.ResultsQualitative interviews (N = 25) achieved concept saturation for asthma respiratory symptoms. Concepts in the E-RS: COPD were relevant to patients and instructions were understood. Most patients (19/25; 76%) reported experiencing all concepts in the E-RS: COPD; no patients indicated missing symptoms. Secondary analyses of clinical trial data supported the original factor structure (RS-Total and three symptom-specific subscales). The two supplemental items did not fit with this factor structure and were not retained. RS-Total and subscale score reliability was high (internal consistency [α] > 0.70). Validity was demonstrated through significant (P < 0.0001) relationships with the St George’s Respiratory Questionnaire (SGRQ) and Asthma Symptom Severity scale. E-RS: Asthma was responsive to change when evaluated using SGRQ, Patient Global Impression of Change and Asthma Quality of Life Questionnaire as anchors (P < 0.0001). Clinically meaningful change thresholds were also identified (RS-Total: − 2.0 units).ConclusionsThe E-RS: Asthma is reliable and responsive for evaluating respiratory symptoms in patients with moderate/severe asthma.

Violence-related distress and lung function in two longitudinal studies of youth.

Exposure to violence has been associated with lower lung function in cross-sectional studies. We examined whether increasing violence-related distress over time is associated with worse lung function and worse asthma control or quality of life in a secondary analysis of a 48-week randomised clinical trial in 98 youth with asthma (aged 9-16 years) treated with low-dose inhaled corticosteroids (Vitamin D Kids Asthma Study (VDKA)). We then replicated our findings for lung function in a prospective study of 232 Puerto Rican youth followed for an average of 5.4 years. Violence-related distress was assessed using the Checklist of Children's Distress Symptoms (CCDS) scale. Our outcomes of interest were percent predicted lung function measures and (in VDKA only) asthma control (assessed using the Asthma Control Test) and asthma-related quality of life (assessed using the Pediatric Asthma Quality of Life Questionnaire (PAQLQ)). In a multivariable analysis in VDKA, each 1-point increment in CCDS score was associated with decrements of 3.27% in forced expiratory volume in 1 s (FEV1) % pred (95% CI -6.44- -0.22%; p=0.04), 2.65% in forced vital capacity (FVC) % pred (95% CI -4.86- -0.45%; p=0.02) and 0.30 points in the overall PAQLQ score (95% CI -0.50- -0.10 points; p<0.01). Similar findings for FEV1 and FVC were obtained in the prospective study of Puerto Rican youth. Our findings suggest that violence-related distress may worsen lung function and quality of life in youth with asthma (even those treated with low-dose inhaled corticosteroids), and further support policies to reduce exposure to violence among children in the USA and Puerto Rico.

Long-term safety and efficacy of dupilumab in patients with moderate-to-severe asthma (TRAVERSE): an open-label extension study

Clinical trials have shown treatment benefits of dupilumab in patients with uncontrolled asthma for up to 1 year. This study aimed to evaluate the long-term safety and efficacy of dupilumab in patients with moderate-to-severe asthma, as data for extended treatment with dupilumab beyond 1 year are not available. TRAVERSE was an open-label extension study in 362 hospitals and clinical centres across 27 countries that assessed the safety and efficacy of dupilumab 300 mg every 2 weeks up to 96 weeks in adults and adolescents (aged 12-84 years) with moderate-to-severe or oral-corticosteroid-dependent severe asthma who had completed a previous dupilumab asthma study (phase 2A EXPEDITION, phase 2B DRI [P2b], phase 3 QUEST, or VENTURE). The primary endpoint was the number and percentage of patients with any treatment-emergent adverse events. Secondary endpoints included annualised exacerbation rate (AER) over the treatment period and change from parent study baseline in pre-bronchodilator FEV1, the five-item asthma control questionnaire (ACQ-5), the asthma quality of life questionnaire (AQLQ), type 2 biomarkers (blood eosinophils and serum total IgE), and anti-drug antibodies (ADAs). Statistical analyses were descriptive. We report safety in all enrolled patients, and efficacy in patients with non-oral-corticosteroid-dependent asthma and in subgroups, including patients with a type 2 inflammatory phenotype who received 148 weeks of treatment. This study is registered with ClinicalTrials.gov, NCT02134028. Between Aug 5, 2014, and Oct 11, 2019, of 2302 patients assessed for eligibility, 2282 adults and adolescents were enrolled (median age 50 years, 62·1% female and 37·9% male). Safety during TRAVERSE was consistent with the known dupilumab safety profile. The proportion of patients reporting treatment-emergent adverse events throughout the study duration was similar to that observed in the parent studies and ranged from 76·3% to 94·7%. The most frequently reported treatment-emergent adverse events were nasopharyngitis (17·5-25·9%), injection-site erythema (2·2-23·4%), and bronchitis (9·3-19·0%). Serious asthma exacerbations (0·5-3·6%) and pneumonia (0·7-2·7%) were the most frequently reported serious adverse events. There were four treatment-emergent adverse events leading to death. Efficacy during TRAVERSE was also consistent with the results of parent studies. In patients who were non-oral-corticosteroid-dependent, AER remained low (0·277-0·327) across parent study and treatment groups, pre-bronchodilator FEV1 improvements were sustained to the end of treatment at week 96 (mean changes from parent study baseline ranged from 0·22 L [SD 0·44] to 0·33 L [0·44] across parent study and treatment groups), and improvements in ACQ-5 and AQLQ scores were sustained to the last timepoint assessed at week 48. Rapid improvements were observed in pre-bronchodilator FEV1 and sustained improvements were seen in all outcome measures for patients given dupilumab who previously received placebo in parent studies; further improvements in AER, asthma control, and health-related quality of life were observed in patients who continued receiving dupilumab. Blood eosinophils and serum total IgE decreased progressively. ADA status had no effect on safety or efficacy. In the subgroup of patients with a type 2 inflammatory phenotype followed-up for 148 weeks, AER decreased progressively, and initial lung function improvements were sustained over 148 weeks. Data show that safety and efficacy of dupilumab in adult and adolescent patients with moderate-to-severe asthma are sustained when treatment is extended up to 148 weeks. These findings therefore support the long-term use of dupilumab in this patient population. Sanofi and Regeneron Pharmaceuticals.

Sociodemographic and Socioeconomic Factors as Determinants for the Health Related Quality of Life of Asthmatic Children and Adolescents

Abstract Background: Asthma is the most prevalent childhood chronic disease worldwide. Although health-related quality of life (HRQoL) in asthmatic children is known to be affected by the disease severity, sociodemographic factors and socio-economic status (SES) may also play a role. Aim of Study: To study the effect of sociodemographic and economic factors on HRQoL in asthmatic children and adolescents. Patients and Methods: This was a cross sectional study during which 370 asthmatic child/adolescent and their parents were interviewed at Chest and allergy clinic and were asked to fill El-Gilany socio-economic status (SES) scale and the arabic version of Pediatric Asthma Quality of Life Question-naire (PAQLQ) then the individual and the total scores were calculated. Results: 79.5% of the participants were children less than 12 years old, 61.9% were females, 73.5% lived in rural areas, and 89.7% were of low socioeconomic class. Regarding the sociodemographic factors, there was statistical significance between the total score of Pediatric asthma quality of life questionnaire (PAQLQ) and the patient's age, residence, parents' education & occupation (p-value <0.001). Regarding the SES, there was statistical significance between PAQLQ score and the family income and the total SES sore (p-value <0.001). Conclusion: Socio demographic and economic status can be considered independent determinants of HRQoL in asth-matic children and adolescents.

Predictors of asthma-related quality of life in a large cohort of asthmatics: A cross-sectional study in a secondary care center.

BackgroundIn recent decades, asthma‐related quality of life questionnaires have joined objective clinical indicators as important outcome measures. In this study, we sought to investigate the predictors of asthma‐related quality of life in a large cohort of patients recruited from a secondary care center.MethodsWe conducted a cross‐sectional study on asthmatics (N = 1301) recruited from the Liège University Hospital asthma clinic (Belgium). After performing a descriptive analysis highlighting the distribution of scores from the Mini Asthma Quality of Life Questionnaire (Mini AQLQ) and its four dimensions (symptoms, activity limitation, emotional function, and environmental stimuli), we did multiple regression analysis to identify the independent predictors of AQLQ.ResultsMultiple regression beta analysis showed that AQLQ and its four dimensions were primarily associated with asthma control (p < 0.0001 in all instances). Female gender was associated with a lower score for the AQLQ's activity and environmental dimensions (p < 0.05 for both), while current smokers had a higher score on the AQLQ's environmental dimension (p < 0.0001). The burden of asthma treatment was associated with a lower score for the AQLQ's emotional (p < 0.05) and environmental (p < 0.05) dimensions. BMI was associated with a lower score in the AQLQ's activity dimension (p < 0.0001), while the opposite was true for the FeNO test (p < 0.0001). Sputum neutrophils were inversely related to the score for the AQLQ's symptom dimension (p < 0.05), whereas post‐bronchodilator FEV1 showed a positive relationship for that same dimension (p < 0.05).ConclusionAsthma control is the main predictor of AQLQ score and impacts all its dimensions, but demographic, functional, and airway inflammatory parameters may also influence some dimensions of the AQLQ.

Determining the Best Tool Comparable with Global Initiative for Asthma Criteria for Assessing Pediatric Asthma Control.

Background: Guidelines such as Global Initiative for Asthma (GINA) recommend disease control as the mainstay of asthma management. Objective: To investigate which measure of asthma control best correlates with the GINA criteria for determining asthma control in children. Methods: Child asthma-patients at a tertiary hospital were enrolled in the study after evaluation of response to treatment. Asthma control test (ACT)/pediatric asthma control test (PACT), Pediatric Asthma Quality of Life Questionnaire (PAQLQ), fractional exhaled nitric oxide (FeNO), and lung function parameters were evaluated. Patients were examined by asthma specialists and control status was evaluated based on GINA. Results: The median age (interquartile range) of patients was 10.7 (8.4-12.9) years, 57.9% of patients were boys. Of 228 children, 84.2%, 9.6%, and 6.1% displayed "well-controlled", "partially controlled", and "uncontrolled" asthma, respectively, according to GINA. The patients with "partially controlled" and "uncontrolled" asthma were grouped as "not well-controlled." The cutoff levels were 22, 21, and 5.9 for PACT, ACT, and PAQLQ, respectively, for determining "well-controlled" asthma (P < 0.001). With these cutoff values, ACT exhibited higher comparability with GINA than PACT and PAQLQ (κ = 0.473, 0.221, and 0.150, respectively, P < 0.001). PAQLQ had higher agreement with GINA criteria in children ≥12 years old (κ = 0.326, P < 0.001 and κ = 0.151, P = 0.014, respectively). Correctly classified patients with PACT, ACT, and PALQLQ based on GINA with these cutoff levels were 93 (64.1%), 63 (75.9%), and 139 (62.9%), respectively. FeNO and lung function parameters were unsuccessful at revealing control status according to GINA. Conclusion: ACT is better than PACT for comparability with GINA. Better correlation of PAQLQ and ACT and better comparability of PAQLQ and GINA were evident in older children.

Quality of life and asthma control related to hormonal transitions in women’s lives

Objectives The aim was to investigate if menstruation and use of exogenous sex hormones influence self-reported asthma related quality of life (QoL) and asthma control. Methods The study is based on two asthma cohorts randomly selected in primary and secondary care. A total of 622 female patients 18–65 years were included and classified as premenopausal ≤ 46 years (n = 338) and peri/postmenopausal 47–65 years (n = 284). Questionnaire data from 2012 and 2014 with demographics, asthma related issues and sex hormone status. Outcome measures were Mini Asthma Quality of Life Questionnaire (Mini-AQLQ) and asthma control including Asthma Control Test (ACT) and exacerbations last six months. Results Premenopausal women with menstruation related asthma worsening, perimenstrual asthma (PMA) (9%), had a clinically relevant lower Mini-AQLQ mean score 4.9 vs. 5.8 (p < 0.001), lower asthma control with ACT score < 20, 72% vs. 28% (p < 0.001) and higher exacerbation frequency 44% vs. 20% (p = 0.004) compared with women without PMA. Women with irregular menstruation had higher exacerbation frequency than women with regular menstruation (p = 0.023). Hormonal contraceptives had no impact on QoL and asthma control. Peri/postmenopausal women with menopausal hormone therapy (MHT) had a clinically relevant lower Mini-AQLQ mean score compared to those without MHT, 4.9 vs 5.4 (p < 0.001), but no differences in asthma control. Conclusion Women with PMA had lower QoL and more uncontrolled asthma than women without PMA. Peri/postmenopausal women with MHT had lower QoL than women without MHT. Individual clinical management of women with asthma may benefit from information about their sex hormone status.