Asthma Control Test Score Research Articles

Response to Omalizumab as an Add-On Therapy in the Treatment of Allergic Asthma in Adult Chinese Patients-A Retrospective Study.

(a) Background: Omalizumab is an anti-IgE humanized monoclonal antibody marketed in China for the conventional treatment of poorly controlled moderate-to-severe allergic asthma. Numerous clinical trials have demonstrated the effectiveness of omalizumab, but the data from studies in actual clinical treatment are still relatively limited. (b) Methods: Thirty-two patients with moderate-to-severe allergic asthma treated with omalizumab on the basis of ICS-LABA (inhaled corticosteroids/long-acting beta2-agonist) were selected. Clinical characteristics before and after treatment were collected to analyze the relationship between changes in serum total IgE levels and peripheral blood EOS (eosinophil) levels, FEV1 (forced expiratory volume in 1 second), PEF (peak expiratory flow), OCS (oral glucocorticoid) dosage, ATC (asthma control test) score, and the number of acute exacerbations and the treatment response, in order to observe the efficacy of omalizumab in addition to primary therapy, and to investigate whether baseline clinical characteristics such as serum total IgE and EOS levels could predict a treatment response. (c) Results: Using the ACT score as an evaluation, 68.75% of patients benefited from omalizumab treatment at the end of 16 weeks. The response group has a reduction in OCS dosage (p-values of 0.026 and 0.039), a significant reduction in ACT scores (both p < 0.001), and a reduction in the number of acute exacerbations (p = 0.034 and 0.025, respectively) after omalizumab treatment. The binary logistics analysis of factors affecting the effectiveness of omalizumab in the treatment of allergic asthma were total serum IgE and the presence of comorbidities (p-values of 0.039 and 0.046, respectively). (d) Conclusions: Combining omalizumab with ICS-LABA for 16 weeks significantly improves asthma symptoms in Chinese adults and can be used as an add-on treatment. In addition, high serum IgE levels and the presence of comorbidities were predictors of its therapeutic efficacy.

Asthma control in normal weight and overweight/obese asthmatic children following adenotonsillectomy.

Childhood adenotonsillar hypertrophy (ATH) with sleep-disordered breathing (SDB) frequently occurs concomitant with asthma. Adenotonsillectomy and reduction in asthma severity association has been reported. We describe changes in asthma control in nonobese or normal weight and obese/overweight children undergoing adenotonsillectomy for SDB. This prospective, nonrandomized cohort trial with 6-month follow-up at a tertiary children's hospital enrolled 41 children with persistent asthma undergoing adenotonsillectomy for SDB. Children with significant chronic medical conditions, premature birth (< 28weeks), or recent respiratory infection were excluded. Patients were stratified by baseline BMI into nonobese or normal weight (BMI < 85 percentile) and obese/overweight (BMI > 85%). The primary outcome was change in Childhood Asthma Control Test (cACT) scores 3 and 6 months following adenotonsillectomy. Secondary outcome examined improvement in Pediatric Asthma Caregiver's Quality of Life Questionnaire (PACQLQ) 3 and 6months following adenotonsillectomy. Baseline characteristics were similar except for anthropometric measures and mean PACQLQ (P = .03). Children with nonobese or normal weight (n = 26) had statistically significant improvement in change in cACT at 3 (22.80 ± 2.33 vs. 17.86 ± 3.53, P < .001) and 6 (20.71±3.29 vs. 18.24 ± 4.16, P = .044) months compared with baseline. PACQLQ scores also improved at 3 (6.20 ± 0.87 vs. 4.56 ± 1.12, P < .001) and 6 (6.36 ± 0.72 vs. 4.93 ± 0.96, P < .001) months. Obese/overweight children (n = 10) had significant improvement in cACT scores at 6months (20.00 ± 3.90 vs. 15.00 ± 6.90, P = .048). Change of cACT scores at 3months (17.86 ± 3.53 vs. 14.86 ± 6.31, P = .272) was not significantly different. PACQLQ scores improved at 3 (5.47 ± 1.09 vs. 3.70 ± 0.85, P < .001) and 6 (5.75 ± 2.19 vs. 3.67 ± 1.04, P = .016) months. Nonobese or normal-weight children undergoing adenotonsillectomy demonstrated significant improvement in asthma control scores at 3 and 6 and obese/overweight children at 6 months. Using the PACQLQ, caregiver quality of life improved for all children at 3 and 6 months. Surgical management of ATH in children with comorbid SBD and asthma is a good treatment option.

A prospective study on the efficacy of dupilumab in chronic rhinosinusitis with type 2 inflammation

Treatment for chronic rhinosinusitis with nasal polyps (CRSwNP) includes endoscopic sinus surgery and topic and/or systemic corticosteroids, which have only temporary effects. The development of biologic therapies has provided a new treatment paradigm for CRSwNP. Dupilumab is the only biological approved in Italy for CRSwNP, but its efficacy in a real-life context is still scarce. We carried out a monocentric prospective study at our institution with a 6-month follow-up on patients administered biweekly 300 mg dupilumab therapy for CRSwNP, prescribed according to EPOS 2020 criteria. Patients were evaluated at baseline and every 2 months. Median values at baseline and 6 months were, respectively, 3/12 and 8/12 for the Brief Smell Identification Test (p = 0.005), 5/8 and 2/8 for the Nasal Polyp Score (p < 0.001), 10/20 and 6/20 for the Lund-Kennedy score (p < 0.001), 65/110 and 14/110 for the Sinonasal Outcome Test (p < 0.001), and 15/25 and 23/25 for the Asthma Control Test score (p = 0.009). Adverse events were mild, consisting mainly in discomfort at the site of injection. Four patients developed asymptomatic hypereosinophilia. The treatment was not discontinued in any patient. Dupilumab was confirmed to be an effective and safe treatment for CRSwNP, as previously seen in registrational studies.

Implementing Spirometry and Fractional Exhaled Nitric Oxide Testing in Childhood Asthma Management in UK Primary Care: An Observational Study to Examine Training and Implementation Cost and Impact on Patient’s Health Use and Outcome

National Asthma Guidelines are important to implement in the primary care setting to provide standardized and improved asthma care. This study was designed to evaluate the implementation and clinical outcomes related to the delivery of spirometry and fractional exhaled nitric oxide (FeNO) testing for children with diagnosed or suspected asthma in the primary care setting.The study included 27 clinical staff from 10 general practices and 612 children with asthma ages 5 to 16 years in a prospective observational cohort in the United Kingdom. Children with asthma were defined as those with the diagnosis of asthma or those suspected to have asthma who were prescribed asthma medications in the last 12 months.Training materials on spirometry and FeNO tests were developed and taught to 27 clinical staff to implement for the study patients. The cost of implementation was estimated based on time, cost of resources, and standard costs of care in the UK-based system. The study then compared this invested cost to the benefits, such as decreased unplanned healthcare utilization and the amount of oral corticosteroids used. Participants were given the 3 questionnaires: Asthma Control Test (ACT), mini Pediatric Asthma Quality of Life Questionnaire (mini PAQLQ), and Child's Health Utility 9D (CHU9D), which measure asthma control, asthmatic quality of life, and general health, respectively, at the time of review and 6 months later to measure the benefits.The overall cost for material development, training time, and purchase of equipment was about £58 317 ($75 171 US dollars). The study equipment included 2 spirometers and 2 FeNO machines that rotated between clinics; however, the spirometry machines were donated and therefore, did not contribute to the total costs. Healthcare utilization was reduced by a total of £26 064 ($33 596) or £43 ($55) per child in the subsequent 6 months after the asthma review. Following the asthma assessments, there was an increase in daily inhaled corticosteroids prescribed, and fewer children required prescribed oral corticosteroids. There was no significant difference in the number of short-acting β-agonist inhalers prescribed. Of the 612 children, only 226 however completed their follow-up surveys at 6 months. ACT scores for ages 5 and up improved significantly. The mini PAQLQ was not statistically significant and the CHU9D decreased significantly at follow-up.Overall, the cost to train the staff and implement spirometry and FeNO measurement practices in the primary care clinic was £95 per child ($123). The potential healthcare dollar savings and benefits demonstrated with improved outcomes are significant and worth consideration and investment.This study from the UK demonstrates how a $150 investment per asthmatic child could lead to fewer emergency department visits, better controller medication compliance, fewer oral steroids, and better healthcare dollar utilization overall. With training and implementation of asthma education using objective asthma data at the primary care provider level, these improved asthma outcomes can be achieved. A similar study based on the most recent EPR-4 guidelines and the American medical system would be beneficial to assess the translation and replication of cost-benefit analysis in the US healthcare system.URL: www.pediatrics.org/cgi/doi/10.1542/peds.10.1136.archdischild-2020-319310

Impacts of residential indoor air quality and environmental risk factors on adult asthma-related health outcomes in Chicago, IL.

Residential environments are known to contribute to asthma. To examine the joint impacts of exposures to residential indoor and outdoor air pollutants and housing risk factors on adult asthma-related health outcomes. We analyzed >1-year of data from 53 participants from 41 homes in the pre-intervention period of the Breathe Easy Project prior to ventilation and filtration retrofits. Health outcomes included surveys of asthma control, health-related quality of life, stress, and healthcare utilizations. Environmental assessments included quarterly measurements of indoor and outdoor pollutants (e.g., HCHO, CO, CO2, NO2, O3, and PM), home walk-throughs, and surveys of environmental risk factors. Indoor pollutant concentrations were also matched with surveys of time spent at home to estimate indoor pollutant exposures. Cross-sectional analyses using mixed-effects models indicated that lower annual average asthma control test (ACT) scores were associated (p < 0.05) with higher indoor NO2 (concentration/exposure: β = -2.42/-1.57), indoor temperature (β = -1.03 to -0.94), and mold/dampness (β = -3.09 to -2.41). In longitudinal analysis, lower ACT scores were also associated (p < 0.05) with higher indoor NO2 concentrations (β = -0.29), PM1 (concentration/exposure: β = -0.12/-0.24), PM2.5 (concentration/exposure: β = -0.12/-0.26), and PM10 (concentration/exposure: β = 10.14/-0.28). Emergency department visits were associated with poorer asthma control [incidence rate ratio (IRR) = 0.84; p < 0.001], physical health (IRR = 0.95; p < 0.05), mental health (IRR = 0.95; p < 0.05), higher I/O NO2 ratios (IRR = 1.30; p < 0.05), and higher indoor temperatures (IRR = 1.41; p < 0.05). Findings suggest that residential risk factors, including indoor air pollution (especially NO2 and particulate matter), higher indoor temperature, and mold/dampness, may contribute to poorer asthma control. This study highlights the importance of residential indoor air quality and environmental risk factors for asthma control, health-related quality of life, and emergency department visits for asthma. Two timescales of mixed models suggest that exposure to indoor NO2 and particulate matter, higher indoor temperature, and mold/dampness was associated with poorer asthma control. Additionally, emergency department visits were associated with poorer asthma control and health-related quality of life, as well as higher I/O NO2 ratios and indoor temperatures. These findings deepen our understanding of the interrelationships between housing, air quality, and health, and have important implications for programs and policy.

Adherence to treatment guidelines and good asthma control in Finland

ABSTRACT Background Asthma program in Finland decreased asthma-related mortality and expenses of care on national level, but there is lack of data on adherence to treatment guidelines and disease control on individual level. We aimed to assess adherence to guidelines and disease control among Finnish adult asthmatics. Methods Questionnaires were sent in Finland to 2000 randomly selected recipients aged 18–80 years, who had bought medication for obstructive airways disease during the previous 12 months. The questionnaire included questions on asthma medication, exacerbations, self-management and follow-up. Asthma symptom control was assessed by the Asthma Control Test (ACT). Results A high proportion (82.4%) of the 541 responders with physician-diagnosed asthma reported regular use of asthma medication and 97.1% of them used inhaled corticosteroids. Almost all (97.0%) of the asthmatics were taught how to use their inhaler and 78.4% had an asthma self-management plan, but only 35.7% reported regular annual follow-up visits. According to symptoms, 60.0% had their asthma well-controlled (ACT score ≥20). On the other hand, 29.2% had a course of oral corticosteroid and 21.8% had an asthma-related unscheduled health care visit during the previous year, but only 2.6% reported a hospitalization. Asthma control was better in those not using regular asthma medication. Conclusions The guidelines are well adopted in Finnish adult asthma care except for regular follow-up visits. Majority of patients had good symptom control and hospitalizations were rare. Better asthma control among those not using regular asthma medication implies they are not undertreated but have a mild disease.

The feeling of loneliness and the sense of meaning in life in patients with various levels of bronchial asthma control

Background: Previously our team has proved bronchial asthma to be associated with a higher incidence of depression than in the healthy population, and that the severity of depression correlates with the severity of asthma symptoms. However, both, the sense of loneliness and the sense of the meaning of life have been little explored by research in the context of this disease so far. Objective: To compare loneliness and meaning of life among asthmatic patients with healthy individuals and assess the relationship of those constructs to the degree of asthma control. Methods: The level of asthma control was assessed according to the Asthma Control Test (ACT), the feeling of loneliness to the De Jong Gierveld Loneliness Scale (DJGLS), and the sense of life to Life Attitude Profile – Revised (LAP-R). Scores were compared between healthy adults and asthma patients and related to asthma control. All models were adjusted for sex and age. Results: The DJGLS score was higher among patients with asthma compared to healthy adults. All the scores measured by LAP-R except for the Existential Vacuum were higher in controls. Loneliness measured by DJGLS was negatively correlated with the degree of asthma control. Choice/Responsibleness was positively, while the Personal Meaning Index score negatively correlated with the ACT score. In the models including LAP-R and DJGLS, only loneliness was associated with asthma control. Conclusion: Loneliness is significantly related to both the development of asthma and the degree of asthma control.

Remote Patient Monitoring Effectively Assures Continuity of Care in Asthma Patients During the COVID-19 Pandemic

Background: Digital health tools to bridge gaps in managing infectious pandemics was a proposition grounded until recently more in the hypothetical than in reality. The last two years have exposed the extraordinary global need for robust digital solutions.&#x0D; Objective: The objective of this study was to determine the ability of remote patient monitoring (RPM) during the COVID-19 pandemic to improve clinical outcomes and assure continuity of care in patients with asthma.&#x0D; Methods and Findings:&#x0D; Design: The intervention combined health coaching telephone calls and remote telemonitoring.&#x0D; Participants: 102 patients with asthma were enrolled in a telemonitoring protocol at the beginning of the COVID-19 pandemic in the United States.&#x0D; Setting: A private, university affiliated, outpatient clinical adult and pediatric allergy/immunology and pulmonary practice.&#x0D; Intervention: Patients were enrolled with the primary rationale of maintaining continuity of care in the face of uncertain clinical care options. Enrollment and data collection proceeded in a fashion to allow detailed retrospective analysis. Telemonitoring included a pulse oximeter linked to a smart phone using the software platform Plan-it Med (PIM)®. A healthcare professional monitored data daily, and patients were contacted by providers due to vital sign abnormalities and treatment plan alterations. Patients were encouraged to remain on the platform daily during the first three months of the pandemic. After respiratory and or clinical stability was achieved and clinic visit opportunities were resumed, patients were encouraged to maintain engagement with the platform but were not expected to use the platform daily.&#x0D; Main Outcome measures: Asthma Control Test (ACT) scores were recorded before and after 6 months. Paired Wilcoxon signed-rank tests (dependent groups, before vs. after) and Wilcoxon rank-sum (Mann-Whitney) tests were performed for unpaired results (independent groups, RPM vs. Control). &#x0D; Results: 19 of 102 patients had physiological abnormalities detected (18.6%). Eight of these 19 patients had actionable changes in prescription regimens based on RPM findings (42.1%). In patients utilizing RPM, there was a reported decrease in shortness of breath episodes and a decreased need for rescue inhalers/nebulizer medications (P=0.005). Daily engagement in the first three months of the protocol was 61%. In a subset analysis, 48 study participants (47.1%) chose to continue to actively use the program for at least 14 months. 54 RPM patients were 99.1% compliant with RPM after 110 patient months. Of the patients that chose to discontinue the RPM program the reasons included: (1) symptom alleviation (41.7%); (2) out-of-pocket costs to patients (38.9%), and (3) difficulty using the RPM program (16.7%).&#x0D; Conclusions: A novel RPM technology positively impacted continuity of care, asthma outcomes, quality of life, and self-care.

Clinical predictors of treatment response to tiotropium add-on therapy in adult asthmatic patients: From multicenter real-world cohort data in Korea

BackgroundTiotropium, a long-acting muscarinic antagonist, is recommended for add-on therapy to inhaled corticosteroids (ICS)-long-acting beta 2 agonists (LABA) for severe asthma. However, real-world studies on the predictors of response to tiotropium are limited. We investigated the real-world use of tiotropium in asthmatic adult patients in Korea and we identified predictors of positive response to tiotropium add-on. MethodsWe performed a multicenter, retrospective, cohort study using data from the Cohort for Reality and Evolution of Adult Asthma in Korea (COREA). We enrolled asthmatic participants who took ICS-LABA with at least 2 consecutive lung function tests at 3-month intervals. We compared tiotropium users and non-users, as well as tiotropium responders and non-responders to predict positive responses to tiotropium, defined as 1) increase in forced expiratory volume in 1 s (FEV1) ≥ 10% or 100 mL; and 2) increase in asthma control test (ACT) score ≥3 after 3 months of treatment. ResultsThe study included 413 tiotropium users and 1756 tiotropium non-users. Tiotropium users had low baseline lung function and high exacerbation rate, suggesting more severe asthma. Clinical predictors for positive response to tiotropium add-on were 1) positive bronchodilator response (BDR) [odds ratio (OR) = 6.8, 95% confidence interval (CI): 1.6–47.4, P = 0.021] for FEV1 responders; 2) doctor-diagnosed asthma-chronic obstructive pulmonary disease overlap (ACO) [OR = 12.6, 95% CI: 1.8–161.5, P = 0.024], and 3) initial ACT score <20 [OR = 24.1, 95% CI: 5.45–158.8, P < 0.001] for ACT responders. FEV1 responders also showed a longer exacerbation-free period than those with no FEV1 increase (P = 0.014), yielding a hazard ratio for the first asthma exacerbation of 0.5 (95% CI: 0.3–0.9, P = 0.016). ConclusionsThe results of this study suggest that tiotropium add-on for uncontrolled asthma with ICS-LABA would be more effective in patients with positive BDR or ACO. Additionally, an increase in FEV1 following tiotropium may predict a lower risk of asthma exacerbation.

Functional immunophenotyping of children with critical status asthmaticus identifies differential gene expression responses in neutrophils exposed to a poly(I:C) stimulus

The host immune response to a viral immune stimulus has not been examined in children during a life-threatening asthma attack. We determined whether we could identify clusters of children with critical asthma by functional immunophenotyping using an intracellular viral analog stimulus. We performed a single-center, prospective, observational cohort study of 43 children ages 6–17 years admitted to a pediatric intensive care unit for an asthma attack between July 2019 to February 2021. Neutrophils were isolated from children, stimulated overnight with LyoVec poly(I:C), and mRNA was analyzed using a targeted Nanostring immunology array. Network analysis of the differentially expressed transcripts for the paired LyoVec poly(I:C) samples was performed. We identified two clusters by functional immunophenotyping that differed by the Asthma Control Test score. Cluster 1 (n = 23) had a higher proportion of children with uncontrolled asthma in the four weeks prior to PICU admission compared with cluster 2 (n = 20). Pathways up-regulated in cluster 1 versus cluster 2 included chemokine receptor/chemokines, interleukin-10 (IL-10), IL-4, and IL-13 signaling. Larger validation studies and clinical phenotyping of children with critical asthma are needed to determine the predictive utility of these clusters in a larger clinical setting.

Variables associated with asthma control among adult patients

Objective: Asthma is one of the most prevalent chronic diseases with a substantial impact on the health status of affected patients. Further research is necessary to identify factors contributing to poor asthma control. The current study aimed to investigate the factors associated with poor asthma control among adult asthmatic patients. Methods: In this case-control study, the Asthma Control Test (ACT) was translated into Arabic and distributed to adults with asthma attending two hospitals in Jordan to evaluate the degree of asthma control. The following variables were collected for each patient: sociodemographic information, comorbidities, appropriate use of inhaler technique, spirometric measurements, and medications use. Binary regression was used to evaluate factors associated with asthma control. Results: A total of 314 participants with a mean age of 51.47 years (±16.37) completed the study. ACT score had a mean of 16.68 (±4.86). The majority of asthmatic patients had insufficiently controlled asthma (64.6%). Binary regression results showed that previous respiratory infection history (p = 0.014, OR = 0.473 (95%CI 0.261–0.857)), higher exposure to irritants (p = 0.010, OR = 0.747 (95%CI 0.598–0.933)) decreased the odds of being in the controlled asthma group. Patients receiving inhaled corticosteroids (ICS) had higher odds of being in the controlled asthma group (p = 0.039, OR = 2.372 (95%CI 1.043–5.392)). Conclusions: The majority of asthma patients had insufficiently managed disease. The main factors that contributed to poor asthma control were respiratory infection history, increased exposure to asthma symptoms triggers, and ICS nonuse.

EFFECTIVENESS OF A MAINTENANCE AND RELIEVER DIGITAL SYSTEM TO IMPROVE ASTHMA CONTROL

<h3>Introduction</h3> In the Maintenance and Reliever Digital System (MRDS), Digihaler integrated inhalers (fluticasone propionate/salmeterol and albuterol Digihalers) transmit data wirelessly to a mobile application, which synchronizes with a Digital Health Platform to store and transfer data to a web-based Dashboard. This allows patients and clinicians to track and review inhaler usage and inhalation quality as part of clinical decision making. The CONNECT2 study (NCT04677959) evaluated asthma control as measured by the Asthma Control Test (ACT) in participants using the MRDS versus participants using the standard of care (SoC) maintenance and reliever inhalers. <h3>Methods</h3> Eligible participants (≥13 years old with suboptimal asthma control [ACT score <19]) were randomized 4:3 to MRDS or SoC for 6 months. Primary outcome: the probability of greater odds for participants to achieve meaningful improvement in asthma control (ACT score ≥20, or increase ≥3 units from baseline at Month 6) with the MRDS versus SoC. Bayesian statistical analysis provided a posterior probability distribution for odds ratios with corresponding credible intervals (CrI). <h3>Results</h3> Participants using the MRDS (n=210) had an 88.7% probability of greater odds of achieving improvements in asthma control vs those using SoC (n=181) after 6 months (Figure). The mean odds ratio (95% CrI) for MRDS/SoC was 1.35 (0.846, 2.038), demonstrating that, on average, participants in the MRDS group had 35% higher odds of achieving meaningful improvement in asthma control than those in the SoC group (Figure). <h3>Conclusion</h3> After 6 months, participants using the MRDS had greater odds of clinically meaningful improvements in asthma control versus SoC.

INHALER TECHNIQUE MAINTENANCE IN PATIENTS WITH UNCONTROLLED ASTHMA USING A RELIEVER DIGITAL SYSTEM

<h3>Introduction</h3> Poor inhaler technique is commonly observed in patients with asthma and is associated with poor asthma control and increased exacerbation risk. Technique deteriorates rapidly following initial training, and correct technique is seldom maintained. The albuterol Digihaler has an integrated electronic module that records peak inspiratory flow and inhalation volume, both of which reflect patients' inhaler technique. It is part of a Reliever Digital System (RDS) that also includes a mobile application and a web-based provider-facing Dashboard. An exploratory analysis of data from participants using the RDS in CONNECT1 (NCT03890666) evaluated inhaler technique throughout the 12-week study. <h3>Methods</h3> 333 eligible participants (≥13 years old with suboptimal asthma control [Asthma Control Test score <19]) were randomized to the RDS (N=167) or SoC (N=166) for 12 weeks. Exploratory outcomes assessed among participants in the RDS group from baseline to Week 12 included percentages of good inhalation (45 L/min≤peak inspiratory flow [PIF]≤199 L/min) and fair inhalation (30 L/min≤PIF≤44 L/min) (Figure). Other categories assessed were air vent block (PIF≥200 L/min), low/no inhalation (PIF<30 L/min) and exhalation. <h3>Results</h3> The proportion of inhalations from albuterol Digihaler categorized as ‘good'/fair' was consistently high (≥87% of all inhalations/week) throughout the 12-week study. Rates of ‘good' inhalation were maintained from Week 1 (80%) and 2 (89%) through to Week 12 (90%). <h3>Conclusion</h3> Inhaler technique was maintained by participants using the RDS throughout the 12-week study period.

DATA FROM A MAINTENANCE AND RELIEVER DIGITAL SYSTEM SUPPORT PATIENT–CLINICIAN INTERACTIONS IN ASTHMA

<h3>Introduction</h3> In the Maintenance and Reliever Digital System (MRDS), the Digihaler integrated inhalers (fluticasone propionate/salmeterol and albuterol Digihalers) transmit data wirelessly to a mobile application, which transfers data to a web-based Dashboard. The 6-month CONNECT2 study (NCT04677959) evaluated the MRDS in participants aged ≥13 years with suboptimal asthma control (Asthma Control Test score <19). This analysis explored differences in frequency/types of participant–clinician interactions undertaken for asthma management of participants using the MRDS versus those using the standard of care (SoC) maintenance and reliever inhalers. <h3>Methods</h3> 427 eligible participants were randomized 4:3 to the MRDS or SoC. For the MRDS group, clinicians obtained inhaler usage and inhalation quality data via the Dashboard, recorded reasons for participant contact outside of scheduled visits, and answered asthma management questions at each visit. Adjusted between-group differences (MRDS vs SoC) are reported with 95% credible intervals (CrI). <h3>Results</h3> More participant–clinician interactions occurred in the MRDS group (n=210) versus the SoC group (n=181) (989 vs 473; mean difference [95% CrI]: 2.06 [1.691, 2.437]) (Figure). Compared with SoC, the MRDS was associated with substantially more technique-related participant–clinician interactions (277 vs 2; mean difference [95% CrI]: 0.94 [0.787, 1.098]), fewer planned follow-up interactions (168 vs 276; mean difference [95% CrI]: −0.66 [−0.881, −0.456]), and more frequent inhaler technique/adherence discussions (735 vs 150; mean difference [95% CrI]: 2.60 [2.301, 2.894]) (Figure). <h3>Conclusion</h3> A correlation was observed between use of the MRDS and interactions prompted by and leading to discussions on inhaler technique/adherence. These results suggest that the MRDS provides relevant information for asthma management.

OBJECTIVE MEASUREMENT OF ADHERENCE TO ASTHMA TREATMENT WITH A MAINTENANCE AND RELIEVER DIGITAL SYSTEM

<h3>Introduction</h3> Suboptimal adherence to inhaled maintenance therapy is common among patients with asthma. In the Maintenance and Reliever Digital System (MRDS), the Digihaler integrated inhalers (fluticasone propionate/salmeterol [FS] and albuterol Digihalers) transmit data wirelessly to a mobile application, which synchronizes with a Digital Health Platform to store and transfer data to a web-based Dashboard. The 6-month CONNECT2 study (NCT04677959) evaluated the MRDS in comparison with the standard of care (SoC) maintenance and reliever inhalers in participants with asthma aged ≥13 years with suboptimal asthma control (Asthma Control Test score <19). This analysis explored patients' adherence to their maintenance treatment while using the MRDS, based on data from the CONNECT2 study. <h3>Methods</h3> 427 eligible participants were randomized 4:3 to the MRDS group or the SoC group. Participants' adherence to maintenance treatment in the MRDS group was assessed throughout the 6-month study period and calculated as percentages of FS doses taken daily, i.e., 0 dose = 0%, 1 dose = 50%, and 2 or more doses = 100%. <h3>Results</h3> The mean monthly adherence to maintenance treatment in participants in the MRDS (n=210) started at 79.2% at Month 1, changed to 70.0% at Month 3, and thereafter remained relatively stable at 68.6% by Month 6 (Figure). <h3>Conclusion</h3> Study participants using the MRDS maintained good adherence throughout the 6-month study period, despite the pragmatic nature of this study without pre-determined adherence thresholds for action.

USABILITY SCORES OF A RELIEVER DIGITAL SYSTEM IN PATIENTS WITH UNCONTROLLED ASTHMA

<h3>Introduction</h3> The CONNECT1 study (NCT03890666) evaluated the Reliever Digihaler System (RDS) in participants with asthma aged ≥13 years with suboptimal asthma control (Asthma Control Test score <19). The RDS comprises an albuterol Digihaler capable of transmitting data wirelessly to a mobile application (App), which transfers data to a web-based provider-facing Dashboard. This exploratory analysis evaluated usability of the RDS, using data from CONNECT1. <h3>Methods</h3> In this 12-week study, 333 eligible participants were randomized to RDS (N=167) or standard of care (SoC) (N=166). Adult participants using the RDS assessed its usability by completing a 10-question System Usability Scale (SUS) questionnaire to rate the App; investigational site staff used the SUS to rate the Dashboard at Week 12. Questionnaire scores were calculated using a 0–100 scale, with higher numbers representing better usability (an SUS score of 71.1–80.7 means good usability and ≥80.8 indicates excellent usability). SUS scores of participants using the RDS were further categorized by age and ethnicity groups. <h3>Results</h3> Usability of the App was rated ‘Good' by the 140 adult participants who used the RDS (mean SUS score [standard deviation (SD)]: 79.8 [15.7]). Investigational site staff (n=21) rated the Dashboard usability as ‘Good' (mean SUS score [SD]: 74.6 [15.0]). SUS scores were similar across different age and ethnicity groups (Figure). <h3>Conclusion</h3> Participants and investigational site staff rated the RDS as having ‘Good' usability, and it is well-accepted by different age and ethnicity groups, indicating that it can be used in a wide population to help with asthma management.

SHORT-ACTING BETA2-AGONIST USE REDUCTION AMONG PATIENTS WITH UNCONTROLLED ASTHMA USING A RELIEVER DIGITAL SYSTEM

<h3>Introduction</h3> Frequent use of short-acting beta₂-agonist (SABA) indicates poor asthma control. Participants in CONNECT1 (NCT03890666) used the Reliever Digital System (RDS), which consists of an albuterol Digihaler that transmits data wirelessly to a mobile application and synchronizes with a web-based Dashboard. This exploratory analysis evaluated SABA use among participants with uncontrolled asthma using the RDS. <h3>Methods</h3> In this 12-week study, 333 eligible participants (≥13 years old with suboptimal asthma control [Asthma Control Test (ACT) score <19]) were randomized to the RDS (N=167) or SoC (N=166). Exploratory outcomes included mean weekly SABA usage and mean weekly number of SABA-free days during the 12-week study period, as well as the number of participant-healthcare professional interactions (office visits/phone calls) that were due to increased SABA use, as identified from the Dashboard in the RDS group. <h3>Results</h3> In participants using the RDS (n=135), the weekly average daily SABA inhalations decreased (from 9.1 at Week 1 to 6.3 at Week 12) and the weekly average SABA-free days increased (from 3.4 at Week 1 to 4.6 at Week 12) over the 12-week study period (Figure). Furthermore, out of the 85 interactions in the RDS group, 32 (37.6%) were due to increased SABA use. <h3>Conclusion</h3> SABA use decreased over 12 weeks among participants using the RDS. The SABA use data recorded by the RDS may provide clinically meaningful information to facilitate physician-patient discussions and guide interventions to improve asthma control and reduce reliever need.

Long-Term Efficacy and Clinical Remission After Benralizumab Treatment in Patients with Severe Eosinophilic Asthma: A Retrospective Study.

Few studies on the long-term efficacy of benralizumab, an anti-interleukin-5 receptor α monoclonal antibody, have been conducted for patients with severe eosinophilic asthma (SEA), especially regarding the improvement of pulmonary function and clinical remission in a real-world setting. To elucidate the long-term efficacy and clinical remission rate (CRR) in patients with SEA. From July 2018 to July 2022, 23 Japanese patients with SEA received benralizumab for two years or more at Jikei University Hospital. We retrospectively evaluated the patients' characteristics, biomarkers, number of exacerbations, pulmonary function, asthma symptoms, maintenance oral corticosteroid (OCS) dose and CRR. The mean observation period was 38.3 (24-49) months. Among the 23 patients, 10 patients switched from mepolizumab to benralizumab. After administration of benralizumab, the forced expiratory volume in one second (FEV1) increased and was maintained for two years in the biologic-naïve group and in the switching group (177 ± 404 and 151 ± 236 [mL], respectively, P = 0.80). In all patients, the %FEV1 improved from 76.7 ± 22.9% to 84.3 ± 18.4% (P = 0.016), and the number of annual exacerbations decreased from 2.5 ± 3.3 to 0.74 ± 1.7 (P = 0.014). Furthermore, the Asthma Control Test score significantly improved, and the reduction in OCS dose was maintained for three years. Ultimately, five patients met the clinical remission criteria and exhibited stabilization of pulmonary function, no exacerbation, no OCS use and well-controlled symptoms. The CRR was significantly higher in patients with a blood basophil count (BBC) ≥ 22 than in those with a BBC < 22 (/µL) (38.5% vs 0%, respectively, P = 0.046). Long-term treatment with benralizumab significantly improved pulmonary function, alleviated asthma symptoms and decreased the number of exacerbations at two years in a real-world setting. The CRR may be associated with the BBC at baseline.

Effectiveness and Treatment Compliance of Salmeterol-Fluticasone Easyhaler® Among Patients with Asthma, COPD, or Asthma-COPD Overlap Syndrome: Real-World Study Findings.

For inhalation therapies to be effective, it is crucial that patients manage inhaler use correctly in their everyday life and achieve treatment compliance. We investigated the effectiveness of the salmeterol-fluticasone propionate Easyhaler® (SF EH) device-metered dry powder inhaler in a real-world setting in Hungary among adult patients with asthma, chronic obstructive pulmonary disease (COPD), or asthma-COPD overlap syndrome (ACO). A prospective, open-label, multicenter, noninterventional, investigator-sponsored study was conducted in outpatient pneumonology centers. Eligible patients were aged ≥ 18years with either a new diagnosis of asthma, COPD, or ACO, or whose disease was not controlled with preexisting medication. Data were collected at baseline and 12 + 4weeks, including the asthma control test (ACT), COPD assessment test (CAT), spirometry parameters [including forced expiratory volume for 1s (FEV1)], and physician- and patient-reported outcomes. Five hundred sixteen patients were recruited from 103 centers: 376 with asthma; 104 with COPD; and 36 with ACO. At week 12, there were significant improvements from baseline in both mean ACT score in patients with asthma (14.4 ± 4.2 versus 21.4 ± 2.8; P < 0.001) and mean CAT score in patients with COPD (24.0 ± 6.1 versus 16.0 ± 5.8; P < 0.001). Significant improvement was observed when the switch from the most frequently used previous inhalers was analyzed separately. Mean FEV1 improved from 76.0% ± 17.2 to 84.7% ± 16.1 (P < 0.001) and from 53.8% ± 15.0 to 59.9% ± 15.0 (P < 0.001) in patients with asthma or COPD, respectively. The study demonstrated improved physician-rated overall treatment compliance and patient preference for the SF EH over 3months use compared with previous inhaler treatment, with patients effectively adopting the SF EH into everyday life. Treatment with SF EH significantly improved patients' lung function parameters and disease control.

A retrospective evaluation of the effectiveness of a targeted medicines use review service in improving asthma and COPD control provided by community pharmacists in England

Abstract Objective Medicines Use Reviews (MUR) may benefit asthma and chronic obstructive pulmonary disease (COPD) control. The present study evaluates the effect of respiratory-targeted MUR-plus (MUR+) services delivered by community pharmacists on disease control. Methods A retrospective analysis of MUR+ data in the PharmOutcomes database was conducted. All patients receiving respiratory-targeted MUR+ in Milton Keynes were included. Changes in asthma control test (ACT) and COPD assessment test (CAT) scores were analysed. Key findings A total of 191 asthma and 81 COPD patients received MUR+. Asthma and COPD control improved as shown by the increase in mean ACT [+1.2 (95% CI, 0.6–1.8)] and decrease in mean CAT [−0.2 (95% CI, −1.4 to 1.0)]. Baseline ACT, smoking cessation, absence of change in drug therapy, patient education, healthcare professional referral, device training and baseline ACT score ≤19 were associated with change in ACT, but only smoking cessation was related to CAT change. A multivariable regression model comprising the aforementioned variables explained 19% of the variance in ACT change (P &amp;lt; 0.001). Only baseline ACT was associated with ACT change (beta = −0.34, P &amp;lt; 0.01). Baseline CAT, absence of change in drug therapy, smoking cessation and baseline CAT score &amp;gt;20 accounted for 12% of the variance in changes in CAT (P = 0.046). No variable was significantly associated with CAT change. Conclusions Respiratory-targeted MUR+ service by community pharmacists was associated with improvements in asthma control among patients with poorer baseline ACT, but not in patients with COPD. Several potentially modifiable factors such as education were associated with changes in control.