Suboptimal Asthma Control Research Articles

2024 Update on Position Statement by Experts from the Polish Society of Allergology and the Polish Respiratory Society on the Evaluation of Efficacy and Effectiveness of Single Inhaler Triple Therapies in Asthma Treatment

Medication non-adherence remains a substantial obstacle in asthma care, prompting the exploration of novel therapeutic modalities that prioritize rapid symptom relief, anti-inflammatory activity, and facilitate patients’ compliance. This task is well-served by the following new form of therapy: inhaled triple-combination medications ICS/LABA/LAMA (inhaled glucocorticosteroid/long-acting beta2-agonist/long-acting muscarinic antagonist). The integration of three medications within a singular inhalation device culminates in the reduction of the effective dose of the principal therapeutic agent for asthma management, namely ICS. This consolidation yields a dual benefit of minimizing the likelihood of adverse effects typically linked with ICS while concurrently optimizing bronchodilator efficacy. The accumulated evidence suggests that adding LAMA to a medium- or high-dose ICS/LABA results in a decrease of asthma exacerbations compared to medium- or high-dose ICS/LABA alone, accompanied by sustained enhancements in lung function parameters. In adult patients experiencing suboptimal asthma control despite medium/high-dose ICS/LABA treatment—regardless of adherence to GINA-recommended strategies, such as MART therapy as a first-line approach, or alternative second-line strategies—we propose that the preferred course for intensifying asthma therapy involves the addition of a LAMA, ideally in the form of SITT.

Asthma control and use of short-acting beta-2-agonists for symptom relief in Africa – A narrative review

More than 100 million people in Africa live with Asthma. With appropriate treatment, predominantly inhaled corticosteroids (ICSs), asthma is controllable in most people. However, in Africa, multiple factors constrain the accessibility, availability, and quality of asthma services, which lead to underdiagnosis and sub-optimal treatment of the disease. These constraints include weak healthcare systems and inadequate knowledge of healthcare providers on asthma diagnosis and treatment. There is also a poor awareness of asthma as a long-term disease in the general population. There are several myths and misconceptions about asthma as a disease. There is also poor access to ICSs, the most effective controller medicines for asthma. This is mostly due to the high cost. Furthermore, the non-use or delays in initiating treatment with inhaled steroids commonly leads to overuse and overreliance on rapid relievers of asthma symptoms, and in particular, short-acting beta-2-agonists (SABAs), both in oral and inhaled forms. This practice is very common and contributes to the sub-optimal treatment and resultant poor control of asthma, which is highly prevalent in Africa. In this paper, we highlight the burden of asthma in Africa, the effects of overuse/overreliance of SABA use on asthma control and provide suggestions to reduce the dependency on SABAs to improve asthma treatment and enhance asthma control on the African continent.

The impact of exposure to tobacco smoke and e-cigarettes on asthma-related outcomes: Systematic review informing the EAACI guidelines on environmental science for allergic diseases and asthma.

To inform the clinical practice guidelines' recommendations developed by the European Academy of Allergy and Clinical Immunology systematic reviews (SR) assessed using GRADE on the impact of environmental tobacco smoke (ETS) and active smoking on the risk of new-onset asthma/recurrent wheezing (RW)/low lung function (LF), and on asthma-related outcomes. Only longitudinal studies were included, almost all on combustion cigarettes, only one assessing e-cigarettes and LF. According to the first SR (67 studies), prenatal ETS increases the risk of RW (moderate certainty evidence) and may increase the risk of new-onset asthma and of low LF (low certainty evidence). Postnatal ETS increases the risk of new-onset asthma and of RW (moderate certainty evidence) and may impact LF (low certainty evidence). Combined in utero and postnatal ETS may increase the risk of new-onset asthma (low certainty evidence) and increases the risk of RW (moderate certainty evidence). According to the second SR (24 studies), ETS increases the risk of severe asthma exacerbations and impairs asthma control and LF (moderate certainty evidence). According to the third SR (25 studies), active smoking increases the risk of severe asthma exacerbations and of suboptimal asthma control (moderate certainty evidence) and may impact asthma-related quality-of-life and LF (low certainty evidence).

Greenhouse gas emissions associated with suboptimal asthma care in the UK: the SABINA healthCARe-Based envirONmental cost of treatment (CARBON) study

BackgroundPoorly controlled asthma is associated with increased morbidity and healthcare resource utilisation (HCRU). Therefore, to quantify the environmental impact of asthma care, this retrospective, cohort, healthCARe-Based envirONmental cost of treatment...

Health-Related Quality of Life of Asthmatic Patients in Al-Baha City, Saudi Arabia.

Introduction According to disability-adjusted life years (DALY), bronchial asthma (BA) is rated 28th among the top causes of disease burden globally and among the most significant reasons for years lived with disability. Internationally, 300 million people have asthma, and another 100 million individuals may develop it by 2025. In Al-Baha City, where environmental factors such as dust and pollen levels can exacerbate asthma symptoms, understanding and addressing the health-related quality of life of asthmatic patients is crucial. Understanding the health-related quality of life of asthmatic patients can inform public health policies and initiatives aimed at reducing environmental triggers and promoting better asthma management in the city. Objectives The study aims to assess the impact of asthma regarding physical, emotional, and social activities that affect health-related quality of life. Subjects and methods A cross-sectional study was conducted from January 2023 to May 2023 at King Fahad Hospital in Al-Baha City, Saudi Arabia. The study used a Mini Asthma Quality of Life Questionnaire that measures physical, emotional, and social activities that affect health-related quality of life. Results One hundred and fifty-one out of 185 participants responded, yielding a response rate of 81.6%. The average age of the participants was 52, with a standard deviation of 15.4 years. Participants' responses regarding symptoms related to the environment during the last two weeks indicated "all the time" experiencing feeling bothered by or having to avoid cigarette smoke (n=104, 69%) and dust (n=92, 61%) in the environment. Moreover, considering emotion-related symptoms, 54% reported they did not feel afraid of not having their asthma medication available. Similarly, 46% reported never feeling frustrated because of asthma, whereas 3.3% of the participants documented hardly ever feeling frustrated. Regarding social activity limitations, 44 individuals (29%) reported no limits in these activities, while 43 (28%) reported being completely limited. While there were limitations in work-related activities, 42 participants (28%) reported no restrictions, whereas 34 (23%) reported being completely limited. Conclusion The study findings highlight a concern about suboptimal asthma control and the need to attain more satisfactory levels of asthma management.

Predictors of asthma control differ from predictors of asthma attacks in children: The Swiss Paediatric Airway Cohort.

It is unclear if predictors of asthma attacks are the same as those of asthma symptom control in children. We evaluated predictors for these two outcomes in a clinical cohort study. The Swiss Paediatric Airway Cohort (SPAC) is a multicentre prospective clinical cohort of children referred to paediatric pulmonologists. This analysis included 516 children (5-16 years old) diagnosed with asthma. At baseline, we collected sociodemographic information, symptoms, personal and family history and environmental exposures from a parental baseline questionnaire, and treatment and test results from hospital records. Outcomes were assessed 1 year later by parental questionnaire: asthma control in the last 4 weeks as defined by GINA guidelines, and asthma attacks defined as any unscheduled visit for asthma in the past year. We used logistic regression to identify and compare predictors for suboptimal asthma control and asthma attacks. At follow-up, 114/516 children (22%), reported suboptimal asthma control, and 114 (22%) an incident asthma attack. Only 37 (7%) reported both. Suboptimal asthma control was associated with poor symptom control at baseline (e.g. ≥1 night wheeze/week OR: 3.2; 95% CI: 1.7-6), wheeze triggered by allergens (2.2; 1.4-3.3), colds (2.3; 1.4-3.6) and exercise (3.2; 2-5), a more intense treatment at baseline (2.4; 1.3-4.4 for Step 3 vs. 1), history of preschool (2.6; 1.5-4.4) and persistent wheeze (2; 1.4-3.2), and exposure to tobacco smoke (1.7; 1-2.6). Incident asthma attacks were associated with previous episodes of severe wheeze (2; 1.2-3.3) and asthma attacks (2.8; 1.6-5 for emergency care visits), younger age (0.8; 0.8-0.9 per 1 year) and non-Swiss origin (0.3; 0.2-0.5 for Swiss origin). Lung function, exhaled nitric oxide (FeNO) and allergic sensitization at baseline were not associated with control or attacks. Children at risk of long-term suboptimal asthma control differ from those at risk of attacks. Prediction tools and preventive efforts should differentiate these two asthma outcomes.

Management of comorbidities in difficult and severe asthma.

Difficult-to-treat and severe asthma are challenging clinical entities. In the face of suboptimal asthma control, the temptation for clinicians is to reflexively escalate asthma-directed therapy, including increasing exposure to corticosteroids and commencement of costly but potent biologic therapies. However, asthma control is objectively and subjectively assessed based on measurable parameters (such as exacerbations or variability in pulmonary physiology), symptoms and patient histories. Crucially, these features can be confounded by common untreated comorbidities, affecting clinicians' assessment of asthma treatment efficacy.

Fertility Challenges in Asthmatic Women: Examining the Complexities of Pregnancy Loss, Infertility, and Assisted Reproductive Technologies.

Asthma is a prevalent chronic respiratory condition affecting a significant portion of women of reproductive age. While the impact of asthma on general health and well-being has been extensively studied, its association with fertility challenges in women remains an area of growing concern. This review article explores the complexities surrounding fertility challenges in asthmatic women, specifically focusing on pregnancy loss, infertility, and the utilization of assisted reproductive technologies (ARTs). Various factors contribute to the heightened risk of pregnancy loss in asthmatic women, including the systemic inflammation associated with asthma, suboptimal asthma control, medication usage, and comorbidities. The review highlights the need for multidisciplinary management approaches to optimize asthma control before and during pregnancy, reducing the risk of adverse pregnancy outcomes. Furthermore, the review investigates the potential impact of asthma on female fertility and the underlying mechanisms involved. Asthma-related factors, such as chronic inflammation, altered hormonal balance, and medication effects, may disrupt the delicate reproductive processes, leading to infertility. It emphasizes the importance of comprehensive fertility evaluations and personalized treatment strategies for asthmatic women experiencing difficulties conceiving. Additionally, the article explores the utilization of ARTs, including in vitro fertilization (IVF) and intracytoplasmic sperm injection (ICSI), in asthmatic women. It discusses the safety considerations and potential challenges associated with these techniques, such as the impact of asthma medications on oocyte quality, the effects of hormonal stimulation on asthma control, and the risk of exacerbations during the IVF process. The review underscores the importance of collaborative efforts among healthcare providers, including allergists, pulmonologists, obstetricians, and fertility specialists, to ensure optimal management of asthmatic women seeking to conceive. It emphasizes the significance of preconception counseling, meticulous asthma control, appropriate medication management, and individualized fertility treatments to enhance the reproductive outcomes in this population.

Exploring Caregiver Interest in and Preferences for Interventions for Children With Risk of Asthma Exacerbation: Web-Based Survey.

Maintaining control of asthma symptoms is the cornerstone of asthma treatment guidelines in the United States. However, suboptimal asthma control and asthma exacerbations among young people are common and are associated with many negative outcomes. Interventions to improve asthma control are needed. For such interventions to be successful, it is necessary to understand the types of interventions that are appealing to caregivers of children with different levels of risk of exacerbation. This study aimed to evaluate whether caregivers of children with high (vs low) risk of asthma exacerbation show different levels of interest in and preferences for potential intervention programs and delivery methods. We contracted with Ipsos to administer a web-based survey to caregivers of children with asthma who were residing in the United States. Caregivers (N=394) reported their interest (1=not at all; 3=a lot) in 9 possible intervention programs and 8 possible intervention delivery methods. Caregivers also indicated their preferences by selecting the 3 intervention programs and 3 delivery methods that "most" interested them. Finally, caregivers completed 2 open-ended questions asking what other resources might be useful for managing their children's asthma. We classified children as having a high risk of exacerbation if they had an exacerbation in the past 3 months (n=116) and a low risk of exacerbation if otherwise (n=278). Caregivers reported higher levels of interest in all intervention programs and delivery methods if they cared for a child with a high risk rather than a low risk of exacerbation. However, regardless of the child's risk status, caregivers expressed the highest levels of interest in programs to increase their child's self-management skills, to help pay for asthma care, and to work with the school to manage asthma. Caregivers expressed the highest levels of interest in delivery methods that maintained personal control over accessing information (websites, videos, printed materials, and smartphone apps). Caregivers' preferences were consistent with their interests; programs and delivery methods that were rated as high in interest were also selected as one of the 3 that "most" interested them. Although most caregivers did not provide additional suggestions for the open-ended questions, a few caregivers suggested intervention programs and delivery methods that we had not included (eg, education about avoiding triggers and medication reminders). Similar interests and preferences among caregivers of children with high and low risk of exacerbation suggest a broad need for support in managing childhood asthma. Providers could help caregivers by directing them toward resources that make asthma care more affordable and by helping their children with asthma self-management. Interventions that accommodate caregivers' concerns about having personal control over access to asthma information are likely to be more successful than interventions that do not.

Suboptimally controlled asthma in patients treated with inhaled ICS/LABA: prevalence, risk factors, and outcomes

This observational claims-linked survey study assessed the prevalence of and risk factors for suboptimal asthma control and healthcare utilization in adults with asthma receiving fixed-dose combination (FDC) inhaled corticosteroid/long-acting β2-agonist (ICS/LABA). Commercially insured adults from the Optum Research Database were invited to complete the Asthma Control Test (ACT) and Asthma Control Questionnaire-6 (ACQ-6). Among participants (N = 428), 36.4% (ACT-assessed) and 55.6% (ACQ-6-assessed) had inadequately controlled asthma. Asthma-related quality of life was worse and asthma-related healthcare resource utilization was higher in poorly controlled asthma. Factors associated with ACT-defined suboptimal asthma control in multivariate analysis included: frequent short-acting β2-agonist (SABA) use, asthma-related outpatient visits, lower treatment adherence, and lower education levels. During follow-up, factors associated with asthma exacerbations and/or high SABA use included: inadequately controlled asthma (ACT-assessed), body mass index ≥30 kg/m2, and high-dose ICS/LABA. Approximately 35–55% of adults with asthma were inadequately controlled despite FDC ICS/LABA; poor control was associated with worse disease outcomes.

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.

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.

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.

Suboptimal Control of Asthma Among Diverse Patients: A US Mixed Methods Focus Group Study.

PurposeThe US National Asthma Education and Prevention Program updates and Global Initiative for Asthma report encourage considering the patient perspective to improve asthma control. The objective of the present study was to collect data about the perceptions, experiences, and concerns of adult patients and caregivers of children with asthma regarding rescue, maintenance, and oral corticosteroid treatments.Patients and MethodsIn-person focus groups were conducted in three cities across the US. Participants also completed patient-reported outcome measures assessing asthma control and experiences.ResultsFocus groups were conducted in demographically and clinically diverse adults with asthma (five groups, n=34), caregivers of children with asthma (five groups, n=35), and adults with a dual diagnosis of asthma and chronic obstructive pulmonary disease (one group, n=5). Only 28% of patients were well-controlled by Asthma Control Test/Asthma Control Test-Caregiver Report and 18% by Asthma Impairment and Risk Questionnaire. Forty-four percent of participants reported not following their prescribed medical plan. Four key themes emerged from the focus groups: (1) asthma symptom control and monitoring are often inadequate; (2) treatments are often used incorrectly; (3) communication between health care professionals and patients or caregivers is often ineffective; and (4) concerns related to treatment and desires to improve treatment.ConclusionControl of asthma symptoms is suboptimal in the vast majority of patients and both patients and caregivers do not feel sufficiently informed about asthma. Health care providers should be encouraged to engage patients and caregivers in shared decision making for managing asthma and selecting treatments that integrate patient values, preferences, and lifestyles.

WITHDRAWN

SESSION TITLE: Biologics and Severe Asthma: Latest Outcome Data SESSION TYPE: Original Investigations PRESENTED ON: 10/16/22 10:30 AM - 11:30 AM PURPOSE: Dupilumab which is an anti-IL-4/13 monoclonal antibody can be used to treat severe uncontrolled asthma. Since its approval, patients who were uncontrolled on other biological therapies are switched to Dupilumab. Our study aims to evaluate the efficacy and safety of switching Mepolizumab to Dupilumab for the treatment of severe asthma in a real-world severe asthma clinic in a tertiary hospital in Riyadh, Saudi Arabia. METHODS: We did a chart review on severe asthma patients who were treated with Mepolizumab for at least 6 months with suboptimal asthma control and are currently on Dupilumab for more than 6 months from January 2017 through August 2021. Multiple outcomes were observed which include the rate of asthma exacerbation (RAE), reduction in maintenance Oral Corticosteroids (mOCS) dose, improvement in Asthma Control, lung function, and effects on total IgE and eosinophils. RESULTS: A total of 14 severe asthma patients (85% females) were on mepolizumab for at least 6 months then switched to Dupilumab. The average age was 43 years with an average BMI of 31, half of the patients have a background of Chronic Rhinosinusitis with Nasal Polyposis. At baseline prior to mepolizumab, patients had an average of 18.5 Emergency Room (ER) visits and 14.5 short courses of Prednisone due to asthma exacerbations. Their average Asthma Control Test (ACT) was 10 at baseline and 57% of them were on mOCS at baseline. The average FEV1 pre-bronchodilator (BD) was 1.67 L. Eosinophils count prior to Mepolizumab was 0.77 and total IgE was 317. After a minimum of 6 months on Mepolizumab, results were as follows: both average ER visits and short courses of Prednisone for asthma attacks were reduced to 3.7 and 5 respectively. The average Asthma Control Test (ACT) improved to 13.2. All 14 patients were uncontrolled on Mepolizumab with 23.7% of them were on mOCS. Their average FEV1 was 1.86. Prior to Dupilumab, the average peripheral eosinophils was 0.23 along with 332 for total IgE. 6 months post-Dupilumab initiation, there was a significant improvement in multiple outcomes. The average RAE was 1.42 and ACT was 18.1. Only 10% of patients are on mOCS. Furthermore, the average FEV1 has also improved compared to previous results with pre FEV1 of 2.48 (82%) and the average total IgE was 156. However, eosinophils were higher compared to Mepolizumab period with an average count of 1.54 and 0.92 at 3 and 6 months period. CONCLUSIONS: In this retrospective real-life study, we have shown that switching patients who were uncontrolled on Mepolizumab to Dupilumab had a significant effect in reducing annual asthma exacerbations. It also helped in reducing daily OCS dose along with improvement in lung function and asthma symptoms. Overall, Dupilumab was a safe medication apart from an increase in eosinophils count. CLINICAL IMPLICATIONS: Dupilumab showed that it can improve severe asthmatics who failed Mepolizumab. DISCLOSURES: No relevant relationships by Riyad Al-Lehebi No relevant relationships by Yasmin Alkhunaizi No relevant relationships by SAUD ALMOUSA

Effectiveness of a Digital Inhaler System for Patients With Asthma: A 12-Week, Open-Label, Randomized Study (CONNECT1)

The albuterol Digihaler (albuterol 90 μg/dose) transmits data wirelessly to a smart device application, which synchronizes with a Digital Health Platform to store and transfer data to a web-based Dashboard. The Reliever Digihaler System (RDS) comprises the albuterol Digihaler, application, Digital Health Platform and Dashboard. This allows patients and health care professionals to review reliever inhaler usage and inhalation quality to aid clinical decision making. To demonstrate the effectiveness, as measured by change in asthma control, of the RDS compared with standard of care. In this 12-week study, participants aged 13 years or older with suboptimal asthma control (Asthma Control Test [ACT] score < 19) were randomized to use either RDS or standard of care albuterol reliever inhalers. The health care professionals were recommended at study start to check each participant's inhalation data (including inhalation quantity and quality parameters) 1 or more times per week. Primary outcome was the proportion of participants achieving clinically meaningful improvement in asthma control (ACT score ≥ 20 at week 12 and/or increase ≥ 3 units from baseline). Bayesian statistical analysis provided a posterior probability distribution for odds ratios with corresponding credible intervals. Participants using the RDS (n= 167) had an 85.3% probability of greater odds of clinically meaningful asthma control improvements than those using SoC (n= 166) after 3 months (mean odds ratio 1.33; 95% credible interval 0.813-2.050). In this study, participants using the RDS had greater odds of clinically meaningful improvements in asthma control versus SoC after 3 months. Further investigation of the potential of the RDS to help improve asthma management is warranted.

Clinical burden related to oral corticosteroid treatment of severe asthma in Spain: LEVANTE study

Background Severe asthma treatment with oral corticosteroids (OCS) added to inhaled corticosteroids and a long-acting β2-agonist (ICS-LABA) may result in more treatment burden and increased adverse effects. Objective and methods This ambispective multicenter observational study aimed at describing the clinical burden in patients with severe asthma on stable high-dose ICS-LABA who received OCS during ≥6 months (maintenance group) or ≥2 cycles in the previous 12 months (bursts group). Data collection comprised a retrospective 12-month baseline period and 2 follow-up visits at 3 and 6 months. Results Eighty-nine patients were evaluable (30 on maintenance, 59 on bursts). At baseline, mean (SD) daily prednisone equivalent exposure in the total population was 24.6 (14.7) mg: 13.8 (9.4) mg on maintenance and 29.9 (14.3) mg on bursts. During the 6-month follow-up period, mean (SD) daily dose in the total cohort was 22.5 (18.8) mg: 17.2 (18.6) mg on maintenance and 28.4 (20.6) mg on bursts. The overall annual severe exacerbations rate during the 12-month baseline period was 2.05 per patient-year and 1.5 per patient-year over the 6-month follow-up, and frequency of hospitalizations and emergency department visits were similar on both maintenance and bursts use. Conclusions Results show a suboptimal control of severe asthma despite such high doses of OCS and persistence of disease burden regardless of the prescribing pattern in maintenance or bursts. There is therapeutic inertia to continue using OCS despite the increased risk of adverse effects and the availability of biologics.