Effectiveness of a Maintenance and Reliever Digihaler System in Asthma: 24-Week Randomized Study (CONNECT2).

BACKGROUND: Digital health tools have been shown to help address challenges in asthma control, including inhaler technique, treatment adherence, and short-acting ß2-agonist overuse. The maintenance and reliever Digihaler System (DS) comprises 2 Digihaler inhalers (fluticasone propionate/salmeterol and albuterol) with an associated patient App and web-based Dashboard. Clinicians can review patients' inhaler use and Digihaler inhalation parameter data to support clinical decision-making. OBJECTIVE: CONNECT2 evaluated asthma control in participants using the DS versus standard-of-care (SoC) maintenance and reliever inhalers. METHODS: Participants (13 years or older) with uncontrolled asthma (Asthma Control Test [ACT] score <19) were randomized 4:3 (open-label) to the DS (n = 210) or SoC (n = 181) for 24 weeks. The primary endpoint was the proportion of patients achieving well-controlled asthma (ie, an ACT score ≥20 or increase from baseline of ≥3 units at week 24). RESULTS: There was an 88.7% probability that participants using the DS would have greater odds of achieving improvement in asthma control compared with SoC after 24 weeks. The mean odds ratio (95% credible interval) for DS versus SoC was 1.35 (0.846-2.038), indicating a 35% higher odds of improved asthma control with the DS. The DS group had more clinician-participant interactions versus SoC, mainly addressing a poor inhaler technique. DS participants' maintenance treatment adherence was good (month 1: 79.2%; month 6: 68.6%); reliever use decreased by 38.2% versus baseline. App and Dashboard usability was rated "good." CONCLUSION: The positive results in asthma control in this study after 24 weeks demonstrate the effectiveness of the DS in asthma management.

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

BACKGROUND: 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. OBJECTIVE: To demonstrate the effectiveness, as measured by change in asthma control, of the RDS compared with standard of care. METHODS: 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. RESULTS: 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). CONCLUSIONS: 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 Outcomes and Health-Care Resource Use Associated With Reslizumab Treatment in Adults With Severe Eosinophilic Asthma in Real-World Practice.

BACKGROUND: Reslizumab, an anti-IL-5 monoclonal antibody, is indicated as add-on maintenance treatment for adults with severe eosinophilic asthma. RESEARCH QUESTION: What are the real-world outcomes associated with reslizumab use in patients with severe eosinophilic asthma in a US clinical practice? STUDY DESIGN AND METHODS: In this retrospective study, patient-level data from adults treated with reslizumab were obtained from center- and panel-based medical chart reviews. Eligible patients had available medical records and treatment history for ≥ 6 months before initiation of reslizumab treatment (index date) to ≥ 7 months after reslizumab initiation. The primary outcome was response to reslizumab treatment, based on clinical expert predefined definitions of response. Other outcomes included clinical asthma exacerbations (CAEs), use of maintenance oral corticosteroids (OCS), FEV1 percent predicted, Asthma Control Test (ACT) score, and health-care resource use (HRU). RESULTS: Medical charts were obtained for 215 patients. Most patients (58.6%) showed an excellent response, 16.3% showed a clinically meaningful response, 21.9% showed a partial response, and 3.3% were nonresponders or treatment failures. A significant reduction was observed in the proportion of patients experiencing a CAE in a 6-month period (from 86.0% to 40.5%; P < .001) and in the mean number of CAEs per patient (2.84 [SD, 2.41] vs 0.94 [SD, 1.86]) after reslizumab initiation. Improvements were observed in FEV1 percent predicted (65.1% [SD, 20.5%] vs 73.1% [SD, 23.1%]; P < .001) and in ACT scores (13.8 [SD, 4.2] vs 18.6 [SD, 4.0]; P < .001) before to after reslizumab initiation. Among patients using maintenance OCS at baseline, more than half discontinued use of these by approximately 10 months after reslizumab initiation. Significant reductions in asthma-related HRU were observed after reslizumab initiation. INTERPRETATION: In clinical practice, reslizumab may have been initiated in response to heavy symptom burden and CAEs. Reslizumab was associated with improved clinical and patient-reported outcomes and significant reductions in asthma-related HRU.

Racial disparities in pediatric asthma: a review of the literature.

The burden of asthma disproportionately affects children living in economically disadvantaged urban communities. The relationships between ethnicity, genetic differences, lower socioeconomic status, poor medication adherence, greater exposure to environmental triggers, and absence of regular asthma care all contribute to this disparity. This review aims to identify and discuss recent studies on additional factors that may also impact to pediatric asthma disparity. The body of work examined in this review suggests that these disparities are the result of gene-environment interactions, vitamin D metabolism, socioeconomic status, urban environment, healthcare setting, and associated health beliefs.