In patients with asthma, use of a digital inhaler system — that is, the Reliever Digihaler System (RDS) — is associated with a higher likelihood of clinically meaningful improvements in disease control compared with the use of standard of care (SoC) after 3 months, according to study results published in The Journal of Allergy and Clinical Immunology: In Practice.
The investigators sought to asess the effectiveness of the RDS, as measured by change in asthma control, compared with SoC. The albuterol Digihaler (albuterol 90 μg per dose) transmits data wirelessly to a smart device application (app), which then synchronizes with a digital health platform (DHP) to store and transfer inhaler use and/or event data to a web-based dashboard. The entire system, which comprises the albuterol Digihaler, app, DHP, and the dashboard, is designed to assist clinical decision-making by providing data on inhaler usage and inhalation quality.
To evaluate the effectiveness of the RDS, investigators conducted the CONNECT1 study (ClinicalTrials.gov identifier: NCT03890666), a 12-week, open-label, randomized, parallel-group, feasibility study conducted across 28 study centers in the United States between October 26, 2020, and October 4, 2021.
All participants were at least 13 years old and had the following clinical characteristics: (1) physician diagnosis of asthma; (2) suboptimal control of asthma (ie, Asthma Control Test (ACT) score of less than 19 at baseline or screening); (3) currently treated with an inhaled corticosteroid (ICS) and a long-acting beta2-agonist (LABA); and (4) currently using inhaled albuterol as a reliever medication.
A total of 333 participants were randomized to either the RDS group (n=167), which used the albuterol RDS (albuterol 90 μg per dose; 1 to 2 inhalations every 4 to 6 hours, on an as-needed basis), or the SoC group (n=166), which used albuterol reliever inhalers. Notably, all participants discontinued all other reliever medications for the duration of the study. The primary study outcome was improvement in asthma control, defined as attainment of well-controlled asthma (ACT score of ≥20) and/or gaining a clinically meaningful improvement in ACT score of at least 3 units from baseline to week 12.
The researchers found that after 3 months, the participants using RDS had an 85.3% probability of having greater odds of experiencing clinically meaningful asthma control improvements compared with those in the SoC arm (mean odds ratio, 1.33; 95% credible interval, 0.813-2.050); well-controlled asthma and/or an improvement in asthma control was achieved at week 12 by 61% of those in the RDS group vs 55% of those receiving SoC.
Researchers also found that participants in the RDS group had more discussions with health care providers regarding inhaler technique and/or adherence than those in the SoC group (107 vs 44 discussions, respectively). Both groups had a similar number of asthma exacerbations and adverse events. For the RDS group, the researchers recorded an increase in the weekly number of SABA-free days during the study period (from 3.4 to 4.6) and a decrease in weekly average daily SABA inhalations (from 9.1 to 6.3). Additionally, at least 87% of all inhalations per week from the albuterol Digihaler were categorized as good or fair in quality throughout the study period.
Study limitations include issues caused by unfamiliarity with the RDS system and the researchers’ inability to ensure that patients did not use additional reliever medications during the study period.
Findings from the CONNECT1 study “suggest that the RDS provides important information for the management of patients with asthma,” the study authors concluded. “Further investigation of the potential of the RDS to help improve asthma management is warranted,” they added.
Disclosure: Some of the study authors have declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.
Hoyte FCL, Mosnaim GS, Rogers L, et al. Effectiveness of a digital inhaler system for patients with asthma: a 12-week, open-label, randomized study (CONNECT1). J Allergy Clin Immunol Pract. Published online August 26, 2022. doi:10.1016/j.jaip.2022.08.023