In the current 6-month observational study, we have recruited approximately 700 adult asthmatic patients that were treated with FDC of budesonide/formoterol via the Elpenhaler device, according to usual clinical practice. The majority of patients reported medium to high adherence at 3 months with an increase in adherence at 6 months. We observed an improvement in quality of life (as evaluated by the Mini AQLQ questionnaire) and in lung function (as expressed by FEV1 in liters) and these improvements were more evident in the high adherence patients. The safety profile of the FDC of budesonide/formoterol via the Elpenhaler device was acceptable and in accordance with previous reports.
The main finding of this study is that patients with medium or high adherence to the inhaled medication under consideration reported higher quality of life even after a relatively small period of time, i.e. 3 or 6 months of treatment. The finding applies to all enrolled patients indifferent to the severity of asthma. Focusing on patient subsets based on asthma severity in order to assess the impact of inhaled medication in each set falls outside the scope of this study, but could be an interesting future prospect. Moreover, we observed that medium and high patient adherence to treatment had a positive impact on spirometric results, especially in terms of FEV1, which is in accordance with the literature. Therefore, our results further support the observation that adherence to treatment is central in the overall course of asthma, and should be stressed by the physicians in every follow-up visit, as proposed by current recommendations. Nevertheless, the design of the study does not allow to conjecture safely about the effectiveness of the budesonide/formoterol combination delivered via the Elpenhaler device.
In patients diagnosed with asthma, the choice of treatment is largely decided based on recent guidelines. Subsequently, the main responsibilities of the treating physician are: (i) identify the specific inhalation device that will satisfy the patient the most and (ii) achieve and maintain adherence to the device over the follow-up. The former point has been studied in a previous study where several inhalation devices were prospectively evaluated in Greek patients with COPD and asthma. The patients' satisfaction was assessed using a standardized questionnaire. Among patients with asthma, the inhalation device used in the current study, i.e. the Elpenhaler, presented significantly higher satisfaction rates compared to the other devices. The patient's satisfaction with their inhaler device has been linked with adherence to treatment, disease control, disease clinical course and clinical outcomes. Therefore, the results of high adherence that improves over time in the present observational study may be partly attributed to the appropriate use of the Elpenhaler device. To this end, it is also noteworthy that the Elpenhaler device, when compared with some other frequently used inhalation devices, exhibited the lowest error rates for critical errors in the inhalation maneuver. Another important finding of that study is that physical demonstration of correct inhalation maneuvers prior to first administration leads to higher percentage of adequate use and minimization of critical errors. Our results are in line with previously published data suggesting Elpenhaler as a ''self-improvement'' device. Based on the results reported in the same study, the Elpenhaler device was rated best in 7 out of 10 questions of the FSI-10 (Feeling of Satisfaction with Inhaler) questionnaire in asthma patients, and in 8 out of 10 questions in COPD patients. The features praised about the Elpenhaler device were: ease in learning and keep using the inhaler, verification of dose delivery, as well as factors related to size, weight, cleanliness and unobtrusiveness in everyday activities. In the recently published BOREAS study, the authors present some important clinical insights regarding the real-life effectiveness of FDC budesonide/formoterol via the Elpenhaler device in 1230 asthmatic patients. Specifically, the authors reported significant improvements in asthma control (based on ACQ-7) and quality of life (Mini AQLQ) at 3 months that were sustained after 6 months.
Another factor that should be taken into consideration before choosing an inhaler device is carbon footprint. Even though it is often neglected during clinical practice, it has recently attracted considerable attention, and nation-wide studies have been conducted for this purpose. Dry-powder inhalers (DPIs) compared to metered dose inhalers (MDIs) have a considerably lower carbon footprint, and the difference is mainly related to the use of the inhaler as well as the disposal of the device. Therefore, Elpenhaler being a DPI offers an appealing solution from an environmental point of view, especially compared to an MDI device. Nevertheless, choosing an inhaler device or switching between devices is an important and multifactorial decision that should be based on thorough clinical assessment coupled with patient education and training.
The combination of ICS and LABA has been studied in large cohorts for the management of asthma with results that have established this treatment option as the basis of the management of a great proportion of patients with asthma; its effectiveness can be partly attributed to the synergy observed between ICS and LABA at molecular level that has been reported via multiple mechanisms and pathways.
Further focusing on the impact of specific devices delivering budesonide/formoterol, Syk et al. have studied the effectiveness of switching between two popular inhalers. This study signifies the importance of the device for inhaled therapies, specifically for the substances under consideration in this article, i.e. budesonide/formoterol. The authors report a statistically significant improvement in asthma control as well as life quality after 6 months, as measured by ACT and Mini AQLQ, respectively. Based on the latest version of the GINA guidelines, ICS-formoterol represents a preferred option for the management of patients with asthma across all steps. It can be used both as a controller and a reliever with variable dosing based on asthma severity and treatment step. Budesonide/Formoterol via the Elpenhaler device that is studied herein, qualifies as a single inhaler maintenance and reliever therapy (SMART), that is the preferred treatment in GINA guidelines, because using ICS-formoterol as reliever reduces the risk of severe exacerbations compared with regimens with SABA as a reliever. Moreover, having the two substances in a single device is more practical for daily administration and facilitates better adherence and compliance.
In the current real-life study, by setting relatively broad inclusion criteria we have achieved a satisfactory sample size with considerable heterogeneity consisting of patients with asthma of variable severity, coming both from the Hospital setting as well as from several private practices. One the other hand, our study has some limitations. Since we enrolled patients from a single country, generalizations in terms of epidemiology should be considered with caution. As in most studies, the Hawthorne effect is also evident, albeit it is difficult to evaluate its contribution. Moreover, due the study design, being one-arm in particular, makes it difficult to assess and quantify the impact of treatment and adherence to lung function; this is partly compensated by the selection of both subjective (MMAS-8, Mini AQLQ) and objective (lung function) metrics for the study purpose. However, the fact that we observed corresponding improvements in both subjective and objective measures further supports the real-life effectiveness of the studied ICS/LABA combination.
BMC Pulm Med. 2022;22(254) © 2022 BioMed Central, Ltd.