Budesonide/formoterol via the Elpenhaler® device in asthmatic patients: A real-world effectiveness study (The BOREAS Study)

Abstract

INTRODUCTION Very limited real-world data have been captured in the Greek asthmatic population regarding the effects of treatment with a fixeddose combination of budesonide/formoterol via the Elpenhaler® device, on the course of the disease and its impact on the patients' quality of life score. METHODS In this multicenter, observational study, 1230 adult asthmatic patients in Greece that had been recently prescribed a fixed-dose combination budesonide/formoterol, Elpenhaler® were enrolled. The primary endpoint was the evaluation of the effectiveness of the treatment at six months in symptom control using the 7-item Asthma Control Questionnaire (ACQ-7). The secondary endpoints included the quality of life score using the Mini Asthma Quality of Life Questionnaire (MiniAQLQ), pulmonary function, patients' satisfaction with the Elpenhaler® device, and safety. RESULTS In total, 60.3% (742/1230) of the participants were female and the mean age was 51.10±16.98 years. A statistically significant improvement of the mean ACQ-7 score was noted at 3 months (1.01±0.70) and 6 months (0.79±0.66), compared to baseline (2.18±0.91). Similar statistically significant results were noted for the MiniAQLQ score with an improvement from 4.58±1.06 at baseline to 5.95±0.79 at 3 months, and 6.21±0.74 at 6 months. The mean Forced Expiratory Volume at 1 second (FEV1) showed continuing improvement, being 2.36±0.86, 2.58±0.88, and 2.64±0.88 L, at baseline, 3, and 6 months, respectively. CONCLUSIONS These real-world data showed that the administration of a fixed dose combination of budesonide/formoterol using the Elpenhaler® device was well-tolerated and effective in significantly reducing the symptoms of asthma and improving the quality of life.

Adherence and quality of life assessment in patients with asthma treatment with budesonide/formoterol via the Elpenhaler device: the COMPLETE study

“…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 [ 30 ], 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.…”

Treatment Adherence and Health Status of Patients With COPD Under Treatment With Salmeterol/Fluticasone via the Elpenhaler® Device: The AHEAD Study

“…Patient satisfaction with the inhaler device is one of the factors affecting the adherence of patients to treatment. In this perspective, the role of the Elpenhaler® device has been evaluated in a Greek population diagnosed with COPD and asthma [28, 29]. As far as adherence is concerned, the Elpenhaler® device, when compared with other frequently used inhalation devices, exhibited the lowest error rates for critical errors in the inhalation maneuver [30].…”

Asthma and Tobacco Smoking

“…Combining the negative effects of smoking on asthma symptoms and exacerbations, which are the two aspects assessed to rate the control and the severity of the disease, it becomes clear that asthmatic smokers usually have more severe and uncontrolled disease and thus display a need to intensify treatment. A small number of real-life trials have shown that the main treatment options used in asthma patients remain effective in smokers, as shown in Table 1 [ 89 , 90 ]. ICS is the mainstay controller medication in asthmatic smokers, but patients might require higher doses due to the relative resistance they display.…”