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. INTRODUCTION The health-related quality of life (HRQoL) of patients with asthma is affected by the presenting symptoms and their limiting effects on their physical, work and social aspects of their everyday life1. Hence, early and effective control of the disease can significantly impact their HRQoL, as assessed through various tools, and, in turn, decrease the use of healthcare resources1,2. When referring to disease control in asthmatic patients, two aspects should be considered, the repression of symptoms and the reduction of the risk for potentially unfavorable outcomes, which include the incidence of exacerbations, persistent effects on lung function, and adverse events emerging from the treatment itself. In prospect, inadequate symptom control usually results in increased exacerbations and overall a negative effect on the quality of life2. Spirometry and, particularly, persistent airway obstruction are additive parameters for predicting future risk2. Self-reported outcomes and physician-assessed tools provide a method for harmonizing and quantifying asthmatic patients’ initial state and changes occurring thereafter. The Asthma Control Questionnaire (ACQ) is a 7-item questionnaire that incorporates and evaluates symptoms and the treating guidelines. Certain cut-off scores, ranging from 0.75–1.50 have been proposed to differentiate between ‘well controlled’ and ‘not well controlled’ patients3. Validated translations of the ACQ-7 questionnaire in different languages, including Greek, are available4. The concurrent use of more than one of these assessment tools may not offer practical advantages to the clinician, as the available questionnaires may not exhibit the same correlation to the patient’s symptoms5. The initial evaluation and monitoring of the patient’s quality of life are often overlooked in daily clinical practice, in favor of time conservation and clinical and laboratory examinations. However, in conditions such as asthma, where the disease can produce debilitating symptoms that affect the person’s health perception and their ability for social AFFILIATION 1 1st University Department of Respiratory Medicine, National and Kapodistrian University of Athens, Athens, Greece 2 Pulmonary Clinic, ‘G. Papanikolaou’ General Hospital, Aristotle University of Thessaloniki, Thessaloniki, Greece 3 School of Medicine, ‘Attikon’ University General Hospital, National and Kapodistrian University of Athens, Athens, Greece CORRESPONDENCE TO Stylianos Loukides. School of Medicine, ‘Attikon’ University General Hospital, National and Kapodistrian University of Athens, 1 Rimini Street, Athens, 12462, Greece. E-mail: loukstel@med.uoa.gr ORCID ID: https://orcid.org/0000-00024278-9922