Adherence and Quality of Life Assessment in Patients With Asthma Treatment With Budesonide/Formoterol via the Elpenhaler Device

The COMPLETE Study

Konstantinos P. Exarchos; Nikoletta Rovina; George Krommidas; Dimitrios Latsios; Athena Gogali; Konstantinos Kostikas

Disclosures

BMC Pulm Med. 2022;22(254) 

In This Article

Abstract and Introduction

Abstract

Background: Asthma is a chronic inflammatory disease of the airways that causes recurring episodes of wheezing, breathlessness, chest tightness and coughing. Inhaled drugs on a daily basis are the cornerstone of asthma treatment, therefore, patient adherence is very important.

Methods: We performed a multicenter, open, non-interventional, observational, prospective study of 716 adult patients diagnosed with asthma receiving FDC (Fixed-dose combination) budesonide/formoterol via the Elpenhaler device. We assessed the adherence to treatment at 3 and 6 months (based on the MMAS-8: 8-item Morisky Medication Adherence Scale), the quality of life and change in forced expiratory volume in 1 s (FEV1) from baseline to follow-up.

Results: Approximately 80% of the patients showed medium to high adherence throughout the study. The mean (SD) MMAS-8 score at 6 months was 6.85 (1.54) and we observed a statistically significant shift of patients from the low adherence group to the high adherence group at 6 months. Moreover, after 6 months of treatment with FDC budesonide/formoterol, we observed an increase in the patients' quality of life that as expressed by a change 2.01 (95%CI 1.93–2.10) units in Mini AQLQ (p < 0.0001) that was more pronounced in the high adherence group. The same trend was also observed in terms of spirometry (mean FEV1 2.58 L (0.85) at the end of the study, increased by 220 mL from baseline) with a higher improvement in the medium and high adherence groups.

Conclusions: Treatment with FDC of budesonide/formoterol via the Elpenhaler device was associated with improvement in asthma-related quality of life and lung function over 6 months that were more prominent in patients with higher adherence.

Trial registration: 2017-HAL-EL-74 (ClinicalTrials.gov Identifier: NCT03300076).

Introduction

Asthma is a chronic, common and heterogeneous respiratory disease, characterized by diffuse airway inflammation. Its prevalence varies between 1–18% across different countries; the respective prevalence in Greece is estimated around 8.6%.[1] Patients often complain about recurring episodes of wheezing, shortness of breath, chest tightness and cough of variable intensity over time, together with variable expiratory airflow limitation. The majority of people diagnosed with asthma achieve good or very good control of their disease and are able to live a normal life, punctuated only by the need to take regular inhaled medication and by occasional exacerbations. Based on the triad of asthma control, severity and exacerbations, the patient's treatment is reevaluated and fine-tuned based on a 5-step treatment scale.[2]

Asthma control refers to the extent that asthma symptoms are reported by the patient. Therefore, asthma control reflects the same domains targeted by asthma management, i.e. symptom control and future risk of adverse outcomes. To this end, several scores have been proposed in the literature such as Asthma APGAR, ACQ (Asthma Control Questionnaire) and ACT (Asthma Control Test) to name a few. Pulmonary function tests, and spirometry in particular, constitute an objective means of assessing the patient's status, either compared to predicted values or by measuring deviations from the patient's baseline or 'personal best'. Even though spirometry does not always correlate strongly with asthma symptoms, it may offer quantitative information for the periodic assessment of asthma patients.

The pharmacological treatment of asthma includes controller/maintenance medication, i.e. inhaled corticosteroids (ICS), with or without long-acting β2-agonists (LABA), and reliever medication taken as required to relieve symptoms, such as short-acting β2- agonists (SABA) or ICS-formoterol combinations. Treatment regimens with ICS-formoterol can be used both as controller and reliever medication, as well as as-needed medication in milder asthma, based on the GINA 2020 recommendations.[2–4] Moreover, the ICS-formoterol combination constitutes the cornerstone of asthma treatment from step 1 up to step 4 of the GINA 2020 recommendations. Therefore, choosing the appropriate controller and/or reliever medication is of great significance in the asthma treatment and the asthma management, overall.

Besides choosing the right treatment for each patient, conforming to the treatment (i.e. medication adherence) is also necessary. Medication adherence is a term of great importance that affects nearly every asthma aspect, such as symptom control, treatment decision and escalation, severity assessment and asthma prognosis. Medication adherence is also important for differentiating between severe asthma and difficult-to-treat asthma. Moreover, poor adherence is an independent risk factor for predicting future asthma exacerbations and persistent airflow limitation. Medication adherence is affected by a wide array of factors, e.g. multiple devices, difficult treatment plan (multiple times per day), forgetfulness, cost, concerns about side-effects.[5] The device in particular has been found to play an important role in the correct drug administration and the patient's adherence to treatment.[6,7] Even though there is already a wide range of devices in the market, the development of novel inhaler devices is a necessity in order to (i) achieve targeted drug delivery and (ii) improve the patients' condition by facilitating adherence.[8]

The routine identification of non-adherent patients followed by targeted interventions can lead to increased adherence. Several methods for adherence assessment are available in the literature each with a set of advantages and disadvantages.[9] These include subjective monitoring tools e.g. physician assessment of adherence or self-report questionnaires, as well as objective monitoring approaches, such as: prescription data, dose counters, directly observed therapy, etc..[10,11] The current gold standard for assessing adherence is electronic monitoring which provides a load of inhaler related information for further analysis. Nevertheless, electronic monitoring devices are often expensive and do not assess the inhaler technique.[10,12]

Another important aspect in asthma management is the quality of life perceived by the patient. As noted earlier, in some cases there is discordance between spirometry and symptomatology which reflects the overall quality of life. For this purpose, clinical scores have been proposed to quantify the life quality of patients diagnosed with asthma of variable severity.[13] AQLQ (Asthma Quality of Life Questionnaire) as well as its short version Mini AQLQ[14] are two most widely used scores for measuring asthma life quality.

In the current study, we have considered a large set of approximately 700 patients diagnosed with asthma of variable severity. The enrolled patients received treatment with fixed dose combinations (FDC) of budesonide/formoterol via the Elpenhaler device, according to usual clinical practice and were reevaluated at 3 and 6 months to assess adherence to treatment, quality of life and change in spirometry.

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