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

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).

Keywords: Adherence; Asthma; Asthma treatment; Budesonide/formoterol; Quality of life.

Conflict of interest statement

K.P. Exarchos has received honoraria for presentations and consultancy fees from Novartis. N. Rovina has no conflict of interest within the scope of the submitted work and has received consultancy fees and/or funding from Chiesi, Menarini, Astra zeneca, ELPEN, CSL Behring. G. Krommidas has received honoraria for presentations and consultancy fees from AstraZeneca, Chiesi, ELPEN, GSK, Menarini, Novartis and Boehringer Ingelheim. D. Latsios reports grants and personal fees for lectures and consultancy from Chiesi, Elpen, GSK and Menarini. A. Gogali has received honoraria for presentations and consultancy fees from AstraZeneca, Boehringer Ingelheim, Chiesi, ELPEN, GSK, Novartis. Κ. Kostikas: I have received honoraria for presentations and consultancy fees from AstraZeneca, Boehringer Ingelheim, Chiesi, CSL Behring, ELPEN, GSK, Menarini, Novartis, Sanofi Genzyme and WebMD. My department has received funding and grants from AstraZeneca, Boehringer Ingelheim, Chiesi, Innovis, ELPEN, GSK, Menarini, Novartis and NuvoAir.

© 2022. The Author(s).

Figures

Fig. 1
Fig. 1
Past treatment for asthma (until the day of enrollment)
Fig. 2
Fig. 2
Adherence to treatment, as assessed by MMAS-8 scale at 3 and 6 months
Fig. 3
Fig. 3
a Total Mini AQLQ score. b Symptoms domain score from the Mini AQLQ score. c Environment domain score from the Mini AQLQ score. d Emotions domain score from the Mini AQLQ score. e Activities domain score from the Mini AQLQ score
Fig. 4
Fig. 4
Change in Mini AQLQ score in the three consecutive visits, per adherence group
Fig. 5
Fig. 5
Mini AQLQ scores in total as well as in each domain, per adherence group
Fig. 6
Fig. 6
Change on FEV1 measured (L) across all visits, per adherence group

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