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

BMC Pulm Med. 2022;22(254)

Conclusions

In this study of 716 asthmatic patients, treatment with FDC of budesonide/formoterol via the Elpenhaler device was associated with medium to high adherence in the majority of patients (~ 80%), with improvement in asthma-related quality of life and lung function over 6 months. These improvements were more prominent in patients with higher adherence.

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Acknowledgements
Investigators participated in the conduct of COMPLETE study: Anastasiou Sophia, Antonaropoulou Athina, Argiriou Panagiotis, Arvanitidis Apostolos, Chamerzokova- Iliadi Eleni, Chatziapostolou Panagiotis, Chekimoglou Maria, Gakis Konstantinos, Georgitsa-Galarioti Kalliopi, Giannarakis Ioannis, Gizopoulou Evagelia, Katsimpoula Sophia, Kazakou Aikaterini, Krommidas Georgios, Latsios Dimitrios, Mermigas Konstantinos, Michailidou Makrina, Moisiadis Nikolaos, Mpampalis Christos, Mparouchos Nikolaos, Nikolakopoulou Ageliki, Nikolopoulou Eleni, Panselinas Efstratios, Papalexatos Dionisios, Papaneofitou Irene, Parisis Chrisovalantis, Pataka Athanasia, Perantoni Eleni, Pigakis Konstantinos, Plastira Irene Protopapadakis Charalampos, Psiloutsikou Maria, Resvani Alexandra, Rovina Nikoletta, Skliris Athanasios, Sotiriadou Maria, Taga Eleni, Topaka Ifigenia, Trigonis Ioannis, Tsakalou Eleni, Tsaldari Garifallia, Tsarouchis Georgios, Tsipilis Dimosthenis, Tsopela Marieta, Tzolidis Christos, Tzortzaki Eleni, Vassos Dimitrios, Vitsas Vlasios, Vittorakis Stilianos, Vlachopoulos Dimitrios, Vlaikos Dimosthenis, Xifteri Areti, Zois Panagiotis. The Morisky Widget, MMAS-8. MMAS-4 are protected by US and International Trademark and Copyright laws. Permission for use is required. A license agreement is available from: MMAS Research LLC 14725 NE 20th St. Bellevue WA 98007.

Funding
Elpen Pharmaceutical Co. Inc.

Availability of data and materials
The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request.

Declarations
Ethics approval and consent to participate
The study was performed in accordance with the principles of the Declaration of Helsinki and was approved by the Ethics Committees of the Sotiria Chest Disease Hospital and the General Hospital of Chalkida. All subjects provided written informed consent.

Consent for publication
Not applicable.

Table 1. Demographic and clinical characteristics of patients at baseline
	(N, %)
Age-yr	N = 716
Mean (SD)	52.3 (16.5)
Age group-no. (%)	N = 716
< 40	169 (23.6%)
40–59	279 (39%)
60–79	248 (34.6%)
≥ 80	20 (2.8%)
Gender-no (%)	N = 716
Male	261 (36.5%)
Female	455 (63.5%)
BMI-kg/m²	N = 716
Mean (SD)	28.6 (5.8)
Education-no. (%)	N = 716
Basic (6 years of education)	149 (20.8%)
Higher (12 years of education)	360 (50.3%)
University (University degree)	207 (28.9%)
Smoking status-no. (%)	N = 716
Non-smoker	423 (59.1%)
Ex-smoker	144 (20.1%)
Current smoker	149 (20.8%)

Table 2. Adherence of asthma patients to treatment, as assessed by the MMAS-8 scale at 3 and 6 months
MMAS-8 score	Visit 1 (month 3) N = 684	Visit 2 (month 6) N = 666
High adherence (score = 8)	274 (40.1)	315 (47.3)
Medium adherence (score = 6–7.99)	227 (33.2)	216 (32.4)
Low adherence (score = 0–5.99)	183 (26.8)	135 (20.3)