TY - JOUR
TI - Adherence and quality of life assessment in patients with asthma treatment with budesonide/formoterol via the Elpenhaler device: the COMPLETE study
AU - Exarchos, K.P.
AU - Rovina, N.
AU - Krommidas, G.
AU - Latsios, D.
AU - Gogali, A.
AU - Kostikas, K.
JO - BMC Pulmonary Medicine
PY - 2022
VL - 22
TODO - 1
SP - null
PB - BioMed Central Ltd.
SN - 1471-2466
TODO - 10.1186/s12890-022-02049-0
TODO - budesonide plus formoterol;  bronchodilating agent;  budesonide;  budesonide plus formoterol;  ethanolamine derivative;  formoterol fumarate, adult;  aged;  Article;  asthma;  clinical assessment;  clinical feature;  clinical practice;  controlled study;  disease severity;  drug safety;  drug withdrawal;  female;  follow up;  forced expiratory volume;  human;  lung function;  major clinical study;  male;  medication compliance;  Morisky Medication Adherence Scale;  multicenter study;  observational study;  patient compliance;  prospective study;  quality of life;  spirometry;  tachycardia;  treatment duration;  asthma;  clinical trial;  drug combination;  treatment outcome, Adult;  Asthma;  Bronchodilator Agents;  Budesonide;  Budesonide, Formoterol Fumarate Drug Combination;  Drug Combinations;  Ethanolamines;  Formoterol Fumarate;  Humans;  Prospective Studies;  Quality of Life;  Treatment Outcome
TODO - 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). © 2022, The Author(s).
ER -