Combining a fixed dose of asthma medications budesonide and formoterol (BUD/FOR) delivered via an Elpenhaler® device significantly improves asthma control, lung function and quality of life in patients with asthma. Budesonide is an inhaled corticosteroid that reduces airway inflammation and formoterol is a bronchodilator that relaxes airway muscles. Researchers reported the confirmation in the recent study, “Real-Life Effectiveness of Budesonide/Formoterol as Maintenance and Reliever Treatment via the Elpenhaler® Device in Patients with Asthma: The NOTOS Observational Study,” which was published in the Journal of Asthma and Allergy.
The NOTOS study was conducted from May 2021 to May 2022 and included 1,107 adult patients from 100 hospital and private practice settings in Greece. It is the first of its kind to evaluate the dual use of BUD/FOR as both a maintenance and reliever therapy in everyday clinical practice and was approved by multiple ethics committees, adhering to international clinical research standards.
Researchers assessed asthma control using the Asthma Control Questionnaire (ACQ-6), quality of life via the Mini Asthma Quality of Life Questionnaire (MiniAQLQ) and lung function through spirometry.
Patients experienced a statistically and clinically significant improvement in asthma control, with an average ACQ-6 score reduction of 1.55 points. Additionally, MiniAQLQ scores improved by an average of 1.76 points, indicating a meaningful enhancement in daily living.
According to the study’s results, forced expiratory volume in one second (FEV1) increased by an average of 0.35 liters, and the need for rescue therapy, including short-acting beta-agonists (SABA), dropped markedly over the study period. Researchers said there were no serious adverse events related to treatment.
The study also found that patients using higher doses of BUD/FOR (400/12 µg) showed the greatest improvements. It noted that the Elpenhaler device was user-friendly and effective, contributing to better adherence and outcomes.
"These results reinforce thee value of using BUD/FOR via the Elpenhaler not only aas a maintenance therapy but also as a flexible, symptom-driven reliever. This aligns with the latest Global Initiative for Asthma (GINA) guidelines and represents a significant advancement in personalized asthma care," said Athena Gogali, MD, PhD, a respiratory physician at University Hospital of Ioannina in Epirus, Greece, and principal investigator of the NOTOS study.
Researchers said the study’s findings suggest value in a shift away from SABA-only treatment, especially in mild asthma, and bolster the case for anti-inflammatory reliever strategies using inhaled corticosteroid (ICS)/formoterol combinations. Current GINA guidelines advocate for ICS/formoterol as both controller and reliever therapy, especially in mild-to-moderate asthma.
