Clinical Effectiveness of Budesonide/Formoterol Fumarate Easyhaler for Patients with Poorly Controlled Obstructive Airway Disease: a Real-World Study of Patient-Reported Outcomes.

INTRODUCTION

The effectiveness of inhaled therapies can be influenced by many factors, including the type of inhaler, which may have clinical implications. We report a real-world, multicenter, open-label, non-randomized, non-interventional study conducted by 200 pulmonologists across 200 centers in Hungary. The effectiveness of budesonide/formoterol inhalation therapy in daily clinical practice, delivered via the Bufomix Easyhaler, was evaluated in patients with asthma, chronic obstructive pulmonary disease (COPD) and asthma-COPD overlap (ACO).

METHODS

Effectiveness was assessed after 12 weeks of treatment by spirometry, the Asthma Control Test, mini-Asthma Quality of Life Questionnaire, COPD Assessment Test and modified Medical Research Council dyspnea scale. Patient satisfaction with the Bufomix Easyhaler and physicians' assessments (ease of use and time taken to learn the technique) were also assessed.

RESULTS

A total of 1498 patients with obstructive airway disease were evaluated (asthma: n = 621; COPD: n = 778; ACO: n = 99), of whom 455 (30.4%) were newly diagnosed inhaler-naïve patients and 1043 (69.6%) were switching from other inhalers. Significant improvements in lung function, disease control and health-related quality of life measures (all p ≤ 0.002) were reported after 12 weeks of Bufomix Easyhaler use. Improvements were observed in both inhaler-naïve patients and those who switched to a Bufomix Easyhaler from other devices. After switching, 72.4% of patients regarded the Bufomix Easyhaler as 'very good' and > 90.0% of physicians described the Bufomix Easyhaler as easy to teach; 73.8% and 98.9% of patients learned the technique within 5 and 10 min of teaching, respectively.

CONCLUSION

Twelve weeks' treatment with the Bufomix Easyhaler resulted in significant improvements in disease control and quality of life. The Bufomix Easyhaler was considered easy to use, and most patients were satisfied with the inhaler. Results confirm the real-world effectiveness of the Bufomix Easyhaler in the treatment of adult outpatients with obstructive airway disease.

FUNDING

Orion Corp., Orion Pharma.