Introduction: The effectiveness of single-inhaler budesonide/formoterol fumarate combination therapy for asthma has been previously shown for the original product. The aim of this nonrandomized, open-label, postauthorization efficacy study (PAES) real-life clinical assessment was to evaluate the clinical effectiveness of a second product (Bufomix Easyhaler®) in the daily clinical practice of asthma therapy.
Methods: This multicenter PAES was conducted by 220 unselected allergologists and pulmonologists who enrolled 2200 adult outpatients (age 49.8 ± 17.9 years) with asthma treated with Bufomix Easyhaler® for at least 14 days before enrolment. Asthma control was assessed during three subsequent visits with 8-12-week intervals on the basis of the Asthma Control Test (ACT). Adherence was assessed with the Medication Adherence Questionnaire. In addition, patient satisfaction with Bufomix Easyhaler® was scored, and adverse drug reactions were recorded.
Results: The percentage of patients with well-controlled asthma or total control of asthma (ACT score 20-25 points) increased from 46.6% at the first visit to 90.8% at the third visit (p < 0.001). In addition, the percentage of patients with poor control of asthma (ACT score less than 15 points) decreased from 14.9% to 1.2% (p < 0.001). The adherence rate increased from 88% at the first visit to 95.3% at the third visit. Patient satisfaction with the use of this dry powder inhaler increased with the duration of its use. Only one adverse drug reaction was reported.
Conclusion: The results obtained confirm the effectiveness of Bufomix Easyhaler® in the treatment of asthma in outpatient adults in daily clinical practice.
Funding: Orion Corporation.
Keywords: Bronchial asthma; Budesonide; Combination therapy; Dry powder inhaler; Formoterol fumarate; Inhaled corticosteroids; Postauthorization efficacy study; Respiratory.