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

Adv Ther. 2018 Aug;35(8):1140-1152. doi: 10.1007/s12325-018-0753-6. Epub 2018 Jul 31.

Abstract

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.

Keywords: ACO; Asthma; Budesonide/formoterol Easyhaler®; COPD; Effectiveness; Real-world study; Respiratory/pulmonary.

Publication types

  • Clinical Study
  • Multicenter Study

MeSH terms

  • Administration, Inhalation
  • Adult
  • Aged
  • Budesonide, Formoterol Fumarate Drug Combination / therapeutic use*
  • Female
  • Humans
  • Male
  • Metered Dose Inhalers*
  • Middle Aged
  • Patient Reported Outcome Measures*
  • Patient Satisfaction
  • Pulmonary Disease, Chronic Obstructive / drug therapy*
  • Quality of Life
  • Respiratory Tract Absorption
  • Treatment Outcome

Substances

  • Budesonide, Formoterol Fumarate Drug Combination