Tuberculosis and Respiratory Diseases

The Korean Academy of Tuberculosis and Respiratory Diseases (대한결핵및호흡기학회)
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Comparison of Two pMDIs in Adult Asthmatics: A Randomized Double-Blind Double-Dummy Clinical Trial

  • Nam, Tae-Hyun (Division of Pulmonology and Allergy, Department of Internal Medicine, Gachon University Gil Medical Center) ;
  • Kang, Sung-Yoon (Division of Pulmonology and Allergy, Department of Internal Medicine, Gachon University Gil Medical Center) ;
  • Lee, Sang Min (Division of Pulmonology and Allergy, Department of Internal Medicine, Gachon University Gil Medical Center) ;
  • Kim, Tae-Bum (Department of Allergy and Clinical Immunology, Asan Medical Center, University of Ulsan College of Medicine) ;
  • Lee, Sang Pyo (Division of Pulmonology and Allergy, Department of Internal Medicine, Gachon University Gil Medical Center)
  • Received : 2021.08.12
  • Accepted : 2021.11.24
  • Published : 2022.01.31
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Abstract

Background: Only a few studies directly compared the therapeutic efficacy and safety of two pressurized metered-dose inhalers (pMDIs) in asthma. We analyzed the asthma treatment outcomes, safety, and patient preferences using formoterol/beclomethasone (FORM/BDP), a pMDI with extra-fine particles, compared with formoterol/budesonide (FORM/BUD), another pMDI with non-extra-fine particles. Methods: In this randomized, double-blind, double-dummy parallel group study, 40 adult asthmatics were randomized to FORM/BDP group (n=18; active FORM/BDP and placebo FORM/BUD) or FORM/BUD group (n=22; active FORM/BUD and placebo FORM/BDP). During the two visits (baseline and end of 8-week treatment), subjects were asked to answer questionnaires including asthma control test (ACT), asthma control questionnaires (ACQ), and Quality of Life Questionnaire for Adult Korean Asthmatics (QLQAKA). Lung function, compliance with inhaler, and inhaler-handling skills were also assessed. Results: Ten subjects in the FORM/BDP group and 14 in the FORM/BUD group completed follow-up visits. ACT, ACQ, QLQAKA (a primary outcome), and adverse events did not differ between two groups. We found that the increase in forced expiratory volume in 1 second/forced vital capacity and forced expiratory flow at 25% to 75% of the pulmonary volume in the FORM/BDP group was higher than in the FORM/BUD group. Regarding preference, subjects responded that the flume velocity of FORM/BDP was higher, but more adequate than that of FORM/BUD. They also answered that FORM/BDP reached the trachea and bronchus and irritated them significantly more than FORM/BUD. Conclusion: The use of pMDI with extra-fine particles may relieve small airway obstruction more than the one with non-extra-fine particles despite no significant differences in overall treatment outcomes. Some asthmatics have a misconception about the adequacy of high flume velocity of pMDIs.

Keywords

Acknowledgement

We are especially grateful to Hyun Joo Im, a clinical research coordinator for her devotion to our study. Placebos of FORM/BDP and FORM/BUD were provided without cost by Kolon pharma (Gwacheon, Republic of Korea) and AstraZeneca Korea (Seoul, Republic of Korea).

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