Comparison of Two pMDIs in Adult Asthmatics: A Randomized Double-Blind Double-Dummy Clinical Trial

Abstract

Background: Only a few studies directly compared the therapeutic efficacy and safety of two pressurized metereddoseinhalers (pMDIs) in asthma. We analyzed the asthma treatment outcomes, safety, and patient preferences usingformoterol/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 toFORM/BDP group (n=18; active FORM/BDP and placebo FORM/BUD) or FORM/BUD group (n=22; active FORM/BUDand placebo FORM/BDP). During the two visits (baseline and end of 8-week treatment), subjects were asked to answerquestionnaires including asthma control test (ACT), asthma control questionnaires (ACQ), and Quality of Life Questionnaire forAdult 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 inforced expiratory volume in 1 second/forced vital capacity and forced expiratory flow at 25% to 75% of the pulmonaryvolume in the FORM/BDP group was higher than in the FORM/BUD group. Regarding preference, subjects respondedthat the flume velocity of FORM/BDP was higher, but more adequate than that of FORM/BUD. They also answered thatFORM/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 withnon-extra-fine particles despite no significant differences in overall treatment outcomes. Some asthmatics have amisconception about the adequacy of high flume velocity of pMDIs.