However, there was no study that performed a direct head-to-head comparison of treatment outcomes between inhaled drugs with extra-fine particles and those with non-extra-fine particles under other controlled clinical conditions (including inhaler device).
An independent, phase IV double-blind, the double-dummy randomised clinical trial compared two pMDIs containing formoterol fumarate dihydrate/beclomethasone dipropionate (FORM/BDP), an ICS/LABA with extra-fine particles and formoterol fumarate dihydrate/budesonide (FORM/BUD), an ICS/LABA with non-extra-fine particles.
The research was funded by the Korean government. Despite a very small study population (40 patients randomised and 24 patients completed), short study duration (eight weeks), asthma control using pMDIs with extra-fine particles may relieve smaller airway obstruction more than those with non-extra-fine particles, despite no significant differences in overall treatment outcomes.
In this randomised, double-blind, double-dummy parallel-group study, 40 adult asthmatics were randomized to the 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 eight-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 an inhaler, and inhaler-handling skills were also assessed.
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 the two groups. We found that the increase in forced expiratory volume in one 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 plume velocity of FORM/BDP was higher but more adequate than that of FORM/BUD.
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. The pMDI with extra-fine particles improved forced expiratory flow (FEF)25-75 (p=0.037) and forced expiratory volume (FEV)1/forced vital capacity (FVC) (p=0.043) more than the non-extra-fine particles after eight weeks of treatment, which suggests that inhaled drugs with extra-fine particles have better therapeutics advantages in treating inflammation and bronchoconstriction of small airways.
Nam T-H, Kang S-Y, Lee SM et al. Comparison of Two pMDIs in Adult Asthmatics: A Randomized Double-Blind Double-Dummy Clinical Trial. Tuberc Respir Dis 2022;85(1):25-36. DOI: https://doi.org/10.4046/trd.2021.0093.