am, Kang et al (2021) analysed 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. It was independent, double-blind, double-dummy head-to-head randomised controlled trial, funded by the Korean Government. This study aimed to assess the treatment outcomes, safety, and patient preferences.
Inhaled drugs with extra-fine particles are more effectively distributed in the peripheral airway
METHODS
In this parallel group study, 40 adult asthmatics were randomised 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 eight-weeks treatment), subjects were asked to answer questionnaires including asthma control test (ACT), asthma control questionnaires (ACQ), and Quality of Life Questionnaire (QoLQ) for adult Korean asthmatics (QLQAKA). Lung function, compliance with inhaler, and inhaler-handling skills were also assessed.
RESULTS
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 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.
The study results suggest that FORM/BDP, an ICS/LABA with extra-fine particles, may be intrinsically more effective in terms of lung function because it reaches the distal airways, consequently relieving airway constriction. Inhaled drugs with small particles are more evenly deposited in the lung after inhalation, which may suggest that asthma can be more effectively controlled using these medications.
Moreover, inhaled drugs with extra-fine particles are more effectively distributed, in the peripheral airway, which can contribute to more uniform therapeutic effects on the patient’s lung. In a clinical study, inhaled drugs with extra-fine particles resulted in better asthma treatment outcomes in elderly asthmatics compared with the same dose of drugs with non-extra-fine particles. Furthermore, ICS/LABA with extra-fine particles resulted in less frequent AE than other ICS/LABAs with non-extra-fine particles.
However, there were no differences in other treatment outcomes, such as ACT, ACQ, QLQAKA, asthma control, AE, FeNO, FVC, or FEV1, during the study.
The relatively short study period and the small number of subjects in this study may have hampered sufficient evaluation of the potential therapeutic benefits of extra-fine formulations. Asthma control using pMDIs with extra-fine particles may relieve smaller airway obstruction more than that those with non-extra-fine particles despite no significant differences in overall treatment outcomes. In addition, asthma patients may prefer specific pMDIs for reasons that may not be consistent with health care providers’ expectations, such as high flume velocity.
CONCLUSION
The study suggests that inhaled drugs with extra-fine particles have better therapeutics advantages in treating inflammation and bronchoconstriction of small airways than those with non-extra-fine particles, despite no significant differences in overall treatment outcomes. This evidence further enriches the dataset regarding the benefits of extra-fine pMDIs in adult asthmatics when compared to non-extra-fine formulations.
REFERENCES: Nam T-H, Kang S-Y et al. Comparison of Two pMDIs in Adult Asthmatics: A Randomized Double-Blind Double-Dummy Clinical Trial. Tuberc Respir Dis 2022;85:25-36. Doi: https://doi.org/10.4046/trd.2021.0093.
