Randomised, multicentre, prospective interventional study to evaluate the efficacy of immediate diet in addition to standard mouth rinsing in reducing local adverse events of inhaled corticosteroid among asthmatic patients: a pilot study

Abstract

Background: Inhaled corticosteroid (ICS) is recommended as first-line therapy for all asthmatic patients. However, regular use of ICS is always associated with occurrence of local adverse events (LAEs) in the oropharyngeal area that may compromise asthma control. This study introduced a new intervention, namely immediate diet in addition to standard mouth rinsing (ID-SMR), for better preventing LAEs. Aim: To investigate the efficacy of the new intervention, in terms of reducing occurrence of ICS-induced LAEs, as compared to standard mouth rinsing. To compare the level of asthma control between standard mouth rinsing method and the new intervention in the participants. Methods: Two public health clinics and two public hospitals in the Kedah area participated in this study. Participants were randomised into a control arm (standard mouth rinsing) and interventional arm (new intervention) to complete four visits with one-month intervals. In each visit, participants were interviewed on incidences of LAEs and asthma control levels were assessed. This study was approved by the Medical Research and Ethics Committee, Malaysia. Results: Twelve participants per arm completed this study. Participants with one or more LAEs in the control group were significantly higher (p < 0.05) than in the interventional group at last visit. Incidence of each LAE showed a declining trend in the interventional group but remained almost the same in the control group. A similar increment was observed in participants with good asthma control from baseline visit to last visit with non-significant difference between the two groups. Conclusions: Immediate diet in addition to mouth rinsing method can effectively minimise the occurrence of LAEs, but is not better in improving asthma control.