The aim of this study was to evaluate the effects of pleuran (β-glucan isolated from Pleurotus ostreatus) on asthma control and respiratory morbidity in children on conventional GINA-based asthma treatment who had partially controlled perennial asthma. A double-blind, placebo-controlled multicentre clinical trial with a 2-arm, parallel design was conducted across three countries
230 children aged 7 to 17 years were randomised (1:1) into an active group (receiving a pleuran/vitamin C combination) or a placebo group (receiving vitamin C only). This study consisted of 24 weeks of treatment (2 capsules a day) and then 24 weeks of follow-up. The primary endpoints included the effects of active treatment versus placebo on asthma control and respiratory tract infections (RTIs). Secondary endpoints included changes in the following measures: number of asthma exacerbations, with or without respiratory infection
quality of life of both asthmatic children and their caregivers
spirometric indices
fractional exhaled nitric oxide (FeNO) levels
safety after 24 weeks of treatment and also after the full 48-week study period. Overall, 206 children completed this study
113 of these children were in the active group and received a pleuran/vitamin C combination for 24 weeks. After the 24-week treatment period, children below 12 years of age who were in the active group achieved significant improvements in asthma control compared to those in the placebo group (21.8 ± 3.5 vs. 20.3 ± 4.0
P = 0.02)
while children at least 12 years old who were in the active group reported lower numbers of RTIs (0.7 ± 1.0 vs. 1.9 ± 1.7
P = 0.002) compared to children of this age in the placebo group. In addition, children below 12 years of age in the active group showed a significant decrease in asthma exacerbations compared to those in the placebo group (2.5 ± 1.6 vs. 3.3 ± 1.9
P = 0.05). At the end of the 48-week trial, a statistically significant improvement in asthma control was observed in 84.7% of children who received pleuran/vitamin C treatment compared to 67.0% of children who received vitamin C only (P = 0.01). The pleuran/vitamin C combined treatment was safe and well-tolerated, and no related serious adverse events were reported. This study highlights the favourable safety profile of pleuran/vitamin C supplementation and demonstrates positive effects of this treatment on asthma control and RTI incidence in children with allergic perennial asthma that was partially controlled by conventional therapy.