Inhaled corticosteroid confers modest improvement in lung function in preterm-born children
Click Here to Manage Email Alerts
Among preterm-born children, treatment with fluticasone propionate for 12 weeks led to a modest improvement in lung function, researchers reported at the European Respiratory Society International Congress.
Researchers conducted a double-blind, randomized trial that enrolled 170 children at age 6 to 12 years who were born less than 32 weeks gestation at Perth, Australia’s only tertiary neonatal ICU center. At baseline, all participants completed a questionnaire and skin prick test. Fractional exhaled nitric oxide (FeNO), oscillometry and spirometry were performed before and after salbutamol 400 µg to assess bronchodilator response. Participants were randomly assigned to the inhaled corticosteroid (ICS) fluticasone propionate 125 µg or placebo twice daily for 12 weeks, followed by a follow-up visit.
More than one-quarter of patients in both groups had bronchopulmonary dysplasia, the mean age was 10 years, mean gestational age was about 28 weeks, and there were more boys in the placebo group (51.8%) than the ICS group (43.7%).
Due to this trial overlapping with the COVID-19 pandemic, 17 participants in the treatment group and 14 participants in the placebo group discontinued the study, leaving 139 participants who completed the trial: 70 participants in the treatment group and 69 participants in the placebo group.
Treatment with fluticasone propionate led to improvement in both FEV1 and FEV1:FVC ratio from baseline to 12 weeks, with percent changes of 5.93 (vs. 1.75 with placebo) and 3.69 (vs. –0.79 with placebo), respectively. Researchers also reported percent changes from baseline in FeNO (–4.92 ppb vs. 0.11 ppb), magnitude of the bronchodilator response for FEV1 (–2.16 vs. 0.97) and FVC (–0.72 vs. 0.38) with fluticasone propionate vs. placebo.
One-fifth (21.3%) of those in the fluticasone propionate group had a clinically significant improvement in FEV1 (more than a 0.5 z score improvement), .Shannon Simpson, PhD, co-head of children’s lung health at Telethon Kids Institute and adjunct research fellow at Curtin University, Perth, Australia, said during the presentation.
In a univariable analysis, bronchodilator response at the first visit was a predictor of FEV1 z score change, with a greater than 12% response predicting participants who would experience an increased response to ICS (–1.86; 95% CI, –2.53 to –1.18; P < .001).
“We have shown that ICS treatment provides a modest improvement in lung function in those born prematurely, but there might be a subset of individuals that this treatment could be quite effective for,” Simpson said. “Further research is needed to predict who those children are, but it might be worthwhile starting with screening via bronchodilator response.”