Efficacy of inhaled salbutamol with and without prednisolone for first acute rhinovirus-induced wheezing episode

Abstract

<h3>Background</h3><p>Acute rhinovirus-induced wheezing is common in young children and may respond to systemic corticosteroid. There are no trials on the efficacy of inhaled beta₂-agonist in this clinical scenario.</p><h3>Objective</h3><p>To study <em>post hoc</em> the short-term (up to 2 months) efficacy of inhaled beta₂-agonist with and without oral corticosteroid in the first acute rhinovirus-induced severe wheezing episode in young hospitalized children.</p><h3>Methods</h3><p>The study population came from two randomized controlled trials comparing oral prednisolone (2 mg/kg/d for 3 days) to placebo: Vinku (<em>n</em> = 35, NCT00494624) used high-dose regular nebulized salbutamol (0.15 mg/kg 2–4 h intervals) and Vinku2 (<em>n</em> = 60, NCT00731575, EudraCT 2006-007100-42) used inhaled salbutamol on-demand. Both studies used identical detailed follow-up assessments. The primary outcome of the former was the duration of hospitalization and of the latter the occurrence of and the time to a new physician-confirmed wheezing episode within 2 months after discharge. Treatment groups included salbutamol high-dose vs. salbutamol on-demand while adjusting for prednisolone status and acknowledging for interactions with exception of the duration of hospitalization in which prednisolone groups could not be fully used due to protocol differences.</p><h3>Results</h3><p>Median age of subjects was 13 months, 32% were sensitized and 22% had doctor-diagnosed eczema. In the duration of hospitalization, salbutamol high-dose/placebo versus salbutamol on-demand/placebo groups did not differ (<em>p</em> = .12). In the occurrence of and time to relapse within 2 months, a significant group × treatment interaction was observed (both <em>p</em> = .02), such that high-dose group had less and longer time to relapses than on-demand group in prednisolone arm (both <em>p</em> < .05), but no difference was detected in placebo arm (both <em>p</em> > .26).</p><h3>Conclusions</h3><p>In young, hospitalized children with first episode of rhinovirus-induced wheezing, high-dose inhaled salbutamol may interact with oral prednisolone. However, further trials are warranted.</p>