Il salbutamolo nella gestione del wheezing in età pediatrica

Wheezing is a frequent respiratory condition in early childhood that affects up to one third of children in the first three years of life and represents a common cause of primary care visits, Emergency Unit access and hospital admission. In Italy, the 2014 AIFA regulatory note introduced major restrictions on the use of inhaled salbutamol in children younger than 2 years, by limiting administration to pressurised metered-dose inhalers (MDI) with spacer and recommending lower doses than those suggested by the international guidelines, without differentiating between care settings or disease severity. This precautionary approach, based on limited and heterogeneous evidence, has generated an ongoing debate within the paediatric community. Evidence suggests that short-acting β2-agonists (SABA) may be effective in selected cases of acute bronchospasm in infants and young children, particularly in wheezing phenotypes suggestive of reversible airway obstruction. They are not indicated for isolated cough or viral upper respiratory infections, and are not recommended in bronchiolitis according to the international guidelines. Since 2024, shortages of salbutamol MDI in Italy and across Europe have further complicated this scenario and increased the risk of undertreatment. Recent evidence, including a meta-analysis of randomised controlled trials, supports the short-term safety of inhaled salbutamol in children under 2 years with acute wheezing, with no increase in serious adverse events and a more favourable safety profile with MDI compared with nebulisation. Overall, the current framework highlights a gap between regulatory constraints, clinical evidence, real-world practice and drug availability, and underscores the need for an evidence-based revision of existing recommendations.