Background:Asthma is the most common chronic illness among children in primary care, causing a significant burden. While nurse-led care has proven effective in secondary and tertiary care, its impact in primary care remains unclear. The aim of the present study was to evaluate the effectiveness of protocolled nurse-led care (PC) versus usual care (UC) on asthma control in children with asthma in primary care. Methods:This was a cluster randomised controlled trial with 18 months' follow-up including children aged 6-12 years with asthma in primary care. Children prescribed inhaled corticosteroids (ICS) at least once, or at least two short-acting β-agonist (SABA) prescriptions, or had at least one SABA prescription combined with an International Classification of Primary Care code for asthma or bronchial spasm within the past year were eligible for inclusion. Clusters were randomised to PC or UC. The primary outcome was change in Childhood Asthma Control Test (C-ACT) scores. Secondary outcomes included uncontrolled asthma rates, quality of life, exacerbations, spirometry and care satisfaction. Results:49 practices enrolled 90 patients (63.3% male, mean age 9.6 years, median C-ACT 23 (interquartile range 5.0)). 51 children received PC and 39 UC. C-ACT scores were consistently higher in the PC group, with significant differences at 6 (p=0.044), 12 (p=0.031) and 18 months (p=0.045). Median nurse review visits were 2 (range 0-6) per child. Conclusion:PC significantly improves asthma control in children aged 6-12 years in primary care, with a feasible number of nurse visits.