AstraZeneca study shows early budesonide benefits

Budesonide is an inhaled corticosteroid delivered by dry powder inhaler to children with mild persistent asthma. It is an active ingredient in AstraZeneca’s Pulmicort products.

The findings are from two analyses of a three-year trial, named START, involving nearly 2,000 children aged five to ten years with mild persistent asthma.

In the first analysis, 1,974 children were randomized to receive either once-daily budesonide or placebo in addition to usual asthma care. The earlier use of budesonide reduced the risk of severe asthma related events by 40% compared to usual asthma care. In addition, children in the budesonide group required fewer interventions with other inhaled corticosteroids (12.3% versus 22.7% for placebo), and had improved lung function.

The second analysis tracked the adverse side effects reported by 1,981 children taking either budesonide plus usual care or placebo over three years. Overall, the incidence of side effects was comparable between the two groups, with fewer asthma exacerbations and adverse events reported in the budesonide group throughout the study (budesonide 43.8%; usual care 42.8%).

“Many children with asthma make repeated trips to the emergency room or are hospitalized because of worsening symptoms,” said Dr Albert Sheffer, clinical professor of medicine at Harvard Medical School, director emeritus at the Allergy Clinic, Brigham and Women’s Hospital in Boston and an investigator in the safety and tolerability portion of the study. “The findings of these two analyses showed that budesonide had a viable long-term treatment effect.”