A two-in-one inhaler cut asthma attacks in children by nearly half compared with the standard “blue” salbutamol inhaler, according to a real-world clinical trial in New Zealand.
Published in The Lancet, the study is the first randomized controlled trial to test a combined anti-inflammatory reliever — a single inhaler with budesonide (a preventer steroid) and formoterol (a fast-acting airway opener) — as the only rescue treatment for children aged 5 to 15. The researchers report a 45% average reduction in attacks with no extra safety concerns, a result they say should bring children’s asthma guidance in line with adults’.
“This is a key step in addressing the evidence gap that exists between asthma management in adults and children. For the first time, we have demonstrated that the budesonide-formoterol 2-in-1 inhaler, used as needed for symptom relief, can significantly reduce asthma attacks in children with mild asthma. This evidence-based treatment could lead to improved asthma outcomes for children worldwide,” said Dr Lee Hatter, Senior Clinical Research Fellow at the Medical Research Institute of New Zealand (MRINZ).
Today, many children are still prescribed salbutamol for quick relief, even though adult guidelines in many countries already recommend the budesonide–formoterol inhaler. With an estimated 113 million young people living with asthma worldwide, narrowing this gap could have a broad impact on health and day-to-day life.
The CARE study enrolled 360 children across New Zealand and randomly assigned them to use either the budesonide–formoterol inhaler or the salbutamol inhaler whenever they had symptoms. Over a year, the combined inhaler group had 0.23 attacks per child versus 0.41 with salbutamol. Put another way, for every 100 children switched to the two-in-one inhaler, there would be 18 fewer attacks each year. The team also tracked safety closely. They found no meaningful differences between groups in growth, lung function, or overall asthma control.
“Implementing these findings could be transformative for asthma management on a global scale. The evidence that budesonide-formoterol is more effective than salbutamol in preventing asthma attacks in children with mild asthma has the potential to redefine the global standard of asthma management,” said Professor Richard Beasley, Director of MRINZ.
The authors note some caveats. The trial took place during the COVID-19 pandemic, when masking and fewer circulating viruses likely made severe attacks less common than usual. Because the study compared two visible inhalers, participants and clinicians knew which treatment they were using, which can introduce bias. Identifying attacks in children can also be challenging. Even so, the researchers designed the trial to reflect day-to-day care, which makes the results easier to apply in clinics.
“Having an asthma attack can be very scary for children and their parents. I’m so pleased that we’ve been able to prove that an inhaler that significantly reduces attacks – already a game-changer for adults – is safe for children with mild asthma too. We believe this will transform asthma care worldwide and are excited to be building on this work with the CARE UK study,” said Professor Andrew Bush, Imperial College London.
The Lancet DOI: 10.1016/S0140-6736(25)00861-X
