Breakthrough Study Finds 2-in-1 Combination Inhaler Close to Halves Childhood Asthma Attacks
A landmark clinical trial led by the Medical Research Institute of New Zealand (MRINZ) has found that a combination 2-in-1 asthma inhaler can reduce attacks in children by nearly half compared to salbutamol, the current global standard of care.
The findings, published today in The Lancet, come from the CARE trial (Children’s Anti-inflammatory REliever) — the first randomised controlled study to directly compare the two treatments in children aged 5-15.
For decades, children with asthma have been prescribed salbutamol, a reliever inhaler that relieves symptoms but does not prevent attacks. Adults, meanwhile, have benefited from updated global guidelines that recommend budesonide–formoterol, a combined anti-inflammatory and bronchodilator inhaler, as the preferred reliever.
The CARE trial’s results are striking. Children using budesonide–formoterol experienced a 45% reduction in asthma attacks compared with salbutamol. On average, there were 18 fewer attacks per 100 children per year when switched from salbutamol to the 2-in-1 inhaler. The treatment was found to be safe, with no differences in growth, lung function, or overall asthma control.
Dr Lee Hatter, Senior Clinical Research Fellow at MRINZ and lead author of the study, said, “This is a key step in addressing the evidence gap that exists between asthma management in adults and children…This evidence-based treatment could lead to improved asthma outcomes for children worldwide.”
Asthma is one of the most common chronic conditions in children, affecting an estimated 113 million young people globally. Attacks can be frightening, disruptive, and, in severe cases, life-threatening. Researchers believe the new findings provide the long-awaited evidence to align children’s asthma care with that of adults, offering better protection and quality of life.
Professor Richard Beasley, Director of MRINZ and senior author, says, “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.”
The trial involved 360 children across New Zealand and was conducted during the COVID-19 pandemic, under real-world conditions.
Professor Andrew Bush, from Imperial College London, senior respiratory paediatrician and co-author of the CARE study, says, “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.”
Professor Bob Hancox, Medical Director of the New Zealand Asthma and Respiratory Foundation, said, “This is a very important study for children with mild asthma. We have known for some time that 2-in-1 budesonide/formoterol inhalers are better than the traditional reliever treatment in adults, but this had not been tested in children.”
The CARE study was designed and led by MRINZ in collaboration with Imperial College London, University of Otago Wellington, Starship Children’s Hospital, and the University of Auckland. It was supported by the Health Research Council of New Zealand, Cure Kids, and the Barbara Basham Medical Charitable Trust.
Experts from the Global Initiative for Asthma (GINA) have already signalled that the study could help close critical evidence gaps and shape future updates to children’s asthma guidelines. Professor Helen Reddel, Chair of the GINA Science Committee, states, “Asthma attacks have a profound impact on children's physical, social and emotional development and their prevention is a high priority for asthma care. It is in childhood, too, that lifelong habits are established, particularly reliance on traditional medications like salbutamol that only relieve symptoms and don't prevent asthma attacks.”
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