New 2-in-1 inhaler cuts asthma attacks in children by 45%

For many children, asthma can be a constant specter, with attacks at the most inconvenient and terrifying times. New research has now found that one inhaler containing two drugs can cut the risk of asthma attacks by almost half, giving hope to an estimated millions of families worldwide.

Asthma is the most prevalent long-term child illness, with around 113 million young people worldwide thought to be affected. The attacks can be fatal, so preventing them is as vital as alleviating them. Children have until now depended on salbutamol inhalers, which rapidly expand the airways but don't do much to stop swelling. Adults, though, have had access to a dual-acting inhaler that does both budesonide, a corticosteroid that minimizes swelling, and formoterol, an accelerator that rapidly opens the airways.

Up to this point, doctors had no clear indication that the same approach would work for children. All of that was revealed through evidence from the CARE study that reveals this 2-in-1 inhaler is not only safe but works for five-year-olds and younger.

The CARE study was undertaken by the Medical Research Institute of New Zealand with collaboration from Imperial College London, University of Otago Wellington, Starship Children's Hospital, and the University of Auckland. Researchers followed 360 New Zealand children aged between 5 and 15 years for a year.

Half of them were told to take the combined budesonide-formoterol inhaler every time they experienced symptoms. The control group utilized the standard salbutamol inhaler. At the end of the trial, children who took the 2-in-1 inhaler experienced a 45 percent reduction in the rate of asthma attacks compared to children receiving salbutamol.

Children on the combined inhaler, on average, experienced 0.23 attacks per year, while children on salbutamol experienced 0.41 attacks. Simply put, if 100 children made the change from salbutamol to the new alternative, 18 attacks would be prevented per year.

Equally as important, no other safety problems were found in the study. Side effect rates were effectively identical in both groups, and there were no differences in lung function, growth, or overall asthma control.

Dr. Lee Hatter, first author of the study and Senior Clinical Research Fellow at Medical Research Institute of New Zealand, called the results a breakthrough. "For the first time, we have demonstrated that the budesonide-formoterol 2-in-1 inhaler, used as needed for relief of symptoms, can markedly prevent asthma attacks in children with mild asthma," he explained. "This evidence-based treatment has the potential to lead to improved asthma outcomes in children globally."

Professor Richard Beasley, Director of the institute and lead author of the research, believes the findings have the capacity to revolutionize treatment globally. "The proof that budesonide-formoterol is more effective than salbutamol at preventing asthma symptoms in children who have mild asthma has the power to redefine the global standard of managing asthma," he said.

Experts in child health have described the research as a breakthrough. Dr Andrew Bush, a senior respiratory pediatrics consultant at Imperial College London and one of the researchers behind the study, said: "For parents and children, an asthma attack can be quite a terrifying experience. I am thrilled that we have been able to show that an inhaler that significantly halves attacks—a breakthrough in itself for adults—is safe for children with mild asthma too. We believe this will transform the management of asthma worldwide."

Professor Helen Reddel, Chair, Science Committee of the Global Initiative for Asthma, emphasized the broader implications. "Asthma attacks strongly impact children's physical, social and emotional health and asthma attack prevention is a key to asthma management. It is also during childhood that lifelong habits are established, such as the use of symptomatic medicines like salbutamol, which only prevent an asthma attack from happening but do not prevent asthma attacks from occurring," she said.

New Zealand Asthma and Respiratory Foundation Medical Director Professor Bob Hancox said the study fills a major gap. "This trial proves the 2-in-1 inhaler works and is safe in children as young as 5 years old. This development will make asthma more manageable for many children, and them, along with their families, will be able to breathe more easily as a result."

As with any clinical trial, this one was not without challenges. Given as it was during the COVID-19 pandemic, when the public health measures were strict, fewer respiratory viruses were in circulation. That likely reduced the number of bad asthma attacks scientists expected. Another challenge was distinguishing attacks accurately in children because the symptoms are so mixed. And because children and parents knew the test inhaler, there was a little bit of chance for bias.

Despite this, researchers emphasize that the trial's setup makes it extremely relevant to practice in the real world. By enrolling children from ordinary environments and observing them over an entire year, the researchers generated data that is immediately translatable to the management of asthma in real-world contexts beyond controlled laboratory settings.

Asthma remains a leading cause of missed school days, emergency department utilization, and hospitalizations among children worldwide. Making attacks less frequent would relieve that burden on families and health systems alike. The new findings build on earlier research in adults that reformed worldwide guidelines to incorporate budesonide-formoterol as a first-line reliever medication. With robust evidence now available in children, researchers argue that pediatric guidelines should be revised equally.

These are the monies that were gifted to carry out the CARE study by the Health Research Council of New Zealand, Cure Kids, and Barbara Basham Medical Charitable Trust. AstraZeneca also gifted the inhalers to be used in the study.

The CARE study has the potential to alter the way asthma in children is treated across the world. By proving that a single inhaler can both treat symptoms and prevent attacks, the study supports combining pediatric with adult recommendations.

If acted upon, millions of kids would benefit from experiencing fewer visits to emergency rooms, hospitalization, and disturbing their usual lifestyles. Parents would no longer worry about their children getting safer and more effective treatments.

For health systems, fewer severe attacks could mean lower expenditures and reduced strain on resources. Research also emphasizes the importance of developing child-specific trials as a means to close medical evidence gaps and avoid children being left behind in terms of treatment advancements.

Research findings are available online in the journal The Lancet.

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