A Combined Budesonide–Formoterol Inhaler Cuts Asthma Attacks by About Half

By Morgan Nwanguma

A Combined Budesonide–Formoterol Inhaler Cuts Asthma Attacks by About Half

By Morgan Nwanguma

A major international study has found that a combined budesonide–formoterol inhaler is significantly more effective than the standard salbutamol inhaler in children with mild asthma, cutting asthma attacks by nearly half.

The trial — the first randomized controlled study to test a 2-in-1 reliever inhaler as the sole treatment for children aged 5 to 15 — showed that the budesonide–formoterol inhaler offered superior protection without additional safety risks. The treatment merges an inhaled corticosteroid (budesonide) with a fast-acting bronchodilator (formoterol), offering both anti-inflammatory and rapid symptom relief in one device.

Compared with the widely used salbutamol inhaler, the combined inhaler reduced the average rate of asthma attacks by 45%. Researchers emphasize that this finding could transform how mild childhood asthma is managed worldwide, aligning pediatric treatment guidelines with those already established for adults.

Asthma attacks in children can be life-threatening, and reducing their frequency remains a major public health goal. Despite the 2-in-1 inhaler being the preferred reliever for adults, salbutamol is still commonly prescribed for children.

Published on September 27 in The Lancet, the CARE (Children’s Anti-inflammatory REliever) study provides strong evidence for updating pediatric asthma care. The trial was led by the Medical Research Institute of New Zealand (MRINZ) in collaboration with Imperial College London, the University of Otago Wellington, Starship Children’s Hospital, and the University of Auckland.

A total of 360 New Zealand children with mild asthma participated, each randomly assigned to receive either the budesonide–formoterol or salbutamol inhaler for on-demand relief over a one-year period. Results showed that the combined inhaler group had a lower annual rate of asthma attacks — 0.23 compared with 0.41 per participant. In practical terms, for every 100 children switched to the budesonide–formoterol inhaler, 18 asthma attacks could be prevented each year.

Importantly, the study found no significant differences in growth, lung function, or overall asthma control between the two groups, confirming the safety and effectiveness of the 2-in-1 approach.

Dr Lee Hatter, lead author of the research as well as Senior Clinical Research Fellow at the MRINZ, stated: “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.”

Professor Richard Beasley, Director of MRINZ and senior author of the study, said: “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.”

Asthma places a heavy burden on the estimated 113 million children and adolescents affected worldwide. The new findings build on earlier research in adults, also led by the Medical Research Institute of New Zealand (MRINZ), which helped shape international asthma treatment guidelines. Those earlier studies were instrumental in establishing the combined inhaled corticosteroid–formoterol (ICS–formoterol) inhaler as the preferred reliever treatment for adults with asthma globally.

Incorporating results from the CARE study into international asthma care strategies could help close treatment gaps and ensure that more children receive effective, evidence-based therapy. The researchers note that global health organizations have long called for targeted asthma interventions for children, and their findings offer vital support for those efforts.

The authors acknowledge several limitations. The trial took place during the COVID-19 pandemic, when public health restrictions and reduced circulation of respiratory viruses likely contributed to fewer severe asthma attacks than expected. They also note the difficulties of accurately identifying asthma attacks in children and the potential bias introduced by the lack of treatment blinding. Nonetheless, they emphasize that the study’s pragmatic, real-world design strengthens its relevance and applicability to everyday clinical practice.

Professor Andrew Bush, from Imperial College London, senior respiratory pediatrician and co-author of the CARE study, said: “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.”

Professor Helen Reddel, Chair of the Science Committee of the Global Initiative for Asthma (GINA), made a comment regarding the global significance of the study, stating that it fills a critically important gap for asthma management worldwide. Professor Reddel said: “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.”

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. This research shows that this 2-in-1 inhaler is effective and safe for children as young as 5. This information will help to reduce the burden of asthma for many children, and both they and their families will breathe easier because of it.”

Research main points:

1. The CARE study is the first randomized controlled trial to compare the effectiveness of an ICS–formoterol anti-inflammatory reliever inhaler with a salbutamol reliever inhaler in children aged 5 to 15 years with asthma.

2. Treatment with budesonide–formoterol led to a significant reduction in asthma attacks — a 45% lower rate compared to salbutamol (0.23 vs. 0.41 attacks per participant per year; relative rate 0.55, 95% CI 0.35–0.86, p=0.01).

3. These results align with well-established findings in adults, where the ICS–formoterol inhaler is already the preferred reliever therapy for asthma management.

4. The study reported no safety concerns associated with using the combined inhaled corticosteroid treatment in children, showing no negative effects on growth or lung function.

5. Overall, the findings provide strong evidence that replacing a salbutamol reliever with a budesonide–formoterol inhaler can significantly reduce asthma attacks in children with mild asthma — even as young as five years old — and could drive a global shift in pediatric asthma care.

The research project was facilitated through the big-hearted support of the Health Research Council of New Zealand, Cure Kids (New Zealand), as well as the Barbara