In the first randomized controlled trial assessing a single 2‑in‑1 inhaler as the sole reliever for children aged 5 to 15, an international research group found the combined therapy more effective than salbutamol, the standard quick‑relief medication for pediatric asthma, with no new safety concerns.
Using an inhaler that delivers both the inhaled corticosteroid budesonide and the fast‑acting bronchodilator formoterol reduced the average number of asthma attacks in children by 45 % compared with the commonly used salbutamol inhaler.
Asthma attacks in children can be life‑threatening, so lowering their frequency and severity is a public health priority.
While adults routinely receive the 2‑in‑1 budesonide‑formoterol inhaler as their preferred reliever, children are still largely prescribed salbutamol.
The study, published in The Lancet, supplies the evidence needed to bring child asthma guidelines in line with those for adults, potentially benefiting millions of youngsters worldwide with mild‑to‑moderate asthma.
The CARE study (Children’s Anti‑Inflammatory REliever) was designed and led by the Medical Research Institute of New Zealand (MRINZ) in partnership with Imperial College London, University of Otago Wellington, Starship Children’s Hospital, and the University of Auckland. It enrolled 360 children across New Zealand who were then randomly assigned to receive either budesonide‑formoterol or salbutamol for on‑demand symptom relief.
Over one year, the budesonide‑formoterol reliever produced a lower rate of asthma attacks than the salbutamol reliever—0.23 versus 0.41 attacks per participant per year. In practical terms, replacing salbutamol with the 2‑in‑1 budesonide‑formoterol inhaler would reduce about 18 attacks per 100 children with mild asthma each year. Crucially, the trial confirmed the safety of the combined approach: no significant differences were found in growth, lung function, or overall asthma control between the groups.
Dr. Lee Hatter, lead author and Senior Clinical Research Fellow at MRINZ, noted: “This study bridges the evidence gap between adult and child asthma management. It shows that a budesonide‑formoterol 2‑in‑1 inhaler, used as needed, significantly lowers attacks in children with mild asthma. The findings can improve outcomes for children worldwide.”
Professor Richard Beasley, Director of MRINZ and senior author, added: “Implementing these results could transform global asthma care. Demonstrating the superiority of budesonide‑formoterol over salbutamol in preventing attacks in children offers a clear direction for worldwide guidelines.”
The high prevalence of asthma—affecting an estimated 113 million children and adolescents globally—makes these findings especially important. Prior adult studies led by MRINZ researchers shaped international guidelines that now recommend the 2‑in‑1 inhaler as the preferred reliever for adults. Integrating the CARE study outcomes into global strategies could reduce care disparities and broaden access to evidence‑based treatments for children.
Authors highlight that health organizations have long urged child‑specific asthma interventions; their results now provide the critical evidence to support such initiatives.
Limitations noted include the trial’s conduct during the COVID‑19 pandemic, when strict public‑health measures and lower circulating respiratory viruses likely reduced severe asthma attacks. Challenges in identifying attacks in children and the lack of blinding may introduce bias. Nonetheless, the pragmatic, real‑world design lends confidence that the findings apply to routine practice.
Professor Andrew Bush, Senior Respiratory Pediatrician at Imperial College London and co‑author, commented: “An asthma attack can deeply frighten children and parents. Showing that the budesonide‑formoterol inhaler significantly reduces attacks—and is safe for mild asthma children—represents a major advance. We look forward to building on this work through the upcoming CARE UK study.”
Professor Helen Reddel, Chair of the Science Committee of the Global Initiative for Asthma (GINA), emphasized: “Asthma attacks have profound effects on a child’s physical, social, and emotional development. Prevention is a top priority. In children, it is essential to shift from symptom‑only relief to therapies that also prevent attacks.”
Professor Bob Hancox, Medical Director of the New Zealand Asthma and Respiratory Foundation, stated: “This study is vital for children with mild asthma. While we already knew the 2‑in‑1 inhaler works better for adults, it had not been tested in kids. The research confirms it is effective and safe for ages 5 and up, easing the burden for both children and families.”