Anti-Inflammatory Reliever Treatment Reduces Underlying Disease Process In Adults With Asthma

Adults with mild-to-moderate asthma who take regular inhaled corticosteroids can achieve greater control of airway inflammation by also using the 2-in-1 combination budesonide-formoterol as a reliever inhaler, according to a new study from the Medical Research Institute of New Zealand (MRINZ), published today in The Lancet Respiratory Medicine.

The INFORM ASTHMA trial, led by Dr Jonathan Noble, principal investigator and MRINZ Research Fellow, enrolled 181 adults taking maintenance inhaled corticosteroids (ICS). The study compared the 2-in-1 budesonide-formoterol reliever with terbutaline, a short-acting reliever. Over 26 weeks, participants using budesonide-formoterol showed a 20% reduction in fractional exhaled nitric oxide (FeNO), a key marker of airway inflammation, the underlying disease process in asthma.

“This is the first randomised controlled trial to show that adults taking regular scheduled maintenance inhaled corticosteroids can safely use budesonide-formoterol as a reliever to directly reduce airway inflammation, the underlying disease process in asthma” says Dr Noble, “FeNO is an indicator of airway inflammation and a predictor of asthma exacerbations.”

Higher FeNO levels mean more inflammation in the airways within the lungs, which can lead to a greater risk of asthma attacks. Reducing FeNO shows that the treatment is addressing the underlying disease process in asthma, not just relieving symptoms. The trial also showed that the anti-inflammatory effect was achieved within 13 weeks and was sustained for the six-month duration of the study. Lung function and symptom control were similar between the two groups, adverse events were comparable, and serious events were rare and unrelated to the study medication.

“This approach empowers patients to better manage their asthma on a day-to-day basis,” Dr Noble adds. “It’s simple and effective, while also potentially reducing long-term risks and asthma attacks.”

“Budesonide-formoterol reliever therapy is well known to reduce the risk of asthma attacks compared with traditional short acting relievers such as salbutamol or terbutaline, whether taken alone in mild asthma or alongside maintenance ICS/long-acting reliever therapy in severe asthma,” says Professor Richard Beasley, MRINZ Director.

“What this study adds is that budesonide-formoterol reliever directly reduces airway inflammation— the underlying disease process — in patients with mild to moderate asthma on maintenance ICS. This is the remaining piece of the jigsaw puzzle that now provides evidence that budesonide/formoterol reliever-based regimens have superior efficacy and safety profile across all asthma severities.”

These findings provide a real-world, evidence-based option for clinicians. Budesonide-formoterol reliever is a safe, effective treatment that complements maintenance ICS therapy and supports patients in taking control of their asthma.

“This is one of a series of important New Zealand-led studies showing that anti-inflammatory reliever therapy achieves better asthma control than traditional approaches to treatment. Patients can guide their own treatment and use their inhalers more efficiently to suppress airway inflammation despite using lower doses than traditional treatment,” says Professor Bob Hancox (University of Otago and Medical Director of the Asthma and Respiratory Foundation), who was not involved in the study.

With support from the Health Research Council of New Zealand and AstraZeneca, the INFORM ASTHMA trial adds to the growing evidence supporting patient-centred anti-inflammatory reliever strategies and aligns with international recommendations to prioritise 2-in-1 combination inhalers over short acting reliever therapy. It represents the fifth in a series of landmark randomised controlled clinical trials from the MRINZ, reporting the efficacy and safety of budesonide-formoterol reliever therapy-based treatments in children, adolescents, and adults.

STUDY LINK HERE: https://www.thelancet.com/journals/lanres/article/PIIS2213-2600(25)00327-3/abstract

STUDY KEY POINTS

1. Adults with mild-to-moderate asthma on maintenance ICS experienced a 20% reduction in FeNO — a marker of airway inflammation —with budesonide/formoterol reliever compared with the short-acting terbutaline reliever. This effect was rapid, appearing by 13 weeks, and was sustained for the 26-week duration of the study.
2. Maintenance ICS is a widely used, inexpensive therapy, making it important to determine the optimum reliever strategy to accompany its use. This is the first RCT showing that budesonide-formoterol reliever is effective in patients on maintenance ICS without a concomitant long-acting beta-agonist, filling a key evidence gap. This provides doctors and patients with clear evidence to guide safer and more effective asthma treatment.
3. The reduction in FeNO suggests that this therapeutic approach will be associated with a decreased risk of future exacerbations and lung function decline.
4. The number of adverse events was similar between budesonide-formoterol and terbutaline, with no safety concerns identified.

Biographies

Dr Jonathan Noble, Senior Clinical Research Fellow, Medical Research Institute of New Zealand (MRINZ)

Jonathan Noble, BSc (Hons), MBBS, MRCP (London), is an advanced trainee in respiratory medicine. He graduated with a BSc degree from Imperial College London and a medical degree from Bart’s and the London. His research interests include evidence-based medicine and the translation of clinical research into practice. He is the Principal Investigator for the INFORM ASTHMA Trial, a clinical trial examining the effect of anti-inflammatory reliever inhalers on airway inflammation in adults with mild-to-moderate asthma.

Professor Richard Beasley, Director, Medical Research Institute of New Zealand (MRINZ)

Richard Beasley, MBChB, MD, FRCP, FRACP, DSc, CNZM, is a physician at Wellington Regional Hospital, Director of the Medical Research Institute of New Zealand, Professor of Medicine at Victoria University of Wellington, and Visiting Professor, University of Southampton, United Kingdom. He was awarded the 2024 Rutherford Medal by the Royal Society Te Apārangi for revolutionising the treatment of asthma worldwide.

Professor Bob Hancox, Research Professor, University of Otago,
New Zealand

Bob Hancox, MBChB, BSc, MD, FRACP, is a Respiratory Physician at Waikato Hospital and Research Professor at the University of Otago. He is currently the Medical Director of the Asthma Foundation of New Zealand and a member of both the NZ Asthma Guidelines and NZ COPD Guidelines working groups.

About the Medical Research Institute of New Zealand

Rangahautia Te Ora
The Medical Research Institute of New Zealand (MRINZ) is New Zealand’s leading independent medical research institute. MRINZ research is guided by a simple philosophy: it must challenge dogma, increase knowledge, and have the potential to improve clinical practice and outcomes, both in New Zealand and internationally. Committed to contributing toward a more equitable society that celebrates Te Ao Māori and upholds Te Tiriti o Waitangi, MRINZ’s research teams are dedicated to investigating important public health problems, delivering high-quality evidence on which to improve the management of disease and patient care.

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