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Albuterol-budesonide reduces asthma exacerbations better than albuterol

Presented by
Prof. Reynold Panettieri Jr., Rutgers University, NJ, USA
Conference
ATS 2025
Trial
Phase 3, BATURA
New data from the phase 3b BATURA trial demonstrated that the anti-inflammatory reliever combination albuterol-budesonide reduced the risk of severe asthma exacerbations by 47%, compared with albuterol alone, in patients aged 12 years and older with intermittent or mild persistent asthma.

The BATURA trial (NCT05505734), a multicentre, decentralised study presented by Prof. Reynold Panettieri Jr. (Rutgers University, NJ, USA) at ATS 2025 and simultaneously published in the New England Journal of Medicine, enrolled 2,516 participants (97.2% adults) and randomised them 1:1 to receive as-needed combined albuterol-budesonide or albuterol for up to 52 weeks [1,2]. The primary endpoint of time to first severe exacerbation was met with strong statistical significance. The combination of albuterol-budesonide reduced the risk of severe exacerbations by 47% (5.1% vs 9.1%; HR 0.53; 95% CI 0.39–0.73; P<0.001). This effect was consistent regardless of baseline controller use or exacerbation risk, confirming efficacy across the spectrum of mild asthma.

Secondary endpoints supported these results. The annualised rate of severe exacerbations was halved in both the ≥12 and ≥18 years subgroups. The combination of albuterol-budesonide also led to a 63% reduction in exposure to systemic corticosteroids in adults (23.0 mg/year vs 63.0 mg/year; P<0.001), an important finding given the risks of even short bursts of corticosteroids, including diabetes, depression, and cardiovascular disease.

Prof. Panettieri pointed to the importance of a rescue therapy that both relieves symptoms and treats underlying inflammation, offering protection without the burden of daily controller use, especially relevant as many patients with mild asthma do not adhere consistently to maintenance regimens. Up to 30% of severe asthma events and deaths occur in patients with so-called mild asthma, underscoring the hidden danger of this disease category.

Safety outcomes in BATURA showed no clinically meaningful differences between treatment groups. While fewer than 3% of participants were aged 12–17, limiting generalisability in adolescents, further data is expected from the ongoing ACADIA study (NCT06307665).

The findings align with updated recommendations from the Global Initiative for Asthma, which now endorses as-needed anti-inflammatory reliever therapy as the preferred approach in mild asthma. Tonya Winders, President of the Global Allergy and Airways Patient Platform (GAAPP), echoed this point: “Using an anti-inflammatory reliever therapy can transform every use of a rescue inhaler into an opportunity for early intervention to address the underlying inflammation of asthma.”

With its ability to unite symptom relief and anti-inflammatory action, the combination of albuterol-budesonide represents a clinically meaningful advancement that could redefine the role of rescue medication in asthma management.

  1. Panettieri R, et al. Efficacy Of As-needed Albuterol‒budesonide Versus Albuterol On Systemic Corticosteroid Exposure In Participants With Mild Asthma: BATURA Prespecified Analysis. Abstract 1002, ATS International Conference, 16–21 May 2025, San Francisco, CA, USA.
  2. LaForce C, et al. N Engl J Med. 2025 May 19.

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