As-needed albuterol-budesonide reduces risk for severe asthma exacerbations
Click Here to Manage Email Alerts
Key takeaways:
- BATURA showed a 47% reduction in severe exacerbation risk with albuterol budesonide vs. albuterol in patients with mild asthma.
- The study was done virtually to expand access and reduce patient burden.
BOSTON — Patients with mild asthma lowered their severe exacerbation risk by almost half by using as-needed albuterol-budesonide, according to data presented at the American College of Allergy, Asthma & Immunology Annual Scientific Meeting.
“The BATURA trial was planned to assess the reduction in risk of a severe exacerbation in people with intermittent or mild persistent asthma,” Monica Kraft, MD, professor of medicine and system chair for the department of medicine at Mount Sinai Health System and the Icahn School of Medicine, told Healio. “The results from BATURA add to the body of evidence supporting an anti-inflammatory rescue approach for reducing the risk of exacerbations across all asthma severities.”
The double-blind, fully virtual, randomized, phase 3b, event-driven BATURA study included participants aged 12 years or older who had mild asthma and used as-needed short-acting beta-2 agonists (SABA) and/or low-dose inhaled corticosteroids (ICS)/leukotriene modifiers to manage their symptoms.
The 2,421 participants (mean age, 42.7 years; 68.3% female; 70.1% white) were randomly assigned 1:1 to a pressurized metered-dose inhaler with either as-needed albuterol budesonide (ALB-BUD; n = 1,209) 180 µg/160 µg or as-needed albuterol (ALB; n = 1,212) 180 µg for 12 to 52 weeks.
Data were collected on severe exacerbation risk, which the researchers measured as time to first severe exacerbation, defined as an ED or urgent care visit (requiring systemic corticosteroids), hospitalization, death or an exacerbation that required 3 days or more of systemic corticosteroid use.
The ALB-BUD group had a reduced risk for severe exacerbation of 47% compared with the ALB group (HR = 0.535; 95% CI, 0.392-0.73).
Also, the annualized severe exacerbation rate was 53% lower and the total systemic corticosteroid dose was 63% lower for the ALB-BUD group compared with the ALB group (P < .001 for both).
The safety profiles for both groups were generally comparable as well, the researchers said.
“While albuterol is effectively alleviating symptoms, it does not address the underlying inflammation,” Kraft said. “An albuterol-budesonide combination addresses both airway inflammation and airway tightening. This dual action provides immediate symptom relief and inflammation control, leading to better overall asthma management.”
Kraft further explained that inflammation in the airway is present even in mild asthma, and many would benefit from an anti-inflammatory medication such as ALB-BUD. She said that currently, patients with mild asthma experience symptoms unpredictably and manage them primarily with an increased SABA, which does not address underlying inflammation and increases risk for an asthma exacerbation.
BATURA was AstraZeneca’s first patient-centric, fully decentralized clinical trial for asthma and enabled a large population of patients to participate from home by removing the need for clinic visits, according to Kraft.
“The independent data monitoring committee recommended the trial stop early due to overwhelming efficacy, based on a pre-planned interim analysis,” she said.
Kraft highlighted that study results build on the clinical body of evidence supporting a treatment paradigm shift toward an anti-inflammatory rescue approach and that publication of the full BATURA trial results are planned.
“The overwhelming efficacy of the BATURA trial is an important step to revolutionize rescue therapy in the U.S.,” she said.