AstraZeneca (AZ) and Avillion have shared positive results from a phase 3b trial of their inhaled anti-inflammatory rescue medication in asthma patients aged 12 years and older.
Airsupra (albuterol/budesonide) demonstrated a statistically significant and clinically meaningful reduction in the risk of severe exacerbations when used as an as-needed rescue medication compared to albuterol alone, meeting the trial’s primary endpoint.
The BATURA study included patients with intermittent or mild persistent asthma, including those receiving a short-acting beta2-agonist (SABA) alone, low-dose inhaled corticosteroid maintenance therapy, or leukotriene receptor antagonist maintenance therapy.
Results also showed that the safety and tolerability of Airsupra was consistent with its established profile, and an independent data monitoring committee recommended that the trial should end early due to “overwhelming efficacy” at the pre-planned analysis, the partners said.
Affecting up to 262 million people worldwide, asthma is a long-term inflammatory disease that can cause symptoms such as recurrent breathlessness and wheezing, and a tight chest.
Patients remain at risk of severe exacerbations regardless of their disease severity, adherence to treatment or level of control, with an estimated 136 million asthma exacerbations occurring globally every year.
Those experiencing asthma symptoms often use a SABA, such as albuterol, as a rescue medicine. However, the companies outlined that taking a SABA alone does not address inflammation, leaving patients at risk of severe exacerbations.
In January 2023, Airsupra became the first and only anti-inflammatory rescue medication to be approved in the US for the as-needed treatment or prevention of bronchoconstriction and to reduce the risk of exacerbations in people with asthma aged 18 years and older.
Sharon Barr, executive vice-president, biopharmaceuticals research and development at AZ, said the latest results for the treatment “add to the body of evidence supporting Airsupra as a first-in-class rescue treatment and its role in reducing the risk of asthma exacerbations in patients regardless of their disease severity, and reducing the need for systemic corticosteroids”.
The new data will now be shared with health authorities and will be presented at this year’s American College of Allergy, Asthma and Immunology Annual Scientific Meeting.