Airsupra (albuterol/budesonide), formerly known as PT027, has been 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.
The approval by the
Airsupra is a first-in-class, pressurised metered-dose inhaler (pMDI), fixed-dose combination rescue medication containing albuterol, a short-acting beta2-agonist (SABA), and budesonide, an anti-inflammatory inhaled corticosteroid (ICS) in the US. It is being developed by
Asthma is a chronic, inflammatory respiratory disease with variable symptoms that affects as many as 262 million people worldwide.3 In the US over 21 million adults have asthma, representing more than 80% of the total number of people with asthma.4 Adults have 8.5 million exacerbations each year in the US.4 Uncontrolled asthma will cost the US economy an estimated
The safety and tolerability of Airsupra in both trials were consistent with the known profiles of the components,1,2 with the most common adverse events including headache, oral candidiasis, cough and dysphonia.6
Results from the MANDALA trial were published in the
Notes
Asthma
Asthma is a chronic, inflammatory respiratory disease with variable symptoms that affects as many as 262 million people worldwide,3 including over 25 million in the US.4
Patients with asthma experience recurrent breathlessness and wheezing, which varies over time, and in severity and frequency.7 These patients are at risk of severe exacerbations regardless of their disease severity, adherence to treatment or level of control.8,9
There are an estimated 136 million asthma exacerbations globally per year,10 including more than 10 million in the US;4 these are physically threatening and emotionally significant for many patients11 and can be fatal.3,12
Inflammation is central to both asthma symptoms8 and exacerbations.13 Many patients experiencing asthma symptoms use a SABA (e.g. albuterol) as a rescue medicine;14-16 however, taking a SABA alone does not address inflammation, leaving patients at risk of severe exacerbations,17 which can result in impaired quality of life,18 hospitalisation19 and frequent oral corticosteroid (OCS) use.19 Treatment of exacerbations with as few as 1-3 short courses of OCS are associated with an increased risk of adverse health conditions including type 2 diabetes, depression/anxiety, renal impairment, cataracts, cardiovascular disease, pneumonia and fracture.20 International recommendations from the Global Initiative for Asthma no longer recommend SABA alone as the preferred rescue therapy.7
MANDALA, DENALI and the CREST (Combination REliever STudies) programme
The CREST clinical trial programme studied the efficacy and safety of PT027 and included the MANDALA,1,21,22 DENALI2,23,24 and TYREE25 Phase III trials.
MANDALA1,21,22 was a Phase III, randomised, double-blind, multicentre, parallel-group, event-driven trial evaluating the efficacy and safety of Airsupra compared to albuterol on the time to first severe asthma exacerbation in 3,132 adults, adolescents, and children (aged 4-11 years) with moderate to severe asthma taking ICS alone or in combination with a range of asthma maintenance therapies, including long-acting beta2-agonists (LABA), leukotriene receptor antagonists (LTRA), long-acting muscarinic antagonists (LAMA) or theophylline. The trial comprised a two-to-four-week screening period, at least a 24-week treatment period and a two-week post-treatment follow-up period.
Patients were randomly assigned to one of the following three treatment groups in a 1:1:1 ratio: Airsupra 180/160mcg (excluding children aged 4-11 years), albuterol/budesonide 180/80mcg or albuterol 180mcg, taken as an as-needed rescue medicine. Airsupra and the albuterol comparator were delivered in a pMDI using
Results from the positive MANDALA Phase III trial showed that Airsupra demonstrated a statistically significant reduction in the risk of a severe exacerbation versus albuterol rescue in patients with moderate to severe asthma.1,22 Compared with albuterol rescue, Airsupra at the 180mcg albuterol/160mcg budesonide dose reduced the risk of a severe exacerbation by 27% (p
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