According to the Asthma and Allergy Foundation, about a 25 million population comprising children and adults in the United States (US) suffer from asthma. A recent study has shown that patients who used a novel combination of two drugs substantially lowered their risks of acute asthma attacks.
Standard maintenance treatment of asthma involves taking an inhalant that combines two drugs, a long-acting beta(β)2-agonist such as benralizumab and a corticosteroid such as beclomethasone. When patients suffer an asthma attack, they usually use a rescue drug such as albuterol. They are also often prescribed oral corticosteroids. Physicians are looking to prescribe oral corticosteroids less frequently due to their powerful adverse effects.
The Phase 3 clinical trial known as the MANDALA trial comprised >3,000 asthma patients from 295 sites throughout the US, South America, and Europe, and was designed to evaluate the safety profile and efficacy of a combination of albuterol and budesonide (both developed by AstraZeneca), for managing patients with moderate to severe asthma.
The trial participants were divided into three groups. With many patients already on daily maintenance therapeutic regimens for asthma, the individuals were given either of the three different rescue therapies, should they suffer from an asthma attack, that included a combination of albuterol with either a high dose of budesonide or a lower dose of budesonide. The control group was only given albuterol. Albuterol is a short-acting β2-agonist that works by attaching to the beta receptor proteins in the human airways and relaxing the airway muscles. Budesonide, being a corticosteroid, reduces inflammation and swelling in the airway tissues.
The study findings showed that the asthmatic patients not only had improved pulmonary function, they also suffered from fewer attacks of asthma. Scientists also found that treatment with albuterol with a higher dose of budesonide lowered the risk of an asthma attack by 27% in the short term and decreased asthma attacks by 24% per year. The novel drug combination also lowered corticosteroid use by 33%, which can otherwise have several adverse effects in the body.
The study author Reynold Panettieri Jr., Professor of Medicine at Rutgers Robert Wood Johnson Medical School, said, “This represents a paradigm shift in the treatment of asthma. We see this combination treatment, which is the first of its kind, as becoming part of standard therapy,”
Panettieri, who is also the Director of the Rutgers Institute for Translational Medicine and Science and conducts research at the Child Health Institute of New Jersey said, “With this new inhaler that delivers more inhaled steroids every time patients take the rescue therapy, they’re getting more at a time when they’re having a flare-up and when they need it. We showed that, beyond decreasing their exacerbations, it decreased their need for oral steroids after a flare-up.”
The trial findings, published in The New England Journal of Medicine, have demonstrated that a combination of albuterol—a drug that provides relief from asthma attacks by causing smooth muscle relaxation, and is used for rapid relief from asthma attacks—and a corticosteroid when taken together via an inhaler, decrease the number of instantaneous episodes of wheezing, coughing and shortness of breath, which can otherwise land patients in emergency care settings, and in a few cases, even lead to death.
Papi A, Chipps BE, Beasley R, et al. Albuterol–Budesonide fixed-dose combination rescue inhaler for asthma. NEJM. 2022. doi: 10.1056/NEJMoa2203163