Asthma
Lauren Howell, PharmD
According to the results of a NEJM study from May 2025, as-needed use of albuterol-budesonide resulted in a lower risk of severe asthma exacerbation than use of albuterol alone, specifically among patients with uncontrolled mild asthma despite treatment.
“Pairing a bronchodilator with an inhaled steroid at the time of symptoms is a practical, guideline-concordant way to prevent bad days from becoming emergencies while cutting down on oral steroid bursts,” said Danielle Alm, PharmD, a pediatric clinical pharmacy specialist at Children’s Regional Hospital at Cooper University Healthcare in New Jersey, who was not involved with the research.
Benefits of a bronchodilator-inhaled steroid combination
Data supporting the as-needed use of albuterol-budesonide to lower the risk of severe asthma exacerbations in patients with moderate to severe asthma is well established.
However, researchers of the NEJM study set out to determine if the same benefit exists for patients with mild asthma. The primary endpoint was the first severe asthma exacerbation, assessed in a time-to-event analysis. Secondary endpoints included the annualized rate of severe asthma exacerbations and exposure to systemic glucocorticoids.
“As-needed albuterol-budesonide cut first severe exacerbations roughly in half versus as-needed albuterol alone, and substantially reduced annualized systemic steroid exposure,” said Alm, who is also associate professor of clinical pharmacy at the Philadelphia College of Pharmacy. “The trial was even stopped early for efficacy, which is unusual in mild asthma studies.”
The study was a fully virtual, decentralized, phase 3b, multicenter, double-blind, event-driven trial that included individuals 12 years and older with mild asthma that was uncontrolled despite treatment with a short-acting b-2 agonist (SABA) with or without a low-dose inhaled glucocorticoid or leukotriene-receptor antagonist.
The participants were randomly assigned 1:1 to either receive a fixed-dose combination of 180 µg of albuterol and 160 µg of budesonide or 180 µg of albuterol as-needed for up to 52 weeks.
A severe exacerbation occurred in 5.1% of the participants in the albuterol-budesonide group and in 9.1% of those in the albuterol group. The annualized rate of severe asthma exacerbations was lower with albuterol-budesonide (0.15) than with albuterol alone (0.32). The mean annualized total dose of systemic glucocorticoids was also lower in the albuterol-budesonide group, at 23.2 mg compared with 61.9 mg per year in the albuterol group.
Lori Ann Wilken, PharmD, clinical associate professor at Retzky College of Pharmacy in Chicago, said she was not particularly surprised by the results of the study.
“Inhaled corticosteroids are currently foundational in managing airway inflammation in asthma, even in mild cases,” said Wilken, who was not involved with the study. ”Their inclusion in rescue therapy reinforces the importance of addressing underlying inflammation rather than just bronchoconstriction.”
Wilken said she hopes that these data can be used to drive meaningful changes in prescribing practices and coverage policies to better support asthma management.
“In practice, awareness of the budesonide-albuterol combination is still growing among prescribers. Even when clinicians are informed and willing to prescribe it, insurance coverage remains a barrier,” she said.
Pharmacists can work to educate both patients and prescribers about the availability of and benefits of using inhaled corticosteroid-containing rescue inhalers.
“This advocacy can lead to more appropriate prescribing and better asthma control, especially in patients who might otherwise rely solely on albuterol,” said Wilken.
Biologics for asthma treatment
The shift to including inhaled corticosteroids in rescue therapy isn’t the only one happening in asthma treatment, though. Biologics are gaining traction for treatment of moderate to severe asthma, and these drugs even bring the possibility of remission, defined as no oral corticosteroid use and well-controlled symptoms.
Severe asthma is often driven by the immune system, and biologic drugs work by disrupting cells or blocking molecules that trigger inflammation and asthma symptoms. Instead of simply treating symptoms, biologics provide the opportunity to treat the underlying cause and improve lung function.
According to the American Academy of Allergy, Asthma, and Immunology, the benefits of biologics in patients with asthma include decreased frequency of asthma exacerbations, emergency department visits, hospitalizations, and oral steroid usage; reduced asthma symptoms, and dosage of controller medication; and improved quality of life, as well as lung function.
There are currently six biologics that are approved for use in asthma. They are either administered by S.C. injection or I.V. infusion. The mechanism of action, setting of administration, dosing interval, and asthma indications vary.
Biologics that are currently approved for asthma use in the United States include Xolair (omalizumab), Nucala (mepolizumab), Fasenra (benralizumab), Cinqair (reslizumab), Dupixent (dupilumab), and Tezspire (Tezepelumab-ekko).
Single maintenance and reliever therapy
The use of a single inhaler for both maintenance and reliever therapy can be viewed as another change in asthma management.
Wilken said that despite its longstanding endorsement in GINA guidelines, uptake of inhaled corticosteroid-formoterol as both maintenance and reliever therapy has been slow but is finally gaining traction.
Single maintenance and reliever therapy (SMART) combines an inhaled corticosteroid to treat inflammation and formoterol, a long-acting b-2 agonist (LABA), to help open up the lungs. These inhalers are used both daily to prevent asthma exacerbations and as a reliever when symptoms of an exacerbation begin.
Both Symbicort (budesonide/formoterol) and Dulera (mometasone/formoterol) are combination inhalers that include an inhaled corticosteroid and formoterol and are approved by FDA for use in the United States. Although there are other LABAs on the market, they should not be used for SMART therapy due to a slower onset of action than that of formoterol.
“Adherence improves when treatment aligns with how patients already behave,” said Alm. “A single as-needed inhaler that couples relief with anti-inflammation meets patients at the moment they reach for help, often better than a separate daily controller they may skip when feeling fine.”
The role of the pharmacist
“Pharmacists are in a key position to bridge the gap between evidence and practice,” said Wilken.
While trends in prescribing may take time to catch up with guideline recommendations, pharmacists can help to close this gap by advocating for patients by talking to their prescribers and taking time to educate patients when they come to the pharmacy.
“Every patient’s needs are unique, and insurance coverage can vary widely. Ensuring that each individual with asthma receives their inhaled corticosteroid in a device that is both preferred and covered is essential for optimizing adherence and outcomes,” said Wilken.
Wilken said pharmacists can also help to prevent hospitalizations and make a meaningful difference by spending just a few minutes to assess inhaler technique and reinforce its intended use. ■