Findings from a first-of-its-kind virtual trial in pulmonary medicine, conducted at Rutgers and many other institutions, suggest adding an inhaled corticosteroid to rescue therapy could sharply reduce the danger of severe attacks for millions of people with mild asthma.
The phase III study, published Wednesday in The New England Journal of Medicine and presented at the American Thoracic Society meeting, tested Airsupra, a fixed-dose inhaler that combines the anti-inflammatory steroid budesonide with the muscle relaxant albuterol. (Albuterol alone is currently the standard rescue therapy after asthma attacks.)
Researchers randomly assigned 2,421 trial patients to use either this combination therapy or albuterol alone after asthma attacks and found that 5.1% of Airsupra users and 9.1% of albuterol-only users suffered the sort of severe exacerbation that required hospitalization or other immediate medical care.
"That's a big reduction that could greatly increase quality-of-life for people with mild asthma," said Reynold Panettieri, an investigator involved in the study and vice chancellor for translational medicine and science at Rutgers. "It could also produce cost savings by avoiding hospital visits and eliminating the need for many patients to take daily treatments."
The fully remote trial was the first of its kind in pulmonary medicine. Participants signed up online, received inhalers by courier and met investigators via telehealth appointments up to a year to save travel time and costs.
Panettieri said this "innovative" trial design will make many future trials faster and cheaper.
"Because people don't have to schlep into a clinic, this decentralized design was cheaper and more accessible," he said. "That gave us a faster way to show that treating the inflammation every time patients reach for relief can prevent hospitalizations."
In addition to halving the risk of a first severe attack, Airsupra reduces the annualized exacerbation rate by 53% and trimmed systemic steroid exposure by 63%, potentially sparing patients from diabetes, fractures and other complications linked to repeated oral steroid courses. Adverse-event rates were comparable between groups. Most side effects were routine respiratory infections.
Airsupra won U.S. approval last year for treating adults with moderate to severe asthma. The new data cover adolescents as young as 12 and the roughly half of asthma patients classified as mild who still account for up to 30% of exacerbations and deaths. Global guidelines already discourage albuterol-only rescue because it does nothing to calm airway inflammation.
With publication in a top journal and a high-profile conference debut, Panettieri said he expects insurers and prescribers to move quickly.
"This can change 50 years of practice," he said.
