Findings from a first-of-its-kind virtual trial in pulmonary medicine suggest that adding an inhaled corticosteroid to rescue therapy could significantly reduce the risk of severe asthma attacks for millions of people with mild asthma.
The phase III study, published in The New England Journal of Medicine and presented at the American Thoracic Society meeting, tested Airsupra, a fixed-dose inhaler combining the anti-inflammatory steroid budesonide with the muscle relaxant albuterol. Researchers found that only 5.1% of Airsupra users experienced severe exacerbations requiring hospitalization or immediate medical care, compared to 9.1% of patients using albuterol alone, the current standard rescue therapy.
"That's a big reduction that could greatly increase quality-of-life for people with mild asthma," said Dr. 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."
Pioneering Virtual Trial Design
The study marked a significant innovation in clinical research methodology as the first fully remote trial in pulmonary medicine. The 2,421 participants enrolled online, received their inhalers via courier service, and met with investigators through telehealth appointments for up to a year.
This decentralized approach eliminated the need for patients to travel to clinical sites, making participation more accessible while reducing costs and accelerating the research timeline.
"Because people don't have to schlep into a clinic, this decentralized design was cheaper and more accessible," Panettieri explained. "That gave us a faster way to show that treating the inflammation every time patients reach for relief can prevent hospitalizations."
Comprehensive Benefits Beyond Preventing Severe Attacks
The study revealed multiple benefits of the combination therapy beyond halving the risk of a first severe attack. Airsupra reduced the annualized exacerbation rate by 53% and decreased systemic steroid exposure by 63%, potentially sparing patients from diabetes, fractures, and other complications associated with repeated oral steroid courses.
Safety data showed comparable adverse event rates between the two treatment groups, with most side effects being routine respiratory infections.
Implications for Mild Asthma Patients
While Airsupra received U.S. approval last year for treating adults with moderate to severe asthma, these new findings extend its potential benefits to adolescents as young as 12 and the approximately 50% of asthma patients classified as having mild disease. Despite their "mild" classification, these patients still account for up to 30% of exacerbations and deaths related to asthma.
The results align with global guidelines that already discourage albuterol-only rescue therapy because it addresses bronchospasm but does nothing to calm the underlying airway inflammation that drives asthma attacks.
Future Impact on Treatment Protocols
With publication in a leading medical journal and presentation at a high-profile conference, Dr. Panettieri anticipates rapid adoption of the findings by insurers and healthcare providers. The combination of strong efficacy data and the innovative trial methodology positions this research to potentially transform both asthma treatment protocols and the future of clinical trial design in respiratory medicine.
The study demonstrates that treating inflammation concurrently with bronchodilation during acute symptoms can significantly improve outcomes for asthma patients, potentially establishing a new standard of care for rescue therapy in asthma management.
