Asthma · As-needed ICS with the reliever
Albuterol-Budesonide Fixed-Dose Combination Rescue Inhaler for Asthma
| Design | Multinational, phase 3, double-blind, event-driven RCT |
|---|---|
| Treatment | As-needed fixed-dose albuterol 180 microg with budesonide 160 microg or 80 microg |
| Control | As-needed albuterol 180 microg alone |
| Population | 3132 patients with uncontrolled moderate-to-severe asthma already on inhaled steroid-containing maintenance therapy |
| Follow-up | Event-driven, at least 24 weeks |
| Primary endpoint | Time to first severe asthma exacerbation |
| Result | Severe exacerbation risk 26% lower with the higher-dose combination than albuterol alone (HR 0.74, 95% CI 0.62 to 0.89, p=0.001). The lower-dose combination gave HR 0.84 (0.71 to 1.00, p=0.052). Adverse event rates were similar across all three groups. |
| Secondary endpoints | Severe exacerbation rate, systemic steroid exposure, adverse events |
The risk of severe asthma exacerbation was significantly lower with as-needed use of a fixed-dose combination of 180 μg of albuterol and 160 μg of budesonide than with as-needed use of albuterol alone among patients with uncontrolled moderate-to-severe asthma who were receiving a wide range of inhaled glucocorticoid-containing maintenance therapies.
The trial authors, in the published abstract
Extends the anti-inflammatory reliever principle of SYGMA 1 and SYGMA 2 to patients who stay on a separate maintenance inhaler, and to short-acting beta agonists rather than formoterol. Practically, it means the reliever itself is now a place to deliver steroid, whatever the maintenance regimen.
Papi A, Chipps BE, Beasley R, et al. Albuterol-Budesonide Fixed-Dose Combination Rescue Inhaler for Asthma. N Engl J Med 2022 Jun 2;386(22):2071-2083.