Both components of albuterol-budesonide combo contribute to lung function efficacy in mild-to-moderate asthma

This study (DENALI) addressed the US Food and Drug Administration Combination Rule requiring combination products to demonstrate each component's contribution to safety or efficacy.

The question is, Do Albuterol and budesonide contribute to the efficacy of an albuterol-budesonide combination of pressurized metered-dose inhalers in asthma patients?

The study design could be summarised as follows:

• 1001 Patients aged ≥ 12 years were randomised with mild-to-moderate asthma 1:1:1:1:1.
• These were randomized for 12 weeks to four times daily albuterol-budesonide 180/160 μg or 180/80 μg, albuterol 180 μg, budesonide 160 μg, or placebo.
• Nine hundred eighty-nine patients were evaluable for efficacy.
• Over 12 weeks, Change from baseline in FEV1 AUC0-6h was greater with albuterol-budesonide 180/160 μg vs budesonide 160 μg.
• At week 12, the Change in trough FEV1 was greater with albuterol-budesonide 180/160 and 180/80 μg vs (compared to) albuterol 180 μg.
• There were similarities in Day 1 time to onset and duration of bronchodilation with albuterol-budesonide and Albuterol.
• The albuterol-budesonide adverse event profile was similar to those of the monocomponents.

They finally interpreted that Both monocomponent contributed to albuterol-budesonide lung function efficacy. This was well tolerated, even at regular, relatively high daily doses for 12 weeks. There were no new safety findings.

Finally, they wrote, "The use of Albuterol-budesonide as a novel rescue therapy is supportable."

Bond Avillion 2 Development LP funded the trial.

Further reading:

Albuterol-Budesonide Pressurized Metered Dose Inhaler in Patients With Mild-to-Moderate Asthma

https://journal.chestnet.org/article/S0012-3692(23)00463-4/fulltext