Albuterol-Budesonide Pressurized Metered Dose Inhaler in Patients With Mild-to-Moderate Asthma: Results of the DENALI Double-Blind Randomized Controlled Trial.

ABSTRACT:

Background

In the phase 3 MANDALA trial, as-needed albuterol-budesonide pressurized metered-dose inhaler significantly reduced severe exacerbation risk vs as-needed albuterol in patients with moderate-to-severe asthma receiving inhaled corticosteroid-containing maintenance therapy. This study (DENALI) was conducted to address the US Food and Drug Administration combination rule, which requires a combination product to demonstrate that each component contributes to its efficacy.

Research question

Do both albuterol and budesonide contribute to the efficacy of the albuterol-budesonide combination pressurized metered-dose inhaler in patients with asthma?

Study design and methods

This phase 3 double-blind trial randomized patients aged ≥ 12 years with mild-to-moderate asth

SUBMITTER: Chipps BE 

PROVIDER: S-EPMC11898224 | biostudies-literature | 2023 Sep

REPOSITORIES: biostudies-literature