A Fully Decentralized Randomized Controlled Study of As-Needed Albuterol–Budesonide Fixed-Dose Inhaler in Mild Asthma: The BATURA Study Design.

Autor: LaForce, Craig, Albers, Frank C, Cooper, Mark, Danilewicz, Anna, Dunsire, Lynn, Rees, Robert, Cappelletti, Christy
Předmět:
Zdroj: Journal of Asthma & Allergy; Aug2024, Vol. 17, p801-811, 11p
Abstrakt: Objective is to evaluate the efficacy of as-needed albuterol–budesonide versus albuterol on severe asthma exacerbation risk, measured by time-to-first severe asthma exacerbation (primary endpoint). Secondary endpoints include annualized rate of severe asthma exacerbation and total systemic corticosteroid exposure. Study medication use is captured via a Hailie sensor attached to the study medication pMDI. The intended sample size is 2500 participants. Conclusion: BATURA evaluates as-needed albuterol–budesonide in participants with mild asthma. The decentralized study model enables the trial to move out of research sites into participant homes, reducing participant burden and improving access. [ABSTRACT FROM AUTHOR]
Databáze: Complementary Index