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. 2024 Aug 23:17:801-811.
doi: 10.2147/JAA.S471134. eCollection 2024.

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

Craig LaForce  1 , Frank C Albers  2 , Mark Cooper  3 , Anna Danilewicz  4 , Lynn Dunsire  3 , Robert Rees  4 , Christy Cappelletti  5
Affiliations

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

Craig LaForce et al. J Asthma Allergy. .

Abstract

Purpose: Decentralized clinical trials, where trial-related activities occur at locations other than traditional clinical sites(eg participant homes, local healthcare facilities), have the potential to improve trial access for people for whom time and/or distance constraints may impede participation. Albuterol-budesonide 180/160 µg pressurized metered-dose inhaler (pMDI) is FDA approved for the as-needed treatment or prevention of bronchoconstriction and to reduce the risk of exacerbations in patients with asthma 18 years or older. BATURA (NCT05505734) is a fully decentralized study, investigating as-needed albuterol-budesonide in participants with mild asthma.

Methods: BATURA is a fully decentralized, phase 3b, randomized, double-blind, event-driven exacerbation study conducted in the United States. Participants aged ≥12 years using as-needed short-acting β2-agonist (SABA), alone or with low-dose inhaled corticosteroid or leukotriene receptor antagonist maintenance, are randomized 1:1 to as-needed albuterol-budesonide 180/160 µg or albuterol 180 µg pMDI for up to 52 weeks (minimum 12 weeks). Participants continue their current maintenance therapy, if applicable. Participants must have used SABA for ≥2 days in the 2 weeks pre-enrollment and have an Asthma Impairment Risk Questionnaire score ≥2 at screening and randomization. All trial-related visits, including screening and consent, are conducted virtually, with study medication shipped directly to each participant's residence. The primary 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.

Keywords: SABA–ICS; albuterol–budesonide; decentralized clinical trials; trial design.

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Conflict of interest statement

CL has received industry-initiated research funding (eg clinical trials) in the past 24 months from Amphastar, AstraZeneca, Avillion, Chiesi, Chugai Pharmaceutical, Cipla, DawnLight, Eli Lilly & Co, GlaxoSmithKline, Kanyos Bio, Knopp Biosciences, Mako Medical Labs, Novartis, Satsuma Pharmaceuticals, Teva, Theravance, UCB Biopharma, and Vorso, and acted as a consultant for AstraZeneca. FCA, AD, and RR are employees of Avillion. CC, MC, and LD are employees of and hold stock in AstraZeneca. The authors report no other conflicts of interest in this work.

Figures

Figure 1
Figure 1
Overview of trial design.
Figure 2
Figure 2
Bringing the study from the research site to the participant’s home: decentralized components of BATURA.
Figure 3
Figure 3
Study endpoints.
See this image and copyright information in PMC

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