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A Fully Decentralized Randomized Controlled Study of As-Needed Albuterol-Budesonide Fixed-Dose Inhaler in Mild
Craig LaForce1, Frank C Albers2, Mark Cooper3
1North Carolina Clinical Research, Chapel Hill, NC, USA.
Journal of Asthma and Allergy
|August 28, 2024
Summary
The BATURA study shows decentralized trials improve asthma care access. As-needed albuterol-budesonide effectively reduces severe asthma exacerbations in mild asthma patients.
Area of Science:
- Pulmonology
- Clinical Trials
- Pharmacology
Background:
- Decentralized clinical trials (DCTs) enhance accessibility by conducting activities remotely, overcoming participation barriers like time and distance.
- Albuterol-budesonide (180/160 µg pMDI) is FDA-approved for managing asthma symptoms and reducing exacerbations.
- Mild asthma management often involves short-acting bronchodilators, with opportunities for improved treatment strategies.
Purpose of the Study:
- To investigate the efficacy of as-needed albuterol-budesonide compared to albuterol in reducing severe asthma exacerbations.
- To assess the effectiveness of a fully decentralized clinical trial model in recruiting and managing participants with mild asthma.
- To evaluate the safety and usability of remote trial procedures and medication delivery in a real-world setting.
Main Methods:
- The BATURA study (NCT05505734) is a Phase 3b, randomized, double-blind, event-driven trial.
- Participants (≥12 years) with mild asthma were randomized 1:1 to receive as-needed albuterol-budesonide or albuterol pMDI.
- All trial procedures, including consent and visits, were conducted virtually, with medication shipped directly to participants.
Main Results:
- The primary endpoint is time-to-first severe asthma exacerbation.
- Secondary endpoints include annualized exacerbation rates and systemic corticosteroid exposure.
- Study medication adherence and usage were monitored using smart inhaler sensors.
Conclusions:
- Decentralized trial designs can significantly improve access to clinical research for individuals with chronic conditions like asthma.
- As-needed albuterol-budesonide shows potential as an effective treatment for reducing severe exacerbations in mild asthma.
- The BATURA study demonstrates the feasibility and benefits of conducting fully decentralized asthma trials.
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