Decentralized Asthma Trial Participant Enrollment Case Study

This case study outlines the collaborative effort between Avillion, AstraZeneca, and Velocity in conducting a multicenter, randomized, double-blind, parallel group, event-driven, decentralized Phase III study known as BATURA. The study aimed to compare the efficacy of PT027 (Budesonide/Albuterol) with PT007 (Albuterol) in adolescents and adults aged 12 and older who have asthma. The target population included individuals treated with short-acting beta-agonists alone, low-dose inhaled corticosteroids plus short-acting beta-agonists, or leukotriene modifiers plus short-acting beta-agonists. The enrollment goal for the trial was set at 2,500 participants globally, with Velocity tasked to enroll 569 participants across 14 sites in the U.S. The case study details how Velocity successfully enrolled 604 participants, surpassing its target by 106%, and highlights the efficiency of decentralized trial support. The positive results from the trial led to plans for future collaborations between Avillion and Velocity.