Efficacy and safety of lebrikizumab in patients with uncontrolled asthma (LAVOLTA I and LAVOLTA II): Replicate, phase 3, randomised, double-blind, placebo-controlled trials

These were two replicate, randomized, double-blind trials designed to evaluate the efficacy and safety of lebrikizumab in 2149 patients with uncontrolled asthma despite treatment with standard-of-care medications. The primary endpoint was the rate of asthma exacerbations; secondary endpoints included change in pre-bronchodilator FEV1, time to first asthma exacerbation, rate of urgent asthma-related healthcare use, change in asthma-specific health-related QoL (assessed using the AQLQ), change in asthma rescue medication use, and change in asthma control (assessed using the ACQ). Patients measured PEF once daily using the Vitalograph In2itive e-Diary, with PEF values, rescue medication usage, and controller medication usage recorded on a daily basis.