This was a pooled analysis of two replicate, randomized, double-blind studies that evaluated the efficacy and safety of different doses of lebrikizumab versus placebo in 463 patients with moderate-to-severe asthma. The primary endpoint was the rate of exacerbations; secondary endpoints included change in pre-bronchodilator FEV1, time to first asthma exacerbation, AQLQ, asthma rescue medication usage, and urgent asthma-related healthcare use. Spirometry was performed using the Vitalograph Pneumotrac spirometer with Spirotrac software. Additionally, patients measured PEF once daily using the Vitalograph In2itive e-Diary, with PEF values, symptoms, and study drug usage recorded on a daily basis.
- Author Hanania N et al.
- Publication Thorax
- Year 2015
- Device Type In2itive e-Diary, Pneumotrac, Spirotrac