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Safety of As-Needed Budesonide-Formoterol in Mild Asthma: Data from the Two Phase III SYGMA Studies by J. Mark FitzGerald; Paul M. O’Byrne; Eric D. Bateman; Peter J. Barnes; Jinping Zheng; Stefan Ivanov; Rosa Lamarca; Ulrika Larsdotter; Ulrika Emerath; Gerreke Jansen; Margareta Puu; Vijay K. T. Alagappan; Filip Surmont; Helen K. Reddel is a Medicine article available to read on EtoBox.
What is Safety of As-Needed Budesonide-Formoterol in Mild Asthma: Data from the Two Phase III SYGMA Studies about?
## Introduction Budesonide-formoterol taken as needed is an emerging treatment for mild asthma. ## Objective We used data from the SYGMA studies to assess the safety of As-needed budesonide-formoterol compared with As-needed terbutaline and compared with maintenance budesonide. ## Methods SYGMA 1 and 2 were 52-week, double-blind, parallel-group studies in patients aged ≥ 12 years with physician-assessed mild asthma. Patients were randomized to As-needed budesonide-formoterol 200/6 μg, twice-daily budesonide 200 μg as maintenance plus As-needed terbutaline 0.5 mg, and As-needed terbutaline 0.5 mg (SYGMA 1 only). Adverse events (AEs), serious AEs (SAEs), discontinuations due to AEs (DAEs), and study-defined asthma-related discontinuations from corresponding treatment groups in both studies were pooled. SYGMA 1 data were used for comparisons with As-needed terbutaline alone. ## Results The pooled analysis included 3366 patients in the As-needed budesonide-formoterol group and 3369 in the budesonide maintenance group, with AEs in 40.8% and 42.5% of patients, respectively. Common AEs included viral upper respiratory tract infection (viral URTI) and URTI. SAE, DAE, and asthma-related dis
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- Author
- J. Mark FitzGerald; Paul M. O’Byrne; Eric D. Bateman; Peter J. Barnes; Jinping Zheng; Stefan Ivanov; Rosa Lamarca; Ulrika Larsdotter; Ulrika Emerath; Gerreke Jansen; Margareta Puu; Vijay K. T. Alagappan; Filip Surmont; Helen K. Reddel
- Publisher
- Springer Science and Business Media LLC
- Published
- 2021
- Language
- EN
- Field
- Medicine (Health Sciences)