Ann Am Thorac Soc 2021 May 12. Epub 2021 May 12.
Woolcock Institute of Medical Research, University of Sydney, Dept of Respiratory Medicine, Royal Prince Alfred Hospital, Sidney, New South Wales, Australia.
Rationale: The SYGMA studies evaluated the efficacy and safety of as-needed budesonide-formoterol (BUD-FORM) in patients whose asthma was uncontrolled on as-needed inhaled short-acting bronchodilators (Subgroup 1) or controlled on inhaled corticosteroid (ICS) or leukotriene receptor antagonist (Subgroup 2).
Objective: To assess the influence of pre-study treatment in a post hoc analysis of the SYGMA studies.
Methods: In the SYGMA 1 (NCT022149199) and SYGMA 2 (NCT02224157) 52-week, double-blind, randomized, parallel-group studies, 6,735 mild asthma patients were randomized to as-needed BUD-FORM, low-dose budesonide + as-needed terbutaline (BUD maintenance), or as-needed terbutaline (SYGMA 1 only). Read More