Methods	Study design: this was a 52-week, randomised, multicentre, parallel-group, open-label, evaluator-blinded study conducted at 27 clinical sites in South America
Participants	Population: 404 adults (> 12 years of age) with persistent asthma Baseline characteristics: mean age 36 years, FEV1 77% predicted, all had received ICS (with or without LABA) for at least 12 weeks Inclusion criteria: patients included in the study were 12 years or older, diagnosed with persistent asthma of ≥12 months, had a forced expiratory volume in 1 second (FEV1) ≥50% predicted values, received medium- or high-dose ICS with or without LABA for ≥12 weeks before screening, and were on a stable regimen for >= 2 weeks before screening. Additional inclusion criteria were evidence of β2-reversibility (increase in FEV1 of ≥ 12% and ≥ 200 mL within 10 to 15 minutes of SABA use); normal electrocardiogram (ECG), clinical laboratory tests, and chest radiograph; and adequate contraceptive precautions for women of childbearing age Exclusion criteria: patients were excluded if they demonstrated a change > 20% in FEV1; required use of >12 inhalations of SABA or two nebulised treatments with 2.5 mg salbutamol on 2 consecutive days at any time between the screening and baseline visits; experienced a clinically judged deterioration (deterioration resulting in emergency treatment, hospitalisation, or treatment with additional asthma medication other than SABA); had intraocular pressure ≥22 mmHg in either eye, glaucoma or evidence of cataract(s) at screening; was a current smoker (had smoked within the previous year) or ex-smoker (> 10 pack-years); received emergency treatment for airway obstruction in the past 3 months; or suffered a respiratory infection within 2 weeks before screening
Interventions	1. Mometasone/formoterol 100/5 (n = 141) or 200/5 (n = 130) μg 2 puffs twice daily 2. Fluticasone/salmeterol 125/25 (n = 68) or 250/25 (n = 65) μg 2 puffs twice daily Delivered by MDI and spacers were not permitted. Dose allocated according to previous ICS use of the participant
Outcomes	Primary outcome: adverse events
Notes	Sponsored by Merck and Co. Two deaths occurred (electrocution and gastric cancer) and these were both in mometasone/formoterol 200/10 group (see FDA report at www.fda.gov/downloads/Drugs/.../UCM224593.pdf
Risk of bias
Bias	Authors’ judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	No details
Allocation concealment (selection bias)	Unclear risk	No details
Blinding of participants and personnel (performance bias) All outcomes	High risk	Open label
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Evaluator blinded
Incomplete outcome data (attrition bias) All outcomes	Low risk	Over 80% completed study in each arm
Selective reporting (reporting bias)	Unclear risk	Mortality details obtained from FDA report
Independent Outcome Assessment Asthma-related serious adverse events	High risk	Not reported