Sethi 2010.

Study characteristics
Methods	Design: randomised, double‐blind, placebo‐controlled, parallel‐group design Duration: 48 weeks Location: multi‐centre study across 15 countries in the USA
Participants	Population: 1149 adults with COPD (GOLD stage ≥ 2) were randomly assigned to moxifloxacin (n = 569) or placebo (n = 580) Baseline characteristics: age (mean years): 66 (SD 8.9); % male (mean): 74; % FEV₁ predicted (mean): 41 (SD 16); pack‐years (mean): 53 (SD 30); exacerbation history: not reported Inclusion criteria: severity of COPD was GOLD stage ≥ 2; had ≥ 2 exacerbations requiring treatment with antibiotics and/or oral steroids in the 12 months before enrolment Exclusion criteria: known hypersensitivity to treatment antibiotic or other quinolones; history of tendon disease/disorder; known congenital or documented‐acquired QT prolongation; hypokalaemia; clinically relevant bradycardia; clinically relevant heart failure with reduced ventricular ejection fraction; previous history of symptomatic arrhythmias; concomitant use of any antiarrhythmics class IA or class III; neuroleptics; certain antihistamines; post‐menopausal women (< 1 year); not using acceptable birth control; any known disease with life expectancy < 24 months; severe hepatic impairment; used investigational drug in the last 30 days; known bronchial carcinoma; pulmonary tuberculosis; cystic fibrosis; documented chronic bronchial asthma; diffuse bronchiectasis; part of pulmonary rehabilitation programme; history of chronic colonisation of resistant pathogenic organisms (moxifloxacin); systemic/inhaled antibiotic therapy during 6 weeks before screening and any long‐term antibiotic use; home ventilatory support; tracheostomy; inability to attend on specified visit dates
Interventions	Moxifloxacin (400 mg daily for 5 days, treatment repeated every 8 weeks for total of 6 courses) Placebo Allowed co‐medications: nearly all participants had concomitant medications. Long‐acting bronchodilators and inhaled steroids (any adjustment to medication was a reason to exclude the participant from the per‐protocol population)
Outcomes	Frequency of exacerbations, number of people with exacerbations, hospitalisations, mortality, quality of life (SGRQ), change in lung function, seriousadverse events
Notes	Funding: Bayer HealthCare AG Identifier: NCT00473460
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Randomisation was done but sequence generation was not well explained
Allocation concealment (selection bias)	Unclear risk	This was not explained
Blinding of participants and personnel (performance bias) All outcomes	Low risk	This was a double‐blind study
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	This was not explained
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	All outcome data were described using a CONSORT diagram for the entire study However data on the secondary outcome: HRQoL ‐ reported loss to follow‐up of 12% in the prophylactic antibiotic arm and 10% in the placebo arm. Reasons for missing data pertaining to HRQoL outcome were not given
Selective reporting (reporting bias)	Low risk	All pre‐specified outcomes were well described
Other bias	Low risk	No other bias was identified