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. 2015 Jan 10;2015(1):CD010139. doi: 10.1002/14651858.CD010139.pub2

Izbicki 2014.

Methods Design: 12‐week multi‐centre, randomised, open‐label study comparing indacaterol versus alternative long‐acting beta2‐agonists for patients whose current treatment regimen included a twice‐daily long‐acting beta2‐agonist
Run‐in: not stated
Participants Population: 90 participants. Mean age 65 years. Predominantly male participants
Inclusion criteria: diagnosis of chronic obstructive pulmonary disease (COPD) (moderate to severe as classified by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines, 2007); postbronchodilator forced expiratory volume in 1 second (FEV1) < 80% and ≥ 30% of predicted normal value; postbronchodilator FEV1/FVC (forced vital capacity) < 70%; current COPD bronchodilator treatment includes a LABA bronchodilator or a fixed‐dose combination of LABA and inhaled corticosteroid (ICS)
Exclusion criteria: history of asthma; currently receiving treatment for COPD with tiotropium; diabetes Type I or uncontrolled diabetes Type II; history of certain cardiovascular co‐morbid conditions
Interventions 1. Indacaterol 150 mcg
2. Alternative twice‐daily beta2‐agonist
Outcomes Primary outcome: change in health‐related quality of life as measured by COPD clinical questionnaire
Notes Trial sponsored by Novartis
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Currently available in abstract format only; method of random sequence generation not stated
Allocation concealment (selection bias) High risk Open‐label study
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Open‐label study
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Method of blinding of outcome assessment was unclear
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Similar rates of dropout were noted across both study arms
Selective reporting (reporting bias) Low risk Only one primary outcome has been reported