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 |
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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 |
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Interventions | 1. Indacaterol 150 mcg 2. Alternative twice‐daily beta2‐agonist |
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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 |