Yao 2014.
| Methods |
Design: 26‐week, multi‐centre, randomised, double‐blind, placebo‐controlled, parallel‐group trial. Participants were recruited from Austalia, China and India, and were predominantly of Asian ethnicity. Intention‐to‐treat analysis was performed Run‐in: washout of LABAs and LAMAs of 2 days and 7 days, respectively |
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| Participants |
Population: 563 participants of predominantly Asian ethnicity were randomly assigned from Australia, China and India. Mean age was 65.4 years. Theophylline was allowed to be continued. 34% to 35% of participants were taking concomitant inhaled corticosteroids. Mean FEV1 was 49% to 50% predicted across all groups Mean age: Indacaterol 150 mcg 66.2 years, indacaterol 300 mcg 65.5 years, placebo 64.6 years Inclusion criteria: Adults > 40 years with at least a 10‐pack‐year smoking history FEV1/FVC < 70%, FEV1 < 80% and > 29% Exclusion criteria: lower respiratory tract infection or hospitalisation with an acute exacerbation of COPD within the previous 6 weeks, requirement for long‐term oxygen therapy, asthma, any alternative significant cardiovascular or respiratory disease, type 1 or poorly controlled type 2 diabetes, history of long QT syndrome or prolonged QTc, a history of vaccination with live attenuated vaccines within the previous 30 days or during the run‐in period |
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| Interventions | 1. Indacaterol 150 mcg 2. Indacaterol 300 mcg 3. Placebo |
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| Outcomes |
Primary outcome: trough FEV1 at 12 weeks Secondary outcomes: trough FEV1 at other time points, TDI and SGRQ at weeks 8, 12, 26, daily symptoms and rescue medication use |
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| Notes | Novartis‐sponsored trial | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Method of randomisation was not specified |
| Allocation concealment (selection bias) | Low risk | Not specified, but both interventions and placebo via identical inhalers; probably done |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Participants, caregivers, investigators all blinded to treatment allocations; probably done |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Outcomes assessors blinded to treatment allocations; probably done |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Slightly greater proportion of participants discontinued in placebo arm; main difference was loss to follow‐up and unsatisfactory therapeutic effect in placebo arm |
| Selective reporting (reporting bias) | Low risk | Prespecified outcomes reported |
6MWD: 6‐minute walk distance; AUC: area under the curve; BODE: body mass index, obstruction, dyspnoea, and exercise; COPD: chronic obstructive pulmonary disease; FEV1: forced expiratory volume in 1 second; FVC: forced vital capacity; GOLD: Global Initiative for Chronic Obstructive Lung Disease; ICS: inhaled corticosteroid; IRT: interactive response technology; LABA: long‐acting beta2‐agonist; LAMA: long‐acting muscarinic agonist; SGRQ: St George's Respiratory Questionnaire; TDI: Transitional Dyspnoea Index.