To 2011.
| Methods | Design: randomised, parallel‐group, open‐label study Duration: 12 months Location: Japan | |
| Participants |
Population: 186 participants were randomised to salmeterol (61) and indacaterol (125) Baseline characteristics ‐ for whole population only Age (mean years): 69.1 % Male: not reported % FEV1 predicted: 53 Pack‐years (mean): not reported Inclusion criteria: patients with moderate‐to‐severe COPD (post‐bronchodilator FEV1/FVC <70% and FEV1 >30% to <80% predicted) and smoking history of at least 20 pack‐years Exclusion criteria: not reported, abstract only |
|
| Interventions | 1. Salmeterol 50 bid (LABA) 2. Indacaterol 300 qd (LABA) Inhaler device: unclear Allowed co‐medications: not described |
|
| Outcomes | trough FEV1, TDI and safety assessments | |
| Notes | Funding: Novartis Identifier(s): unknown | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Patients meeting inclusion criteria were randomised in the ratio 2:1 to indacaterol and salmeterol (methods not described) |
| Allocation concealment (selection bias) | Unclear risk | no details |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Both treatments were administered open‐label |
| Blinding of outcome assessment (detection bias) All outcomes | High risk | Both treatments were administered open‐label |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Unclear, abstract only |
| Selective reporting (reporting bias) | High risk | Data could not be included in meta‐analysis, only abstract available |