Lee 2014.
| Methods | Design: multi‐centre, randomised, parallel‐group, open‐label study |
| Participants | 578 participants with COPD. Mean age: 67 years, 96% male |
| Interventions | Following a 14‐day run‐in period during which participants received tiotropium 18 mcg once daily, participants were randomised to BUD/FORM 160/4.5 mcg 2 inhalations twice daily + tiotropium 18 mcg once daily (BUD/FORM+T), or tiotropium alone (18 mcg once daily), for 12 weeks |
| Outcomes |
Primary endpoint: ratio of treatment period mean to baseline in pre‐dose FEV1 Secondary outcomes: post‐dose FEV1, pre‐dose FVC, post‐dose IC, pre‐dose PEF, use of reliever medication, change in COPD symptoms, COPD exacerbations |
| Notes |
BUD: budesonide
COPD: chronic obstructive pulmonary disease
FEV1: forced expiratory volume in one second
FORM: formoterol
FVC: forced vital capacity
IC: inspiratory capacity
LABA: long‐acting beta‐agonists
PEF: peak expiratory flow
T: tiotropium