Figure 1
From: Appropriate use of inhaled corticosteroids in COPD: the candidates for safe withdrawal
INSTEAD: Non-inferiority of indacaterol to SFC in trough FEV1 at week 12 in patients with moderate COPD (FEV1 50–80% predicted) and no exacerbations for >1 year prior to study entry28. LSM treatment differences and 95% CI between indacaterol and SFC in trough FEV1 at week 12. In non-inferiority testing, the null hypothesis is that the new therapy (here, ICS withdrawal) is inferior to the current therapy (ICS continuation).59 This is disproved and non-inferiority established if the efficacy of the new therapy does not exceed the predetermined non-inferiority margin when compared with the current therapy. The dotted line indicates the non-inferiority margin of −60 ml. CI, confidence interval; ICS, inhaled corticosteroid; LSM, least-squares mean; FAS, full analysis set; FEV1, forced expiratory volume in 1 s; PPS, per-protocol set (primary analysis); q.d., once daily; SFC, salmeterol/fluticasone propionate. Reproduced with permission of the European Respiratory Society.60
