BDP/F | BUD/F | |
Randomised | n = 109 | n = 110 |
SAF | n = 109 | n = 109One patient had no evidence of drug intake (randomised and immediately withdrawn, the diary card was not filled in) |
ITT | n = 107Two patients had no post-baseline data for the primary efficacy variable | n = 109 |
m-ITT | n = 107 | n = 109 |
PP | n = 103: four patients excludedTwo patients due to an increase >20% in PEF at visit 2 with respect to visit 1Two patients had a time window >5 days between the last two visitsOne patient had no intake of salbutamol for >5 days during the run-in period | n = 99: 10 patients excludedFour patients due to an increase >20% in PEF at visit 2 with respect to visit 1Three patients due to poor compliance with study medicationTwo patients had no intake of salbutamol for >5 days during the run-in periodOne patient due to significant and unreliable discrepancies between pulmonary function tests, i.e. FEV1 and PEF, monitored daily by patients and measured at sitesOne patient due to study drug exposure <2 weeks |
BDP/F: beclomethasone/formoterol; BUD/F: budesonide/formoterol; SAF: safety population; ITT: intention-to-treat population; m-ITT: modified ITT; PP: per-protocol population; PEF: peak expiratory flow; FEV1: forced expiratory volume in one second. Patients can have more than one reason for exclusion.