Efficacy and safety of aclidinium bromide/formoterol fumarate fixed-dose combinations compared with individual components and placebo in patients with COPD (ACLIFORM-COPD): a multicentre, randomised study

Table 1 Timeline of study assessments

^aRandomisation visit; ^bTwo sets of manoeuvres were performed during the hour pre-morning-dose; ^cOne set of manoeuvres was performed at 0.5, 1, 2, and 3 hours post-morning-dose; ^dAn additional set of manoeuvres was performed at 5 minutes post-morning-dose; ^eBDI was used at Day 1, TDI at all other visits; ^fEXACT was completed every evening; ^gNT and EM symptoms were recorded every morning; ^hAdditional spirometry measurements at 4, 6, 8, 10, and 12 hours post-morning-dose were performed in a sub-set of patients; ⁱBlood samples were taken pre-morning-dose; ^jECG and blood pressure were measured pre- and 2-hours post-morning-dose; ^k24-hour Holter recordings were started from 5 minutes pre-dose on the morning prior to these visits.
AE, adverse event; BDI, Baseline Dyspnoea Index; COPD, chronic obstructive pulmonary disease; ECG, electrocardiogram; EM, early morning; EXACT, EXAcerbations of Chronic obstructive pulmonary disease Tool; NT, night-time; SGRQ, St George’s Respiratory Questionnaire; TDI, Transition Dyspnoea Index.

ISSN: 1471-2466