Introduction and objectives FF/VI, the first once daily inhaled corticosteroid/long-acting ß2-agonist combination available for the treatment of asthma, has demonstrated a sustained 24 hour improvement in lung function and improvement in symptom-free 24 hour periods.

Methods Post-hoc analyses of diary card data from three Phase III studies were performed to examine whether there was an improvement in night-time awakening during the studies for those patients treated with the addition of vilanterol to fluticasone furoate. The diary card scale used is described below. Changes in night-time awakenings over the duration of the studies were analysed for percentage of patients with ≥50% symptom-free nights, including the time taken for 50% of patients to achieve 7 nights without symptoms.

Night-time Symptom Score:

0 = No symptoms during the night

1 = Symptoms causing me to wake once (or wake early)

2 = Symptoms causing me to wake twice or more (including waking early)

3 = Symptoms causing me to be awake for most of the night

4 = Symptoms so severe that I did not sleep at all

To be counted as symptom-free during the night the patient needed to record a score of 0.

Results The percentage of patients with ≥50% symptom-free nights was generally higher in patients treated with FF/VI compared to either FF or FP alone (Table below). The time (in days) for 50% of patients to achieve 7 nights without symptoms was achieved sooner with patients treated with FF/VI compared to FF alone (Table).

Conclusions In general, night-time awakenings improved over time in asthma patients with FF/VI and improved faster with FF/VI compared with FF or placebo.