Introduction and objectives FF/VI is the first once daily inhaled corticosteroid/long-acting b2-agonist combination available for the treatment of asthma. Results from five phase III studies that have previously been presented demonstrated a sustained 24 h improvement in lung function and improvement in symptom-free 24 h periods.
Methods Post-hoc analyses of diary card data from these studies were performed to examine whether there was any difference in the contribution of the day and night time symptom-free period to the 24 h symptom-free period. The diary card scale used is described below.
Day-time Symptom Score:
0 = No symptoms during the day
1 = Symptoms for one short period during the day
2 = Symptoms for two or more short periods during the day
3 = Symptoms for most of the day which did not affect my normal daily activities
4 = Symptoms for most of the day which did affect my normal daily activities
5 = Symptoms so severe that I could not go to work or perform normal daily activities
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 day or night the patient needed to record a score of 0.
Results The post-hoc analyses demonstrated that the improvements in day and night time symptom –free periods were similar to the 24 h symptom free periods. See Figure 1 below.
Conclusions In general benefits in symptom free days and symptom free nights contributed to the benefit of FF/VI over comparator groups in terms of 24 h symptom free periods.
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