Table 1 Schedule of events
Visit No | 1 | 2 | 3 | 4 | 5 | 6 | 7 |
|---|---|---|---|---|---|---|---|
Baseline | Randomisation: Start treatment phase 1 | Mid-Treatment phase 1 | End of Treatment phase-Washout | Start Treatment phase 2 | Mid-Treatment phase 2 | End treatment, Final visit | |
Week No. | 0 | 4 | 10 | 16 | 24 | 30 | 36 |
Consent | X | ||||||
Inclusion/exclusion criteria | X | X | |||||
Physical exam | X | X | |||||
Vital signs | X | X | X | X | X | X | X |
Blood drawn | X | X | X | ||||
Pregnancy test | X | X | X | ||||
Bronchodilator reversibility | X | ||||||
Spirometry | X | X | X | X | X | X | X |
Asthma exacerbations | X | X | X | X | X | X | X |
AQLQ | X | X | X | X | X | X | X |
ACQ | X | X | X | X | X | X | X |
LCQ | X | X | X | X | X | X | X |
Bronchodilator use | X | X | X | X | X | X | X |
Dispense study medication | X | X | X | X | X | X | |
Randomisation | X |