Table 1 Study visit schedule
Visit | 1 | 2 | 3 | 4 | 5 |
|---|---|---|---|---|---|
Month | 0 | 3 | 6 | 9 | 12 |
Visit window | +/-2 weeks | +/-2 weeks | +/-2 weeks | +/-2 weeks | |
Inclusion/exclusion criteria | x | ||||
Informed consent | x | ||||
Randomisation (post-recruitment) | x | ||||
Allocation of study number | x | ||||
Documentation of URTI | x | x | x | x | |
Documentation of commencement of study drug | x | x | x | x | |
Documentation of recent relapse | x | x | x | x | x |
Recent medical and drug history | x | x | x | x | x |
Adverse event documentation | x | x | x | x | |
Compliance check (tablet count using counting triangle) | x | x | x | x | |
Physical exam | x | x | x | x | x |
Assessment of steroid toxicity | x | x | x | x | x |
Height and weight | x | x | x | x | x |
Blood pressure | x | x | x | x | |
Calculation of study drug dose to be administered in event of URTI and explanation and provision of documentation of this to parents and guardians – includes review of height, weight and body surface area to confirm correct dose | x | x | x | x | x |
If three or more courses of study drug have been administered since previous visit, confirm parental understanding of definition of URTI | x | x | x | x | |
Blood sample for DNA/RNAa | x | x | x | x | x |
Achenbach Child Behaviour Checklist | x | x | x | x | x |
PedsQL questionnaire | x | x | x | x | x |
CHU-9D and EQ-5D questionnaires | x | x | x | x | x |
Study drug returned to central pharmacy for accountability | x |