Table 3.
Schedule for collection of response data.
Visit | V1 | V2 | V3 | V4 | V5 |
---|---|---|---|---|---|
Time (weeks) | 0 | 2 | 10 | 18 | 26 |
Consent/Assent | X | ||||
Screening | X | ||||
Baseline hx | X | ||||
Saliva for genotyping | X | ||||
Asthma and GERD counseling | X | X | |||
PK | X | ||||
Diary Card | X | X | X | X | X |
Health history | X | X | X | X | |
Med adherence | X | X | X | ||
Spirometry | X | X | X | X | X |
Asthma questionnaires | X | X | X | X | X |
GSAS | X | X | X | X | |
Adverse event screening | X | X | X | X | X |
Pregnancy testing | X | X | X | X | X |
Nasal samples | X | X | X | X |
PK – pharmacokinetic testing, GSAS – GERD Symptom Assessment Score.