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.