Procedures | Screening Day-7 to -1 | Enrollment/baseline Visit 1, Day 1 | Study visit 2 Week 4 | Study visit 3 Week 8 | Study visit 4 Week 12 | Follow up Week 16 |
---|---|---|---|---|---|---|
Informed consent | X | |||||
Demographics | X | |||||
Medical history | X | |||||
Randomization | X | |||||
Administer study intervention | X | |||||
Concomitant medication review | X | X | X | X | X | |
Physical exam (including height and weight) | X | X | X | |||
Vital signs | X | X | X | |||
ACT Scoring/ Questionnaire | X | X | X | X | ||
Spirometry (FVC, FEV1) | X | X | X | X | ||
Blood studies (eosinophils, IgE) | X | X | ||||
Exhaled nitric oxide | X | X | X | X | ||
INR and PTT | X | |||||
Urine pregnancy test (if applicable) | X | X | X | X | ||
Adverse event review and evaluation | X | X | X | X | X | |
Complete Forms | X | X | X | X | X | X |