Table 2 Time and events schedule
Screening | Treatment period | Follow-up | ||||
|---|---|---|---|---|---|---|
Visit 0 months | Visit 1 month (+2 weeks) | Visit 3 months (+/- 1 week) | Visit 5 months (+/- 1 week) | Visit 7 months (+/- 1 week) | 9 months | |
Informed consent | X | |||||
Demographics | X | |||||
Inclusion/Exclusion criteria review | X | |||||
INTERVENTION: | ||||||
Randomization | X | |||||
Azithromycin/Placebo |
| |||||
Adherence | X | X | X | |||
ASSESSMENTS: | ||||||
QOL-PCD | X | X | X | X | X | X |
Patient interview | X | X | X | X | X | |
Concomitant medication | X | X | X | X | X | |
Weekly patient diary | X | X | X | X | ||
Physical examination & vital signs | X | X | X | X | X | |
Pregnancy test | X | X | X | X | X | |
Electrocardiogram | X | |||||
Spirometry | X | X | X | X | X | |
Body plethysmography | X | X | X | X | ||
N2 MBW | X | X | X | X | ||
Audiometry & tympanometry | X | X | ||||
Sputum microbiology & antibiotic susceptibility | X | X | X | X | X | |
Inflammatory markers (sputum & blood) | X | X | ||||
Blood samples (bone marrow, liver & kidney) | X | X | ||||
