Table 1.
Timing of visits and schedule of assessments
Assessment | Visit 1 (baseline) Pre-switch/study start |
Visit 2 (control visit) Week 2 (+ 1 week) |
Visit 3 (end of study) Week 12 (+ 2 weeks)a |
---|---|---|---|
Informed consent | X | ||
Inclusion/exclusion criteria | X | ||
Demography | X | ||
Concomitant medication | X | ||
Smoking status | X | ||
Patient questionnaire | Xb | Xc | Xc |
Patient assessment of device handling and inhalation technique | Xb | Xc | Xc |
Physician/nurse assessment of teaching and inhaler use | Xc | Xc | Xc |
Asthma control test | Xb | Xc | |
Mini-AQLQ | Xb | Xc | |
Spirometry | Xb | Xc | |
Adverse events | Xc | Xc |
AQLQ Asthma Quality of Life Questionnaire, B/F budesonide and formoterol fumarate
aOr early withdrawal from study
bAssessment of B/F Turbuhaler®
cAssessment of B/F Easyhaler®