Table 1

Schedule of study assessments

Visit numberV1P1V2P2V3P3V4P4P5V5P6P7V6P8P9V7D1
Assessment descriptionScreening and baselineFollow-upEnd of studyEnd of down-titration
Time since randomisation
W=weeks, M=months
0 W2 W4 W8 W12 W16 W6 M8 M10 M12 M14 M16 M18 M20 M22 M24 M24 M+1–3 W
Visit typeClinicPhoneClinicPhoneClinicPhoneClinicPhonePhoneClinicPhonePhoneClinicPhonePhoneClinicClinic
Visit window±0 W±1 W±2 W±1 W±2 W−2 W+4 W±4 W±1 W±1 W±4 W±1 W±1 W±4 W±1 W±1 W±4 W±1 W
Informed consent/eligibilityX
Reasons for non-participationX
Demographics, medical, clinical and smoking historyX
Physical examination and anthropometricsXX*
RandomisationX
Vital signs and vital status
BP, HR
X†XXXXXXX
SpirometryX‡XXXXXXX
ECGXXXXX
CAT, SGRQ and EQ-5D-5L¶XXXXX
Adverse eventsXXXXXXXXXXXXXXXXX
Concomitant medicationsXXXXXXXXXXXXXXXX
6MWT**XX
Medication dosage reviewXXX
Participant diary reviewXXXXXX
Treatment adherence††XXXXXXXXXXXXXXX
  • * Weight only for anthropometrics at V7.

  • †BP at screening will be measured at 0 minutes, 30 minutes, 1 hour and 2 hours after first test dose of bisoprolol.

  • ‡Spirometry at screening will be measured at 0 minutes, 1 hour and 2 hours after first test dose of bisoprolol.

  • §Screening ECG will be 12-lead, all other measurements will be 3-lead.

  • ¶CAT; SGRQ; EQ-5D-5L questionnaires.

  • ** 6MWT (6 Minute Walk Test) is for a subset of the study population.

  • †† Clinic visits will involve pill counts. At phone visits, participants will be asked how many doses they missed.

  • CAT, COPD Assessment Test; ECG, Electrocardiogram; EQ-5D-5L, EuroQoL Group 5-Dimension self-report questionnaire; 6MWT, 6-minute walk test; SGRQ, St. George Respiratory Questionnaire.