Visit number | V1 | P1 | V2 | P2 | V3 | P3 | V4 | P4 | P5 | V5 | P6 | P7 | V6 | P8 | P9 | V7 | D1 |
Assessment description | Screening and baseline | Follow-up | End of study | End of down-titration | |||||||||||||
Time since randomisation W=weeks, M=months | 0 W | 2 W | 4 W | 8 W | 12 W | 16 W | 6 M | 8 M | 10 M | 12 M | 14 M | 16 M | 18 M | 20 M | 22 M | 24 M | 24 M+1–3 W |
Visit type | Clinic | Phone | Clinic | Phone | Clinic | Phone | Clinic | Phone | Phone | Clinic | Phone | Phone | Clinic | Phone | Phone | Clinic | Clinic |
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/eligibility | X | ||||||||||||||||
Reasons for non-participation | X | ||||||||||||||||
Demographics, medical, clinical and smoking history | X | ||||||||||||||||
Physical examination and anthropometrics | X | X* | |||||||||||||||
Randomisation | X | ||||||||||||||||
Vital signs and vital status BP, HR | X† | X | X | X | X | X | X | X | |||||||||
Spirometry | X‡ | X | X | X | X | X | X | X | |||||||||
ECG | X§ | X | X | X | X | X | |||||||||||
CAT, SGRQ and EQ-5D-5L¶ | X | X | X | X | X | ||||||||||||
Adverse events | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X |
Concomitant medications | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | |
6MWT** | X | X | |||||||||||||||
Medication dosage review | X | X | X | ||||||||||||||
Participant diary review | X | X | X | X | X | X | |||||||||||
Treatment adherence†† | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X |
* 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.