Fluticasonefuroate/vilanterol100/25mcgcompared with fluticasonefuroate 100mcgin asthma: a randomized trial

E-TABLES

Online Repository Table 1. Time and events table

Procedures / Screen/Run-in Period / Randomisation / Treatment Period / End of Therapy / Early Withdrawal (EW) / Follow-up
Clinic Visit
Visit/Contact / 1 / 2 / 3 / 4 / 5 / 6 / 7 / 8
Week of Study / -4 / -2 / 0 / 2 / 4 / 8 / 12
Treatment Day / -28 (±3) / -14 (±3) / 0 / 14 (-4/+2) / 28 (-4/+2) / 56(-4/+2) / 84 (-4/+2) / 14 (±2) post V7 or EW
Written Informed Consent / X
Subject Demography / X
Medical History / X
Asthma History / X
Therapy History / X
Physical Exam / X / X / X
Inclusion/Exclusion Criteria / X / X
EFFICACY ASSESSMENTS
Spirometry Pulmonary Function / X / X / X / X / X / X / X
Reversibility / X
Serial FEV1 (0-24hrs) in subset of subjects / X1 / X1
Issue Subject Diaries / X
Subject Diary Review & Upload / X / X / X / X / X / X / X / X
SAFETY ASSESSMENTS
Concomitant Medication / X / X / X / X / X / X / X / X / X2
Oropharyngeal Examination / X / X / X / X / X / X / X
12-lead ECG / X / X3 / X3 / X
Vital Signs / X / X / X / X / X / X / X
Adverse Events / X / X / X / X / X / X / X
Serious Adverse Events / X5 / X5 / X5 / X / X / X / X / X / X
LABORATORY ASSESSMENTS
Haematology / X
Chemistry (includes liver safety testing) / X / X / X
Glucose and Potassium in subset of subjects / X4 / X4
PGx Sampling (one visit only) / X7
Serum pregnancy test / X / X / X
Urine Pregnancy test / X / X
24-hr Urine Collection Supplies dispensed / X / X
24-hr Urine collection / X / X
HBsAg and hepatitis C antibody screening / X
PK sampling / X8 / X8
Questionnaires
ACT / X / X / X / X
AQLQ (+12) / X / X / X
Unscheduled Healthcare
contact/Resource Utilization / X9 / X9 / X9 / X9 / X9 / X9
Global Change Questionnaire / X / X / X / X
Inhaler use assessment / X / X / X
Ease of use questions for inhaler / X
INVESTIGATIONAL PRODUCT (IP)
Dispense IP / X / X / X
Assess IP compliance / X / X / X / X / X
Collect IP / X / X / X / X / X6
Dispense Rescue Albuterol/Salbutamol / X / X / X / X / X / X
Collect Rescue Albuterol/Salbutamol / X / X / X / X / X / X / X / X
1.In addition to pre-dose assessment (within 30 minutes prior to dosing at Visit 3 and within 5 minutes prior to dosing at Visit 7), serial FEV1 measurements will be taken at 5, 15, 30 minutes and 1, 2, 3, 4, 5, 12, 16, 20, 23 and 24 hours post dose.
2.Concomitant medication details collected for adverse events only between end of treatment and follow-up visit.
3.ECGs: Pre-dose ECGs at Visit 2, Visit 3, Visit 7 and Early Withdrawal in all subjects. In addition post dose (5-20minutes for GW642444) assessments at Visit 3 (Day 0) and Visit 7 (end of 12 weeks of treatment) in subset of subjects NOT performing Serial Lung Function measurements;.
4.Potassium and Glucose: Pre-dose in all subjects at Visit 3 and Visit 7. In addition post dose(5-20minutes) at Visit 3 (Day 0) and Visit 7 (end of 12 weeks of treatment) in subset of subjects performing Serial Lung Function measurements. Subjects should be fasted for ≥ 4hours prior to blood draw.
5.SAEs related to study participation that occur during run-in should be recorded in the eCRF
6.If not performed at End of treatment (Visit 7 or EW visit)
7.The PGx sample can be collected at any one visit after the PGx consent has been signed and the subject has been randomised
8.Upon arrival at the clinic a 4mL blood sample will be collected and the subjects will administer their evening dose of study medication after all pre-dose assessments are completed. Prior to leaving the clinic, two more 4mL blood samples will be collected from the subject between 5-15 minutes post-dose and between 1 – 1.5 hours post dose.
9.To be completed associated with a severe asthma exacerbation and other asthma-related health care