Table 2.
Visit overview
| Visit number | Consent and enrolment | 1 | 2 | 3 | 4 | 5 | 6 | Unscheduled visit |
| Week | ≤0* | 0 | 4 | 16 | 28 | 40 | 52 | As required |
| Day | ≤0* | 0 | 28 | 112 | 196 | 280 | 364 | As required |
| Visit window (days) | n/a | n/a | ±5 | ±5 | ±5 | ±5 | ±5 | n/a |
| Predispensing monitor check† | X | X | X | X | X | X | ||
| Written informed consent | X | |||||||
| Optional future unspecified research written informed consent§ | X | |||||||
| Inclusion/Exclusion criteria check | X | X* | ||||||
| Five-Item Asthma Control Questionnaire | X | X | X | X | X | X | ||
| Beliefs about medicines questionnaire | X | X | ||||||
| WPAI: asthma questionnaire | X | X | X | |||||
| Housing status questions | X | |||||||
| Asthma Quality of Life Questionnaire with Standardised Activities | X | |||||||
| Valuation of Lost Productivity Questionnaire | X | |||||||
| EQ-5D-5S health-related quality of life questionnaire | X | |||||||
| Medical history and demographics | X | |||||||
| Education status, job title, job description | X | |||||||
| Weight and height | X | |||||||
| FeNO‡ | X | X | X | |||||
| Spirometry | X | X | X | |||||
| Blood test for periostin§ | X | |||||||
| Blood test for full blood count | X | |||||||
| Blood test for biomarkers§¶ | X | |||||||
| Randomisation | X | |||||||
| Study ICS inhaler technique assessment | X | X | X | X | X | X | ||
| Participant education and issuing of study inhalers | X | X | X | X | X | |||
| Issue written asthma action plan and other written information | X | |||||||
| Inform GP of study enrolment | X | |||||||
| Review — Exacerbations — AEs, SAEs — Medication changes — Issues with equipment use† |
X | X | X | X | X | X | ||
| Returned electronic monitors† — Check for damage — Upload from monitor via USB cable |
X | X | X | X | X | X | ||
| If participant is to be withdrawn, documentation of cause and notification to GP and sponsor | X | X | X | X | X | X | ||
| Inform GP and sponsor of study completion | X |
*Performed if consent and enrolment done on a different day to visit 1.
†Participants allocated to electronic monitoring only.
‡Performed prior to spirometry.
§Participants recruited at MRINZ only.
¶In participants who consent to the optional future unspecified research only.
AE, Adverse event; EQ-5D-5L, EuroQoL five level five dimension health status level; FeNO, nitric oxide; GP, general practitioner; ICS, inhaled corticosteroid; MRINZ, Medical Research Institute of New Zealand; n/a, not applicable; SAE, severe adverse event.