Table 2

Visit overview

Visit numberConsent and enrolment123456Unscheduled visit
Week 0*0416284052As required
Day 0*028112196280364As required
Visit window (days)n/an/a±5±5±5±5±5n/a
 Predispensing monitor check†XXXXXX
 Written informed consentX
 Optional future unspecified research written informed consent§X
 Inclusion/Exclusion criteria checkXX*
 Five-Item Asthma Control QuestionnaireXXXXXX
 Beliefs about medicines questionnaireXX
 WPAI: asthma questionnaireXXX
 Housing status questionsX
 Asthma Quality of Life Questionnaire with Standardised ActivitiesX
 Valuation of Lost Productivity QuestionnaireX
 EQ-5D-5S health-related quality of life questionnaireX
 Medical history and demographicsX
 Education status, job title, job descriptionX
 Weight and heightX
 FeNO‡XXX
 SpirometryXXX
 Blood test for periostin§X
 Blood test for full blood countX
 Blood test for biomarkers§¶X
 RandomisationX
 Study ICS inhaler technique assessmentXXXXXX
 Participant education and issuing of study inhalersXXXXX
 Issue written asthma action plan and other written informationX
 Inform GP of study enrolmentX
Review
— Exacerbations
— AEs, SAEs
— Medication changes
— Issues with equipment use†
XXXXXX
Returned electronic monitors†
— Check for damage
— Upload from monitor via USB cable
XXXXXX
If participant is to be withdrawn, documentation of cause and notification to GP and sponsorXXXXXX
Inform GP and sponsor of study completionX
  • *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.