Why are we doing this study?
Most children with asthma use a preventer inhaler (e.g. Flixotide or Seretide) and a separate reliever inhaler (e.g. Respigen or Ventolin). However, in adolescents and adults, the preferred approach is to use a 2-in-1 combination preventer and reliever inhaler (e.g. Symbicort), as this is better at preventing asthma attacks. We want to find out if it is also better for children.
How many children are we recruiting?
We are inviting 400 children aged between 5 and 11 years old, with asthma, to take part in the START CARE study.
How long will the study take and what will happen?
The study is 56 weeks long. For the first 4 weeks, everyone will use the same treatments, to make sure they are comfortable with the new inhalers (called Turbuhalers). These will be a preventer (Pulmicort or Symbicort) and a separate reliever inhaler (Bricanyl).
They will then be given either two separate inhalers or a single 2-in-1 inhaler (chosen at random) to use for a year. There are 6 visits to the study site, where we will ask you questions about your asthma, provide inhalers, and do breathing tests. Travel costs will be reimbursed and each child will get a $25 koha/ gift card at each visit.
Between visits, we ask you to keep a record of any times you see a doctor or take time off school or work. If your child has an asthma attack during the study, we might want to change their preventer inhaler or increase how often they take it.
What criteria must be met to take part?
To take part, your child must:
- Be between 5 and 11 years old
- Have a diagnosis of asthma
- Have used a preventer inhaler (e.g. Flixotide or Seretide) in the last 6 months
Your child can't take part if they have:
- Ever been admitted to an intensive care unit for their asthma
Who is running this study?
The study is being undertaken at multiple research centres throughout New Zealand. It is being coordinated by the Medical Research Institute of New Zealand (MRINZ) and funded by AstraZeneca (the company who makes the inhalers). The study has been approved by the Northern B Health and Disability Ethics Committee (reference: 2022 FULL 13221).
Privacy Notice
The information we collect and hold about you will be used exclusively for the purpose of allowing us to contact you about the START CARE study. Your information will be shared with the team at the site you have selected.
By submitting the survey you agree that your information will be held securely by the Medical Research Institute of New Zealand, on servers in Sydney, Australia. In accordance with the NZ Privacy Act (2020), you have the right to ask us to correct any information we hold about you that is incorrect or out of date. Your information will be deleted once the study has fully recruited, which should be no later than December 2025.