The participant’s NHI number and medical records will only be used to validate data collected prior to the date of lost to follow up.
9.17 End of study The end of trial is the date of the last visit of the last participant. The Sponsor will stop the study prematurely if any safety concerns are apparent, either arising from this study, of if the Sponsor is informed of any safety issues arising outside of this study, including but not limited to safety concerns regarding the study medications. Sites will be informed of early termination of the study due to safety concerns, as soon as possible. In the case of safety concerns arising during the study, investigators may deviate from the protocol in order to ensure the health and wellbeing of participants. The Sponsor must be informed of any cases where the protocol is not adhered to and the reasons for non-adherence, as soon as possible. Nonadherence will be reported to the appropriate ethics committees and regulatory authorities in line with local requirements.
9.18 DCE sub-study See separate DCE sub-study protocol (for selected sites only).
10
10.1
INVESTIGATIONAL MEDICINAL PRODUCT (IMP)
Description
Product
Drug
Actuations per inhaler
Shelf-life
Approval
Symbicort Rapihaler 50/3, AstraZeneca (AZ)
Budesonideformoterol
120
3 months out of foil wrapping (12 months in foil)
Not currently approved in NZ
Ventolin 100, GlaxoSmithKline (GSK)
Salbutamol
200
24 months
Approved in NZ for the treatment of asthma in children
Flixotide 50, GSK
Fluticasone
120
24 months
Approved in NZ for the treatment of asthma in children
Seretide 50/25, GSK
Fluticasonesalmeterol
120
24 months
Approved in NZ for the treatment of asthma in children
10.2
IMP labelling
IMPs will be labelled according to Good Manufacturing Practices, Annex 13: Manufacture of Investigational Medicinal Products. All IMPs will be labelled with a study label, according to local regulations and requirements. The IMP will be released by the Sponsor in accordance with the IMP Supply Plan.
CONFIDENTIAL
Protocol: Children’s Anti-Inflammatory Reliever
Version 4.1 (04/02/2022)
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