10.9.2 Salbutamol treatment arm Treatment at the end of the trial
Post-trial treatment (5 to 11 years)
Post-trial treatment (12 to 15 years)
Salbutamol (Ventolin), 2 actuations as needed
Budesonide-formoterol (Symbicort Turbuhaler 200/6), 1 actuation as needed
Maintenance fluticasone (Flixotide 50) plus salbutamol (Ventolin 100) as needed
Maintenance fluticasone (Flixotide 50) 1 actuation twice daily, plus salbutamol (Ventolin 100) 2 actuations as needed
Budesonide-formoterol (Symbicort Turbuhaler 200/6), 1 actuation as needed
Maintenance fluticasonesalmeterol(Seretide 50/25) plus salbutamol (Ventolin 100) as needed
Maintenance fluticasonesalmeterol (Seretide 50/25) 1 actuation twice daily, plus salbutamol (Ventolin 100) 2 actuations as needed
Low-dose budesonideformoterol (Symbicort Turbuhaler 200/6), 1 actuation twice daily and as needed
Salbutamol (Ventolin 100) as needed
11 DATA COLLECTION AND MANAGEMENT
11.1
Data collection
An electronic Clinical Data Management Application (CDMA) created using REDCap will be used to enable study data collection. Site staff will be given appropriate access to enter data into the CDMA after they have received appropriate training. The electronic CDMA will be designed to collect data in real time during clinic visits. Data will also be collected via MyCap, and/or through documentation on the back of the participant’s asthma management plan or, if unrecorded by the participant, through self-report at each study visit. Where data are collected on paper, or derived from other sources, site staff will complete study data entry into the CDMA on an ongoing and timely basis. For the primary outcome measure, data collection will be through participant-reported data/logs, and through review of GP electronic medical records, and the hospital, ambulance and After-Hours electronic records in each region. We will also access prescription data using the participants NHI number. Participant-reported data will include a log of asthma attacks (urgent medical review and prednisone/prednisolone use), days lost from school/work due to asthma, and use of additional prescribed asthma medications. Medical records and self-reported data will be reviewed together. Discrepancies and queries raised by monitors or via pre-programmed checks will be arbitrated by investigators using predefined criteria.
CONFIDENTIAL
Protocol: Children’s Anti-Inflammatory Reliever
Version 4.1 (04/02/2022)
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