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APPENDIX E: CARE STEPWISE TREATMENT ALGORITHMS.................................................59
by WBOP PHO
10.6 Adherence to randomised treatment regimen
Adherence to the randomised treatment regimens will be captured at study visits through participant self-reported inhaler use. Non-adherence will not result in withdrawal.
10.7 Accountability of the trial treatment
IMP should be used only in accordance with the protocol. Site personnel will be required to record all receipt, dispensing and collection activity regarding IMPs in addition to ensuring delivery documentation is retained at site. Used or unused IMP may be destroyed by site personnel only after approval has been provided by the Sponsor. Destruction should be documented and performed at site, or if not possible, at a site approved by the Sponsor, according to local regulations.
10.8 Concomitant medication
Concomitant medications will be reviewed at the screening visit to ensure the participant fulfils the eligibility criteria in respect to current use of asthma medications. Concomitant medications will then be reviewed and updated during each study visit. Should a participant be prescribed additional asthma treatments, this will be documented, and the participant will remain in the study.
10.9 Post-trial treatment
At Visit 5 (52 weeks or withdrawal), all participants will be given one reliever inhaler and a prescription for one additional reliever inhaler. Participants who have been escalated to maintenance therapy during the trial will also receive a prescription for a maintenance inhaler.
Post-trial treatment will differ according to age group (<11 years or ≥12 years) and treatment step. The proposed post-trial treatment is outlined below. This may be amended to comply with NZ asthma guidelines at the time of participant study completion or withdrawal. Participants will be advised to see their GP within one month of completing the study to review their ongoing asthma therapy.
All participants will receive a relevant NZ Asthma and Respiratory Foundation asthma action plan. This will detail the prescribed regimen.
10.9.1 Budesonide-formoterol treatment arm
Treatment at the end of the trial Post-trial treatment (5 to 11 years) Post-trial treatment (12 to 15 years)
Budesonide-formoterol (Symbicort Rapihaler 50/3) as needed
Very-low dose budesonideformoterol (Symbicort Rapihaler 50/3) maintenance and as needed
Low-dose budesonideformoterol (Symbicort Rapihaler 50/3) maintenance and as needed Salbutamol (Ventolin), 2 actuations as needed
Maintenance fluticasone (Flixotide 50) 1 actuation twice daily, plus salbutamol (Ventolin 100) 2 actuations as needed Maintenance fluticasonesalmeterol (Seretide 50/25) 1 actuation twice daily, plus salbutamol (Ventolin 100) 2 actuations as needed Budesonide-formoterol (Symbicort Turbuhaler 200/6), 1 actuation as needed
Budesonide-formoterol (Symbicort Turbuhaler 200/6), 1 actuation as needed
Low-dose budesonideformoterol (Symbicort Turbuhaler 200/6), 1 actuation twice daily and as needed
