Trial phase Screening
(pre-trial)
Randomisation and RUSH day Build up phase
(visit every 2 weeks)
Maintenance phase
(visit every 4 weeks)
Week 78+ DBPCFC
(minimum of 6 months maintenance)
Post treatment 1 clinic visit
(2 – 6 weeks after T1 DBPCFC)
Post treatment 2 clinic visit
(3 months after T1 DBPCFC)
Post treatment 3 phone interview
(6 months after T1 DBPCFC)
Post treatment 4 clinic visit
(12 months after T1 DBPCFC)
Post treatment 5 clinic visit
(3-4 years after T1 DBPCFC)
Follow up phone/email questionnaires
(every 6 months)
Final email/phone follow up
(3 years after T5)
Time point RUSH / T0 T1 T2 T3 T4 T5
Month of study (minimum) 0 0 1-8 9-18 18 > 18.5 > 21 > 24 > 30 > 54-66 > 60-96 > 90-102
Skin prick test O:SPT O:SPT O:SPT O:SPT O:SPT
PPOIT: 19
Placebo: 19
(optional)
Oral double blind placebo
controlled food challenge
O:DBPCFC
PPOIT: 13
Placebo: 11
(optional)
O:DBPCFC
PPOIT: 29
Placebo: 28
O:DBPCFC
PPOIT: 25
Placebo: 2
(if passed at T1)
O:DBPCFC
PPOIT: 12
Placebo: 15
(optional)
Asthma P:PAQ P:PAQ
(week 17)
P:SDV
P:PAQ
(first maintenance visit, week 49)
P:PAQ P:PAQ P:PAQ
Eczema P:PAQ
O:SCORAD
P:PAQ
(week 17)
O:SCORAD
P:PAQ
(first maintenance visit, week 49)
O:SCORAD
O:SCORAD O:SCORAD P:PAQ
O:SCORAD
P:PAQ
O:SCORAD
P:PAQ
O:SCORAD
Food allergy P:PAQ P:PAQ
(week 17)
P:SDV
P:PAQ
(first maintenance visit, week 49)
P:PAQ P:PAQ P:PAQ
Wheeze P:PAQ P:PAQ
(week 17)
P:PAQ
(first maintenance visit, week 49)
P:PAQ P:PAQ P:PAQ
Quality of life P:FAQLQ-PF P:FAQLQ-PF P:FAQLQ-PF P:FAQLQ-PF P:FAQLQ-PF P:FAQLQ-PF P:FAQLQ-PF P:FAQLQ-PF
Trial phase Sc
Screening
(pre-trial)
T0
RUSH day
Build up phase
(visit every 2 weeks)
Maintenance phase
(visit every 4 weeks)
T2
(final day of study treatment)
T3
(8 weeks after end of study treatment)
T4
(1 year after end of study treatment)
T5
(3 years after end of study treatment)
Month of study 0 0 1-4 5-18 18 20 30 54
Skin prick test O:SPT O:SPT O:SPT O:SPT O:SPT O:SPT
Oral double blind placebo
controlled food challenge
O:DBPCFC O:DBPCFC O:DBPCFC
(if passed at T2)
O:DBPCFC
(if passed at T2 and T3)
Asthma P:PAQ P:SDV P:PAQ P:PAQ P:PAQ P:PAQ P:PAQ
Eczema P:PAQ
O:SCORAD
O:SCORAD P:PAQ
O:SCORAD
P:PAQ
O:SCORAD
P:PAQ
O:SCORAD
P:PAQ
O:SCORAD
P:PAQ
O:SCORAD
Food allergy P:PAQ P:SDV P:PAQ P:PAQ P:PAQ P:PAQ P:PAQ
Wheeze P:PAQ P:PAQ P:PAQ P:PAQ P:PAQ P:PAQ
Quality of life P:FAQLQ-PF P:FAQLQ-PF P:FAQLQ-PF P:FAQLQ-PF P:FAQLQ-PF
Trial phase Screening
(pre-trial)
T0
RUSH day
Build up phase
(visit every 2 weeks)
Maintenance phase
(visit every 12 weeks)
T1
(1 day after final day of treatment)
T2
(12 weeks after final day of treatment)
Telephone Contact
(26 weeks after final day of treatment)
T3
(1 year after final day of treatment)
Month of study  up to -3 0 1-4 5-18 18 21 24 30
Week of study  up to -12 0 1-16 17-78 78 90 104 130
Skin prick test O:SPT O:SPT O:SPT O:SPT
Oral double blind placebo
controlled food challenge
O:DBPCFC O:DBPCFC O:DBPCFC
(if passed DBPCFC at T1)
Asthma P:PAQ P:PAQ P:PAQ P:PAQ P:PAQ P:PAQ P:PAQ P:PAQ
Eczema P:PAQ
O:SCORAD
P:PAQ
O:SCORAD
P:PAQ
O:SCORAD
P:PAQ
O:SCORAD
P:PAQ
O:SCORAD
P:PAQ
O:SCORAD
P:PAQ
O:SCORAD
P:PAQ
O:SCORAD
Food allergy P:PAQ P:PAQ P:PAQ P:PAQ P:PAQ P:PAQ P:PAQ P:PAQ
Wheeze P:PAQ P:PAQ P:PAQ P:PAQ P:PAQ P:PAQ P:PAQ P:PAQ
Quality of life P:FAQLQ-PF P:FAQLQ-PF P:FAQLQ-PF

Featured measurements

DBPCFC: Double Blind Placebo Controlled Food Challenge
FAQLQ: Food Allergy Quality of Life Questionnaire – Parent Form for Children Aged 0-12 Years
PAQ: PPOIT Allergy Questionnaires (various versions)
SCORAD: SCORing Atopic Dermatitis
SDV: Study Devised Variable
SPT: Skin Prick Test

Notes

The PPOIT Allergy Questionnaires are a series of in-depth allergy questions developed by the PPOIT team. For further information about the questionnaires and collaboration opportunities, please contact Christine Axelrad (Christine.Axelrad@rch.org.au, +613 9345 6974)

Legend

A = Administration report abstraction
C = Index child report (reporting on others)
L = Linkage (to other databases)
M = Medical records data abstraction
O = Observation/direct assessment
N = Nurse report
P = Parent/primary caregiver report
Pe = Peer report
S = Self report
T = Teacher report
X = Undefined
XBF = Pertaining to biological father
XBM = Pertaining to biological mother
XC = Pertaining to index child
XF = Pertaining to father
XFam = Pertaining to family
XG = Pertaining to grandparent(s)
XM = Pertaining to mother
XP = Pertaining to parent(s)
XPa = Pertaining to partner
XPe = Pertaining to peers
XPr = Pertaining to primary caregiver
XSi = Pertaining to sibling(s)