Please insert on local Trust headed paper
Short course daily prednisolone therapy at the time of upper respiratory tract infection in
children with relapsing steroid sensitive nephrotic syndrome; the PREDNOS 2 study.
Information about the precise number of tablets of study medication to administer
Advice for Parents and Participants
For participants receiving regular alternate day prednisolone therapy
Insert today’s date: DD/MMM/YYYY
This letter replaces any previous advice provided about the PREDNOS 2 study medication
Dear Parent
Thank you for agreeing to take part in this study.
At entry into the study, your child’s study medication, which is either 5mg prednisolone
tablets or placebo tablets, will have been posted direct to your chosen address. You will
have received 2 pots of study medication, each containing 50 x 5mg prednisolone or
placebo tablets. The study is double blind so neither you, your child or your doctor will
know whether your child is taking active or placebo prednisolone tablets.
If your child develops an upper respiratory tract infection (URTI) they should commence
study medication for 6 days. This process should be repeated each and every time your
child develops an URTI over the 12 month follow-up period. Please see definition of URTI
below:
DEFINITION OF AN UPPER RESPIRATORY TRACT INFECTION (URTI)
An URTI will be defined as the presence of at least 2 of the following for at least 24 hours:
•
sore throat
•
ear pain/discharge
•
runny nose
•
cough (dry/barking)
•
hoarse voice
•
fever >37oC (measured using the electronic thermometer provided for you)
COMMENCEMENT OF STUDY MEDICATION
Once your child meets the definition above for URTI (two or more criteria for at least 24
hours), you should commence your child on the study medication.
If you are in any way uncertain whether you are doing the right thing, please contact your
local hospital, or if this is not possible, the national PREDNOS 2 helpline on 07896 818647.
PREDNOS 2 Advice to parents – AD prednisolone, Version 1.2, Jul 13th 2015 Page 1 of 5
EudraCT Number: 2012-003476-39
OTHER SYMPTOMS
If your child develops any of the following symptoms, or you have any concern that they
may have something more serious that a straightforward URTI, you should not commence
study medication, but seek urgent medical attention through your GP or local A+E
Department.
•
non-blanching rash (a blotchy red rash that does not fade or change colour when
you place a glass against it)
•
leg pain
•
cool extremities
•
rapid breathing
•
blue lips
•
fitting
•
loss of or reduced consciousness
PRECISE DOSING REGIMEN (boxes to be filled in by your doctor)
This will be reviewed at each study visit or following any change in your child’s treatment.
Calculated at: Baseline study visit iiLii 3 months iiLii 6 months iiLii 9 months iiLii
iiLii Other, please specify: ...............................................
.
Subject surface area in m2: iiLii iiLii
Your child is currently receiving prednisolone at a dose of : iiLii iiLii mg
( iiLii iiLii tablets) every other day.
Using the study medicines, the number of tablets needs to be increased so your child
receives a total of iiLii iiLii tablets for six days.
If your child is starting the study drug on a day when regular prednisolone is due, you
should give the following;
Day 1 Regular prednisolone iiLii iiLii tablets + iiLii iiLii tablets of study medicine
Day 2 iiLii iiLii tablets of study medication
Day 3 Regular prednisolone iiLii iiLii tablets + iiLii iiLii tablets of study medicine
Day 4 iiLii iiLii tablets of study medication
Day 5 Regular prednisolone iiLii iiLii tablets + iiLii iiLii tablets of study medicine
Day 6 iiLii iiLii tablets of study medication
(boxes to be filled in by your doctor)
If your child is starting the study medication on a day when regular prednisolone is not due,
you should give the following;
Day 1 iiLii iiLii tablets of study medication
Day 2 Regular prednisolone iiLii iiLii tablets + iiLii iiLii tablets of study medicine
Day 3 iiLii iiLii tablets of study medication
Day 4 Regular prednisolone iiLii iiLii tablets + iiLii iiLii tablets of study medicine
PREDNOS 2 Advice to parents – AD prednisolone, Version 1.2, Jul 13th 2015 Page 2 of 5
EudraCT Number: 2012-003476-39
Day 5 iiLii iiLii tablets of study medication
Day 6 Regular prednisolone iiLii iiLii tablets + iiLii iiLii tablets of study medicine
When the six days are completed, you should return to the previous regular prednisolone
dose that your child was receiving.
Any other medicines that have been prescribed should continue unchanged.
Please contact your local hospital before or within 24 hours of commencing study
medication to inform your doctor or research nurse. Please take the opportunity to discuss
any of your child’s symptoms that may be of concern to you and to check that your child is
otherwise well. If you have any doubt about whether you are doing the right thing, please
contact your local study site.
Name of contact: ................................................................................................................
Contact telephone number: ................................................................................................
This process should be repeated each and every time your child develops an URTI over the
12 month follow-up period.
At 12 months, the end of the study period, please return any unused medication to
Birmingham Children’s Hospital Pharmacy, Pharmacy Clinical Trials Unit, Birmingham
Children’s Hospital NHS Foundation Trust, Steelhouse Lane, Birmingham B4 6NH.
If your child becomes ill whilst taking this medication, please tell your doctor that he or she
is taking part in this study. If your doctor has any urgent queries about your child’s medicine
please give them the following contact details – Prof Nicholas Webb, Telephone 0161 701
2961, PREDNOS 2 Chief Investigator.
HOW TO STORE YOUR CHILD’S STUDY MEDICATION:
Please store your child’s study medication in a cool place below 25˚C away from heat, light
and strong smelling items. Do not freeze or store in a humid place.
THERMOMETER
You have been provided with an electronic thermometer (Braun thermoscan). Please use
this to measure your child’s temperature.
STUDY DIARY
A study diary has been provided. Please use this to record the results of the daily morning
dipstick urine tests and any URTIs that occur. Please also make a record when your child is
seen by a doctor, nurse or other healthcare professional because of any illness along with
any medicines prescribed or purchased by yourself.
If your child comes into contact with someone with chicken pox or shingles whilst on this
medication it is essential that you contact your doctor as soon as you can.
PREDNOS 2 Advice to parents – AD prednisolone, Version 1.2, Jul 13th 2015 Page 3 of 5
EudraCT Number: 2012-003476-39
Please remember to bring the medicine package with you to each of your child’s hospital
appointments. This is so as your child’s doctor can assess that the study mediation has
been taken correctly. Your child’s doctor will note if any of the doses have been missed
and the reason that this may have happened.
A Steroid Treatment Card is enclosed with this letter. Please carry this card with you,
together with this letter, and show to anyone who treats your child.
The PREDNOS 2 study co-ordinating centre is located at the Birmingham Clinical Trials Unit,
College of Medical & Dental Sciences, Public Health Building, University of Birmingham,
Edgbaston, Birmingham, B15 2TT, Tel 0121 415 9132, Fax: 0121 415 9135, Email:
prednos2@trials.bham.ac.uk, Web address: www.birmingham.ac.uk/PREDNOS2 .
PREDNOS 2 Chief Investigator: Prof Nicholas Webb, Royal Manchester Children’s Hospital,
Manchester 0161 701 2961
PREDNOS 2 Funding body: National Institute for Health Research Health Technology
Assessment programme (NIHR HTA)
PREDNOS 2 Co-Sponsors: University of Birmingham and Central Manchester University
Hospitals NHS Foundation Trust
Enc: Steroid Treatment Card
PREDNOS 2 Advice to parents – AD prednisolone, Version 1.2, Jul 13th 2015 Page 4 of 5
EudraCT Number: 2012-003476-39
Steroid Treatment Card
PREDNOS 2 Advice to parents – AD prednisolone, Version 1.2, Jul 13th 2015 Page 5 of 5
EudraCT Number: 2012-003476-39