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 Participants Aged 16-18yrs
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 Participant
Thank you for agreeing to take part in this study.
At entry into the study, your 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 or your doctor will know whether you are taking active
or placebo prednisolone tablets.
If you develop an upper respiratory tract infection (URTI) you should commence study
medication for 6 days. This process should be repeated each and every time you develop 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 you meet the definition above for URTI (two or more criteria for at least 24 hours),
you should commence 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 participants - AD prednisolone, Version 1.1, Nov 22nd 2012
EudraCT Number: 2012-003476-39
Page 1 of 5
OTHER SYMPTOMS
If you develop any of the following symptoms, or you have any concern that you may have
something more serious than 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 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 are 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 you receive a
total of iiLii iiLii tablets for six days.
If you are starting the study medication on a day when regular prednisolone is due, you
should have 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
If you are starting the study medication on a day when regular prednisolone is not due, you
should have 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
Day 5 iiLii iiLii tablets of study medication
Day 6 Regular prednisolone iiLii iiLii tablets + iiLii iiLii tablets of study medicine
PREDNOS 2 Advice to participants - AD prednisolone, Version 1.1, Nov 22nd 2012
EudraCT Number: 2012-003476-39
Page 2 of 5
When the six days are completed, you should return to the previous regular prednisolone
dose that you were receiving.
Any other medicines that have been prescribed should continue unchanged.
Please contact your local hospital within 24 hours of commencing study medication to
inform your doctor or research nurse. Please take the opportunity to discuss any of your
symptoms that may be of concern to you and to check that you are 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 you develop 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 you become ill whilst taking this medication, please tell your doctor that you are taking
part in this study. If your doctor has any urgent queries about your medicine please give
them the following contact details – Dr Nicholas Webb, Telephone 0161 701 2961,
PREDNOS 2 Chief Investigator.
HOW TO STORE YOUR STUDY MEDICATION:
Please store your trial 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 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 you are seen
by a doctor, nurse or other healthcare professional because of any illness along with any
medicines prescribed or purchased by yourself.
If you come 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.
Please remember to bring the medicine package with you to each of your hospital
appointments. This is so as your doctor can assess that the study mediation has been
PREDNOS 2 Advice to participants - AD prednisolone, Version 1.1, Nov 22nd 2012
EudraCT Number: 2012-003476-39
Page 3 of 5
taken correctly. Your 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 you.
The PREDNOS 2 study co-ordinating centre is located at the Birmingham Clinical Trials Unit,
College of Medical & Dental Sciences, Robert Aitken Institute, University of Birmingham,
Edgbaston, Birmingham, B15 2TT, Tel 0121 415 9132/9133, Fax: 0121 415 9135, Email:
prednos2@trials.bham.ac.uk, Web address: www.birmingham.ac.uk/PREDNOS2 .
PREDNOS 2 Chief Investigator: Dr 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 participants - AD prednisolone, Version 1.1, Nov 22nd 2012
EudraCT Number: 2012-003476-39
Page 4 of 5
Steroid Treatment Card
PREDNOS 2 Advice to participants - AD prednisolone, Version 1.1, Nov 22nd 2012
EudraCT Number: 2012-003476-39
Page 5 of 5