Study Title: Oral Steroids for acute cough (OSAC) trial.
Local PCRN Contact: Aman Johal
Tel: 02476 574127
Email: amanpreet.johal@warwick.ac.uk
Study Co-ordinator:David TimminsTel: 01865 289290
Email:david.timmins@phc.ox.ac.uk
Type of Study: Intervention
Funder : NIHR National School for Primary Care Research (NIHR NSPCR)
Sponsor : University of Bristol
Study Objectives:
To test whether the use of oral Prednisolone 40mg daily for 5 days will reduce the duration
of moderately bad or worse cough, and its associated severity, by at least 20% when
compared to placebo
Number of Patients Needed:
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436 nationally
60 patients for WMS ( 12 per 5 practices )
Practice Involvement in the Study:
1) Identify eligible patient(s) opportunistically: The practice receptionist /nurse will
identify non asthmatic patients , who have presented to the practice for an
appointment because they have an acute cough ( persistent for <28days) . The
receptionist /nurse will give the patient a patient information sheet (PIS) about the
study whilst they are waiting for their appointment.
2)Routine appointment (index consultation): with GP /Nurse Practitioner*
*GCP training essential (
APPROX 10 MINS)
GP / Nurse Practitioner will:
 Invite patient to take part in study, take verbal consent and screen the patient to see
if they are eligible for the trial. Using the inclusion /exclusion criteria listed.
Check patient notes for interactions with existing medications and perform a clinical
examination for respiratory observations.
 Check whether the patient has one more symptom (such as phlegm, chest pain,
wheeziness or shortness of breath) suggestive to an acute lower respiratory tract
infection (RTI) in addition to their acute cough.
 Request eligible patient to attend a subsequent baseline appointment, ideally on the
same day with a nurse.
 Authorise the trial prescription and give this to clinician carrying out the baseline
appointment.
 As the patients GP/Nurse practitioner continue to manage the patient in accordance
to RTI NICE guidelines.
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3)Baseline Appointment : with Practice Nurse /Research Nurse* (APPROX 1 HR)
*GCP training essential
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Obtain written informed consent whilst explaining the trial , measure the patients
peak flow.
Documenting clinical data on a Case Report form (CRF). The patient will need to be
registered online and all patient data needs to be entered within 5 working days .
Patients will be issued with a patient pack and they will be given an explanation on
how to take trial medication , measure their peak flow twice a day (mornings &
evenings) and they will be told how to complete the symptom diary.
4)Notes Review :completed by a practice nurse /research nurse (APPROX 30 MINS)
 For each patient consented into the study a primary care notes review will need to
be completed after 3months.
 Report any Adverse events and Severe Adverse events to the study team
Patient Involvement:
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Read patient information sheet in waiting area
Patient must have the capacity & willingness to take part by providing verbal and
written consent.
Patients will be asked to take the trial drug (for up to 5 days), patients will be asked
complete a symptoms diary (for up to 28 days), questions will be based on
symptom severity and patients will be asked to measure their own peak flow twice a
day (mornings & evenings ), and receive telephone calls on a weekly basis from the
study team to answer questions on health care resources and quality of life for up to
4 weeks.
Eligibility Criteria:
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Aged 18 years or over
Consulting for an acute (≤ 28 days) cough as the main presenting symptom
In the past 24 hours, the patient has had at least one of the screening symptoms
(listed below)localizing to the lower respiratory tract and suggestive of an acute
lower respiratory tract infection (RTI):
1. Phlegm (sputum)
2. Chest pain
3. Shortness of breath
4. Wheeze
 Patient and practice have sufficient time for consent and randomisation into the trial
by the end of today
 Patient able and willing to give informed consent , complete the daily symptom
diary and receive weekly telephone calls from the trial team.
Exclusion Criteria:
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Known lung cancer or chronic lung disease (e.g. cystic fibrosis, COPD,
bronchiectasis)
Has an ‘active’ diagnosis of asthma (for which any treatment has been given in the
past 5 years)
The patient’s RTI warrants same day hospital admission or immediate antibiotics
(NB: use of delayed prescription does not preclude OSAC trial participation):
According to NICE guidelines, the patient warrants immediate antibiotic
treatment by virtue of ONE OR MORE of the following:
a Is clinically very unwell or has symptoms and signs suggestive of
pneumonia, e.g. tachypnoea (>20bpm), unilateral chest signs or
consolidation, or hypoxia (oxygen saturation <94%) or other systemic
infection, e.g. suspected bacteraemia OR
b Is at high risk of complications, including patients with chronic heart, chronic
lung (e.g. COPD, bronchiectasis and cystic fibrosis), chronic renal, chronic
liver or neuromuscular disease or immunosuppression; or with complications
from previous episodes of lower respiratory tract infection, e.g. hospital
admission for pneumonia OR
c AGED OVER 65 years with at least TWO of the following criteria, or AGED
OVER 80 years with at least ONE of the following criteria:
I Unplanned hospitalisation within the previous year
II Type 1 or Type 2 diabetes
III History of cardiac failure
Requires an antibiotic today to treat another infection unrelated to their acute
cough, e.g. a co-existing cellulitis
Recently (≤1 month) used inhaled corticosteroids
Recently (≤1 month) used short (up to 2 weeks) course systemic corticosteroids
Currently using, or has previously (≤12 months) used systemic steroids for a
cumulative period greater than 2 weeks, i.e. “long-term” use
Known to be pregnant, is trying to conceive or is at risk of pregnancy (e.g. unwilling
to take a reliable form of contraception) in the next month
Currently breast-feeding
This is not the patient’s usual practice, i.e. patient is visiting or is not intending to
stay with the practice for the 3 month trial follow up period
Previously randomised in the OSAC trial
Has been involved in another medicinal trial within the last 90 days or any other
clinical research study within the last 30 days
Is unable to give informed consent or complete the trial paperwork (including the
symptom diary) through mental incapacity, e.g. major current psychiatric illness,
learning difficulties and dementia
Known immune-deficiency, e.g. chemotherapy causing immunosuppression,
asplenia or splenic dysfunction, advanced cancer or HIV infection
Has any of the following (A – P) known contra-indications or cautions to oral
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steroids
Current OR previous history of:
1. Peptic ulcer disease
2. Previous TB
3. NO previous chickenpox AND known recent (≤28 days) history of close
personal contact with chickenpox OR herpes zoster
4. Known allergy to prednisolone or other OSAC trial tablet ingredients (potato
starch, lactose monohydrate, colloidal silicon dioxide, sodium starch
glycolate, magnesium stearate), galactose intolerance, Lapp lactase
deficiency or glucose-galactose malabsorption
5. Osteoporosis
6. Glaucoma
7. Suspected ocular herpes simplex
8. Cushing’s disease
9. Epilepsy
10. Severe affective disorders, e.g. manic depression, previous steroid
psychosis
11. Previous steroid myopathy
12. L. Intention to use a live vaccine in the next 3 months (NB: assess live
vaccine status by cross-checking with BNF)
13. Uncontrolled diabetes (HbA1C > 8%)
14. Uncontrolled hypertension
15. Taking other interacting medication (e.g. phenytoin and anti-coagulants)
16. ANY OTHER BNF listed contra-indication or caution
Is unable to swallow tablets
Reimbursement: The service support costs have been agreed for the study and are
on a per patient recruited basis - £315 if the study is run with a practice nurse and £276.84
if the study is run by a PCRN Research Nurse.
For further details contact:
amanpreet.johal@warwick.ac.uk
Thank you for your interest in this study