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The Oral Steroids for Acute Cough (OSAC) Trial
ISRCTN ISRCTN57309858
DOI 10.1186/ISRCTN57309858
ClinicalTrials.gov identifier
EudraCT number
Public title The Oral Steroids for Acute Cough (OSAC) Trial
Scientific title What is the clinical and cost effectiveness of oral steroids in the treatment of acute lower respiratory tract infection (LRTI)? A placebo controlled randomised trial
Acronym OSAC
Serial number at source 13751
Study hypothesis 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 no steroid treatment (usual care).

A two-arm, individually-randomised, placebo-controlled, blinded superiority trial comparing oral steroids with placebo in patients attending primary care with acute LRTI.

More details can be found at: http://public.ukcrn.org.uk/Search/StudyDetail.aspx?StudyID=13751
Lay summary Lay summary under review 3
Ethics approval 12/SW/0180
Study design Two arm individually randomised placebo controlled blinded superiority trial
Countries of recruitment United Kingdom
Disease/condition/study domain Acute lower respiratory tract infection
Participants - inclusion criteria 1. Aged 18 years or over
2. Consulting for an acute (<= 28 days) cough as the main presenting symptom
3. In the past 24 hours, the patient has had at least one of the screening symptoms listed below (a-d), localizing to the lower respiratory tract and suggestive of an acute lower respiratory tract infection (RTI):
3.1. Phlegm (sputum)
3.2. Chest pain
3.3. Shortness of breath
3.4. Wheeze
4. Patient and practice have sufficient time for consent and randomisation into the trial by the end of today
5. Patient able and willing to give informed consent themselves
6. Patient able and willing to complete the daily symptom diary themselves
7. Patient able and willing to receive weekly telephone calls from the trial team
Participants - exclusion criteria 1. Known lung cancer or chronic lung disease (e.g. cystic fibrosis, COPD, bronchiectasis)
2. Has an ‘active’ diagnosis of asthma (for which any treatment has been given in the past 5 years)
3. 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:
1. 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
2. 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

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:
1. Unplanned hospitalisation within the previous year
2. Type 1 or Type 2 diabetes
3. History of cardiac failure
4. Requires an antibiotic today to treat another infection unrelated to their acute cough, e.g. a co-existing cellulitis
5. Recently (<=1 month) used inhaled corticosteroids
6. Recently (<=1 month) used short (up to 2 weeks) course systemic corticosteroids
7. Currently using, or has previously (<=12 months) used systemic steroids for a cumulative period greater than 2 weeks, i.e. “long-term” use
8. 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
9. Currently breast-feeding
10. 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
11. Previously randomised in the OSAC trial
12. Has been involved in another medicinal trial within the last 90 days or any other clinical research study within the last 30 days
13. 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
14. Known immune-deficiency, e.g. chemotherapy causing immunosuppression, asplenia or splenic dysfunction, advanced cancer or HIV infection
15. Has any of the following known contra-indications or cautions to oral steroids current OR previous history of:
15.1. Peptic ulcer disease
15.2. Osteoporosis
15.3. Previous TB
15.4. Glaucoma
15.5. No previous chickenpox AND known recent (<=28 days) history of close personal contact with chickenpox OR herpes zoster
15.6. Suspected ocular herpes simplex
15.7. Cushing’s disease
15.8. Epilepsy
15.9. 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
15.10. Severe affective disorders, e.g. manic depression, previous steroid psychosis
15.11. Previous steroid myopathy
15.12. Intention to use a live vaccine in the next 3 months (NB: assess live vaccine status by cross-checking with BNF)
Current history only:
15.13. Uncontrolled diabetes (HbA1C > 8%)
15.14. Taking other interacting medication (e.g. phenytoin and anti-coagulants)
15.15. Uncontrolled hypertension
15.16. Any other BNF listed contra-indication or caution
15.17. Is unable to swallow tablets

Clinicians will be asked to use the British National Formulary (BNF) and their clinical prescribing systems to check for significant interactions for all patients. A SOP will be produced to describe the checking process.
Anticipated start date 01/02/2013
Anticipated end date 30/04/2014
Status of trial Completed
Patient information material
Target number of participants UK Sample Size: 436
Interventions Oral prednisolone or placebo, Oral prednisolone (40mg daily) or matched placebo, for up to five consecutive days
Primary outcome measure(s) Duration of moderately bad or worse cough (using a validated1 web/paper based symptom diary)
Secondary outcome measure(s) 1. The mean of all symptom severity scores on days 2 to 4 (where day 1 is the day after the consultation day, measured using the symptom diary).
2. Antibiotic consumption (symptom diary)
3. Duration of steroid tablet use (symptom diary)
4. Total duration and severity of other symptoms (cough until very little problem; phlegm; wheeze; fever; chest pain; shortness of breath; sleep disturbance; activity disturbance; and feeling unwell) and abnormal peak flow (symptom diary1)
5. Adverse events including reconsultation for a documented deterioration in illness or hospital admission (symptom diary and primary care notes review)
6. Patient satisfaction with treatment and intention to consult for future similar illnesses (symptom diary)
7. Clinical diagnosis of asthma at 3 months (primary care notes review)
8. Quality of life using the EQ-5D (as recommended by NICE2, web/paper based questionnaire)
9. NHS treatment and investigation (e.g. chest x-rays, reconsultation) costs (primary care notes review), out-of-pocket patient costs, and societal cost of time off work (symptom diary).
Sources of funding National Institute for Health Research (NIHR) (UK) - School for Primary Care Research
Trial website
Publications
Contact name Mrs  Harriet  Downing
  Address Department of Social Medicine
Canynge Hall
Whiteladies Road
  City/town Bristol
  Zip/Postcode BS8 2PR
  Country United Kingdom
  Email harriet.downing@bristol.ac.uk
Sponsor University of Bristol (UK)
  Address Senate House
Tyndall Avenue
  City/town Bristol
  Zip/Postcode BS8 1TH
  Country United Kingdom
  Sponsor website: http://www.bris.ac.uk/
Date applied 31/01/2013
Last edited 31/01/2013
Date ISRCTN assigned 31/01/2013
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