The Oral Steroids for Acute Cough (OSAC) Trial
| ISRCTN | ISRCTN57309858 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN57309858 |
| Protocol serial number | 13751 |
| Sponsor | University of Bristol (UK) |
| Funder | National Institute for Health Research (NIHR) (UK) - School for Primary Care Research |
- Submission date
- 31/01/2013
- Registration date
- 31/01/2013
- Last edited
- 17/02/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Plain English summary of protocol
Background and study aims
Most people get at least one chest infection every year and a high proportion present to health services and need to take time off work/other responsibilities. Symptoms are frequently prolonged (lasting 3 to 4 weeks) and no treatment (including antibiotics) has been shown to reduce either symptom severity or duration. Despite this, and strong evidence that inappropriate antibiotic prescribing fuels the development of the antibiotic-resistant bacterial strains (including MRSA), around 75% of adults presenting to GPs are still prescribed antibiotics. Many of the symptoms of chest infections (cough, phlegm, shortness of breath and wheeze) overlap with those of asthma attacks. While there is good evidence that steroids help patients with asthma, very little research has been conducted to assess if steroids can have the same beneficial effects in non-asthmatic patients suffering from chest infections. More evidence is needed to help doctors to understand if a high dose of steroids (given by tablets) are better than antibiotics, and could help doctors and patients to rely less on antibiotics. A high dose has been selected to maximise the chances of the study detecting an effect. If effects are found, lower doses will be tested in the future.
Who can participate?
Non-asthmatic adults with a chest infection
What does the study involve?
Participants are randomly allocated to be given either a 5-day course of (active) steroid tablets or placebo (dummy) tablets. They are asked to complete a daily symptom diary for up to 4 weeks.
What are the possible benefits and risks of participating?
If the use of steroids was to reduce the annual cost of treating chest infections by as little as 1%, then the NHS would recoup the cost of the study in one year. Participation will not affect patients’ access to all other aspects of usual care and, in an emergency, their doctor will be able to find out which treatment they were given.
Where is the study run from?
University of Bristol (UK)
When is the study starting and how long is it expected to run for?
February 2013 to April 2014
Who is funding the study?
National Institute for Health Research (NIHR) (UK)
Who is the main contact?
Harriet Downing
harriet.downing@bristol.ac.uk
Contact information
Scientific
Department of Social Medicine
Canynge Hall
Whiteladies Road
Bristol
BS8 2PR
United Kingdom
| harriet.downing@bristol.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Two-arm individually randomised placebo-controlled blinded superiority trial |
| Secondary study design | Randomised controlled 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 |
| Study acronym | OSAC |
| 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 no steroid treatment (usual care). |
| Ethics approval(s) | 12/SW/0180 |
| Health condition(s) or problem(s) studied | Acute lower respiratory tract infection |
| Intervention | Oral prednisolone (40 mg daily) or matched placebo for up to five consecutive days |
| Intervention type | Drug |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Prednisolone |
| Primary outcome measure(s) |
Duration of moderately bad or worse cough (using a validated web/paper based symptom diary) |
| Key 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) |
| Completion date | 30/04/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 436 |
| Key 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 |
| Key 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. |
| Date of first enrolment | 01/02/2013 |
| Date of final enrolment | 30/04/2014 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
BS8 2PR
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 22/08/2017 | Yes | No | |
| Protocol article | protocol | 07/03/2015 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No | ||
| Other publications | economic evaluation | 18/02/2020 | 17/02/2021 | Yes | No |
Editorial Notes
17/02/2021: Publication reference added.
23/08/2017: Publication reference added.
