Acute lower respiratory tract infection Respiratory Unspecified acute lower respiratory infection
Conditions
Interventions
Oral prednisolone (40 mg daily) or matched placebo for up to five consecutive days
Sponsors
University of Bristol (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
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 OS
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Duration of moderately bad or worse cough (using a validated web/paper based symptom diary) | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 diary) 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 NICE, 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) | — |
Countries
United Kingdom
Outcome results
None listed