The Oral Steroids for Acute Cough (OSAC) Trial

Not Applicable

Completed

• Conditions: Acute lower respiratory tract infection; Respiratory; Unspecified acute lower respiratory infection

• Registration Number: ISRCTN57309858
• Lead Sponsor: niversity of Bristol (UK)

Brief Summary

2015 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/25885677 2017 results in: http://www.ncbi.nlm.nih.gov/pubmed/28829884 2020 economic evaluation in https://pubmed.ncbi.nlm.nih.gov/32075830/ (added 17/02/2021)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-01-31
• Study Completion: 2014-04-30
• Last Update Posted: 1 March 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 436

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified