The Oral Steroids for Acute Cough (OSAC) Trial

• Research type

  Research Study

• Full 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

• IRAS ID

  102138

• Contact name

  Alastair Hay

• Eudract number

  2012-000851-15

• Research summary

  Most people get at least one chest infection every year. Many will visit their doctor to seek medical advice, and may have to take time off work. Their illness may also affect other responsibilities e.g. caring for dependents. Acute chest infections can cause symptoms lasting 3-4 weeks. There is currently no treatment that has been shown to reduce the duration or severity of symptoms. This includes antibiotics, which have not been shown to be effective in treating chest infections. Despite this, and strong evidence that inappropriate antibiotic prescribing encourages the development of antibiotic-resistant infections (e.g. MRSA and other serious hospital infections), most adults who visit their doctor still expect, and are prescribed, antibiotics. Some of the symptoms of chest infections are similar to those of asthma including cough, wheeze and phlegm. The medical profession has good evidence that prescribed ??cortisone steroid?? tablets and inhalers help patients with asthma. However, little research has been conducted to see if these ??steroids?? can have the same beneficial effects in non-asthmatic patients suffering from chest infections. In this trial we want to see if steroid tablets can help reduce the severity and duration of the symptoms of acute chest infections, and consequently reduce antibiotic consumption. Adult patients visiting their doctor to seek medical advice for a cough and its symptoms will be invited. Consenting patients will be asked to: take the trial medication (randomised allocation of prednisolone or placebo) for 5 days; record peak flow measurements and complete a symptom diary daily for >7 days and up to 28 days, record side effects for 10 days and receive weekly telephone calls from a researcher to answer questions about quality of life. Return of the completed symptom diary will mark the end of patient involvement. A review of primary care notes will be conducted after 3 months post-randomisation.

• REC name

  South West - Central Bristol Research Ethics Committee

• REC reference

  12/SW/0180

• Date of REC Opinion

  25 Oct 2012

• REC opinion

  Further Information Favourable Opinion