The project tests the hypothesis that oral corticosteroids tablets (prednisolone) can reduce the duration of moderately bad or worse cough, and the severity of the unpleasant symptoms associated with a lower respiratory tract infection (LRTI).
LRTI is one of the most common conditions managed in UK primary care and costs an estimated £200m per year in NHS consultations and antibiotic prescriptions. Antibiotics continue to be heavily prescribed for LRTI, even though it is known that they are not effective in treating uncomplicated cases, and several other studies of potential alternative treatments have not come up with strong evidence of effectiveness. The OSAC team is looking for a clinically relevant difference in cough duration and/or symptom severity of at least 20%. If steroids do prove clinically effective, the team will also assess how cost-effective they could be as a potential alternative future treatment option.
“Our patient target for OSAC is 436 and we originally anticipated a rate of attrition (primary outcome data loss) of 20%,” said Harriet Downing, OSAC Trial Manager from the Centre for Academic Primary Care at Bristol. “Because of our very dedicated Research Nurse, Sue Harris, and our excellent Administrative Assistant, Kate Rowley, we have managed to keep this down to 11%.”
Our patient target for OSAC is 436 and we originally anticipated a rate of attrition (primary outcome data loss) of 20%. Because of our very dedicated Research Nurse, Sue Harris, and our excellent Administrative Assistant, Kate Rowley, we have managed to keep this down to 11%." - Harriet Downing, OSAC Trial Manager
This means the trial needs fewer than 436 to achieve 90% power to answer the research question. “We currently have 359 participants in the trial, and we need to get only a further 30-40 (rather than 80) to give us a sufficiently good dataset,” said Downing. “We have a good chance of achieving that or of getting pretty close in the four remaining weeks of recruitment.”