Objectives:
A validation study in Chronic Obstructive Pulmonary Disease sufferers, to address the relationship between a patient self-report measure of exacerbation likelihood, the actual occurrence of exacerbations, and changes in COPD symptoms. This relationship was to be analysed with the use of an electronic patient diary. This was a non IMP study, however, was part of a broader development program. If patients were able to reliably predict oncoming exacerbation, it would add weight to the argument that patients should be allowed to self-regulate their medication to pre-emptively prevent COPD exacerbation.
Scope:
An open, European, prospective, validation study, with approximately 240 outpatients, men and women between 40 and 80 years of age with a clinical diagnosis of severe COPD and a history of at least two exacerbations of COPD in last year, either smokers or previous smokers. The countries to be considered were UK, France, Denmark and Hungary - approximately 10 sites in each country. The study was scheduled to last 16 months, from protocol development to archiving.
Challenges:
Some countries seemed to have higher site interest and recruiting potential than others (UK was particularly good). The study was working to very tight timelines, to fit with plans to begin pre-emptive interventional studies in mid-2007.
Solutions:
The site distribution increased in UK. An interim analysis was planned to allow an interim assessment of whether patient reported outcomes were predictive (since the mid-2007 deadline for final analysis was not feasible).
Outcome:
The study has been placed on hold due to a revision of the client’s development program but may still be rolled out as part of a larger interventional study.