Novel methods within a randomised controlled trial in respiratory disease

A systematic review was also completed for the use of mucoactives in acute respiratory failure, which together with the other methods explored in the CLEAR trial, informed the conditional design of a new trial in respiratory medicine.<br><br>Results:<br>Remote spirometry was completed by patients at home with moderate adherence and was not significantly different to supervised spirometry performed at clinic visits for a number of lung function tests (FEV1, FVC, FEF25-75 and PEF).

The EMBARC definition was found to be equivalent to the Fuchs criteria for classifying exacerbations and it was feasible to assess key symptoms using remote patient reported outcomes. In addition, the symptoms contained within EMBARC corresponded to those that deteriorated most at the start of exacerbations. For the SWAT, modifications to the invitation letters had no significant effect on recruitment and giving patients enrolled in the trial a thank you card had no effect on retention, albeit both SWAT had small sample sizes.

The systematic review found limited evidence for mucoactives in critically ill patients and justified the design of a large robust clinical trial.<br><br>Conclusion:<br>A comprehensive programme of important methodological research can be undertaken within a large clinical trial with aims that are distinct from those of the main trial. Remote spirometry and using the EMBARC definition with patient reported outcomes can be implemented in further bronchiectasis trials to increase pragmatism and quality.

Further research is needed to identify methods to increase recruitment and retention. A large, randomised trial for common mucoactives in the critically ill is needed.