Divergences from the early protocol
exhaled breath condensate
INFLAMMATION
This study reports data from a large research initiative registered on ClinicalTrails.gov (ID#: NCT02630511) in 2015. The study has since evolved and the following updates to the research procedures were made: a) pulmonary inflammatory markers were to be evaluated in exhaled breath condensate (EBC). Initial testing determined that EBC did not contain detectable levels of analytes and EBC testing was thus discontinued. b) The initial protocol planned for testing at 15 minutes, 1h and 24h following each challenge, which was proven unfeasible from operational and participant time-commitment perspectives. As such, data were only collected at the 1h time-point; and c) the analysis of inflammatory markers was planned to be outsourced to an external laboratory; however, more cost-effective options within our institution were discovered and used (see Outcome measures–systemic inflammation).