Qualification for use in drug development trials in COPD
The history of the EXACT and E-RS are described in Leidy and Murray 2013 and Murray and Leidy 2018.
A list of publications using the EXACT and/or E-RS are provided here.
8 March 20168 March 2016
9 January 20149 January 2014
These documents specify that the EXACT and E-RS:COPD are qualified for use as exploratory endpoints in drug development trials evaluating the effect of treatment on exacerbations (EXACT) and respiratory symptoms (E-RS:COPD) of COPD.
This does NOT preclude their use as secondary, co-primary, or primary endpoints. Sponsors should discuss their proposed use of the EXACT and/or E-RS with regulatory authorities prior to positioning in pivotal trials. Decisions related to positioning and potential for labeling claims will be made on a case-by-case basis.