Qualification

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.