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Welcome to the EXACT-PRO® website

This site was designed to provide you with information about the EXACT® and E-RS™, two patient-reported outcome measures for use in clinical studies of chronic obstructive pulmonary disease (COPD).

The site includes an overview of the methods used to develop these instruments and resources and references for further information.

The E-RS has a new name

We are pleased to announce a name change for the EXAcerbations of Chronic Pulmonary Disease Tool-Respiratory Symptoms [E-RS]).

During the development of the Draft Qualification Statement for the E-RS, the FDA asked us to change the name of the instrument so the term “Exacerbation” would not appear in labeling related to symptoms of stable disease. In response to this request, we are pleased to announce the new name for the E-RS:

Evaluating Respiratory Symptoms (E-RS™) measure

When referring to its use in COPD, the proposed context of use for qualification, the full name is:

Evaluating Respiratory Symptoms in COPD (E-RS™: COPD)

The EXACT and E-RS User Manuals have been updated accordingly. Licensed users may login and download these updated manuals. If you do not have an account/password and would like to set one up, please email exactpro@evidera.com and a member of our team will create an account for you.

-Posted 7 March 2016-

EXACT and E-RS overview

For those unfamiliar the EXACT and E-RS, here are the basics:

What is the EXACT-PRO?

  • EXACT is an acronym to represent “The EXAcerbations of Chronic Pulmonary Disease Tool.”
  • PRO is an acronym for “Patient-Reported Outcome.”
  • The EXACT is a daily diary designed to standardize the method for evaluating acute exacerbations of chronic obstructive pulmonary disease (COPD) and chronic bronchitis (AECB) in natural history studies and clinical trials.
Read more here.


What is the E-RS?

  • The E-RS (Evaluating Respiratory Symptoms) is a derivative instrument of the EXACT, designed to address the need for a standardized daily diary to assess respiratory symptoms in patients with stable COPD.
  • Formerly known as the EXACT-Respiratory Symptoms Scale, it was renamed the Evaluating Respiratory Symptoms (E-RS) measure, announced 7 March 2016.
  • When referring specifically to its use in COPD, the proposed context of use for qualification, the full name is now “Evaluating Respiratory Symptoms in COPD (E-RS™: COPD).”
  • The E-RS is administered as part of the EXACT.
Read more here.


Are the EXACT and E-RS qualified by the FDA and EMA for use
in drug development trials?

Read more here.


Are the EXACT and E-RS ready and available for use in clinical studies?

  • Yes, both have been and are currently being used in clinical trials of COPD.
Read more here.

For more information, please contact the EXACT team at exactpro@evidera.com.



The EXACT® was developed under the EXACT-PRO Initiative®, a multi-year, multi-sponsor project involving experts in pulmonary medicine, instrument development, and drug development regulatory issues, dedicated to the development of a single, standardized instrument for evaluating the effects of treatment on acute exacerbations of COPD.
Read more here.
The EXACT®, E-RS™, and all related materials are owned by Evidera and are subject to Evidera’s Legal Disclaimer.
© 2016 Evidera     +1 301 654 9729 (US)     +44 (0) 208 576 5000 (EU)