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 email@example.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.
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.
Are the EXACT and E-RS qualified by the FDA and EMA for use
in drug development trials?
- On 13 April 2015, the EMA released a Draft Qualification Opinion of Qualification of Exacerbations of Chronic Pulmonary Disease Tool (EXACT), and EXACT-Respiratory Symptoms Measure (E-RS) for Evaluating Treatment Outcomes in Clinical Trials in COPD. This document specifies that the EXACT is qualified as an exploratory endpoint in drug development trials for the prevention of exacerbations in COPD and the E-RS is qualified as an exploratory endpoint in drug development trials evaluating the effect of treatment on respiratory symptoms of COPD.
- On 9 January 2014, the FDA released a Draft Guidance on the Qualification of the EXACT for the Measurement of Symptoms of Acute Bacterial Exacerbations of Chronic Bronchitis in Patients with Chronic Obstructive Pulmonary Disease. This document specifies that the EXACT is qualified as a measure of symptoms of acute bacterial exacerbation of chronic bronchitis in patients with COPD.
- On 8 March 2016, the FDA released a Draft Guidance on Evaluating Respiratory Symptoms in Chronic Obstructive Pulmonary Disease, a Patient-Reported Outcome, for the Measurement of Severity of Respiratory Symptoms in Stable Chronic Obstructive Pulmonary Disease: Qualification for Exploratory Use. This document specifies that the E-RS: COPD total score is qualified for exploratory use as a PRO instrument to measure respiratory symptoms of stable COPD in clinical studies.
- This site will be updated as new information becomes available.
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.
For more information, please contact the EXACT team at firstname.lastname@example.org.
Read more here.