Detailed Descriptions

EXACT®

The EXAcerbations of Chronic pulmonary disease Tool (EXACT) is a 14-item patient-reported outcome (PRO) daily diary used to quantify and measure exacerbations of chronic obstructive pulmonary disease (COPD).

This instrument provides a single, standardized approach for assessing the symptomatic manifestations of COPD exacerbations, with a development and validation history consistent with guidelines proposed by the FDA, EMA, and well-known measurement principles.

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Exacerbations are events characterized by an acute, sustained worsening in the patient’s COPD beyond normal day-to-day variability, including an increase in respiratory symptoms such as dyspnea, cough, and sputum production that may require a change in treatment.

The EXACT total score, computed daily over time, is designed to standardize the assessment of the patient’s condition in order to capture this dynamic process.

EXACT scores complement and extend information provided by traditional health care resource utilization (HCRU) data by:

Standardizing the magnitude of symptomatic change around HCRU events (those seen in the clinic, emergency room, or hospital); and,
Quantifying frequency, severity, and duration of reported and unreported, symptom-defined events.

The EXACT may be used in longitudinal, natural history studies, or clinical trials, including:

Maintenance/prevention trials testing the efficacy of therapies to modify or prevent COPD exacerbations; and,
Acute treatment trials evaluating therapies to treat exacerbations of COPD.

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. See the summary of development methods here.

The EXACT has been translated into more than 55 languages. A full list of translations is available here.

To facilitate standardized use, an EXACT User Manual describing the instrument’s development, intended use, administration procedures, and scoring is provided to all licensed users.

The E-RS®:COPD

The Evaluating Respiratory Symptoms (E-RS):COPD scale is a derivative instrument used to measure the effect of treatment on the severity of respiratory symptoms in stable COPD.

The E-RS:COPD was designed to address the need for a standardized respiratory symptom diary with a development history consistent with good research practices and FDA PRO requirements. See the FDA PRO guidance here.
Formerly known as the EXACT-Respiratory Symptoms Scale (E-RS), it was renamed the E-RS: Evaluating Respiratory Symptoms measure at the request of the FDA, to avoid use of the term “EXACT” or “exacerbations” in cases were the E-RS is named in a product label. When referring specifically to its use in COPD, the proposed context of use for qualification, the instrument is now referred to as the “Evaluating Respiratory Symptoms in COPD (E-RS: COPD).”

The E-RS: COPD was qualified by the EMA (2015) and FDA (2016) as a PRO instrument to assess respiratory symptoms in patients with stable COPD.

In June 2023, Evidera and the COPD Foundation submitted a Type V Drug Master File (DMF) to the FDA with reference and supporting information related to responder definitions and longitudinal sensitivity to change of E-RS: COPD total and subscale scores.
The E-RS: COPD DMF is available as a reference to individual sponsors as they engage in discussions with the FDA regarding use of the instrument as a key endpoint in pivotal trials.
For additional information or to request a Letter of Authorization to access this DMF, send an e-mail to [email protected].

The E-RS:COPD utilizes the 11 respiratory symptom items contained in the 14-item EXACT.

The RS-Total score represents respiratory symptom severity, overall.
Three subscales can be used to assess breathlessness (RS-Breathlessness), cough and sputum (RS-Cough and Sputum), and chest-related symptoms (RS-Chest Symptoms).

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One diary, two uses.

The 11-item E-RS:COPD was developed and tested for use as part of the 14-item EXACT.
Subject and investigator burden is minimized by providing two validated uses for one diary:
Assessment of COPD exacerbations via EXACT Total Score; and,
Quantification of respiratory symptoms in stable COPD using RS-Total and subscale scores.

Because the 11-items comprising the E-RS:COPD are part of the EXACT, translations of the EXACT apply. The full list of translations is available here.

To facilitate standardized use, an E-RS:COPD User Manual describing the instrument’s development, intended use, administration procedures, and scoring is provided to all licensed users.

The E-RS®:IPF

The E-RS:IPF scale is an adaptation of the E-RS:COPD for use in Interstitial Pulmonary Fibrosis. The 11-item E-RS:COPD was evaluated for use as a measure of respiratory symptoms in studies of patients with interstitial pulmonary fibrosis (IPF).

The E-RS:IPF utilizes the 11 respiratory symptom items contained in the 14-item EXACT.

Four subscales can be used to assess breathlessness (IPF-Breathlessness), cough (IPF-Cough), sputum (IPF- Sputum), and chest-related symptoms (IPF-Chest Symptoms).

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Because the 11-items comprising the E-RS:IPF are part of the EXACT, translations of the EXACT apply. The full list of translations is available here.

To facilitate standardized use, an E-RS:IPF User Manual describing the instrument’s development, intended use, administration procedures, and scoring is provided to all licensed users.

Detailed Descriptions

EXACT®

The E-RS®:COPD

The E-RS®:IPF

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