Members of the COPD Biomarker Qualification Consortium have proposed that the chronic obstructive pulmonary disease (COPD) Assessment Test (CAT) should be used as a US Food and Drug Administration (FDA) clinical outcomes assessment tool, according to an article published in the American Journal of Respiratory and Critical Care Medicine.
CAT is a short digital or paper tool that can be used to assess the symptoms and effects of COPD, developed by an expert panel on COPD in accordance with “FDA guidance on the development of patient-reported outcome measures supporting product labeling.” Since its launch in 2009, CAT has been used globally, with >90 approved and linguistically validated translations. Further, clinical and observational studies, as well as randomized controlled trials, have used CAT as a measure of health-related quality of life and clinical efficacy, respectively. CAT has also been evaluated and evaluated across several chronic respiratory diseases, including interstitial pulmonary fibrosis, asthma, and bronchiectasis.
Between-country functional testing has showed “excellent internal consistency.” Additionally, test-retest in stable patients has been “very good.” In a sample of patients from the United States, correlation with the COPD-specific St. George’s Respiratory Questionnaire was r=0.80. Overall, CAT scores have reliably detected health-related quality of life changes in people with COPD. Because of the multidimensional nature of the disease, the Consortium noted that CAT is a “reliable, simple, and effective clinical outcomes assessment tool.”
Routine CAT assessment is feasible and can also increase the efficacy of office visit encounters; as such, the use of CAT has been advocated for by “multiple professional bodies” and has been incorporated in multiple electronic health record systems in both the United States and the United Kingdom.
Members of the COPD Biomarker Qualification Consortium believe that CAT is a tool that meets the goals of a drug development tool as defined by the 21st Century Cures Act. As such, the Drug Master File — an integrated data summary supporting CAT validation and supporting efficacy claims — has been submitted to the FDA.
“This recommendation is based on its frequent use in clinical practice in Global Initiative for Chronic Obstructive Lung Disease (GOLD) to assess health status, as well as its frequent application as an entry criterion and efficacy outcome in clinical development programs,” the authors concluded.
Disclosure: Several study authors declared affiliations with the pharmaceutical industry. Please see the original reference for a full list of authors’ disclosures.
Müllerová H, Dransfield MT, Thomashow B, et al; on behalf the COPD Biomarker Qualification Consortium and the CAT Governance Board. Clinical development and research applications of the COPD Assessment Test (CAT) [published online December 9, 2019]. Am J Respir Crit Care Med. doi:10.1164/rccm.201907-1369PP