Issue Date: March 26, 2018
Issued by: Center for Drug Evaluation and Research
Topic(s): Clinical – Medical
Status: Final
Chronic Obstructive Pulmonary Disease: Use of the St. George’s Respiratory Questionnaire as a PRO Assessment Tool Guidance for Industry
The purpose of this guidance is to provide information to sponsors developing drugs for the treatment of chronic obstructive pulmonary disease (COPD).2 This guidance addresses the use of the St. George’s Respiratory Questionnaire (SGRQ), a patientreported outcome measure (PRO) assessment tool used in interventional clinical trials in patients with COPD.
Download the Guidance Document
