Related Experiment Video
Updated: Jul 18, 2026

Generation of a Chronic Obstructive Pulmonary Disease Model in Mice by Repeated Ozone Exposure
Published on: August 25, 2017
U.S. regulatory perspective on the minimal clinically important difference in chronic obstructive pulmonary disease
1Office of Drug Evaluation II, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Room 13B-28, HFD-102, 5600 Fishers Lane, Rockville, Maryland 20857, USA. meyerro@cder.fda.gov
Abstract:
This paper outlines the regulatory issues surrounding the determination and use of minimally clinically important differences (MCID) in assessing measures of outcomes from treatments of chronic obstructive pulmonary disease (COPD). To place this discussion in context, it is important to understand the current state of approved therapies for COPD, as well as newer directions in therapy. This paper discusses the currently available, approved drug therapies for COPD in the United States and how they were approved. This is followed by an overview on the use of MCID for assessing outcomes in therapies for COPD, as well the more general experience with MCID from the U.S. regulatory perspective.
Related Concept Videos
Chronic Obstructive Pulmonary Disease-I: Introduction
Chronic Obstructive Pulmonary Disease-V: Management
Smoking Cessation
Chronic Obstructive Pulmonary Disease-IV: Assessement and Diagnostic Studies
Medical History
Chronic Obstructive Pulmonary Disease III: Chronic Bronchitis Features
Chronic Obstructive Pulmonary Disease-V: Nursing Management
Assessment
Chronic Obstructive Pulmonary Disease
Smoking is a primary risk factor for COPD, with over 80% of patients having a history of it. Patients typically experience progressive dyspnea or labored breathing, frequent coughing, and recurrent pulmonary infections. Many eventually succumb to respiratory failure, characterized by...