FDA Includes First PRO Measure for COPD


Applied Clinical Trials

Applied Clinical TrialsApplied Clinical Trials-10-01-2016
Volume 25
Issue 10

Updated guidance incorporates the use of a patient-reported outcomes questionnaire-which could enable more endpoints and greater patient stratification for COPD trials.

Chronic obstructive pulmonary disorder (COPD) is on track to be the third-leading cause of death worldwide by 2020. Beyond the currently approved drugs, which treat the symptoms of the disease, there are limited drugs that address the underlying inflammation of COPD or affect disease progression. In May, the FDA issued its first update to the draft guidance on developing drugs for COPD since 2007. 

Of note, the guidance includes the use of a patient-reported health-related quality of life questionnaire-The St. George’s Respiratory Questionnaire (SGRQ). According to an FDA press release, the SGRQ has been used extensively since its introduction 20 years ago, and has large support among COPD experts as a key endpoint toward developing new COPD drugs. 

Kai-Michael Beeh, MD, founder and medical director of the Respiratory Research Institute in Wiesbaden, Germany, told Applied Clinical Trials the new FDA guidance reflects the knowledge gained in the past nine years since the original draft guidance was released. Beeh says the update allows for other endpoints in COPD trials that are not just granted on lung function. “It’s a step forward and offers encouragement to use stratification in clinical trials and increase the likelihood of success.”

However, diagnosing COPD in patients remains an obstacle. As pointed out in The Lancet Respiratory Medicine Commission’s recent 54-page report, “Meeting the challenge of COPD care delivery in the USA: a multiprovider perspective,” patients report delays in diagnosis of, on average, two years and nine months. Patients cited delay factors including their own belief that early symptoms were due to decreased fitness, being overweight, or ageing, especially those who were current or former smokers. 

Another problem, according to the report, is the spirometer, which measures forced expiratory volume (FEV) to determine lung function. Primary care providers note they lack trained staff, training for results interpretation, and in-office time to conduct spirometry tests, which can lead to both under- or over-diagnosis of COPD. Achim Schuelke, EVP of Respiratory at ERT Research, told Applied Clinical Trials that spirometer use in clinical trials would suffer the same fate if left to untrained staff and interpretation.

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