The Relationship Between GOLD Risk Group and Clinical Outcomes in a Community-based COPD Cohort

Stopped early

Conditions studied: Chronic Obstructive Pulmonary Disease (COPD), Emphysema, Chronic Bronchitis

In brief

This is an observational study examining outcomes and treatment patterns in a community-based cohort of subjects with Chronic obstructive pulmonary disease (COPD) who are based in the Kannapolis, NC area.

Key facts

Study ID

NCT02838108

Run by

Duke University

People needed

452

Starts

2016-10-01

Expected to finish

2018-04-19

Last updated by the study team

2019-10-29

Who can join

Age: 40 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects must have the ability to understand and sign a written informed consent form, which must be obtained prior to initiation of data collection
• Subjects must be ≥40 years of age
• Subjects must have a greater than or equal to 10 pack-year history of tobacco exposure
• Subjects must have:
• COPD confirmed by spirometry performed at screening (as demonstrated by FEV1/FVC < 0.70) or
• If the FEV1/FVC is ≥ 0.7, the subject must be a symptomatic current or past Smoker with Respiratory Symptoms (SRS) as defined by meeting the following spirometry and respiratory symptom criteria at screening: FVC ≥ 80% of predicted and CAT score ≥ 10 or
• Preserved Ratio Impaired Spirometry (PRISm), defined as a reduced
• FEV1 in the setting of a preserved FEV1/FVC ratio:
• FEV1/FVC ≥ 0.7 AND FEV1 < 80% of predicted

You may not qualify if…

• Participation in an investigational drug trial at the time of screening
• Subjects listed for lung transplantation at the time of screening

Where it is running

• MURDOCK Study Office — Kannapolis, North Carolina, United States

Full record on ClinicalTrials.gov

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