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

October 28, 2019 updated by: Duke University

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

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.

Study Overview

Status

Terminated

Conditions

Detailed Description

This study is designed to collect information on the current level of symptoms and ability to breathe, treatment and outcomes of patients with 1) Chronic Obstructive Pulmonary Disease (COPD), or 2) in current or former smokers with respiratory symptoms but preserved pulmonary function or 3) in current or former smokers with respiratory symptoms and preserved ratio with impaired spirometry. This information will be used by the researchers to better understand the impact of COPD on patients. It will also help the researchers study the current recommendations for treatment of COPD.

Chronic obstructive pulmonary disease (COPD) represents a growing public health problem and is now the third leading cause of death in the United States. The risk of exacerbations, hospitalizations and death in patients with COPD tends to increase with increasing severity of airflow limitation. However, the correlation between forced expiratory volume in 1 second (FEV1), symptoms, and health-related quality of life is weak. The shortcomings of using airflow limitation alone to assess the clinical severity of COPD led the Global Initiative for Chronic Obstructive Lung Disease (GOLD) committee to develop a potentially more clinically meaningful approach to assess the impact of COPD on the patient. The GOLD committee has subsequently proposed a model for pharmacologic therapy of patients with stable COPD (i.e. those not currently experiencing a COPD exacerbation) according to GOLD risk group. The therapeutic recommendations proposed by GOLD are widely cited as a strategy for selecting therapy even though this model is predominantly based on expert opinion.

This study will acquire data in a community-based cohort in which patients with COPD or current or former smokers with respiratory symptoms will be classified into GOLD risk groups A-D at enrollment and followed longitudinally. This study will assess the frequency of change in GOLD risk group during 5 years of follow-up, look at the use of COPD medications this cohort and how provider-selected therapy for COPD compares to GOLD-recommended pharmacologic therapy thus addressing a critical knowledge gap in the scientific community.

Study Type

Observational

Enrollment (Actual)

452

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Kannapolis, North Carolina, United States, 28081
        • MURDOCK Study Office

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Subjects in The MURDOCK Registry and Biorepository Study cohort who are confirmed to have COPD or are symptomatic current or former smokers.

Description

Inclusion Criteria:

  • 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:

    1. COPD confirmed by spirometry performed at screening (as demonstrated by FEV1/FVC < 0.70) or
    2. 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
    3. 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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
patients with COPD

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Composite Endpoint
Time Frame: Measured at the completion of each year of follow-up (years 1, 2, 3, 4 and 5)
Composite of COPD exacerbation, all-cause hospitalization, and all-cause mortality
Measured at the completion of each year of follow-up (years 1, 2, 3, 4 and 5)

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in COPD Exacerbation
Time Frame: Measured at the completion of each year of follow-up (years 1, 2, 3, 4 and 5)
Measured at the completion of each year of follow-up (years 1, 2, 3, 4 and 5)
Change in All-Cause Hospitalization
Time Frame: Measured at the completion of each year of follow-up (years 1, 2, 3, 4 and 5)
Measured at the completion of each year of follow-up (years 1, 2, 3, 4 and 5)
Change in Respiratory-related Hospitalization
Time Frame: Measured at the completion of each year of follow-up (years 1, 2, 3, 4 and 5)
Measured at the completion of each year of follow-up (years 1, 2, 3, 4 and 5)
Change in All-Cause Mortality
Time Frame: Measured at the completion of each year of follow-up (years 1, 2, 3, 4 and 5)
Measured at the completion of each year of follow-up (years 1, 2, 3, 4 and 5)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Collaborators

Boehringer Ingelheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2016

Primary Completion (Actual)

April 19, 2018

Study Completion (Actual)

April 19, 2018

Study Registration Dates

First Submitted

July 13, 2016

First Submitted That Met QC Criteria

July 15, 2016

First Posted (Estimate)

July 20, 2016

Study Record Updates

Last Update Posted (Actual)

October 29, 2019

Last Update Submitted That Met QC Criteria

October 28, 2019

Last Verified

March 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00072667

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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