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

Sponsor
Duke University (Other)
Overall Status
Terminated
CT.gov ID
NCT02838108
Collaborator
Boehringer Ingelheim (Industry)
452
Enrollment
1
Location
18.6
Actual Duration (Months)
24.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Actual Enrollment :
    452 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    MURDOCK COPD Observational Study: The Relationship Between GOLD Risk Group and Clinical Outcomes in a Community-based COPD Cohort
    Actual Study Start Date :
    Oct 1, 2016
    Actual Primary Completion Date :
    Apr 19, 2018
    Actual Study Completion Date :
    Apr 19, 2018

    Arms and Interventions

    Arm Intervention/Treatment
    patients with COPD

    Outcome Measures

    Primary Outcome Measures

    1. Change in Composite Endpoint [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

    Secondary Outcome Measures

    1. Change in COPD Exacerbation [Measured at the completion of each year of follow-up (years 1, 2, 3, 4 and 5)]

    2. Change in All-Cause Hospitalization [Measured at the completion of each year of follow-up (years 1, 2, 3, 4 and 5)]

    3. Change in Respiratory-related Hospitalization [Measured at the completion of each year of follow-up (years 1, 2, 3, 4 and 5)]

    4. Change in All-Cause Mortality [Measured at the completion of each year of follow-up (years 1, 2, 3, 4 and 5)]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    40 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 MURDOCK Study Office Kannapolis North Carolina United States 28081

    Sponsors and Collaborators

    • Duke University
    • Boehringer Ingelheim

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Duke University
    ClinicalTrials.gov Identifier:
    NCT02838108
    Other Study ID Numbers:
    • Pro00072667
    First Posted:
    Jul 20, 2016
    Last Update Posted:
    Oct 29, 2019
    Last Verified:
    Mar 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Additional relevant MeSH terms:
    Bronchitis
    Bronchitis, Chronic
    Lung Diseases, Obstructive
    Pulmonary Disease, Chronic Obstructive
    Emphysema

    Study Results

    No Results Posted as of Oct 29, 2019