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

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ClinicalTrials.gov Identifier: NCT02838108
Recruitment Status : Suspended (Sponsor Decision to Stop Recruitment)
First Posted : July 20, 2016
Last Update Posted : April 2, 2018
Sponsor:
Collaborator:
Boehringer Ingelheim
Information provided by (Responsible Party):
Duke University

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
Chronic Obstructive Pulmonary Disease (COPD) Emphysema Chronic Bronchitis

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
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 : October 2016
Estimated Primary Completion Date : April 19, 2018
Estimated Study Completion Date : April 19, 2018

Group/Cohort
patients with COPD



Primary Outcome Measures :
  1. 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


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


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Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02838108


Locations
United States, North Carolina
MURDOCK Study Office
Kannapolis, North Carolina, United States, 28081
Sponsors and Collaborators
Duke University
Boehringer Ingelheim

Publications:
Zou H, Hastie T. Regularization and variable selection via the elastic net. Journal of the Royal Statistical Society 2005;series B:301-320.
Hans C, Dobra A, West M. Shotgun Stochastic Search for "Large p" regression" Journal of the American Statistical Society 2007;102:507-516.
Powell T, Bagnell M. Your "Survival" guide to using time-dependent covariates. SAS Global Forum 2012:68-178.
Lin G, So Y, Johnston G. Analyzing survival data with competing risks using SAS system. SAS Global Forum 2012:344-352

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT02838108     History of Changes
Other Study ID Numbers: Pro00072667
First Posted: July 20, 2016    Key Record Dates
Last Update Posted: April 2, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Emphysema
Bronchitis
Bronchitis, Chronic
Respiratory Tract Diseases
Pathologic Processes
Bronchial Diseases
Respiratory Tract Infections