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 : Terminated (Sponsor Decision to Stop Recruitment)
First Posted : July 20, 2016
Last Update Posted : June 4, 2018
|Condition or disease|
|Chronic Obstructive Pulmonary Disease (COPD) Emphysema Chronic Bronchitis|
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|
|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|
|Actual Primary Completion Date :||April 19, 2018|
|Actual Study Completion Date :||April 19, 2018|
|patients with COPD|
- 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
- Change in COPD Exacerbation [ Time Frame: 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) ]
- Change in Respiratory-related Hospitalization [ Time Frame: 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) ]
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
|United States, North Carolina|
|MURDOCK Study Office|
|Kannapolis, North Carolina, United States, 28081|