Clinical trial NCT02838108: The Relationship Between GOLD Risk Group and Clinical Outcomes in a Community-based COPD Cohort
Official title: MURDOCK COPD Observational Study: The Relationship Between GOLD Risk Group and Clinical Outcomes in a Community-based COPD Cohort
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Emphysema
Chronic Bronchitis
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: Boehringer Ingelheim
First posted: 2016-07-20
Enrollment: 452
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility 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

Primary outcomes:
measure: Change in Composite Endpoint
timeFrame: Measured at the completion of each year of follow-up (years 1, 2, 3, 4 and 5)
Secondary outcomes:
measure: Change in COPD Exacerbation
timeFrame: Measured at the completion of each year of follow-up (years 1, 2, 3, 4 and 5)
measure: Change in All-Cause Hospitalization
timeFrame: Measured at the completion of each year of follow-up (years 1, 2, 3, 4 and 5)
measure: Change in Respiratory-related Hospitalization
timeFrame: Measured at the completion of each year of follow-up (years 1, 2, 3, 4 and 5)
measure: Change in All-Cause Mortality
timeFrame: Measured at the completion of each year of follow-up (years 1, 2, 3, 4 and 5)
Other outcomes:
Locations:
city: Kannapolis
country: United States
facility: MURDOCK Study Office
state: North Carolina
Study officials:
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