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

This study is currently recruiting participants.
Verified April 2017 by Duke University
Sponsor:
ClinicalTrials.gov Identifier:
NCT02838108
First Posted: July 20, 2016
Last Update Posted: August 8, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Boehringer Ingelheim
Information provided by (Responsible Party):
Duke University
  Purpose
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
Chronic Obstructive Pulmonary Disease (COPD) Emphysema Chronic Bronchitis

Study Type: Observational
Study Design: 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

Further study details as provided by Duke University:

Primary Outcome Measures:
  • 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:
  • 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) ]

Estimated Enrollment: 850
Actual Study Start Date: October 2016
Estimated Study Completion Date: April 2024
Estimated Primary Completion Date: July 2023 (Final data collection date for primary outcome measure)
Groups/Cohorts
patients with COPD

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 Chronic Obstructive Pulmonary Disease (COPD). 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 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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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.
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 with COPD confirmed by spirometry performed at screening (as demonstrated by FEV1/FVC < 0.70)
  • Subjects must have a greater than or equal to 10 pack-year history of tobacco exposure

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
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


Contacts
Contact: Laura Johnson 919-323-6831 laura.m.johnson@duke.edu
Contact: Micki Roseman (919) 257-3298 micki.roseman@duke.edu

Locations
United States, North Carolina
MURDOCK Study Office Recruiting
Kannapolis, North Carolina, United States, 28081
Contact: Micki Roseman    919-257-3298    micki.roseman@duke.edu   
Contact: Abha Singh    (704) 250-5861      
Principal Investigator: Scott Palmer, MD, MHS         
Principal Investigator: Jamie Todd, MD         
Sponsors and Collaborators
Duke University
Boehringer Ingelheim
  More Information

Publications:
Hoyert DL, Xu J. Deaths: preliminary data for 2011. Natl Vital Stat Rep. 2012 Oct 10;61(6):1-51.
Vestbo J, Hurd SS, Agustí AG, Jones PW, Vogelmeier C, Anzueto A, Barnes PJ, Fabbri LM, Martinez FJ, Nishimura M, Stockley RA, Sin DD, Rodriguez-Roisin R. Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease: GOLD executive summary. Am J Respir Crit Care Med. 2013 Feb 15;187(4):347-65. doi: 10.1164/rccm.201204-0596PP. Epub 2012 Aug 9. Review.
Agusti A, Edwards LD, Celli B, Macnee W, Calverley PM, Müllerova H, Lomas DA, Wouters E, Bakke P, Rennard S, Crim C, Miller BE, Coxson HO, Yates JC, Tal-Singer R, Vestbo J; ECLIPSE Investigators. Characteristics, stability and outcomes of the 2011 GOLD COPD groups in the ECLIPSE cohort. Eur Respir J. 2013 Sep;42(3):636-46. doi: 10.1183/09031936.00195212. Epub 2013 Jun 13.
Han MK, Muellerova H, Curran-Everett D, Dransfield MT, Washko GR, Regan EA, Bowler RP, Beaty TH, Hokanson JE, Lynch DA, Jones PW, Anzueto A, Martinez FJ, Crapo JD, Silverman EK, Make BJ. GOLD 2011 disease severity classification in COPDGene: a prospective cohort study. Lancet Respir Med. 2013 Mar;1(1):43-50. doi: 10.1016/S2213-2600(12)70044-9. Epub 2012 Sep 3.
Lange P, Marott JL, Vestbo J, Olsen KR, Ingebrigtsen TS, Dahl M, Nordestgaard BG. Prediction of the clinical course of chronic obstructive pulmonary disease, using the new GOLD classification: a study of the general population. Am J Respir Crit Care Med. 2012 Nov 15;186(10):975-81. doi: 10.1164/rccm.201207-1299OC. Epub 2012 Sep 20.
Soriano JB, Alfageme I, Almagro P, Casanova C, Esteban C, Soler-Cataluña JJ, de Torres JP, Martinez-Camblor P, Miravitlles M, Celli BR, Marin JM. Distribution and prognostic validity of the new Global Initiative for Chronic Obstructive Lung Disease grading classification. Chest. 2013 Mar;143(3):694-702. doi: 10.1378/chest.12-1053.
Centers for Disease Control and Prevention (CDC). Chronic obstructive pulmonary disease among adults--United States, 2011. MMWR Morb Mortal Wkly Rep. 2012 Nov 23;61(46):938-43.
Miller MR, Hankinson J, Brusasco V, Burgos F, Casaburi R, Coates A, Crapo R, Enright P, van der Grinten CP, Gustafsson P, Jensen R, Johnson DC, MacIntyre N, McKay R, Navajas D, Pedersen OF, Pellegrino R, Viegi G, Wanger J; ATS/ERS Task Force. Standardisation of spirometry. Eur Respir J. 2005 Aug;26(2):319-38.
Pellegrino R, Viegi G, Brusasco V, Crapo RO, Burgos F, Casaburi R, Coates A, van der Grinten CP, Gustafsson P, Hankinson J, Jensen R, Johnson DC, MacIntyre N, McKay R, Miller MR, Navajas D, Pedersen OF, Wanger J. Interpretative strategies for lung function tests. Eur Respir J. 2005 Nov;26(5):948-68.
ATS Committee on Proficiency Standards for Clinical Pulmonary Function Laboratories. ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med. 2002 Jul 1;166(1):111-7.
Jones PW, Harding G, Berry P, Wiklund I, Chen WH, Kline Leidy N. Development and first validation of the COPD Assessment Test. Eur Respir J. 2009 Sep;34(3):648-54. doi: 10.1183/09031936.00102509.
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
Elashoff RM, Li G, Li N. A joint model for longitudinal measurements and survival data in the presence of multiple failure types. Biometrics. 2008 Sep;64(3):762-71. Epub 2007 Dec 20.

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT02838108     History of Changes
Other Study ID Numbers: Pro00072667
First Submitted: July 13, 2016
First Posted: July 20, 2016
Last Update Posted: August 8, 2017
Last Verified: April 2017
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


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