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

NCT02838108 | Terminated

• 1 other identifier: Pro00072667
• Study Type: observational
• Target: 452
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Pulmonary Disease (COPD); Emphysema; Chronic Bronchitis

Outcome Measures

Primary Outcomes (1)

• Change in Composite Endpoint

  Composite of COPD exacerbation, all-cause hospitalization, and all-cause mortality

  Measured at the completion of each year of follow-up (years 1, 2, 3, 4 and 5)

Secondary Outcomes (4)

• Change in COPD Exacerbation

  Measured at the completion of each year of follow-up (years 1, 2, 3, 4 and 5)

• Change in All-Cause Hospitalization

  Measured at the completion of each year of follow-up (years 1, 2, 3, 4 and 5)

• Change in Respiratory-related Hospitalization

  Measured at the completion of each year of follow-up (years 1, 2, 3, 4 and 5)

• Change in All-Cause Mortality

  Measured at the completion of each year of follow-up (years 1, 2, 3, 4 and 5)

Study Arms (1)

patients with COPD

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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:
• COPD confirmed by spirometry performed at screening (as demonstrated by FEV1/FVC \< 0.70) or
• 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
• 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

You may not qualify if:

• Participation in an investigational drug trial at the time of screening
• Subjects listed for lung transplantation at the time of screening

Sponsors & Collaborators

• Duke University: lead
• Boehringer Ingelheim: collaborator

Study Sites (1)

MURDOCK Study Office

Kannapolis, North Carolina, 28081, United States

Location

Related Publications (16)

• Hoyert DL, Xu J. Deaths: preliminary data for 2011. Natl Vital Stat Rep. 2012 Oct 10;61(6):1-51.

  PMID: 24984457 BACKGROUND

• Vestbo J, Hurd SS, Agusti 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.

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• Agusti A, Edwards LD, Celli B, Macnee W, Calverley PM, Mullerova 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.

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• 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.

  PMID: 24321803 BACKGROUND

• 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.

  PMID: 22997207 BACKGROUND

• Soriano JB, Alfageme I, Almagro P, Casanova C, Esteban C, Soler-Cataluna 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.

  PMID: 23187891 BACKGROUND

• 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.

  PMID: 23169314 BACKGROUND

• 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. doi: 10.1183/09031936.05.00034805. No abstract available.

  PMID: 16055882 BACKGROUND

• 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. doi: 10.1183/09031936.05.00035205. No abstract available.

  PMID: 16264058 BACKGROUND

• 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. doi: 10.1164/ajrccm.166.1.at1102. No abstract available.

  PMID: 12091180 BACKGROUND

• 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.

  PMID: 19720809 BACKGROUND

• Zou H, Hastie T. Regularization and variable selection via the elastic net. Journal of the Royal Statistical Society 2005;series B:301-320.

  BACKGROUND

• Hans C, Dobra A, West M. Shotgun Stochastic Search for "Large p" regression" Journal of the American Statistical Society 2007;102:507-516.

  BACKGROUND

• Powell T, Bagnell M. Your "Survival" guide to using time-dependent covariates. SAS Global Forum 2012:68-178.

  BACKGROUND

• Lin G, So Y, Johnston G. Analyzing survival data with competing risks using SAS system. SAS Global Forum 2012:344-352

  BACKGROUND

• 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):762-771. doi: 10.1111/j.1541-0420.2007.00952.x. Epub 2007 Dec 20.

  PMID: 18162112 BACKGROUND

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Emphysema; Bronchitis, Chronic

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Bronchitis; Respiratory Tract Infections; Infections; Bronchial Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2016
• First Posted: July 20, 2016
• Study Start: October 1, 2016
• Primary Completion: April 19, 2018
• Study Completion: April 19, 2018
• Last Updated: October 29, 2019

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)