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

Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02838108
• Other study ID #: Pro00072667
• Status: Terminated
• Start date: October 2016
• Est. completion date: April 19, 2018

Study information

• Verified date: March 2018
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 452
• Est. completion date: April 19, 2018
• Est. primary completion date: April 19, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bronchitis
• Bronchitis, Chronic
• Chronic Bronchitis
• Chronic Obstructive Pulmonary Disease (COPD)
• Emphysema
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Locations

Country	Name	City	State
United States	MURDOCK Study Office	Kannapolis	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	Boehringer Ingelheim

Country where clinical trial is conducted

United States, 

References & Publications (16)

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. — View Citation

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. Erratum in: Am J Respir Crit Care Med. 2016 May 15;193(10):1185. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

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

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. — View Citation

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. — View Citation

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

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. — View Citation

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. — View Citation

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

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. — View Citation

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. — View Citation

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

* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in COPD Exacerbation		Measured at the completion of each year of follow-up (years 1, 2, 3, 4 and 5)
Secondary	Change in All-Cause Hospitalization		Measured at the completion of each year of follow-up (years 1, 2, 3, 4 and 5)
Secondary	Change in Respiratory-related Hospitalization		Measured at the completion of each year of follow-up (years 1, 2, 3, 4 and 5)
Secondary	Change in All-Cause Mortality		Measured at the completion of each year of follow-up (years 1, 2, 3, 4 and 5)