Biomarkers and Genetic Factors Related to Emphysema

NCT ID: NCT00757120

Last Updated: 2018-05-04

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 145 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2007-10-31
• Study Completion Date: 2011-09-30

Brief Summary

Emphysema, a common type of chronic obstructive pulmonary disease (COPD), is a long-term lung disease that is usually caused by cigarette smoking. This study will examine both current smokers and former smokers who have emphysema, as well as current and former smokers who do not have emphysema, to determine if certain factors found in the blood are related to the risk of developing emphysema.

Detailed Description

COPD is a disease in which the lung is damaged and breathing passages become partly obstructed, making it difficult to breathe. Millions of people in the United States have COPD, and it is the fourth leading cause of death in the country. Symptoms include coughing, excess mucus production, shortness of breath and wheezing. Emphysema and chronic bronchitis are illnesses associated with COPD. Emphysema is usually the result of many years of cigarette smoking, but it remains unknown exactly how cigarette smoking causes emphysema. The purpose of this study is to examine current and former smokers who have emphysema and those who do not have emphysema to determine if certain biomarkers or genetic factors are associated with an increased risk of developing the disease. Specifically, study researchers will examine various genes and two proteins, membrane-type-1 matrix metalloproteinase (MT1-MMP) and extracellular matrix metalloproteinase inducer (EMMPRIN), to determine the role they play in the development of emphysema.

Participants will attend one study visit, which will include a medical history review, a blood collection, lung function testing, a 6-minute walk test, and a chest computed tomography (CT) scan. A portion of blood will be stored for current and future genetic research. Participants will also complete questionnaires to collect information on activities, health, and quality of life. Some participants will be invited to return for a bronchoscopy, which is a procedure that allows a doctor to sample the inside of the lungs. Study researchers will contact all participants at the end of the study to collect follow-up medical information.

Conditions

Emphysema; Pulmonary Disease, Chronic Obstructive

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

1

This group will include current and former smokers who have emphysema.

No interventions assigned to this group

2

This group will include current and former smokers who do not have emphysema.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Able to read and write English
• At least 30 pack-year smoking history (the equivalent of smoking a pack a day for 30 years)
• Able to participate in the informed consent process
• Relatively stable clinical status for the past six weeks (i.e., no illness in the 6 weeks before study entry)

• Global Initiative for Chronic Obstructive Lung Disease (GOLD) class II, III, or IV COPD, as determined by post-bronchodilator spirometry values OR
• More than minimal emphysema on an acceptable-quality chest CT scan

• GOLD class I COPD or GOLD class 0 (2005 classification), as determined post-bronchodilator spirometry values AND
• No or minimal emphysema on an acceptable-quality chest CT scan

Exclusion Criteria

• Pregnant
• Prisoner
• Vulnerable populations
• Recent illness (defined as increased cough, sputum production, worsening malaise, or need for unscheduled physician visit in the 6 weeks prior to enrollment)
• Coexisting active chronic inflammatory or collagen vascular disease, immunodeficiency of any kind, non-cutaneous malignancy (melanoma is an exclusion), or previous organ transplant
• Congenital abnormalities of the lung or previous lung surgery
• Known active hepatitis B, hepatitis C, or HIV/AIDS (not prospectively evaluated)
• CT evidence of lung disease other than emphysema (including significant fibrosis, bronchiectasis, consolidation, or indeterminate nodules)

• Minimum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Washington University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael Holtzman, MD

Role: STUDY_DIRECTOR

Pulmonary and Critical Care, Washington University in St. Louis

Steven Brody, MD

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

Washington University School of Medicine

St Louis, Missouri, United States

Countries

United States

References

Atkinson JJ, Lutey BA, Suzuki Y, Toennies HM, Kelley DG, Kobayashi DK, Ijem WG, Deslee G, Moore CH, Jacobs ME, Conradi SH, Gierada DS, Pierce RA, Betsuyaku T, Senior RM. The role of matrix metalloproteinase-9 in cigarette smoke-induced emphysema. Am J Respir Crit Care Med. 2011 Apr 1;183(7):876-84. doi: 10.1164/rccm.201005-0718OC. Epub 2010 Nov 5.

Reference Type: DERIVED

PMID: 21057003 (View on PubMed)

Other Identifiers

577

Identifier Type: -

Identifier Source: org_study_id