Factors That Affect the Development of COPD Symptoms

NCT ID: NCT00740337

Last Updated: 2018-06-18

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 82 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2007-10-31
• Study Completion Date: 2016-02-29

Brief Summary

Chronic obstructive pulmonary disease (COPD) is the fourth most common cause of death in the United States. There is no cure and the disease gets worse over time. Although it usually occurs in people who smoke cigarettes, researchers do not know exactly how smoking leads to COPD. This study will compare blood and tissue samples from smokers and nonsmokers with and without COPD to determine why some COPD symptoms occur in some people and not others.

Detailed Description

COPD is a chronic lung disease in which the lungs' airways and balloon-like air sacs, called alveoli, are damaged, lose their shape, and become floppy. As a result, they cannot fully inflate to allow the maximum amount of air through. COPD is usually the result of many years of cigarette smoking. Breathing in other kinds of lung irritants, such as pollution, dust, or chemicals, over a long period of time may also cause or contribute to COPD. Some people with COPD have an excess of mucus in their lungs, possibly caused by an overactive immune response, which can lead to coughing and shortness of breath. Although cigarette smoking seems to make this symptom worse, researchers are not sure why it occurs in some people and not others. This study will examine and compare blood and lung tissue samples from smokers and nonsmokers with and without COPD to determine what physiological differences, environmental factors, genes, and biomarkers contribute to the development of and symptoms associated with COPD.

Before their scheduled lung resection surgery, participants in this study will attend one study visit. It will last approximately 1 to 2 hours and will consist of answering questions about medical history, filling out health questionnaires, and providing a blood sample. After the surgery, study researchers will take the lung tissue that was removed and examine it in a laboratory. Participants will be contacted by study staff if, when examining the lung tissue, researchers discover that a participant has a medical disorder that current treatment can stop or improve. Also, participants will be contacted at the end of the study to answer brief questions about their health.

Conditions

Pulmonary Disease, Chronic Obstructive

Study Design

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

Study Groups

COPD

Participants in this group will be people who have COPD and plan to undergo lung resection surgery at Barnes-Jewish Hospital (BJH).

No interventions assigned to this group

Control

Participants in this group will be people who do not have COPD and plan to undergo lung resection surgery at BJH.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Ability to read and write in English
• Able to participate in the informed consent process
• Planned lung resection at BJH
• Acceptable pulmonary function tests done at BJH within 1 month of enrollment
• Acceptable chest CT scan done at BJH within 3 years of enrollment

Exclusion Criteria

• Pregnant
• Prisoner
• Vulnerable populations
• Clinically significant lung disease other than COPD and the indication for resection (e.g., cystic fibrosis, bronchiectasis, obliterative bronchiolitis, airway lesion)
• Coexisting active chronic inflammatory or collagen vascular disease, immune deficiency of any kind, or previous organ transplant
• Known active hepatitis B, hepatitis C, or HIV/AIDS (not prospectively evaluated)
• Systemic chemotherapy within past 1 month (30 days)
• Hematologic malignancy or thoracic radiation within past year

• Minimum Eligible Age: 18 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 J. Holtzman, MD

Role: PRINCIPAL_INVESTIGATOR

Pulmonary and Critical Care, Washington University School of Medicine

Locations

Washington University School of Medicine

St Louis, Missouri, United States

Countries

United States

Other Identifiers

582

Identifier Type: -

Identifier Source: org_study_id