Factors That Affect the Development of COPD Symptoms

Pulmonary Disease, Chronic Obstructive Clinical Trial

Official title:

Specialized Center of Clinically Oriented Research: Alveolar and Airway Mechanisms of COPD. Airway Determinants: Innate Immune Signaling (Project 4)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00740337
• Other study ID #: 582
• Status: Completed
• Start date: October 2007
• Est. completion date: February 2016

Study information

• Verified date: June 2018
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Disease
• Lung Diseases
• Pulmonary Disease, Chronic Obstructive

Locations

Country	Name	City	State
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States,