Factors That Affect the Development of COPD Symptoms

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT00740337
First received: August 20, 2008
Last updated: September 14, 2012
Last verified: September 2012
  Purpose

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.


Condition
Pulmonary Disease, Chronic Obstructive

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Specialized Center of Clinically Oriented Research: Alveolar and Airway Mechanisms of COPD. Airway Determinants: Innate Immune Signaling (Project 4)

Resource links provided by NLM:


Further study details as provided by Washington University School of Medicine:

Biospecimen Retention:   Samples With DNA

Plasma, serum, isolated RNA and DNA, lung tissue


Enrollment: 82
Study Start Date: October 2007
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
COPD
Participants in this group will be people who have COPD and plan to undergo lung resection surgery at Barnes-Jewish Hospital (BJH).
Control
Participants in this group will be people who do not have COPD and plan to undergo lung resection surgery at BJH.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

People in this study will be invited to participate if they plan to undergo lung resection surgery at BJH.

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00740337

Locations
United States, Missouri
Washington University School of Medicine
St. Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Investigators
Principal Investigator: Michael J. Holtzman, MD Pulmonary and Critical Care, Washington University School of Medicine
  More Information

No publications provided

Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT00740337     History of Changes
Other Study ID Numbers: 582, P50 HL084922-01
Study First Received: August 20, 2008
Last Updated: September 14, 2012
Health Authority: United States: Federal Government

Keywords provided by Washington University School of Medicine:
Chronic Obstructive Pulmonary Disease
COPD
Emphysema
Natural Killer T-cell
Interleukin-13
Innate Immune Signaling

Additional relevant MeSH terms:
Chronic Disease
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Disease Attributes
Pathologic Processes
Respiratory Tract Diseases
Lung Diseases, Obstructive

ClinicalTrials.gov processed this record on April 15, 2014