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Factors That Affect the Development of COPD Symptoms (The SCCOR_4 Study)
This study is enrolling participants by invitation only.
Sponsored by: National Heart, Lung, and Blood Institute (NHLBI)
Information provided by: National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier: NCT00740337
  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

MedlinePlus related topics: COPD (Chronic Obstructive Pulmonary Disease)
U.S. FDA Resources
Study Type: Observational
Study Design: Case Control, Cross-Sectional
Official Title: Specialized Center of Clinically Oriented Research: Alveolar and Airway Mechanisms of COPD. Airway Determinants: Innate Immune Signaling (Project 4)

Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Biospecimen Retention:   Samples With DNA

Biospecimen Description:

Plasma, serum, isolated RNA and DNA, lung tissue


Estimated Enrollment: 80
Study Start Date: October 2007
Estimated Study Completion Date: November 2011
Estimated Primary Completion Date: November 2011 (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 5 years after study entry 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:

  • Able to read and write in English
  • Able to participate in the informed consent process
  • Planned lung resection at BJH
  • Certain scores on pulmonary function tests done at BJH within 1 month before study entry
  • Acceptable chest CT scan done at BJH within 3 years before study entry

Exclusion Criteria:

  • Pregnant
  • Currently in prison
  • Unable to make rational decisions
  • Clinically significant lung disease other than COPD and the reason 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 (as determined from medical record review)
  • Systemic chemotherapy within 30 days before study entry
  • Any types of cancer that affect blood, bone marrow, or lymph nodes
  • Received thoracic radiation within 1 year before study entry
  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
Investigators
Principal Investigator: Michael J. Holtzman, MD Pulmonary and Critical Care, Washington University School of Medicine
  More Information

Responsible Party: Pulmonary and Critical Care, Washington University in St. Louis ( Michael J. Holtzman, MD, Professor of Medicine )
Study ID Numbers: 582, P50 HL084922-01
Study First Received: August 20, 2008
Last Updated: August 20, 2008
ClinicalTrials.gov Identifier: NCT00740337  
Health Authority: United States: Federal Government

Keywords provided by National Heart, Lung, and Blood Institute (NHLBI):
Chronic Obstructive Pulmonary Disease
COPD
Emphysema
Natural Killer T-cell
Interleukin-13
Innate Immune Signaling

Study placed in the following topic categories:
Pulmonary Emphysema
Emphysema
Lung Diseases, Obstructive
Respiratory Tract Diseases
Lung Diseases
Respiration Disorders
Chronic Disease
Pulmonary Disease, Chronic Obstructive

Additional relevant MeSH terms:
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on January 16, 2009