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- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00740337
Factors That Affect the Development of COPD Symptoms
Specialized Center of Clinically Oriented Research: Alveolar and Airway Mechanisms of COPD. Airway Determinants: Innate Immune Signaling (Project 4)
Descripción general del estudio
Estado
Condiciones
Descripción detallada
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.
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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Missouri
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Saint Louis, Missouri, Estados Unidos, 63110
- Washington University School of Medicine
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
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COPD
Participants in this group will be people who have COPD and plan to undergo lung resection surgery at Barnes-Jewish Hospital (BJH).
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Control
Participants in this group will be people who do not have COPD and plan to undergo lung resection surgery at BJH.
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Michael J. Holtzman, MD, Pulmonary and Critical Care, Washington University School of Medicine
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 582
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