- ICH GCP
- Registre américain des essais cliniques
- Essai clinique 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)
Aperçu de l'étude
Statut
Les conditions
Description détaillée
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.
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
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Missouri
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Saint Louis, Missouri, États-Unis, 63110
- Washington University School of Medicine
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
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 d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / 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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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Michael J. Holtzman, MD, Pulmonary and Critical Care, Washington University School of Medicine
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 582
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