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Active Not Recruiting
NCT04932811
The Lung Microbiome and Endobronchial Valve Treatment
Conditions: Chronic Obstructive Pulmonary Disease, Emphysema
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 120
Sponsor: Aarhus University Hospital
Location: Aarhus University Hospital Aarhus
Summary
Lung emphysema is an incurable disease and is often associated with chronic obstructive pulmonary disease (COPD). Dyspnea is the main, debilitating symptom and is relieved by inhaled bronchodilators and rehabilitation. However, a substantial number of patients continue to suffer from dyspnea, and among these, many patients have severe hyperinflated lungs due to emphysema. For selected patients, lung transplantation or lung volume reduction by surgical removal (LVRS) of the most emphysematous parts of the lungs can improve symptoms and survival. However, LVRS has a relatively large risk of adverse events, and therefore not all patients are suitable for surgery. An alternative to LVRS is bronchial lung volume reduction with endobronchial valves (EBV), where one-way valves are inserted in the bronchial system. It has emerged as a valid treatment option, with reduction of hyperinflation and increased pulmonary function, quality of life, and exercise capacity.
The normal lung is colonized with several types of bacteria, and together these are called the microbiome. Some bacteria are potentially beneficial, while others are potentially harmful. After the insertion of EBVs, some patients develop chronic infections. The hypothesis is that the microbiome can affect the risk of chronic infection, and therefore the objective of this study is to assess the microbiome during the insertion of the EBVs and afterwards observe which patients develop chronic infection and whether these patients are harboring specific bacterial species.
Eligibility Criteria
Inclusion Criteria:
* COPD patients with emphysema selected for EBV treatment by a multidiciplinary team, independent of this study.
* Written informed consent
Exclusion Criteria:
\- Intake of oral antibiotics within 1 month before the procedure. Patients receiving prophylactic long-term treatment with antibiotics can be included.
Source: ClinicalTrials.gov (NCT04932811). StuddyBuddy aggregates publicly available trial information.