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ACTIVE NOT RECRUITING
NCT04932811

The Lung Microbiome and Endobronchial Valve Treatment

Sponsor: Aarhus University Hospital

View on ClinicalTrials.gov

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.

Official title: The Lung Microbiome in Patients With Emphysema and Chronic Obstructive Lung Disease Treated With Endobronchial Valves: Complications and Prognosis

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

120

Start Date

2021-06-16

Completion Date

2027-06-30

Last Updated

2026-09-25

Healthy Volunteers

No

Interventions

PROCEDURE

Endobronchial valve treatment

Insertion of endobronchial valves via bronchoscopy as a treatment for COPD

Locations (1)

Aarhus University Hospital

Aarhus, Denmark