The Lung Microbiome and Endobronchial Valve Treatment

Condition(s) studied

Investigational drug(s) / intervention(s)

Endobronchial valve treatment: Insertion of endobronchial valves via bronchoscopy as a treatment for COPD

Study 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

Primary outcome measure(s)

• Number of pulmonary infections — 2 years
  Number and severity of pulmonary infection after surgery
• Frequency of Valve dysfunction — 2 years
  Dysfunction of valves requiring clean up
• Diversity of Microbiome — During surgery
  Diversity of microbiome

Trial sites (1)

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