The Lung Microbiome and Endobronchial Valve Treatment

Brief summary (registry, in English)

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.

What you commit to

• Study type: Observational
• Planned participants: 120
• From 16 Jun 2021 to the primary completion date, 30 Oct 2026
• 1 site in 1 country
• Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Who the study is looking for

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

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