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Clinical Trials/NCT04932811
NCT04932811
Recruiting
Not Applicable

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

Aarhus University Hospital1 site in 1 country120 target enrollmentJune 16, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic Obstructive Pulmonary Disease
Sponsor
Aarhus University Hospital
Enrollment
120
Locations
1
Primary Endpoint
Valve dysfunction
Status
Recruiting
Last Updated
4 years ago

Overview

Brief Summary

Lung emphysema is often associated with chronic obstructive pulmonary disease (COPD) and without any cure. 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 severely hyperinflated lungs due to predominant emphysema. For selected patients, lung transplantation or lung volume reduction by surgical removal (LVRS) of the most emphysematous parts of the lung can improve symptoms and survival. However, LVRS is related to complications and not all patients are suitable for surgery. An alternative to LVRS is bronchial lung volume reduction with endobronchial valves (EBV). One-way valves are inserted in the bronchial system using a bronchoscope and it has emerged as a valid treatment option with similar effects as LVRS with reduction of hyperinflation and increasing pulmonary function, quality of life, and exercise capacity.

The normal lung is colonized with several types of bacteria, and together this is called the microbiome. Some bacteria are potentially beneficial, while others are potentially harmful. After the insertion EBV, some patients develop chronic infections. The hypothesis is that the microbiome can affect the risk of this chronic infection, and therefore the objective of this study is to access the microbiome during the insertion of the EBV, and afterwards observe which patients develop chronic infection and if these patients are harbouring specific types of bacteria.

Detailed Description

The objective of this study is primarily to investigate the significance of the lung microbiome on the outcome and morbidity after EBV treatment. Second, to investigate the evolution of the lung microbiome in patients later requiring valve removal or clean-up. Before the insertion of the EBV, but during the procedure, the patient will undergo a bronchoalveolar lavage (BAL). BAL fluid will undergo bacterial profiling through S16-ribosomal analysis and ordinary bacterial culturing. Number of infections and need for clean-up or valve removal will be registered during the following 24 months, where the patient follows the ordinary follow-up programme. As a secondary part of the study, during the potential clean-up or valve removal, the removed material will again undergo S16-ribosomal analysis and bacterial culturing to investigate shift in microbiome.

Registry
clinicaltrials.gov
Start Date
June 16, 2021
End Date
June 30, 2025
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Aarhus University Hospital
Responsible Party
Principal Investigator
Principal Investigator

Kirstine Hermann

Cand. med.

Aarhus University Hospital

Eligibility Criteria

Inclusion Criteria

  • COPD patients with emphysema selected for EBV treatment by multidiciplinary team, independent of this study.
  • Written informed consent

Exclusion Criteria

  • Intake of oral antibiotics within 1 month before the procedure. Patients receiving preventive long-term treatment with antibiotics can be included.

Outcomes

Primary Outcomes

Valve dysfunction

Time Frame: 2 years

Dysfunction of valves requiring clean up

Microbiome

Time Frame: During surgery

Microbiome in bronchioalveolar lavage

Pulmonary infection

Time Frame: 2 years

Number and severity of pulmonary infection after surgery

Secondary Outcomes

  • Formation of atelectasis(2 years)

Study Sites (1)

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