The Lung Microbiome and Endobronchial Valve Treatment

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

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Obstructive Pulmonary Disease; Emphysema

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.

• Study Type: Observational
• Enrollment (Anticipated): 120

Contacts and Locations

• Study Contact: Name: Elisabeth Bendstrup, Professor; Phone Number: +45 7846 2201; Email: karbends@rm.dk
• Study Contact Backup: Name: Thomas D Christensen, Professor; Email: tdc@clin.au.dk

Study Locations

• Denmark
  • Aarhus, Denmark, 8200
    • Recruiting
    • Aarhus University Hospital
    • Contact: Elisabeth Bendstrup, Professor; Phone Number: +45 7846 2201; Email: karbends@rm.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The study population will consist of patients with emphysema treated at Aarhus University Hospital, Odense University Hospital or Rigshospitalet, selected for EBV treatment independent from this study.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pulmonary infection	Number and severity of pulmonary infection after surgery	2 years
Valve dysfunction	Dysfunction of valves requiring clean up	2 years
Microbiome	Microbiome in bronchioalveolar lavage	During surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Formation of atelectasis	Formation and maintainance of atelectasis after insertion of valve	2 years

Collaborators and Investigators

• Sponsor: Aarhus University Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): June 16, 2021
• Primary Completion (Anticipated): June 30, 2024
• Study Completion (Anticipated): June 30, 2025

Study Registration Dates

• First Submitted: June 13, 2021
• First Submitted That Met QC Criteria: June 13, 2021
• First Posted (Actual): June 21, 2021

Study Record Updates

• Last Update Posted (Actual): June 21, 2021
• Last Update Submitted That Met QC Criteria: June 13, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Pulmonary Emphysema; Emphysema
• Other Study ID Numbers: 1-10-72-323-20

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No