The Lung Microbiome and Endobronchial Valve Treatment

NCT04932811 | Unknown

• 1 other identifier: 1-10-72-323-20
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Pulmonary Disease; Emphysema

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Formation of atelectasis

  2 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Aarhus University Hospital: lead

Study Sites (1)

Aarhus University Hospital

Aarhus, 8200, Denmark

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Fluid from bronchioalveolar lavage

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Emphysema

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Elisabeth Bendstrup, Professor

CONTACT

+45 7846 2201; karbends@rm.dk

Thomas D Christensen, Professor

CONTACT

tdc@clin.au.dk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Cand. med.

Study Record Dates

• First Submitted: June 13, 2021
• First Posted: June 21, 2021
• Study Start: June 16, 2021
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2025
• Last Updated: June 21, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)