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NCT Number: NCT04932811

The Lung Microbiome and Endobronchial Valve Treatment

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.

Active, not recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Aarhus University Hospital

Aarhus, 8200, Denmark

About this study

The objective of this study is primarily to investigate the effect of the lung microbiome on outcomes 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, during the procedure, the patient will undergo a bronchoalveolar lavage (BAL). BAL fluid will be used for bacterial profiling through 16S ribosomal analysis and conventional bacterial culture. The number of infections and the need for clean-up or valve removal will be registered during the following 24 months, during which the patient follows the ordinary follow-up programme. As a secondary part of the study, during potential clean-up or valve removal, the removed material will again undergo 16S ribosomal analysis and culture to investigate shifts in the microbiome.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Endobronchial valve treatment

Procedure

Insertion of endobronchial valves via bronchoscopy as a treatment for COPD

Primary outcomes

  1. Number of pulmonary infections

    Time frame: 2 years

    Number and severity of pulmonary infection after surgery

  2. Frequency of Valve dysfunction

    Time frame: 2 years

    Dysfunction of valves requiring clean up

  3. Diversity of Microbiome

    Time frame: During surgery

    Diversity of microbiome

Secondary outcomes

  1. Frequency of formation of atelectasis

    Time frame: 2 years

    Formation and maintainance of atelectasis after insertion of valve

Interested in participating?

Active, not recruiting

This study is active but is not currently recruiting participants.

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Sponsors and collaborators

Lead sponsor

Aarhus University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2026
Study completion
2027
First posted
Jun 21, 2021
Registry last updated
Sep 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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