Chronic Obstructive Pulmonary DiseaseNCT04932811
The Lung Microbiome and Endobronchial Valve Treatment
An observational study of Chronic Obstructive Pulmonary Disease and Emphysema, run by Aarhus University Hospital at 1 site in Denmark.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease, Emphysema
- What is being tested?
- Endobronchial valve treatment
- Type of treatment
- Surgery or procedure
- How many people
- 120 participants
- Where
- 1 siteDenmark
- Study dates
- 16 Jun 2021to 30 Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- COPD patients with emphysema selected for EBV treatment by a multidiciplinary team, independent of this study.
- Written informed consent
Who cannot join
- Intake of oral antibiotics within 1 month before the procedure. Patients receiving prophylactic long-term treatment with antibiotics can be included.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Lung Microbiome in Patients With Emphysema and Chronic Obstructive Lung Disease Treated With Endobronchial Valves: Complications and Prognosis
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.
Read the detailed description
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.
- Conditions
- Chronic Obstructive Pulmonary Disease, Emphysema
- Being tested
- Endobronchial valve treatment
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Emphysema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endobronchial valve treatmentProcedure or surgery
Insertion of endobronchial valves via bronchoscopy as a treatment for COPD
| Study group | Role | What they receive |
|---|---|---|
| Patients | COPD patients treated with endobronchial valves Receives: Procedure: Endobronchial valve treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of pulmonary infections
Number and severity of pulmonary infection after surgery
Measured: 2 years
Frequency of Valve dysfunction
Dysfunction of valves requiring clean up
Measured: 2 years
Secondary outcomes (6)
Frequency of formation of atelectasis
Formation and maintainance of atelectasis after insertion of valve
Measured: 2 years
Diversity of Microbiome
Diversity of microbiome
Measured: During surgery
Change in FEV1
Change in FEV1 from baseline to 12 months after treatment
Measured: 12 months
Change in residual volume
Change in residual volume from baseline to 12 months after treatment
Measured: 12 months
Change in MRC dyspnea scale
Change in MRC dyspnea scale from baseline to 12 months after treatment
Measured: 12 months
Change in 6-minute walk test distance
Change in 6-minute walk test distance from baseline to 12 months after treatment
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2021
- Study start16 Jun 2021
- Primary completion30 Oct 2026 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by Aarhus University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aarhus University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kirstine Hermann, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04932811
- Sponsor's protocol ID
- 1-10-72-323-20
- Status last verified
- Oct 2026
- First submitted
- 13 Jun 2021
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Lung Microbiome in Patients With Emphysema and Chronic Obstructive Lung Disease Treated With Endobronchial Valves: Complications and Prognosis
- ClinicalTrials.gov ID
- NCT04932811
- Acronym / sponsor ID
- 1-10-72-323-20
- Conditions
- Chronic Obstructive Pulmonary Disease, Emphysema
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Aarhus University HospitalUniversity, hospital or other
- Study start
- 16 Jun 2021 (actual)
- Primary completion
- 30 Oct 2026 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 21 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Procedure: Endobronchial valve treatmentCOPD patients treated with endobronchial valves |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- COPD patients with emphysema selected for EBV treatment by a multidiciplinary team, independent of this study.
- Written informed consent
Key exclusion criteria (1 listed)
- Intake of oral antibiotics within 1 month before the procedure. Patients receiving prophylactic long-term treatment with antibiotics can be included.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endobronchial valve treatmentInsertion of endobronchial valves via bronchoscopy as a treatment for COPD | Procedure or surgery | Patients |
Primary outcome
Number of pulmonary infections
Time frame: 2 years
Number and severity of pulmonary infection after surgery
Frequency of Valve dysfunction
Time frame: 2 years
Dysfunction of valves requiring clean up
6 secondary outcomes
Frequency of formation of atelectasis
Time frame: 2 years
Diversity of Microbiome
Time frame: During surgery
Change in FEV1
Time frame: 12 months
Change in residual volume
Time frame: 12 months
Change in MRC dyspnea scale
Time frame: 12 months
Change in 6-minute walk test distance
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Obstructive Pulmonary Disease and Emphysema, run by Aarhus University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of pulmonary infections (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2026.