Chronic Obstructive Pulmonary DiseaseLVRC-MicroNCT03010566
Lung Volume Reduction Coil Microbiome Study
An observational study of Chronic Obstructive Pulmonary Disease and Emphysema, run by Royal Brompton & Harefield NHS Foundation Trust at 2 sites in United Kingdom.
Trial summary
Studying the microbiome of the lung in patients treated with endobronchial lung volume reduction coils for emphysema Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease, Emphysema
- How many people
- 30 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 30 Jan 2017to Jan 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with severe emphysema who are scheduled to undergo endobronchial lung volume reduction coils insertion
Who may be able to join
- Scheduled for lung volume reduction coil treatment for the management of severe emphysema
Who cannot join
- Unwilling or unable to sign the informed consent form
- Patients with known Category 3 Organisms as per the Advisory Committee on Dangerous Pathogens (ACDP) for example, Tuberculosis or Human Immunodeficiency Virus.
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites, 2 recruiting
- Recruiting
Chelsea & Westminster Hospital
London, Chelsea, SW10 9NH
Nadia Shabbir, 02033156684, Nadia.Shabbir@chelwest.nhs.uk
Pallav L Shah, MBBS MD FRCP
- Not yet recruiting
Royal Brompton & Harefields Hospital
London, Fulham, SW3 6NP
Patrik Pettersson, 02073528121, p.pettersson@rbht.nhs.uk
Samuel V Kemp, MBBS MD MRCP
About this study
Official title: Studying the Microbiome of the Lung in Patients Treated With Endobronchial Lung Volume Reduction Coils for Emphysema
Studying the microbiome of the lung in patients treated with endobronchial lung volume reduction coils for emphysema
Read the detailed description
Patients with severe emphysema and hyperinflation can benefit from lung volume reduction techniques designed to reduce gas trapping, improve air flow, and restore more natural chest wall and lung mechanics. The best evidence exists for lung volume reduction surgery (LVRS), but more recently there has been increasing interest in, and use of, bronchoscopic lung volume reduction (BLVR) techniques. One of the more intriguing methods has been the use of endobronchial lung volume reduction coils (LVRCs), nitinol wires which when deployed in the lung take up their preformed shape similar to that of a tennis ball seam, and seem to work both by mechanical compression of lung tissue and by replacing some of the elastic recoil forces that are lost when there is emphysematous destruction of lung tissue. Treatment aims to place 10 coils in each upper lobe in 2 procedures separated by 1-3 months.
A number of studies on the use of LVRCs have now been published, but most of these provide only relatively short term follow-up and safety data. Fairly widespread clinical use of the LVRC is now occurring in Germany, however. It is now being increasingly recognised that a minority of patients treated with LVRCs (approximately 5-10%) develop dense consolidation around one or more of their devices, with the development of significant cavitation in some of these patients. At least 1 death has been attributed to decline associated with the development of such changes, and a number of other patients have now developed infection with persistent and resistant organisms. Unlike endobronchial valves (currently the most widely used of the BLVR devices), patients are told that LVRC treatment is permanent and that the devices cannot be removed after implantation, something which obviously has implications if devices become infected or colonised with micro-organisms.
The lung microbiome is the complete collection of microorganisms that inhabit the lung, including bacteria, viruses, and fungi. Studies have demonstrated the importance of microorganisms in the pathogenesis of chronic obstructive pulmonary disease (COPD), and in driving exacerbations and loss of lung function, and the lungs of patients with severe COPD (those potentially suitable for LVRC treatment) contain a different community of bacteria to those of healthy people. Culture-independent molecular techniques are now available for precise cataloguing of the lung microbiome, with results that are far more detailed and informative than standard culture techniques. By DNA sequencing the 16S rRNA gene and using it as a barcode to identify all bacterial organisms in any given sample and also their relative proportions, a much broader, less selective group of bacteria can be assayed.
The bilateral sequential nature of LVRC treatment provides a unique opportunity for the collection of multiple samples from each patient at different time points in their treatment, and thus to track changes in the lung microbiome that may be caused by LVRC implantation. It is now our practice to perform a bronchoscopy 6 months after initial treatment in all patients who have undergone BLVR (LVRCs, endobronchial valves, thermal vapour ablation) in order to monitor for device migration, granulation tissue formation, and to obtain specimens for bacterial culture. This therefore means that LVRC patients undergo bronchoscopy on 3 occasions, spaced approximately 3 months apart.
- Conditions
- Chronic Obstructive Pulmonary Disease, Emphysema
- Keywords
- Lung volume reduction coil, Lung Microbiome
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Emphysema
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the microbiome of the lungs in patients treated with lung volume reduction coils (LVRCs).
Measured: 6 months
Secondary outcomes (4)
Correlation between signals from 16S rRNA gene-sequencing analysis at baseline and infective complications following LVRC treatment.
Measured: 6 months
Genome sequencing of dominant pathogens to determine virulence factors.
Measured: 6 months
Genome sequencing of dominant pathogens to determine antibiotic resistance.
Measured: 6 months
Genome sequencing of dominant pathogens for strain-level identification.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2017 (estimated)
- Study start30 Jan 2017
- Primary completionJan 2020 (estimated)
- Study completionJan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Royal Brompton & Harefield NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Imperial College London
- Responsible party
- Sponsor
- Investigators
- Samuel V Kemp, MBBS MD, Principal investigator, Royal Brompton & Harefields Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03010566
- Sponsor's protocol ID
- 215696
- Acronym
- LVRC-Micro
- Status last verified
- Apr 2019
- First submitted
- 20 Dec 2016
- Last updated
- 23 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kozich JJ, Westcott SL, Baxter NT, Highlander SK, Schloss PD. Development of a dual-index sequencing strategy and curation pipeline for analyzing amplicon sequence data on the MiSeq Illumina sequencing platform. Appl Environ Microbiol. 2013 Sep;79(17):5112-20. doi: 10.1128/AEM.01043-13. Epub 2013 Jun 21.
PubMed 23793624
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Studying the Microbiome of the Lung in Patients Treated With Endobronchial Lung Volume Reduction Coils for Emphysema
- ClinicalTrials.gov ID
- NCT03010566
- Acronym / sponsor ID
- LVRC-Micro / 215696
- Conditions
- Chronic Obstructive Pulmonary Disease, Emphysema
- Keywords
- Lung volume reduction coil, Lung Microbiome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Royal Brompton & Harefield NHS Foundation TrustUniversity, hospital or other
- Collaborators
- Imperial College London
- Study start
- 30 Jan 2017 (actual)
- Primary completion
- Jan 2020 (estimated)
- Study completion
- Jan 2020 (estimated)
- First posted
- 5 Jan 2017 (estimated)
- 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.
Studying the microbiome of the lung in patients treated with endobronchial lung volume reduction coils for emphysema
Detailed description
Patients with severe emphysema and hyperinflation can benefit from lung volume reduction techniques designed to reduce gas trapping, improve air flow, and restore more natural chest wall and lung mechanics. The best evidence exists for lung volume reduction surgery (LVRS), but more recently there has been increasing interest in, and use of, bronchoscopic lung volume reduction (BLVR) techniques. One of the more intriguing methods has been the use of endobronchial lung volume reduction coils (LVRCs), nitinol wires which when deployed in the lung take up their preformed shape similar to that of a tennis ball seam, and seem to work both by mechanical compression of lung tissue and by replacing some of the elastic recoil forces that are lost when there is emphysematous destruction of lung tissue. Treatment aims to place 10 coils in each upper lobe in 2 procedures separated by 1-3 months.
A number of studies on the use of LVRCs have now been published, but most of these provide only relatively short term follow-up and safety data. Fairly widespread clinical use of the LVRC is now occurring in Germany, however. It is now being increasingly recognised that a minority of patients treated with LVRCs (approximately 5-10%) develop dense consolidation around one or more of their devices, with the development of significant cavitation in some of these patients. At least 1 death has been attributed to decline associated with the development of such changes, and a number of other patients have now developed infection with persistent and resistant organisms. Unlike endobronchial valves (currently the most widely used of the BLVR devices), patients are told that LVRC treatment is permanent and that the devices cannot be removed after implantation, something which obviously has implications if devices become infected or colonised with micro-organisms.
The lung microbiome is the complete collection of microorganisms that inhabit the lung, including bacteria, viruses, and fungi. Studies have demonstrated the importance of microorganisms in the pathogenesis of chronic obstructive pulmonary disease (COPD), and in driving exacerbations and loss of lung function, and the lungs of patients with severe COPD (those potentially suitable for LVRC treatment) contain a different community of bacteria to those of healthy people. Culture-independent molecular techniques are now available for precise cataloguing of the lung microbiome, with results that are far more detailed and informative than standard culture techniques. By DNA sequencing the 16S rRNA gene and using it as a barcode to identify all bacterial organisms in any given sample and also their relative proportions, a much broader, less selective group of bacteria can be assayed.
The bilateral sequential nature of LVRC treatment provides a unique opportunity for the collection of multiple samples from each patient at different time points in their treatment, and thus to track changes in the lung microbiome that may be caused by LVRC implantation. It is now our practice to perform a bronchoscopy 6 months after initial treatment in all patients who have undergone BLVR (LVRCs, endobronchial valves, thermal vapour ablation) in order to monitor for device migration, granulation tissue formation, and to obtain specimens for bacterial culture. This therefore means that LVRC patients undergo bronchoscopy on 3 occasions, spaced approximately 3 months apart.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with severe emphysema who are scheduled to undergo endobronchial lung volume reduction coils insertion
Key inclusion criteria (1 listed)
- Scheduled for lung volume reduction coil treatment for the management of severe emphysema
Key exclusion criteria (2 listed)
- Unwilling or unable to sign the informed consent form
- Patients with known Category 3 Organisms as per the Advisory Committee on Dangerous Pathogens (ACDP) for example, Tuberculosis or Human Immunodeficiency Virus.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in the microbiome of the lungs in patients treated with lung volume reduction coils (LVRCs).
Time frame: 6 months
4 secondary outcomes
Correlation between signals from 16S rRNA gene-sequencing analysis at baseline and infective complications following LVRC treatment.
Time frame: 6 months
Genome sequencing of dominant pathogens to determine virulence factors.
Time frame: 6 months
Genome sequencing of dominant pathogens to determine antibiotic resistance.
Time frame: 6 months
Genome sequencing of dominant pathogens for strain-level identification.
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2019.
- Background: PubMed 23793624Kozich JJ, Westcott SL, Baxter NT, Highlander SK, Schloss PD. Development of a dual-index sequencing strategy and curation pipeline for analyzing amplicon sequence data on the MiSeq Illumina sequencing platform. Appl Environ Microbiol. 2013 Sep;79(17):5112-20. doi: 10.1128/AEM.01043-13. Epub 2013 Jun 21.
- 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.
Samuel V Kemp, MBBS MD principal investigator
Royal Brompton & Harefields Hospital
2 sites 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 Royal Brompton & Harefield NHS Foundation Trust at 2 sites in United Kingdom.
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 1 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 23 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Samuel V Kemp, MBBS MD (02073518029, s.kemp@rbht.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the microbiome of the lungs in patients treated with lung volume reduction coils (LVRCs). (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03010566, which also lists 1 linked publication.
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 23 Apr 2019.