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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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
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.

Samuel V Kemp, MBBS MD contact

02073518029

s.kemp@rbht.nhs.uk

United Kingdom2 sites, 2 recruiting
  • Chelsea & Westminster Hospital

    London, Chelsea, SW10 9NH

    Nadia Shabbir, 02033156684, Nadia.Shabbir@chelwest.nhs.uk

    Pallav L Shah, MBBS MD FRCP

    Recruiting
  • Royal Brompton & Harefields Hospital

    London, Fulham, SW3 6NP

    Patrik Pettersson, 02073528121, p.pettersson@rbht.nhs.uk

    Samuel V Kemp, MBBS MD MRCP

    Not yet recruiting

Other trials in United Kingdom

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.

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.

  1. Change in the microbiome of the lungs in patients treated with lung volume reduction coils (LVRCs).

    Measured: 6 months

Secondary outcomes (4)
  1. Correlation between signals from 16S rRNA gene-sequencing analysis at baseline and infective complications following LVRC treatment.

    Measured: 6 months

  2. Genome sequencing of dominant pathogens to determine virulence factors.

    Measured: 6 months

  3. Genome sequencing of dominant pathogens to determine antibiotic resistance.

    Measured: 6 months

  4. 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.

  1. First posted5 Jan 2017 (estimated)
  2. Study start30 Jan 2017
  3. Primary completionJan 2020 (estimated)
  4. Study completionJan 2020 (estimated)

Resources

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)
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

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.

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