NCT03010566

Brief Summary

Studying the microbiome of the lung in patients treated with endobronchial lung volume reduction coils for emphysema

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2017

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 20, 2016

Completed
16 days until next milestone

First Posted

Study publicly available on registry

January 5, 2017

Completed
25 days until next milestone

Study Start

First participant enrolled

January 30, 2017

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
Last Updated

April 23, 2019

Status Verified

April 1, 2019

Enrollment Period

2.9 years

First QC Date

December 20, 2016

Last Update Submit

April 22, 2019

Conditions

Chronic Obstructive Pulmonary DiseaseEmphysema

Keywords

Lung volume reduction coilLung Microbiome

Outcome Measures

Primary Outcomes (1)

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

    6 months

Secondary Outcomes (4)

  • Correlation between signals from 16S rRNA gene-sequencing analysis at baseline and infective complications following LVRC treatment.

    6 months

  • Genome sequencing of dominant pathogens to determine virulence factors.

    6 months

  • Genome sequencing of dominant pathogens to determine antibiotic resistance.

    6 months

  • Genome sequencing of dominant pathogens for strain-level identification.

    6 months

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with severe emphysema who are scheduled to undergo endobronchial lung volume reduction coils insertion

You may qualify if:

  • Scheduled for lung volume reduction coil treatment for the management of severe emphysema

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Chelsea & Westminster Hospital

London, Chelsea, SW10 9NH, United Kingdom

RECRUITING

Royal Brompton & Harefields Hospital

London, Fulham, SW3 6NP, United Kingdom

NOT YET RECRUITING

Related Publications (1)

  • 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.

    PMID: 23793624BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Oropharyngeal swab, Broncho-alveolar lavage, Bronchial brushings

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveEmphysema

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Samuel V Kemp, MBBS MD

    Royal Brompton & Harefields Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Samuel V Kemp, MBBS MD

CONTACT

02073518029s.kemp@rbht.nhs.uk

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 20, 2016

First Posted

January 5, 2017

Study Start

January 30, 2017

Primary Completion

January 1, 2020

Study Completion

January 1, 2020

Last Updated

April 23, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Locations

GB(2)