NCT03010592

Brief Summary

Studying the airway microenvironment in patients undergoing surgical and bronchoscopic interventions for COPD

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
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2017

Longer than P75 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
1 month until next milestone

Study Start

First participant enrolled

February 6, 2017

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2023

Completed
Last Updated

September 16, 2021

Status Verified

September 1, 2021

Enrollment Period

5.9 years

First QC Date

December 20, 2016

Last Update Submit

September 14, 2021

Conditions

Chronic Obstructive Pulmonary DiseaseEmphysemaChronic Bronchitis

Keywords

Lung volume reduction treatmentEndobronchial cryotherapyMicrovesicles

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in airway cytokine levels at 3 months follow-up

    Change in airway cytokine levels measured using a multiplex assay, 3 months following interventional treatment

    Baseline versus 3 months follow-up

Secondary Outcomes (5)

  • Association between baseline cytokine levels and future exacerbation frequency at 3 months follow-up

    Baseline versus 3 months follow-up

  • Association between baseline cytokine levels and future decline in lung function at 3 months follow-up

    Baseline versus 3 months follow-up

  • Association between baseline microvesicle levels and future exacerbation frequency at 3 months follow-up

    Baseline versus 3 months follow-up

  • Association between baseline microvesicle levels and future decline in lung function at 3 months follow-up

    Baseline versus 3 months follow-up

  • Change from baseline in airway microvesicle levels at 3 months follow-up

    Baseline versus 3 months follow-up

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with severe COPD who are scheduled to undergo surgical or bronchoscopic lung intervention (n=80)

You may qualify if:

  • Scheduled for lung volume reduction treatment or endobronchial cryotherapy for the management of severe COPD.

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, SW3 6NP, United Kingdom

RECRUITING

Royal Brompton & Harefields Hospital

London, Fulham, SW3 6NP, United Kingdom

NOT YET RECRUITING

Related Publications (11)

  • Barnes PJ. Immunology of asthma and chronic obstructive pulmonary disease. Nat Rev Immunol. 2008 Mar;8(3):183-92. doi: 10.1038/nri2254. Epub 2008 Feb 15.

    PMID: 18274560RESULT

  • Donaldson GC, Seemungal TA, Bhowmik A, Wedzicha JA. Relationship between exacerbation frequency and lung function decline in chronic obstructive pulmonary disease. Thorax. 2002 Oct;57(10):847-52. doi: 10.1136/thorax.57.10.847.

    PMID: 12324669RESULT

  • Takahashi T, Kobayashi S, Fujino N, Suzuki T, Ota C, He M, Yamada M, Suzuki S, Yanai M, Kurosawa S, Yamaya M, Kubo H. Increased circulating endothelial microparticles in COPD patients: a potential biomarker for COPD exacerbation susceptibility. Thorax. 2012 Dec;67(12):1067-74. doi: 10.1136/thoraxjnl-2011-201395. Epub 2012 Jul 27.

    PMID: 22843558RESULT

  • Eltom S, Dale N, Raemdonck KR, Stevenson CS, Snelgrove RJ, Sacitharan PK, Recchi C, Wavre-Shapton S, McAuley DF, O'Kane C, Belvisi MG, Birrell MA. Respiratory infections cause the release of extracellular vesicles: implications in exacerbation of asthma/COPD. PLoS One. 2014 Jun 27;9(6):e101087. doi: 10.1371/journal.pone.0101087. eCollection 2014.

    PMID: 24972036RESULT

  • Raposo G, Stoorvogel W. Extracellular vesicles: exosomes, microvesicles, and friends. J Cell Biol. 2013 Feb 18;200(4):373-83. doi: 10.1083/jcb.201211138.

    PMID: 23420871RESULT

  • Nieri D, Neri T, Petrini S, Vagaggini B, Paggiaro P, Celi A. Cell-derived microparticles and the lung. Eur Respir Rev. 2016 Sep;25(141):266-77. doi: 10.1183/16000617.0009-2016.

    PMID: 27581826RESULT

  • Gordon C, Gudi K, Krause A, Sackrowitz R, Harvey BG, Strulovici-Barel Y, Mezey JG, Crystal RG. Circulating endothelial microparticles as a measure of early lung destruction in cigarette smokers. Am J Respir Crit Care Med. 2011 Jul 15;184(2):224-32. doi: 10.1164/rccm.201012-2061OC. Epub 2011 Mar 11.

    PMID: 21471087RESULT

  • Thomashow MA, Shimbo D, Parikh MA, Hoffman EA, Vogel-Claussen J, Hueper K, Fu J, Liu CY, Bluemke DA, Ventetuolo CE, Doyle MF, Barr RG. Endothelial microparticles in mild chronic obstructive pulmonary disease and emphysema. The Multi-Ethnic Study of Atherosclerosis Chronic Obstructive Pulmonary Disease study. Am J Respir Crit Care Med. 2013 Jul 1;188(1):60-8. doi: 10.1164/rccm.201209-1697OC.

    PMID: 23600492RESULT

  • Takahashi T, Kobayashi S, Fujino N, Suzuki T, Ota C, Tando Y, Yamada M, Yanai M, Yamaya M, Kurosawa S, Yamauchi M, Kubo H. Annual FEV1 changes and numbers of circulating endothelial microparticles in patients with COPD: a prospective study. BMJ Open. 2014 Mar 6;4(3):e004571. doi: 10.1136/bmjopen-2013-004571.

    PMID: 24604485RESULT

  • Soni S, Wilson MR, O'Dea KP, Yoshida M, Katbeh U, Woods SJ, Takata M. Alveolar macrophage-derived microvesicles mediate acute lung injury. Thorax. 2016 Nov;71(11):1020-1029. doi: 10.1136/thoraxjnl-2015-208032. Epub 2016 Jun 10.

    PMID: 27287089RESULT

  • Leaker BR, Nicholson GC, Ali FY, Daudi N, O'Connor BJ, Barnes PJ. Bronchoabsorption; a novel bronchoscopic technique to improve biomarker sampling of the airway. Respir Res. 2015 Sep 4;16(1):102. doi: 10.1186/s12931-015-0268-5.

    PMID: 26338015RESULT

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveEmphysemaBronchitis, Chronic

Condition Hierarchy (Ancestors)

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

Study Officials

  • Pallav L Shah, MBBS MD FRCP

    Royal Brompton & Harefields Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Justin L Garner, MBBS MRCP

CONTACT

02073518029J.Garner@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

February 6, 2017

Primary Completion

January 1, 2023

Study Completion

January 1, 2023

Last Updated

September 16, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations

GB(2)