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Studying the Airway Microenvironment in Patients Undergoing Surgical and Bronchoscopic Interventions for COPD (COPD-ENVIRON)

This study is not yet open for participant recruitment.
See Contacts and Locations
Verified January 2017 by Royal Brompton & Harefield NHS Foundation Trust
Sponsor:
Information provided by (Responsible Party):
Royal Brompton & Harefield NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT03010592
First received: December 20, 2016
Last updated: January 4, 2017
Last verified: January 2017
  Purpose
Studying the airway microenvironment in patients undergoing surgical and bronchoscopic interventions for COPD

Condition
Chronic Obstructive Pulmonary Disease Emphysema Chronic Bronchitis

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Studying the Airway Microenvironment in Patients Undergoing Surgical and Bronchoscopic Interventions for COPD

Further study details as provided by Royal Brompton & Harefield NHS Foundation Trust:

Primary Outcome Measures:
  • Change from baseline in airway cytokine levels at 3 months follow-up [ Time Frame: Baseline versus 3 months follow-up ]
    Change in airway cytokine levels measured using a multiplex assay, 3 months following interventional treatment


Secondary Outcome Measures:
  • Association between baseline cytokine levels and future exacerbation frequency at 3 months follow-up [ Time Frame: Baseline versus 3 months follow-up ]
  • Association between baseline cytokine levels and future decline in lung function at 3 months follow-up [ Time Frame: Baseline versus 3 months follow-up ]
  • Association between baseline microvesicle levels and future exacerbation frequency at 3 months follow-up [ Time Frame: Baseline versus 3 months follow-up ]
  • Association between baseline microvesicle levels and future decline in lung function at 3 months follow-up [ Time Frame: Baseline versus 3 months follow-up ]
  • Change from baseline in airway microvesicle levels at 3 months follow-up [ Time Frame: Baseline versus 3 months follow-up ]
    Change in airway microvesicle levels measured using flow cytometry, 3 months following interventional treatment


Estimated Enrollment: 80
Study Start Date: January 2017
Estimated Study Completion Date: January 2020
Estimated Primary Completion Date: January 2020 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with severe COPD who are scheduled to undergo surgical or bronchoscopic lung intervention (n=80)
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03010592

Contacts
Contact: Justin L Garner, MBBS MRCP J.Garner@rbht.nhs.uk

Locations
United Kingdom
Chelsea & Westminster Hospital Not yet recruiting
London, Chelsea, United Kingdom, SW3 6NP
Contact: Nadia Shabbir    02033156684    Nadia.Shabbir@chelwest.nhs.uk   
Principal Investigator: Masao Takata, Professor         
Sub-Investigator: Suveer Singh, MBBS PhD         
Sub-Investigator: Kieran O'Dea, PhD         
Sub-Investigator: Michael R Wilson, PhD         
Sub-Investigator: Sanooj Soni, MBBS MRCP         
Principal Investigator: Pallav L Shah, MBBS FRCP         
Royal Brompton & Harefields Hospital Not yet recruiting
London, Fulham, United Kingdom, SW3 6NP
Contact: Patrik Patrik Pettersson    02073528121    p.pettersson@rbht.nhs.uk   
Principal Investigator: Pallav L Shah, MBBS MD FRCP         
Sub-Investigator: Samuel V Kemp, MBBS MD MRCP         
Sub-Investigator: Justin Garner, MBBS MRCP         
Sub-Investigator: Karthi Srikanthan, MBBS MRCP         
Sponsors and Collaborators
Royal Brompton & Harefield NHS Foundation Trust
Investigators
Principal Investigator: Pallav L Shah, MBBS MD FRCP Royal Brompton & Harefields Hospital
  More Information

Publications:

Responsible Party: Royal Brompton & Harefield NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT03010592     History of Changes
Other Study ID Numbers: 217587
Study First Received: December 20, 2016
Last Updated: January 4, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Royal Brompton & Harefield NHS Foundation Trust:
Lung volume reduction treatment
Endobronchial cryotherapy
Microvesicles

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Emphysema
Bronchitis
Bronchitis, Chronic
Respiratory Tract Diseases
Pathologic Processes
Bronchial Diseases
Respiratory Tract Infections

ClinicalTrials.gov processed this record on August 22, 2017