Trial record 20 of 77 for:    Emphysema: Clinical Trials

Endobronchial Valves in Moderate COPD (REMODEL)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Sherwood Forest Hospitals NHS Foundation Trust
Sponsor:
Information provided by (Responsible Party):
Sherwood Forest Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT01969734
First received: October 21, 2013
Last updated: May 16, 2014
Last verified: May 2014
  Purpose

Despite the best medical therapy many people with emphysema remain breathless and limited in their daily activities. In emphysema the lungs do not empty properly when the person breathes out. This "gas trapping" makes it harder to breathe. Endobronchial valve placement, a treatment that stops air getting into the worst affected parts of the lung and so stops them from trapping gas, improves lung function, breathlessness and exercise capacity in selected patients with severe COPD (chronic obstructive airways disease, sometimes referred to as emphysema). We want to see if people with less severe COPD who are very breathless can benefit from the same treatment. The treatment involves placing small valves into the airways using a fibre optic camera (a bronchoscopy). Bronchoscopy is a standard clinical procedure carried out in our department.


Condition Intervention Phase
Moderate COPD
Device: Zephyr endobronchial valve placement
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Response to Endobronchial Valves in Moderate Obstructive Airways Disease and Exercise Limitation - The REMODEL Trial

Resource links provided by NLM:


Further study details as provided by Sherwood Forest Hospitals NHS Foundation Trust:

Primary Outcome Measures:
  • Change in residual volume [ Time Frame: 3 months following treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in FEV1 [ Time Frame: 3 months following treatment ] [ Designated as safety issue: No ]
  • Change in vital capacity [ Time Frame: 3 months following treatment ] [ Designated as safety issue: No ]
  • Change in RV/TLC ratio [ Time Frame: 3 months following treatment ] [ Designated as safety issue: No ]
  • Change in the SGRQ score [ Time Frame: 3 months following treatment ] [ Designated as safety issue: No ]
  • Change in the MRC score [ Time Frame: 3 months following treatment ] [ Designated as safety issue: No ]
  • Change in CAT score [ Time Frame: 3 months after treatment ] [ Designated as safety issue: No ]
  • Change in the 6MWD [ Time Frame: 3 months following treatment ] [ Designated as safety issue: No ]
  • Change in CT measured lobar volumes [ Time Frame: 3 months following treatment ] [ Designated as safety issue: No ]
  • Change in BODE index [ Time Frame: 3 months following treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 10
Study Start Date: March 2014
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Endobronchial valves
All subjects will have endobronchial valves inserted into the target lobe of the lung with the aim of complete lobar exclusion.
Device: Zephyr endobronchial valve placement

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult patients with stable moderate COPD (FEV1 45-80%pred)
  • Emphysema on CT with a defined target lobe
  • CT thorax must demonstrate intact interlobar fissures adjacent to the target lobe
  • Hyperinflation - TLC ≥100% predicted, RV ≥150% predicted
  • Exertional breathlessness with MRC dyspnoea score ≥3
  • Optimum COPD treatment for at least 6 weeks
  • No COPD exacerbation for at least 6 weeks
  • Fewer than 3 admissions for infective exacerbations in the preceding 12 months
  • Six minute walk distance of <450m

Exclusion Criteria:

  • Inability to obtain informed consent
  • Significant co morbidity which limits exercise capacity or prognosis
  • Co-morbidities that would render bronchoscopy or sedation unsafe
  • Clinically significant bronchiectasis
  • Lung nodule requiring further investigation or treatment
  • Subject taking clopidogrel, warfarin, or other anticoagulants and unable to abstain for 5 days pre-procedure
  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: NCT01969734

Contacts
Contact: Samuel V Kemp, MBBS +441623622515 ext 6204 samuel.kemp@sfh-tr.nhs.uk

Locations
United Kingdom
Kings Mill Hospital Recruiting
Sutton-in-Ashfield, Nottinghamshire, United Kingdom, NG17 4JL
Contact: Samantha Jones    +441623622515 ext 3313    samantha.jones@sfh-tr.nhs.uk   
Principal Investigator: Samuel V Kemp, MBBS         
Sponsors and Collaborators
Sherwood Forest Hospitals NHS Foundation Trust
  More Information

No publications provided

Responsible Party: Sherwood Forest Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT01969734     History of Changes
Other Study ID Numbers: SFH2
Study First Received: October 21, 2013
Last Updated: May 16, 2014
Health Authority: United Kingdom: National Health Service

Keywords provided by Sherwood Forest Hospitals NHS Foundation Trust:
Emphysema
Moderate COPD
Hyperinflation
Endobronchial valves

Additional relevant MeSH terms:
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on August 19, 2014