Endobronchial Valves in Moderate COPD (REMODEL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01969734
Recruitment Status : Completed
First Posted : October 25, 2013
Last Update Posted : May 23, 2017
Information provided by (Responsible Party):
Sherwood Forest Hospitals NHS Foundation Trust

Brief Summary:
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 or disease Intervention/treatment Phase
Moderate COPD Device: Zephyr endobronchial valve placement Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Response to Endobronchial Valves in Moderate Obstructive Airways Disease and Exercise Limitation - The REMODEL Trial
Study Start Date : March 2014
Actual Primary Completion Date : March 2015
Actual Study Completion Date : March 2015

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Change in residual volume [ Time Frame: 3 months following treatment ]

Secondary Outcome Measures :
  1. Change in FEV1 [ Time Frame: 3 months following treatment ]
  2. Change in vital capacity [ Time Frame: 3 months following treatment ]
  3. Change in RV/TLC ratio [ Time Frame: 3 months following treatment ]
  4. Change in the SGRQ score [ Time Frame: 3 months following treatment ]
  5. Change in the MRC score [ Time Frame: 3 months following treatment ]
  6. Change in CAT score [ Time Frame: 3 months after treatment ]
  7. Change in the 6MWD [ Time Frame: 3 months following treatment ]
  8. Change in CT measured lobar volumes [ Time Frame: 3 months following treatment ]
  9. Change in BODE index [ Time Frame: 3 months following treatment ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01969734

United Kingdom
Kings Mill Hospital
Sutton-in-Ashfield, Nottinghamshire, United Kingdom, NG17 4JL
Sponsors and Collaborators
Sherwood Forest Hospitals NHS Foundation Trust

Responsible Party: Sherwood Forest Hospitals NHS Foundation Trust Identifier: NCT01969734     History of Changes
Other Study ID Numbers: SFH2
First Posted: October 25, 2013    Key Record Dates
Last Update Posted: May 23, 2017
Last Verified: May 2017

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