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Use of Endobronchial Valves in Non-Upper Lobe Heterogeneous Emphysema

Primary Purpose

Heterogeneous Emphysema

Status
Completed
Phase
Phase 3
Locations
United Kingdom
Study Type
Interventional
Intervention
Intra-bronchial valve (Spiration IBV)
Sponsored by
Royal Brompton & Harefield NHS Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heterogeneous Emphysema focused on measuring intrabronchial valve, heterogeneous emphysema, non-upper lobe

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age 18-80 years
  • Ex-smoker with smoking cessation confirmed by exhaled carbon monoxide (CO) levels
  • Moderate to severe airflow obstruction FEV1 <50% Predicted
  • Severe dyspnoea - mMRC ≥2
  • Hyperinflation - total lung capacity (TLC) ≥100% predicted, RV ≥150% predicted
  • SWT ≥75m
  • Optimum COPD treatment for at least 6 weeks
  • No COPD exacerbation for at least 6 weeks
  • Less than 4 admissions for exacerbation in the preceding 12 months

Exclusion Criteria:

  • Patient unable to provide informed consent
  • Patient without clear targets for airflow re-distribution
  • Total lung CO uptake (TLCO) <15% predicted and FEV1 <15% predicted
  • pO2 on air <6.0kPa
  • pCO2 on air >8.0kPa
  • Neurological, rheumatological or other cause of exercise limitation
  • Other major medical illness, e.g. lung cancer that will limit participation
  • Production of purulent sputum more often than not (more than 50% of days)
  • Clinically significant bronchiectasis
  • Large bulla - more than 1/3 of hemithorax volume (i.e. where bullectomy would be more suitable) on CT scan
  • Arrhythmia or cardiovascular disease that poses a risk during procedure or exercise
  • Prednisolone dose greater than 15mg a day
  • Significant pulmonary hypertension - RVSP ≥45mmHg
  • Left ventricular failure - left ventricular ejection fraction <45% or left ventricular fraction shortening <23%
  • Prior LVRS or lobectomy
  • Lung nodule requiring surgery
  • Subject completed or is participating in a standard pulmonary rehabilitation program within 3 months of enrolment
  • Female of childbearing age with positive pregnancy test
  • Subject participated in a research study of investigational drug or device in prior 30 days
  • Subject taking clopidogrel, warfarin, or other anticoagulants and unable to abstain for 5 days pre-procedure

Sites / Locations

  • Royal Brompton Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

1

2

Arm Description

Upper-lobe predominant emphysema

Non-upper lobe predominant emphysema

Outcomes

Primary Outcome Measures

To estimate the difference between study arms in volume changes of the treated lobe(s) by CT scan

Secondary Outcome Measures

To estimate the difference between study arms in volume changes of the non-treated lobes by CT scan
To estimate the difference between study arms in residual volume
To estimate the difference between study arms in FEV1
To estimate the difference between study arms in gas transfer
To estimate the difference between study arms in modified MRC dyspnoea score
To estimate the difference between study arms on a 6 minute walk test
To estimate the difference between study arms in disease specific health status
To estimate the difference between study arms in dynamic hyperinflation during cycle ergometry
To estimate the difference between study arms in changes in respiratory and quadriceps muscle strength

Full Information

First Posted
January 19, 2009
Last Updated
February 3, 2012
Sponsor
Royal Brompton & Harefield NHS Foundation Trust
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1. Study Identification

Unique Protocol Identification Number
NCT00825578
Brief Title
Use of Endobronchial Valves in Non-Upper Lobe Heterogeneous Emphysema
Official Title
Comparative Study of Bronchoscopic Lung Volume Reduction to Evaluate Relative Efficacy in Patients With Non-Upper Lobe Emphysema
Study Type
Interventional

2. Study Status

Record Verification Date
February 2012
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Royal Brompton & Harefield NHS Foundation Trust

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Hypothesis: Patients with advanced emphysema with predominance of the disease in areas other than the upper lobes, as determined by high resolution computed tomography (HRCT), could have a positive response to valve treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heterogeneous Emphysema
Keywords
intrabronchial valve, heterogeneous emphysema, non-upper lobe

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Upper-lobe predominant emphysema
Arm Title
2
Arm Type
Active Comparator
Arm Description
Non-upper lobe predominant emphysema
Intervention Type
Device
Intervention Name(s)
Intra-bronchial valve (Spiration IBV)
Other Intervention Name(s)
Spiration IBV
Intervention Description
Device: Intra-bronchial valve (Spiration IBV) The IBV is comprised of a Nitnol frame and a polymer membrane, which is held against the airway mucosa by six elastic struts and will expand and contract with airway movement during breathing. The valve is designed to conform to the size and shape of the airways. The frame has 5 flexible anchors that gently secure to the mucosal wall at a controlled depth. Valves are available in 5, 6 and 7mm diameters appropriate for different airways. During a minimally invasive procedure, a catheter is passed through a bronchoscope (a flexible tube passed into the airways through the mouth) to deploy the umbrella-shaped valves into the airways. Only flexible bronchoscopy equipment is required. The valves are designed to be removed if indicated.
Primary Outcome Measure Information:
Title
To estimate the difference between study arms in volume changes of the treated lobe(s) by CT scan
Time Frame
6 months
Secondary Outcome Measure Information:
Title
To estimate the difference between study arms in volume changes of the non-treated lobes by CT scan
Time Frame
6 months
Title
To estimate the difference between study arms in residual volume
Time Frame
6 months
Title
To estimate the difference between study arms in FEV1
Time Frame
6 months
Title
To estimate the difference between study arms in gas transfer
Time Frame
6 months
Title
To estimate the difference between study arms in modified MRC dyspnoea score
Time Frame
6 months
Title
To estimate the difference between study arms on a 6 minute walk test
Time Frame
6 months
Title
To estimate the difference between study arms in disease specific health status
Time Frame
6 months
Title
To estimate the difference between study arms in dynamic hyperinflation during cycle ergometry
Time Frame
6 months
Title
To estimate the difference between study arms in changes in respiratory and quadriceps muscle strength
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 18-80 years Ex-smoker with smoking cessation confirmed by exhaled carbon monoxide (CO) levels Moderate to severe airflow obstruction FEV1 <50% Predicted Severe dyspnoea - mMRC ≥2 Hyperinflation - total lung capacity (TLC) ≥100% predicted, RV ≥150% predicted SWT ≥75m Optimum COPD treatment for at least 6 weeks No COPD exacerbation for at least 6 weeks Less than 4 admissions for exacerbation in the preceding 12 months Exclusion Criteria: Patient unable to provide informed consent Patient without clear targets for airflow re-distribution Total lung CO uptake (TLCO) <15% predicted and FEV1 <15% predicted pO2 on air <6.0kPa pCO2 on air >8.0kPa Neurological, rheumatological or other cause of exercise limitation Other major medical illness, e.g. lung cancer that will limit participation Production of purulent sputum more often than not (more than 50% of days) Clinically significant bronchiectasis Large bulla - more than 1/3 of hemithorax volume (i.e. where bullectomy would be more suitable) on CT scan Arrhythmia or cardiovascular disease that poses a risk during procedure or exercise Prednisolone dose greater than 15mg a day Significant pulmonary hypertension - RVSP ≥45mmHg Left ventricular failure - left ventricular ejection fraction <45% or left ventricular fraction shortening <23% Prior LVRS or lobectomy Lung nodule requiring surgery Subject completed or is participating in a standard pulmonary rehabilitation program within 3 months of enrolment Female of childbearing age with positive pregnancy test Subject participated in a research study of investigational drug or device in prior 30 days Subject taking clopidogrel, warfarin, or other anticoagulants and unable to abstain for 5 days pre-procedure
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pallav Shah, MBBS, MD
Organizational Affiliation
Royal Brompton & Harefield NHS Foundation Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Royal Brompton Hospital
City
London
ZIP/Postal Code
SW3 6NP
Country
United Kingdom

12. IPD Sharing Statement

Links:
URL
http://www.respiratorymuscle.com
Description
Royal Brompton Hospital Respiratory Research Group website

Learn more about this trial

Use of Endobronchial Valves in Non-Upper Lobe Heterogeneous Emphysema

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