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Bronchoscopic Intrabullous Autologous Blood Instillation (BIABI) for Emphysema (BIABI)

Primary Purpose

Bullous Emphysema

Status
Unknown status
Phase
Phase 2
Locations
United Kingdom
Study Type
Interventional
Intervention
Bronchoscopic intrabullous autologous blood instillation
Sponsored by
Chelsea and Westminster NHS Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bullous Emphysema focused on measuring Emphysema, Chronic obstructive pulmonary disease, COPD, Bulla, Interventional bronchoscopy, Lung volume reduction

Eligibility Criteria

35 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age > 35 years
  • Large bulla on CT scan where bullectomy is contraindicated or is actively avoided.
  • Hyperinflation - TLC ≥100% predicted, RV ≥150% predicted
  • Exertional breathlessness (mMRC >0)
  • 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
  • Written informed consent

Exclusion Criteria:

  • Inability to obtain informed consent
  • Co-morbidities that would render bronchoscopy or sedation unsafe.
  • Anaemia or other reasons precluding venesection.
  • Clinically significant bronchiectasis
  • Arrhythmia or cardiovascular disease that poses a risk during procedure
  • Lung nodule requiring further investigation or treatment
  • Subject taking clopidogrel, warfarin, or other anticoagulants and unable to abstain for 5 days pre-procedure

Sites / Locations

  • Kings Mill Hospital, Sherwood Forest Hospitals NHS TrustRecruiting
  • The Royal Brompton and Harefield NHS TrustRecruiting
  • Chelsea and Westminster Hospital NHS Foundation trustRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

BIABI arm

Arm Description

Patients will undergo intrabullous autologous blood instillation

Outcomes

Primary Outcome Measures

Change in the Residual Volume (RV) following treatment

Secondary Outcome Measures

Change in TLC 6 months following treatment
Change in RV/TLC ratio 6 months following treatment
Changes in FEV1 and FVC 6 months following treatment
Change in the intrathoracic gas volume 6 months following treatment
Change in DLCOc 6 months following treatment
Change in the SGRQ score 6 months following treatment
Change in the mMRC score 6 months following treatment
Change in the 6MWD 6 months following treatment
Change in CT measured lung volumes 6 months following treatment
Adverse events

Full Information

First Posted
November 12, 2012
Last Updated
November 19, 2012
Sponsor
Chelsea and Westminster NHS Foundation Trust
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1. Study Identification

Unique Protocol Identification Number
NCT01727037
Brief Title
Bronchoscopic Intrabullous Autologous Blood Instillation (BIABI) for Emphysema
Acronym
BIABI
Official Title
A Feasibility and Safety Study of Bronchoscopic Intrabullous Autologous Blood Instillation for the Treatment of Severe Bullous Emphysema (BIABI Study)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2012
Overall Recruitment Status
Unknown status
Study Start Date
October 2012 (undefined)
Primary Completion Date
September 2014 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chelsea and Westminster NHS Foundation Trust

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Patients with large bullae (large empty air sacs in the lung) may benefit from bullectomy (surgery to resect these bullae), however this is a major surgery with significant potential morbidity and long hospital stays. Many patients are not well enough to have this surgery, or may not wish to have it. A less invasive means of attempting to shrink the size of the bullae is to directly inject the patients' own blood into the bullae (we believe that this can lead to an inflammatory reaction leading to gradual scarring and volume loss). This can be performed bronchoscopically in a 20-30 minute procedure using conscious sedation (avoiding general anaesthesia). The aim of this study is to assess the effects on lung function, quality of life measures, functional measures and CT measured lung volumes of bronchoscopic intrabullous blood instillation in patients with bullous emphysema.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bullous Emphysema
Keywords
Emphysema, Chronic obstructive pulmonary disease, COPD, Bulla, Interventional bronchoscopy, Lung volume reduction

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
BIABI arm
Arm Type
Experimental
Arm Description
Patients will undergo intrabullous autologous blood instillation
Intervention Type
Procedure
Intervention Name(s)
Bronchoscopic intrabullous autologous blood instillation
Other Intervention Name(s)
BIABI
Primary Outcome Measure Information:
Title
Change in the Residual Volume (RV) following treatment
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Change in TLC 6 months following treatment
Time Frame
6 months
Title
Change in RV/TLC ratio 6 months following treatment
Time Frame
6 months
Title
Changes in FEV1 and FVC 6 months following treatment
Time Frame
6 months
Title
Change in the intrathoracic gas volume 6 months following treatment
Time Frame
6 months
Title
Change in DLCOc 6 months following treatment
Time Frame
6 months
Title
Change in the SGRQ score 6 months following treatment
Time Frame
6 months
Title
Change in the mMRC score 6 months following treatment
Time Frame
6 months
Title
Change in the 6MWD 6 months following treatment
Time Frame
6 months
Title
Change in CT measured lung volumes 6 months following treatment
Time Frame
6 months
Title
Adverse events
Time Frame
6 monhts

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age > 35 years Large bulla on CT scan where bullectomy is contraindicated or is actively avoided. Hyperinflation - TLC ≥100% predicted, RV ≥150% predicted Exertional breathlessness (mMRC >0) 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 Written informed consent Exclusion Criteria: Inability to obtain informed consent Co-morbidities that would render bronchoscopy or sedation unsafe. Anaemia or other reasons precluding venesection. Clinically significant bronchiectasis Arrhythmia or cardiovascular disease that poses a risk during procedure Lung nodule requiring further investigation or treatment Subject taking clopidogrel, warfarin, or other anticoagulants and unable to abstain for 5 days pre-procedure
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zaid Zoumot, MBBS MRCP MSc
Phone
+442073518029
Email
zzoumot@doctors.org.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pallav L Shah, MD FRCP
Organizational Affiliation
Royal Brompton and Chelsea and Westminster Hospitals
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kings Mill Hospital, Sherwood Forest Hospitals NHS Trust
City
Mansfield,
State/Province
Nottinghamshire,
ZIP/Postal Code
N
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Samuel V Kemp, MBBs MRCP
Phone
+44162362251
First Name & Middle Initial & Last Name & Degree
Samuel V Kemp, MBBS, MRCP
Facility Name
The Royal Brompton and Harefield NHS Trust
City
London
ZIP/Postal Code
SW3 6NP
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zaid Zoumot, MBBS MRCP MSc
Phone
+442073518029
Email
zzoumot@doctors.otg.uk
First Name & Middle Initial & Last Name & Degree
Zaid Zoumot, MBBS MRCP MSc
Facility Name
Chelsea and Westminster Hospital NHS Foundation trust
City
London
ZIP/Postal Code
SW9 0HN
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zaid Zoumot, MBBS MRCP MSc

12. IPD Sharing Statement

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Bronchoscopic Intrabullous Autologous Blood Instillation (BIABI) for Emphysema

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