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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01727037
Other study ID # BIABI v1
Secondary ID
Status Recruiting
Phase Phase 2
First received November 12, 2012
Last updated November 19, 2012
Start date October 2012

Study information

Verified date November 2012
Source Chelsea and Westminster NHS Foundation Trust
Contact Zaid Zoumot, MBBS MRCP MSc
Phone +442073518029
Email zzoumot@doctors.org.uk
Is FDA regulated No
Health authority United Kingdom: National Health Service
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date
Est. primary completion date September 2014
Accepts healthy volunteers No
Gender Both
Age group 35 Years to 90 Years
Eligibility 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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Procedure:
Bronchoscopic intrabullous autologous blood instillation


Locations

Country Name City State
United Kingdom Chelsea and Westminster Hospital NHS Foundation trust London
United Kingdom The Royal Brompton and Harefield NHS Trust London
United Kingdom Kings Mill Hospital, Sherwood Forest Hospitals NHS Trust Mansfield, Nottinghamshire,

Sponsors (1)

Lead Sponsor Collaborator
Chelsea and Westminster NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in the Residual Volume (RV) following treatment 6 months No
Secondary Change in TLC 6 months following treatment 6 months No
Secondary Change in RV/TLC ratio 6 months following treatment 6 months No
Secondary Changes in FEV1 and FVC 6 months following treatment 6 months No
Secondary Change in the intrathoracic gas volume 6 months following treatment 6 months No
Secondary Change in DLCOc 6 months following treatment 6 months No
Secondary Change in the SGRQ score 6 months following treatment 6 months No
Secondary Change in the mMRC score 6 months following treatment 6 months No
Secondary Change in the 6MWD 6 months following treatment 6 months No
Secondary Change in CT measured lung volumes 6 months following treatment 6 months No
Secondary Adverse events 6 monhts No