A feasibility and safety study of bronchoscopic intrabullous autologous blood instillation for the treatment of severe bullous emphysema.

Phase 2

Withdrawn

Conditions: COPD
Emphysema
10038716

Registration Number: NL-OMON38731

Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Withdrawn

Sex: Not specified

Target Recruitment: 20

Inclusion Criteria

- Age > 35 years
- Large bulla on CT scan were bullectomy is contraindicated or is actively avoided
- Hyperinflation --> TLC * 100%predcited and 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
- Patients has stopped smoking for a minimum of 6 months prior to entering the study

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

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Change in RV 6 months following treatment</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Change in TLC 6 months following treatment<br /><br>Change in RV/TLC ratio 6 months following treatment<br /><br>Changes in FEV1 and FVC 6 months following treatment<br /><br>Change in the intrathoracic gas volume 6 months following treatment<br /><br>Change in DLCOc 6 months following treatment<br /><br>Change in the SGRQ score 6 months following treatment<br /><br>Change in the mMRC score 6 months following treatment<br /><br>Change in the 6MWD 6 months following treatment<br /><br>Changes in the above mentioned lung function, functional and quality of life<br /><br>outcome measures at 3 months.<br /><br>Change in CT measured lung volumes 6 months following treatment</p><br>