Trial record 11 of 72 for:
Open Studies | "Emphysema"
Bronchoscopic Intrabullous Autologous Blood Instillation (BIABI) for Emphysema
This study is currently recruiting participants.
Verified November 2012 by Chelsea and Westminster NHS Foundation Trust
Sponsor:
Chelsea and Westminster NHS Foundation Trust
Information provided by (Responsible Party):
Chelsea and Westminster NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT01727037
First received: November 12, 2012
Last updated: November 19, 2012
Last verified: November 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Bullous Emphysema |
Procedure: Bronchoscopic intrabullous autologous blood instillation |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Feasibility and Safety Study of Bronchoscopic Intrabullous Autologous Blood Instillation for the Treatment of Severe Bullous Emphysema (BIABI Study) |
Resource links provided by NLM:
Further study details as provided by Chelsea and Westminster NHS Foundation Trust:
Primary Outcome Measures:
- Change in the Residual Volume (RV) following treatment [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Change in TLC 6 months following treatment [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Change in RV/TLC ratio 6 months following treatment [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Changes in FEV1 and FVC 6 months following treatment [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Change in the intrathoracic gas volume 6 months following treatment [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Change in DLCOc 6 months following treatment [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Change in the SGRQ score 6 months following treatment [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Change in the mMRC score 6 months following treatment [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Change in the 6MWD 6 months following treatment [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Change in CT measured lung volumes 6 months following treatment [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Adverse events [ Time Frame: 6 monhts ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 30 |
| Study Start Date: | October 2012 |
| Estimated Primary Completion Date: | September 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: BIABI arm
Patients will undergo intrabullous autologous blood instillation
|
Procedure: Bronchoscopic intrabullous autologous blood instillation
Other Name: BIABI
|
Eligibility| Ages Eligible for Study: | 35 Years to 90 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01727037
Contacts
| Contact: Zaid Zoumot, MBBS MRCP MSc | +442073518029 | zzoumot@doctors.org.uk |
Locations
| United Kingdom | |
| Kings Mill Hospital, Sherwood Forest Hospitals NHS Trust | Recruiting |
| Mansfield,, Nottinghamshire,, United Kingdom, N | |
| Contact: Samuel V Kemp, MBBs MRCP +44162362251 | |
| Principal Investigator: Samuel V Kemp, MBBS, MRCP | |
| Chelsea and Westminster Hospital NHS Foundation trust | Recruiting |
| London, United Kingdom, SW9 0HN | |
| Sub-Investigator: Zaid Zoumot, MBBS MRCP MSc | |
| The Royal Brompton and Harefield NHS Trust | Recruiting |
| London, United Kingdom, SW3 6NP | |
| Contact: Zaid Zoumot, MBBS MRCP MSc +442073518029 zzoumot@doctors.otg.uk | |
| Sub-Investigator: Zaid Zoumot, MBBS MRCP MSc | |
Sponsors and Collaborators
Chelsea and Westminster NHS Foundation Trust
Investigators
| Principal Investigator: | Pallav L Shah, MD FRCP | Royal Brompton and Chelsea and Westminster Hospitals |
More Information
No publications provided
| Responsible Party: | Chelsea and Westminster NHS Foundation Trust |
| ClinicalTrials.gov Identifier: | NCT01727037 History of Changes |
| Other Study ID Numbers: | BIABI v1 |
| Study First Received: | November 12, 2012 |
| Last Updated: | November 19, 2012 |
| Health Authority: | United Kingdom: National Health Service |
Keywords provided by Chelsea and Westminster NHS Foundation Trust:
|
Emphysema Chronic obstructive pulmonary disease COPD |
Bulla Interventional bronchoscopy Lung volume reduction |
Additional relevant MeSH terms:
|
Emphysema Pulmonary Emphysema Pathologic Processes Lung Diseases Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on May 16, 2013