Bullous EmphysemaPhase 2BIABINCT01727037
Bronchoscopic Intrabullous Autologous Blood Instillation (BIABI) for Emphysema
A Phase 2 study testing Bronchoscopic intrabullous autologous blood instillation in people with Bullous Emphysema, run by Chelsea and Westminster NHS Foundation Trust at 3 sites in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 35 to 90 years
- Conditions the study is for
- Bullous Emphysema
- What is being tested?
- Bronchoscopic intrabullous autologous blood instillation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- Oct 2012to Sep 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
United Kingdom3 sites, 3 recruiting
- Recruiting
The Royal Brompton and Harefield NHS Trust
London, SW3 6NP
Zaid Zoumot, MBBS MRCP MSc, +442073518029, zzoumot@doctors.otg.uk
Zaid Zoumot, MBBS MRCP MSc
- Recruiting
Chelsea and Westminster Hospital NHS Foundation trust
London, SW9 0HN
Zaid Zoumot, MBBS MRCP MSc
- Recruiting
Kings Mill Hospital, Sherwood Forest Hospitals NHS Trust
Mansfield, Nottinghamshire,, N
Samuel V Kemp, MBBs MRCP, +44162362251
Samuel V Kemp, MBBS, MRCP
About this study
Official title: A Feasibility and Safety Study of Bronchoscopic Intrabullous Autologous Blood Instillation for the Treatment of Severe Bullous Emphysema (BIABI Study)
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.
- Conditions
- Bullous Emphysema
- Being tested
- Bronchoscopic intrabullous autologous blood instillation
- Keywords
- Emphysema, Chronic obstructive pulmonary disease, COPD, Bulla, Interventional bronchoscopy, Lung volume reduction
- Medical subject headings
- Emphysema, Pulmonary Disease, Chronic Obstructive, Blister
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bronchoscopic intrabullous autologous blood instillationProcedure or surgery
Also called BIABI
| Study group | Role | What they receive |
|---|---|---|
| BIABI arm | Experimental | Patients will undergo intrabullous autologous blood instillation Receives: Procedure: Bronchoscopic intrabullous autologous blood instillation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the Residual Volume (RV) following treatment
Measured: 6 months
Secondary outcomes (10)
Change in TLC 6 months following treatment
Measured: 6 months
Change in RV/TLC ratio 6 months following treatment
Measured: 6 months
Changes in FEV1 and FVC 6 months following treatment
Measured: 6 months
Change in the intrathoracic gas volume 6 months following treatment
Measured: 6 months
Change in DLCOc 6 months following treatment
Measured: 6 months
Change in the SGRQ score 6 months following treatment
Measured: 6 months
Change in the mMRC score 6 months following treatment
Measured: 6 months
Change in the 6MWD 6 months following treatment
Measured: 6 months
Change in CT measured lung volumes 6 months following treatment
Measured: 6 months
Adverse events
Measured: 6 monhts
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2012 (estimated)
- Study startOct 2012
- Primary completionSep 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bullous EmphysemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chelsea and Westminster NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pallav L Shah, MD FRCP, Principal investigator, Royal Brompton and Chelsea and Westminster Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01727037
- Sponsor's protocol ID
- BIABI v1
- Acronym
- BIABI
- Status last verified
- Nov 2012
- First submitted
- 12 Nov 2012
- Last updated
- 20 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility and Safety Study of Bronchoscopic Intrabullous Autologous Blood Instillation for the Treatment of Severe Bullous Emphysema (BIABI Study)
- ClinicalTrials.gov ID
- NCT01727037
- Acronym / sponsor ID
- BIABI / BIABI v1
- Conditions
- Bullous Emphysema
- Keywords
- Emphysema, Chronic obstructive pulmonary disease, COPD, Bulla, Interventional bronchoscopy, Lung volume reduction
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Chelsea and Westminster NHS Foundation TrustUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Sep 2014 (estimated)
- First posted
- 15 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BIABI arm | Experimental | Procedure: Bronchoscopic intrabullous autologous blood instillationPatients will undergo intrabullous autologous blood instillation |
Who may qualify
- Ages
- 35 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bronchoscopic intrabullous autologous blood instillationAlso: BIABI | Procedure or surgery | BIABI arm |
Primary outcome
Change in the Residual Volume (RV) following treatment
Time frame: 6 months
10 secondary outcomes
Change in TLC 6 months following treatment
Time frame: 6 months
Change in RV/TLC ratio 6 months following treatment
Time frame: 6 months
Changes in FEV1 and FVC 6 months following treatment
Time frame: 6 months
Change in the intrathoracic gas volume 6 months following treatment
Time frame: 6 months
Change in DLCOc 6 months following treatment
Time frame: 6 months
Change in the SGRQ score 6 months following treatment
Time frame: 6 months
Change in the mMRC score 6 months following treatment
Time frame: 6 months
Change in the 6MWD 6 months following treatment
Time frame: 6 months
Change in CT measured lung volumes 6 months following treatment
Time frame: 6 months
Adverse events
Time frame: 6 monhts
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2012.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pallav L Shah, MD FRCP principal investigator
Royal Brompton and Chelsea and Westminster Hospitals
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Bronchoscopic intrabullous autologous blood instillation in people with Bullous Emphysema, run by Chelsea and Westminster NHS Foundation Trust at 3 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zaid Zoumot, MBBS MRCP MSc (+442073518029, zzoumot@doctors.org.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the Residual Volume (RV) following treatment (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2012.