Bronchoscopic Lung Volume Reduction Using Blood

Emphysema Clinical Trial

Official title:

A Randomised, Double Blind, Sham Controlled Trial of Autologous Blood Lung Volume Reduction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01528267
• Other study ID #: 08/H0708/100
• Status: Completed
• Phase: Phase 2
• First received: February 3, 2012
• Last updated: December 19, 2013
• Start date: November 2009
• Est. completion date: March 2013

Study information

• Verified date: December 2013
• Source: Chelsea and Westminster NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The prupose of this study is to determine the feasibility, effectiveness, and safety of injecting blood into the airways to cause lung volume reduction in people with severe emphysema.

Description:

This will be a randomised, double blind, placebo controlled trial where the response in patients treated with blood LVR will be compared to patients treated with placebo (control group). Analysis will evaluate the mean change in lobar lung volumes as determined by computed tomography (CT) scanning at 6 weeks in two study arms based on subjects' blinded bronchoscopic intervention.

Initial assessment will comprise

• Clinical evaluation

• Full pulmonary function tests (PFTs) - static and dynamic lung volumes and gas transfer

• SGRQ

• Dyspnoea Score

• CT scan

Suitable patients will then be randomised to receive either autologous blood, or normal saline injected into the target airways.

Procedures in all patients will be carried out under conscious sedation and/or anaesthesia. After bronchoscopic examination of the airways, 100ml of the patients own blood will be collected using two 50ml syringes. A balloon catheter will be inserted into the target segment and 25 mls of the blood will be injected via the balloon catheter. The balloon will be inflated and maintained in position for about 6 minutes in order to minimise the risk of overspill of blood into other areas of the lung. The balloon catheter will then be repositioned in the next segment of the target lobe of the lung and the process repeated until all the segments are treated. It is anticipated that the whole procedure will last 45-60 minutes, up to and including balloon removal.

The placebo arm will involve an identical protocol, except that injections of 30mls of 0.9% saline will replace the injections of blood. 3 segments will be 'treated'. The blood retrieved at the start of the procedure will be discarded.

A course of antibiotics or pulse of corticosteroids after the procedure will be at the discretion of the investigator. Post-operative CXRs will only be ordered if there are clinical indications (e.g. cough, fever, increased breathlessness).

Reassessment will occur at 6 weeks. This will be undertaken by a blinded assessment team with no knowledge of which study arm a patient has been randomised into, and with no access to the initial procedure record. This removes expectation and subjectivity from the assessment. Assessment will consist of the following:

• Clinical evaluation

• Full pulmonary function tests (PFTs) - static and dynamic lung volumes and gas transfer

• SGRQ

• Dyspnoea Score

• Blinding questionnaire for patient and assessment team

• CT scan

After the assessments have been completed the patients will be un-blinded and informed which treatment group they had been assigned to.

Subjects will be made aware that the process is expected to be irreversible. However, if there are any problems during the bronchoscopy (for example worsening hypoxia), then the procedure will be abandoned as soon as it is safe to do so.

A log of adverse and serious adverse events for each patient will be kept as part of the safety monitoring of the trial.

Those who are entered into the control arm of the study will be offered the real procedure at the end of the study if benefits are apparent

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Age 18-80 years

• Moderate to severe airflow obstruction FEV1 <50% Predicted

• Severe dyspnoea - mMRC =2

• Hyperinflation - total lung capacity (TLC) =100% predicted, RV =150% predicted

• Optimum COPD treatment for at least 6 weeks

• No COPD exacerbation for at least 6 weeks

• Less than 3 admissions for exacerbation in the preceding 12 months

Exclusion Criteria:

• Patient unable to provide informed consent

• Total lung CO uptake (TLCO) <15% predicted and FEV1 <15% predicted

• pO2 on air <6.0kPa

• pCO2 on air >8.0kPa

• Other major medical illness, e.g. lung cancer that will limit participation

• Clinically significant bronchiectasis

• Large bulla - more than 1/3 of hemithorax volume (i.e. where bullectomy would be more suitable) on CT scan

• Arrhythmia or cardiovascular disease that poses a risk during procedure

• Prednisolone dose greater than 10mg a day

• Prior LVRS or lobectomy

• Lung nodule requiring surgery

• Female of childbearing age with positive pregnancy test

• Subject participated in a research study of investigational drug or device in prior 30 days

• Subject taking clopidogrel, warfarin, or other anticoagulants and unable to abstain for 5 days pre-procedure

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Emphysema

Intervention

Other:
• Autologous blood
50mls of autologous blood injected into each of 3 bronchopulmonary segments.
• Normal saline
50mls of normal saline injected into each of 3 bronchopulmonary segments.

Locations

Country	Name	City	State
United Kingdom	Chelsea and Westminster NHS Foundation Trust	London

Sponsors (1)

Lead Sponsor	Collaborator
Chelsea and Westminster NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

Kobayashi H, Kanoh S. [Bronchoscopic autologous blood injection for lung volume reduction]. Nihon Kokyuki Gakkai Zasshi. 2009 Sep;47(9):765-71. Japanese. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evidence of scarring and volume loss on CT scanning		6 weeks	No
Secondary	To ensure no significant lung function deteriorations at 6 weeks post-procedure		6 weeks	Yes