Bronchoscopic Lung Volume Reduction Using Blood

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Chelsea and Westminster NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT01528267
First received: February 3, 2012
Last updated: December 19, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention Phase
Emphysema
Other: Autologous blood
Other: Normal saline
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Official Title: A Randomised, Double Blind, Sham Controlled Trial of Autologous Blood Lung Volume Reduction

Resource links provided by NLM:


Further study details as provided by Chelsea and Westminster NHS Foundation Trust:

Primary Outcome Measures:
  • Evidence of scarring and volume loss on CT scanning [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To ensure no significant lung function deteriorations at 6 weeks post-procedure [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 10
Study Start Date: November 2009
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Autologous blood
Patients will have 50mls of autologous blood injected into each of 3 bronchopulmonary segments during bronchoscopy under conscious sedation.
Other: Autologous blood
50mls of autologous blood injected into each of 3 bronchopulmonary segments.
Sham Comparator: Saline
Patients will have 50mls of normal saline injected into each of 3 bronchopulmonary segments during bronchoscopy under conscious sedation.
Other: Normal saline
50mls of normal saline injected into each of 3 bronchopulmonary segments.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01528267

Locations
United Kingdom
Chelsea and Westminster NHS Foundation Trust
London, United Kingdom
Sponsors and Collaborators
Chelsea and Westminster NHS Foundation Trust
Investigators
Principal Investigator: Pallav Shah, MBBS, MD Chelsea and Westminster Hospital NHS Foundation Trust
  More Information

Publications:
Responsible Party: Chelsea and Westminster NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT01528267     History of Changes
Other Study ID Numbers: 08/H0708/100
Study First Received: February 3, 2012
Last Updated: December 19, 2013
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by Chelsea and Westminster NHS Foundation Trust:
Emphysema, lung volume reduction, autologous blood

Additional relevant MeSH terms:
Emphysema
Pathologic Processes

ClinicalTrials.gov processed this record on September 29, 2014