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Bronchoscopic Lung Volume Reduction Using Blood

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01528267
First Posted: February 7, 2012
Last Update Posted: December 20, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Chelsea and Westminster NHS Foundation Trust
  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
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
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 ]

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Submitted: February 3, 2012
First Posted: February 7, 2012
Last Update Posted: December 20, 2013
Last Verified: December 2013

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

Additional relevant MeSH terms:
Emphysema
Pulmonary Emphysema
Pathologic Processes
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Diseases