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Use of Endobronchial Valves in Non-Upper Lobe Heterogeneous Emphysema

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Royal Brompton & Harefield NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT00825578
First received: January 19, 2009
Last updated: February 3, 2012
Last verified: February 2012
  Purpose

Hypothesis: Patients with advanced emphysema with predominance of the disease in areas other than the upper lobes, as determined by high resolution computed tomography (HRCT), could have a positive response to valve treatment.


Condition Intervention Phase
Heterogeneous Emphysema
Device: Intra-bronchial valve (Spiration IBV)
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparative Study of Bronchoscopic Lung Volume Reduction to Evaluate Relative Efficacy in Patients With Non-Upper Lobe Emphysema

Resource links provided by NLM:


Further study details as provided by Royal Brompton & Harefield NHS Foundation Trust:

Primary Outcome Measures:
  • To estimate the difference between study arms in volume changes of the treated lobe(s) by CT scan [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To estimate the difference between study arms in volume changes of the non-treated lobes by CT scan [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • To estimate the difference between study arms in residual volume [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • To estimate the difference between study arms in FEV1 [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • To estimate the difference between study arms in gas transfer [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • To estimate the difference between study arms in modified MRC dyspnoea score [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • To estimate the difference between study arms on a 6 minute walk test [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • To estimate the difference between study arms in disease specific health status [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • To estimate the difference between study arms in dynamic hyperinflation during cycle ergometry [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • To estimate the difference between study arms in changes in respiratory and quadriceps muscle strength [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 32
Study Start Date: January 2009
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Upper-lobe predominant emphysema
Device: Intra-bronchial valve (Spiration IBV)
Device: Intra-bronchial valve (Spiration IBV) The IBV is comprised of a Nitnol frame and a polymer membrane, which is held against the airway mucosa by six elastic struts and will expand and contract with airway movement during breathing. The valve is designed to conform to the size and shape of the airways. The frame has 5 flexible anchors that gently secure to the mucosal wall at a controlled depth. Valves are available in 5, 6 and 7mm diameters appropriate for different airways. During a minimally invasive procedure, a catheter is passed through a bronchoscope (a flexible tube passed into the airways through the mouth) to deploy the umbrella-shaped valves into the airways. Only flexible bronchoscopy equipment is required. The valves are designed to be removed if indicated.
Other Name: Spiration IBV
Active Comparator: 2
Non-upper lobe predominant emphysema
Device: Intra-bronchial valve (Spiration IBV)
Device: Intra-bronchial valve (Spiration IBV) The IBV is comprised of a Nitnol frame and a polymer membrane, which is held against the airway mucosa by six elastic struts and will expand and contract with airway movement during breathing. The valve is designed to conform to the size and shape of the airways. The frame has 5 flexible anchors that gently secure to the mucosal wall at a controlled depth. Valves are available in 5, 6 and 7mm diameters appropriate for different airways. During a minimally invasive procedure, a catheter is passed through a bronchoscope (a flexible tube passed into the airways through the mouth) to deploy the umbrella-shaped valves into the airways. Only flexible bronchoscopy equipment is required. The valves are designed to be removed if indicated.
Other Name: Spiration IBV

  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
  • Ex-smoker with smoking cessation confirmed by exhaled carbon monoxide (CO) levels
  • Moderate to severe airflow obstruction FEV1 <50% Predicted
  • Severe dyspnoea - mMRC ≥2
  • Hyperinflation - total lung capacity (TLC) ≥100% predicted, RV ≥150% predicted
  • SWT ≥75m
  • Optimum COPD treatment for at least 6 weeks
  • No COPD exacerbation for at least 6 weeks
  • Less than 4 admissions for exacerbation in the preceding 12 months

Exclusion Criteria:

  • Patient unable to provide informed consent
  • Patient without clear targets for airflow re-distribution
  • Total lung CO uptake (TLCO) <15% predicted and FEV1 <15% predicted
  • pO2 on air <6.0kPa
  • pCO2 on air >8.0kPa
  • Neurological, rheumatological or other cause of exercise limitation
  • Other major medical illness, e.g. lung cancer that will limit participation
  • Production of purulent sputum more often than not (more than 50% of days)
  • 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 or exercise
  • Prednisolone dose greater than 15mg a day
  • Significant pulmonary hypertension - RVSP ≥45mmHg
  • Left ventricular failure - left ventricular ejection fraction <45% or left ventricular fraction shortening <23%
  • Prior LVRS or lobectomy
  • Lung nodule requiring surgery
  • Subject completed or is participating in a standard pulmonary rehabilitation program within 3 months of enrolment
  • 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: NCT00825578

Locations
United Kingdom
Royal Brompton Hospital
London, United Kingdom, SW3 6NP
Sponsors and Collaborators
Royal Brompton & Harefield NHS Foundation Trust
Investigators
Principal Investigator: Pallav Shah, MBBS, MD Royal Brompton & Harefield NHS Foundation Trust
  More Information

Additional Information:
No publications provided

Responsible Party: Royal Brompton & Harefield NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT00825578     History of Changes
Other Study ID Numbers: 08/H0708/84
Study First Received: January 19, 2009
Last Updated: February 3, 2012
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by Royal Brompton & Harefield NHS Foundation Trust:
intrabronchial valve
heterogeneous emphysema
non-upper lobe

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

ClinicalTrials.gov processed this record on November 23, 2014