Use of Endobronchial Valves in Non-Upper Lobe Heterogeneous Emphysema

Comparative Study of Bronchoscopic Lung Volume Reduction to Evaluate Relative Efficacy in Patients With Non-Upper Lobe Emphysema

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.

Study Overview

• Status: Completed
• Conditions: Heterogeneous Emphysema
• Intervention / Treatment: Device: Intra-bronchial valve (Spiration IBV)

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Phase 3

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, SW3 6NP
    • Royal Brompton Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 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 Names: Spiration IBV

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To estimate the difference between study arms in volume changes of the treated lobe(s) by CT scan	6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
To estimate the difference between study arms in volume changes of the non-treated lobes by CT scan	6 months
To estimate the difference between study arms in residual volume	6 months
To estimate the difference between study arms in FEV1	6 months
To estimate the difference between study arms in gas transfer	6 months
To estimate the difference between study arms in modified MRC dyspnoea score	6 months
To estimate the difference between study arms on a 6 minute walk test	6 months
To estimate the difference between study arms in disease specific health status	6 months
To estimate the difference between study arms in dynamic hyperinflation during cycle ergometry	6 months
To estimate the difference between study arms in changes in respiratory and quadriceps muscle strength	6 months

Collaborators and Investigators

• Sponsor: Royal Brompton & Harefield NHS Foundation Trust

Publications and helpful links

Helpful Links

• Royal Brompton Hospital Respiratory Research Group website

Study record dates

Study Major Dates

• Study Start: January 1, 2009
• Primary Completion (Actual): December 1, 2010
• Study Completion (Actual): December 1, 2010

Study Registration Dates

• First Submitted: January 19, 2009
• First Submitted That Met QC Criteria: January 20, 2009
• First Posted (Estimate): January 21, 2009

Study Record Updates

• Last Update Posted (Estimate): February 6, 2012
• Last Update Submitted That Met QC Criteria: February 3, 2012
• Last Verified: February 1, 2012

More Information

Terms related to this study

• Keywords: intrabronchial valve; heterogeneous emphysema; non-upper lobe
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Pulmonary Emphysema; Emphysema
• Other Study ID Numbers: 08/H0708/84