Use of Endobronchial Valves in Non-Upper Lobe Heterogeneous Emphysema

Study Overview
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Brief Summary
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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.

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

Conditions
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Heterogeneous Emphysema

Intervention / Treatment
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* Device: Intra-bronchial valve (Spiration IBV)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Upper-lobe predominant emphysema | Device: Intra-bronchial valve (Spiration IBV)<br>* 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.<br>* Other names: Spiration IBV;|
| Active Comparator: 2<br>Non-upper lobe predominant emphysema | Device: Intra-bronchial valve (Spiration IBV)<br>* 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.<br>* Other names: Spiration IBV;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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intrabronchial valve, heterogeneous emphysema, non-upper lobe