Heterogeneous Emphysema
Conditions
Keywords
intrabronchial valve, heterogeneous emphysema, non-upper lobe
Brief summary
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.
Interventions
DEVICEIntra-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.
Sponsors
Royal Brompton & Harefield NHS Foundation Trust
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To estimate the difference between study arms in volume changes of the treated lobe(s) by CT scan | 6 months |
Secondary
| Measure | Time frame |
|---|---|
| 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 in volume changes of the non-treated lobes by CT scan | 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 |
| To estimate the difference between study arms on a 6 minute walk test | 6 months |
Countries
United Kingdom
Outcome results
None listed