NCT00825578CompletedPhase 3
Comparative Study of Bronchoscopic Lung Volume Reduction to Evaluate Relative Efficacy in Patients With Non-Upper Lobe Emphysema
Royal Brompton & Harefield NHS Foundation Trust1 site in 1 country32 target enrollmentStarted: January 1, 2009Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Enrollment
- 32
- Locations
- 1
- Primary Endpoint
- To estimate the difference between study arms in volume changes of the treated lobe(s) by CT scan
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
- •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
Arms & Interventions
1
Active Comparator
Upper-lobe predominant emphysema
Intervention: Intra-bronchial valve (Spiration IBV) (Device)
2
Active Comparator
Non-upper lobe predominant emphysema
Intervention: Intra-bronchial valve (Spiration IBV) (Device)
Outcomes
Primary Outcomes
To estimate the difference between study arms in volume changes of the treated lobe(s) by CT scan
Time Frame: 6 months
Secondary Outcomes
- 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)
Investigators
Study Sites (1)
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