Bronchoscopic Lung Volume Reduction in Severe Emphysema Using Thermoablation
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Emphysema or Chronic Obstructive Pulmonary Disease
- Sponsor
- IHF GmbH - Institut für Herzinfarktforschung
- Enrollment
- 224
- Locations
- 12
- Primary Endpoint
- Change in patient-reported disease-specific quality of life
- Status
- Recruiting
- Last Updated
- 8 months ago
Overview
Brief Summary
Prospective, 2-arm, randomised (2:1), multicentre, open-label clinical trial in patients with severe emphysema. The intervention arm will be treated with Bronchoscopic lung volume reduction in severe emphysema using thermoablation.The interventional treatment (bronchoscopic lung volume reduction) is compared with the usual conservative standard therapy (GOLD guidelines).
Detailed Description
Currently, there is less data on the use of bronchoscopic thermoablation (BTVA) for the treatment of patients with emphysema. However, the current studies suggest with a high degree of certainty that bronchoscopic lung volume reduction for severe emphysema using thermoablation has the potential to be a necessary treatment alternative. The trial study should therefore contribute to proving the benefit of this procedure as an effective and safe treatment option in order to guarantee emphysema patients sufficient, appropriate and economical care, taking into account evidence-based medical knowledge.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age: ≥ 40 years and ≤ 75 years
- •Written informed consent obtained from the patient
- •Severe emphysema with indication for BTVA:
- •bilateral heterogeneous emphysema of the upper lobes in GOLD stage 3/4 and
- •evidence of severe emphysema in high-resolution computed tomography (not older than 6 months prior to inclusion) and
- •functional evidence of severe pulmonary hyperinflation and
- •FEV1 post lysis between 20% and \< 45% (calculated) and
- •Total lung capacity (TLC) ≥ 100% (calculated) and
- •Residual volume (RV) \> 175% (calculated) and
- •arterial blood gas values of: PaCO2 ≤ 50 mmHg; PaO2 \> 50 mmHg on room air and
Exclusion Criteria
- •Any condition that would interfere with the conduct of the clinical trial follow-up or bronchoscopy or affect the outcome of the clinical trial
- •DLCO \< 20% (calculated)
- •Body mass index (BMI) \< 18 kg/m2 or \> 32 kg/m2
- •Pulmonary hypertension
- •Peak systolic PAP \> 45 mmHg or mean PAP \> 25 mmHg
- •Right heart catheter measurements are considered authoritative over echocardiogram measurements
- •Clinically significant bronchiectasis
- •Pneumothorax or pleural effusions within the last 6 months
- •Heart and/or lung transplantation, surgical lung volume reduction (LVRS), bullectomy, lobectomy or pneumonectomy, pleurodesis or any surgery in the target lobes (upper lobes).
- •Recent respiratory infection or COPD exacerbation in the last 6 weeks
Outcomes
Primary Outcomes
Change in patient-reported disease-specific quality of life
Time Frame: 9 months
Change in patient-reported, disease-specific quality of life based on St. George's Respiratory Questionnaire (SGRQ-C) between randomisation and 9-month visit. The instrument has 3 domains (activity, symptoms, and impacts) and a total score. A Total and three-component scores are calculated: Symptoms; Activity; Impacts. Each questionnaire response has a unique empirically derived 'weight'. The lowest possible weight is zero and the highest is 100. Each component of the questionnaire is scored separately. Sum of maximum possible weights for each component and Total: Symptoms 566.2, Activity 982.9, Impacts 1652.8. Total (sum of maximum for all three components) 3201.9 Higher weights indicate worse outcomes. The difference in the domain scores and total score at follow-up visits relative to baseline will be calculated and reported.
Secondary Outcomes
- Change in FEV 1(3, 9 and 12 months)
- Vital status(3, 9 and 12 months)
- Change in RV(3, 9 and 12 months)
- Serious Adverse Events(3, 9 and 12 months)
- 6-minute walk test (6MWT)(3, 9 and 12 months)
- Mortality(3, 9 and 12 months)
- Change in patient-reported, disease-specific quality of life(3, 9 and 12 months)
- Severe excacerbations(3, 9 and 12 months)