A Trial on the Effects of Bronchoscopic Lung Volume Reduction in Severe Emphysema.

Launched by UNIVERSITY MEDICAL CENTER GRONINGEN · Mar 15, 2018

Keywords

ClinConnect Summary

Rationale: The published clinical trials investigating the bronchoscopic lung volume reduction, showing important patient-related improvements in efficacy, led to the acknowledgement of the treatment in the GOLD-COPD2017 guidelines. Interaction with pulmonary rehabilitation, impact on patient-reported outcomes, physical activity, and extrapulmonary consequences are all topics to gain more insight in. This importantly, to further develop and optimize this innovative and personalized therapy.

Objective: To study in detail the impact and optimal timing of pulmonary rehabilitation (PR) on exer...

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Eligibility criteria

• Inclusion Criteria:
• • COPD.
• • FEV1 ≤45%pred AND FEV1/FVC \<70%.
• • TLC \>100%pred AND RV\>175%pred.
• • CAT ≥18.
• • \>50% emphysema destruction @-910HU.
• • \>95% complete major fissure measured by quantitative CT analysis.
• • Non-smoking \>6 months.
• • Signed informed consent.
• Exclusion Criteria:
• • PaCO2\>8.0 kPa, or PaO2\<6.0kPa.
• • 6-minute walk test \<160m.
• • Significant chronic bronchitis, bronchiectasis, or other infectious lung disease.
• • 3 of more hospitalizations due to pulmonary infection within last 12 months before baseline assessments
• • Previous lobectomy, LVRS, or lung transplantation.
• • LVEF\<45% and or RVSP\>50mmHg.
• • Anticoagulant therapy which cannot be weaned off prior to procedure.
• • Patient is significantly immunodeficient.
• • Involved in other pulmonary drug studies within 30 days prior to this study.
• • Pulmonary nodule which requires intervention
• • Any disease or condition that interferes with completion of initial or follow-up assessments