A prospective randomized controlled trial on the Systemic effects of bronchoscopic Lung Volume reduction in patients with severe Emphysema.

Completed

• Conditions: COPD; emphysema; 10038716

• Registration Number: NL-OMON52962
• Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 96

Inclusion Criteria

- COPD.
- FEV1 <=45%pred AND FEV1/FVC <70%.
- TLC >100%pred AND RV>175%pred.
- CAT >=10.
- >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 or 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main study parameter is the difference in change in endurance time measured<br /><br>by an endurance cycle test between the EBV treatment group and the<br /><br>bronchoscopic lung volume reduction + rehabilitation group (EBV+PR).</p><br>