Pulmonary Emphysema
Conditions
Keywords
pulmonary emphysema, coils, cycloergometry, lung volume reduction
Brief summary
The study hypothesis is that patients with homogeneous emphysema behave differently compared to heterogeneous emphysema with respect to exercise capacity. A better understanding of this difference will allow the investigators to choose the best treatment for each type of patient. The main purpose of this study is to evaluate the change in exercise capacity measured by cycle ergometry in patients with severe emphysema after endoscopic lung volume reduction with coils (eLVR). As a secondary purpose, the investigators want to perform an exploratory, randomized study to compare the results of two different therapeutic approaches in a small sample of patients with homogeneous emphysema.
Detailed description
The study plans to include patients with severe emphysema candidates to go through eLVR with coils that fulfill all inclusion criteria and none of the exclusion criteria. Patients with both homogeneous and heterogeneous emphysema will be included. The main study intervention is the performance of a cyclo ergometry (not included in daily clinical practice) before (basal) and 6 months after going through the eLVR with coils. The subgroup of patients with homogeneous emphysema will be randomly assigned to the following therapeutic approaches: * Group A: treatment with 10 coils in upper lobes * Group B: treatment with 15 coils spared in upper and lower lobes Thus, the study includes: * for all patients, the performance of two cycloergometries, before and 6 months after the eLVR * Also, for the subset of homogeneous emphysema patients, an open label, randomized, parallel, two arm exploratory clinical trial. Sample size has not been formally calculated as there are no previous available data for the primary endpoint (change inspiratory capacity). Thus, 35 patients will be included according to the expected number of patients. Recruitment period will be 24 months and patient follow up will be 6 months.
Interventions
PROCEDURE10 coils in upper lobes
PROCEDURE15 coils in upper and lower lobes
PROCEDUREcycloergometry
Sponsors
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Emphysematous patient * FEV1 \< 50% * RV \> 200% * Diffusion \<60% \>20% * PSP \<55 mmHg
Exclusion criteria
* Anticoagulants/antiplatelets * Giant bullae (\> 8 cm , 1/3 hemithorax) * More tan three moderate/severe exacerbation per year * Negative to sign informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Inspiratory Capacity (L) | three months before procedure and six months after first procedure | Change in Inspiratory Capacity (L) at 6 months from baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 6-MWT (m) | three months before procedure and six months after first procedure | Six minute walk test (m) |
| SGQLT (measured in points) | three months before procedure and six months after first procedure | Saint George quality of life test (points) |
| FEV1(measured in liters) | three months before procedure and six months after first procedure | Forced Expiratory Volume in 1 Second (L) |
| RV (L) | three months before procedure and six months after first procedure | Residual Volume (L) |
| Endoscopic Volume Reduction-Associated Complications Rate | 6 months | Endoscopic Volume Reduction Complications Rate |
| Cycloergometry-associated Complications Rate | 6 months | Cycloergometry-associated Complications Rate |
| FVC (measured in liters) | three months before procedure and six months after first procedure | Forced Vital Capacity (L) |
Countries
Spain
Contacts
Primary ContactLucia Llanos, MD, PhD
Backup ContactJavier Flandes, MD, PhD
Outcome results
None listed