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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.
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:
Thus, the study includes:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 10 coils in upper lobes | Active Comparator | 10 coils in upper lobes |
|
| 15 coils in upper and lower lobes | Experimental | 15 coils in upper and lower lobes |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 10 coils in upper lobes | Procedure |
| ||
| 15 coils in upper and lower lobes |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Inspiratory Capacity (L) | Change in Inspiratory Capacity (L) at 6 months from baseline | three months before procedure and six months after first procedure |
| Measure | Description | Time Frame |
|---|---|---|
| RV (L) | Residual Volume (L) | three months before procedure and six months after first procedure |
| 6-MWT (m) | Six minute walk test (m) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lucia Llanos, MD, PhD | Contact | 915504800 | 3144 | luciallanos@fjd.es |
| Javier Flandes, MD, PhD | Contact | 915504813 | 3543 | iferbas@fjd.es |
| Name | Affiliation | Role |
|---|---|---|
| Iker Fernandez-Navamuel, MD, PhD | FJD | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fundación Jiménez Díaz | Recruiting | Madrid | 28040 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26113524 | Background | Hartman JE, Klooster K, Ten Hacken NH, Slebos DJ. Treatment of emphysema using bronchoscopic lung volume reduction coil technology: an update on efficacy and safety. Ther Adv Respir Dis. 2015 Oct;9(5):251-9. doi: 10.1177/1753465815589904. Epub 2015 Jun 25. | |
| 24891327 | Background | Deslee G, Klooster K, Hetzel M, Stanzel F, Kessler R, Marquette CH, Witt C, Blaas S, Gesierich W, Herth FJ, Hetzel J, van Rikxoort EM, Slebos DJ. Lung volume reduction coil treatment for patients with severe emphysema: a European multicentre trial. Thorax. 2014 Nov;69(11):980-6. doi: 10.1136/thoraxjnl-2014-205221. Epub 2014 Jun 2. |
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| Procedure |
|
| cycloergometry | Procedure |
|
| three months before procedure and six months after first procedure |
| SGQLT (measured in points) | Saint George quality of life test (points) | three months before procedure and six months after first procedure |
| FEV1(measured in liters) | Forced Expiratory Volume in 1 Second (L) | three months before procedure and six months after first procedure |
| FVC (measured in liters) | Forced Vital Capacity (L) | three months before procedure and six months after first procedure |
| Endoscopic Volume Reduction-Associated Complications Rate | Endoscopic Volume Reduction Complications Rate | 6 months |
| Cycloergometry-associated Complications Rate | Cycloergometry-associated Complications Rate | 6 months |
| 26398112 | Background | Boutou AK, Zoumot Z, Nair A, Davey C, Hansell DM, Jamurtas A, Polkey MI, Hopkinson NS. The Impact of Homogeneous Versus Heterogeneous Emphysema on Dynamic Hyperinflation in Patients With Severe COPD Assessed for Lung Volume Reduction. COPD. 2015;12(6):598-605. doi: 10.3109/15412555.2015.1020149. Epub 2015 Sep 23. |
| 10956604 | Background | Aros F, Boraita A, Alegria E, Alonso AM, Bardaji A, Lamiel R, Luengo E, Rabadan M, Alijarde M, Aznar J, Bano A, Cabanero M, Calderon C, Camprubi M, Candell J, Crespo M, de la Morena G, Fernandez A, Ferrero JA, Gayan R, Bolao IG, Hernandez M, Maceira A, Marin E, Muela de Lara A, Placer L, San Roman JA, Serratosa L, Sosa V, Subirana MT, Wilke M. [Guidelines of the Spanish Society of Cardiology for clinical practice in exercise testing]. Rev Esp Cardiol. 2000 Aug;53(8):1063-94. Spanish. |
| ID | Term |
|---|---|
| D011656 | Pulmonary Emphysema |
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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