Clinical Study to Evaluate the Exercise Capacity in Patients With Severe Emphysema Treated With Coils

NCT02879331 | Unknown

• 1 other identifier: EC 33-16/IIS-FJD
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary Emphysema

Keywords

pulmonary emphysema; coils; cycloergometry; lung volume reduction

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (7)

• RV (L)

  three months before procedure and six months after first procedure

• 6-MWT (m)

  three months before procedure and six months after first procedure

• SGQLT (measured in points)

  three months before procedure and six months after first procedure

• FEV1(measured in liters)

  three months before procedure and six months after first procedure

• FVC (measured in liters)

  three months before procedure and six months after first procedure

Study Arms (2)

10 coils in upper lobes

ACTIVE COMPARATOR

10 coils in upper lobes

Procedure: 10 coils in upper lobes; Procedure: cycloergometry

15 coils in upper and lower lobes

EXPERIMENTAL

15 coils in upper and lower lobes

Procedure: 15 coils in upper and lower lobes; Procedure: cycloergometry

Interventions

10 coils in upper lobes PROCEDURE

10 coils in upper lobes

15 coils in upper and lower lobes PROCEDURE

15 coils in upper and lower lobes

cycloergometry PROCEDURE

10 coils in upper lobes; 15 coils in upper and lower lobes

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Emphysematous patient
• FEV1 \< 50%
• RV \> 200%
• Diffusion \<60% \>20%
• PSP \<55 mmHg

You may not qualify if:

• Anticoagulants/antiplatelets
• Giant bullae (\> 8 cm , 1/3 hemithorax)
• More tan three moderate/severe exacerbation per year
• Negative to sign informed consent

Sponsors & Collaborators

• Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz: lead

Study Sites (1)

Fundación Jiménez Díaz

Madrid, 28040, Spain

RECRUITING

Related Publications (4)

• 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.

  PMID: 26113524 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.

  PMID: 24891327 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.

  PMID: 26398112 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.

  PMID: 10956604 BACKGROUND

MeSH Terms

Conditions

Pulmonary Emphysema

Condition Hierarchy (Ancestors)

Pulmonary Disease, Chronic Obstructive; Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Iker Fernandez-Navamuel, MD, PhD

  FJD

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lucia Llanos, MD, PhD

CONTACT

915504800; luciallanos@fjd.es

Javier Flandes, MD, PhD

CONTACT

915504813; iferbas@fjd.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2016
• First Posted: August 25, 2016
• Study Start: November 1, 2016
• Primary Completion: September 1, 2021
• Study Completion: December 1, 2021
• Last Updated: March 1, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)