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

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: September 2021

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

  • Procedure: 10 coils in upper lobes
  • Procedure: 15 coils in upper and lower lobes
  • Procedure: cycloergometry

Arms, Groups and Cohorts

  • Active Comparator: 10 coils in upper lobes
    • 10 coils in upper lobes
  • Experimental: 15 coils in upper and lower lobes
    • 15 coils in upper and lower lobes

Clinical Trial Outcome Measures

Primary Measures

  • Change in Inspiratory Capacity (L)
    • Time Frame: three months before procedure and six months after first procedure
    • Change in Inspiratory Capacity (L) at 6 months from baseline

Secondary Measures

  • RV (L)
    • Time Frame: three months before procedure and six months after first procedure
    • Residual Volume (L)
  • 6-MWT (m)
    • Time Frame: three months before procedure and six months after first procedure
    • Six minute walk test (m)
  • SGQLT (measured in points)
    • Time Frame: three months before procedure and six months after first procedure
    • Saint George quality of life test (points)
  • FEV1(measured in liters)
    • Time Frame: three months before procedure and six months after first procedure
    • Forced Expiratory Volume in 1 Second (L)
  • FVC (measured in liters)
    • Time Frame: three months before procedure and six months after first procedure
    • Forced Vital Capacity (L)
  • Endoscopic Volume Reduction-Associated Complications Rate
    • Time Frame: 6 months
    • Endoscopic Volume Reduction Complications Rate
  • Cycloergometry-associated Complications Rate
    • Time Frame: 6 months
    • Cycloergometry-associated Complications Rate

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 40 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Iker Fernandez-Navamuel, MD, PhD, Principal Investigator, FJD
  • Overall Contact(s)
    • Lucia Llanos, MD, PhD, 915504800, luciallanos@fjd.es

References

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.

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.

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.

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.

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