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

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 Overview

• Status: Unknown
• Conditions: Pulmonary Emphysema
• Intervention / Treatment: Procedure: 10 coils in upper lobes; Procedure: cycloergometry; Procedure: 15 coils in upper and lower lobes

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.

• Study Type: Interventional
• Enrollment (Anticipated): 35
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lucia Llanos, MD, PhD; Phone Number: 3144 915504800; Email: luciallanos@fjd.es
• Study Contact Backup: Name: Javier Flandes, MD, PhD; Phone Number: 3543 915504813; Email: iferbas@fjd.es

Study Locations

• Spain
  • Madrid, Spain, 28040
    • Recruiting
    • Fundacion Jimenez Diaz
    • Contact: Iker Fernandez-Navamuel, MD, PhD; Phone Number: 3543 915504800; Email: iferbas@fjd.es
    • Contact: Javier Flandes, MD, PhD; Phone Number: 3543 915504800; Email: jflandes@fjd.es
    • Principal Investigator: Iker Fernandez-Navamuel, MD
    • Sub-Investigator: Javier Flandes, MD, PhD
    • Sub-Investigator: Maria Jesús Rodriguez, MD, PhD
    • Sub-Investigator: Laura Álvarez, MD
    • Sub-Investigator: Lucía Llanos, MD, PhD
    • Sub-Investigator: Ignacio Mahillo, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 38 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 10 coils in upper lobes	Procedure: 10 coils in upper lobes; Procedure: cycloergometry
Experimental: 15 coils in upper and lower lobes	Procedure: cycloergometry; Procedure: 15 coils in upper and lower lobes

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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)	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

Collaborators and Investigators

• Sponsor: Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
• Investigators: Principal Investigator: Iker Fernandez-Navamuel, MD, PhD, FJD

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2016
• Primary Completion (Anticipated): September 1, 2021
• Study Completion (Anticipated): December 1, 2021

Study Registration Dates

• First Submitted: July 29, 2016
• First Submitted That Met QC Criteria: August 24, 2016
• First Posted (Estimate): August 25, 2016

Study Record Updates

• Last Update Posted (Actual): March 1, 2019
• Last Update Submitted That Met QC Criteria: February 28, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: coils; lung volume reduction; pulmonary emphysema; cycloergometry
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Pulmonary Emphysema; Emphysema
• Other Study ID Numbers: EC 33-16/IIS-FJD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No