Clinical Study to Evaluate the Exercise Capacity in Patients With Severe Emphysema Treated With Coils (CYCLONE)
Primary Purpose
Pulmonary Emphysema
Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
10 coils in upper lobes
15 coils in upper and lower lobes
cycloergometry
Sponsored by
About this trial
This is an interventional treatment trial for Pulmonary Emphysema focused on measuring pulmonary emphysema, coils, cycloergometry, lung volume reduction
Eligibility Criteria
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
Sites / Locations
- Fundación Jiménez DíazRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
10 coils in upper lobes
15 coils in upper and lower lobes
Arm Description
10 coils in upper lobes
15 coils in upper and lower lobes
Outcomes
Primary Outcome Measures
Change in Inspiratory Capacity (L)
Change in Inspiratory Capacity (L) at 6 months from baseline
Secondary Outcome Measures
RV (L)
Residual Volume (L)
6-MWT (m)
Six minute walk test (m)
SGQLT (measured in points)
Saint George quality of life test (points)
FEV1(measured in liters)
Forced Expiratory Volume in 1 Second (L)
FVC (measured in liters)
Forced Vital Capacity (L)
Endoscopic Volume Reduction-Associated Complications Rate
Endoscopic Volume Reduction Complications Rate
Cycloergometry-associated Complications Rate
Cycloergometry-associated Complications Rate
Full Information
NCT ID
NCT02879331
First Posted
July 29, 2016
Last Updated
February 28, 2019
Sponsor
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
1. Study Identification
Unique Protocol Identification Number
NCT02879331
Brief Title
Clinical Study to Evaluate the Exercise Capacity in Patients With Severe Emphysema Treated With Coils
Acronym
CYCLONE
Official Title
Clinical Study to Evaluate the Exercise Capacity in Patients With Severe Emphysema Treated With Coils
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Unknown status
Study Start Date
November 2016 (Actual)
Primary Completion Date
September 2021 (Anticipated)
Study Completion Date
December 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Emphysema
Keywords
pulmonary emphysema, coils, cycloergometry, lung volume reduction
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
35 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
10 coils in upper lobes
Arm Type
Active Comparator
Arm Description
10 coils in upper lobes
Arm Title
15 coils in upper and lower lobes
Arm Type
Experimental
Arm Description
15 coils in upper and lower lobes
Intervention Type
Procedure
Intervention Name(s)
10 coils in upper lobes
Intervention Type
Procedure
Intervention Name(s)
15 coils in upper and lower lobes
Intervention Type
Procedure
Intervention Name(s)
cycloergometry
Primary Outcome Measure Information:
Title
Change in Inspiratory Capacity (L)
Description
Change in Inspiratory Capacity (L) at 6 months from baseline
Time Frame
three months before procedure and six months after first procedure
Secondary Outcome Measure Information:
Title
RV (L)
Description
Residual Volume (L)
Time Frame
three months before procedure and six months after first procedure
Title
6-MWT (m)
Description
Six minute walk test (m)
Time Frame
three months before procedure and six months after first procedure
Title
SGQLT (measured in points)
Description
Saint George quality of life test (points)
Time Frame
three months before procedure and six months after first procedure
Title
FEV1(measured in liters)
Description
Forced Expiratory Volume in 1 Second (L)
Time Frame
three months before procedure and six months after first procedure
Title
FVC (measured in liters)
Description
Forced Vital Capacity (L)
Time Frame
three months before procedure and six months after first procedure
Title
Endoscopic Volume Reduction-Associated Complications Rate
Description
Endoscopic Volume Reduction Complications Rate
Time Frame
6 months
Title
Cycloergometry-associated Complications Rate
Description
Cycloergometry-associated Complications Rate
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lucia Llanos, MD, PhD
Phone
915504800
Ext
3144
Email
luciallanos@fjd.es
First Name & Middle Initial & Last Name or Official Title & Degree
Javier Flandes, MD, PhD
Phone
915504813
Ext
3543
Email
iferbas@fjd.es
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Iker Fernandez-Navamuel, MD, PhD
Organizational Affiliation
FJD
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fundación Jiménez Díaz
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Iker Fernandez-Navamuel, MD, PhD
Phone
915504800
Ext
3543
Email
iferbas@fjd.es
First Name & Middle Initial & Last Name & Degree
Javier Flandes, MD, PhD
Phone
915504800
Ext
3543
Email
jflandes@fjd.es
First Name & Middle Initial & Last Name & Degree
Iker Fernandez-Navamuel, MD
First Name & Middle Initial & Last Name & Degree
Javier Flandes, MD, PhD
First Name & Middle Initial & Last Name & Degree
Maria Jesús Rodriguez, MD, PhD
First Name & Middle Initial & Last Name & Degree
Laura Álvarez, MD
First Name & Middle Initial & Last Name & Degree
Lucía Llanos, MD, PhD
First Name & Middle Initial & Last Name & Degree
Ignacio Mahillo, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
26113524
Citation
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.
Results Reference
background
PubMed Identifier
24891327
Citation
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.
Results Reference
background
PubMed Identifier
26398112
Citation
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.
Results Reference
background
PubMed Identifier
10956604
Citation
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.
Results Reference
background
Learn more about this trial
Clinical Study to Evaluate the Exercise Capacity in Patients With Severe Emphysema Treated With Coils
We'll reach out to this number within 24 hrs