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

Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

Status: Unknown

Conditions: Pulmonary Emphysema

Treatments: Procedure: 15 coils in upper and lower lobes; Procedure: 10 coils in upper lobes; Procedure: cycloergometry

Study type: Interventional

Funder types: Other

Identifiers

NCT02879331

EC 33-16/IIS-FJD

Details and patient eligibility

About

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.

Full 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.

Enrollment: 35 estimated patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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35 participants in 2 patient groups

10 coils in upper lobes

Active Comparator group

Description:

10 coils in upper lobes

Treatment:

Procedure: cycloergometry

Procedure: 10 coils in upper lobes

15 coils in upper and lower lobes

Experimental group

Description:

15 coils in upper and lower lobes

Treatment:

Procedure: cycloergometry

Procedure: 15 coils in upper and lower lobes