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

Pulmonary Emphysema Clinical Trial

— CYCLONE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02879331
• Other study ID #: EC 33-16/IIS-FJD
• Status: Recruiting
• Phase: N/A
• Start date: November 2016
• Est. completion date: December 2021

Study information

• Verified date: February 2019
• Source: Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
• Contact: Lucia Llanos, MD, PhD
• Phone: 915504800
• Email: luciallanos[@]fjd.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 35
• Est. completion date: December 2021
• Est. primary completion date: September 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Emphysema
• Pulmonary Emphysema

Intervention

Procedure:
• 10 coils in upper lobes

• 15 coils in upper and lower lobes

• cycloergometry

Locations

Country	Name	City	State
Spain	Fundación Jiménez Díaz	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

Country where clinical trial is conducted

Spain, 

References & Publications (4)

Arós F, Boraita A, Alegría E, Alonso AM, Bardají A, Lamiel R, Luengo E, Rabadán M, Alijarde M, Aznar J, Baño A, Cabañero M, Calderón C, Camprubí M, Candell J, Crespo M, de la Morena G, Fernández A, Ferrero JA, Gayán R, Bolao IG, Hernández M, Maceira A, Marín E, Muela de Lara A, Placer L, San Román 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. — View 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. — View 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. — View 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. Review. — View Citation

Outcome

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