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Pulmonary EmphysemaCYCLONENCT02879331

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

A study testing 10 coils in upper lobes, 15 coils in upper and lower lobes and cycloergometry in people with Pulmonary Emphysema, run by Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz at 1 site in Spain.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 40 years and older
Conditions the study is for
Pulmonary Emphysema
What is being tested?
10 coils in upper lobes, 15 coils in upper and lower lobes and cycloergometry
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
35 participants
Where
1 siteSpain
Study dates
Nov 2016to Dec 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Emphysematous patient
  • FEV1 < 50%
  • RV > 200%
  • Diffusion <60% >20%
  • PSP <55 mmHg

Who cannot join

  • Anticoagulants/antiplatelets
  • Giant bullae (> 8 cm , 1/3 hemithorax)
  • More tan three moderate/severe exacerbation per year
  • Negative to sign informed consent

Trial locations and contacts

1 site in 1 country.

Lucia Llanos, MD, PhD contact

915504800 ext. 3144

luciallanos@fjd.es

Javier Flandes, MD, PhD contact

915504813 ext. 3543

iferbas@fjd.es

Spain1 site, 1 recruiting

  • Fundación Jiménez Díaz

    Madrid, 28040

    Iker Fernandez-Navamuel, MD, PhD, 915504800 ext. 3543, iferbas@fjd.es

    Javier Flandes, MD, PhD, 915504800 ext. 3543, jflandes@fjd.es

    Recruiting

Other trials in Spain

About this study

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.

Read the 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.

Being tested
10 coils in upper lobes, 15 coils in upper and lower lobes, cycloergometry
Keywords
pulmonary emphysema, coils, cycloergometry, lung volume reduction
Medical subject headings
Pulmonary Emphysema

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 10 coils in upper lobesProcedure or surgery

  • 15 coils in upper and lower lobesProcedure or surgery

  • cycloergometryProcedure or surgery

Study groups in NCT02879331
Study groupRoleWhat they receive
10 coils in upper lobesActive comparator10 coils in upper lobes
Receives: Procedure: 10 coils in upper lobes; Procedure: cycloergometry
15 coils in upper and lower lobesExperimental15 coils in upper and lower lobes
Receives: Procedure: 15 coils in upper and lower lobes; Procedure: cycloergometry

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Inspiratory Capacity (L)

    Change in Inspiratory Capacity (L) at 6 months from baseline

    Measured: three months before procedure and six months after first procedure

Secondary outcomes (7)

  1. RV (L)

    Residual Volume (L)

    Measured: three months before procedure and six months after first procedure

  2. 6-MWT (m)

    Six minute walk test (m)

    Measured: three months before procedure and six months after first procedure

  3. SGQLT (measured in points)

    Saint George quality of life test (points)

    Measured: three months before procedure and six months after first procedure

  4. FEV1(measured in liters)

    Forced Expiratory Volume in 1 Second (L)

    Measured: three months before procedure and six months after first procedure

  5. FVC (measured in liters)

    Forced Vital Capacity (L)

    Measured: three months before procedure and six months after first procedure

  6. Endoscopic Volume Reduction-Associated Complications Rate

    Endoscopic Volume Reduction Complications Rate

    Measured: 6 months

  7. Cycloergometry-associated Complications Rate

    Cycloergometry-associated Complications Rate

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Aug 2016 (estimated)
  2. Study startNov 2016
  3. Primary completionSep 2021 (estimated)
  4. Study completionDec 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
35 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02879331
Sponsor's protocol ID
EC 33-16/IIS-FJD
Acronym
CYCLONE
Status last verified
Feb 2019
First submitted
29 Jul 2016
Last updated
1 Mar 2019
Results posted
No
Data monitoring committee
No
Individual data sharing
No

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.

    PubMed 26113524

  • 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.

    PubMed 24891327

  • 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.

    PubMed 26398112

  • 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.

    PubMed 10956604

Questions about this trial

What is this clinical trial studying?

A study testing 10 coils in upper lobes, 15 coils in upper and lower lobes and cycloergometry in people with Pulmonary Emphysema, run by Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 1 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Lucia Llanos, MD, PhD (915504800 ext. 3144, luciallanos@fjd.es), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Inspiratory Capacity (L) (time frame: three months before procedure and six months after first procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02879331, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2019.

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