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Moderate COPDREMODELNCT01969734

Endobronchial Valves in Moderate COPD

A study testing Zephyr endobronchial valve placement in people with Moderate COPD, run by Sherwood Forest Hospitals NHS Foundation Trust at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Despite the best medical therapy many people with emphysema remain breathless and limited in their daily activities. In emphysema the lungs do not empty properly when the person breathes out. This "gas trapping" makes it harder to breathe. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Moderate COPD
What is being tested?
Zephyr endobronchial valve placement
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
7 participants
Where
1 siteUnited Kingdom
Study dates
Mar 2014to Mar 2015
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adult patients with stable moderate COPD (FEV1 45-80%pred)
  • Emphysema on CT with a defined target lobe
  • CT thorax must demonstrate intact interlobar fissures adjacent to the target lobe
  • Hyperinflation - TLC ≥100% predicted, RV ≥150% predicted
  • Exertional breathlessness with MRC dyspnoea score ≥3
  • Optimum COPD treatment for at least 6 weeks
Show all 9Show fewer
  • No COPD exacerbation for at least 6 weeks
  • Fewer than 3 admissions for infective exacerbations in the preceding 12 months
  • Six minute walk distance of <450m

Who cannot join

  • Inability to obtain informed consent
  • Significant co morbidity which limits exercise capacity or prognosis
  • Co-morbidities that would render bronchoscopy or sedation unsafe
  • Clinically significant bronchiectasis
  • Lung nodule requiring further investigation or treatment
  • Subject taking clopidogrel, warfarin, or other anticoagulants and unable to abstain for 5 days pre-procedure

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site
  • Kings Mill Hospital

    Sutton in Ashfield, Nottinghamshire, NG17 4JL

Other trials in United Kingdom

About this study

Official title: Response to Endobronchial Valves in Moderate Obstructive Airways Disease and Exercise Limitation - The REMODEL Trial

Despite the best medical therapy many people with emphysema remain breathless and limited in their daily activities. In emphysema the lungs do not empty properly when the person breathes out. This "gas trapping" makes it harder to breathe. Endobronchial valve placement, a treatment that stops air getting into the worst affected parts of the lung and so stops them from trapping gas, improves lung function, breathlessness and exercise capacity in selected patients with severe COPD (chronic obstructive airways disease, sometimes referred to as emphysema). We want to see if people with less severe COPD who are very breathless can benefit from the same treatment. The treatment involves placing small valves into the airways using a fibre optic camera (a bronchoscopy). Bronchoscopy is a standard clinical procedure carried out in our department.

Read the detailed description

Chronic Obstructive Pulmonary disease (COPD) is a common condition that affects millions of adults worldwide with a prevalence and burden projected to increase in the coming decades. This projected increase is explained by the ongoing exposure to cigarette smoke and other COPD risk factors, particularly in the developing world, along with population demographic changes and increasing life expectancy. The Global Burden of Disease Study predicted that by 2020 COPD will be ranked 5th behind ischaemic heart disease, depression, road traffic accidents and cerebrovascular disease as a cause of disability-adjusted life years lost1. The UK population prevalence of clinically significant COPD was estimated to be 1.7% for men and 1.4% for women.

Emphysema can be a debilitating illness and can result in death. The damaged alveoli lose their elasticity, and loss of structural elements leads to collapse of the terminal bronchioles on expiration. This leads to gas trapping and hyperinflation. In severe cases, alveolar walls can become destroyed creating bullae and collateral ventilation. Overinflated areas of lung may compress adjacent lung tissue reducing perfusion and ventilation to healthier tissue. Because the principal defect in emphysema is hyperinflation owing to destruction of the elastic tissue of the lung, usual medical therapies targeted at alleviating dyspnoea provide only limited benefit compared to patients with other forms of COPD. Therefore, non-pharmacological methods of palliating dyspnoea in this patient group have been developed, specifically lung volume reduction procedures.

Lung volume reduction improves function by the return of more normal respiratory muscle shape and function, and also by improving the elastic recoil of the lung which in turn increases the outward pull on the bronchioles. This reduces terminal bronchiole collapse and improves expiratory airflow thereby reducing gas trapping. The decrease in the functional residual capacity improves diaphragmatic and intercostal muscle function and reduces the work of breathing. In carefully selected patients, lung volume reduction surgery (LVRS) has been clearly shown to be effective at improving outcomes. It is, however, associated with significant morbidity, a 5% mortality rate and a modest cost-benefit return. Unfortunately, only a small minority of patients with emphysema are fit enough to undergo such major surgeries, and therefore a variety of alternative less invasive techniques are being developed to achieve lung volume reduction. These techniques include insertion of unidirectional endobronchial valves (EBVs), lung volume reduction coils (RePneu©) to internally compress hyperinflated emphysematous areas of lung, and the injection of sclerosant material to induce scarring and fibrosis of the most damaged portions of lung.

Endobronchial valves work by allowing air to be expelled from the treated areas of lung during expiration whilst preventing inspiratory airflow, with subsequent collapse of the distal lung. This results in volume loss and allows reinflation of healthier lung tissue with improved ventilation-perfusion matching. The Zephyr Valve (PulmonX, Redwood City, CA, USA) allows exhaled air and secretions to be expelled through or around the valve but prevent ventilation to the distal lung. It is implanted using a flexible bronchoscope under conscious sedation as a day case procedure.

The Valves for Emphysema palliatioN Trial (VENT) is the largest randomised controlled trial of valves published to date. Endobronchial valves were placed in the most diseased lobe to achieve unilateral occlusion. This trial together with its European counterpart, EuroVENT, demonstrated that significant improvements in lung function, exercise capacity, and quality of life could be achieved.

Endobronchial valve insertion appears safe with the most commonly reported complications being COPD exacerbation and small volume haemoptysis. Pneumothoraces are a more significant complication but have only been reported at rates below 5% in these studies, although the true rate in clinical practice with correctly chosen patients is likely to be nearer 20% (a significant proportion of patients in the above trials did not have complete fissures, and therefore would not be expected to have significant volume loss and hence pneumothorax). Endobronchial valves are easily removed should the need arise.

The criteria for patient selection are currently very specific, limiting the procedure to a small subgroup of patients with emphysema - specifically those with an FEV1 <45%. However, the aim of EBV therapy is to reduce hyperinflation by deflating the most disease areas of lung, resulting in improved respiratory mechanics and a greater inspiratory capacity, rather than to correct airflow obstruction. In spite of significant reductions in the amount of trapped gas, or residual volume (RV), in the lungs of patients treated with EBVs, some patients see only modest improvements in functional outcomes such as the 6 minute walking test. Airflow limitation alone causes reductions in exercise capacity, and it may be that this limits treated patients even in the face of a reduction in the RV. Therefore, patients with severe hyperinflation and limiting breathlessness (MRC dyspnoea score 3/5 or greater) but relatively well preserved FEV1 might be expected to derive greater benefits in terms of functional and patient reported outcomes as they will not be as limited by airflow obstruction after the procedure.

Conditions
Moderate COPD
Being tested
Zephyr endobronchial valve placement
Keywords
Emphysema, Moderate COPD, Hyperinflation, Endobronchial valves
Medical subject headings
Emphysema

What participants receive

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

  • Zephyr endobronchial valve placementDevice

Study groups in NCT01969734
Study groupRoleWhat they receive
Endobronchial valvesExperimentalAll subjects will have endobronchial valves inserted into the target lobe of the lung with the aim of complete lobar exclusion.
Receives: Device: Zephyr endobronchial valve placement

What is being measured

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

  1. Change in residual volume

    Measured: 3 months following treatment

Secondary outcomes (9)
  1. Change in FEV1

    Measured: 3 months following treatment

  2. Change in vital capacity

    Measured: 3 months following treatment

  3. Change in RV/TLC ratio

    Measured: 3 months following treatment

  4. Change in the SGRQ score

    Measured: 3 months following treatment

  5. Change in the MRC score

    Measured: 3 months following treatment

  6. Change in CAT score

    Measured: 3 months after treatment

  7. Change in the 6MWD

    Measured: 3 months following treatment

  8. Change in CT measured lobar volumes

    Measured: 3 months following treatment

  9. Change in BODE index

    Measured: 3 months following treatment

Timeline

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

  1. First posted25 Oct 2013 (estimated)
  2. Study startMar 2014
  3. Primary completionMar 2015
  4. Study completionMar 2015

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
7 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01969734
Sponsor's protocol ID
SFH2
Acronym
REMODEL
Status last verified
May 2017
First submitted
21 Oct 2013
Last updated
23 May 2017
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing Zephyr endobronchial valve placement in people with Moderate COPD, run by Sherwood Forest Hospitals NHS Foundation Trust at 1 site in United Kingdom.

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 9 inclusion and 6 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: finished, as of the sponsor's last update on 23 May 2017. 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 United Kingdom. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in residual volume (time frame: 3 months following treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 23 May 2017.

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