Chronic Obstructive Pulmonary Disease (COPD)REACTIONNCT02179125
Identifying REsponders and Exploring Mechanisms of ACTION of the Endobronchial Coil Treatment for Emphysema
A study testing RePneu Lung Volume Reduction Coil System in people with Chronic Obstructive Pulmonary Disease (COPD), run by University Medical Center Groningen at 2 sites in 2 countries.
Trial summary
Rationale: The PneumRx RePneu Lung Volume Reduction Coil (RePneu LVR-coil) is a bronchoscopic lung volume reduction treatment designed to compress the areas of lung parenchyma most damaged by emphysema. The LVRC treatment was found to be feasible, safe and effective in previous studies. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease (COPD)
- What is being tested?
- RePneu Lung Volume Reduction Coil System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Mar 2015to Jul 2019
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Diagnosis of COPD
- FEV1%pred <45% and FEV1/FVC <60%
- RV/TLC >55%
- TLC%pred >100% AND RV%pred >175%
- Dyspnea scoring ≥2 on mMRC scale of 0-4.
- Stopped smoking for at least 6 months prior to entering the study.
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- Completed a pulmonary rehabilitation program within 6 months prior to treatment and/or regularly performing maintenance respiratory rehabilitation if initial supervised therapy occurred more than 6 months prior to baseline testing.
- Received Influenza vaccinations consistent with local recommendations and/or policy.
- Read, understood and signed the Informed Consent form.
Who cannot join
- Subject has co-morbidities that may significantly reduce subject's ability to improve exercise capacity (e.g., severe arthritis, planned knee surgery) or baseline limitation on 6MWT is not due to dyspnea.
- Subject has severe gas exchange abnormalities as defined by: PaCO2 >8.0 kPa and/or PaO2 < 6.0 kPa (on room air).
- Subject has a history of recurrent clinically significant respiratory infections, defined as 3 or more hospitalizations for respiratory infection during the year prior to enrolment.
- Subject has severe pulmonary hypertension defined by right ventricular systolic pressure >45 mm Hg via echocardiogram.
- Subject has an inability to walk >140 meters in 6 minutes.
- Subject has evidence of other severe disease (such as, but not limited to, lung cancer or renal failure), which in the judgment of the investigator may compromise survival of the subject for the duration of the study.
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- Subject is pregnant or lactating, or plans to become pregnant within the study timeframe.
- Subject has an inability to tolerate bronchoscopy under conscious sedation or general anaesthesia.
- Subject has clinically significant bronchiectasis.
- Subject has giant bullae >1/3 lung volume.
- Subject has had previous LVR surgery, lung transplantation or lobectomy.
- Subject has been involved in pulmonary drug or device studies within 30 days prior to this study.
- Subject is taking >10 mg prednisone (or equivalent dose of a similar steroid) daily.
- Subject requires high level chronic immunomodulatory therapy to treat a moderate to severe chronic inflammatory autoimmune disorder.
- Subject is on an antiplatelet (such as Plavix) or anticoagulant therapy (such as heparin or Coumadin) which cannot be stopped prior to procedure.
- Subject has a known sensitivity or allergy to Nickel
- Subject has a known sensitivity to drugs required to perform bronchoscopy.
- Subject has any other disease, condition(s) or habit(s) that would interfere with completion of study and follow up assessments, would increase risks of bronchoscopy or assessments, or in the judgment of the investigator would potentially interfere.
- Alfa-1 AT deficiency
- Medical history of asthma
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Rationale: The PneumRx RePneu Lung Volume Reduction Coil (RePneu LVR-coil) is a bronchoscopic lung volume reduction treatment designed to compress the areas of lung parenchyma most damaged by emphysema. The LVRC treatment was found to be feasible, safe and effective in previous studies. However, patient-based outcomes besides quality of life questionnaires are hardly measured after intervention treatments for COPD. Furthermore, the exact underlying physiological mechanism of the LVR-coil treatment is unknown. Another aspect of the treatment which we to date do not fully understand is which group of patients benefit of the treatment and which group of patients do not, this knowing that the responder rate is already about 60%.
Objective: The objectives of the study are to gain more knowledge on 1) the effect of the LVRC treatment on patient-based outcomes like physical activity, 2) the underlying physiological mechanism of the treatment, 3) the predictors of response to the treatment at baseline, and 4) on a targetted treatment number of coils to be placed per lung using lung compliance.
Read more
Study design: This study is a non-randomised open label multi-center intervention study.
Study population: The study population exists of adult patients with severe emphysema with no other treatment options left besides surgical procedures.
Intervention: Bilateral bronchoscopic lung volume reduction treatment with RePneu coils.
Main study parameters/endpoints: The main study endpoint is the change in physical activity between baseline and 3 months follow-up after the second treatment. The secondary endpoints are the changes between baseline and 3 months follow-up after the second treatment in: patient reported outcomes of the treatment, dynamic lung hyperinflation, static lung volumes, lung compliance, diaphragm function, lung perfusion, systemic inflammation and small airways function.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The LVR Coil has been designed to be as safe as possible. It was shown that the risks associated with the LVRC system are largely attributable to the bronchoscopic procedure itself rather than to the device per se. Therefore, it appears that the LVRC device itself does not appreciably increase the risk of serious adverse events beyond the risk of undergoing a bronchoscopy procedure or simply having emphysema. Currently, this treatment is not commercially available in the Netherlands and study participants will have to visit the hospital multiple times. Previous studies have shown that the treatment has beneficial effect for the patient, however not all patients respond. Part of this new study is to try to identify which group of patients respond to the treatment and which patients do not. Therefore, it is possible that a patient will not receive any benefits from the treatment.
- Being tested
- RePneu Lung Volume Reduction Coil System
- Keywords
- COPD, Endobronchial treatment
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RePneu Lung Volume Reduction Coil SystemDevice
Bronchoscopic lung volume reduction treatment with Coils.
| Study group | Role | What they receive |
|---|---|---|
| Bronchoscopic LVR-coil treatment | Experimental | Bronchoscopic lung volume reduction with coil treatment Receives: Device: RePneu Lung Volume Reduction Coil System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in physical activity at 3 months.
*Change in physical activity measured by an accelerometer, 3 months following treatment.
Measured: Baseline vs 3 months follow up
Secondary outcomes (8)
Change from baseline in patient reported outcomes of the treatment at 3 months follow up.
*Change in patient reported outcomes measured by the PSK (Patient Specifieke Klachten)-questionnaire, 3 months following treatment.
Measured: Baseline vs 3 months follow up
Change from baseline in dynamic lung hyperinflation at 3 months follow up.
- Change in dynamic hyperinflation measured by a metronome-paced tachypnea test, 3 months following treatment.
- Change in dynamic hyperinflation measured by a maximum incremental cycle ergometer test, 3 months following treatment.
- Change in inspiratory capacity (IC) measurement before and after the 6-minute walk distance test, 3 months following treatment.
Measured: Baseline vs 3 months follow up
Change from baseline in static lung volumes at 3 months follow up.
- Change in lung volumes measured by bodyplethysmography, 3 months following treatment.
- Change in lung volumes measured using HRCT analysis, 3 months following treatment.
Measured: Baseline vs 3 months follow up
Change from baseline in lung compliance at 3 months follow up.
*Change in lung compliance measured by a balloon catheter system, 3 months following treatment.
Measured: Baseline vs 3 months follow up
Change from baseline in diaphragm function at 3 months follow up.
*Change in diaphragm function measured by inspiratory and expiratory muscle strength (PI-max \& PE-max), 3 months following treatment.
Measured: Baseline vs 3 months follow up.
Change from baseline in lung perfusion at 3 months follow up.
*Change in quantified lung perfusion assessment measured by a perfusion scan using 99mTc albumin, 3 months following treatment.
Measured: Baseline vs 3 months follow up.
Change from baseline in small airways function at 3 months follow up.
- Change in air trapping scores of in-and expiratory HRCT scan analysis, 3 months following treatment.
- Change in multiple breath nitrogen N2-washout (up to 1/20) measurement, 3 months following treatment.
Measured: Baseline vs 3 months follow up
Change from baseline in systemic inflammation at 3 months follow up.
*Change in systemic inflammation markers measured in blood (hs-CRP, IL-6, IL-8, TNFα, fibrinogen), 3 months following treatment.
Measured: Baseline vs 3 months follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2014 (estimated)
- Study startMar 2015
- Primary completionJul 2019
- Study completionJul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary Disease (COPD)Studies of the same condition, open and under way.
- More trials run by University Medical Center GroningenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dirk-Jan Slebos, University Medical Center Groningen
- Investigators
- Dirk-Jan Slebos, MD PhD, Principal investigator, University Medical Center Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02179125
- Sponsor's protocol ID
- REACTION
- Other IDs
- NL49716.042.14
- Acronym
- REACTION
- Status last verified
- Sep 2019
- First submitted
- 25 Jun 2014
- Last updated
- 25 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identifying REsponders and Exploring Mechanisms of ACTION of the Endobronchial Coil Treatment for Emphysema
- ClinicalTrials.gov ID
- NCT02179125
- Acronym / sponsor ID
- REACTION / REACTION
- Keywords
- COPD, Endobronchial treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Jul 2019 (actual)
- Study completion
- Jul 2019 (actual)
- First posted
- 1 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Rationale: The PneumRx RePneu Lung Volume Reduction Coil (RePneu LVR-coil) is a bronchoscopic lung volume reduction treatment designed to compress the areas of lung parenchyma most damaged by emphysema. The LVRC treatment was found to be feasible, safe and effective in previous studies. However, patient-based outcomes besides quality of life questionnaires are hardly measured after intervention treatments for COPD. Furthermore, the exact underlying physiological mechanism of the LVR-coil treatment is unknown. Another aspect of the treatment which we to date do not fully understand is which group of patients benefit of the treatment and which group of patients do not, this knowing that the responder rate is already about 60%.
Objective: The objectives of the study are to gain more knowledge on 1) the effect of the LVRC treatment on patient-based outcomes like physical activity, 2) the underlying physiological mechanism of the treatment, 3) the predictors of response to the treatment at baseline, and 4) on a targetted treatment number of coils to be placed per lung using lung compliance.
Study design: This study is a non-randomised open label multi-center intervention study.
Study population: The study population exists of adult patients with severe emphysema with no other treatment options left besides surgical procedures.
Intervention: Bilateral bronchoscopic lung volume reduction treatment with RePneu coils.
Main study parameters/endpoints: The main study endpoint is the change in physical activity between baseline and 3 months follow-up after the second treatment. The secondary endpoints are the changes between baseline and 3 months follow-up after the second treatment in: patient reported outcomes of the treatment, dynamic lung hyperinflation, static lung volumes, lung compliance, diaphragm function, lung perfusion, systemic inflammation and small airways function.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The LVR Coil has been designed to be as safe as possible. It was shown that the risks associated with the LVRC system are largely attributable to the bronchoscopic procedure itself rather than to the device per se. Therefore, it appears that the LVRC device itself does not appreciably increase the risk of serious adverse events beyond the risk of undergoing a bronchoscopy procedure or simply having emphysema. Currently, this treatment is not commercially available in the Netherlands and study participants will have to visit the hospital multiple times. Previous studies have shown that the treatment has beneficial effect for the patient, however not all patients respond. Part of this new study is to try to identify which group of patients respond to the treatment and which patients do not. Therefore, it is possible that a patient will not receive any benefits from the treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bronchoscopic LVR-coil treatment | Experimental | Device: RePneu Lung Volume Reduction Coil SystemBronchoscopic lung volume reduction with coil treatment |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- Diagnosis of COPD
- FEV1%pred <45% and FEV1/FVC <60%
- RV/TLC >55%
- TLC%pred >100% AND RV%pred >175%
- Dyspnea scoring ≥2 on mMRC scale of 0-4.
Key exclusion criteria (20 listed)
- Subject has co-morbidities that may significantly reduce subject's ability to improve exercise capacity (e.g., severe arthritis, planned knee surgery) or baseline limitation on 6MWT is not due to dyspnea.
- Subject has severe gas exchange abnormalities as defined by: PaCO2 >8.0 kPa and/or PaO2 < 6.0 kPa (on room air).
- Subject has a history of recurrent clinically significant respiratory infections, defined as 3 or more hospitalizations for respiratory infection during the year prior to enrolment.
- Subject has severe pulmonary hypertension defined by right ventricular systolic pressure >45 mm Hg via echocardiogram.
- Subject has an inability to walk >140 meters in 6 minutes.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RePneu Lung Volume Reduction Coil SystemBronchoscopic lung volume reduction treatment with Coils. | Device | Bronchoscopic LVR-coil treatment |
Primary outcome
Change from baseline in physical activity at 3 months.
Time frame: Baseline vs 3 months follow up
*Change in physical activity measured by an accelerometer, 3 months following treatment.
8 secondary outcomes
Change from baseline in patient reported outcomes of the treatment at 3 months follow up.
Time frame: Baseline vs 3 months follow up
Change from baseline in dynamic lung hyperinflation at 3 months follow up.
Time frame: Baseline vs 3 months follow up
Change from baseline in static lung volumes at 3 months follow up.
Time frame: Baseline vs 3 months follow up
Change from baseline in lung compliance at 3 months follow up.
Time frame: Baseline vs 3 months follow up
Change from baseline in diaphragm function at 3 months follow up.
Time frame: Baseline vs 3 months follow up.
Change from baseline in lung perfusion at 3 months follow up.
Time frame: Baseline vs 3 months follow up.
Change from baseline in small airways function at 3 months follow up.
Time frame: Baseline vs 3 months follow up
Change from baseline in systemic inflammation at 3 months follow up.
Time frame: Baseline vs 3 months follow up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2019.
- Website of the bronchoscopic intervention center of the UMCGLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dirk-Jan Slebos, MD PhD principal investigator
University Medical Center Groningen
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RePneu Lung Volume Reduction Coil System in people with Chronic Obstructive Pulmonary Disease (COPD), run by University Medical Center Groningen at 2 sites in 2 countries.
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 20 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 25 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands, 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 from baseline in physical activity at 3 months. (time frame: Baseline vs 3 months follow up). 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 25 Sep 2019.