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, and 3) the predictors of response to the…
ID
Source
Brief title
Condition
- Respiratory disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
1) The main study endpoint is the change in physical activity between baseline
and 3 months follow-up after the second treatment.
Secondary outcome
2) To investigate the change between baseline and 3 months follow up after the
LVR-coil treatment in:
- patient reported outcomes of the treatment using a dedicated questionnaire
(PSK)
- dynamic lung hyperinflation (metronome paced)
- static lung volumes
- lung compliance
- diaphragm function
- lung-perfusion
- small airways function
- systemic inflammation
3) To investigate which patient characteristics at baseline predicts response
to the LVRC treatment at 3 months follow up.
Background summary
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%.
Study 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, and 3) the predictors of
response to the treatment at baseline.
Study design
This study is a non-randomised open label multi-center intervention study.
Intervention
Bilateral bronchoscopic lung volume reduction treatment with RePneu coils.
Study burden and risks
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.
Hanzeplein 1
Groningen 9713GZ
NL
Hanzeplein 1
Groningen 9713GZ
NL
Listed location countries
Age
Inclusion criteria
1) Diagnosis of COPD
2) FEV1%pred <45% and FEV1/FVC <60%
3) RV/TLC >55%
4) TLC%pred >100% AND RV%pred >175%
5) Dyspnea scoring >=2 on mMRC scale of 0-4.
6) Stopped smoking for at least 6 months prior to entering the study.
7) 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.
8) Received Influenza vaccinations consistent with local recommendations and/or policy.
9) Read, understood and signed the Informed Consent form.
Exclusion criteria
1) 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.
2) Subject has severe gas exchange abnormalities as defined by: PaCO2 >8.0 kPa and/or PaO2 < 6.0 kPa (on room air).
3) 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.
4) Subject has severe pulmonary hypertension defined by right ventricular systolic pressure >45 mm Hg via echocardiogram.
5) Subject has an inability to walk >140 meters in 6 minutes.
6) 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.
7) Subject is pregnant or lactating, or plans to become pregnant within the study timeframe.
8) Subject has an inability to tolerate bronchoscopy under conscious sedation or general anaesthesia.
9) Subject has clinically significant bronchiectasis.
10) Subject has giant bullae >1/3 lung volume.
11) Subject has had previous LVR surgery, lung transplantation or lobectomy.
12) Subject has been involved in pulmonary drug or device studies within 30 days prior to this study.
13) Subject is taking >10 mg prednisone (or equivalent dose of a similar steroid) daily.
14) Subject requires high level chronic immunomodulatory therapy to treat a moderate to severe chronic inflammatory autoimmune disorder.
15) Subject is on an antiplatelet (such as Plavix) or anticoagulant therapy (such as heparin or Coumadin) which cannot be stopped prior to procedure.
16) Subject has a known sensitivity or allergy to Nickel
17) Subject has a known sensitivity to drugs required to perform bronchoscopy.
18) 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.
19) Alfa-1 AT deficiency
20) Medical history of asthma
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL49716.042.14 |