The primary objective of this study is to determine whether treatment with the RePneu LVRC System results in improved exercise capacity and quality of life, as measured by improvements in the 6 Minute Walk Test (6MWT).
ID
Source
Brief title
Condition
- Respiratory disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary effectiveness variable will be the mean absolute change from
baseline at 12 months in the 6 Minute Walk Test (6MWT), comparing LVRC and
control groups (overall type I error one-sided, α = 0.025).
Secondary outcome
Secondary Effectiveness Endpoints:
- Six Minute Walk Test (6MWT): responder analysis, comparing baseline to 12
months, LVRC vs. control, responders defined as those with an
improvement of >=25 meters
- Mean percent change in Forced Expiratory Volume in one second (FEV1),
comparing baseline to 12 months, LVRC vs. control
- St. George's Respiratory Questionnaire (SGRQ): mean absolute difference in
SGRQ results comparing baseline to 12 months, LVRC vs. control
Background summary
Current treatment of emphysema (COPD gold III-IV) generally is limited to
palliative measures that include supplemental oxygen, bronchodilators,
anti-inflammatory drugs and pulmonary rehabilitation or to lung
transplantation. A small subset of patients with emphysema might benefit by
lung volume reduction surgery, but this procedure is highly invasive and often
results in high morbidity and mortality. A minimally invasive treatment with
the potential to improve pulmonary function and reduce dyspnea in patients with
both heterogeneous and homogeneous emphysema would provide meaningful clinical
benefit.
Study objective
The primary objective of this study is to determine whether treatment with the
RePneu LVRC System results in improved exercise capacity and quality of life,
as measured by improvements in the 6 Minute Walk Test (6MWT).
Study design
This will be a prospective, multicenter, randomized, assessor-blinded
controlled study comparing outcomes between the Treatment and Control Groups.
Subjects will be 1:1 randomized to Treatment (LVR-Coil) or to Control.
Intervention
Nitinol Lung Volume Ruduction Coils will be placed in both lungs during two
bronchoscopic procedures, aiming to induce a volume reduction and therefore
aiming to improve the clinical status of emphysema patients with severe
hyperinflation by improving pulmonary mechanics.
Study burden and risks
The patients that will be screened for potential participation will recieve
pulmonary function testing, thoracic HRCT scanning and an outpatient visit. The
patients that will be included will have to come to our outpatient clinic,
perform pulmonary function testing, a 6 min walking test, thoracic x-ray and
testing of blood samples and arterial bloodgas. For the actual treatment with
bronchoscopy under general anesthesia the patients will stay two times two
nights in our hospital. For the follow-up, 1 CT scan at 12 months and
outpatient clinic visits will be needed with additional pulmonary function and
exercise testing. The included patients will have to put large effort in the
study, but is in balance with the expected outcome and very limited compared
'alternative' treatments like highly invasive surgery: Lung volume reduction
surgery or Lung transplantation. All included patients have a severe limitation
of their activities of daily living. With the development and validation of the
use of the lung volume reduction coil treatment does it seem possible to give
relieve of shortness of breath and improvement in excercise performance.
Furthermore can this technique be used as a 'bridge' to lung transplantation in
future, or will be the only possible therapeutic tool available by then. The
risks are not bigger than the risks any individual has for the investigations
described. The actual treatment with the LVR-Coils can cause: airway bleeding,
airway infections and fever, pneumothorax, cough (that might result in an
additional bronchoscopy to remove the coils), or death as a result of one of
these complications.
Logue Ave 530
Mountainview California CA 94043
US
Logue Ave 530
Mountainview California CA 94043
US
Listed location countries
Age
Inclusion criteria
>=35 years of age.
CT scan indicates bilateral emphysema.
Subject has post-bronchodilator FEV1 <=45% predicted.
Subject has Total Lung Capacity >100% predicted.
Subject has residual volume (RV) >=225% predicted.
Subject has marked dyspnea scoring >=2 on mMRC scale of 0-4.
Subject has stopped smoking for at least 8 weeks prior to entering the study
Subject has completed a pulmonary rehabilitation program within 6 months prior to treatment and/or is regularly performing maintenance respiratory rehabilitation if initial supervised therapy occurred more than 6 months prior to baseline testing.
Exclusion criteria
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 a change in FEV1 >20% (or, for subjects with pre-bronchodilator FEV1 below 1 L, a change of > 200 mL) post-bronchodilator.
Subject has DLCO <20% of predicted.
Subject has severe gas exchange abnormalities as defined by: PaCO2 >55 mm Hg, PaO2 <45mm Hg on room air.
Subject has a history of recurrent clinically significant respiratory infections, defined as 3 hospitalizations for respiratory infection during the year prior to enrollment.
Subject has severe pulmonary hypertension defined by right ventricular systolic pressure >50 mm Hg via right heart catheterization and/or echocardiogram.
Subject has an inability to walk >140 meters.
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.
Subject has clinically significant bronchiectasis.
Subject has giant bullae >1/3 lung volume.
Subject has had previous LVR surgery, lungtransplantation, lobectomy , LVR devices or other
devices to treat COPD in either lung.
Subject has been involved in pulmonary drug or device studies within 30 days prior to this study.
Subject is taking >20 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 agent (such as Plavix) or anticoagulant therapy (such as heparin or Coumadin) which cannot be stopped for seven (7) days prior to procedure.
Subject has a sensitivity or allergy to Nickel
Subject has been diagnosed with alpha-1 antitrypsin
deficiency (AATD).
Design
Recruitment
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 |
|---|---|
| ClinicalTrials.gov | NCT01608490 |
| CCMO | NL42165.042.12 |