COPD emphysema
Conditions
Interventions
Bilateral bronchoscopic lung volume reduction treatment with RePneu coils.
Sponsors
Universitair Medisch Centrum Groningen
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1) Diagnosis of COPD 2) FEV1%pred 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
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 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 outcomes
Primary
| Measure | Time frame |
|---|---|
| 1) The main study endpoint is the change in physical activity between baseline and 3 months follow-up after the second treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Netherlands
Outcome results
None listed