Primary Objective: In this trial we will investigate the efficacy of BVR using best responder criteria in patients with severe heterogeneous emphysema compared to usual care. Secondary Objective: Economic evaluation: Estimation of costs of BVR…
ID
Bron
Verkorte titel
Aandoening
COPD
Emphysema
Emfyseem
Ondersteuning
UMC-Groningen
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Statistical and clinical significant improvement in both the FVC and FEV1 as well as in the 6 minute walk test.
Achtergrond van het onderzoek
Title:
Bronchoscopic Lung Volume reduction with endobronchial valves using best responder criteria in patients with severe COPD: “STEVIO-trial”.
Primary Objective:
We will investigate the efficacy of BVR using best responder criteria in patients with severe heterogeneous emphysema compared to usual care.
Secondary Objective:
Economic evaluation: Estimation of costs of BVR compared to care as usual and (historical) costs of LVRS.
Study Design:
Prospective, randomized (1:1) clinical intervention single center trial with a crossover of the control group to treatment.
Study Population:
22 Patients with COPD Gold stage III-IV, who stopped smoking at least 6 months ago and who have severe dyspnea despite optimal medical treatment with heterogeneous distributed emphysema with intact interlobular fissures present on thin slice CT scan.
Device:
Zephyr (PulmonX, USA) endobronchial valve. Follow-Up 6 months, with crossover for the control group after 6 months to active treatment.
Duration:
24 months.
Primary endpoint:
Statistical and clinical significant improvement in both the FVC and FEV1 as well as in the 6 minute walk test.
Doel van het onderzoek
Primary Objective:
In this trial we will investigate the efficacy of BVR using best responder criteria in patients with severe heterogeneous emphysema compared to usual care.
Secondary Objective:
Economic evaluation: Estimation of costs of BVR compared to care as usual and (historical) costs of LVRS.
Onderzoeksopzet
Follow-up after treatment is 6 months, crossover for control is also after 6 months
Onderzoeksproduct en/of interventie
Bronchoscopic lung volume reduction using Zephyr one-way endobronchial valves (PulmonX USA).
There will be a crossover of the control group to treatment.
Publiek
University Medical Center Groningen<br>
PO Box 30001
Karin Klooster
Groningen 9700 RB
The Netherlands
+31 (0)50 3613279
k.klooster@long.umcg.nl
Wetenschappelijk
University Medical Center Groningen<br>
PO Box 30001
Karin Klooster
Groningen 9700 RB
The Netherlands
+31 (0)50 3613279
k.klooster@long.umcg.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. Patient > 35 years of age;
2. CT scan indicates heterogeneous emphysema (>25% difference in destruction score between ipsilateral lobes);
3. CT shows ≥ 60% destruction of the target lobe;
4. CT scan indicates intact fissures as assessed on the sagittal reconstructions of a thin slice CT, or previously performed assessment of collateral flow show absence of collateral ventilation;
5. Post- bronchodilator FEV1 <60% predicted;
6. Post- bronchodilator TLC>100% en RV>150%;
7. Dyspnea score of ≥2 on the mMRC scale of 0-4;
8. Patient has stopped smoking for a minimum of 6 months prior to entering the study;
9. Signed informed Consent;
10. Subject is willing and able to comply with all study testing and procedures according to protocol and guidelines;
11. Lobar exclusion during EBV treatment is achieved.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. Hypercapnia defined by PaCO2>8.0 kPa, or hypoxemia defined by PaO2<6.0kPa, both measured on room air;
2. 6MWT <140 meters;
3. Previous LVR-surgery, lung transplantation or lobectomy;
4. Patient is on an antiplatelet agent (such as Plavix) or anticoagulant therapy (such as LMWH or coumarins) or has not been weaned off prior to procedure;
5. Involved in other pulmonary drug studies within 30 days prior to this study;
6. Evidence of other disease that may compromise survival, would interfere with completion of study, follow up assessments or that would adversely affect outcomes, such as lung cancer, and/or ASA class >III.
Opzet
Deelname
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL2738 |
| NTR-old | NTR2876 |
| Ander register | ZonMW/VEMI : 80-82305-97-11018 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |