Identifying REsponders and Exploring Mechanisms of ACTION of the Endobronchial Coil Treatment for Emphysema
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Change from baseline in physical activity at 3 months.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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-
- •Stopped smoking for at least 6 months prior to entering the study.
- •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.
排除标准
- •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.
- •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
研究组 & 干预措施
Bronchoscopic LVR-coil treatment
Bronchoscopic lung volume reduction with coil treatment
干预措施: RePneu Lung Volume Reduction Coil System (Device)
结局指标
主要结局
Change from baseline in physical activity at 3 months.
时间窗: Baseline vs 3 months follow up
\*Change in physical activity measured by an accelerometer, 3 months following treatment.
次要结局
- Change from baseline in dynamic lung hyperinflation at 3 months follow up.(Baseline vs 3 months follow up)
- Change from baseline in small airways function at 3 months follow up.(Baseline vs 3 months follow up)
- Change from baseline in patient reported outcomes of the treatment at 3 months follow up.(Baseline vs 3 months follow up)
- Change from baseline in static lung volumes at 3 months follow up.(Baseline vs 3 months follow up)
- Change from baseline in lung compliance at 3 months follow up.(Baseline vs 3 months follow up)
- Change from baseline in lung perfusion at 3 months follow up.(Baseline vs 3 months follow up.)
- Change from baseline in diaphragm function at 3 months follow up.(Baseline vs 3 months follow up.)
- Change from baseline in systemic inflammation at 3 months follow up.(Baseline vs 3 months follow up)
研究者
Dirk-Jan Slebos
MD PhD
University Medical Center Groningen