NL-OMON44603已完成不适用
Identifying REsponders and exploring mechanisms of ACTION of the endobronchial coil treatment for emphysema - REACTIO
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •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.
排除标准
- •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
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