NL-OMON42116已完成不适用
ung Function Improvement after Bronchoscopic Lung Volume Reduction with Pulmonx Endobronchial Valves used in Treatment of Emphysema - LIBERATE STUDY
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
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. Signed Screening or Study Procedure Informed Consent using a form that was reviewed and approved by the IRB;
- •2. Age 40 to 75 years;
- •3. BMI less than 35 kg/m2;
- •4 Stable with less than 20 mg prednisone (or equivalent) per day;
- •5 Nonsmoking for 4 months prior to screening interview.
- •6.Completed a supervised pulmonary rehabilitation program less than equal to 6 months prior to the baseline exam or is regularly performing maintenance respiratory rehabilitation if initial supervised therapy occurred greater than 6 months prior
- •7.FEV1 between 15% and 45% of predicted value at baseline exam
- •Post-rehabilitation 6-minute walk distance between 100 meters and 500 meters at baseline exam
- •8.Current Pneumococcus vaccination & Current Influenza vaccination
- •9.Little or no collateral ventilation (CV-) as determined using the Chartis System
排除标准
- •1. Currently enrolled in another clinical trial studying an experimental treatment;
- •2. Previously enrolled in this study for which protocol required follow up is not complete;
- •3. Clinically significant (greater than 4 tablespoons per day) sputum production;
- •4. Two or more COPD exacerbation episodes requiring hospitalization in the last year at screening;
- •5. Two or more instances of pneumonia episodes in the last year at screening;
- •6. Unplanned weight loss >10% usual weight <90 days prior to enrollment;
- •7. History of exercise-related syncope;
- •8. Myocardial Infarction or congestive heart failure within 6 months of screening;
- •9. Prior lung transplant, LVRS, bullectomy or lobectomy;
- •10. Clinically significant bronchiectasis;
- •11. Unable to safely discontinue anti-coagulants or platelet activity inhibitors for 7 days;
- •12. Uncontrolled pulmonary hypertension (systolic pulmonary arterial pressure > 45 mm Hg) or evidence or history of CorPulmonale as determined by recent echocardiogram (completed within the last 3 months prior to screening visit);
- •13. Pulmonary nodule requiring surgery as noted by chest X-ray or CT scan;
- •14. HRCT collected per CT scanning protocol within the last 3 months of screening date and evaluated by clinical site personnel using 510k cleared CT software shows:
- •a Parenchymal destruction score of greater than 75% in all three right lobes or both left lobes
- •b Emphysema heterogeneity score less than 15%
- •c Large bullae encompassing greater than 30% of either lung
- •d Insufficient landmarks to evaluate the CT study using the software as it is intended;
- •15. Left ventricular ejection fraction (LVEF) less than 45% as determined by recent echocardiogram (completed within the last 3 months prior to screening visit);
- •16. Resting bradycardia (<50 beats/min), frequent multifocal PVCs, complex ventricular arrhythmia, sustained SVT;
- •17. Dysrhythmia that might pose a risk during exercise or training;
- •18. Post-bronchodilator FEV1 less than 15% or greater than 45% of predicted value at screening;
- •19. TLC less than 100% predicted (determined by body plethysmography) at screening;
- •20. RV less than 175% predicted (determined by body plethysmography) at screening;
- •21. DLCO less than 20% predicted value at screening;
- •22. 6-minute walk distance less than 100 meters or greater than 450 meters at screening;
- •23. PaCO2 greater than 50mm Hg (Denver greater than 55 mm Hg) on room air at screening;
- •24. PaO2 less than 45 mm Hg (Denver less than 30 mm Hg) on room air at screening;
- •25. Elevated white cell count (>10,000 cells/mcL) at screening;
- •26. Presence of alpha-1 anti-trypsin deficiency as determined by local laboratory ranges;
- •27. Plasma cotinine level greater than 13.7 ng/ml (or arterial carboxyhemoglobin > 2.5% if using nicotine products) at screening;
- •28. Any disease or condition that interferes with completion of initial or follow-up assessments.
研究者
相似试验
招募中
不适用
Investigating the changes in physiological function following bronchoscopic lung volume reduction treatment of chronic obstructive pulmonary disease (COPD)Chronic Obstructive Pulmonary DiseaseRespiratory physiologyCardiac PhysiologyPulmonary Vascular ResistanceExercise PhysiologyRespiratory - Chronic obstructive pulmonary diseaseCardiovascular - Diseases of the vasculature and circulation including the lymphatic systemPhysical Medicine / Rehabilitation - Other physical medicine / rehabilitationEmphysemaCor PulmonaleACTRN12618001805268niversity of Adelaide50
招募中
不适用
The Improvement of lung function after long-term use of Dupilumab in Korean severe asthma patientsKCT0007817Asan Medical Center222
尚未招募
Unknown
Effect of therapeutic bronchoscopy in critically ill patients in terms of oxygenation and ventilatory mechanicsCTRI/2023/09/057440Self
尚未招募
不适用
Does overweight change the pattern of lung function during the airway narrowing of asthma?Respiratory - AsthmaDiet and Nutrition - ObesityObesityAsthmaACTRN12606000455561Professor Robin Taylor, principle investigator, Respiratory Research Unit, Department of Medical and Surgical Sciences, University of Otago, Dunedin New Zealand30
已完成
3 期
Effectiveness of additional ultrathin bronchoscopy for peripheral pulmonary lesions to which a radial endobronchial ultrasound (EBUS) probe cannot be advanced during bronchoscopyBenign or malignant pulmonary lesionsJPRN-UMIN000024306agoya Medical Center260