NL-OMON55018已完成不适用
Characterizing the Mechanism of Action of Metered Cryospray for the Treatment of Patients with Chronic Obstructive Pulmonary Disease with Chronic Bronchitis - REJUVENAIR MCS MOA
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
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) Males and females >=40 to <80 years of age.
- •2) Subject is able to read, understand, and sign a written Informed Consent in
- •order to participate in the study.
- •3) Subject has a diagnosis of CB and COPD and has been symptomatic for a
- •minimum of two years. (Chronic Bronchitis is defined clinically as chronic
- •productive cough for 3 months in each of 2 successive years in a patient in
- •whom other causes of productive cough have been excluded).
- •4) Subject is classified as having moderate or severe (GOLD stage 2-3) airflow
- •obstruction defined by a post-bronchodilator of =>30% FEV1 to <80% predicted
- •with a baseline FEV1/FVC of <0.70.
- •5) Subject has a COPD assessment tool (CAT) score of >=10.
- •6) Subject is being treated according to current medically accepted treatment
- •guidelines without successful resolution of chronic bronchitis and agrees to
- •continue maintenance pulmonary/COPD medications (as defined per GOLD Standard
- •for medications) for the duration of the study (subject must be on a regime of
- •pulmonary medications for a minimum of 2 weeks prior to enrolment into the
- •7) Smoking history of at least 10 pack years.
- •8) Non-smoking for a minimum of 2 months prior to consent and agrees to
- •continue not smoking for the duration of the study.
- •9) Subject is able to adhere to and undergo 4 bronchoscopic procedures (5 for
- •control subjects accepting cross over option), in the opinion of the
- •investigator or per hospital guidelines.
- •10) For women of childbearing potential: non-pregnant, non-lactating, and agree
- •to practice an adequate birth control method (abstinence, combination barrier
- •and spermicide, or hormonal) for the duration of the study.
排除标准
- •1)Subject has had an acute pulmonary infection, exacerbation or pneumonia
- •requiring medical treatment (with antibiotics and/or steroids) within 6 weeks
- •of initially planned study bronchoscopy.
- •2) Diagnosis of asthma with an onset before 30 years of age.
- •3) Subject has Alpha-1 antitrypsin deficiency.
- •4) Subject has other origins of respiratory disease aside from chronic
- •bronchitis and COPD.
- •5) Subject is using e-cigarettes, vaping or taking any oral or inhaled
- •substances not prescribed by a physician.
- •6) Subject has untreatable or life-threatening arrhythmias, or history of
- •inability to adequately oxygenate during a bronchoscopy, or has acute
- •respiratory failure with hypercapnia.
- •7) Subject has bullous emphysema characterized as large bullae >30 millimetres
- •on HRCT; or subject has stenosis in the tracheobronchial system,
- •tracheobronchomegaly, trachea-bronchomalacia, amyloidosis or cystic fibrosis.
- •8)Subject has clinically significant bronchiectasis
- •9)Subject has had a transplant procedure (any).
- •10) Subject has a known mucosal tear, has undergone prior lung surgery such as
- •pneumonectomy, lobectomy, bullectomy, or lung volume reduction surgery,
- •bronchial thermoplasty or cryotherapy.
- •11) Subject has had a prior lung device procedure, including emphysema stent(s)
- •implanted, lung coils, valves, lung denervation or other devices for emphysema.
- •12) Subject is unable to temporarily discontinue use of anticoagulant therapy:
- •warfarin, Coumadin, LMWH, heparin, clopidrogel (or equal).
- •13) Subject has a serious medical condition, such as: uncontrolled coagulopathy
- •or bleeding disorder, congestive heart failure, uncontrolled angina, myocardial
- •infarction in the past year, renal failure, liver disease, cerebrovascular
- •accident within the past 6 months, uncontrolled diabetes, uncontrolled
- •hypertension, autoimmune disease or uncontrolled gastric reflux.
- •14) Subject has or is receiving chemotherapy or active radiation therapy within
- •the past 6 months or is expected to receive chemotherapy during participation
- •in this study.
- •15) Subject is or has been in another clinical investigational study within 6
- •weeks of enrolment.
- •16) Subject has known sensitivity to medication required to perform
- •bronchoscopy (such as lidocaine, atropine, and benzodiazepines).
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