EUCTR2016-002389-29-BE进行中（未招募）1 期
An Exploratory Clinical Study to Assess the Effect of Pulsed, Inhaled Nitric Oxide (iNO) on Functional Respiratory Imaging (FRI) Parameters in Subjects with World Health Organization (WHO) Group 3 Pulmonary Hypertension (PH) Associated with Chronic Obstructive Pulmonary Disease (COPD) on Long Term Oxygen Therapy (LTOT).
Bellerophon Pulse Technologies, LLC0 个研究点开始时间: 2016年6月28日最近更新:
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试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Male or female patient
- •2. A confirmed diagnosis of COPD by the Global initiative for chronic Obstructive Lung Disease (GOLD) criteria
- •3. Pulmonary hypertension will be defined as sPAP = 38 mmHg as determined by echocardiogram (not obtained within ± 7 days of an exacerbation) within the past 12 months.
- •4. Current or former smokers with at least 10 pack-years of tobacco cigarette smoking before study entry
- •5. Age = 40 years, = 85 years
- •6. A post-bronchodilatory FEV1/FVC < 0.7 and a FEV1 < 60% predicted (values obtained within 6 months prior to screening can be used unless obtained within ± 7 days of an exacerbation; otherwise, the test must be performed during screening)
- •7. Receiving LTOT for = 3 months and = 10 hours per day as determined by history
- •8. Females of childbearing potential must have a negative pre-scan urine pregnancy test
- •9. Signed informed consent prior to the initiation of any study mandated procedures or assessments.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 5
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 5
排除标准
- •1. Males who have the intention to father a child during the study.
- •2. A diagnosis of asthma or other non-COPD respiratory disease, in the opinion of the Investigator
- •3. Lack of patency of nares upon physical examination
- •4. Experienced during the last month an exacerbation requiring:
- •a) start of or increase in systemic oral corticosteroid therapy and/or
- •b) hospitalization
- •5. Left ventricular dysfunction as measured by:
- •a) Screening echocardiographic evidence of left ventricular systolic dysfunction (left ventricular ejection fraction [LVEF] < 40%), or
- •b) Screening echocardiographic evidence of left ventricular diastolic dysfunction > moderate (i.e., > Grade 3), or
- •c) Any history of pulmonary capillary wedge pressure (PCWP), left atrial pressure (LAP) or left ventricular end diastolic pressure (LVEDP) > 18 mmHg as measured during cardiac catheterization
- •within the past 6 months unless documented to have resolved by a subsequent cardiac catheterization
- •6. Renal impairment (i.e., an estimated GFRCKD-EPI < 30 ml/min/1.73 m2) or history of renal failure using the equation:
- •crs< 0.9 mg/dL:
- •eGFRCKD-EPI = 141 × (crs /0.9)-0.411 × 0.993Age
- •crs= 0.9 mg/dL:
- •eGFRCKD-EPI = 141 × (crs /0.9)-1.209 × 0.993Age
- •crs< 0.7 mg/dL:
- •eGFRCKD-EPI = 144 × (crs /0.7)-0.329 × 0.993Age
- •crs= 0.7 mg/dL:
- •eGFRCKD-EPI = 144 × (crs /0.7)-1.209 × 0.993Age
- •where crs= Normal and elevated serum creatinine
- •Subjects with possible compromised kidney function (i.e., Glomerular Filtration Rate estimated using the Modification of Diet in Renal Disease equation [eGFR CKD-EPI] between 30 and 60 ml/min/1.73 m2) may be enrolled provided the Radiology Department and Principal Investigator review the medical records of subjects with an eGFR CKD-EPI between 30 and 60 ml/min/1.73 m2 in order to confirm the contrast agent can be safely administered to these subjects and approval by both the Radiology Department and Principal Investigator must be obtained before enrolling these subjects.
- •7. Known allergy to contrast media.
- •8. Clinically significant valvular heart disease that may contribute to PH, including mild or greater aortic valvular disease (aortic stenosis or regurgitation) and/or moderate or greater mitral valve disease (mitral stenosis or regurgitation), or status post mitral valve replacement
- •9. Use within 30 days of screening or current use of approved PH medications such as sildenafil or bosentan (use of Cialis® or Viagra® for erectile dysfunction is permitted)
- •10. Use of investigational drugs or devices within 30 days prior to enrollment into the study
- •11. Any underlying medical or psychiatric condition that, in the opinion of the Investigator, makes the subject an unsuitable candidate for the study
研究者
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