EUCTR2014-003423-21-BE进行中（未招募）1 期
An Exploratory, Two-Part, Clinical Study to Assess the Effect of Pulsed, Inhaled Nitric Oxide (iNO) on Functional Pulmonary Imaging 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) (Part 1) and in Subjects with WHO Group 3 PH associated with Idiopathic pulmonary fibrosis (IPF) on LTOT (Part 2).
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
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. A confirmed diagnosis of COPD by the Global initiative for chronic Obstructive Lung Disease (GOLD) criteria
- •2. Pulmonary hypertension determined by 1 of the following within the past 12 months
- •a. A right heart catherization (not obtained within ± 7 days of an exacerbation) with an mPAP = 25 mmHg, or
- •b. An echocardiogram (not obtained within ± 7 days of an exacerbation) with a TRV = 2.9 meters per second (m/s), or a systolic PAP = 38 mmHg by 2-D echocardiogram.
- •(Note: a subject with a TRV < 2.9 m/s will meet this inclusion criteria if there is an acceptable mPAP = 25 mmHg determined by right heart catherization)
- •3. Current or former smokers with at least 10 pack-years of tobacco cigarette smoking history before study entry
- •4. Age = 40 years, = 80 years
- •5. 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)
- •6. Receiving LTOT for = 3 months and = 10 hours per day as determined by history
- •7. Females of childbearing potential must have a negative pre-treatment urine pregnancy test
- •8. Signed informed consent prior to the initiation of any study mandated procedures or assessments
- •1. Patients will have a diagnosis of IPF as determined by a responsible and experienced Respiratory physician and based on;
- •HCRT: usual interstitial pneumonia
- •FVC: 50-90% of predicted FVC
- •2. PH defined as sPAP = 50 mm Hg by echocardiogram
- •3. Age = 40 years
- •4. Receiving LTOT for = 3 months
- •5. Females of childbearing potential must have a negative pre-treatment urine pregnancy test
- •6. 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. A diagnosis of asthma or other non-COPD respiratory disease, in the opinion of the Investigator
- •2. Lack of patency of nares upon physical examination
- •3. Experienced during the last month an exacerbation requiring:
- •a) start of or increase in systemic oral corticosteroid therapy, and/or
- •b) hospitalization
- •4. Left ventricular dysfunction as measured by:
- •Screening echocardiographic evidence of left ventricular systolic dysfunction (left ventricular ejection fraction [LVEF] < 40%), or
- •Screening echocardiographic evidence of left ventricular diastolic dysfunction greater than moderate (i.e., > Grade 2), or
- •Any history of pulmonary capillary wedge pressure (PCWP), left atrial pressure (LAP) or left ventricular end diastolic pressure (LVEDP) > 18 mm Hg as measured during cardiac catheterization within the past 6 months unless documented to have resolved by a subsequent cardiac catheterization
- •5. Renal impairment (i.e., an estimated GFRMDRD < 30 ml/min/1.73 m2) or history of renal failure using the equation (Levey et al., 2007):
- •estimated GFRMDRD = 175×Scr-1.154×Age-0.203 ×1.212 (if black) ×0.742 (if female)
- •where Scr = Standardized serum creatinine
- •Subjects with possible compromised kidney function (eGFRMDRD 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 eGFRMDRD 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.
- •6. Known allergy to contrast media.
- •7. 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
- •8. 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)
- •9. Use of investigational drugs or devices within 30 days prior to enrollment into the study
- •10. Any underlying medical or psychiatric condition that, in the opinion of the Investigator, makes the subject an unsuitable candidate for the study
- •1. Patients with a current IPF exacerbation or exacerbation within the past 30 days.
- •2. Lack of patency of nares upon physical examination
- •3. 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
- •4. Renal impairment (i.e., an estimated GFRMDRD < 30 ml/min/1.73 m2) or history of renal failure using the equation (Levey et al., 2007): estimated GFRMDRD = 175 × Scr -1.154 × Age-0.203 × 1.212 (if black) × 0.742 (if female) where Scr = Standardized serum creatinine
- •Subjects with possible compromised kidney function (eGFRMD
研究者
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