Two-Part Dose-Confirming Study of Pulsed Inhaled Nitric Oxide in Subjects With WHO Group 3 Pulmon… (NCT01728220) | Clinical Trial Compass
CompletedPhase 2
Two-Part Dose-Confirming Study of Pulsed Inhaled Nitric Oxide in Subjects With WHO Group 3 Pulmonary Hypertension Associated With COPD
United States159 participantsStarted 2012-12
Plain-language summary
This is a placebo-controlled, double-blind, parallel, randomized, two-part, dose-confirming clinical study characterizing the pharmacodynamic effects of pulsed iNO using the combination product, inhaled nitric oxide/INOpulse DS-C vs. placebo 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).
Who can participate
Age range40 Years – 80 Years
SexALL
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Inclusion criteria
✓. Former smokers with at least 10 pack-years of tobacco cigarette smoking history before study entry and who have stopped smoking ≥ 1 month prior to enrollment
✓. Age ≥ 40 years, ≤ 80 years
✓. A confirmed diagnosis of COPD by the Global initiative for chronic Obstructive Lung Disease (GOLD) criteria
✓. A post-bronchodilatory forced expiratory volume in 1 second/forced vital capacity (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)
✓. Receiving LTOT for ≥ 3 months and ≥ 10 hours per day as determined by history
✓. Echocardiogram with technical adequacy demonstrating tricuspid regurgitation velocity (TRV) ≥ 2.9 m/s at Screening, as determined by a blinded central echocardiography laboratory
✓. Females of childbearing potential must have a negative pre-treatment urine pregnancy test
✓. Signed informed consent prior to the initiation of any study mandated procedures or assessments
Exclusion criteria
✕. Positive urine cotinine test
✕. Currently using, or having used within the past month, a nicotine patch
✕. A diagnosis of asthma or other non-COPD respiratory disease, in the opinion of the Investigator
What they're measuring
1
Change in pulmonary arterial systolic pressure (PASP) from Baseline after treatment with iNO (measured by 2D transthoracic echocardiography with Doppler)
✕. Lack of patency of nares upon physical examination
✕. Experienced an exacerbation requiring start of or increase in systemic oral corticosteroid therapy and/or hospitalization during the last month (ATS COPD Guidelines 2004)
✕. 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 \> moderate (i.e., \> Grade 2), or