NEWS HIGHLIGHTS
Published Studies Related to Inomax (Nitric Oxide Inhalation)
Maximal response plateau to adenosine 5'-monophosphate in asthma. Relationship with the response to methacholine, exhaled nitric oxide, and exhaled breath condensate pH. [2009.06]
BACKGROUND: No information is available on the plateau in response to adenosine 5'-monophosphate(AMP). The aims of the present study were (1) to determine whether plateau can be detected with AMP and the relation with the plateau in response to methacholine, and (2) to identify the relation between the plateau and indirect markers of airway inflammation, such as exhaled nitric oxide (ENO) and exhaled breath condensate (EBC) pH... CONCLUSIONS: In well-controlled asthmatics, the plateau in response to AMP can be identified at a milder degree of obstruction than the plateau in response to methacholine, but the two agonists are not identifying the same airway abnormalities. Furthermore, if ENO and EBC pH are markers of inflammation, the determination of the presence or level of plateau is not a reliable method to identify airway inflammation in asthma.
Inhaled nitric oxide for preterm premature rupture of membranes, oligohydramnios, and pulmonary hypoplasia. [2009.04]
We sought to determine if inhaled nitric oxide (iNO) administered to preterm infants with premature rupture of membranes (PPROM), oligohydramnios, and pulmonary hypoplasia improved oxygenation, survival, or other clinical outcomes. Data were analyzed from infants with suspected pulmonary hypoplasia, oligohydramnios, and PPROM enrolled in the National Institute of Child Health and Development Neonatal Research Network Preemie Inhaled Nitric Oxide (PiNO) trial, where patients were randomized to receive placebo (oxygen) or iNO at 5 to 10 ppm...
Effects of aminoguanidine, an inhibitor of inducible nitric oxide synthase, on nitric oxide production and its metabolites in healthy control subjects, healthy smokers, and COPD patients. [2009.02]
BACKGROUND: Nitric oxide (NO) is produced by resident and inflammatory cells in the respiratory tract by the enzyme NO synthase (NOS), which exists in three isoforms: neuronal NOS (nNOS), inducible NOS (iNOS), and endothelial NOS. NO production is increased in patients with COPD, and the production of NO under oxidative stress conditions generates reactive nitrogen species that may amplify the inflammatory response in COPD... CONCLUSIONS: These results suggest that the constitutive NOS isoform as well as iNOS might be involved in NO release and contribute to the high Calv and ONOO(-) production in patients with COPD. Trial registration: Clinicaltrials.gov Identifier: NCT00180635.
Daily telemonitoring of exhaled nitric oxide and symptoms in the treatment of childhood asthma. [2009.01.15]
RATIONALE: Asthma treatment might improve when inhaled steroids are titrated on airway inflammation. Fractional exhaled nitric oxide (FeNO0.05), a marker of eosinophilic airway inflammation, can be measured at home. OBJECTIVES: We assessed daily FeNO0.05 telemonitoring in the management of childhood asthma... CONCLUSIONS: Thirty weeks of daily FeNO0.05 and symptom telemonitoring was associated with improved asthma control and a lower steroid dose. We found no added value of daily FeNO0.05 monitoring compared with daily symptom monitoring only.
Nitric oxide administration using an oxygen hood: a pilot trial. [2009]
CONCLUSIONS: Administration of iNO by oxygen hood is feasible. Larger randomized controlled trials are required to measure the efficacy and determine an appropriate target population for this technique. TRIAL REGISTRATION: ClinicalTrials.gov NCT00041548.
Clinical Trials Related to Inomax (Nitric Oxide Inhalation)
Comparison of Inhaled Nitric Oxide Versus Oxygen in Patient Reactivity During Acute Pulmonary Vasodilator Testing [Completed]
A minimum of 100 patients will be enrolled in the study to demonstrate which diagnostic
treatment (oxygen or nitric oxide) is most capable of identifying patients with a reactive
pulmonary vascular bed. Each patient will be given all three treatment regimen, nitric
oxide, oxygen, and the comparison treatment (either nitric oxide or oxygen), with a wash out
period of 10 minutes between each dose. Patients will be randomized at the time of
enrollment to determine which comparison treatment they will receive.
Safety and Efficacy Study of Nitric Oxide for Inhalation on Chronic Lung Disease in Premature Babies [Active, not recruiting]
The purpose of this study is to assess the safety and efficacy of inhaled nitric oxide to
reduce the risk of chronic lung disease in pre-term infants with respiratory distress, and to
assess the long-term effects of the therapy on the development of these children over 7 years
of clinical follow-up.
Hospital-Based Program for Treatment of Severe Cardiopulmonary Disease With Inhaled Nitric Oxide [Terminated]
The purpose of this program is to evaluate the logistic issues and patient requirements for
chronic pulsed INOmax delivery in ambulatory, home-care patients. To understand patient
needs, patients with a variety of underlying diseases will be included. Safety of chronic
therapy will be monitored by serial measurements of methemoglobin, platelet function assay
and reported adverse events.
Nitric Oxide and Transfusion Therapy for Sickle Cell Patients With Pulmonary Hypertension [Active, not recruiting]
This study will test whether inhaling nitric oxide (NO) gas mixed with room air can improve
pulmonary hypertension (high blood pressure in the lungs) in patients with sickle cell
anemia.
Patients with sickle cell disease 18 years of age or older may be eligible to participate in
one or more parts of this three-stage study, as follows:
Stage 1
Patients undergo the following tests to determine the cause of their pulmonary hypertension:
blood tests; echocardiogram (heart ultrasound); asthma test; oxygen breathing study with
measurement of arterial blood oxygen levels; chest X-ray; lung scans; MRI of the heart;
6-minute walk test; night-time oxygen measurement while sleeping; and exercise studies.
Stage 2
Patients have a detailed MRI evaluation of the heart and are admitted to the NIH Clinical
Center intensive care unit (ICU) for the following test: A plastic tube is placed in a vein
in the patient's arm and another tube is placed in a deeper neck or leg vein. A third tube
is inserted through the vein into the heart and the lung artery to measure blood pressures in
the heart and lungs directly. Following baseline measurements, three medications (inhaled
oxygen, infused prostaglandin, and inhaled NO) are delivered for 2 hours each, separated by a
30-minute washout period. A small blood sample is drawn during the NO administration.
Patients who cannot be treated with nitric oxide or for whom the treatment does not work may
receive monthly exchange transfusions for 3 months. For this procedure, 3 to 5 five units of
the patient's blood is removed and replaced with 3 to 5 units that do not have sickle
hemoglobin. Some patients who do not respond to NO or exchange transfusions may receive an
alternative therapy, such as oxygen, prostacyclin, L-arginine, bosentan or sidenafil.
Stage 3
Patients remain in the ICU with catheters in place for another 24 hours. During this time
they breathe NO. Lung pressures are measured every 4 hours and blood is drawn every 8 hours.
They then stay in the hospital 1 more day for observation. Patients then breathe nitric oxide
continuously for 2 months using a tank of gas that delivers the NO through tubes placed in
the nose. They may do this at home on an outpatient basis or may remain in the hospital for
the 2 months.
Patients have an echocardiogram and blood tests every week and do a 6-minute walk test every
2 weeks.
Effects of Inhaled Nitric Oxide in the Treatment of Acute Hypoxemic Respiratory Failure (AHRF) in Pediatrics [Terminated]
The purpose of this study is to determine the effect of nitric oxide for inhalation on the
duration of mechanical ventilation in pediatric patients with AHRF.
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