[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Novlead Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":116},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,43,69,95],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100622333","a-clinical-study-of-inhaled-nitric-oxide-in-patients-with-chronic-obstructive-pulmonary-disease-100622333",false,"NCT07382258","A Clinical Study of Inhaled Nitric Oxide in Patients With Chronic Obstructive Pulmonary Disease","A Prospective, Single-Center Study of Inhaled Nitric Oxide in Individuals Diagnosed With Moderate-to-Severe Chronic Obstructive Pulmonary Disease","Inclusion Criteria:\n\n1. Aged between 40 and 75 years, inclusive.\n2. History of smoking with a cumulative exposure of ≥10 pack-years, and having ceased smoking for at least one month prior to study participation.\n3. Diagnosis of moderate-to-severe COPD confirmed by post-bronchodilator spirometry: FEV1\u002FFVC \\\u003C 0.7 and FEV1 between 30% and 80% of predicted value.\n4. Willing and able to provide written informed consent and comply with all study-related procedures.\n\nExclusion Criteria:\n\n1. Pregnancy or lactation.\n2. Use of nicotine-containing products (e.g., patches, gum) within the past month.\n3. Current diagnosis of asthma or any other active respiratory condition considered non-COPD by the investigator.\n4. Physical obstruction of the nasal passages.\n5. Experienced a COPD exacerbation within the past month requiring initiation or escalation of systemic corticosteroids.\n6. Impaired left ventricular systolic function, defined as left ventricular ejection fraction (LVEF) \\\u003C 50%.\n7. Significant valvular heart disease (moderate\u002Fsevere aortic or mitral stenosis\u002Fregurgitation) or prior mitral valve replacement.\n8. Use of approved pulmonary hypertension medications (e.g., sildenafil, bosentan, prostacyclins) within 30 days prior to screening or during the study.\n9. Participation in another interventional clinical trial involving drugs or devices within 30 days prior to enrollment.\n10. Any other medical or psychiatric condition that, in the investigator's judgment, would compromise patient safety or study integrity.","ALL","40 Years","75 Years",{"count":20,"type":21},16,"ESTIMATED","INTERVENTIONAL",[24],"NA","This clinical trial aims to assess the impact on exercise tolerance and the safety of inhaled nitric oxide in subjects with moderate-to-severe COPD. The findings are expected to contribute to the development of safe and effective therapeutic strategies for COPD management.",[27],"Chronic Obstructive Pulmonary Disease (COPD)",[29],"COPD","RECRUITING","2026-01-25",{"date":33,"type":34},"2026-02-02","ACTUAL",{"date":36,"type":34},"2023-05-17",{"date":38,"type":21},"2026-04-30",{"name":40,"class":41},"Novlead Inc.","INDUSTRY",1,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":16,"minAge":51,"maxAge":52,"enrollmentInfo":53,"targetDuration":4,"studyType":22,"phases":55,"briefSummary":56,"conditions":57,"keywords":59,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":42},"100581639","inhaled-nitric-oxide-for-high-amplitude-pulmonary-edema-hape-100581639","NCT06852924","Inhaled Nitric Oxide for High Amplitude Pulmonary Edema (HAPE)","A Single-center Prospective Randomized Controlled Trial of Inhaled Nitric Oxide in the Treatment of High Amplitude Pulmonary Edema(HAPE)","HAPE","Inclusion Criteria:\n\n1. Individuals aged between 18 and 65 years.\n2. A score on the Lake Louise Acute Mountain Sickness Scale ranging from 3 to 9 points, as outlined in Annex 2, recorded in 2018.\n3. Chest X-ray findings that demonstrate either thickening of the lung texture bilaterally or the presence of nodular opacities in the lower regions of both lungs.\n4. Capacity to provide informed consent in accordance with local regulatory requirements.\n\nExclusion Criteria:\n\n1. Confirmed contraindications for the use of nitric oxide include the following (refer to \"5.3.4 NO Contraindications\"):\n\n   * Severe hypoplasia of the left heart or duct-dependent congenital heart disease;\n   * Life-threatening congenital anomalies and congestive heart failure;\n   * Congenital methemoglobinemia;\n   * Severe hemorrhagic conditions, including intracranial hemorrhage, intraventricular hemorrhage, and pulmonary hemorrhage.\n2. Severe left ventricular dysfunction, characterized by a left ventricular ejection fraction (LVEF) of less than 40%.\n3. Pulmonary edema resulting from other cardiac, pulmonary, thoracic, or systemic disorders.\n4. Coexistence with high altitude cerebral edema.\n5. A history of lung malignancy, lung resection, or lung transplantation.\n6. Barotrauma, which may include pneumothorax, subcutaneous and mediastinal emphysema, or the presence of a closed drainage tube in the thoracic cavity.\n7. Clinically significant or persistent thrombocytopenia, defined as a platelet count of less than 50×10\\^9\u002FL.\n8. Administration of pulmonary hypertension medications, such as sildenafil, bosentan, or prostacyclins, within the preceding 30 days.\n9. Noncompliance with study protocols and unwillingness to provide informed consent.\n10. Any other conditions that the clinician deems render the subject unsuitable for participation in the study.","18 Years","65 Years",{"count":54,"type":21},100,[24],"High Altitude Pulmonary Edema (HAPE) is a critical, non-cardiogenic pulmonary edema that manifests in high-altitude conditions, marked by the rapid onset of symptoms such as dyspnea, cough, frothy sputum, and cyanosis. It represents a significant cause of mortality among high-altitude illnesses due to its swift progression and elevated fatality rates if not addressed promptly. The pathophysiological mechanisms underlying HAPE include excessive hypoxic pulmonary vasoconstriction, increased permeability of the pulmonary vasculature, impaired clearance of fluid from the lungs, and systemic fluid retention. A pivotal factor in HAPE is pulmonary arterial hypertension (PAH), characterized by a progressive rise in pulmonary arterial pressure and resistance, which can ultimately lead to right heart failure. Recent developments in the management of HAPE have introduced inhaled nitric oxide (iNO) as a selective pulmonary vasodilator, which effectively lowers pulmonary arterial pressure and enhances oxygenation without inducing systemic hypotension. The INOwill N300 device, created by Nanjing Novlead Biotech, is a portable iNO delivery system that produces nitric oxide gas on-site, thereby obviating the need for gas cylinders. This device also facilitates real-time monitoring of nitric oxide, nitrogen dioxide, and oxygen concentrations, ensuring safe and effective treatment. This innovative strategy shows potential for improving clinical outcomes in patients with HAPE while addressing logistical challenges encountered in high-altitude environments.",[58],"High Altitude Pulmonary Hypertension",[60,49],"iNO","2025-02-25",{"date":63,"type":34},"2025-02-28",{"date":65,"type":34},"2023-08-10",{"date":67,"type":21},"2025-12-31",{"name":40,"class":41},{"id":70,"slug":71,"hasResults":11,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":4,"eligibilityCriteria":75,"healthyVolunteers":76,"sex":16,"minAge":51,"maxAge":4,"enrollmentInfo":77,"targetDuration":4,"studyType":22,"phases":79,"briefSummary":80,"conditions":81,"keywords":84,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":88,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":94},"100581638","feno-detection-in-asthma-diagnosis-a-new-technology-approach-100581638","NCT06852911","FeNO Detection in Asthma Diagnosis: A New Technology Approach","The Diagnostic Significance of Exhaled Nitric Oxide (FeNO) With a Novel Technology in the Assessment of Bronchial Asthma","Patients:\n\nInclusion Criteria:\n\n1. Participants must be a minimum of 18 years of age, irrespective of gender;\n2. Individuals must possess a diagnosis of bronchial asthma that aligns with the international GINA 2023 diagnostic criteria;\n3. Respiratory symptoms must have been evident for at least 6 weeks;\n4. Participants should either have no history of smoking or have discontinued smoking for a period exceeding 5 years.\n\nExclusion Criteria:\n\n1. The concurrent use of additional asthma medications (such as glucocorticoids) alongside short-acting bronchodilators within the prior 4 weeks;\n2. A diagnosis of respiratory infection within the preceding 4 weeks;\n3. Conditions such as pregnancy, lactation, or menstruation;\n4. Participation in other clinical research studies;\n5. Any underlying medical or psychiatric conditions that, in the investigator's assessment, would render the individual unsuitable for participation in the study.\n\nHealthy:\n\nInclusion Criteria:\n\n1. Participants must be at least 18 years of age, with no restrictions on gender;\n2. Individuals should not have a history of allergic diseases or chronic respiratory conditions, and must not exhibit any significant abnormalities in health assessments conducted within the past year;\n3. There should be no acute illnesses or medication history within the preceding four weeks, and participants must not display any typical symptoms of respiratory infections;\n4. A history of smoking is not permitted, or individuals must have ceased smoking for a minimum of five years.\n\nExclusion Criteria:\n\n1. Individuals who are pregnant, breastfeeding, or currently experiencing menstruation;\n2. Those who have been on long-term medication;\n3. Participants involved in other clinical research studies;\n4. Any potential medical or psychological conditions that the researcher deems may render the subject unsuitable for participation in the study.",true,{"count":78,"type":21},170,[24],"The detection of exhaled nitric oxide (FeNO) represents a non-invasive, safe, and rapid approach for assessing endogenous nitric oxide (NO) levels within the airway. FeNO concentrations are closely associated with airway inflammation and hyperresponsiveness, and are currently recognized as biomarkers indicative of type II airway inflammation. Recent advancements in nitric oxide detection technology for both upper and lower airways, as well as for small and large airways, have provided significant insights for the diagnosis and management of conditions such as bronchial asthma, chronic cough, upper airway diseases, chronic obstructive pulmonary disease, and even rare airway disorders. Presently, FeNO measurement is frequently employed in the differential diagnosis and monitoring of airway inflammatory diseases.\n\nThe FeNO test is conducted using a FeNO test analyzer. Internationally, FeNO detection analyzers utilize three primary methodologies: chemiluminescence, laser, and electrochemical techniques. Among these, chemiluminescence is regarded as the \"gold standard\" globally. However, due to technical constraints, this methodology has not been clinically accessible within domestic settings. In China, the electrochemical FeNO analyzer is predominantly utilized, characterized by its compact size and portability. Nonetheless, this method necessitates patient cooperation during inhalation and exhalation, rendering it impractical for individuals who are unable to comply, such as children, the elderly, and severely ill patients. Consequently, FeNO detection poses significant challenges for these populations in China, representing a notable clinical gap.\n\nThe newly implemented technology employs an innovative domestic chemiluminescence FeNO analyzer, which is exclusively available in China. This analyzer, owing to its methodological advantages, is capable of obtaining FeNO detection values from patients' natural breathing patterns, facilitating rapid response and comprehensive FeNO assessment without requiring patient cooperation. This approach, referred to as the \"Tidal-breathing of FeNO\" enables the completion of FeNO assessments in patients who are unable to engage in inspiratory and expiratory maneuvers. This advancement is anticipated to enhance the diagnostic accuracy of airway inflammation in this demographic, thereby facilitating early diagnosis, precise treatment, and improved management of disease progression.",[82,83],"Bronchial Asthma","Airway Disease",[85,86,87],"FeNO","Bronchial asthma","Tidal breathing",{"date":63,"type":34},{"date":90,"type":34},"2024-09-12",{"date":92,"type":21},"2025-09-01",{"name":40,"class":41},2,{"id":96,"slug":97,"hasResults":11,"nctId":98,"briefTitle":99,"officialTitle":100,"acronym":4,"eligibilityCriteria":101,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":102,"targetDuration":4,"studyType":104,"phases":4,"briefSummary":105,"conditions":106,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":42},"100493287","a-real-world-study-of-nitric-oxide-generator-and-delivery-system-100493287","NCT05703191","A Real-world Study of Nitric Oxide Generator and Delivery System","The Efficacy and Safety of Nitric Oxide Generator and Delivery System in Pulmonary Hypertension of Newborn: A Non-interventional, Observational, Real-world Study","Inclusion Criteria:\n\n1. Clinically considered to benefit from inhaled nitric oxide (iNO) and decided to use Nitric Oxide Generator and Delivery System by clinicians\n2. Admitted to the Department of Neonatology at the hospital, gender unlimited\n3. Diagnosed as pulmonary hypertension and undergoing\u002Fdecided to undergo respiratory support\n4. Documented Oxygenation index (OI) ≥8 prior to the treatment\n5. Signed informed consent by the parent(s) or the legal representative(s) with fully aware of the benefits and risks of this study\n\nExclusion Criteria:\n\n1. Proven risks of nitric oxide contraindication\n2. Undergoing or expected to need a combination of other pulmonary vasodilators, surfactants or extracorporeal membrane oxygenation\n3. Other circumstances that investigators believe unsuitable for enrollment",{"count":103,"type":21},10,"OBSERVATIONAL","The study is aimed to observe the efficacy and safety of Nitric Oxide Generator and Delivery System in Pulmonary Hypertension of Newborn in real clinical settings.",[107],"Pulmonary Hypertension of Newborn","2025-02-14",{"date":110,"type":34},"2025-02-19",{"date":112,"type":34},"2023-02-03",{"date":114,"type":21},"2025-05-31",{"name":40,"class":41},""]