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| Name | Class |
|---|---|
| Novlead Inc. | INDUSTRY |
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There is a lack of effective treatments for chronic obstructive pulmonary disease (COPD) complicated with pulmonary hypertension. Previous studies have found that inhaled nitric oxide (iNO) can reduce pulmonary artery pressure and improve exercise capacity in COPD with pulmonary hypertension patients. However, the specific mechanism is unclear. The study aims to evaluate pulmonary ventilation/perfusion, pulmonary artery pressure, oxygenation, symptoms and quality of life in COPD with pulmonary hypertension patients after short-term treatment with iNO. Observing a series of pathophysiological changes caused by the treatment of pulmonary hypertension with iNO in COPD, the investigators hope to provide new theoretical basis and research ideas.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Inhaled Nitric Oxide (iNO) | Experimental | iNO 20ppm,≥8 hours/day for 3 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nitric Oxide Generation and Delivery System | Device | The Nitric Oxide Generation and Delivery System is used to deliver nitric oxide for inhalation therapy into the inspiratory limb of the patient breathing circuit in a way that provides a constant concentration of nitric oxide (NO), as set by the user, to the patient throughout the inspired breath. |
| Measure | Description | Time Frame |
|---|---|---|
| Ventilation-perfusion ratio | Change in ventilation-perfusion ratio (V/Q) from Baseline after treatment with iNO, measured by pulmonary ventilation/perfusion imaging | Baseline, Minutes 30 |
| Tricuspid regurgitation velocity (TRV) | Change in TRV from Baseline after treatment with iNO, measured by echocardiogram | Baseline, Day 3 |
| Pulmonary arterial systolic pressure (sPAP) | Change in sPAP from Baseline after treatment with iNO, measured by echocardiogram | Baseline, Day 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Percutaneous arterial oxygen saturation (SpO2) | Change in SpO2 from Baseline after treatment with iNO | Baseline, Day 3 |
| Pulmonary function:Forced expiratory volume in 1 second(FEV1) | Change in FEV1 from Baseline after treatment with iNO |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ruoxi He | Contact | +8618874167666 | heruoxi1985@yeah.net | |
| Zhou Fang | Contact | +8615655595707 | zhou.fang@novlead.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| China-Japan Friendship Hospital | Recruiting | Beijing | China |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D006976 | Hypertension, Pulmonary |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| Baseline, Day 3 |
| Pulmonary function: Forced vital capacity (FVC) | Change in FVC from Baseline after treatment with iNO | Baseline, Day 3 |
| Pulmonary function: FEV1/FVC | Change in ratio of FEV1 and FVC (FEV1/FVC) from Baseline after treatment with iNO | Baseline, Day 3 |
| Pulmonary function: Diffusion lung capacity for carbon monoxide(DLCO) | Change in DLCO from Baseline after treatment with iNO | Baseline, Day 3 |
| Cardiopulmonary Exercise Test: Maximal oxygen uptake(VO2max) | Change in VO2max from Baseline after treatment with iNO | Baseline, Day 3 |
| Cardiopulmonary Exercise Test: Anaerobic threshold(AT) | Change in AT from Baseline after treatment with iNO | Baseline, Day 3 |
| Cardiopulmonary Exercise Test: Minute ventilation-to-carbon dioxide output(VE/VCO2) | Change in VE/VCO2 from Baseline after treatment with iNO | Baseline, Day 3 |
| Cardiopulmonary Exercise Test: Physiological dead space ventilation (physiological deadspace volume/tidal volume, Vd/Vt) | Change in Vd/Vt from Baseline after treatment with iNO | Baseline, Day 3 |
| Six-minute walk distance (6MWD) | Change in 6MWD from Baseline after treatment with iNO | Baseline, Day 3 |
| Arterial blood gas: Arterial partial pressure of oxygen (PaO2) | Change in PaO2 from Baseline after treatment with iNO | Baseline, Day 3 |
| Arterial blood gas: Arterial partial pressure of carbon dioxide (PaCO2) | Change in PaCO2 from Baseline after treatment with iNO | Baseline, Day 3 |
| Arterial blood gas: Alveolar-arterial oxygen partial pressure difference (A-aDO2) | Change in A-aDO2 from Baseline after treatment with iNO | Baseline, Day 3 |
| Life quality and symtom severity questionnaires: COPD assessment test (CAT) | Change in CAT scores (0-40 scores, higher scores mean a worse outcome) from Baseline after treatment with iNO | Baseline, Day 3 |
| Life quality and symtom severity questionnaires: Modified Medical Research Council (mMRC) Dyspnea Scale | Change in (mMRC) Dyspnea Scale scores (0-4 scores, higher scores mean a worse outcome) from Baseline after treatment with iNO | Baseline, Day 3 |
| Life quality and symtom severity questionnaires: Saint George Respiratory Questionnaire (SGRQ) | Change in SGRQ scores (0-100 scores, higher scores mean a worse outcome) from Baseline after treatment with iNO | Baseline, Day 3 |
| Adverse events | Incidence of adverse events = Number of subjects with adverse events/Total number of subjects in treatment×100% | Baseline up to Day 3 |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006973 | Hypertension |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |